Food Labelling [1 ed.] 9780849308529, 9781855734968, 0849308526, 1855734966, 9781855736368

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Food labelling

Related titles on food science and technology from Woodhead Publishing: Food intolerance (ISBN: 1 85573 497 4) Taraneh Dean This book is the first to have an industry rather than medical focus and provides food industry professionals with an appreciation of food intolerance together with its diagnosis, symptoms and management. It will be an essential reference for the food industry, covering issues such as the handling of allergenic food in retail and manufacturing as well as applicable legislation. The stability and shelf-life of food (ISBN: 1 85573 500 8) David Kilcast and Persis Subramaniam The stability and shelf-life of foods are major issues for the entire food and drink industry. This book discusses the tools that can be used to measure shelf-life, what determines shelf-life and the ways it can be extended. Functional foods – concept to product (ISBN: 1 85573 503 2) Glenn R. Gibson and Christine M. Williams Bringing together a range of international experts this book first defines and classifies this complex and evolving field. It then summarises the key work on functional foods and the prevention of disease, from coronary heart disease to cancer and gastrointestinal disorders. Finally, there are a series of chapters on the commercial exploitation of the health benefits of these functional ingredients. Details of these books and a complete list of Woodhead’s food science, technology and nutrition titles can be obtained by: • visiting our website at www.woodhead-publishing.com • contacting Customer Services (e-mail: [email protected]; fax: +44 (0)1223 893694; tel: +44 (0)1223 891358 ext. 30; address: Woodhead Publishing Ltd, Abington Hall, Abington, Cambridge CB1 6AH, England)

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Food labelling Edited by

J. Ralph Blanchfield, MBE

Published by Woodhead Publishing Limited Abington Hall, Abington Cambridge CB1 6AH England Published in North and South America by CRC Press LLC 2000 Corporate Blvd, NW Boca Raton FL 33431 USA First published 2000, Woodhead Publishing Limited and CRC Press LLC ß 2000, Woodhead Publishing Limited The authors have asserted their moral rights. Conditions of sale This book contains information obtained from authentic and highly regarded sources. Reprinted material is quoted with permission, and sources are indicated. Reasonable efforts have been made to publish reliable data and information, but the authors and the publishers cannot assume responsibility for the validity of all materials. Neither the authors nor the publishers, nor anyone else associated with this publication, shall be liable for any loss, damage or liability directly or indirectly caused or alleged to be caused by this book. Neither this book nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, microfilming, and recording, or by any information storage or retrieval system, without prior permission in writing from the publishers. The consent of Woodhead Publishing Limited and CRC Press LLC does not extend to copying for general distribution, for promotion, for creating new works, or for resale. Specific permission must be obtained in writing from Woodhead Publishing Limited or CRC Press LLC for such copying. Trademark notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation, without intent to infringe. British Library Cataloguing in Publication Data A catalogue record for this book is available from the British Library. Library of Congress Cataloging-in-Publication Data A catalog record for this book is available from the Library of Congress. Woodhead Publishing Limited ISBN 1 85573 496 6 CRC Press ISBN 0 8493 0852 6 CRC Press order number: WP0852 Cover design by The ColourStudio Project managed by Macfarlane Production Services, Markyate, Hertfordshire Typeset by MHL Typesetting Ltd, Coventry, Warwickshire Printed by TJ International, Padstow, Cornwall, England

Contents

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xi

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xv

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1

Key issues in food labelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D. Jukes, University of Reading Consumer needs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C. Bruhn, Center for Consumer Research, University of California Manufacturers’ needs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . M. Hunt, Food and Drink Federation, London Legislators’ perspectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D. A. Love, formerly MAFF, London An enforcement perspective . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D. Walker, Trading Standards, Shropshire County Council, Shrewsbury

1

Editor’s foreword List of contributors 1 Introduction 1.1 1.2 1.3 1.4 1.5

5 13 19 22

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31

2.1 Key principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2 The organisation of EU legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.3 EU legislation and Codex standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.4 The main requirements for prepacked foods . . . . . . . . . . . . . . . . . . . . . . . . 2.5 Nutrition labelling and claims . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.6 Specific labelling requirements in food composition Directives . . . . . 2.7 Specific labelling requirements in CAP marketing regulations . . . . . . 2.8 Novel foods and genetically modified foods: labelling rules . . . . . . . . 2.9 Future developments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.10 References and sources of further information . . . . . . . . . . . . . . . . . . . . . . Appendix: Comparison of Codex and UK claims criteria . . . . . . . . . . . . . . . . . .

31 32 33 34 37 39 40 41 43 44 45

2 Labelling requirements: European Union D. A. Love, formerly MAFF, London

vi

Contents

3 Labeling requirements: United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . J. Vanderveen (Center for Food Safety and Applied Nutrition, Food and Drug Administration, Washington DC) and E. J. Campbell (AAC Group, Bethesda) 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 3.10 3.11 3.12 3.13 3.14

49

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The legislative and rule-making process . . . . . . . . . . . . . . . . . . . . . . . . . . . . The main enforcement agencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Regulations on product name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ingredients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Responsible agent for product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Net contents labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Nutrition facts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Country of origin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Nutrition content claims . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Health claims . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Details of regulations by competent authorities . . . . . . . . . . . . . . . . . . . . Future trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

49 50 52 52 53 54 54 55 56 56 57 63 63 64

4 Declaration of ingredients and additives: European Union . . . . . . . . . . . . D. W. Flowerdew, Consultant (formerly Leatherhead Food Research Association)

65

4.1 4.2 4.3 4.4 4.5 4.6

Declaring ingredients and additives: the basic principles . . . . . . . . . . . Review of key legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Future trends in labelling requirements for ingredients and additives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Summary of manufacturers’ responsibilities . . . . . . . . . . . . . . . . . . . . . . . . How it can go wrong . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5.4

81

Declaring ingredients and additives: the basic principles . . . . . . . . . . . Review of key legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Manufacturers’ responsibilities for ingredient and additive declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

81 82

6 Durability indication: European Union . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A. Mro¨hs, Bund fu¨r Lebensmittelrecht und Lebensmittelkunde e.V., Bonn 6.1 6.2 6.3 6.4 6.5 6.6

76 76 77 78

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5 Declaration of ingredients and additives: United States R. H. Schmidt, University of Florida 5.1 5.2 5.3

65 66

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The legal situation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Manufacturers’ responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The product on its way to the consumer . . . . . . . . . . . . . . . . . . . . . . . . . . . Varied application in the EU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Special provision for short-life products: introduction . . . . . . . . . . . . . .

85 100 101

101 102 104 104 105 105

Contents 6.7 6.8 6.9 6.10 6.11 6.12 6.13

vii

The legal situation: use-by date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Products with use-by date on their way to the consumer . . . . . . . . . . . Varied interpretations of ‘use-by’ provisions in EU Member States . . Guidelines on how dates should be calculated and presented . . . . . . . Future trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sources of further information and advice . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

105 106 106 106 107 107 109

7 Durability indication: United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . R. A. LaBudde, North Carolina State University and Least Cost Formulations, Ltd

111

7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 7.10 7.11

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conflicting purposes of durability indications . . . . . . . . . . . . . . . . . . . . . . Cost of durability indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Guidelines for durability indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Telltale indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Future trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sources of further information and advice . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

111 111 112 112 114 118 119 119 121 121 122

8 Nutrition information: European Union . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . L. Insall, Food and Drink Federation, London

125

8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8 8.9

Introduction: key issues in presenting nutrition information . . . . . . . . EU nutrition legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Manufacturers’ responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Consumer expectations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Voluntary codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Future trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sources of further information and advice . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Further reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

125 127 132 133 139 142 145 145 146

9 Nutrition information: United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . T. A. Altman, Professional Fluency, Chicago

147

9.1 9.2 9.3 9.4 9.5 9.6 9.7

Key principles of US labeling requirements . . . . . . . . . . . . . . . . . . . . . . . . Making nutrient declarations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Format requirements and exemptions: conventional foods . . . . . . . . . . Dietary supplement labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Compliance management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Future trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Additional information sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

147 150 156 159 162 163 164

viii

Contents .........................

165

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Nutrition and health claims in the EU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Substantiation of health claims . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Nutrition labelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The future . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

165 166 174 175 175 176

11 Nutrition and health claims: United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . M. K. Schmidl and T. P. Labuza, University of Minnesota

179

10 Nutrition and health claims: European Union P. Berry Ottaway, Consultant 10.1 10.2 10.3 10.4 10.5 10.7

11.1 11.2 11.3 11.4 11.5 11.6 11.7 11.8 11.9 11.10 11.11

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Disease-specific claims or disease-prevention claims . . . . . . . . . . . . . . FDA Modernization Act of 1997 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Medical foods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dietary Supplement Health and Education Act of 1994 . . . . . . . . . . . Controversy over labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Advertising and the Federal Trade Commission (FTC) . . . . . . . . . . . The future . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Further reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..........................................

205

Good design in food labelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E. J. Whiteley, Institute of Grocery Distribution, Watford Multi-language requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . J-P. Kern, Mars Incorporated, McLean Food allergen labelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . J. Ralph Blanchfield, Food Science, Food Technology and Food Law Consultant Genetically modified foods and ingredients . . . . . . . . . . . . . . . . . . . . . . . M. J. Sadler, Institute of Grocery Distribution, Watford Irradiated foods and ingredients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . G. W. Gould, Food Science, Food Technology and Food Law Consultant Label problems for blind and visually impaired people . . . . . . . . . . . J. Ralph Blanchfield, Food Science, Food Technology and Food Law Consultant

205

12 Special issues in food labelling 12.1 12.2 12.3

12.4 12.5

12.6

13 Determining shelf-life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C. M. D. Man, South Bank University, London 13.1 13.2 13.3

179 180 185 192 193 194 200 201 202 202 203

What do we mean by ‘shelf-life’? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Introducing the main categories of product . . . . . . . . . . . . . . . . . . . . . . . Principal ways of determining and extending shelf-life . . . . . . . . . . .

211 216

221 225

233

237

237 242 243

Contents 13.4 13.5 13.6

ix

Future trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sources of further information and advice . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

249 250 252

14 Instructions for storage and use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . K. G. Anderson, Consultant and Visiting Professor, University of North London

255

14.1 14.2 14.3 14.4 14.5 14.6 14.7 14.8 14.9 14.10 14.11 14.12 14.13

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Risk categorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clarity of language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date marking (appropriate durability indication) . . . . . . . . . . . . . . . . . . Storage and post-opening storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Freezing, treatment post-freezing and re-freezing . . . . . . . . . . . . . . . . . . Cooking and reheating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Microwaveable foods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Use in recipes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Special circumstances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Future trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sources of further information and advice . . . . . . . . . . . . . . . . . . . . . . . . . Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

255 258 258 259 260 260 261 261 263 263 264 264 265

15 The role of traceability in food labelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C. Morrison, Youngs Bluecrest Seafoods Ltd, Grimsby

267

15.1 15.2 15.3 15.4 15.5 15.6 15.7 15.8 Index

The key objectives of traceability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Legal requirements concerning traceability coding . . . . . . . . . . . . . . . . Wider aspects of traceability coding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A modern computerised production and management control system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Use of care lines on product packaging in traceability . . . . . . . . . . . . . Applying traceability systems when problems arise . . . . . . . . . . . . . . . . Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

267 268 270 271 275 275 276 280

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Editor’s foreword

A food label may literally be a label – a piece (or pieces) of printed paper attached to a food package – or it may comprise all or part of the printed or lithographed exterior surface of the package. In either case, it consists of a finite area to carry what needs to be meaningful (and, therefore, legible and intelligible) information. Different ‘stakeholders’ require the label to do different things. There is thus considerable ‘competition’ for the available space. Through its legislators, the country for which the product is destined determines certain information that the label must include, and in what form. The manufacturer of the product, through his/her marketing managers and creative label designer, wants the label primarily to help sell the product in preference to competing products. This purpose is sometimes pursued with little or no reference to legal requirements, sometimes sailing as close to the wind as possible. At the same time, the manufacturer, advised by his/her technical manager, regulatory affairs manager or consultant, also needs to ensure that the label complies with the law. This may lead to internal competition, not only for space but about what is written and how it is presented, usually – but not always – resulting in a compromise that meets both requirements. Compliance with labelling legislation is by no means a straightforward process. Labelling regulations are themselves in a virtually continuous state of evolution, often changing with a transition period during which the old regulations and the new ones exist simultaneously. Compliance sometimes involves requirements stated in more than one location; for example, general requirements in horizontal legislation, and particular requirements in vertical legislation affecting the class of products. Moreover, compliance very often involves interpretation of how requirements relate to the particular circumstances of the product, For the regulatory agency and the analyst, the label provides an essential part of the data required for checking that compositional and labelling regulations are being met. For both the manufacturer and the regulatory agency, the label provides the indispensable means for traceability of products in the event of need for withdrawal or recall.

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For consumers, the label provides the essential means of informed choice when purchasing: the means of identification of what is in the package, of what it consists, what quantity, how to store it (and for how long) and how to prepare and use it. Consumer organisations look for more, and more easily understood, information on labels. For some consumer activists, no amount of information provided appears to satisfy the Oliver Twist-like call for ‘More’. But what about the mass of consumers for whose benefit the label is primarily intended? If one is to believe the message of many consumer surveys, the majority want detailed label information but few use it, many because they do not fully understand it, particularly nutrition information. Few are said to understand the meaning of percentages – even when expressed as quantity per 100 g; or the significance of kilojoules (kJ); or that the kcals on a label are actually the ‘calories’ that dieters confidently count. Very few relate sodium on a label to the salt about which they hear health messages, or realise that 0.4 g of sodium per 100 ml on an EU food label (say, soup), equals 1 g of salt in 100 ml, which in turn means 2.5 g salt in a good-sized cup of the soup. Beyond nutrition information lies the topic of health claims. This has long been a grey area in respect of labelling of health foods. As knowledge increases about the relationship between diet and health, research and development give rise increasingly to food products designed to provide positive health benefits. Many consumers will wish to know, and many manufacturers will wish to tell them, about the health merits (or supposed merits) of particular food products, sometimes on the basis of evidence far short of what would legally be required in a medicine. At what point does a health claim on a label become a medicinal claim? Indeed, are the marketing-invented terms ‘functional foods’ and ‘nutraceticals’ convenient euphemisms for ‘medicinal foods’? In the absence of adequate labelling measures that are required to satisfy an independent body of experts on the scientific validity of the evidence for efficacy and safety, how is the consumer to be given useful information while being protected from the modern equivalent of the old-time snake oil salesman? Clearly, if consumers are to utilise information on labels, there is a need for a major education effort to enable them to appreciate the significance of what they read there. It is, however, difficult to see how the label can be the education medium. This needs to be provided by other means and through other media. ‘What do they read there?’ This raises several problem areas. In the era of global marketing, and of the internal European market, the same product with the same label may be marketed in several countries and will need to carry information in several languages. Multi-ethnicity in a single country may also necessitate several languages. This, of course, intensifies the competition for the label ‘real estate’ previously noted. Even the keenest-sighted of consumers would have difficulty in reading the extremely small print of some ingredients lists or nutrition information tables, particularly if the print is not on a strongly contrasting background. This problem can be partly alleviated with better label design, but there remains the dilemma that the more information that has to be crowded onto a finite area, the more difficult it will be to read. How much more difficult it is for the partially sighted to ‘read what is there’ and how impossible for the blind. Efforts to find ways of solving the latter problem have resulted in a technically successful solution which so far cannot be put into practice. The last decade has seen new labelling needs. The advent of genetically modified foods and irradiated foods has necessitated the development of new labelling provisions to facilitate informed consumer choice. The belated recognition by legislators and industry that food allergy, though affecting a minority of the population, can be life-

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threatening, and is a major food safety issue, has led to measures in manufacture, and, as regards labelling, to the need for label warnings about the presence, or potential presence, of major food allergens. These are the main issues that are discussed in detail by the specialist authors of the various chapters, in terms not only of present problems and requirements but also of possible future developments. The latter are important because any book on a topic that is the subject of food legislation is to a considerable extent a ‘snapshot in time’; and nowhere is that truer than of food labelling. This book is a unique and valuable compilation on all aspects of the subject and should prove helpful to legislators, regulators, marketeers, label designers, food technologists, consumer organisations and perhaps even individual consumers. J. Ralph Blanchfield

Contributors

Chapter 1

Introduction

Section 1.1 Key issues Dr David Jukes Department of Food Science University of Reading Whiteknights Reading RG6 2AP England Tel: 01189 318700 Fax: 01189 310080 E-mail: [email protected]

6 Catherine Street London WC2B 5JJ England Tel: 020 7836 2460 Fax: 020 7836 0580 E-mail: [email protected] Section 1.4 Legislators’ perspectives Ms Denise Love 50 St Peter’s Street London N1 8JT England

Section 1.2 Consumer needs Professor Christine M. Bruhn Center for Consumer Research University of California One Shields Avenue Davis California 95616 USA

Tel: 020 7359 1049

Tel: (530) 752 2774 Fax: (530) 752 3975 E-mail: [email protected]

Tel: 01743 254101 Fax: 01743 254114

Section 1.3 Manufacturers’ needs Mr Michael Hunt Scientific Regulatory Affairs Division Food and Drink Federation

Section 1.5 An enforcement perspective Mr David Walker Oxton Hall Lodge Holyhead Road Bicton Shrewsbury SY3 8BW

Chapter 2 Labelling requirements: European Union Ms Denise Love 50 St Peter’s Street

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Contributors

London N1 8JT England

Chapter 6 Durability indication: European Union

Tel: 020 7359 1049

Ms Angelika Mro¨hs Bund fu¨r Lebensmittelrecht und Lebensmittelkund e.V. Godesberger Allee 142–8 53175 Bonn Germany

Chapter 3 Labelling requirements: United States Dr John E. Vanderveen Food and Drug Administration Center for Food Safety and Applied Nutrition 200 C Street SW (HFS-300) Washington DC 20204-001 USA Tel: (202) 205 4066 Fax: (202) 205 4422 E-mail: [email protected] Chapter 4 Declaration of ingredients and additives: European Union Ms Dorothy Flowerdew Consultant – Technical Food Laws 8 Broomhurst Court Ridgway Road Dorking RH4 3EY England Tel: 01306 886626 Fax: 01306 886626 E-mail: [email protected] Chapter 5 Declaration of ingredients and additives: United States Dr Ronald H. Schmidt Department of Food Science and Nutrition University of Florida Gainsville Florida 32611-0370 USA Tel: (352) 392 1991 Fax: (352) 392 9467 E-mail: [email protected]

Tel: (49) 228 819930 Fax: (49) 228 375069 E-mail: [email protected] Chapter 7 Durability indication: United States Dr Robert A. LaBudde 824 Timberlake Drive Virginia Beach Virginia 23464-3239 USA Tel: (757) 467 0954 Fax: (757) 467 2947 E-mail: [email protected] Chapter 8 Nutrition information: European Union Ms Lynn Insall Food and Drink Federation 6 Catherine Street London WC2B 5JJ England Tel: 020 7836 2460 Fax: 020 7836 0580 E-mail: [email protected] Chapter 9 Nutrition information: United States Dr Tracy Altman 550 North Kingsbury Street Apt 314 Chicago Illinois 60610-4060 USA Tel: (312) 494 9483 Fax: (312) 494 9583 E-mail: [email protected]

Contributors xvii Chapter 10 Nutrition and health claims: European Union Mr Peter Berry Ottaway Berry Ottaway and Associates Limited 1a Fields Yard Plough Lane Hereford HR4 0EL England Tel: 01432 270886 Fax: 01432 270808 E-mail: [email protected] Chapter 11 Nutrition and health claims: United States Professors Mary K. Schmidl and Theodore P. Labuza Department of Food Science and Nutrition University of Minnesota 1354 Eckles Avenue St Paul Minnesota 55108 USA Tel: (612) 624 9701 Fax: (612) 483 3302 E-mail: [email protected] Chapter 12 labelling

Special issues in food

Section 12.1 Good design in food labelling Ms E. Jane Whiteley IGD Grange Lane Letchmore Heath Watford WD2 8DQ England Tel: 01923 857141 Fax: 01923 852531 E-mail: [email protected] Section 12.2 Multi-language requirements Jean-Paul Kern Mars Incorporated

McLean Virginia USA Tel: + 32 2 647 06 60 Fax: + 32 2 647 11 24 E-mail: [email protected] Section 12.3 Food allergen labelling J. Ralph Blanchfield MBE 17 Arabia Close Chingford London E4 7DU England Tel: 020 8524 1800 Fax: 020 8523 9945 E-mail: [email protected] Section 12.4 Genetically modified foods and ingredients Dr Michelle Sadler IGD Grange Lane Letchmore Heath Watford WD2 8DQ England Tel: 01923 857141 Fax: 01923 852531 E-mail: [email protected] Section 12.5 Irradiated foods and ingredients Professor G.W. Gould 17 Dove Road Bedford MK41 7AA England Tel: 01234 262576 Fax: 01234 222277 Section 12.6 Label problems for blind and visually impaired people J. Ralph Blanchfield MBE 17 Arabia Close Chingford London E4 7DU England

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Contributors

Tel: 020 8524 1800 Fax: 020 8523 9945 E-mail: [email protected] Chapter 13

Determining shelf-life

Mr Dominic Man School of Applied Science South Bank University Southwark Campus 103 Borough Road London SE1 0AA Tel: 020 7815 7900 Fax: 020 7815 7999 E-mail: [email protected] Chapter 14 and use

Instructions for storage

Professor Keith Anderson 341 Reigate Road

Epsom Downs KT17 3LT England Tel: 01737 210086 Fax: 01737 358238 E-mail: [email protected] Chapter 15 The role of traceability in food labelling Mr Cliff Morrison Technical Director UB Frozen and Chilled Foods Limited Ross House Wickham Road Grimsby DN31 3SW England Tel: 01472 365950 Fax: 01472 365170 E-mail: [email protected]

1 Introduction

1.1 Key issues in food labelling D. Jukes, University of Reading The development of issues in food labelling has arisen only recently and is linked to the increasing sale of food in prepackaged form. In most industrialised economies, the food manufacturing industry is highly developed and sophisticated. Food is harvested and passes along a tightly controlled food chain ultimately reaching the consumer. The need for consistent high quality safe food has led the industry to incorporate packaging systems which minimise the handling of the food and hence contribute to the overall safety of the food. The days have largely gone in these industrial countries where food is cut, prepared and wrapped at the request of the purchaser. There has, however, been something of a reaction against the apparent industrialisation of the food supply. Many supermarkets are increasingly adding specialist counters to their stores where customers can request foods such as bacon, ham or cheese. However, this provides only for a small amount of today’s purchases. The majority of food is prepacked and presented to the customer in a labelled container. The focus of the consumers’ choice is therefore on this label. It is the label which has increasingly been subject to detailed demands, analysis, abuse and subsequent control.

1.1.1 Why is food labelling a problem? The label serves many functions and it is the combination of these functions which bring conflict to the issue of food labelling. The two key objectives of the label are: • to provide information for the consumer • to help sell the product.

These two functions may be complementary. For example, in these days of healthy eating when low fat foods appear to be important, the provision of information indicating that a food has a lower fat content than a competitor’s equivalent product, will help sell the

2

Food labelling

food. However, conversely, the competitor’s higher fat product may seek to avoid providing information on its fat content and will try to promote other aspects – a smoother texture or a better flavour, for example. Faced with these different products, the consumer has to take a decision on which to purchase. Whilst marketing requires freedom to promote the particular benefits of a food item, the consumer needs to be able to take decisions based on comparable information. However, consumers’ reasons for choosing one food over another will relate to their own perceptions and needs. Some consumers will be looking for information about nutrition, others to convenience in preparation, whilst others may have safety concerns over additives. In addition to the provision of appropriate marketing information, the label has another very important function to serve. With a rise in the number of food poisoning outbreaks, information on the safe handling and cooking of foods is important. The label must provide details on the correct storage conditions, shelf-life and cooking instructions, and these should be clearly displayed for the consumer to use. More specifically, with some consumers suffering from allergic reactions to certain food ingredients, specific label warnings as well as the list of ingredients can also be important for their health. Recently, however, the issue of the role of the food label has been dominated by the consumers’ demand for information on certain ingredients which, according to current scientific evidence, present health hazard. The issue appears to have become a major topic of political interest in Europe and is spilling over into international trade issues which could ultimately cause serious problems for the global market. The issue of the consumer’s right to information on a food product is presenting the greatest challenge to the food industry. The concerns arose in the early 1980s with the appearance of ‘E’ numbers on food labels in Europe. The consumer perception at that time, fuelled by media speculation over apparent safety concerns and links to hyperactivity in children, prompted a reaction by manufacturers and the development of ‘additive-free’ products. Now, at the end of the 1990s, the focus has turned to genetically modified (GM) foods. The import into Europe of GM maize and soya in the autumn of 1998 led to the development of EU-wide labelling controls which require that, where these are used as ingredients, the words ‘genetically modified’ should be included in the list of ingredients. The consumers’ response, fuelled by continuing debate in the media about both the safety and the environmental effects of genetically modified crops, has been to demand the provision of foods which do not contain GM ingredients. The provision of accurate information regarding the source of ingredient adds to the cost of supplying the food. Manufacturers are required to develop sophisticated techniques for ensuring that supplies are accurately labelled. Since a failure to label with the words ‘genetically modified’ indicates that the ingredient used is not genetically modified, manufacturers have been cautious and used this wording simply to save the expensive analytical costs of ensuring that the product is GM free. However, given the public response, manufacturers are increasingly making a commitment to selling only foods that are GM-free. The acceptance by the legislators in Europe that consumers have a right to be told about ingredients in foods, and the subsequent adoption of legislation, has caused manufacturers to respond. In the case of food additives, the response was to reduce or eliminate those additives where the consumer perception of a safety hazard was greatest. In the case of GM ingredients, the response has been similar, with many UK retailers and manufacturers giving a commitment to provide, where possible, GM-free foods.

Introduction

3

What is at issue here is not the scientific evidence of safety but the consumer perception of safety. Within Europe, there has been a perception that neither the safety issue nor the environmental protection issue has been adequately addressed by the legislators. The situation can be contrasted with that in North America. In the USA the legislators have maintained the confidence of the consumer; the use of GM ingredients in food is not a consumer issue. The products have been cleared as safe and consumers have not demanded specific labelling controls. The ingredients are therefore being widely used. Similarly, in the USA, the authorities have approved the use of certain growthpromoting hormones in cattle. The safety of the substances has been evaluated and they have been approved. No specific labelling was considered necessary. In Europe, however, consumer concerns (and possible economic pressures) led to a ban on the use of the hormones and the import of beef containing them. The resulting trade dispute has taken several years to progress through the World Trade Organisation’s dispute procedures and at the time of writing has yet to be resolved successfully. One possible way of resolving the issue would be for Europe to allow the imports but to require that the beef be labelled as coming from hormone treated cattle. The current view of the US authorities is that this is unacceptable since it would maintain a barrier to trade. They believe, probably correctly, that consumers would respond by refusing to buy the beef (or products derived from it) since reference to the hormones on a label would prompt safety concerns among consumers. What these arguments demonstrate is that there is no absolute standard against which food labelling controls are judged. Different societies and different cultures have different perceptions of what is appropriate to incorporate on a food label. The demands of the consumer or, more often, consumer activists are varied and complex. The manufacturer has to meet the requirements of the legislator, the consumer and their own marketing strategy. Meeting them is not easy.

1.1.2 Who is involved in food labelling? The above discussion has highlighted the major players in a complex network which will lead ultimately to the creation of a food label. The label provides the method by which a manufacturer communicates directly to a consumer – initially at the point of sale but also later when the product is consumed in the home. The process has to be controlled so as to ensure fair competition among the competing manufacturers and to ensure that agreed minimum information is provided. The legislator is therefore involved in the process of establishing the rules for the label. However, since no legislation can be effective without appropriate enforcement action, the content of any food label will be subject to inspection and verification by enforcement officers supported by appropriate laboratory analytical methodology. Consumers Although the consumer is often regarded as a single entity, the term covers us all. As such, it is in practice impossible to define a specific ‘consumer’ need since, as individuals, we have different needs and concerns. The majority of consumers never actually demand anything from their label. They will have an expectation that the food label provides sufficient information for them to choose a product. What that expectation is will depend partly on their experiences of food labels over the years. There is now, for example, an expectation within the UK that food labels will provide certain nutrition

4

Food labelling

information. That expectation is relatively new since nutrition information on food labels became common practice only in the last twenty years. Although there may be an expectation of certain information, this does not mean that the majority of consumers will actually use the information that is provided. Evidence suggests that only a limited number of people actually make regular use of the nutrition information which is provided. The other influence on the consumer’s expectation comes from present-day influences. These can range from newspapers, television and radio to advertising pressures and the demands of consumer activists. The media have a powerful influence on the consumer and play a key role in presenting the issues. The media, however, do not always have the space or time (or inclination) to present the complex issues in a balanced manner. The interaction between the media and the consumer is complex but does manifest itself in the purchasing behaviour of the consumer. Manufacturers and retailers As described above, the manufacturer is ultimately responsible for the design and content of a food label. In this, he is often supported or controlled by the retailer who, by selling own-label products, has increasingly been taking responsibility for the food label. In this context their needs are the same although their final decisions about the appearance of the label may well be different, governed largely by different marketing strategies. The manufacturer (or retailer) has the objective of trying to sell as much of their product as possible, usually in competition with a rival product. The label, supported by advertising, is primarily designed to encourage the consumer to pick up the product and to ensure a purchase is completed. Whether a second subsequent purchase is made will largely depend upon whether the product meets the consumer’s expectations derived from the label and related advertising. The label must therefore not inflate the consumer’s expectations inappropriately and care must be taken by the manufacturer in this. Legislators The legislator has to provide for the needs of society. Food legislation represents the minimum standard laid down by the government to ensure that the needs of the population for safe food, information and protection from unfair trade practices are met. As discussed above under the consumer, there is a difficulty in defining precisely what consumers’ needs are. The legislator has to balance the often detailed demands expressed by the consumer activist against the needs of the manufacturer to have controls that are fair and are actually achievable without increasing the costs disproportionately. A national legislator also has to balance what might be the perceived needs of their own society for detailed information on a food label, with the requirements of international agreements. As already discussed, failure to take international trade rules into account can result in claims of unfair barriers to trade. The resulting dispute may adversely affect the country to the detriment of the society which the legislator was trying to protect. Enforcers The fourth major category of players is the enforcer. Responsibility for ensuring compliance with the rules is usually in the hands of trained individuals who carry out surveillance and who respond to specific requests from consumers. Increasingly complex legislative requirements make enforcement action difficult. No enforcement officer wishes to pursue a weak case which will ultimately fail to satisfy the courts. Failure to

Introduction

5

specify clear requirements in the legislation means that the enforcer is unlikely to be confident in bringing a prosecution. In this respect, the enforcer has similar needs to those of the manufacturer and requires clear labelling rules. However, in representing consumers’ interests, they may also at times need to take difficult cases so as to clarify the meaning and limits of a particular legal control.

1.2 Consumer needs C.M. Bruhn, University of California Consumers want to make an informed decision regarding food quality and health. Some also want to make choices that support a lifestyle or food production philosophy. Information which will enable the consumer to select a safe and nutritious diet constitutes basic consumer needs. This includes identity and contact information for the food manufacturer, product composition, nutritional value and freshness for a perishable product. Since this information is unique to a food item it should be contained on the label. Other information, such as processing or production methods, do not compromise food safety based upon a scientific evaluation, and could be considered peripheral to basic needs. Some consumers, however, perceive a safety difference leading to a debate as to the need for mandatory labeling for food processed by irradiation or produced using techniques of recombinant DNA technology. Guidelines and information for safe handling, preparation and use are helpful and convenient, but can be obtained through other sources. These represent consumer wants rather than basic needs; however, it is mandated in some countries. Consumer appeal is increased when label information extends beyond basic needs and responds to consumer lifestyle and philosophy.

1.2.1 Food composition Listing food ingredients and net weight or volume is basic to any purchase. Ingredients and their relative quantity provide an indication of quality and an expectation of taste. Listing ingredients in order by weight is a standard practice consumers recognize.1

1.2.2 Health Although taste is the driving force for food selection, people recognize that food choice affects health.2 Women’s and health magazines regularly feature nutrition and health information. Television news and feature programs include health segments which address nutrition and food safety. Surveys indicate consumers want and will use nutritional information.3,4 Label information can change consumers’ understanding of food quality attributes and their purchase decisions.5 Nutrients Information on calorie and fat content followed by sugar and fat are of key consumer interest.2,6–9 Information on protein, vitamins, minerals, and fiber content is also appropriate. People prefer labels which list content per serving using household measures. EU legislation requires label declaration of nutrient value content per 100g, but consumers are interested in per serving information and guideline figures on energy, fat and salt daily intakes for men and women; and manufacturers are increasingly providing such information voluntarily, pending the EU review of the labeling information.7 As

6

Food labelling

increased information becomes available about the health impact of specific nutrients or food components, labels should indicate the component quantity and health effect. Nutrients of current interest include specific types of fiber, antioxidants and probiotic cultures. Consumers may also find label information about the health impact of specific nutrients helpful. To the extent permitted in national legislation, health-related statements which indicate these interactions, such as the relationship between high calcium diets and the risk of osteoporosis or high fiber and low fat diets and the risk for certain cancers remind the consumer about the benefits of specific components which are high in the labeled food. Food allergies or sensitivities A food allergy (hypersensitivity) is defined as an abnormal reaction resulting from heightened immunologic responses to glycoprotein components in food.10 (See Chapter 12.3.) In US national surveys, between 25% and 30% of adults respond that they have food allergies.11,12 Data on the actual prevalence of food hypersensitivity reactions is limited; however, there is general consensus that between 1% and 2% of adults and 5% of children under 4 years of age have food allergies.13,14 The prevalence of food additive intolerance appears to be lower, estimated at 0.0% to 0.23% among adults.15 Allergic sensitivities to specific foods vary from one country to another depending on the frequency with which the food is eaten and the typical age at which it is introduced into the diet. Most common allergenic foods include legumes, especially peanuts and soybeans, crustacea, cow’s and goat’s milk, eggs from all avian species, tree nuts, fish, molluscs and wheat.16 Although these foods account for over 90% of the serious allergic reactions to foods, allergies to certain fresh fruits and vegetables are also reported.17 Persons allergic to a specific food can avoid the food when it is in a pure form, but may consume the food accidentally when it is an intentional or unintentional ingredient. Death has resulted when an allergic component has been unknowingly consumed.18 See Chapter 12.3.5 for suggested label warning statements. Food additives Although safety is a basic requirement, consumers may interpret safety differently from each other, the food industry and regulatory agencies. Food additives are evaluated for safety before use. Some consumers are either not aware of this requirement or skeptical regarding the adequacy of testing. Some prefer to avoid additives because of safety concerns or a philosophic preference for natural ingredients. Concern is directed toward synthetic rather than naturally occurring additives. Inhome interviews found that concern about additives was related to a general fear of chemicals and diseases.19 Consumers believe chemicals present hidden and unknown dangers which people are powerless to predict.20,21 Chemicals are thought to cause cancer. Since artificial ingredients are chemicals, consumers are concerned that artificial ingredients may cause cancer. Concern about food allergies also triggers concern about additives. In the early 1980s 26% of US consumers said they feared an allergic reaction to artificial ingredients and 22% avoided particular foods fearing the food may contain an allergen.19 Similarly in Australia, the main reason given for looking for food additives was allergies.21 The European and Australian food additive labeling systems are based upon numerical codes.21 Interviews with over 500 consumers found only 39% were able correctly to identify a food additive. Almost half of the respondents in the sample who used food

Introduction

7

additive labeling found it confusing or difficult to understand. Consumers thought that manufacturers were trying to disguise the additives by giving them numbers rather than names. Similarly, many consumers in Norway thought that high E-numbers were more detrimental to health than the lower ones, and they tried to avoid all additives over a certain number.6 When given a choice between labels in which additives were identified by chemical name or number, more chose those with chemical names (39%) compared to E-numbers (23%). When asked what improvements they would make, consumers suggest that labels should carry more information.21 People also request information on the function of individual additives and the side effects related to human consumption. EU legislation requires any additive to be declared in the ingredient list by name or number, followed by one of a number of mandatory designations indicating the purpose and function it fulfills.

1.2.3 Processing or production methods Today consumers are interested in food production and processing methods. Attitudes span the continuum with some preferring traditional approaches while others are anxious to try food produced or processed by the latest technologies. Labeling enables the consumer to identify and select products produced under an approach consistent with their values. Environmentally oriented practices Consumer interest in organic production has increased. Exact requirements for organic production vary. Consumer surveys in the United States indicate people misunderstand organic production requirements. Although organic leaders specify the term is not a pesticide free claim, many consumers believe organic products are produced without pesticide use.22,23 Some also erroneously believe organic products are more nutritious than products produced conventionally. Labeling which specifies organic requirements would clarify choices. Production following integrated pest management guidelines is becoming more widespread. This approach uses soil and plant management practices, beneficial insects, and resistant plants to produce in an ecologically sensitive manner. Insecticides or herbicides can be used under this system, but the decision is based upon an evaluation of effectiveness, safety, worker and environmental impact rather than the natural versus synthetic approach common in organic production. Consumers have indicated interest in the integrated pest management approach and some growers are experimenting with label use.24 Labeling that a package is recyclable or made from recycled material reflects public interest in environmental issues and would be well received.25–27 Other indicators of environmental consciousness appear today and may become more widespread. For example, farmers that produce agricultural crops in a manner that conserves the quality of fishing streams in the Pacific northwest may chose to use a ‘Salmon Safe’ label. New technology: genetic modification of food using recombinant DNA techniques (rDNA) Although any new variety of plant and each new animal is a ‘genetic modification’, special attention today is focused on modifications which recombine specific areas of the

8

Food labelling

genetic code to produce new varieties with selected traits. When applied to food, rDNA technology can improve food taste, quality, safety and nutritional value. It can also introduce traits that enable more environmentally sensitive production through less pesticide use or use of target specific pesticides that break down rapidly. Consumer attitudes toward labeling of rDNA modified products differ. The US Food and Drug Administration (FDA) policy of labeling has focused on the safety of the product, rather than the method of production. This policy calls for a review of any food with nutritional changes, potential allergens, or the addition of pesticides or herbicides. Consumers in the United States appear to support this approach. When the FDA policy was described, 78% expressed support both in 1997 and 1999.28 When presented with the option of labeling all products modified by this means, 58% continue to support the FDA targeted labeling policy. The desire for labeling among consumers in other countries appears to be stronger than in the United States, however, direct comparison is not possible since consumers are asked different questions. When Canadian consumers were simply asked if products modified by biotechnology (rDNA) should be labeled, 83% responded affirmatively.29 The European Union has chosen to focus on method of production. All food products containing ‘genetically modified organisms’ (GMOs) must be labeled.30 At this time, a substantial majority of persons in the EU appear to want modified products excluded from retail sales. (See Section 12.4.) In Australia, Japan and the US, consumer interest in purchasing products modified by rDNA technology varies, depending on the application. More consumers indicated that they are very or somewhat likely to buy products modified for environmental reasons, such as use of less pesticides, than flavor reasons.28,31,32 Conveying the reason for application is useful consumer information which may increase likelihood of purchase. New technology: food irradiation Irradiation is the exposure of food to a source of radiation energy: gamma rays, electrons and X-rays. This energy inactivates parasites and destroys pathogens in food including Escherichia coli O157:H7, Salmonella, Campylobacter and Trichinella spiralis. Irradiation can also destroy insects and it extends the shelf-life of fresh fruit and vegetables.33 In 1958, the United States Congress defined the process of food irradiation as a food additive. Consequently, the United States Food and Drug Administration must approve any food application of irradiation, and irradiated foods must be labeled with the international symbol for radiation and the words, ‘treated by radiation’ or ‘treated with irradiation.’ Irradiated foods are approved by the appropriate regulatory authority in over 40 countries and more than 26 countries currently irradiate commercial quantities of food. Generally, irradiated products sold to the consumer must be labeled. Regulatory and health authorities indicate there is no health or food safety reason for consumers to be warned about irradiated foods. Labeling is intended to be informational.34 When meat, poultry, or seafood are irradiated, labeling can alert consumers to products processed for added safety. This information is considered useful by consumers and can lead to increased interest in purchase.35 As with other technologies, consumers express an interest in knowing why irradiation is used and what benefits they should expect. (See Section 12.5 for additional information on labeling.)

Introduction

9

1.2.4 Freshness and freshness dating Because of its influence on quality, value, and shelf-life, consumers want to know if food is fresh or previously frozen. People value freshness dating but can be confused unless the dating scheme is clearly explained.36,37 Labeling in the United States, for example, does not always distinguish between sell-by and use-by dates, nor does it always indicate if the date refers to quality or safety parameters. The EU abolished sell-by dates some years ago. All EU countries mandate ‘best-before’ or ‘use-by’ dates which includes the conditions under which the product should be stored. Time/temperature indicator tags are another method to indicate the temperature history of food and the remaining shelf-life. A US study on consumer attitudes toward consumer readable time/temperature tags was positive with over 90% indicating tags were a good accompaniment to freshness dating.38 (See Chapters 6 and 7 for a discussion of durability indicators in the EU and US, respectively.)

1.2.5 Handling and storage information Many consumers believe they know how to handle food safely, but consumer information is not always correct, and mishandling occurs.37,39–44 Consumers need to know how to store packaged foods before and after opening, how to prevent cross-contamination during preparation, how to cook for optimal safety, and how to store leftovers after preparation. The label is a logical place to provide information on safe food handling. Information on proper storage is essential for expiry dates to have validity and is needed particularly both for new consumers unfamiliar with standard products and for new products. Confusion can exist when a minimally processed product is mistaken for a shelf stable traditional product. A US National Advisory Committee on Microbiological Criteria for Foods recommended that a uniform format be developed for perishable refrigerated items.45 This should include a standard logo and the words, ‘Important Must be Kept Refrigerated’. Also a uniform labeling for ‘Keep Frozen’ should be added to packaged foods designed to be frozen. Preserved packaged foods that will spoil after opening if exposed to room temperature should have a uniform statement that the product must be refrigerated after opening. This mandatory labeling should be on a principal display panel, with a standardized logo and color with standardized type-size requirements. Other statements regarding temperature storage not related to food safety should use a different logo and working. ‘Use by’ dates were also recommended. Label information on proper handling to prevent cross-contamination between raw and cooked foods and ensure adequate cooking and safe holding temperature lead to an increased percentage of consumers following recommended handling practices.46 In focus groups, consumers indicate they prefer labels with icons, short messages, and ‘why it is important’ messages.47 Information should distinguish between care recommendations based on quality considerations and those required to prevent food-borne illness.37 All raw meat and poultry packages in the United States must contain safe handling instructions. The label uses words and a logo to advise consumers to refrigerate the product, wash hands, cook thoroughly, and refrigerate leftovers promptly. National surveys conducted after the labeling was enacted indicate consumers changed behavior. In 1995, one year after labeling was initiated, 37% of people reported seeing the labels, with 80% recalling a safety message and 41% indicating they changed their food preparation practices. Those that most often prepared foods at home had the best recall of information.48 In 1996, those reporting awareness of safe-handling labels increased to

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59%; among those aware, 41% indicated they washed counters and cooking areas more frequently and 19% washed hands more frequently.25

1.2.6 Preparation and use information Labels should include warnings about special risks to select populations. Generally, consumers are not advised about potential risks for immune compromised persons or those at increased risk for food-borne illness. As a result of legal action initiated by a consumer group, raw milk sold in California must contain a warning statement, but many areas do not require warning labels for products that are not pasteurized. Juice blends and other foods which contain honey and may be given to infants should include a warning about the risk of infant botulism. Many consumers appreciate recipes and ideas for product use. When asked to rate the importance of packaging information, only 15% considered recipes extremely or very important.27 Nevertheless, 40% of people surveyed indicate that recipes are one of the factors that will increase product use.23 Recipes on labels provide a convenient guide for preparation, especially for people with limited cooking skills.

1.2.7 Geographic origin Consumers associate quality and value with foods produced or processed at specific geographic locations. Consumers have expressed interest in purchasing locally grown products, believing them to be higher quality or fresher. Some also wish to support local farmers or businesses. However, ‘local’ is not always easy to define and consumers are frequently not aware of what is produced locally.49–52 Use of locally grown descriptors would avoid consumer confusion by specifying precisely where products are produced. In a broader sense, identifying a food product by a country or region conveys the area’s reputation for value and quality. United States consumer perception of quality differs for food produced in California, Florida, or Hawaii compared to Mexico or Asia.53 Association with a geographic place name should meet specific criteria.53 Consumers believe the major ingredient should have been produced at the specified location or the product should have been manufactured at the location. Consumers do not consider repackaging at the geographic location to be an appropriate use of the location name. When seafood is caught in international waters and brought back to the home port of the catching vessel, consumers consider use of the geographic location appropriate. When these requirements are not followed, consumers believe they have been misled and they consider the label deceptive.53

1.2.8 Seals and endorsements The quality of a product can be conveyed by the use of seals. Several approaches have been used successfully to convey quality. The United States dairy industry has adopted the ‘real’ seal to indicate that a product contains real as opposed to imitation cheese. A frozen entree is given the appearance of quality by including a blue ribbon and photo of the chef who created the recipe. The credibility of a health statement regarding benefits which could result from consuming a specific food or nutrient can be enhanced by an endorsement by a recognized health expert or professional association. Consumers place the greatest credibility in knowledgeable experts who communicate effectively, have the public’s best interest in mind, appear truthful and have a good record of reliability.54

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1.2.9 Challenges of communicating to children With dual household employment, an increasing percentage of children shop for the family a well as for themselves. Many prepare their own snacks and some also prepare family meals. These novice cooks can follow guidelines more easily if they are clearly presented. Preparation steps should be listed in a bullet rather than paragraph format. Pictures should be used when possible. Precautions for safe handling should be provided. In addition to safeguards previously mentioned, novice cooks should be advised how to avoid burns from steam or hot containers.

1.2.10 Challenges of communicating to those with limited literacy Surveys have indicated that labels may be too technical and advanced for easy use by some consumers.6 Some people read or use labels to a very limited extent. Others focus only on a relatively small part of the information on labels. A study in Canada of reading skills indicated reading skills of 16% of adults are too limited to allow them to read material from everyday life.55 An additional 22% can read materials and carry out simple reading tasks if material is clearly laid out. A US study at two public hospitals found that a high proportion of indigent and ethnic minority patients were unable to perform basic reading tasks necessary to understand medical instructions.56 Increased use of pictographs on product labels will help those with limited reading skills. This approach will also be beneficial to those whose native language is not that used on the label. (See Section 12.1 for a discussion of good label design.)

1.2.11 Challenge of communicating to those with vision impairment The proportion of people in the older age group is increasing in developed countries. For example, in 1996, 26% of the US population was 50 years old or older.57 By the year 2050, 36% will be over 50, with 18 million people over 85 years of age. The needs of the older generation will play an increased role in the marketplace. As people age, the ability to see small print clearly is lost. To the extent possible, labels should be designed for easy reading by those who are visually impaired. (See also Sections 12.1 and 12.6.)

1.2.12 Summary and future projections Labels which meet consumer needs should provide clearly information about product content, health impact, style of production and safe handling. Large easily read print, simple words, pictures and icons communicate to the broadest audience. Consumer interest in indicators of flavor, quality, health impact, and method of production will likely increase. Extensive media coverage of health issues will likely result in increased interest in foods with health promoting properties. Health promoting components virtually unknown today may be so sought after tomorrow that they are identified by name. Openness and clarity of communication are the hallmarks of effective communication. Label statements which indicate what, how and why ingredients and processes are used will go far in meeting consumer needs. Information on safe use and storage to produce a variety of flavorful dishes will provide additional consumer benefit.

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1.2.13

References

1. Hodgson A, Bruhn C, ‘Consumer attitudes toward the use of geographical product descriptors as a marketing technique for locally grown or manufactured foods,’ Journal of Food Quality, 1993 16 (3) 163– 174. 2. Abt Associates Inc, Trends in the United States, consumer attitudes and the supermarket. Trends, Food Marketing Institute, 1997 88. 3. Bender MM, Derby BM, ‘Prevalence of reading nutritional information and ingredient information on food labels among adult Americans: 1982–1988,’ Journal of Nutrition Education, 1992 24 (6) 292–297. 4. Jacoby J, Chestnut RW, Silberman W, ‘Consumer use and comprehension of nutritional information,’ Journal of Consumer Affairs, 1977 4 (2) 119–128. 5. Caswell J, Mojduszk E, ‘Using informational labeling to influence the market for quality in food products,’ American Journal of Agricultural Economics, 1996 78 1248–1253. 6. Wandel M, ‘Food labeling from a consumer perspective,’ British Food Journal, 1997 99 (6) 212–219. 7. Institute of Grocery Distribution, Voluntary nutrition labelling guidelines to benefit the consumer. Institute of Grocery Distribution. United Kingdom, 1997. 8. Tordjman A, Trends in Europe. Trends, Food Marketing Institute, 1995 96. 9. Rodolfo MN, Fr., Lipinski D, Savur N, ‘Consumers’ use of nutritional labels while food shopping and at home,’ Journal of Consumer Affairs, 1998 32 (1) 106–120. 10. Metcalfe DD. Food allergy in adults. In: Metcalfe DD, Sampson HA, Simon RA, eds. Food Allergy: Adverse Reactions To Food And Food Additives. Cambridge, Massachusetts, Blackwell Science, 1997 183–191. 11. Sloan A, ‘A perspective on popular perception of adverse reactions to foods,’ Journal of Allergy and Clin Immunol, 1986 78 127–132. 12. Taylor S, Hefle S, Munoz-Furlong A, ‘Food allergies and avoidance diets,’ Nutrition Today, 1999 34 (1) 15–22. 13. Jansen J, Kardiaal A, Huijbers G, ‘Prevalence of food allergy and intolerance in the adult Dutch population,’ Journal of Allergy and Clin Immunol, 1994 93 446. 14. Sampson HA. Immediate reactions to foods in infants and children. In: Metcalfe DD, Sampson HS, Simon RS, eds. Food Allergy: Adverse Reactions To Foods And Food Additives. Cambridge, Massachusetts, Blackwell Science, 1997. 15. Young E, Patel S, Stoneham M, Rona R, Wilkinson J, ‘The prevalence of reaction to food additives in a survey population,’ J Royal College of Physicians of London, 1987 21 241. 16. Taylor S, ‘Chemistry and detection of food allergens,’ Food Technology, 1992 46 148–151. 17. Helfe S, Nordlee J, Taylor S, ‘Allergenic foods,’ Critical Reviews in Food Science and Nutrition, 1996. 18. Steinman H, ‘Hidden allergens in foods,’ Journal of Allergy and Clin Immunol, 1996 98 (2) 241–250. 19. Sloan A, Powers M, Hom B, ‘Consumer attitudes toward additives,’ Cereal Foods World, 1986 31 (8) 523–532. 20. McNutt K, Powers M, Sloan A, ‘Food colors, flavors, and safety: a consumer viewpoint,’ Food Technology, 1986 40 (1) 72–78. 21. Crowe M, Harris S, Maggiore P, Binns C, ‘Consumer understanding of food-additive labels,’ Australian Journal of Nutrition and Dietetics, 1992 49 19–22. 22. Jolly D, Schutz H, Diaz-Knauf D, Johal J, ‘Organic foods: consumer attitudes and use,’ Food Technology, 1989 43 (11) 60–66. 23. The Packer, Profile of the Fresh Produce Consumer. Vance. Lincolnshire, IL, 1996. 24. Bruhn C, Peterson S, Phillips P, Sakovidh N, ‘Consumer response to information on integrated pest management,’ Journal of Food Safety, 1992 12 315–326. 25. Abt Associates Inc, Trends in the United States, consumer attitudes and the supermarket. Trends, Food Marketing Institute, 1996 88. 26. Abt Associates Inc, Trends in the United States, consumer attitudes and the supermarket. Trends, Food Marketing Institute, 1998 88. 27. The Packer, A profile of the fresh produce consumer. Vance. Lincolnshire, IL, 1999. 28. Council IFI, New survey finds Americans as positive as ever on food biotechnology. International Food Information Council. Washington DC, 1999. 29. Optima Consultants, Study findings, Understanding the consumer interest in the new biotechnology industry. Ottawa, 1994. 30. Lewis S, ‘Europe to require labeling of genetically modified soybeans and maize beginning November 1,’ Food Chemical News, 1997 11 5–7. 31. Hoban T, ‘Consumer acceptance of biotechnology: an international perspective,’ Nature Biotechnology, 1997 15 232–234. 32. Hoban T, ‘How Japanese consumers view biotechnology,’ Food Technology, 1996 50 85–88. 33. Diehl J, ‘Safety of irradiated foods,’ Marcel Dekker, Inc., 1995. 34. Robson C, Payne M, ‘Consumer Food,’ Nutrition and Food Science, 1988 January/February 22–23. 35. American Meat Institute, New consumer research good news for irradiated foods. Washington, DC, American Meat Institute, 1998.

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36. Ministry of Agriculture, Fisheries and Food, Food Advisory Committee report on its review of food labelling and advertising 1990. London, England, 1991. 37. Woodburn M, Raab C, ‘Product care directions on food labels: Status and Needs,’ Food Technology, 1993 47 (2) 97–99. 38. Sherlock M, Labuza T, ‘Consumer perceptions of consumer type time-temperature indicators for use on refrigerated dairy foods,’ Dairy, Food and Environmental Sanitarians, 1992 75 (12) 559–565. 39. Brewer S, Hentges D, ‘Food safety in your home,’ Illinois Research, 1993 Fall 17–20. 40. Bruhn C, Schutz H, ‘Consumer food safety knowledge and practices,’ Journal of Food Safety, 1999 19 73– 87. 41. Daniels R, ‘Home food safety,’ Food Technology, 1998 52 54–56. 42. Knabel S, ‘Foodborne illness; role of home food handling practices, scientific status summary,’ Food Technology, 1995 49 (4) 119–131. 43. Agriculture Canada, National Safe Food Handling Study. Agriculture Canada. Toronto, 1990. 44. Williamson D, Gravani R, Lawless H, ‘Correlating food safety knowledge with home food-preparation practices,’ Food Technology, 1992 46 (5) 94–100. 45. Rhodes M, ‘Educating professionals and consumers about extended-shelf-life refrigerated foods,’ Food Technology, 1991 45 162–164. 46. Woodburn M, Van De Rite S, ‘Safe food: care labeling for perishable foods,’ Home Economics Research Journal, 1985 14 (10) 3–10. 47. Teague J, Anderson D, ‘Consumer preferences for safe handling labels on meat and poultry,’ Journal of Consumer Affairs, 1995 29 (1) 108–127. 48. Altekruse S, ‘Effectiveness of consumer labels for the safety of foods of animal origin,’ Public Veterinary Medicine, 1996 209 (12) 2056. 49. Bacon J, Ulrich C, Shippy R, Consumer food shopping study, Newark, DE, Produce Marketing Association, 1988. 50. Bruhn C, ‘Consumer attitude toward locally grown produce,’ California Agriculture, 1992 46 (4) 13. 51. Connell C, Beierlein J, Vroomen H, Consumer preferences and attitudes regarding fruit and vegetables purchased from direct market outlets. Agricultural Experiment Station. University Park, PA, Pennsylvania State University, 1986. 52. Lockeretz W, ‘Urban consumer’s attitudes toward locally grown produce,’ American Journal of Alternative Agriculture, 1986 1 (2) 83–88. 53. Hodgson A, Bruhn C, ‘Geographical names on product labels – consumer attitudes toward their use,’ Food Technology, 1992 46 (2) 83–86. 54. Frewer L, Howard C, Hedderley D, Shepherd R, ‘What determines trust in information about food-related risks? Underlying psychological constructs,’ Risk Analysis, 1996 16 (4) 473–485. 55. Canada S, Adult literacy in Canada: Results of a national study. Industry, Science and Technology. Ottawa, Canada, 1991. 56. Williams N, Parker R, Baker D, et al., ‘Inadequate functional health literacy among patients at two public hospitals,’ Journal of the American Medical Association, 1995 274 (21) 1677–1682. 57. Food Institute, ‘Population Trends 1996–2050,’ Fair Lawn, NJ, 1996 31.

1.3 Manufacturers’ needs M. Hunt, Food and Drink Federation, London 1.3.1 Getting the right balance Food manufacturing and labelling are heavily regulated activities, perhaps not surprisingly given their centrality to daily life and their important public health implications. Decisions on food labelling are potentially complex due not only to the legal requirements themselves but also the interpretative aspects of applying some of these requirements in practice and the broader context of consumer information within which they have to be delivered. The label is the principal means of selling a product as well as conveying information about it. Manufacturers need to be able, therefore, to present their products distinctively and attractively and to communicate about them on the label in an understandable manner. They need a clear grasp of the requirements of all the legislation relating to the labelling of their products in order to ensure legality, promote consistency of application and avoid unnecessary label changes. A sound understanding, allied to a common approach, is also needed by enforcement officers if there is to be consistency between the

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many food authorities. Reasonable and relevant product labelling constraints expressed in understandable legislation are essential requirements. These objectives would be assisted by better-drafted, user-friendly legislation and by a regulatory system, in both the EU and the UK, which encouraged the development of legislation on the basis of sound science and common need rather than political expediency and special interests, with adequate time being allowed for consultation with all interested parties. There needs also to be a minimum of scope for derogation from EU labelling law, and a common interpretation of the texts across the Member States, if labelling is not to give rise to barriers to trade. These criteria illustrate the balance necessary to achieving sound and clearly worded legislation, and consistent application and enforcement, which are in the best interests of consumer protection, economic efficiency and fair trading. It is also worth noting that, whereas manufacturers commonly use market research to determine consumer views, until fairly recently this has not featured at all in the practice of legislating authorities when developing food law, which should preferably reflect researched needs and not partial opinions. The basic need for the label to comply with legislation is not country- or regionspecific. The example of UK statutory requirements is used here, however, to illustrate the principles involved. The fundamental labelling requirement is that any mandatory information, both general and product-specific, must be given and it has to be appropriately sited and sufficiently intelligible to the intending purchaser, in accordance with the ‘manner of marking’ requirements of The Food Labelling Regulations 1996 as amended (FLR) which specifically address ‘intelligibility’ and ‘field of vision’ aspects. The Food Safety Act 1990 generally requires that food labelling must not be so presented as to falsely describe the food or be likely to mislead as to its nature or substance or quality. The Trade Descriptions Act 1968 prohibits false trade descriptions, as defined. It applies, in principle, to all consumer goods including food but, most usually, the appropriate description of food products is assessed under the general provisions of the Food Safety Act and the numerous Regulations and Orders made thereunder. Within the constraints of the legislation, the amount and balance of information on a food label is ultimately a matter for individual decision by the responsible manufacturer or retailer. Once label space has been allocated to product branding, product positioning (claims, etc.) and the necessary statutory information, the residual space will be given over to other relevant information, having regard to the possibility of using other means of consumer communication such as helplines. Varying amounts of space may be required for claims, including logos; offers; inclusion of commercial data, such as bar codes; requirements of other, specific legislation, such as health marks; or voluntary measures associated, for example, with special dietary needs, packaging disposal etc. Fundamentally, a food label is of limited size and only so much information can be included if it is to be clearly understood and as apparent as the Regulations require. Nevertheless, new requirements continue to be added and consumer demands for more voluntary information increase. In recent years, the growing need for multi-lingual labels, on grounds of economy associated with international trading, has placed further pressure on label space. The reduced labelling requirements for small packs, i.e. where the area of the largest surface is less than 10 cm2, is necessary but of very limited application. Not surprisingly, there is a tendency for the statutory information to be allotted less space than that for marketing needs. Label designers should be aware, therefore, of the recommendations of the Institute of Grocery Distribution (IGD) on packaging and legibility1 regarding minimum standards of legibility in terms of print size, style and

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contrast (see Section 12.1). It should also be borne in mind that the UK Food Advisory Committee (FAC), in its 1990 report2 recommended as follows: We take the view that a standard panel, prominently displayed on the label, would help to counter the difficulties over the relative prominence and placing of the statutory and non-statutory information. We recommend that all the statutory information, with the exception of the name and address of the responsible manufacturer, packer or seller, should be included in the box, together with nutrition labelling information and any additional safety information. All other information should be excluded from the box. To allow a degree of flexibility we recommend that ‘signposting’ (for example, ‘see lid’ or ‘back of pack’) should be allowed for the following information: the date-mark, storage instructions, conditions of use, instructions for use, and nutrition labelling. To be enforceable, such a recommendation would have to be embodied in EU labelling legislation. Although voluntarily used in some instances, a statutory panel has generally been resisted as being too inflexible an approach to the presentation of information. It would certainly be impractical with some sizes and shapes of pack and would be a formidable constraint on multi-lingual labels. Those responsible for food label design should, however, bear in mind the perceived need for improved clarity and the continuing pressure for a statutory information panel. In deciding what to include on the label, in addition to the statutory information, it is necessary to adopt a position on a number of issues, which are expressed here in the form of opinions. Whereas the consumer’s entitlement to information about a food product is not disputed, the label is not necessarily the vehicle for all parts of that information, although it should carry those aspects which are essential to the purchasing decision. There are alternative means of providing further information, both generally and on request. At point of sale, there is a limit to the amount of information that a shopper can take in. To exceed that limit does not assist the buying decision and it may effectively distract attention from key items of information. The ‘general labelling requirement’ of the FLR, supplemented by commodity labelling rules, provides for ample information on which the majority of shoppers should be able to arrive at informed decisions. To take a specific example, labelling laws should enable provision of information to allow a consumer to follow ‘healthy eating’ advisory messages by selecting a range of foods to construct an appropriate, balanced diet. The law should, however, enable and not require the provision of such detail on all products, given the wide variation of interest in these issues and in individual consumer requirements. Although labelling may complement educational programmes through the information it provides, it is not, nor should it be regarded as, an educational tool. Because of spatial constraints, any moves in this direction could lead to over-simplifications and misleading messages. For example, while a food label should provide information to enable a consumer to handle, store and prepare food safely, the promotion of food safety in respect of consumer attitudes, knowledge and practices, is an educational matter and should be approached by means other than labelling. Processes and food production systems may influence choice in some instances but should not have to be described on the label except where they materially affect the quality/characteristics of the final product. The present FLR requirement for a food process or treatment to be indicated, should its omission be misleading, is sufficient to

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satisfy most consumer needs. A more general move to ‘labelling for process’ could overburden the label with information which may be of interest only to special interest groups. Further, it will always be open to manufacturers to label voluntarily, although this may need to take account of particular constraints, for example as with ‘organic’ foods. In general, where information is desired by a section of the population (which might regard it as essential to their interests although it would not be so regarded by the population as a whole) then there should be freedom for this information to be given in whatever ways are deemed to be most appropriate, including the label, provided that the statements made are truthful and verifiable on request by enforcement officers. Currently, some differences between the EU Member States in the freedom to give certain additional information need to be addressed, for example in respect of allergen labelling. The product label is still by far the most powerful means of informing consumers about the attributes of products but it should not be over-loaded. The EU Commission, in its Green Paper on the General Principles of Food Law in the EU,3 expressed the following ‘functional’ view of labelling in respect of the EU Labelling Directive: Directive 79/112/EEC* is based upon the principle of functional labelling. The objective of the Directive is to ensure that consumers are provided with the essential information as regards composition of the product, its manufacturer, and its method of storage and preparation which are necessary to ensure consumer safety and fair competition. Producers and manufacturers are free to provide whatever additional information they wish, provided that this is accurate and does not mislead the consumer. A balance is needed in respect of the derivation and accuracy of any numerical data presented on labelling, for example nutrition information. It will be necessary to ensure that data are sourced as required, from analyses or recognised authorities, and consideration may need to be given to rounding of values in order to convey information with sufficient accuracy without suggesting an unrealistic degree of precision. The costs of deriving any numerical data, and then monitoring product against them, must also be taken into account.

1.3.2 What do manufacturers need to consider? Given the foregoing context, manufacturers need to be sure that they have taken account of • all the legislation and related guidance relevant to the labelling of their products • any codes of practice or other agreements which might assist in its appropriate interpretation and application.

It must also be ensured that appropriate control is maintained over label production so that regulatory advice and prescribed wording are not so combined with creative design and marketing input as to result in a label which does not comply with legal requirements. Legislation The MAFF/Department of Health Joint Food Safety and Standards Group (JFSSG)** has occasionally produced a compendium titled ‘Food Law’4 listing both the general and * This Directive and its seven amendments were consolidated in Directive 2000/13/EC on 20 March 2000. ** The JFSSG is an interim body pending establishment of a UK Food Standards Agency.

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specific UK legislation relating to food manufacturing, labelling, advertising and presentation. There are several UK regulations, most reflecting EU legislation, which cover the composition and labelling of specific foods and there are labelling requirements in some health and hygiene legislation. This is all usefully identified in the JFSSG Compendium. Reference has been made above to the general requirements of the Trades Description Act. Also relevant to the total labelling of foodstuffs are the Weights and Measures Act 1985, and applicable subsidiary legislation and The Food (Lot Marking) Regulations 1996. Manufacturers will need to consider their legal responsibilities to particular groups of consumers. In this respect, the provisions of The General Product Safety Regulations 1994 may be relevant in requiring that in producing a ‘safe product’ which does not present any risk, or only the minimum risks compatible with the product’s use, manufacturers take into account a number of factors including the labelling of the product, any instructions for its use and disposal and the categories of consumers at serious risk when using the product, in particular children. The particular issue of allergen labelling, dealt with in detail in Section 12.3, is an example of the need to take account of the broader context of consumer protection legislation when considering vulnerable groups. Returning to food law as such, the Food Safety Act sets out the general provisions of consumer protection in respect of selling food not of the nature or substance or quality demanded or falsely describing or presenting foods. The FLR, made under the Act, implement the EU Labelling Directive 2000/13/EC, as amended, and also to date, separate EU legislation on nutrition labelling, on the labelling of sweeteners, on the use of packaging gases. EU Regulations on the labelling of foodstuffs containing ingredients derived from genetically modified (GM) soya and genetically modified (GM) maize and on foods and ingredients containing additives and flavourings of GM origin are implemented by The Genetically Modified and Novel Foods (Labelling) (England) Regulations 2000. Specifically, it must be considered whether or not to give nutrition labelling, which is voluntary unless any nutrition claim is made. If given it must be in a prescribed format. A high proportion of UK-manufactured pre-packaged food is nutrition labelled. The voluntary nature of the requirement does, however, enable it not to be given where it is of little value to the consumer or of little relevance to the product concerned. Guidance MAFF, and subsequently the JFSSG, have produced guidelines on the application of some legislation. These are on the FLR in general,5 and on those aspects which deal with nutrition labelling,6 quantitative ingredient declaration7 and place of origin.8 Also on the labelling of products containing ingredients derived from GM soya or GM maize.9 There are also guidance notes on lot-marking.10 It is assumed that these will all be periodically updated as appropriate. A ‘Listing of Codes of Practice Applicable to Foods’11 has been produced by the Institute of Food Science and Technology (UK). Also to be borne in mind is any specific guidance issued by product sector associations and guidelines issued by the FAC or JFSSG on issues which are not directly regulated. At present, these latter categories cover use of the word ‘natural’ and similar terms (including a section on some negative claims)2 and certain nutrition claims.12 When considering very specific interpretation of labelling legislation it is also prudent to find out whether or not any precedent has been set by case law. One route to

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ascertaining this would be to consult a commercial compendium of legislation updated with relevant case law. The Local Authorities Co-ordinating Body on Food and Trading Standards (LACOTS) develops advice on some aspects of the interpretation and enforcement of labelling legislation, either directly in response to questions or by agreements with the specific industry sectors. These outcomes are notified by means of circulars sent by LACOTS to Chief Trading Standards and Environmental Health Officers. LACOTS deals with trade associations rather than individual companies and manufacturers should enquire via their trade association if they wish to know whether or not LACOTS has produced advice on any particular aspect of food labelling. Manufacturers will wish to consider the appropriateness of seeking advice from their local food authority on labelling matters, or of regularly informing it of their labelling decisions. This is particularly relevant to relationships with a ‘home authority’. Participation in a food and drink industry trade association is a further, valuable route to understanding labelling requirements and developments and seeking views from Government or enforcement bodies.

1.3.3 Due diligence There is inevitably an interpretative element in the application and the enforcement of food labelling requirements, whether this relates to forms of words being used or to evidence in support of what is being stated on the label. There may be several routes to deciding upon what is a reasonable interpretation in any particular case. The Food Safety Act, and Regulations made under it, create a number of ‘strict liability’ offences, that is, if there is clear evidence that a particular statute has been contravened, a conviction is possible whether or not the person accused intended to break the law. The regime of strict liability can cause injustice if a person is held to have committed an offence for which he had no responsibility at all, or which occurred because of an accident or some cause completely beyond his control. In order to create a balance of fairness in such cases, a defence is normally included in consumer protection legislation which contains strict liability offences. This has come to be known as the ‘due diligence’ defence and such a defence is provided in section 21 of the Food Safety Act. This provides that it shall be a defence for the person charged to prove that he took all reasonable precautions and exercised all due diligence to avoid the committing of the offence by himself or by a person under his control. There is a more specific due diligence defence for traders who neither manufactured nor imported the food. In general, taking reasonable precautions involves the setting up of a system of control having regard to the nature of the risks involved, whilst due diligence involves securing the proper operation of that system. What is ‘reasonable’ depends on the particular circumstances, and what is considered reasonable for a large-scale food business may not be considered so for a much smaller business. Nevertheless, the relevant levels of management of all manufacturers should be thoroughly familiar with their legal obligations in respect of the labelling, advertising and presentation of foodstuffs or, if appropriate, be able to demonstrate that they have good reason to have placed reliance upon a consultancy or other body whose advice they have followed. Case studies have shown that only positive action will satisfy a court that a person knows and understands what is meant by taking all reasonable precautions and exercising all due diligence. For example, where advice has been sought or decisions have been made regarding compliance with some aspect of food labelling requirements, it would be appropriate to

Introduction

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record such decisions, with reasons and any supporting data, for future reference if needed. The same would also apply, for example, to all analyses carried out to monitor the accuracy of numerical data on labels. Also relevant to a due diligence approach is discussion with the manufacturer’s local food authority in cases where it seems appropriate to seek a view, or confirmation of an interpretation, from an enforcement officer.

1.3.4

References

1. Packaging Legibility – Recommendations for Improvements, Watford, Institute of Grocery Distribution, 1994. 2. Food Advisory Committee Report of its Review of Food Labelling and Advertising 1990, London, HMSO, 1991. 3. The General Principles of Food Law in the European Union, Brussels, Commission of the European Communities, 1997. 4. Food Law – a guide to the legislation applicable to the labelling, composition and safety of foods, London, MAFF/Department of Health Joint Food Safety & Standards Group (JFSSG), 1998. 5. The Food Labelling Regulations 1996: Guidance Notes, London, MAFF, 1997. 6. Guidance Notes on Nutrition Labelling, London, JFSSG, 1998. 7. The Food Labelling Regulations 1996: Guidance Notes on Quantitative Ingredient Declaration (‘QUID’) , London, JFSSG, 1999. 8. Guidance Notes on Place of Origin, London, JFSSG, 2000. 9. Guidance Notes: Labelling of food containing genetically modified soya or maize, London, MAFF/ Department of Health, 1999 (amended 2000). 10. The Food (Lot Marking) Regulations 1996: Guidance Notes, London, MAFF, 1996. 11. Listing of Codes of Practice Applicable to Foods, London, Institute of Food Science & Technology (UK), 1993. 12. Guidelines for the Use of Certain Nutrition Claims in Food Labelling and Advertising, London, MAFF, 1999.

1.4 Legislators’ perspectives D. A. Love, formerly MAFF, London 1.4.1 The guiding principles behind food labelling legislation Every mature industrial country has a highly developed body of fair trade and consumer protection legislation, and a very important part of such legislation are the laws about the labelling of food sold to the consumer. They serve the needs of both traders and purchasers of food and are designed to be enforceable at a local level of intervention. In the UK the main statutes are the Trade Descriptions Act 1968 and the Food Safety Act 1990. The relevant sections of these Acts, sections 3.2 of the former and sections 14 and 15 of the latter, exemplify the first important guiding principle behind food labelling legislation: that the information given about a food should not mislead the purchaser. This principle will be found not only in the UK but in EU labelling legislation and in the internationally agreed labelling standards of the Codex Alimentarius, developed jointly by the member countries of the UN’s Food and Agriculture and World Health Organisations. Beyond this general rule, which also applies to advertising and presentation, more detailed legislation about the label has developed in two main directions. The first has been to set out the minimum information about a food which must be given by those supplying it, and to apply that obligation in principle to all foodstuffs. The second has been to define the meaning of certain names, descriptions or claims given to certain foods, in order to prevent fraud, unfair competition or confusion among consumers. The first strategy could be described as the development of ‘horizontal’ rules, which apply in

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principle to all foods; the second strategy as the development of ‘vertical’ rules, which apply only to one food or a group of foodstuffs. In both these strategies, legislators (I use this term to denote the people in governments, parliaments and bureaucracies, both national and international, who make the rules) have tended to concentrate on requiring information about the nature of the food as presented to the purchaser or as consumed, and not on other types of information which could be given, for example where it came from, how it was grown, what it was treated with. There are, of course, important exceptions to this, for example the very detailed rules adopted in the UK and the EU about the meaning of the claim ‘organic’. However, they remain exceptions for the present. Legislators have recognised that there are two important constraints on information provided on labels: the finite size of the label and the ability of consumers to absorb information at the point of sale. There are many ideas about what should go on labels and constant calls for more information. Legislators have sought to balance what is regarded as essential, what is desirable for consumer information, and what is necessary for the legitimate demands of marketing the product.

1.4.2 The main requirements of food labelling legislation The main information demanded by food labelling rules is that a food should be given an accurate name or description which indicates its true nature to the purchaser and prevents the purchaser confusing it with any other food. If it is made up of several ingredients, they should be listed. If it has been treated to a particular process, such as freezing or dehydration, this should also be clear from the labelling or presentation. Important handling information is also usually mandatory: the food’s shelf-life, how it should be stored and how it should be cooked, if necessary. The name and address of the supplier or manufacturer is also required so that the consumer or enforcement officer can seek more information or take up any complaint about the food. The legislation will usually require that any other information, given voluntarily, is subject to the general obligation not to mislead, but in some cases the legislation will be more specific and usually prescriptive. Names and descriptions, particularly of basic foodstuffs such as bread or milk products, or of high value products such as alcoholic drinks, may be specified and reserved to these foods. Use of certain descriptions may be subject to conditions. Rules can also be imposed to ensure that the information given is readily comprehensible, for example when it is technical or numerical, as is the case with nutrition labelling. They can address the special needs of particular sections of the population or of significant minority interests, provided that the majority of consumers are not likely to be confused.

1.4.3 Factors influencing the process of rule-making The process of making or changing food labelling laws is almost continuous. Governments come to power with their own policies for new laws or for deregulating over-burdensome regulations. It seems to be in the nature of things for pressure groups to call always for more information on labels and not for less, although they are often dismissive of the information already given. Industry sectors pull in several directions, either to resist the obligation for more information or to demand the freedom to provide what they perceive as consumers’ demands as quickly as possible and in the ways which they regard as most appropriate.

Introduction

21

New technologies, processes and products pose particular problems. They may have been adopted to solve problems early in the food producing chain and may result in foods which are identical to ‘conventional’ products, for example the genetic modification of growing crops. In such cases special labelling will be resisted by industry but may be of intense interest to pressure groups and consumers who have particular concerns about these innovations. On the other hand food suppliers might wish to trumpet other new products because they offer something of benefit to consumers, for example a new fat which has fewer calories than conventional fats or a baby milk which more closely replicates breast milk. If existing legislation constrains them (because fats are legally defined as delivering so many calories or claims on baby milks are prohibited), then it is accused of being over-regulatory and anti-innovation. Other pressures for change arise from membership of the EU, which is committed to harmonising the existing legislation of its Member States and is also subject to the kinds of pressures described above. There are differences in the legislative traditions of the EU’s Member States, some of which have concentrated on horizontal rule-making while others have enacted more detailed legislation on the composition and description of individual foods. In seeking to create a single or common market the EU has faced a choice between these different traditions. In practice it has sometimes followed one, sometimes the other, depending on the strength of voting power and alliances of its membership on different issues. It now has a mix of horizontal and vertical regulations and directives with little coherence or logical organisation to them. Early in its history it tended to favour vertical food legislation. However, the attempt to produce detailed EU laws on the composition and description of particular foods, such as chocolate, jam or fruit juice, proved so time-consuming and so contentious that it was largely abandoned in the mid-1980s and efforts were directed to securing agreements on general labelling rules, approval of additives, control of contaminants and promotion of best hygiene practices. This has been the broad trend since but there have always been counteracting pressures to continue to control certain foodstuffs in more detail, most notably those which are marketed to particular groups of consumers for health or nutritional reasons. In managing this continuous process of rule-making, legislators depend on establishing a constructive dialogue with all the interested parties involved in order to understand the concerns expressed, the context of proposed changes and the likely effect of new laws on both businesses and on the person reading the label. Any groups which are not interested in dialogue inevitably have less influence on the rules which usually emerge after a long process of drafting, negotiation and compromise. Legislators also need objective information about consumers’ behaviour and understanding against which to test the assertions or predictions of industry or pressure groups. Many surveys and research projects are carried out in this area but unless they are financed by governments or official bodies they can be suspected of bias, according to the vested interests of the group which funded the survey. All this means that getting a new rule onto the statute book takes time. Legislative action can be swift when speed is necessary, but even then there are statutory obligations to consult any parties likely to be affected by the proposed rules. However, another factor which can delay legislation is the need to agree to joint action internationally. Membership of the EU means that the UK has very little freedom to act unilaterally on food labelling. International obligations in the World Trade Organisation also constrain unilateral action which cannot be justified on narrowly defined grounds of safety or national security.

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Food labelling

1.5 An enforcement perspective D. Walker, Trading Standards, Shropshire County Council, Shrewsbury 1.5.1 Introduction Recent food scares and the corresponding media interest in the food industry have raised the issue of food labelling and the profile of food law enforcement to an unprecedented level. The introduction of the Food Standards Agency will almost inevitably raise the profile even further. This section examines the issue of food labelling from an enforcement perspective and considers by way of background: • the role of local authorities and their relationship with central government • the role of LACOTS (the Local Authority Co-ordinating Body on Food and Trading Standards) and the Home Authority Principle • the statutory powers of enforcement officers.

The section will then outline a brief summary of the legislative framework and provide some insight into the nature of the problems associated with food labelling. Whilst the issues will be considered from an enforcement perspective it must be remembered that many of these problems also adversely affect reputable sectors of the food industry. Correct product labelling ensures that manufacturers compete on level terms with each other by preventing unfair competition. From a consumer viewpoint, the current debate surrounding the labelling of genetically modified foods graphically illustrates how food labelling laws enshrine their fundamental right to make fully informed choices of what they eat and drink. Food law enforcement, therefore, has to be considered in all these contexts and resolving or minimising the associated problems is clearly in the best interests of all concerned. The section concludes with some suggestions to help maintain the improved working relationship which already exists between the food industry and enforcement agencies. There are a large number of regulations relating to specific foodstuffs which prescribe the form of labelling required. The relevant controls extend to the labelling of foods at point of retail sale. This section, however, highlights the position in relation to the more general food labelling requirements and health claims applied by food manufacturers.

1.5.2 The role of local authorities Overall responsibility for food safety matters currently rests with the Department of Health whilst that for food standards rests with the Ministry of Agriculture Fisheries and Food. This was set to change at the time of writing with the publication of the bill to establish the Food Standards Agency. Whilst overall responsibility rests with central government, Section 5 of the Food Safety Act 1990 provides for a local authority based system of enforcement. Section 5(4) of the Act enables ministers to assign responsibility for certain functions to a particular tier of local authority. This is not applicable to those local authorities who have responsibility for the entire enforcement function. However, within the area covered by the non-metropolitan counties in England, ministers have assigned responsibility for the food safety function to District Councils enforced by Environmental Health Officers, and responsibility for those provisions relating to quality composition and labelling (food standards) to County Councils enforced by Trading Standards Officers.

Introduction

23

Section 40 of the Food Safety Act allows appropriate ministers to issue codes of practice to enforcement authorities which they ‘shall have regard to’ when fulfilling their statutory duties. Code of Practice No. 1 issued jointly by the Ministry of Agriculture Fisheries and Food and the Department of Health provides for effective liaison arrangements between the respective authorities referred to above. The codes are currently under review. Those relating to Food Standards are as follows: • • • • • •

No.1 Responsibility for Enforcement No.2 Legal Matters No.3 Inspection Procedures (General) No.7 Sampling and Analysis No.8 Food Standards Inspections No.19 Qualifications and Experience of Authorised Officers and Experts.

Section 41 of the Act requires food authorities to provide ministers with reports and returns on their activities under the Act. Section 42 allows ministers to take the designated appropriate action against those local authorities who have failed to discharge their statutory duties to the extent that it ‘affects the general interests of consumers of food’. Ministers have reserved extensive powers to audit the work undertaken by local authorities in the draft Bill on the Food Standards Agency. It follows from the above that, whilst individual local authorities are autonomous in relation to their enforcement activities, they are directly accountable to central government for the effective performance of this function. This requires commitment, staff and resources and there are increasing concerns within local government that insufficient funds are made available by central government for them to perform effectively. Experience has shown that food manufacturers do not take kindly to challenges to their product descriptions. They will often have the support of their respective trade association, and will often be advised by leading experts in the relevant subject matter in question. If the matter proceeds to court they are often defended by some of the best and most expensive legal teams available. The decision to mount such a challenge, therefore, has to be taken very seriously and the fragmentation of many of the larger food authorities into smaller unitary councils with fewer resources and clout following local government reorganisation tends to speak for itself.

1.5.3 Authorised officers and public analysts Section 29 of the Food Safety Act gives powers to authorised officers of local authorities to take or purchase samples of food or any substance capable of being used in the preparation of food. Chemical analysis of the sample must be undertaken by the appointed public analyst who in turn is likely to comment on any suspected problems associated with the labelling of the product for action or investigation, as necessary, by the local authority. Working together, therefore, authorised officers and public analysts are in the front line of food labelling enforcement. Proactive routine inspections by authorised officers are undertaken at premises throughout the food chain, to include manufacturers, retailers and caterers, based on a risk assessment of the individual premise. As an aside, the Trading Standards Departments of many authorities also enforce the provisions of the Agriculture Act 1970 controlling the quality, composition and labelling of fertilisers and feeding stuffs. Many departments also enforce Animal Health and Welfare legislation ensuring a comprehensive ‘plough to plate’ approach on relevant food-related issues.

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Section 30 of the Food Safety Act confers powers of entry on authorised officers of the enforcement authority. The following extract from Code of Practice No. 21 illustrates the determination of the legislators to ensure compliance with the law. Authorised officers are empowered to inspect anything which may help establish whether or not an offence has been committed. This includes premises, equipment, machinery, food, process and any relevant records held in any form (including records kept on a computer). They may interview personnel and examine companies’ quality control systems. Documents may be copied, seized and detained if they may be needed as evidence. Where records are on a computer, officers can require the records to be produced in a form which can then be taken away. Officers may also take photographic and video evidence. Fortunately, the vast majority of labelling irregularities are relatively minor and are dealt with by way of advice and assistance to the manufacturer or importer concerned. Local authorities are mindful of the costs associated with changes to the label and in normal circumstances companies can expect a sympathetic hearing in relation to the time-scale for implementing the changes. Officers are only called upon to undertake a full investigation in the more serious cases.

1.5.4 LACOTS One of the main concerns expressed by the food industry in the context of food labelling legislation is consistency of interpretation and uniformity of enforcement. LACOTS is the body charged with addressing these and other relevant issues. LACOTS is the Local Authority Co-ordinating Body on Food and Trading Standards, funded by revenue monies ‘top sliced’ from the Revenue Support Grant in England and Wales. It aims to: • • • • • • • •

promote quality regulation, co-ordinate enforcement and good practice provide advice, guidance and codes for food safety and trading standards authorities advise central government and the European Union on relevant legislation promote the Home Authority Principle as the key method of enforcement coordination administer statutory arrangements as the UK Single Liaison Body for trans-border food problems develop information and central records databases to assist enforcement practitioners liaise with industry, trade and consumer bodies collaborate with enforcement agencies overseas.

In addition to its invaluable co-ordinating role for local authorities, LACOTS works closely with various trade organisations to clarify areas of confusion in the existing law and establish common standards to minimise the need to resort to legal action. This is outlined in greater detail in Section 1.5.11.

1.5.5 The Home Authority Principle – replacing confrontation with co-operation The Home Authority Principle encourages authorities to place special emphasis on the legality of goods and services originating within its area. It operates on the basis that giving advice and guidance on regulation, good practice and remedial action is to be encouraged because it not only facilitates a good dialogue between the parties concerned but also, if used effectively, prevents infringements at source.

Introduction

25

It also supports efficient liaison between local authorities and provides a system for the resolution of problems and disputes. Many of these problems relate to product labelling and authorities are encouraged to channel all minor labelling problems to the home local authority for appropriate action. The Home Authority Principle is perhaps the biggest single factor which has contributed to a far greater understanding between individual authorities and their ‘home based’ food companies. It has significantly modified the perception within the food industry that local authorities act only in an adversarial enforcement capacity by replacing confrontation with co-operation. Not surprisingly, it commands the support of central government, trade and industry associations, consumer and professional regulatory bodies.

1.5.6 The framework of food labelling legislation Food ‘labelling’ is defined in the Food Labelling Directive as ‘any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a foodstuff and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such foodstuff’. The Directive is enacted in England and Wales by the Food Labelling Regulations 1996 prescribing the statutory information which must appear on relevant labels. The regulations are complemented by Section 15 of the Food Safety Act which makes it unlawful to give, display or attach a label ‘which falsely describes the food or is misleading as to its nature substance or quality’. The Trade Descriptions Act 1968, which makes it unlawful to apply a false trade description to goods, completes the legislative framework. Put simply, with the exception of a name or description reserved by law for the class of products concerned, anything stated on a food label is a trade description and must therefore be correct. In practice most of the more serious labelling irregularities relate to misdescribed or adulterated foodstuffs. The marketing of foods with claims that it impart some health property also presents problems for reasons which will be addressed later.

1.5.7 The marketing environment – or the ‘not me first’ syndrome The food industry has traditionally been very competitive with low margins and the emergence of the large multiple retailers has also had a dramatic impact. It is generally accepted that a small number of multiple retailers effectively control and dominate around 75% of the retail food sector. On the credit side, major retailers have sought, through supplier assurance schemes, to promote minimum standards of safety and quality amongst food manufacturers. There can also be no doubt that they have provided a standard of service to the consumer which is second to none – bright, attractive shopping surroundings, easy parking, a large range of different foodstuffs, often at a very competitive price – all thanks to their efforts and investment. On the debit side, however, given the fact that so few multiple retailers operate in what can best be described as a buyers’ market, it is abundantly clear that their concentrated buying power has led to considerable problems for individual food manufacturers, with sometimes adverse implications for the quality and labelling of the end product. Insofar as the quality is concerned, there are enormous pressures on manufacturers to produce and sell their goods at the most competitive price. Nothing wrong with that some might say in the normal course of events, but it is clear that this can manifest itself into

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subtle changes to the recipe of the product, and in some cases a lowering of quality standards. Insofar as the labelling of the product is concerned, the problem can best be summarised by the ‘not me first’ syndrome, illustrated by the prosecution of an importer some years ago for selling canned cured shoulder of pork containing undeclared added water and undeclared cereal starch. The extent of the adulteration was such that there was less meat in the so-called all meat product than in a pork sausage! Following the case, the importer rang the local authority to say that he was in something of a dilemma. If he took out the cereal starch his unit costs would increase, his prices would rise, and as a result the multiple retailer would place the business elsewhere. If, on the other hand, he left the cereal starch in the product and then declared its presence in accordance with the decision of the court, the multiple retailer would refuse to buy it – Catch 22! Little wonder that even when companies accept that there is some merit to the challenge to the label by an enforcement authority, (as often happens) they are still reluctant to correct matters on the basis that their competitors could be left in a more advantageous position. In other words they would be more than happy to comply with the law as long as they did not have to do it first! The marketing environment and the ‘not me first’ syndrome is therefore a major constraint to resolving problems associated with incorrect product labelling.

1.5.8 Modern technology – or ‘if you can’t beat them, join them’ Intense competition in the marketplace places additional pressures on food manufacturers to reduce their unit costs. Modern technology provides quite legitimate opportunities in this respect but sometimes its use can result in a change to the nature and characteristics of the product in question. The problem is best illustrated by reference to some of the claims made by those involved in the marketing of the equipment or ingredients used in the production of various foods: • Injection equipment for cured meat products – ‘Marked weight increase through constant and even injection’ • Dehydrated rind – ‘Absorbs four times its weight of water . . . to replace 5 lbs of meat add 1 lb of . . . and 4 lbs of water’ • Milk powder – ‘. . . improves the yield . . . allows pumping level increases’ • Textured soya protein – ‘. . . has the appearance and mouthfeel of meat, and can be used to extend meat products by up to 25%’ • Cheese substitute – ‘As a complete or partial replacement for natural cheese in so many mouth watering, money saving ways. Gives you the smooth texture and wholesome food value of natural food cooking but for up to 35% less cost’ • Ice cream mix – ‘Use less powder to make more ice cream’.

No exception is taken to the availability of such ingredients or processes but unless careful consideration is given to corresponding changes to the label, to reflect the way in which the product has been changed, their undeclared use can amount to product debasement or adulteration. The problem is compounded by the fact that the technology to establish whether some foods have been subjected to processes, or contain ingredients, which have changed the nature of the product, does not always exist. For example, the presence of ingredients such as bone protein or blood plasma cannot be detected by the chemical analysis of the end meat product. Furthermore, irrespective of any technological function they might serve, when the end product is analysed they have the added effect of increasing its

Introduction

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‘apparent’ meat content or disguising the presence or amount of added water. The scope for misuse is therefore self evident. When one manufacturer uses a technological innovation of this kind to gain a competitive advantage, the particular practice in question can very quickly spread throughout the relevant trade sector. Based on personal contact in the industry over a long period, it is clear that there are many who would prefer to produce their products without using a particular ingredient or process which is said to ‘add value’ to the product in question. Despite these reservations, however, market forces tend to predominate and many companies have often adopted the technological innovation on the basis that ‘if you can’t beat them, join them!’ The financial implications can also be enormous. One company which was challenged by a local authority for failing to declare the presence of textured soya protein in its meat products was faced with a decision at boardroom level either to declare the presence of the TSP, as requested by the authority, or reincorporate the meat that it otherwise replaced. To replace the meat over the range of products produced by the company would have cost over £1 million. The company took the commercial decision to continue using the ingredient and made an appropriate change to the label!

1.5.9 Ambiguous legislation – the name of the food Food manufacturers in the main, do not aim deliberately to flout the law and are especially law abiding when the legislative requirements are clear, straightforward and unambiguous. For example, the statutory requirement to detail the name and address of the manufacturer on a pre-packed product leaves little or no room for misinterpretation. The result is virtually 100% compliance. When it comes to Regulation 8 of the Food Labelling Regulations 1996, however, the situation is somewhat different. This places the statutory obligation on the manufacturer to label food with ‘a name which indicates its true nature and which enables it to be distinguished from products with which it could be confused’. This is a seemingly straightforward requirement but, based on experience over the years, it is quite clear that one person’s version of a name which indicates a product’s true nature, is another person’s false trade description. Throw in the competitive marketing environment referred to above and an over-zealous marketing department, whose job it is to sell the product (and therefore present it in the best possible manner) and there is clearly a potential problem. Conflicting interpretations between food manufacturers and enforcement authorities on the legality of the name used for the food have led to challenges to the description in the following cases (amongst others): • • • • • • •

minced or reformed scampi described simply as ‘Scampi’ undeclared added water in meat and fish products undeclared mechanically recovered meat in meat products undeclared meat extenders in meat products undeclared cheese substitutes in cheese products undeclared fish mince in fish products the undeclared presentation of separate pieces of meat or fish as a single slice of meat or portion of fish.

It will perhaps not have gone unnoticed that all of these generic products contain a high cost raw material which has been given ‘added value’ in one form or another.

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Challenges to the name and description of the food were, in the main, initially resisted by the manufacturers concerned, resulting in some test cases to establish the position. Whilst most of these issues have now been resolved, the need for such challenges would be considerably reduced if there was less scope for misinterpretation and misunderstanding in the first instance.

1.5.10 Ambiguous legislation – health claims In 1989 the Consumers Association undertook a survey2 and established that 55% of consumers were prepared to pay more for a product which had a health-related claim. The marketing advantages for those who claim a direct health benefit attributed to eating the food are therefore self evident and little wonder that with increasing consumer interest in the link between diet and health, the market for such foods is rapidly expanding. There are no specific labelling requirements in relation to foods with a health claim but Regulation 40 and Schedule 6 of the Food Labelling Regulations 1996 makes it unlawful to make an express claim, or even an implied claim to the effect that a food has ‘the property of preventing, treating or curing a human disease or any reference to such a property’. Human disease is defined as any adverse condition of body or mind. These claims were previously referred to as medicinal claims. Again, at first sight, this seems to be a fairly straightforward requirement. Unfortunately one person’s version of a claim which implies that a food is capable of preventing a disease and therefore unlawful is sometimes another person’s health message and perfectly legal. The issue was considered in some detail by the Food Advisory Committee3 which came to the conclusion: The borderline between medical claims which are subject to strict controls and health claims which are not subject to specific controls is unclear and the increasing use of health claims on the labelling and advertising of certain foodstuffs has led to a great deal of controversy. The interpretation of health claims on foods therefore presents particular problems and is a major constraint on correct product labelling.

1.5.11 Health claims – substantiation Health claims on foods also present a quite separate problem in relation to the substantiation of the claim. The problem can be summarised by reference to the report of the MAFF/DoH Working Group on Dietary Supplements and Health Foods4 which stated that: The second area of concern is the potential to mislead consumers. This arises when consumers are led to believe that certain products are necessary and/or beneficial to health when claims are unsubstantiated. In the opinion of the Working Group excessive claims are being made for some supplements. There are major constraints on enforcement authorities attempting to prove that a particular health claim is not substantiated. The courtroom is not necessarily the best place to settle differences between respective scientists, arguing the merits of the claim for the prosecution and defence, disputing the interpretation of the results obtained in the tests, methodology, and anything else which supports the one scientific view or the other. The issue is likely to be extremely complicated in any event, but the task facing the

Introduction

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enforcement authority in mounting such a challenge is made more complex, as the onus is on the prosecution to prove that the claim is false beyond any reasonable doubt. Given the acknowledged marketing advantages to those making health claims, the vulnerability of consumers as outlined above and the problems facing local authorities in this respect, there is clearly a need to redress some of the current imbalance. This could be achieved by placing an obligation on the manufacturer to substantiate the health claim in question before the claim was made. Reputable manufacturers would benefit from a more effective enforcement regime which prevented unsubstantiated claims and therefore unfair competition from the less scrupulous. This should also lead to increased consumer confidence in the validated claims – no bad thing!

1.5.12 The future The above describes a fairly negative picture in relation to food labelling. However, the position is not as bad as it otherwise appears. The vast majority of foods are indeed correctly named and labelled and the above problems must be seen in that context. More importantly, however, there is a growing recognition within the industry that the above problems simply have to be addressed. This has led to a closer working relationship between LACOTS and the food industry and formal agreement on many contentious food labelling issues. Adopting this approach ensures that whole sectors of industry agree to accept a common format avoiding the ‘not me first’ syndrome with all the attendant problems this has for individual manufacturers. The following codes of practice illustrate the point: • Reassembled meat products. This code details the labelling requirements to enable consumers to distinguish between meat products consisting of single slices of meat and those made up from separate pieces of meat from different animals to give the appearance of a single slice of meat. • Declarations of added water in cured meat products. This code details the steps which need to be taken for manufacturers to make the statutory declarations in relation to added water in meat products. • Declarations of fish contents in fish product. In addition to detailing the steps to be taken in relation to fish content declarations in relation to QUID, this code resolves many contentious labelling issues to include the declaration of minced fish, reformed scampi, added water and products consisting of many pieces of fish having the appearance of a single portion of breaded fish. • Health claims. This code is due to be published by the Joint Health Claims Initiative consisting of an alliance between the food industry, consumer organisations and LACOTS. It resolves many contentious issues in relation to the borderline between health claims and prohibited (medicinal) claims as outlined above. It also details the steps required to ensure that only substantiated health claims are made.

This is not to suggest that all such problems can be resolved in this way. A proposed code of practice on the labelling of products containing mechanically recovered meat has never been finalised. However, there is room for optimism that more of the contentious labelling issues can be resolved by discussion and agreement rather than settled in a court of law. Resolving these problems by co-operation rather than confrontation should result in less adverse publicity for the food industry and greater consumer confidence in the labelling of food. That has to be in everyone’s best interests.

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1.5.13 1. 2. 3. 4.

References

Food Safety Act 1990 Code of Practice No. 2: Legal Matters HMSO 1991. Consumers and Food Claims Consumers Association 1989. Food Advisory Committee Report on its Review of Food Labelling and Advertising 1990 HMSO. Dietary Supplements and Health Foods Report of the Working Group MAFF and DOH 1991 HMSO.

2 Labelling requirements: European Union D. A. Love, formerly MAFF, London

2.1

Key principles

This chapter will deal with food labelling legislation of direct relevance to the consumer of food, i.e. the person who purchases food in a shop or a restaurant. It will not deal with the many rules relating to labelling of food at the pre-retail level. It will not, for example, look at the complex body of EU food hygiene rules even though some of the labelling provisions in them can result in information seen by the consumer in the shop. The EU’s food labelling legislation has developed piecemeal, without co-ordination and in the hands of different organisations with different objectives (see Section 2.2) but the majority of rules, including the main legislative text, Council Directive 79/112/EEC, are based on Articles 100 or 100A of the Treaty of Rome, which are concerned with the harmonisation of national legislation. When such harmonisation takes place, the EU’s rules take precedence at the national level so that products from different Member States are treated equally in every part of the Union. In other words the principle of nondiscrimination between Member States is established in the field of legislation ‘occupied’ by the EU rules. Where the rules are not comprehensive the EU text usually signals that national action is permitted but equally imposes on a Member State the obligation to inform its partners and the EU Commission about its proposed action and often to obtain at least the Commission’s approval. In this vetting procedure those informed will be motivated to promote the general Treaty principle of non-discrimination between Member States. Council Directive 79/112/EEC1 is the principal food labelling legislation of the EU. It is also one of the earliest texts and has as a result been influential on most subsequent statutes It has as its key principles: (a) to contribute to the smooth functioning of the common market (this was the terminology in 1979, references to ‘internal market’ come later) by removing impediments to free circulation of products and equal conditions of competition; (b) to inform and protect the consumer; (c) to prohibit the use of information that might mislead the purchaser.

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These principles are embodied in rules for minimum mandatory information, or ‘compulsory indications’ in the language of the Directive, which apply ‘horizontally’ to all foodstuffs put on the market and intended for sale. In other words, all foodstuffs must, unless exempted, carry labelling which contains certain minimum information and this list of mandatory information is set out in the Directive. Any additional information, given either voluntarily by the supplier of the food or in response to specific rules laid down by the EU or by the Member States, is subject to the principle that it should not mislead the purchaser. Any national rules are made subject to an EU vetting procedure laid down in the Directive. Some EU food labelling legislation, depending on its subject matter, may have additional objectives. The Directive on Nutrition Labelling, 90/496/EEC,2 is based first on the need to further ‘the progressive establishment of the internal market’ and secondly to assist the consumer in choosing foods appropriate to a healthy diet. The Regulation on Novel Foods, (EC) No. 258/97,3 cites first the internal market, second the protection of public health and third the need to give the consumer ‘necessary information’. For a significant body of statutes, which lay down labelling information for foodstuffs subject to Common Agricultural Policy regimes, the key principles tend to be more concerned with the interests of food producers and of EU trade policy. They have, in fact, already been expressed in the Treaty of Rome, Article 39 of which lists the objectives of the Common Agricultural Policy as (a) (b) (c) (d) (e)

increasing agricultural productivity, thus ensuring a fair standard of living for the agricultural community, stabilising markets, assuring the availability of supplies, and ensuring supplies reach consumers at reasonable prices.

Using the powers in the Treaty the EU has replaced national market organisations of agricultural products with common equivalents. Some of these products, e.g. fruits, vegetables and eggs, can be marketed without processing to consumers. Others, e.g. milk and meat, need some processing but are still covered by common market organisations. For many of these products the common organisations include rules on labelling for the retail stage and, therefore, for the consumer.

2.2

The organisation of EU legislation

The collection of rules which make up the EU’s food labelling legislation can be organised as follows: (a) the main food labelling Directive, 79/112/EEC, and its amendments and associated subsidiary Directives (now consolidated into Directive 2000/13/EC); (b) labelling rules in other horizontal food Directives or regulations, currently covering nutrition labelling and novel foods; (c) labelling rules in marketing regulations adopted as components of Common Agricultural Policy management regimes for basic agricultural products, e.g. for eggs, apples, beef and even wine; and in Directives dealing with the composition of certain processed foods; (d) miscellaneous rules such as regulations which establish schemes for food producers and suppliers to register their labels with the appropriate authorities so that they will

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be recognised throughout the EU, namely for protected designations of origin and traditional recipes or foods with ‘specific character’; (e) disciplines on national labelling rule-making so that they do not conflict with the overriding EU principles of non-discrimination between Member States and fair trade. Most of these rules were generated by the group of officials who worked in that part of the Commission called Directorate-General III, responsible for industry and internal market policies. As the guardians of Directive 79/112/EEC they had an interest in trying to ensure that the rules were coherent, not repetitive and conform to the key principles. However, it has to be said that such objectives have sometimes not been achieved. Some EU rules have been made in response to strong pressure from consumer lobby groups and increasingly the EU Parliament or certain Member States. The motivations of the prime movers in these developments may have been on the one hand defensive or hostile to new technologies, irrespective of the evidence that these were properly assessed and controlled, and on the other frankly protectionist. The resulting EU rules often do not fit easily with existing rules or with the key principles. For example, it is now compulsory to inform the purchaser of the use of artificial sweeteners not only in the ingredients list (where all the other additives and ingredients are listed) but also in the legal name of the food. There is no safety reason for highlighting the use of approved sweeteners in this way and no requirement to treat other additives similarly. It has also recently been made compulsory to make a special declaration on the label when packaging gases are used in containers. The gases are used to extend the shelf-life of products but, because they are not ingredients of the food, they will not be listed in the ingredients list. There are no safety concerns about the use of these gases and the meaning of the declaration for the vast number of purchasers is obscure. An important body of rules is in the care of officials in the Directorate-General VI, responsible for the Common Agricultural Policy. There is no ‘Food DG’ among the Directorates in the EU Commission or even one which has food in its title. (A recent creation among DGs, number XXIV, has taken the title Consumer Policy and Health Protection and the responsibilities for the enforcement of food law, the assesment of risks from food and for controls on claims made in labelling or advertising. However, it has not yet produced any proposals for legislation on this last matter.) There is no ‘Food’ chapter in the Treaty of Rome or in any of its supplementary or amending treaties agreed since 1957. Food legislation, including food labelling legislation, is clearly a means by which certain general policies, on the internal market or the support of agricultural producers, are pursued. The BSE disaster and other food controversies have prompted many organisations, including the EU’s institutions, to criticise this situation and to consider the need for a review of all food legislation in the light of agreed food policy. (See Section 2.9 below.) This is likely to be affected by further reorganisation of the Commission itself.

2.3

EU legislation and Codex standards

With some exceptions this collection of EU food labelling rules does not differ markedly from the standards and guidelines of the Codex Alimentarius. The Codex Alimentarius is the body of food standards which has commanded the consensus of countries which have participated and negotiated in regular meetings of the Codex Committees established by the UN’s Food and Agriculture Organisation and World Health Organisation. Food

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labelling is the subject of well-organised, annual meetings in Canada of the Codex Committee on Food Labelling, which is a powerful committee with responsibility for setting horizontal standards and guidelines and for vetting the more specific labelling rules proposed by other Codex Committees responsible for product sectors. There has hitherto been broad international consensus on what labelling rules should cover. Briefly, they should require that the food is correctly identified and described, including all its ingredients, if necessary. Legislators have taken the view that it is the nature of the food as purchased and consumed which is of prime concern to the purchaser. Other types of information, e.g. production methods, are treated as voluntarily made claims which are controlled only by the general obligation not to mislead. However, if certain claims become widespread, rules are usually devised to define such terms in order to protect consumers from fraud and bona fide producers from unfair competition. However, there are signs that these traditional labelling principles may no longer be enough and that the international consensus is beginning to break down. It is being increasingly challenged by self-styled ‘public interest’ groups which are seeking mandatory information on labels about such matters as geographical origin, production methods, treatment of animals and use of new technologies. The labelling of foods produced from genetically modified crops or from processes involving at some stage a genetic modification is currently the main focus of this debate. The reports of recent meetings of the Codex Committee on Food Labelling, which has discussed the labelling of foods produced by modern biotechnology, reveal clearly the serious lack of consensus on this issue.4 Some member countries, with the strong support of some pressure groups, now accept that information must appear on the label about the use of the technology, irrespective of its effect on the food as purchased. Others see no need for such an indication, unless the technology has changed the food in some way.

2.4

The main requirements for prepacked foods

The EU’s main food labelling Directive, 79/112/EEC, has been amended several times and the following description of its provisions takes account of all amendments up to 1998.5 It applies to all foodstuffs delivered to the consumer, whether at the retail stage or in catering establishments. It imposes two general rules: that labelling, presentation and advertising should not mislead the purchaser to a material degree, with some helpful elaboration on how that might occur; nor should they carry any medicinal claim about a foodstuff, i.e. a statement that it has the property of preventing, treating or curing a human disease or a statement with any reference to such properties. The Directive lays down the following categories of information which must appear on labelling: • • • • • • • • • •

the name of the food the list of ingredients the quantity of certain ingredients the net quantity the date of minimum durability any special storage conditions or conditions of use the name and address of the manufacturer, packager or seller place of origin, if omission of such information would mislead any necessary instructions for use alcoholic strength by volume for beverages containing more than 1.2% by volume.

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Of these categories some must appear in the same field of vision on the label: the name, the net quantity and the date-mark, plus the alcoholic strength for alcoholic drinks. Most of the rest of the Directive lays down more detailed rules for several of these categories. It also prevents Member States from imposing other mandatory information unless this has been authorised at EU level.

2.4.1 The name of the food If a name of a food is laid down in EU legislation, it must be used for the foodstuff in question. Failing that, the name prescribed in the Member State where the product is marketed must be followed. If there is none, the supplier must use either a customary name or a description of the foodstuff which is clear enough to convey to the purchaser its true nature. The legal name in the Member State where the food is produced is given equal status to the legal name of that food in the Member State where it is marketed, but if together with the other label information it would not enable consumers to know the true nature of the food, then descriptive information must accompany the name or in exceptional cases the name cannot be used. The legal name cannot be the brand or fancy name nor the trade mark used on the label. If the food has been treated or its physical condition has been changed, e.g. dried, concentrated or frozen, this must be indicated in the legal name, if omission of such information would confuse. For one treatment, irradiation, the precise terminology to be used has been laid down.

2.4.2 The list of ingredients The Directive sets out fairly detailed rules on ingredients, with the help of three Annexes. The main provisions in the Article text define ingredients and require that they be listed in descending order of weight as recorded at the time of their use in the manufacture of the food, and that they be given specific names. A specified list of foodstuffs, most notably alcoholic drinks containing more than 1.2% alcohol by volume, need not carry ingredients lists. ‘Ingredient’ is any substance which is used in the manufacture or preparation of the food and is still present in the finished product. It, therefore, includes additives but not those which are used as processing aids, solvents or media for other additives or flavourings nor those which may be present in the final product but serve no technological function in it. Specific rules deal with added water, concentrated or dehydrated ingredients and mixtures of fruit, vegetables, herbs and spices. Annexes I and III provide that flavourings and categories of certain ingredients may be described in the ingredients list with general rather than specific names. Annex II lays down the additive category names which must be used. A compound ingredient may be included in the list under its own name and in terms of its overall weight, provided that its name is immediately followed by a list of its own ingredients, unless it constitutes less than 25% of the product or is a food exempt from ingredient listing. The 25% rule exemption does not apply to those additives in a compound ingredient which serve a technological function in the final food, which must all be listed.

2.4.3 The quantitative declaration of ingredients Article 7 of the Directive contains the recently agreed, so-called QUID rules relating to quantitative declaration of ingredients. All ingredients which appear in the legal name, or are usually associated with the food, or which are emphasised on the label, or which are

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Food labelling

essential to characterise a food and to distinguish it from products with which it might be confused, should be quantified. Exemptions apply to foods already covered by quantitative information requirements in other EU legislation, and remove the obligation to quantify for ingredients used in small quantities for the purposes of flavouring, for the mixtures of fruits, vegetables, herbs and spices which do not need to be separately identified in the ingredients list, and for ingredients which while appearing in the name of the food are judged not to influence the choice of the consumer as far as their quantities are concerned. The quantity must be shown as a percentage; it must relate to the ‘mixing bowl’ or preparation of the food, not the finished product; and it must appear next to the name of the food or to the name of the ingredient in the ingredients list. (See also Section 2.4.7.)

2.4.4 Net quantity The rule on net quantity applies only to pre-packed foods and establishes the principle that net quantity must be expressed in metric units of volume (for liquids) or mass (for other products), unless EU or national provisions lay down that some other type of quantity is required. More detailed requirements are laid down in Council Directives 75/ 106/EEC and 76/211/EEC and Commission Directive 78/891: that ‘nominal weight’ or ‘nominal volume’ must be shown on the package, that the contents must on average not be less than the nominal quantity and that a small ‘e’ must be placed in the same field of view as a guarantee that the information meets the requirements of the directives.6 For solid foodstuffs sold in liquid media (as defined) the drained net weight must also be shown.

2.4.5 Minimum durability There are two detailed Articles in the Directive on the important issue of date of minimum durability, which is defined as the date until which the foodstuff retains its specific properties when properly stored. It must be indicated by use of the words ‘best before’ and the date itself, which can be shown in several ways depending on the food’s shelf-life. Certain foods and drinks are exempted from date-marking. Foodstuffs which are microbiologically highly perishable must carry a ‘use by’ in place of the ‘best before’ indication, and the form of the date is specified.

2.4.6 Other requirements The remaining Articles of the Directive deal with the ‘competence’ of the Member States in relation to some important general issues. One permits them not to apply some or all of the minimum mandatory information to foods sold without prepackaging or those sold in fancy packaging. In the UK there are very significant differences between the information required for prepacked foods and for those sold loose, e.g. at greengrocery or delicatessen counters, or those sold ‘prepacked for direct sale’, i.e. wrapped at the retail stage usually following the customer’s order. Another Article obliges Member States to require that the minimum mandatory information on labels should be in a language easily understood by the purchaser, although they may also stipulate that certain EU languages must be used.

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2.4.7 Recent amendments This Directive has been supplemented by three further Directives, in 1994, 1996 and 1999.7 The two earlier ones use the power in Article 4(2) of the principal Directive to add to the minimum mandatory information for certain foodstuffs. The first requires that the words ‘packaged in a protective atmosphere’ should appear on the labels of foodstuffs whose shelf-life has been extended by means of packaging gases. The second requires mention of sweeteners both in the ingredients list and in the name of the food, as well as other wording when certain sweeteners are used. The most recent subsidiary Directive modifies the QUID rules in the light of further consideration about how they could be implemented (an exercise largely driven by the UK, which accepted the original rules with great reluctance because of their vagueness and subjectivity). Now volatile ingredients must be indicated on the basis of their proportion by weight in the final product, and concentrated or dehydrated ingredients may be indicated in their whole form if that is how they are consumed. Unnecessary quantifications of sweeteners, vitamins and minerals are now set aside. The EU has also adopted a set of guidelines, again largely drafted by the UK, on the practical application of the QUID rules. This body of generally applicable food labelling requirements is very similar to the General Standard on the Labelling of Prepacked Food of the Codex Alimentarius.8 The most important difference is that the Codex Standard does not include mandatory requirements for the quantitative declaration of ingredients. Nevertheless, there is no reason why Codex should not adopt these requirements. They conform to the internationally accepted principles of informing the consumer about the nature of the food as purchased and of enhancing equal conditions of competition between food suppliers. Quantitative declaration of ingredients is an important additional piece of information about the composition of many so-called compound foods, which allows consumers to compare competing products which may appear similar. It becomes less important if the products in question are all made to the same recipe because legislation defines the composition. QUID, when adopted, facilitates the repeal of sometimes rather old-fashioned ‘recipe law’, although the attachment of some legislators and indeed some industry sectors to ‘their’ laws should not be underestimated.

2.5

Nutrition labelling and claims

Council Directive 90/496/EEC on nutrition labelling2 established a standardised format within the EU for quantitative nutrition information on foods. Its legal basis is Article 100A of the Treaty of Rome, making it an internal market measure and this is reinforced by references in its preamble to enabling consumer choice and avoiding technical barriers to trade. However, there is also recognition that there are other dimensions to this particular subject; the growing public interest in the relationship between diet and health and the improvement of nutrition in order to assist the European programme against cancer. Therefore, the legislation is presented as providing for a voluntary, standardised, simple, easy to understand scheme which should be introduced gradually and then reviewed and amended in the light of its operation. The rules are potentially applicable to all food and drink except natural mineral waters or other waters intended for human consumption. The Directive provides that nutrition labelling as defined is optional but it becomes mandatory if a nutrition claim as defined appears on labelling, presentation or advertising of a product. Nutrition labelling means any information on the label which refers to the energy value of the food, or to protein,

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carbohydrate, fat, fibre, sodium or to other minerals or vitamins listed in the Annex to the Directive. Nutrition claim is defined as any representation and any advertising message which states, suggests or implies that a foodstuff has particular nutrition properties relating to energy value or to its nutrients. The Directive goes on to prohibit any nutrition claims which do not relate to energy, the nutrients mentioned above or the substances which belong to or are components of a category of those nutrients, e.g. starch as a type of carbohydrate. Whenever nutrition infomation is given it must be given in one of two basic formats, preferably in tabular form with numbers aligned: (a) Group 1, which consists of energy value in kJ or kcal and the amount of protein, carbohydrate and fat in grams; (b) Group 2, which consists of those plus sugars, saturates, fibre and sodium, also in grams. If a nutrition claim is made for any of the additional Group 2 nutrients, the Group 1 format cannot be used. Both formats could be expanded to include additional components, namely starch, polyols, mono-unsaturates, polyunsaturates, cholesterol and the vitamins and minerals listed in the Annex; but if information about monounsaturates, polyunsaturates and/or cholesterol is given, the amount of saturates must also be specified. The effect of these rules is to prevent the voluntary addition of information about certain nutrient components which are not mentioned in the Directive. The most important of these in terms of current interest is trans-fatty acids. If a claim about transfatty acids is made, the quantity must be shown in the nutrition labelling format used; if no claim is made, strictly speaking no information about trans-fatty acids can be given. The Directive goes on to lay down definitions of certain nutrients, energy values for the main nutrients and further rules on the formats. For example, the quantities given must be expressed per 100 gm or per 100 ml of the product and may be expressed also per serving or per portion of the product. They must be given in relation to the food as sold but may alternatively be in relation to the food as consumed, provided sufficiently detailed preparation instructions are given. The quantities of vitamins and minerals must be given not only per 100 gm/ml but also as percentages of the recommended daily allowances (RDAs) specified in the Annex. The Annex itself contains an important little statement, the effect of which is to prevent in most cases any quantitive information on vitamins and minerals unless the food contains 15% of the relevant RDA. Finally, the Directive requires the Commission to produce a report on its application together with any appropriate proposals for amendment by October 1998. It did not do so and at the time of writing there is little sign of a report. Although the Directive is a lucidly drafted set of instructions to Member States, the UK’s experience of implementing it was dogged with uncertainty about its practical operation. Food suppliers and food law enforcers have needed a great deal of advice and guidance, and the Ministry of Agriculture, Fisheries and Food (MAFF) eventually produced detailed guidance notes in a question and answer format in order to elucidate the rules and tackle issues of detail such as calculations of vitamins, energy conversion factors for novel nutrients, and the understanding of phrases such as ‘generally speaking’. The UK has for some time been a leading player in the EU on the development of nutrition labelling legislation. In anticipation of the Commission’s report expected in October 1998 MAFF held a public consultation about the operation of the nutrition labelling rules and the need for changes. The results were submitted to ministers in the second half of 1997 and a fairly comprehensive set of proposals sent to the Commission

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in November 1997. It consisted of three major suggestions: that nutrition labelling should be compulsory and always in the Group 2 format (but allowing a small package exemption); that per serving information should probably also become compulsory; and that criteria for nutrition claims should be laid down on the basis of the work already done in the Codex Committee on Food Labelling. The UK’s paper also included a list of detailed comments on technical issues.9 Since the adoption of the nutrition labelling Directive the Commission has expressed its intention of making proposals for the harmonisation of Member States’ rules on nutrition claims. There have been several attempts but they have never got beyond internal consultation drafts, because of differences of opinion within the Commission, some resistance from industry and very different attitudes to such claims in Member States. In the UK the control of such claims is patchy. Apart from the general rules that a claim should not mislead the purchaser and that medicinal claims are prohibited, there are legislative criteria for claims about energy, protein, vitamins, minerals and cholesterol. The UK’s Food Advisory Committee has also recommended criteria for claims about fat, saturates, sugar(s), salt/sodium and fibre, which have been adopted by many manufacturing and retailing companies but not by all, because of serious disagreement about the applicability of the recommended criterion for the ‘low fat’ claim to certain types of products. The UK has acknowledged for some time that this situation needs to be improved but has held back, first in the expectation of proposals from the Commission and later because of promising progress on developing guidelines in the Codex Committee on Food Labelling. That Committee now has agreed guidelines for criteria for a longer list of claims than are covered by the UK’s legislation and recommendations combined. MAFF’s very useful tabular comparison of Codex and UK criteria is reproduced in the Annex to this chapter. The UK’s criteria have been amended as a result of consultations and adopted formally. They are now available from the Food Standards Agency.9

2.6

Specific labelling requirements in food composition Directives

This group of Directives was put together mainly during the 1970s, when the EU had embarked on the attempt to harmonise national laws on specific foodstuffs. All the Directives are based on Article 100 and most of them are also based on Article 43 because they are controlling foods which are subject to the common organisations of agricultural markets. Nine food sectors are covered: cocoa and chocolate products, coffee extracts and chicory extracts, certain preserved milks, fruit juices and similar products, honey, certain sugars, jam, caseins and erucic acid. The first seven of these have been reviewed by the EU Commission during the 1990s and it has made proposals to simplify and update them in the light of the horizontal rules adopted on labelling and additives. At the time of writing all the proposals except those on coffee and chicory extracts were still under negotiation in the EU’s institutions. The following paragraphs give examples of the kind of provisions which the existing seven Directives contain.10 The preambular clauses always base the need for harmonised rules on the fact that national laws exist which define the products in question and impose labelling conditions, on the likelihood that these national laws will constitute a barrier to the free movement of goods and on the assertion that they therefore have a direct bearing on the establishment and functioning of the common market. Council Directive 73/437/EEC on the approximation of the laws of the Member States concerning certain sugars intended for human consumption also justifies its provisions by the need to ensure the smooth

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running of the common organisation of the market in sugar. This Directive in common with some of the others makes no reference to the consumer, while others in the seven do contain justifications about protecting and informing consumers and about laying down conditions which take account of consumer requirements. All the Directives in this group define the products which they cover and assign each product a name which can only be applied to a food meeting the product’s definition and moreover which must be used for that food in trade. The Directives, because they were adopted before the principal food labelling Directive, 79/112/EEC, also list the information which must appear on the labels of the foods in question. All list the reserved name and the name of the manufacturer, packer or seller in the EU. Many require net weight to be shown and in some sale quantities are prescribed. Depending on the product in question other descriptions or types of information are made compulsory. For example, some chocolate product labels must carry the total dry cocoa content; if coffee has been decaffeinated that must be shown; preserved milks must show the percentage of milk fat. Member States are generally not permitted to make any other information mandatory but there are many exemptions, indicative of the difficulties which arise when vertical harmonisation is attemped. Product names specific to one or a few Member States have to be listed, e.g. evaporated milk is allowed to be a reserved name in the UK and Republic of Ireland. Some of the Directives permit Member States to retain their national rules requiring the origin of products to be stated, provided that they are not applied to products of EU origin. National rules on the addition of vitamins to preserved milks and fruit juices are permitted. National rules on how the information should be presented on the label are prohibited but Member States are allowed to specify the languages which must be used.

2.7

Specific labelling requirements in CAP marketing regulations

CAP marketing regulations which contain labelling provisions of direct interest to consumers deal with eggs, poultry, fruit and vegetables, olive oil, beef, milk and milk products and spreadable fats; and also with wines and some spirit drinks (because of the use of agricultural produce, namely grapes and cereals, in their production). All these rules are devised by officials in DG VI (see Section 2.2) and negotiated within the Council of Agricultural Ministers or in the committees charged with the day-to-day management of the common markets in agricultural produce. The preambles of the regulations generally state that the aims are to promote the stability of the agricultural market in question, safeguard the interests of producers and help consumers identify and distinguish foods which may be confused or foods which may differ in quality. The labelling rules have been devised to meet the different marketing conditions of each foodstuff and it is not possible to treat the foods as a homogeneous group, unlike the foods covered by the food composition Directives described in the previous section. The rules range from simple provisions in the olive oil regulations, which are concerned mainly with defining the meaning of descriptions such as olive oil and virgin olive oil, to detailed rules on eggs or on the use of dairy product names.11 One important similarity between some of the regulations is the grading of the foods they control by quality. This applies to fruits and vegetables, eggs and poultry and such classifications are justified as contributing to the improvement in the quality of the foods in question, facilitating trade and making it easier for consumers to distinguish between

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products of different quality. The regulations require that labels should indicate the quality class. Another similarity between some regulations is the requirement to show country of origin. This applies to fruits and vegetables and is justified as an important means of conveying to consumers the characteristics of these foods. Poultrymeat from countries outside the EU must show its origin. The recently agreed regulation on the labelling of beef indicates that country of origin will become compulsory in due course. Production methods for eggs and poultry are of interest to many consumers and the regulations duly define the chief features of such systems as free range or barn reared and require that products marketed under those terms should conform to the definitions. Other information prescribed or controlled by the marketing regulations include date-marking, weight, the condition of the food (i.e. fresh, frozen), variety, even price indications and the size of lettering, some of which is clearly not necessary, given the existence of the general rules in 79/112. Finally, most of the regulations set out names and descriptions which should be used for the foods when they are marketed to the consumer. This feature is most developed in the rules covering milk products and spreadable fats. Council Regulation (EEC) No. 1898/87 on the protection of designations used in the marketing of milk and milk products has as its stated objectives that the natural composition of these foods should be protected in the interests of EU producers and consumers by means of appropriate labelling, and that confusion between milk products and competing products, e.g. margarines, should be avoided. The related Council Regulation (EEC) No. 2991/94 laying down standards for spreadable fats also aims to help consumers distinguish between the products covered, which may be comparable in terms of fat content but differ in terms of the types of fats used, i.e. milk, animal or vegetable. These objectives are achieved by detailed rules on names and descriptions of the products in question. Regulation 1898/87 defines milk and milk products (whey, cream, butter, buttermilk, butteroil, cheese, yoghurt and some others), reserves the names and prohibits their application or the use of related terms, such as ‘dairy’, to other products. Regulation 2991/94 distinguishes spreadable fats by name and by fat content and the names are reserved. Both regulations recognise that some of the reserved names have traditionally been used for completely different foods, e.g. cream cracker, coconut milk, and they provide for exemptions for the use of reserved names in ‘products the exact nature of which is clear from traditional usage and/or when the designations are clearly used to describe a characteristic quality of the product’, e.g. cream of tomato soup. However, use of the term ‘butter’ in what are called composite products is permitted only if the products are recognised in the regulations, which have been amended to list permitted names, such as brandy butter, and to specify their minimum milk fat content.

2.8

Novel foods and genetically modified foods: labelling rules

Six and a half years after the Commission formally tabled a proposal for the harmonised control of novel foods (including genetically modified foods) the Council and European Parliament agreed a joint text, which was promulgated on 27 January 1997.3 This regulation (258/97) subjects novel foods, as defined, to a pre-marketing approval procedure, resulting either in no objection to a Member State’s approval or an ‘authorisation decision’ at EU level for each approved novel food. The authorisation is likely to require the supplier of the novel food to include labelling information on his

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product in addition to the information required by existing EU labelling rules. This additional information is set out in Article 8 of the regulation as follows: (a) the presence of genetically modified organisms; (b) the presence of material in a novel food which is not present in an existing equivalent food and which gives rise to ethical concerns; (c) the presence of material in a novel food which is not present in existing equivalent food which may affect the health of certain sections of the population; (d) a characteristic or property of the food, such as composition, nutritional value or effect, or intended use, which renders it no longer equivalent to an existing food. In this case equivalence is to be assessed scientifically and the assessment will take account of accepted limits of natural variations of the characteristics assessed. Also in this case the labelling will identify the modified characteristic or property and the method by which it was obtained. Because of its definition of novel foods, the provisions of this regulation could not be applied to novel foods and genetically modified foods which were already on the EU market. Two such examples were foods which resulted from the application of genetic modification techniques to soya and maize. Commission Decisions of April 1996 and January 1997, made under the EU’s Directive on the deliberate release into the environment of genetically modified organisms, had approved genetically modified soya beans with increased tolerance to the herbicide, glyphosate, and genetically modified maize with both insecticidal properties and increased tolerance to the herbicide, glufosinate ammonium. These raw products were on the EU market and, although they themselves contained live genetically modified organisms, food products derived from them, e.g. oil and flour, do not. Nevertheless there was considerable concern about them among some Member States, who did not regard the existing food labelling rules as sufficient for them. The Commission, therefore, introduced a proposal to harmonise Member States’ treatment of these foods, using the power in Article 4(2) of the food labelling Directive, 79/112/EEC, which also had the advantage of speed, since it allowed the Commission to legislate without reference to the Council. By September 1997 Commission Regulation 1813/9712 had been adopted extending the special labelling requirements of the novel foods regulation to products derived from the genetically modified soya and maize. But it became clear that this regulation would have little effect, except as an advance warning to potential suppliers of the processed soya and maize products and as a response to consumers’ concerns, until the EU had worked out an agreement on more detailed issues. The next step in this tortuous process was taken in May 1998 in Council Regulation 1139/98.13 This replaced 1813/97 and also specified the wording required on labels when foodstuffs contained ingredients derived from genetically modified soya and maize, if they contained protein or DNA material resulting from genetic modification. If they did not contain such protein or DNA, even though they might have been obtained from genetically modified soya beans or maize, these labelling rules did not apply. The regulation also provides for the construction of a list of processed soya and maize products not subject to the additional labelling requirements. When it appears (probably including refined oils and starch derivatives) it will help companies by giving greater certainty about the products affected by the regulation. Another area of rule-making is signalled in the regulation’s preamble, namely setting a de minimis threshold for the presence of DNA or protein resulting from genetic modification in order to take account of adventitious contamination. This was subsequently set at 1 per cent.

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Regulation 1139/98 is important because it gives legislative form for the first time to the EU’s developing ideas on what ‘equivalence’ means for labelling purposes in the context of genetic modification. Internationally, the concept of ‘substantial equivalence’ is used in relation to the safety assessment of genetically modified foods. ‘Substantial equivalence’ has been described in the WHO/FAO paper, ‘Biotechnology and Food Safety’.14 Its basic concepts are repeated almost verbatim in Article 8 of the novel foods regulation (258/97). However, the EU’s refinement of these concepts in regulation 1139/ 98 is regarded by the other main international regulators (in the USA and Canada) as requiring labelling in more cases than may be justified.

2.9

Future developments

During 1997 the Commission published two documents which it presented as developing a new approach to consumer health and food safety and laying the foundations for a ‘proper food policy’. These documents were a Communication, ‘Consumer Health and Food Safety’ and a Green Paper, ‘The General Principles of Food Law in the European Union’.15 The Communication dealt with the organisation and management of scientific advice, risk assessment and control services in the Commission and in its advisory committees, and will not be considered further in this chapter. The Green Paper examined the extent to which current EU legislation met identified objectives and how EU food law could be developed in the future. It did so in a lengthy, repetitive and not very wellorganised way, but it did give the patient reader a comprehensive overview of existing legislation, for example on food labelling, and its probable future evolution. In its overview of existing EU legislation the Commission acknowledged that measures taken to achieve the objectives of the Common Agricultural Policy inevitably resulted in rules which affected the sale of foodstuffs. It has called these ‘quality specifications’ and ‘quality marks or labels’ and the recent rules on ‘traceability’ of beef. When these were viewed together with the rules on food labelling determined under the internal market policy, the Commission had to admit that the rules applicable to foodstuffs have developed from a variety of different legal bases in order to serve different policy objectives and that the situation was complicated, even to the specialist. The Commission offered no general proposals for ameliorating this complexity or for bringing all foodstuffs legislation within one policy area. Most of its suggestions for change, made rather tentatively, related to increasing its own powers and diminishing the freedom of Member States to make national rules. However, in the labelling sphere of legislation it did invite comments on whether the labelling rules which were to be found in Common Agricultural Policy marketing regulations or in other texts should be consolidated into a single labelling text or whether ‘in the interests of flexibility they should be set out in specific texts’. Probably because of differences of view between Directorates-General III and VI the Commission has given no hint about which option it might prefer. The British response to the Green Paper, which is available from MAFF, pressed for EU law to be simpler, more coherent and easier for the ordinary citizen to understand. It supported a review of labelling provisions in all texts to check whether they were necessary in the light of the general rules in 79/ 112 or for consumer information or enforcement purposes. On substantive labelling issues the Green Paper also invited comments on the EU’s approach to the regulation of health and nutrition claims; on whether nutrition labelling should be made compulsory and whether it provided sufficient information; and on how

44

Food labelling

production methods which do not have an impact on the ‘food characteristics of the finished product’ (i.e. use of chemical inputs, treatment of livestock) should be communicated to the food purchaser. On this point the Commission seemed reluctant to go down the road of mandatory labelling except in certain cases, as it has already done on beef. However, it also suggested that there might be scope for ‘Community measures to encourage the development of voluntary information’ but did go into detail. In April 1998 the Commission issued a summary15 of the 140 responses received from Member States, third countries and European and international organisations. This revealed: (a) that ‘generally a review of . . . existing labelling provisions . . . would be favoured’ but that there were opposing positions on whether labelling provisions in marketing regulations should be consolidated; (b) that the ‘25% rule’ should be amended so that the allowance is reduced or abolished; (c) that fourteen Member States favoured harmonisation of rules on claims, possibly building on the work done by the Codex Committee on Food Labelling; (d) that a new look was needed at nutrition labelling. These are obviously the areas in which we should expect to see more activity in future and they are similar to developments in the Codex Committee on Food Labelling. Recent changes to that forum’s standard and guidelines include a modification to the 25% rule to zero for a specified list of foods which have been demonstrated to cause hypersensitivity, and established criteria for the most commonly used nutrition claims. It has also embarked on guidelines for health claims. There is also an outstanding proposal from the Commission to extend ingredient listing to all alcoholic drinks. Whether more radical changes or new directions will be seen in EU food labelling legislation is still a matter for debate. The Commission does not seem to be keen to lead the way and in the absence of a commitment from it, the realistic prospect for EU legislation is to continue to develop in a piecemeal and unco-ordinated fashion.

2.10

References and sources of further information

NOTE: the abbreviation OJ is used below for the Official Journal of the European Communities, which can be consulted in specialist libraries. A useful directory to these sources is Vacher’s European Companion, published quarterly by Vacher’s Publications, 113 High Street, Berkhamstead, Herts., HP4 2DJ. 1. 2. 3. 4.

Council Directive 79/112/EEC, OJ No L33 of 8.2.1979, page 1. NB see note 5 below. Council Directive 90/496/EEC, OJ No L276 of 6.10.1990, page 40. Regulation (EC) No 258/97 of the European Parliament and the Council, OJ No L43 of 14.2.1997, page 1. Reports of the twenty-fourth and twenty-fifth sessions of the Codex Committee on Food Labelling, FAO, Rome, 1976 and 1977. 5. The amendments are: Commission Directive 83/463/EEC (OJ No L255 of 15.9.1983, page 1); Council Directive 85/7/EEC (OJ No L2 of 3.1.1985, page 22); Council Directive 86/197/EEC (OJ No L144 of 29.5.1986, page 38); Commission Directive 87/250/EEC (OJ No L113 of 30.4.1987, page 57); Council Directive 89/395/EEC (OJ No L186 of 30.6.1989, page 57); Commission Directive 91/72/EEC (OJ No L42 of 15.2.1991, page 27); Commission Directive 93/102/EC (OJ No L291 of 29.11.1993, page 14); Directive 97/4/EC of the European Parliament and Council (OJ No L43 of 14.2.1997, page 21). These have now been consolidated with 79/112/EEC into Council Directive 2000/13/EC/OJ No L 109 of 6.5.2000, page 29. 6. Council Directive 75/106/EEC, OJ No L42 of 15.2.1975, page 1; Council Directive 76/211/EEC, OJ No L46 of 21.2.1976, page 1; Commission Directive 78/891/EEC, OJ No L311 of 4.11.1978, page 21. 7. They are Commission Directive 94/54/EC, OJ No L300 of 23.11.1994, page 14; Council Directive 96/21/ EC, OJ No L88 of 5.4.1996, page 5; and Commission Directive 99/10/EC, OJ No L69 of 16.3.1999, page 22.

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45

8. General Standard of the Labelling of Prepacked Foods of the Codex Alimentarius, FAO, Rome, 1998. 9. The UK’s guidance notes and proposals for further amendments are available from the Food Standards Agency. Its address at the time of writing is Ergon House, 17 Smith Square, London SW1P 3JR. 10. These seven Directives are: Council Directive 73/241/EEC (cocoa and chocolate products), OJ No L288 of 16.8.1973, page 23; Council Directive 77/436/EEC (coffee extracts and chicory extracts), OJ No L172 of 12.7.1977, page 20; Council Directive 76/118/EEC (preserved milks), OJ No L24 of 30.1.1974, page 49; Council Directive 75/726/EEC (fruit juices, etc.), OJ No L311 of 1.12.1975, page 40; Council Directive 74/409/EEC (honey), OJ No L221 of 12.8.1974, page 10; Council Directive 79/693/EEC (jams), OJ No L205 of 13.8.1979, page 5; and Council Directive 73/437/EEC (sugar products), OJ No L356 of 27.12.1973, page 71. 11. The list of regulations covering this group of foodstuffs is very long and amendments appear frequently. Specialist libraries will be able to provide access to the texts and the relevant databases. 12. Commission Regulation (EC) 1813/97, OJ No L257 of 20.7.1997, page 7. 13. Council Regulation (EC) 1139/98, OJ No L159 of 3.6.1998, page 4. 14. ‘Biotechnology and Food Safety’, FAO food and nutrition paper 61, FAO, Rome, 1996. 15. These papers are available from the Food Standards Agency (address at reference 9 above) and from specialist libraries listed in Vacher’s European Companion (see note at the beginning of this section).

Appendix: Comparison of Codex and UK claims criteria I. Criteria for low or free claims Component

Claim

UK provision not more than

Codex provision3 not more than

Energy

Low

40 kcal per 100 g or 100 ml and 40 kcal per serving1

40 kcal per 100 g (solids) or 20 kcal per 100 ml (liquids)

Energy

Free

no criteria

4 kcal per 100 ml

Fat

Low

5 g per 100 g or per 100 ml and 5 g per serving2

3 g per 100 g (solids) 1.5 g per 100 ml (liquids)

Fat

Free

0.15 g per 100 g or 100 ml2

0.5 g per 100 g or 100 ml

Saturated fat

Low

3 g per 100 g or 100 ml and 3 g per serving2

1.5 g per 100 g (solids) 0.75 g per 100 g (liquids) and 10% of energy

Saturated fat

Free

0.1 g per 100 g or 100 ml2

0.1 g/100 g (solids) 0.1 g/100 ml (liquids)

Cholesterol

Low

no criteria

0.02 g per 100 g (solids) 0.01 g per 100 ml (liquids) and less than: 1.5 g saturates per 100 g (solids) 0.75 g saturates per 100 g (liquids) and 10% of energy

Cholesterol

Free

0.005% (i.e. 0.005 g per 100 g)1

0.005 g/100 g (solids) 0.005 g/100 ml (liquids) and less than: 1.5 g saturates per 100 g (solids) 0.75 g saturates per 100 g (liquids) and 10% of energy

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Food labelling

Sugars

Free

0.2 g per 100 g or 100 ml2

0.5 g per 100 g or 100 ml

Sodium

Low

40 mg per 100 g or 100 ml and 40 mg per serving2

120 mg per 100 g

Sodium

Very low no criteria (UK ‘low’ claim equivalent to Codex ‘very low’ claim)

Sodium

Free

5 mg per 100 g or 100 ml2

40 mg per 100 g

5 mg per 100 g

II. Criteria for source or high (rich) claims Component

Claim

UK provision1

Codex provision4

not less than

not less than

Most appropriate Codex provision not less than

Protein

Source

12 g per day and 12% energy from protein

10% of NRV per 100 g (solids) 5% of NRV per 100 ml (liquids) or 5% of NRV per 100 kcal or 10% of NRV per serving

10% of NRV per serving

Protein

High

12 g per day and 20% energy from protein

20% 10% or 10% or 20%

20% of NRV per serving

of NRV per 100 g (solids) of NRV per 100 ml (liquids) of NRV per 100 kcal of NRV per serving

Vitamins and minerals

Source

1/6 RDA per day (approx. 17% RDA)

15% of NRV per 100 g (solids) 15% of NRV per 7.5% of NRV per 100 ml (liquids) serving or 5% pf NRV per 100 kcal or 15% of NRV per serving

Vitamins and minerals

High

1/2 RDA per day (50% RDA)

30% 15% or 10% or 30%

of NRV per 100 g (solids) of NRV per 100 ml (liquids)

30% of NRV per serving

of NRV per 100 kcal of NRV per serving

NRV = Nutrient Reference Value RDA = Recommended Daily Allowance Codex NRVs and UK RDAs for vitamins and minerals, where set, are the same. Protein claims: The Codex Nutrient Reference Value for protein is 50 g per day. Therefore the Codex criteria are equivalent to: Source: or or

5 g per 100 g 2.5 g per 100 ml 2.5 g protein per 100 kcal (equivalent to 10% energy) 5 g per serving

Labelling requirements: European Union High: or or

10 g per 100 g 5 g per 100 ml 5 g per 100 kcal (equivalent to 20% energy) 10 g per serving

Notes: 1. Food Labelling Regulations 1996 2. Draft MAFF Guidelines, 1993. 3. Guidelines adopted at 22nd Codex Alimentarius Commission (ALINORM 97/37). 4. Criteria agreed at 21st CCNFSDU (ALINORM 99/26, Appendix II).

47

3 Labeling requirements: United States J. Vanderveen (Center for Food Safety and Applied Nutrition, Food and Drug Administration, Washington DC) and E. J. Campbell (AAC Group, Bethesda)

3.1

Introduction

This chapter is an introduction to food labeling requirements in the United States from which readers can move on to later chapters dealing with specific aspects of food labeling. The guiding principles of the laws and implementing regulations for food labeling in the United States are fostered by both economic and public health concerns. These concerns include the need to provide adequate information to: • assure informed choice by consumers • create an awareness of actions necessary to assure food safety and wholesomeness • to promote honesty and fair dealing in the market place.

There are eight major laws that provide the authority to regulating agencies to implement and enforce food-labeling requirements in the United States. These are the Federal Food, Drug, and Cosmetic Act,1 the Fair Packaging and Labeling Act,2 the Federal Meat Inspection Act,3 the Poultry Products Inspection Act,4 the Egg Products Inspection Act,5 the Federal Trade Commission Act,6 the Federal Alcohol Administration Act,7 and the Tariff Act.8 These provide the foundation on which regulations covering specific aspects of labeling (e.g. nutrition labeling) rest. The Federal Food, Drug, and Cosmetic Act (FD&C Act) is the main law governing food labeling in the United States because it applies to all foods except meat from domesticated animals, poultry and poultry products derived from domesticated birds and alcoholic beverages. The FD&C Act requires that the product label have a statement of identity (name of the food), an ingredient statement, the name and address for the responsible agent for the product, a net contents declaration, and nutrition labeling. The FD&C Act provides for the inclusion of nutrient content claims and health claims on products that qualify. The FD&C Act also provides for the establishment of standards of identity regulations for applicable foods that can require specific composition and/or processing procedures. The United States Food and Drug Administration (FDA) administers this Act. The Federal Meat Inspection Act, which provides authority for the regulation of food derived from the tissue of domesticated animals and the Poultry Products Inspection Act,

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Food labelling

which provides authority for the regulation of foods derived from the tissue of domesticated birds include authority for the labeling of those products. However, no specific authority is granted to require nutrition labeling, nutrient content claims or health claims for these products. These Acts do provide authority for establishing requirements for the naming of the product, the establishment of standards of identity (compositional standards), ingredient listing, listing the responsible agent for the product, and requirement of an official inspection legend. The Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture administers these acts. The Fair Packaging and Labeling Act applies to all foods sold in interstate commerce in the United States. In addition to the requirements for specifying the identity of the commodity and providing the name of the place of business of manufacturer, packer, or distributor, the Act requires that the net quantity of contents be declared in terms of weight or mass, measure or numerical count. Both the FDA and the FSIS administer this act for the foods they regulate. The provisions of the Federal Trade Commission (FTC) Act apply to all interstate commerce, including sale of foods, in the United States. Under the FTC Act, false advertisement for the purpose of inducing or which is likely to induce directly or indirectly the purchase in or having an affect upon the commerce of food is prohibited. In the United States, statements made on the label or on any promotional material displayed at the point of sale are considered part of labeling. These statements can also be considered as advertisements and, therefore, subject to the FTC Act. From time to time the Federal Trade Commission, which administers the FTC Act, has taken regulatory action against claims in labeling. In the United States, the labeling of most beverages that contain alcohol is regulated under the provisions of the Federal Alcohol Administration Act. The Bureau of Alcohol, Tobacco and Firearms (BATF), which administers this Act, has established regulations on the labeling of wine, malt beverages and distilled spirits or any beverage containing distilled spirits. A specific warning statement is required for all alcoholic beverages sold in the United States which informs about the risk of birth defects associated with drinking alcoholic beverages during pregnancy, the impairment of ability to drive a vehicle or operate machinery, and the potential for causing other health effects. Finally, the Tariff Act administered by the United States Customs Service requires that labels of all food containers or the labels on packaged foods include the English name of the country of origin of the food. In the United States the federal, state and local governments can have laws and regulations which cover the production, manufacturing, and distribution of foods. However, in most areas of food labeling the federal law requires national uniformity. The labels for all meat and poultry products and all other packaged foods sold in interstate commerce are subject to uniform labeling rules with the exception of certain warning statements, and other information determined to be important to consumers is not preempted by federal laws or regulations.

3.2

The legislative and rule-making process

All three branches of the US government (legislative, executive, and judicial) have a role in establishing food labeling requirements. Congress passes laws that establish general requirements and provide authority to regulating agencies to implement and enforce specific labeling requirements. Once the President (the executive branch) signs the

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51

legislation, it becomes an official statute and is published in the United States Code (USC). Because laws are broad and non-specific, the President is given the responsibility of implementing them through the various regulatory departments by establishing regulations. These regulations provide more specific requirements. As mentioned above, the main administrative organization within the executive branch responsible for food is the FDA, which is part of the Department of Health and Human Services. Labeling for meat and poultry products is under the control of the FSIS in the Department of Agriculture. All regulations promulgated by the executive branch of the government must go through a public rule-making process which is mandated by the Administrative Procedure Act9 of 1946 (APA). This procedure is initiated by publishing a proposal in the Federal Register (FR). The FR is published by the Government Printing Office (GPO) every working day of the year and provides an enormous array of notices by all administrative units. The FR process allows all affected citizens and organizations to comment on the provisions of the proposed regulation, and gives the agency a chance to respond. The regulation has the force and effect of law, unless reinterpreted by the courts (the third part of the US legislature–executive–judicial government design). The FR provides in a preamble to a proposed regulation a discussion of why the regulation is being proposed and the science base for the requirements. The preamble for a final regulation contains responses to comments received, a cost/benefit analysis (especially for impact on small businesses), any potential environmental impacts, and an analysis of paperwork required of the public as a result of the regulation. The actual wording and format (numbering of paragraphs) of the regulation as it will appear in the CFR completes the FR notice. The preambles provide the public with valuable information on the agency’s intent and how it will implement the regulation. Final regulations are published in the FR and, once a year, new regulations are compiled into the Code of Federal Regulations (CFR). The CFR does not include the preamble. However, it includes references to FR notices relevant to each regulation. All effective regulations, government-wide, are published once a year in a massive collection of volumes. As noted before, FDA regulations are published in Title 21 of the CFR while USDA labeling regulations are published in Title 9. References to the CFR are usually in a form such as 21 CFR 101.12, where ‘21’ refers to the title, ‘101’ is the Part number, and ‘.12’ refers to the specific section in the identified Part of the CFR. Most FDA food labeling regulations appear in 21 CFR Part 101. The role of the US Federal Court in the rule-making process is to resolve disputes on the appropriateness of the regulation. The Court takes into consideration the provisions of the US Constitution, the intent of Congress, and the concept of whether a particular regulation is arbitrary or capricious. In order to challenge a regulation in court, the affected party must be able to prove actual harm has occurred or likely will occur. The seminal case of Abbott Labs v. Gardner (38 US 136, 1967) set the standard for when the party is sufficiently adversely affected that the case is ‘ripe’ for review by the court. As a result, merely the possibility that a company’s product would be misbranded under a particular requirement would not be enough ‘harm’ to meet the ripeness test. A regulation could not be challenged until after the FDA had decided a product was misbranded and attempted to seize the product. However, legal action by the FDA is not the only ‘harm’ that can meet the ripeness test. If the regulation precluded a claim that a party wished to make, one could argue that prevention of the potential use of the claim on the label would cause financial harm. Judicial review is not an uncommon way by which regulations are

52

Food labelling

redefined. The Courts have the final say as to what a law means unless Congress disagrees with the Courts’ interpretation and passes a new law. The regulatory agencies must follow the decisions of the Courts and Congress.

3.3

The main enforcement agencies

In the United States, enforcement of food labeling laws and implementing regulations is a shared responsibility among several federal and state agencies. For the most part each federal agency has specific responsibilities assigned by law; however, in some instances there are overlapping responsibilities. In cases where overlap occurs, the federal agencies involved have established a Memorandum of Understanding which establishes a lead agency for enforcement. State agencies have authority to enforce federal labeling laws and regulations in many situations, provided the responsible federal agency elects not to pursue a particular case. The Food and Drug Administration has jurisdiction for enforcement of food labeling laws and regulation on most foods that enter interstate commerce in the United States. (Imported goods are considered to be in interstate commerce.) The exceptions are meat and meat products derived from domestic animals, poultry and poultry products derived from domestic birds, liquid egg and liquid egg products produced in egg cracking plants, alcoholic beverages, and products which do not enter interstate commerce (i.e., products entirely produced, packaged and marketed within one state). The FDA’s jurisdiction does include bottled water, meat from game animals, birds and reptiles, and fermented fruit beverages containing less than 7% alcohol. There is no pre-market approval of labels for FDA-regulated foods. The Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture has jurisdiction for enforcement of food labeling laws and implementing regulations on meat and meat products derived from domestic animals, poultry and poultry products derived from domestic birds, and liquid egg and liquid egg products produced in cracking plants. Labels for all these products must be approved before marketing the products. By agreement the FDA has enforcement responsibility for foods containing less than 3% meat and 2% poultry and all closed meat-containing sandwiches. The Bureau of Alcohol, Tobacco and Firearms of the Department of Treasury has legal jurisdiction over laws and implementing regulations for the labeling of all alcoholcontaining beverages with the exception of diluted fermented fruit beverages containing less than 7% alcohol. Pre-market approval of all alcoholic beverage labels is required. The United States Customs Service has jurisdiction for laws and implementing regulations on country of origin labeling required on all imported foods. A Memorandum of Understanding between the Federal Trade Commission (FTC) and the FDA provides that the FTC has responsibility for all advertisement on foods and the FDA has responsibility for all other labeling issues on FDA-regulated foods.10

3.4

Regulations on product name

In the United States packaged foods must bear a statement of identity on the principal display panel (PDP) of the label. (The PDP is the part of the label that is most likely to be displayed to the consumer; generally it is the front of the package.) Any food for which a name is specified by a federal law or regulation must use that name. In the absence of

Labeling requirements: United States

53

such a designated mandatory name, the common or usual name must be used if one exists. In the absence of either a designated or common or usual name, an appropriately descriptive term or fanciful name commonly used by the public may be used. In addition, under several conditions the name of the product may have to include specific descriptive terms. For example, when a food can be marketed with varying composition such as with or without salt or in various forms such as whole or in pieces, the appropriate descriptive terms must be included as part of the name of the product. Further, special requirements in the naming of a food apply when the food is an imitation of another food, or the food contains one or more characterizing ingredients, the quantity of which has an impact on the value of the food. If the food resembles and substitutes for another food and is considered to be nutritionally inferior to the traditional food, the word ‘imitation’ must modify the name of the food. Under US regulations a food is considered to be nutritionally inferior if it contains a lower level of an essential nutrient that is present in the traditional food in a measurable amount. Exceptions are made for a reduction in calorie or fat content and for the nutrients selenium, molybdenum, chromium and chloride. The term ‘measurable amount’ is defined as 2% or more of daily intake values established for nutrition labeling. In situations where the value of a product is dependent on the level of a characterizing ingredient(s) or presence or absence of an ingredient(s), the name of the product must be modified to reveal information about the level(s) of such ingredients. For example, the percentage of fish in fish sticks or percentage of juice in a diluted juice beverage or the percentage of peanuts (considered a lower cost item) in mixed nuts must be indicated.

3.5

Ingredients

The ingredients of packaged foods sold in interstate commerce in the United States must be declared in descending order of predominance by weight on either the principal display panel or the information panel of the product label. There are very few exceptions to this requirement and they are for ingredients present only at very low levels in the food. Incidental additives are exempt from ingredient declaration. Incidental additives are present in foods in insignificant amounts and do not have any technical or functional effect in the food being labeled. These include • substances which have been added to an ingredient of the food but have no function in the final food • substances which have been added to a food during processing but then removed in some manner before being packaged (processing aids) • substances which are added to the food during processing but are converted to constituents normally found in the food • substances added to a food for some technical or functional reason but which only constitute an insignificant level in the product and serve no technical or functional effect after processing • substances migrating into foods from processing equipment or packaging.

All ingredients must be designated by a specific name and not a collective or generic name except for the labeling of spices, flavorings, and colorings. The law provides that spices, flavors and colors other than the artificial colors required to be certified (FD&C colors), do not have to be named. They can be declared using such words as ‘spices’, ‘flavor’ or ‘color.’ The certified colors have to be named, e.g., blue no. 1, and violet no. 2.

54

Food labelling

Ingredients which are themselves composed of two or more ingredients (sometimes referred to as compound ingredients) and which have established common or usual names or conform to a standard of identity may be designated in one of two ways. The first option is to declare the compound ingredient by the established common or usual name followed by a parenthetical listing of all ingredients contained therein in descending order of predominance. The second option is simply to incorporate into the statement of ingredients in descending order of predominance in the finished food, the common or usual name of every ingredient of the compound ingredient without listing the compound ingredient itself. A series of special provisions, which allow some flexibility and alternative declaration procedures, exist for a number of ingredients. The unique requirements for each of these types of food ingredients are too detailed for this chapter. These special provisions can be found in the Code of Federal Regulations and include the following ingredient categories: milk and milk-derived ingredients; egg and egg-derived ingredients; individual fats and oils and/or oil ingredients and mixtures of fats and oils; wheat flour and wheat flour-derived ingredients; leavening agents; dough conditioners; firming agents; waxes and resins; water; yeast nutrients; and dairy-derived ingredients in non-dairy foods. If a food, except for butter, cheese and ice cream, contains any artificial flavoring, artificial coloring or chemical preservative, it must bear labeling stating that fact. This requirement is usually met by using the appropriate wording in the ingredient list. A separate statement is not required. The issue of ingredient labeling is dealt with in more detail in Chapter 5.

3.6

Responsible agent for product

Any food in packaged form offered for sale in interstate commerce in the United States must list on its label the name and place of business of the US manufacturer, packer or distributor. If the name used is other than the manufacturer then a modifying phrase such as ‘distributed by’ or ‘manufactured for’ must accompany the name and address of the responsible agent. The address used on all product labels designed for consumers must include the street address, city, state and US zip code.

3.7

Net contents labeling

All package foods sold in the United States must bear a statement of net quantity of contents. This statement must appear on the PDP and, if more than one PDP exists, the statement must appear on each. The statement must be expressed in terms of weight, measure, numerical count or a combination of numerical count and weight or measure. Statements of weight must be in terms of avoirdupois pound and ounce. Statements of fluid measure must be in terms of the US gallon, quart, pint and fluid ounce subdivisions thereof. The statement must be in terms of fluid measure if the food is liquid or in terms of weight if the food is solid, semi-solid or viscous or a mixture of solid and liquid except that the statement may be expressed in terms of dry measure if the food is fresh fruit, fresh vegetables, or other dry commodity that is customarily sold by dry measure. US law also requires the net contents statement to appear in metric (SI) units. However, the requirement for metric units is not always enforced. There are a number of specific options that apply to specific commodities, which have been firmly established by

Labeling requirements: United States

55

general consumer use and trade custom. These options, together with more detailed requirements for size of print for the statement of net quantity of contents, are further explained in the US Code of Federal Regulations. Separate declaration of net quantity of contents in terms other than those provided are prohibited on the PDP. However, such a declaration can appear elsewhere on the package provided it does not include misleading terms.

3.8

Nutrition facts

The United States laws and implementing regulations intend that all food products for human consumption bear nutrition information related to that food. Packaged food must have the nutrition information in the prescribed format on the product label. Raw fruits and vegetables and fish as well as meat and poultry are covered by an in-store voluntary nutrition labeling program. This voluntary program is sufficiently extensive that nutrition information is usually available for the most popular raw foods. Exemptions from the requirement for nutrition labeling include: products of firms with fewer than 100 employees of which fewer than 100,000 units a year have been sold; foods served in restaurants or other establishments where the food is served for immediate consumption; and foods that contain insignificant amounts of all the nutrients and food components required to be included on the label. However, these foods lose their exemptions and must bear nutrition labeling if they bear a nutrition claim. Infant formulas and medical foods are also exempt from the requirement for nutrition labeling. The nutrition labeling information is presented in amounts relative to a serving of the food as defined by regulation. The term ‘serving’ or ‘serving size’ is defined as an amount of the food that is customarily consumed per eating occasion by persons four years of age and older and is expressed in a common household measure that is appropriate for the food. A series of so-called reference amounts customarily consumed per eating occasion have been established for use in determining the specific serving size for use in the nutrition label and are listed in the US Code of Federal Regulations. The declaration of nutrition information must include the following nutrients: total calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, Vitamin A, Vitamin C, calcium, and iron. Any other vitamin or mineral for which a Reference Daily Intake (RDI) has been established that is added to the food or for which a claim is made, must also be included. Voluntary information can be included on: calories from saturated fat, polyunsaturated fat, monounsaturated fat, potassium, soluble fiber, insoluble fiber, sugar alcohol, other carbohydrates, and any vitamin or mineral for which an RDI has been established. The nutrient labeling information, both that which is mandatory and that which is voluntary, is required to be presented in a prescribed format. The format includes specifications for graphic presentation, color and minimum type size for each part of the nutrition label. Some flexibility in these specifications is permitted for small and intermediate size packages. In all cases the information must be presented in a prescribed order and under the main heading ‘Nutrition Facts’. Under that heading are the subheadings for required information on ‘Serving Size’, ‘Servings per Container’ (unless a single serving container) and then ‘Amount per Serving’ in that order. Compliance procedures for the accuracy of the nutrient information include selection of products available for retail distribution and sale and analysis by appropriate methods as prescribed in the ‘Official Methods of Analysis of the AOAC International.’ The

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Food labelling

sample is generally a composite of 12 different sub-samples selected at random from a production lot or run. Nutrients which are added to a food through fortification are expected to be at or above labeled values. Nutrients which are naturally occurring (indigenous) are expected to be present for at least 80% of label claims. Nutrition labeling is dealt with in more detail in Chapter 9.

3.9

Country of origin

All packaged foods of foreign origin imported into the United States must be marked in a conspicuous manner as legibly, indelibly, and permanently as the nature of the container will permit with the English name of the country of origin. Foods imported into the United States in bulk containers and further packaged into consumer packages must bear appropriate descriptive words to indicate that the product was imported from . . . . . . . . (name of the country) and packaged in the United States. In some instances where an imported product is co-mingled with one or more products from another country(s), then the label must indicate all countries of origin. The country of origin marking on products labeled in the United States by an importer, distributor or other person must appear in close proximity to the name and address of the responsible agent. The marking should make clear the country of origin with an appropriate phrase such as ‘Contents made in . . . . . . . .’ or ‘Contents product of . . . . . . . .’ where the blank is filled in with the English name of the country of origin.

3.10

Nutrient content claims

The United States permits the use of a nutrient content claim(s) on a food label provided such a claim is permitted by an implementing regulation. A nutrient content claim is defined as any direct or implied statement that characterizes the level of a nutrient in a food. The general principles that apply to all nutrient content claims can be found in the Code of Federal Regulations. They include special rules for some foods for special dietary use; the label location and print size for information required to accompany certain claims, and provisions for claims made for products that are main dishes or total meals. Except for statements of the percentage of the RDI of vitamins and minerals, nutrient content claims may not be made on a food intended specifically for use by infants and children under two years of age unless the implementing regulation explicitly permits it. Similarly, the regulations on nutrient content claims do not apply to infant formulas and medical foods. When a nutrient content claim is made, if the food contains a nutrient at a level that may increase risk of disease or health-related condition, the food must bear a statement calling the consumer’s attention to the nutrition label and the amount of that nutrient. The FDA has determined that four nutrients: total fat, saturated fat, cholesterol and sodium fall into the category of possibly increasing risk of disease and has set the levels shown in Table 3.1, as the levels triggering the label statement. The approved nutrient content claims fall into several categories. Definitions have been established for claims using the adjectives ‘free’, ‘low’, and ‘reduced’ or ‘less’ for the nutrient’s calories, total fat, saturated fat, cholesterol, sodium and sugars (except low sugar). The use of the descriptors ‘light’ or ‘lite’, ‘reduced’, ‘added’ (‘fortified’ or ‘enriched’), and ‘more’ and ‘less’ when used in comparative nutrient content claims has also been defined. In addition, the descriptors ‘lean’ and ‘extra lean’, have been

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Table 3.1 Specified levels of nutrients for disclosure (nutrient content claims) and disqualification (health claims) Nutrient

Individual foods

Fat (g) Saturated fat (g) Cholesterol (mg) Sodium (mg)

13 4 60 480

Main dishes 19.5 6 90 720

Meals 26 8 120 960

established for describing meat with lower fat content and ‘high potency’, ‘high’ (‘rich in’ or ‘excellent source of’), ‘good source’ (‘contains’ or ‘provides’); ‘more’, ‘added’, ‘extra’, or ‘plus’ have been established to describe vitamin and mineral content. This subject is discussed in more detail in Chapter 11.

3.11

Health claims

The United States’ laws permit the use of health claims (risk reduction claims) on the label or in labeling of foods. A health claim is officially defined as a statement or any implication conveyed by references, symbols, or vignettes which characterizes the relationship of any substance to a disease or health-related condition. The substance can be a food or any component of food, including vitamins, minerals, herbs, or other similar nutritional substances. All health claims must be authorized by the FDA. A health claim can be authorized by regulation as a result of a finding by the FDA that there is significant scientific agreement that the claim is valid. A health claim can also be authorized by statute based on an authoritative statement of certain scientific entities. There need not be a regulation authorizing the claim under this procedure. The food must contain the substance that is the subject of the claim in the amount specified in the authorization documents. In addition, the food must meet the following conditions to be eligible for the use of an authorized health claim: (1) the product cannot contain amounts of the four nutrients (fat, saturated fat, cholesterol and sodium) greater than those shown in Table 3.1. (2) the product must provide at least ten per cent of the RDI or DRV of protein, fiber, vitamin A, vitamin C, calcium or iron. For a health claim to be authorized on the basis of an authoritative statement, the manufacturer of the food must notify the FDA that it intends to use the particular claim. The wording of the claim on the label is restricted to the wording in the submission to the FDA. There is more flexibility in the statement used on the label or labeling for a health claim authorized by regulation on the basis of scientific information submitted to the FDA in a petition. The claim must include all the information elements specified in the regulation, and model claim statements are included in the regulations. However, the manufacturer can determine the phrasing of the label statement, provided that the meaning of the claim is consistent with the regulation. Currently there are twelve health claims authorized through the petition/regulation procedure and one through the authoritative statement/notification procedure (see Table 3.2). Interested parties can petition the FDA for additional health claims by providing the necessary documentation cited in the Code of Federal Regulations. The regulations on health claims do not apply to

Food requirements

High in calcium Assimilable (bioavailable) Supplements must disintegrate and dissolve Phosphorus content cannot exceed calcium content

Low sodium

Low fat Fish and game meats: ‘extra lean’

Calcium and osteoporosis § 101.72

Sodium and hypertension § 101.74

Dietary fat and cancer § 101.73

Health claims chart – authorized claims

Approved claims

Table 3.2

Required terms: ‘total fat’ or ‘fat’ some types of cancer’ or ‘some cancers’ Does not specify types of fats or fatty acids that may be related

Development of cancer depends on many factors. A diet low in fat may reduce the risk of some cancers.

Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors.

Regular exercise and a healthy diet with enough calcium helps teens and young adult Caucasian and Asian women maintain good bone health and may reduce their risk of osteoporosis later in life.

Indicates disease depends on many factors by listing risk factors for the disease: gender – female race – Caucasian and Asian age – growing older Primary target population: females Caucasian and Asian races teens and young adults in their bone forming years Additional factors necessary to reduce risk: eating healthful meals regular exercise Mechanism relating calcium to osteoporosis: optimizes peak bone mass Foods or supplements containing more than 400 mg calcium must state that total intakes of greater than 2,000 mg calcium provide no added benefit to bond health Required terms: ‘sodium’ ‘high blood pressure’ Includes physician statement (individuals with high blood pressure should consult their physicians) if claim defines high or normal blood pressure

Model claim statements

Claim requirements

While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease.

Low fat diets rich in fibercontaining grain products, fruits, and vegetables may reduce the risk of some types of cancer, a disease associated with many factors. Diets low in saturated fat and cholesterol and rich in fruits, vegetables, and grain products that contain some types of dietary fiber, particularly soluble fiber, may reduce the risk of heart disease, a disease associated with many factors. Low fat diets rich in fruits and vegetables (foods that are low in fat and may contain dietary fiber, vitamin A, or vitamin C) may reduce the risk of some types of cancer, a disease associated with many factors. Broccoli is high in vitamins A and C, and it is a good source of dietary fiber.

Required terms: ‘saturated fat and cholesterol’ coronary heart disease’ or ‘heart disease’ Includes physician statement (individuals with elevated blood total or LDL-cholesterol should consult their physicians) if claim defines high or normal blood total and LDL-cholesterol Required terms: ‘fiber’, ‘dietary fiber’, or ‘total dietary fiber’ ‘some types of cancer’ or ‘some cancers’ Does not specify types of dietary fiber that may be related to risk of cancer Required terms: ‘fiber’, ‘dietary fiber’, ‘some types of dietary fiber’, ‘some dietary fibers’, or ‘some fibers’ ‘saturated fat’ and ‘cholesterol’ ‘coronary heart disease’ or ‘heart disease’ Includes physician statement (individuals with elevated blood total or LDL-cholesterol should consult their physicians) if claim defines high or normal blood total and LDL-cholesterol Required terms: ‘fiber’, ‘dietary fiber’, or ‘total dietary fiber’ ‘total fat’ or ‘fat’ ‘some types of cancer’ or ‘some cancers’ Characterizes fruits and vegetables as ‘foods that are low in fat and may contain vitamin A, vitamin C, and dietary fiber’ Characterizes specific food as a ‘good source’ of one or more of the following: dietary fiber, vitamin A, or vitamin C Does not specify types of fats or fatty acids or types of dietary fiber that may be related to risk of cancer

Low saturated fat Low cholesterol Low fat Fish and game meats: ‘extra lean’

A grain product, fruit, or vegetable that contains dietary fiber Low fat Good source of dietary fiber (without fortification)

A fruit, vegetable, or grain product that contains fiber Low saturated fat Low cholesterol Low fat At least 0.6 grams of soluble fiber per RA (without fortification) Soluble fiber content provided on label

A fruit or vegetable Low fat Good source (without fortification) of at least one of the following: vitamin A vitamin C dietary fiber

Dietary saturated fat and cholesterol and risk of coronary heart disease § 101.75

Fiber-containing grain products, fruits, and vegetables and cancer § 101.76

Fruits, vegetables, and grain products that contain fiber particularly soluble fiber, and risk of coronary heart disease § 101.77

Fruits and vegetables and cancer § 101.78

Food requirements

‘Good sources’ of folate The claim shall not be made on products that contain more than 100% of the RDI for vitamin A as retinol or preformed vitamin A or vitamin D Dietary supplements shall meet USP standards for disintegration and dissolution or otherwise bioavailable Nurtition label shall include folate

Sugar free The sugar alcohol must be xylitol, sorbitol, mannitol, maltitol, isomalt, lactitol, hydrogenated starch hydrolysates, hydrogenated glucose syrups, erythritol, or a combination of these. When a fermentable carbohydrate is present, the food must not lower plaque pH below 5.7.

Folate and neural tube defects § 101.79

Dietary sugar alcohols and dental caries § 101.80

Continued

Approved claims

Table 3.2

Required terms: ‘does not promote’, ‘may reduce the risk of’, ‘useful [or is useful] in not promoting’ or ‘expressly [or is expressly] for not promoting’ dental caries ‘sugar alcohol’ or the names of the sugar alcohols, sorbitol ‘dental caries’, or ‘tooth decay’ Includes statements that frequent between meal consumption of foods high in sugars and starches can promote tooth decay Packages with less than 15 square inches of surface area available for labeling may use a shortened claim

For foods containing 100% or less of the DV for folate per RA: healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord defect.

Required terms: Terms that specify the relationship (e.g. women who are capable of becoming pregnant and who consume adequate amounts of folate daily during their childbearing years); ‘folate’, ‘folic acid’, ‘folacin’, ‘flate, a B vitamin’, ‘folic acid, a B vitamin’, or ‘folacin, a B vitamin’ ‘neural tube defects’, ‘birth defects spina bifida or anencephaly’, ‘birth defects of the brain or spinal cord anencephaly or spina bifida’, ‘spina bifida and anencephaly, birth defects of the brain or spinal cord’, or ‘brain or spinal cord birth defects’ Must also include information on the multifactorial nature of neural tube defects and the safe upper limit of daily intake Part of healthful diet

Shortened claim: does not promote tooth decay.

Full claim: frequent between meal consumption of foods high in sugars and starches promotes tooth decay. The sugar alcohols in [name of food] do not promote tooth decay.

For foods containing more than 100% of the DV for folate per RA: healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord defect. Folate intake should not exceed 250% of the DV (1,000 mcg).

Model claim statements

Claim requirements

Required terms: ‘heart disease’ or ‘coronary heart disease’ ‘soluble fiber’ qualified by the name of the eligible food sources ‘saturated fat’ and ‘cholesterol’ Eligible sources of soluble fiber: (A) Beta ( ) glucan soluble fiber from oat bran, rolled oats (or oatmeal), and whole oat flour. (B) Psyllium husk Claim specifies daily dietary intake levels of soluble fiber sources associated with reduced risk Warning about consuming psyllium with adequate fluid required on some products

Required wording of the claim: ‘Diets rich in whole grain foods and other plant foods and low in total fat, saturated fat, and cholesterol may reduce the risk of heart disease and some cancers’.

Required terms: ‘heart disease’ or ‘coronary heart disease’ ‘soy protein’ ‘saturated fat’ and ‘cholesterol’ Claim specifies daily dietary intake levels of soy protein associated with reduced risk

Low saturated fat Low cholesterol Low fat (A) Includes one or more eligible sources of whole oats, and at least 0.75 gram (g) of whole oat soluble fiber per RA (B) Includes psyllium husk meeting purity standards, and at least 1.7 g of psyllium husk soluble fiber per RA Amount of soluble fiber per RA declared in nutrition label

Contains 51 per cent or more whole gain ingredients by weight per RA Dietary fiber content at least: 3.0 g per RA of 55 g 2.8 g per RA of 50 g 2.5 g per RA of 45 g 1.7 g per RA of 35 g Low fat

At least 6.25 g soy protein per RA Low saturated fat Low cholesterol Low fat (except that foods made from whole soybeans that contain no fat in addition to that inherent in the whole

Soluble fiber from certain foods and risk of coronary heart disease § 101.81

Whole grain foods and risk of heart disease and certain cancers

Soy protein and risk of coronary heart disease § 101.82

(1) 25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies __ grams of soy protein.

(1) Soluble fiber from foods such as [name of eligible soluble fiber source], as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies __ grams of the [grams of soluble fiber specified] soluble fiber from [name of eligible soluble fiber source] necessary per day to have this effect. (2) Diets low in saturated fat and cholesterol that include __ grams of soluble fiber from ___ per day may reduce the risk of heart disease. One serving of [name of food] provides __ grams of this soluble fiber.

Continued Claim requirements Claim specifies amount of soy protein in a serving of food

Food requirements

soybean are exempt from the ‘low fat’ requirement)

(2) Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease. One serving of [name of food] provides __ grams of soy protein.

Model claim statements

• • • • • •

Calcium 100 mg Protein 5 g Fiber 2.5 g

Disqualifying nutrients Fat Saturated fat Cholesterol Sodium

Foods 13 g 4g 60 mg 480 mg

Main dishes 19.5 g 6g 90 mg 720 mg

Meal products 26 g 8g 120 mg 960 mg

All information in one place without intervening material (Reference statement permitted). Not represented for infants or toddlers less than 2 years of age. Uses ‘may’ or ‘might’ to express relationship between substance and disease. Does not quantify any degree of risk reduction. Indicates disease depends on many factors. Food contains less than the specified levels of four disqualifying nutrients:

Vitamin A 500 IU Vitamin C 6 mg Iron 1.8 mg

Notes: general criteria all claims must meet • Only information on the value that intake or reduced intake, as part of a total dietary pattern, may have on a disease or health-related condition. • Enables the public to understand information provided and significance of information in the context of a total daily diet. • Complete, truthful, and not misleading. • Food contains, without fortification, 10% or more of the daily value for one of six nutrients (dietary supplements excepted):

Approved claims

Table 3.2

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infant formulas or medical foods as defined by the FD&C Act. Health claims are discussed in more detail in Chapter 11.

3.12

Details of regulations by competent authorities

There is uniformity in the required labeling of foods regulated by both the FDA and the FSIS who jointly regulate virtually all foods sold in the United States. Although each agency requires warning or cautionary statements on some foods, the FSIS cautionary statement concerning the potential presence of harmful bacteria required on all raw meats is a significant exception. Other warning or cautionary statements required on food, which relate almost exclusively to the presence of additives, are required on both FDA and FSIS regulated foods. Although the FSIS does not have regulations on health claims, it has allowed meat and poultry to bear such claims consistent with FDA regulations. Alcoholic beverages regulated by the Bureau of Alcohol, Tobacco and Firearms (BATF) do represent a significant departure from food and other beverage labeling. BATF approves all labels before marketing of alcoholic beverages. Required labeling consists of established name, manufacturer or other responsible agent, net content declaration, a warning statement concerning consumption of alcohol and pregnancy, and country of origin labeling. Under some circumstances the presence of certain additives are required to be listed. However, full ingredient labeling is not required nor is nutrition labeling. The BATF has announced that health claims could be approved for wine but such claims are currently not present in the marketplace. The FDA under the provision of the Dietary Supplements Act has published regulations which permit structure function claims for dietary supplement products without FDA review and approval. When such claims are used by a manufacturer, there must be a disclaimer indicating that the US government has not reviewed or approved the claims.

3.13

Future trends

The focus of labeling requirements has shifted from general requirements applicable to all foods to special labeling for a particular type of food or group of foods. The challenge for the future will be how to decide which aspects of a food or the consequences of consuming it should be described in a label statement. The FDA’s authority to require label statements other than those specifically provided in the law is limited to statements that are material in light of other statements made on the label, or in light of consequences of using the product. For example, the FDA requires warning statements on juice beverages that have not been treated to remove microbiological pathogens, and the FSIS requires raw meat and poultry to bear safe handling instructions because of potential contamination with pathogens. The agencies are frequently requested to require other warnings and special statements, and they must choose carefully which statements are truly needed. Too many warnings on labels would likely result in consumers ignoring all of them. Special labeling for foods produced using modern biotechnology is another difficult policy issue that will set precedents for future decisions. Some parties want mandatory label statements on all foods that are genetically engineered or that contain genetically engineered ingredients. The current position in the US government is that where there is

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no material difference in the genetically engineered food from the version of the food produced by traditional means, there is no need for special labeling. Where there is a material difference, the difference should be described on the label. The proponents of general mandatory labeling believe all genetically engineered foods should bear a label stating that the food is a product of genetic engineering. They believe that genetically engineered foods are inherently different from traditional foods. Another aspect of this issue is whether instead of requiring genetically engineered foods to bear a special label statement, the authorities should permit voluntary label statements for foods that have not been produced using biotechnology. Voluntary label statements that claim the absence of a substance (e.g., ‘contains no genetically modified organisms’) can be useful, but they must be regulated carefully. They can easily imply that other foods that do not bear the statement are of less value. Where a difference between the products due to the substance in the label statement is not documented, agencies must regulate use of the statement carefully to prevent the consumer from being misled. Voluntary label statements about the way a food was processed would likely lead to increased use of identity preservation systems (organic food certification is a familiar identity preservation system) because in many cases there is no means to determine from the finished product whether the label statement is truthful. These current labeling policy issues set the stage for the future. Mandatory label statements are needed in some cases, but they must be used with caution lest there be consumer overload that renders them useless. Voluntary label statements are useful to some groups of consumers, but they must be carefully controlled to ensure that they are truthful and that they do not misleadingly imply differences that have not been documented. Acknowledgment: The section in this chapter covering the regulatory process in the United States is based on a draft prepared by Professors Theodore P. Labuza and Mary K. Schmidl.

3.14

References

1. Federal Food, Drug, and Cosmetic Act of 1938 as amended, Title 21, Section 343 United States Code, Government Printing Office (GPO), Washington, 1994 and Supplements 1996, 1997 and 1998. 2. Fair Packaging and Labeling Act of 1996 as amended, Title 15 Sections 1451–1455 United States Code, GPO, Washington, 1994. 3. Federal Meat Inspection Act of 1907 as amended, Title 21 Section 601 United States Code, GPO, Washington, 1994. 4. Poultry Products Inspection Act of 1957 as amended, Title 21 Sections 451–453 United States Code, GPO, Washington 1994. 5. Egg Products Inspection Act of 1970 as amended, Title 21 Sections 1033 and 1036 United States Code, GPO, Washington, 1994. 6. Federal Trade Commission Act of 1914 as amended, Title 15 Section 45 United States Code, GPO, Washington, 1994. 7. Federal Alcohol Administration Act of 1935 as amended, Title 27 Sections 214–217 United States Code, GPO, Washington, 1994. 8. Tariff Act of 1930 as amended, Title 19 Section 1304 United States Code, GPO, Washington, 1994. 9. Administrative Procedure Act of 1946 as amended, Title 5 Sections 551 and 553 United States Code, GPO, Washington, 1994. 10. Referral Arrangement for Food Advertisements and Labels between the Federal Trade Commission and the Food and Drug Administration, 36 Fed. Reg. 18,538, 1971 and MOU August 1992.

4 Declaration of ingredients and additives: European Union D. W. Flowerdew, Consultant (formerly Leatherhead Food Research Association)

4.1

Declaring ingredients and additives: the basic principles

Ingredients and additives were required to be identified in food labelling in the UK before the labelling Directive 79/112/EEC1 was adopted, but precise requirements in the different Member States varied widely. Harmonisation in this area was therefore regarded as a priority because the disparate laws concerning the statement of the ingredients present, the permitted generic terms and the methods by which additives were identified hindered the free circulation of food products within the European Union. It was also recognised that the information on the food label must be understandable and clear to the consumer. It must take account of the need for both consumer protection and provision of required information about the product. At the same time the difficulties of identifying all the ingredients and particularly the additives used in food products, some of which are quite complex, had to be addressed. The resultant labelling Directive 79/112/EEC and its amendments have addressed problems such as the use of compound ingredients, ingredients that are added in concentrated and dehydrated form, the need to declare the presence of added water, authorised generic terms to describe certain ingredients and categories of ingredients, the correct indication of additives used and the foods for which a list of ingredients is unnecessary. Directive 79/112/EEC contained a number of derogations which meant that ingredients and additives labelling was not completely harmonised, but subsequent amendments to the Directive have removed most of the derogations, and also applied the total Directive to mass caterers such as restaurants and hospitals as well as to the ultimate consumer. A number of generic terms had to be removed from UK labelling laws, and The Food Labelling Regulations 19962 are more closely aligned with those in other Member States. Consumer demands for more information about the food they are eating have also played a large part in the development of laws that require specific identification of the constituents of the foodstuff. Directive 97/4/EC,3 now incorporated in The Food Labelling (Amendment) Regulations 1998,4 takes the consumer information aspect a step further by requiring that the quantities of certain characterising or emphasised ingredients are stated as well as the type of ingredient. With increasing diversity of types of food

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products available, this information enables consumers to compare products that appear alike in the marketplace. A number of national food standards have been revoked in recent years, and the requirement for quantitative declaration of certain ingredients, commonly known as the ‘QUID’ requirement, is intended to provide better labelling information that helps consumers to make their own decisions about the most appropriate product for their needs. The EU Regulation concerning novel foods5 includes requirements that the labelling of foods that contain novel food ingredients must include specific information about the presence in the novel ingredients of any material that is not present in the existing equivalent foodstuff, which may have implications for the health of certain sections of the population or which may give rise to ethical concerns, and about the presence of a genetically modified organism. Consumer concerns about specific identification of genetically modified (GM) soya and maize, which were approved for food use before the novel foods Regulation came into force, have been addressed by EU Regulation 1139/98, as amended by Regulation 49/2000,6 which requires specific identification where food ingredients for delivery to the final consumer or mass caterers consist of or contain GM soya or maize, and protein or DNA resulting from genetic modification are still present in the food. Regulation 49/20006 also sets a GM threshold of 1% in each ingredient, below which distinctive labelling is not necessary provided that the manufacturer can demonstrate that the ingredient was obtained from a non-GM source. EU Regulation 50/20007 applies similar labelling requirements to food ingredients that contain additives and flavourings that have been genetically modified or produced from genetically modified organisms, but extends beyond GM soya or maize to all GM sources. The Genetically Modified and Novel Food (Labelling) (England) Regulations 20008 provide for the UK enforcement of the these EU Regulations, and also extend the requirements, with modifications, to foods sold in catering establishments. The EU laws, as extended by the UK regulations, are intended to provide meaningful and practical information about GM ingredients, and to allow consumers to choose whether or not they eat foods that contain GM or GM-derived ingredients. Although the basic requirements for declaration of ingredients and additives have been set in place, there remain certain areas that are not harmonised, and new developments that are being addressed. The labelling Directive does not, in general, cover nonprepackaged foods and national provisions are still applicable. It is impractical to require details of all the ingredients and additives used in, for instance, restaurant meals. Certain national measures are included in The Food Labelling Regulations 1996, but it could be argued that there are very few laws that control this aspect, while the trend towards eating out continues to increase. Problems of intolerance and allergy to food ingredients and additives are under consideration, though few laws address these aspects as yet (see Section 12.3). However, The Food Labelling (Amendment) Regulations 1998 require that the vegetable origin of starch and modified starch must always be stated when these starches may contain gluten.

4.2

Review of key legislation

4.2.1 Declaration of ingredients Most prepackages for food and drink products must carry a list of the ingredients used in the product, in accordance with the requirements of The Food Labelling Regulations 1996.2 The list must be headed by the word ‘ingredients’ or a phrase that includes this

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word, and the ingredients must be listed in descending order by weight (greatest first) as used during manufacture of the product, except that water and volatile ingredients may be listed according to their weight in the finished product. Ingredients must be correctly designated, using the name that would be used if the ingredient was being sold as a food. There are a number of provisions that allow for the complexity of some food products. Where an ingredient is used in concentrated or dehydrated form and reconstitutes during the manufacture of the food, the weight used in determining the order in the list may be that before concentration or dehydration. Where the food is concentrated or dehydrated and is intended to be reconstituted with water, the ingredients may be listed as if the food was reconstituted, provided the words ‘ingredients of the reconstituted/ready-to-use product’, or similar, are included in the heading to the list. If the food consists of or contains mixed fruit, nuts, vegetables, spice or herbs and none of these predominate significantly by weight, they may be listed in any order provided the heading of the list or the relevant part of the list includes words such as ‘in variable proportion’. With regard to compound ingredients, the Regulations allow that the names of the ingredients used in a compound ingredient may be listed either instead of the name of the compound ingredient or in addition to it. If the latter option is chosen, the names of the ingredients must follow immediately that of the compound ingredient, listed so that their association with the compound ingredient is clear. Constituents of compound ingredients need not be identified if a list of ingredients would not be required if the compound ingredient was being sold as a food by itself, if the compound ingredient is a generic term, or when it constitutes less than 25% of the product. However, under the 25% provision, additives must be declared unless they do not perform a significant function in the final product (but see Section 4.3). Water is an ingredient and it must be declared unless it is used solely for reconstitution of ingredients used in concentrated or dehydrated form, it is part of a medium not normally consumed, it is used in frozen or quick frozen chickens in accordance with EU Regulations, or it constitutes less than 5% of the final product. A number of generic terms are listed in schedule 3 to the Regulations and may be used under the conditions laid down in that schedule. Although terms such as ‘other meat’ are no longer permitted in the 1996 Regulations, there are a number of useful terms that are frequently used by manufacturers. These include ‘cheese’ for cheese or mixed cheese provided the labelling does not refer to a specific type of cheese, ‘crumbs’ or ‘rusks’ to describe any type of crumbed, baked cereal product, ‘crystallised fruit’ if less than 10% is present, ‘fish’ provided no specific fish is mentioned on the label, ‘flour’ to describe mixed flour (followed by a list of cereals from which the flour is derived), ‘glucose syrup’, ‘gum base’ for gum preparations used in chewing gum, ‘milk proteins’, ‘sugar’, ‘vegetables’ if less than 10% mixed vegetables is present and ‘wine’ to describe wine as defined in EU Regulation 822/87. The terms ‘herb/s’, ‘mixed herbs’ may be used for combinations of herbs provided the proportion in the product does not exceed 2%, and a similar provision exists in respect of the terms ‘spice/s’, and ‘mixed spices’. The term ‘fat’ may describe any refined fat provided the word is accompanied by the description ‘animal’ or ‘vegetable’ or a specific indication of the correct animal or vegetable origin of the fat. Where the fat is hydrogenated the generic term must also state ‘hydrogenated’. The term ‘oil’ may be used under conditions similar to those for fat, but olive oil must be specifically designated. In practice the word ‘hydrogenated’ is also applicable to partially hydrogenated fats and oils; there is no provision for use of the term partially hydrogenated fat/oil. Any declaration that would be required to accompany the name of an ingredient were it being sold as a food must be considered and also included in the ingredients list if this

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prevents consumer confusion. If an irradiated ingredient is used in a food, the declaration in the list must include the term ‘irradiated’ or ‘treated with ionising radiation’. EU Regulation 1139/98, as amended,6 and the Genetically Modified and Novel Foods (Labelling) (England) Regulations 20008 require that where a food contains any ingredient produced wholly or partly from GM soya or maize, the words ‘produced from genetically modified soya/maize’ (as appropriate) must be stated in the list of ingredients, in parentheses immediately after the name of the relevant ingredient. If soya or maize are already listed as the source of the ingredient the phrase may read ‘genetically modified’. These phrases may, alternatively, be placed in an asterisked footnote to the list of ingredients; the typeface of the footnote must be at least the same size as that used for the list. Where the product does not carry a list of ingredients the words ‘produced from genetically modified soya/maize’ must appear clearly on the label. If the ingredient is designated by a category name, this must be completed by the words ‘contains (name of ingredient) produced from genetically modified soya/maize’, as appropriate. If a constituent ingredient of a compound ingredient is derived from GM soya or maize it must be mentioned on the label of the final product together with the words ‘produced from genetically modified soya/maize’. The declarations in respect of ingredients derived from GM foods are not required when neither protein nor DNA resulting from genetic modification are present in the food ingredient. They are not required if material derived from genetic modification is present due to adventitious contamination in a food ingredient, provided the level of such material in each ingredient does not exceed 1%, and that the manufacturer can demonstrate that the ingredient was obtained from a non-GM source. Exemptions from ingredients listing Constituents of ingredients that have been temporarily separated during manufacture and are subsequently reintroduced in their original proportions need not be separately named. Although the majority of prepacked foods must bear an ingredients list, there are a few foods for which a list is inappropriate or unnecessary, and these are specifically exempted from this requirement. They include fresh fruit and vegetables that have not been peeled or cut; carbonated water that contains no other ingredient except carbon dioxide, where the name indicates that it has been carbonated; vinegar derived from a single basic product with no other ingredients; cheese, butter, fermented milk and fermented cream that contain only lactic products, enzymes and micro-organism cultures essential for their manufacture and, for cheese (except fresh curd cheese and processed cheese), salt; drinks with an alcoholic strength of more than 1.2%; any single ingredient food where the name of the food and the name of the ingredient are the same or where the nature of the ingredient can be clearly identified from the food name. In the case of vinegar and cheese, butter, fermented milk and fermented cream to which other ingredients have been added, only the added ingredients need be indicated, provided the heading to the list states ‘added ingredients’ or similar words. Exempt also are foods to which the labelling Regulations in general are not applicable, such as condensed milk and dried milk products for delivery to catering establishments, specified sugar products that comply with the Specified Sugar Products Regulations 1976, cocoa products and chocolate products, spreadable fats, and wines and spirit drinks where these products comply with the EU laws applicable to them. In practice, however, it has become customary to include a list of ingredients for certain products, and most prepacked cocoa and chocolate products do carry a list of ingredients.

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4.2.2 Declaration of additives Additives are regarded as ingredients and must be correctly identified in the ingredients list. Additives are substances that are not normally used as food or as characterising ingredients in themselves, but which are used for a technological purpose during manufacture and processing and may therefore become components of the final product. The use of sweeteners, colours, flour treatment agents and miscellaneous additives including preservatives, antioxidants, acids and anti-caking agents is controlled by separate Regulations; as yet there is no positive list of flavourings, but one is being developed at EU level. Schedule 4 to the Regulations lists category names for food additives, and additives used in a product must be identified using the category name that represents the function of the additive in that product, followed by the specific name of the additive or its E number, if any; for instance ‘preservative, sodium metabisulphite’ or ‘preservative E 223’. If an additive performs more than one function in a food the category name that represents the principal function must be stated. A permitted additive that does not perform any of the category functions listed in Table 4.1 (except flavourings), must be listed by its specific name. Where an additive is used as an acid and its name includes the word ‘acid’, the category name need not be used. For instance citric acid, used as an acid, need only be listed as ‘citric acid’; however, alternatively it may be identified as ‘acid E 330’. In the case of modified starches neither the specific name nor the E number need be indicated, but where the modified starch contains gluten the specific vegetable origin of the starch must be stated together with the category name. Declaration of flavourings Since most flavourings are complex combinations of substances it is almost impossible to declare the individual chemicals present. Flavourings added as ingredients may be either designated as ‘flavouring/s’ or by their specific names in the correct position in the ingredients list. The word ‘flavouring’ may be qualified by the word ‘natural’ only if the components of that flavouring consist exclusively of a chemical flavouring substance/s obtained by physical, enzymatic or microbiological processes from material of vegetable or animal origin that is either raw or prepared only by a process normally used for preparing food for human consumption (including drying, torrefaction and fermentation). Alternatively it may consist of a flavouring preparation prepared in the same way, or it may be a mixture of a flavouring substance and a flavouring preparation. If the flavouring is labelled to indicate the vegetable or animal origin of the material in it, the word Table 4.1 Category names for food additives Acid Acidity regulator Anti-caking agent Anti-foaming agent Antioxidant Bulking agent Colour Emulsifier Emulsifying salts Firming agent Flavour enhancer

Flour treatment agent Gelling agent Glazing agent Humectant Modified starch Preservative Propellant gas Raising agent Stabiliser Sweetener Thickener

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‘natural’ or similar may only qualify the expression if, in addition to meeting the above requirements, the flavouring component/s are obtained solely or almost solely from the named vegetable or animal source. Additives exempt from declaration Usually all additives used in the food or in food ingredients must be correctly identified. However, an additive that is present in an ingredient but does not serve a significant technological function in the finished product need not be listed. Processing aids and any solvent or carrier used only for technological purposes (other than water) need not be mentioned in the list. However, where a flour treatment agent has been used in bread its presence must always be correctly declared in the list of ingredients. Foods exempt from the requirement to carry a list of ingredients need not bear a statement of the additives present, unless other provisions require a declaration to be made. Additional declarations required for some additives When certain additives are used during manufacture of food products, extra declarations are required. Added sweeteners must be indicated by the expression ‘with sweetener/s’, and if sugar and sweeteners are used, the statement must read ‘with sugar/s and sweetener/s’. Both these indications must accompany the product name. Where aspartame is used as permitted a statement must be made that the food ‘contains a source of phenylalanine’, and a food containing more than 10% polyols (sorbitol, lactitol, etc.) must bear the warning statement ‘excessive consumption may produce laxative effects’. All these declarations are required in addition to correct identification of the relevant additive in the list of ingredients. Where packaging gases are used for packing food products they need not be included in the list of ingredients. However, where the durability of a food has been extended by use of a permitted packaging gas, the product must be labelled with the statement ‘packaged in a protective atmosphere’. EU Regulation 50/20007 and the Genetically Modified and Novel Foods (Labelling) (England) Regulations 20008 prescribe the conditions under which identification of additives and flavourings used in foods and food ingredients is required if such additives and flavourings are, contain or are produced from GM organisms. The phrases ‘produced from genetically modified . . . . . . . .’ or ‘genetically modified’, as relevant, must be stated, under conditions similar to those for GM-derived ingredients, see Section 4.2.1 above.

4.2.3 Other labelling requirements relating to ingredients and additives used in foods Declarations for non-prepacked and similar foods In general, the following need not bear a list of ingredients: • foods that are not prepacked, or are packed by a retailer at point of sale • certain flour confectionery products packed in a crimp case or wholly transparent packaging • individually wrapped fancy confectionery products for sale as single items.

However, where an additive is used as an antioxidant, colour, flavouring, flavour enhancer, preservative or sweetener, the category of additive must be indicated though the specific additive need not be identified. An example might be ‘sausages contain colour and preservative’. For edible ices and flour confectionery, information that the

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foods may contain such categories may, alternatively, be placed on a notice displayed near the product. If a flour treatment agent has been used in bread an indication of its presence must always be given. The use of any irradiated ingredients must always be stated in a prescribed form, and there are specific requirements relating to presentation of this information in the case of non-prepacked foods. When non-prepacked foods contain GM-derived ingredients these ingredients must be specifically identified in accordance with the requirements of EU Regulations 1139/986 or 50/20007 and The Genetically Modified and Novel Foods (Labelling) (England) Regulations 2000.8 However, for such foods sold to the final consumer at appropriate premises the particulars may, alternatively, be indicated as follows. There must be an indication on a menu, notice, ticket or label that some of the food sold at the premises contains ingredients produced from GM soya and/or maize, and/or additives (including flavourings) produced from genetically modified organisms, and that further information is available from staff. Staff must identify such food, on request, and a procedure for provision of this information to staff must be in place on the premises. Position and legibility of the information Generally, for prepacked foods the particulars must be shown on the packaging or on a label attached to the packaging or on a label that is clearly visible through the packaging. For sales not to the ultimate consumer the list of ingredients may, alternatively, be given on commercial documentation that either accompanies the food or is sent before or at the same time as delivery of the food. For non-prepacked foods the declaration/s may appear on a label attached to the food or on a menu, notice, ticket or label that can easily be seen by the person buying the food. Declarations relating to non-prepacked food sold otherwise than to the ultimate consumer must appear on a label attached to the food, or on a ticket or notice that can easily be seen by the person buying the food or on commercial documents that accompany the food or are sent before or at the same time as delivery of the food. All particulars given on packaging, labels, notices, tickets or menus must be easy to understand, clearly legible, indelible and, when sold to the consumer, conspicuous to the purchaser at point of sale. They must not be hidden, obscured or interrupted by other writing or pictures. There are no specific requirements that the letters used be of a particular size. Additional statements required for certain foods Laws specific to some products require statements to be made regarding the presence of certain ingredients, generally in addition to the declaration in the ingredients list. Most of these requirements are derived from EU Directives or Regulations, some of which predate The Food Labelling Regulations. Examples of commonly used foods with such requirements are given below. The labelling of jams, fruit jellies, marmalades and sweetened chestnut pure´e9 must bear a statement of the fruit content in the form ‘prepared with X g of fruit per 100 g’ (where X = grams of fruit from which the fruit preparation/s used per 100 g of product are derived), and of sugar content as ‘total sugar content: Y g per 100 g’ (where Y = grams of soluble solids per 100 g food). For reduced sugar products and UK standard jelly the labelling may, alternatively, comply with the requirements for quantitative ingredients declaration (QUID) (see Section 4.2.4). Where jams and similar products, including fruit curds and mincemeat, contain a residual sulphur dioxide content of more than 30 mg/kg,

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this must be stated in the list of ingredients as percentage by weight of residue in the product as ‘sulphur dioxide’, in addition to the declaration of the additive in the list of ingredients. Meat products must be labelled with a declaration of their minimum meat content,10 as ‘minimum X% meat/type of meat’ (where X = minimum meat content of product); the phrase is varied appropriately for products with small and large meat content and for corned meats. Alternatively, the labelling may comply with the requirements for QUID (see Section 4.2.4). Meat products that resemble cuts, slices, portions or joints of raw, cooked or cured meat (except raw minced shaped meat) and contain added water, must be marked instead with a declaration of the added water content. If such product includes the names of ingredients in the product name and contains added water, the minimum meat content must be declared and the presence of added water indicated. For fruit juices11 specified declarations must be made where the products are made from concentrates or contain added sugars, and for carbonated products. Fruit nectars must be labelled with the fruit content and, where they are made from fruit pure´e, the label must state that the product contains fruit pulp. Currently cocoa products and chocolate products are not under the control of The Food Labelling Regulations and a full list of ingredients is not required,12 though most manufacturers choose to include this list. Regulations that control the composition of cocoa products and chocolate products require several statements to be made regarding key ingredients in certain products, including the minimum cocoa solids of chocolate, the minimum milk solids content of milk chocolate and a statement that the product contains vegetable fat or a full list of ingredients when vegetable fat other than cocoa butter is present. UK laws will be altered so that full ingredients listing is obligatory and will make more stringent requirements for the indication of vegetable fat when a new EU Directive concerning these products is adopted by the UK. Butter, margarine and other spreadable fats must be labelled with the percentage fat and salt contents,13 and compound fat spreads must be labelled with the content of milk, other animal and vegetable fat in decreasing order. Condensed milk must be labelled with the percentage content of milk fat and the percentage milk solids not fats; dried milk must indicate the percentage content of milk fat.14 Icing sugar or icing dextrose that contains starch or permitted anti-caking agent and glucose syrup or dried glucose syrup that contains any permitted anti-foaming agent, must be labelled to indicate the presence of these substances.15 The relevant compositional Regulations include requirements for the positioning of the required statements, some of which must be placed in close proximity to the product name.

4.2.4 Quantitative ingredients declaration (QUID) For many years it has been necessary to state the percentage of an ingredient where that ingredient is specially emphasised on the food label. This provision has now been replaced and extended by an amendment to The Food Labelling Regulations4 that requires the quantity of an ingredient or categories of ingredients to be stated in the following cases: • it appears in the name of the food or can be associated with the product name by the consumer • it is emphasised in the labelling by words, pictures or graphics

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• it is essential in order to characterise the food and distinguish it from products with which it might be confused because of its name or appearance.

Exempt from the requirement are ingredients for which the drained net weight is correctly indicated; ingredients for which the quantities are already required to be stated under other EU laws; ingredients used in small quantities for flavouring purposes; ingredients that appear in the product name but the variations in quantities do not characterise the food or distinguish it from similar foods, and thus do not affect consumer choice; products for which EU laws provide for the exact quantity of ingredients to be used without requiring a labelling indication of such quantity; and products where mixtures of fruits, nuts, etc., are used ‘in variable proportion’ as described in Section 4.2.1. The quantity of the ingredient or category of ingredients must be stated as a percentage, determined during its use in the preparation of the food. It must be placed either in or next to the product name or in the list of ingredients in association with the relevant ingredient or category of ingredients. The QUID requirements are couched in somewhat general terms, and a number of problems relating to their application to specific food types have arisen and been discussed at EU and UK levels. An EU Directive16 that provides exemptions and derogations from the main requirement is implemented by The Food Labelling (Amendment) (No. 2) Regulations 1999.17 The label statement ‘with sweetener/s’ or ‘with sugars and sweetener/s’, and the indication of added vitamins and minerals in nutrition labelling do not trigger the QUID requirement. Derogations from the method for calculating the quantities of ingredients or categories of ingredients apply to foods that lose moisture during processing, volatile ingredients which must be indicated as proportion by weight in the finished product, ingredients used in concentrated or dehydrated form and are reconstituted during manufacture, and concentrated or dehydrated foods that are intended to be reconstituted with water. In addition, guidelines to assist interpretation of the requirements in respect of numerous other foods have been developed by the EU18 and the UK;19 some of these aspects are discussed further in Section 4.4.

4.2.5 Labelling of food additives and ingredients that are sold as such Ingredients and additives that are sold for business purposes must bear a lot mark in accordance with the Lot Marking Regulations20 and a statement of the quantity present as required by the Quantity Marking Regulations,21 unless other provisions exempt them. Labelling regulations concerning hazardous substances may also apply. Ingredients sold as such to the consumer must comply with the requirements contained in The Food Labelling Regulations2 and EU Regulation 1139/98,6 but there are no other specific requirements in the case of ingredients sold for business purposes. Clearly the product must be identified and sufficient information must be given to enable correct use of the substance and correct labelling on the final product that is sold to the consumer. However, for additives there are additional specific labelling requirements. Provisions concerning the labelling of food additives when sold as such for business or consumer purposes are derived from EU Directive 89/107/EEC,22 articles 7 and 8, and are implemented by The Food Additives Labelling Regulations 1992.23 The requirements apply to most classes of additives commonly used during food manufacture except flavourings. The complete list of the additive categories is shown in Table 4.2.

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Food labelling Table 4.2 Additive categories covered by the Food Additives Labelling Regulations Colours Antioxidants Preservatives Emulsifiers Emulsifying salts Thickeners Gelling agents Stabilisers Flavour enhancers Acids Acidity regulators Anti-caking agents Modified starch Sweeteners

Raising agents Anti-foaming agents Glazing agents Flour bleaching agents Flour treatment agents Firming agents Humectants Enzyme preparations Sequestrants Bulking agents Propellants Packaging gas Carriers and carrier solvents

In general, for business sales, the following information must be shown on the label, though some points may, alternatively, be stated on trade documents: • the name and E number laid down by law, or, if none, a precise description that prevents confusion, of every additive present, in descending order of proportion by weight present; • an indication of any material used to facilitate storage, sale, standardisation, dilution or dissolution of the food additive, in descending order of proportion by weight; • a statement ‘for use in food’ or ‘restricted use in food’ or a more specific reference to the food use for which the food additives are intended; • any special storage conditions; • any special conditions of use of the additives; • instructions for use, if necessary; • the batch or lot mark; • the name or business name and address of the manufacturer, packer or EU seller of the food additives; • where other regulations prescribe maximum quantities of use either the percentage of such food additives present or sufficient information to enable the purchaser to ascertain whether he may use the additive in a particular food and the maximum levels permitted.

In the case of consumer sales the product name must consist of a description of the food additives listed in any regulations and their E number, or in other cases a description that is sufficiently precise to avoid confusion. Information as required for business sales must be stated (except the final requirement regarding proportions present). The minimum durability of the product must also be stated according to the details in The Food Labelling Regulations 19962 (see Chapter 6). The information must be conspicuous, clearly legible and indelible. The regulations do not apply to processing aids, plant protection substances, flavourings and nutrients. The labelling of flavourings, for both business and consumer sales is controlled by specific regulations24 that require identification of the flavouring and the person responsible for placing it on the market. For business sales the components of the flavouring must be stated or provided, in accordance with the requirements of the regulations. For consumer sales the minimum durability must be given as well as any necessary storage and use instructions. The Regulations also specify the conditions under

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which the flavouring or its components may be described as ‘natural’ or other similar expression. Specific labelling requirements also exist for extraction solvents for use in trade25 and require correct identification of the extraction solvent and the persons responsible for trading it, the net quantity and, if necessary, special conditions of storage and use.

4.2.6 Guidance notes, guidelines and Codes of Practice In order to provide help in understanding the Regulations, the UK Ministry of Agriculture, Fisheries and Food has produced guidance notes to The Food Labelling Regulations,26 which provide informal non-statutory guidance to the meaning of the main requirements. The guidance notes were drawn up following extensive consultation with interested parties and include examples to help clarify the various points. The EU has issued general guidelines for implementing the principle of QUID,18 and the UK has produced similar guidance notes to the QUID requirement,19 placing the EU guidance in a UK context. These guidance notes are particularly helpful in giving examples to illustrate the QUID requirements, and they draw attention to the somewhat obscure differences between the various types of products that attract a declaration as well as those that are not covered by the requirements. The Food Advisory Committee has produced guidelines to control use of the word ‘natural’ and similar words in food labelling and advertising.27 These are not applicable to flavourings where legislation has superseded them, but apply to descriptions of other food ingredients and additives. The word ‘natural’ or similar should be restricted to food ingredients that are of a traditional nature and have been subjected only to processing necessary to make them suitable for human consumption, such as freezing, sterilisation, etc., and traditional cooking processes, and to food additives (other than flavourings) obtained from recognised food sources only by appropriate physical processes or by traditional food preparation processes. Guidance Notes on the Labelling of Food containing genetically modified soya or maize,28 amended to apply also to ingredients containing additives and flavourings from GM sources,29 provide useful help in interpretation and application to food businesses of the regulations on labelling of GM-derived food ingredients. Guidance Notes on Place of Origin30 include recommendations for product labelling in instances where the place of origin of the ingredients is different from that of the final product. Copies of Guidance Notes can be obtained from: Food Standards Agency PO Box 31037 Ergon House c/o 17 Smith Square London SW1P 3WG Traditionally Codes of Practice, usually agreements between the trade and government and/or enforcement bodies, provide useful advice and interpretation of the food Regulations, frequently with suggestions for suitable levels of ingredients in foods. Although many of these are now outdated, the concept still operates. The UK Association of Frozen Food Producers and other organisations in the fish and frozen food sectors have drawn up a Code of Practice31 regarding calculation and declaration of the fish content of fish products, including those in which cooked or processed fish is used, which will be helpful to those needing to comply with QUID requirements for these products.

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4.3 Future trends in labelling requirements for ingredients and additives Although core rules for identification of food ingredients and additives are in force throughout the EU, developments towards more detailed laws that will require manufacturers to divulge further the contents of their products are taking place. Many of these are being generated by consumer demands that the label shows more precisely and clearly the content of the foods they are purchasing. The 25% exemption for identification of constituents of compound ingredients, an arbitrary figure, is now considered too high, and it will probably be reduced, possibly to around 5%. Discussions concerning distinctive label warning of the presence or possible presence of potential food allergens are also in progress and specific identification of any of a specified list of such ingredients will eventually be required (see Section 12.3). Draft documents containing proposals for ingredients listing for alcoholic drinks containing more than 1.2% alcohol by volume are also under discussion. In the longer term rules may be made to require declaration of processing aids used in food products. The governments of the UK and other Member States are also encouraging voluntary declarations in cases where genuine consumer demands for further information exist. EU recipe Directives on several products have been reviewed with a view to simplification of their compositional requirements, and new directives concerning coffee extracts and chicory extracts, and cocoa and chocolate products have been agreed; those on other products including jams and similar products and fruit juices and similar products will follow. Controversial points regarding the use and labelling of vegetable fats other than cocoa butter in chocolate have been resolved, but will result in requirements for more informative labelling to indicate the presence of non-cocoa vegetable fats. The EU Commission is developing rules concerning obligatory declarations for GM additives and flavourings that are sold as such, and is also considering a possible threshold level to avoid labelling if material derived from genetic modification is present in such additives and flavourings due to adventitious contamination. The Commission will propose a list of food ingredients that to not require GM-labelling because they do not contain GM material.

4.4

Summary of manufacturers’ responsibilities

The manufacturer carries the main responsibility for ensuring that ingredients, including additives, are correctly identified in the labelling, the labelling information accords with the types and quantities actually used in the product, and that correct information is provided to distributors, retailers and others who subsequently handle the product. Under Section 21 of the Food Safety Act, a due diligence defence is available to persons in the food chain who may be charged with a labelling offence. In addition, retailers and others who handle the product after manufacture can, effectively, pass the responsibility back to suppliers, manufacturers, etc., provided they have exercised all ‘due diligence’ in carrying out their own responsibilities. Food labelling, including correct calculation and declaration of ingredients and additives, should form part of the total quality control system that is applied to the manufacture of the product; it must be remembered that the label is the main face of a packaged product to the consumer. It is most important to ensure that draft labels are thoroughly checked by qualified persons before they are printed. Commercial pressures should not allow this important procedure to be omitted.

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Adverse publicity quickly results from an incorrect label, and the process of re-designing a label for a product is very expensive. The manager must ensure that procedures are in place so that all responsible are aware if, for instance, a product recipe is changed so that identification of its contents is affected. Increasingly, requirements for ingredient statements have become more specific, so that any change made to the product recipe becomes more likely to affect the label declarations. The manufacturer should have some understanding about the complete field of food law, since labelling requirements, although partially consolidated in the 1996 Regulations, can still be found in other types of regulations. It should be noted, in particular, that a number of declarations concerning ingredients are still contained in food compositional laws, and that strict limits for use of many food additives are prescribed in the additives Regulations, together with rules concerning expression of maximum levels and carry-over provisions. The manufacturer needs to keep ‘up to date’ in this area, and be aware of legislative changes and proposals for changes. Difficulties are encountered when deciding the correct name for certain ingredients and compound ingredients. It is important that these are sorted out before the label is finalised, and discussions with local enforcement officers can do much to clarify difficult issues. Help can also be obtained through the government and trade bodies and some research associations, and opportunities for training and consultation in this area should not be missed.

4.5

How it can go wrong

Most food companies have good control and checking procedures in place so that defects on food labels are minimal. However, a number of potential areas for error still exist. It is not always realised that terminology and descriptions of ingredients must be accurate and any descriptions of declarations required by law, which are usually placed in quotes in the Regulations, must be repeated exactly on the label; the wording may not be changed. Calculations for limits of additives and quantities of ingredients must follow any prescribed laws or, in their absence, standards generally used in good trade practice and acceptable to the authorities. Requirements applicable to specific products must be applied. As examples, the Spreadable Fats Regulations, as amended,13 adopt EU Council Regulations requiring that the average fat not differ by more than 2% from the declared percentage. All samples must comply with the limits laid down by Council Regulation 2991/94, and with the verification procedure for compliance with the rules that is prescribed in Annex II to the Council Regulation. The Jam and Similar Products Regulations9 require that the declared sugar content of these products is determined by refractometer at 20ºC and must be accurate to within 3% refractometric degrees. The new QUID requirements raise a number of labelling issues that need careful handling by the food industry in order to prevent consumer confusion, which would negate the main objective of QUID; that is, to assist consumer choice in the marketplace. Problem areas include deciding whether or not a particular food ingredient is caught by the requirements, deciding which ingredients need to be declared when a product is identified by a customary name or by a complex description, and the basis of declaration which must not conflict with any other quantity declarations made on the label. Helpful guidance on these questions is contained in the EU guidelines18 and the UK guidance notes,19 and manufacturers are recommended to become acquainted with the issues that

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are addressed in them, in order to minimise errors in the quantity declarations on their products. The food industry is also advised to adopt a common practice when making decisions concerning expressions of quantity so that consumers can make meaningful comparisons about products. The issue of variation in quality of raw materials has not been resolved, but it is in the manufacturer’s own interests to ensure that good quality foods are used. Analytical methods for checking declared quantities are not prescribed, and enforcement officers and manufacturers should use generally accepted methods and keep abreast of scientific developments in this area. Problems concerning the use of correct linguistic terms frequently arise, both in EU trade and with exports to other countries. The correct term accepted in the country of destination or export must always be used, and it is advisable to check ingredients lists with qualified experts in the country concerned. Those involved in EU trade need to be aware that labelling rules are still changing and transitional situations exist. Most countries accept foods that comply with EU Directives, but some Member States may claim grounds for not accepting a label that does not comply with their national laws which may not yet comply with a new Directive. Different scientific interpretations of food and ingredient names also arise; procedures will eventually be put in place to clarify misunderstandings, but at present this could be a hindrance to the movement of food products. Those importing foods from the United States need to ensure that labels have been altered to meet UK requirements. US Regulations, though detailed, differ in many respects from EU/UK requirements, and new labels are usually required for products brought into the United Kingdom from the United States.

4.6

References

1. Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs, (Official Journal of the European Communities (L33) of 8 February 1979, pp. 1–14), as amended several times, including Directives 89/395/EEC, 91/72/EEC, 93/102/EC, 94/54/EC, 96/21/EC and 97/4/EC. 2. The Food Labelling Regulations 1996 (S.I. 1996 No. 1499). 3. Directive 97/4 of the European Parliament and of the Council of 27 January 1997 amending Directive 79/ 112/EEC (Official Journal of the European Communities (L43) of 14 February 1997, pp. 21–3). 4. The Food Labelling (Amendment) Regulations 1998 (S.I. 1998 No. 1398). 5. Regulation (EC) No. 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (Official Journal of the European Communities (L43) of 14 February 1997, pp. 1–6). 6. Council Regulation (EC) No. 1139/98 of 26 May 1998 concerning the compulsory indication of the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Directive 79/112/EEC (Official Journal of the European Communities (L159) of 3 June 1998, pp. 4–7) as amended by Regulation 49/2000 of 10 January 2000 (Official Journal of the European Communities (L6) of 11 January 2000, pp. 13–14). 7. Commission Regulation (EC) No. 50/2000 of 10 January 2000 on the labelling of foodstuffs and food ingredients containing additives and flavourings that have been genetically modified or have been produced from genetically modified organisms (Official Journal of the European Communities (L6) of 11 January 2000, pp. 15–17). 8. The Genetically Modified and Novel Foods (Labelling) (England) Regulations 2000 (S.I. 2000 No. 768). 9. The Jam and Similar Products Regulations 1981 (S.I. 1981 No. 1063, as amended by S.I. 1990 No. 2085). 10. The Meat Products and Spreadable Fish Products Regulations 1984 (S.I. 1984 No. 1566, as amended by S.I. 1986 No. 987). 11. The Fruit Juices and Fruit Nectars Regulations 1977 (S.I. 1977 No. 927, as amended by S.I. 1982 No. 1311, S.I. 1991 No. 1284 and S.I. 1995 No. 236). 12. The Cocoa and Chocolate Products Regulations 1976 (S.I. 1976 No. 541, as amended by S.I. 1982 No. 17). 13. The Spreadable Fats (Marketing Standards) Regulations 1995 (S.I. 1995 No. 3116, as amended by S.I. 1998 No. 452 and S.I. 1999 No. 540).

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14. The Condensed Milk and Dried Milk Regulations 1977 (S.I. 1977 No. 928, as amended by S.I. 1982 No. 1066, S.I. 1986 No. 2299 and S.I. 1989 No. 1959). 15. The Specified Sugar Products Regulations 1976 (S.I. 1976 No. 509, as amended by S.I. 1982 No. 255). 16. Commission Directive 1999/10/EC of 8 March 1999 providing for derogations from the provisions of Article 7 of Council Directive 79/112/EEC as regards the labelling of foodstuffs (Official Journal of the European Communities (L69) of 16 March 1999, pp. 22–3). 17. The Food Labelling (Amendment) (No. 2) Regulations 1999, S.I. 1999 No. 1483. 18. EC general guidelines for implementing the principle of Quantitative Ingredients Declaration (QUID) – Article 7 of Directive 79/112/EEC as amended by Directive 97/4/EC, document III/5260-rev 5/98, 21 December 1998. 19. The Food Labelling Regulations 1996: Guidance Notes on Quantitative Ingredients Declaration (QUID), Joint Food Safety and Standards Group, April 1999. 20. The Food (Lot Marking) Regulations 1996 (S.I. 1996 No. 1502). 21. The Weights and Measures (Quantity Marking and Abbreviations of Units) Regulations 1987 (S.I. 1987 No. 1538, as amended by S.I. 1988 No. 627). 22. Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption (Official Journal of the European Communities (L40) of 11 February 1989, pp. 27–33). 23. The Food Additives Labelling Regulations 1992 (S.I. 1992 No. 1978). 24. The Flavourings in Food Regulations 1992 (S.I. 1992 No. 1971, as amended by S.I. 1994 No. 1486). 25. The Extraction Solvents in Food Regulations 1993 (S.I. 1993 No. 1658, as amended by S.I. 1995 No. 1440 and S.I. 1998 No. 2257). 26. The Food Labelling Regulations 1996: Guidance Notes (revision 1), January 1997, Joint Food Standards and Safety Group, Ministry of Agriculture, Fisheries and Food. 27. Food Advisory Committee Guidelines. Recommended Conditions for the Use of the Term ‘Natural’ in Food Labelling and Advertising. 28. Guidance Notes. Labelling of Food containing Genetically Modified Soya or Maize, PB4447, June 1999, Ministry of Agriculture, Fisheries and Food/Department of Health. 29. Revisions to the Guidance Notes on Labelling of Food containing Genetically Modified Soya or Maize, March 2000, Additives and Novel Foods Division, JFSSG. 30. The Food Labelling Regulations 1996. Guidance Notes on Place of Origin, January 2000, Joint Food Safety and Standards Group. 31. Code of Practice on the Declaration of Fish Content in Fish Products, March 1998, available from the UK Association of Frozen Food Producers, price £15.

5 Declaration of ingredients and additives: United States R. H. Schmidt, University of Florida

5.1

Declaring ingredients and additives: the basic principles

The basic principles guiding food additive and ingredient labeling requirements in the United States have evolved throughout the 20th century paralleling food industry and consumer trends. These basic principles include: • the ingredient list shall not be false or misleading in any particular; • there shall not be an omission of or a substitution for a valuable constituent; • there shall not be deception as to quality, either by concealing inferiority or by the use of additives/ingredients to make the food appear of greater value; • the informed choice of the consumer is enhanced by the disclosure of ingredient information (the consumer has the right to know what is in the product); • inclusion of certain specific ingredient information or statements on food labels is necessary to inform consumers with special dietary needs, including allergies and related sensitivities and the desire to avoid certain ingredients and additives for religious or cultural reasons.

Food ingredients and food additives have been the subject of periodic public concern and political interest throughout US history. In the early 1900s, reacting to widely publicized examples of filth and deception, the federal government asserted authority over the quality and safety as well as product identity and compositional disclosure. The primary concern of these early food regulators was to uncover fraud and deception with regard to concealing the presence of unsafe food ingredients, or misleading the consumer by improper label declaration.1,2 As industrial food technology advanced, innovations evolved to expand, extend, and improve or to imitate existing food products. The development of new functional food additives and preservatives brought about additional concerns as to safety and label disclosure. Likewise, the development of substitutes and/or imitations of traditional foods brought concerns that these products may be of lower functional and nutritional quality than traditional foods. As a result, standards of identity were established for many traditional food products. In general, to be labeled with the name of a standardized food, a

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formulated food must meet all of the specified requirements of the standard including ingredients. For example, a product named ‘macaroni’ must meet the requirements of the standard for macaroni. Early standards of identity were very restrictive and did not allow much flexibility to food manufacturers in formulating processed foods. More recently, standards of identity were changed to permit more optional ingredients. While standards of identity have provided consumers with the confidence that they are not misled, it has also been suggested that they may inhibit the development of new and novel food products. Ingredient labeling requirements have evolved and have been refined and clarified to keep abreast with consumer interests. In general, today’s health conscious consumer is more demanding than previous generations with regard to ingredient declaration. Further, more complete ingredient declaration is needed by consumers with restrictive diets, because of allergies to certain ingredients or other reasons. In recent years, ingredient labeling requirements have been modernized to meet these consumer demands. Further, the recent trend by food manufacturers towards developing foods to meet a therapeutic function (e.g. functional foods or nutraceuticals) will create additional issues with regard to ingredient labeling.

5.2

Review of key legislation

5.2.1 Food and Drug Administration (FDA) The US Deptartment of Health and Human Services (DHHS)/Food and Drug Administration (FDA)3 has the primary authority in interstate commerce for establishing labeling requirements for all domestic and imported food products (except meat products with greater than 3% meat, and poultry products with greater than 2% poultry), bottled water and wine beverages with less than 7% alcohol. Food regulatory activity is located in FDA’s Center for Food Safety and Applied Nutrition (CFSAN).3 Federal Food, Drug and Cosmetic Act (FDCA) (1938) The basic regulatory framework for the prohibition of adulteration and misbranding of food products was provided with the passage of the Pure Food and Drugs Act of 1906. This act was rescinded and replaced by the passage of the Federal Food, Drug & Cosmetic Act (FDCA) in 1938 [21 USC §301]. The FDCA has been amended by congress several times either directly or indirectly through passage of other acts. The congressional actions which have amended FDCA and have affected food additives, food ingredients and their labeling are as follows: • • • • •

Food Additives Amendment (1958); Color Additives Amendment (1960); Saccharin Study and Labeling Act (1977); Nutrition Labeling and Education Act (NLEA) (1990); Dietary Supplement Health and Education Act (DSHEA) (1994).

The Food Additives Amendment provided for a pre-market approval system for food ingredients (FDCA, Sec. 409) requiring that a food additive be shown to be safe for its intended use. In addition, the term ‘food additive’ has been more clearly defined as a result of this historical amendment. Under the FDCA definition, a food additive is a substance which, through its intended use, may reasonably be expected (directly or indirectly) to become a component or affect the characteristics of any food. A food additive is a substance and not a process (with the

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exception of food irradiation which is classed as a food additive in the United States). Excluded from the food additive definition are those substances which are generally recognized as safe (GRAS), prior sanctioned substances (i.e. used in accordance with a sanction or approval prior to 1958), and substances which are regulated separately under the Act (e.g. pesticide chemicals, color additives, and new animal drugs). The Food Additives Amendment was further modified by the addition of the Delaney Clause which established a zero tolerance for food additives which have been found to induce cancer in man or animal. By definition, food additives are distinguished from food or natural food constituents. A food or a natural food constituent becomes a food additive when added to another food. The definition includes both direct additives (substances added to foods) and indirect additives (substances that indirectly become a food component or affect its characteristics). However, environmental contaminants and accidental contaminants are not considered food additives since they do not meet the intended use criterion and they typically do not become a component or affect the characteristics of the food. Regulations under the Color Additives Amendment specifically define color additives. To be defined as a color additive, a substance must be specifically added for the purpose of imparting color. A substance which may impart color, but is added to food solely for a purpose other than coloring is not a color additive under the definition and would be classed as a food additive. While the intent of pre-market safety evaluation for color additives is similar to that of food additives, subtle differences exist. In general, a listing system is used where the regulatory status of a color additive is either permanent, provisional, or prohibited. Fair Packaging and Labeling Act (FPLA) (1966) The Fair Packaging and Labeling Act (FPLA) [15 USC §1451] was enacted by the US Congress to prevent unfair and deceptive practices by requiring accurate label information with regard to quantity of contents on packaged consumer products. The specific requirements of FPLA have been promulgated into FDA labeling regulations for foods, drugs and cosmetics. FPLA has indirectly provided FDA with the authority for establishing voluntary nutrition label regulations in 1974 and current requirements under the Nutrition Labeling and Education Act (NLEA) of 1990. Saccharin Study and Labeling Act (1977) The non-nutritive sweetener, saccharin, was found to cause cancer in laboratory animals and, thus, the FDA attempted to ban this food additive under the Delaney Clause of the Food Additives Amendment to FDCA. As this sweetener was in widespread use and, essentially, the only non-nutritive sweetener available for soft drinks, consumer pressure resulted in the passage of the Saccharin Study and Labeling Act [21 USC §343]. This Act placed an 18-month moratorium on banning saccharin to allow more study as to its carcinogenicity and provided for a warning statement on foods containing saccharin. The moratorium on banning saccharin has been extended five times since 1977. The last fiveyear extension officially expired on 1 May 1992. However, the moratorium on banning saccharin has been informally extended. Under amendments to FDCA, foods containing saccharin that do not contain a warning statement on their label are considered misbranded. Nutrition Labeling and Education Act (NLEA) (1990) The Nutrition Labeling and Education Act (NLEA) [Public Law 101–535; 104 STAT. 2353] provided for promulgation of additional labeling requirements for food products

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(see Chapter 3) and promoted uniformity between states by pre-empting all previous state labeling regulations. In general, NLEA regulations, initially published in 1993,4 and related amendments to FDCA require nutrition information on all food labels with few exceptions. Further, NLEA regulations provide more clarity than previously with respect to labeling terms and definition, nutrient content claims, and health-related claims. In its NLEA regulations, the FDA has also attempted to provide more information and avoid confusion in ingredient listing and declaration. There are several provisions of the final rule which directly affect ingredient labeling requirements. Most of these regulations have been developed in the interest of providing more complete information for consumers. Traditionally, full ingredient labeling was not required on standardized foods. The basic philosophy behind this exemption was that consumers, in general, had knowledge of the composition of these food products since home baking was fairly commonplace. However, today’s consumer, with a faster paced lifestyle would not be expected to possess as much food compositional knowledge. Thus, through NLEA, the FDA now requires full ingredient labeling on all foods (including standardized foods) with one or more ingredient. There has also been some confusion with regard to the naming and labeling requirements for beverages that contain juice. NLEA regulations require that such beverages declare the full percentage of juice on the information panel. Further, the regulations have clarified the naming requirements for multi-juice beverages. Before NLEA regulations, flavorings, colorings, or spices could be identified collectively under the general terms ‘flavoring’, ‘spices’, or ‘colorings’. Such collective labeling has been the subject of some controversy and criticism by consumer groups wanting to avoid certain synthetic additives (especially color additives). Since NLEA, FDA certified color additives (e.g. FD&C Yellow No. 5) must be identified by name on most food labels. NLEA regulations have also provided more information to potentially sensitive consumers by requiring: • that caseinate, a protein derived from milk, be identified as such on the labeling of products termed ‘non-dairy’; and • specific information as to the source of protein hydolysates used as additives in foods.

Dietary Supplement Health and Education Act (DSHEA) (1994) The passage of the Dietary Supplement Health and Education Act (DSHEA) had little impact on ingredient and additive labeling requirements for food products. However, significant changes have occurred in those products which are defined as dietary supplements. Under DSHEA, the broad, expanded definition of dietary supplement includes any product intended to supplement the diet (and does not contain tobacco) that bears or contains a vitamin, a mineral, a herb or other botanical, an amino acid, or any substance for use by man to supplant the diet by increasing the total dietary intake and includes metabolites, constituents, extracts, concentrates, or any combination thereof. An important provision of the definition is that a dietary supplement is not represented as a food, meal, or diet. Since passage of DSHEA, dietary supplement manufacturers have increased marketing freedom and are allowed to provide more information about their products’ benefits in product labeling (with some constraints). The FDA has developed labeling requirements for these products with a similar format as those for food products, especially with regard to the ingredient list. However, an explicit amendment has been

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added to FDCA which clearly exempts ingredients and additives used in dietary supplements from the stringent pre-market clearance requirements applied to food additives. A dietary supplement will, however, be deemed adulterated if it presents a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in the labeling. A current trend in the United States is for manufacturers to develop functional foods (or nutraceuticals) which have been amended with specific functional or therapeutic additives (e.g., ginseng, ginkgo biloba, St John’s Wort, and others). Since these may border on falling into the dietary supplement category, there may be a temptation for manufacturers to market them as such. However, until further definitions are developed for functional foods, the FDA has been very conservative in its approach to their regulation. The current FDA interpretation is that they are foods (since they are represented as foods). Thus, they are subject to food labeling and safety regulations with regard to their ingredients.

5.2.2 Food Safety and Inspection Service (FSIS) The US Department of Agriculture/Food Safety and Inspection Service (FSIS)5 Labeling Review Branch (LRB) has the primary authority for establishing labeling requirements and pre-market approval of labels for all domestic and imported meats, poultry, and egg products under the following Acts and Regulations: • Federal Meat Inspection Act (FMIA) [also termed Wholesome Meat Act] of 1906 (as amended) [21 USC §601]; • Poultry Products Inspection Act of 1957 (as amended) [21 USC §85]; • Egg Product Inspection Act of 1970 [21 USC §1031]; • Nutrition Labeling of Meat and Poultry Products; Final Rule.6

A meat food product is generally defined by the FMIA as any food which contains greater than 3% meat (cattle, sheep, swine, or goats). Similarly, a poultry product is defined by the PPIA as any food product which contains greater than 2% poultry. Food products containing 3% meat or less and food products containing 2% poultry or less are regulated by the FDA under the FDCA.

5.3 Manufacturers’ responsibility for ingredient and additive declaration 5.3.1 Food and Drug Administration (FDA) It is the responsibility of the manufacturer to comply with the provisions of the FDCA with regard to adulteration and misbranding. In general, all ingredients and additives used in food products must be safe and nontoxic under conditions of use as provided in FDCA. Further, the manufacturer is responsible for assuring that the listing on the label is not in any way false or misleading. FDA ingredient declaration regulations are codified7 (21 CFR §101.4) and have been summarized in various printed and internet sources.1, 8–11 Foods with special ingredient specifications The three food product categories with special restrictions and specifications as to ingredients and additives or additional specific labeling requirements are: standardized

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foods (e.g., foods with codified standards of identity under 21 CFR §130), nonstandardized foods with defined and codified common or usual names (21 CFR §102), and foods which contain a characterizing ingredient (21 CFR §101.3). Standardized food products The 21 categories of US foods for which standards of identity have been developed are listed in Table 5.1. A standard of identity establishes the common or usual name for the product. In general, any food bearing that name must meet all the requirements of the standard. These standards usually specify which ingredients must be present, may be used, or are prohibited. For example, specified fruit must be used in fruit butters or fruit preserves, while optional ingredients may be used (e.g. spice, pectin, acidifying agents, anti-foaming agents). To allow flexibility for manufacturers of nutritionally modified foods, the general regulations for food standards (21 CFR §130) have been altered to allow and establish conditions whereby such nutritionally modified foods may be identified under the name of a standardized food. Specific ingredient requirements for nutritionally modified foods bearing the name of a standardized food are as follows: • nutrients may be added so that the food is not nutritionally inferior to the unmodified standardized food; • safe and suitable ingredients may be added to the modified food to enhance properties and ensure performance characteristics equal to the unmodified product; • an ingredient or component of an ingredient that is required by the standard shall not be reduced or replaced with a similar ingredient from another source; • an ingredient that is prohibited by a standard may not be added to the modified food; • water and fat analogs may be added to replace fat and calories; Table 5.1

Standards of identity by food category (Adapted from Vetter1)

Category Milk and cream Cheeses and related products Frozen desserts Bakery products Cereal flours and related products Macaroni and noodle products Canned fruits Fruit juices Fruit butters, jellies, preserves Fruit pies Canned vegetables Vegetable juices Frozen vegetables Eggs and egg products Fish and shellfish Cacao products Tree nuts and peanut products Beverages Margarine Sweeteners and table syrups Food dressings and flavorings

Reference (21 CFR part)

Number of standards

131 133 135 136 137 139 145 146 150 152 155 156 158 160 161 163 164 165 166 158 169

21 73 5 5 29 15 21 19 5 1 10 1 1 10 8 14 3 1 1 9 11

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• any ingredient used at a level that is higher than permitted under the standard, or that is not permitted by the standard, must be identified with an asterisk in the ingredient declaration and clarified by the use of a footnote (e.g. *Ingredient(s) in excess of amount permitted in regular . . . . . . . .; or *Ingredient(s) not in regular . . . . . . . ..).

Foods with established common or usual name regulations For certain foods (e.g., peanut spreads, frozen ‘heat and serve’ dinners, diluted orange juice beverages and others) not covered by standards of identity, common or usual names have been established by regulation (21 CFR §102). In many cases, these regulations describe product composition and ingredient specifications. Like standardized foods, a food with an established common or usual name regulation must meet the requirements of such regulation in every respect. Foods with characterizing ingredients Often the amount, presence or absence of a specific ingredient may affect the value or consumer acceptance of a food. Thus, it is imperative that the labeling or the product identity not be misleading as to the presence and/or amount of such a characterizing ingredient. In general, FDA regulations (21 CFR §101.3(f) and 102.5) require that the product identity statement include: • the percentage(s) of any characterizing ingredient(s), or • information concerning the presence or absence of such ingredient if the proportion, presence or absence of such ingredient has a bearing on price or consumer acceptance, or when the lack of such declaration may mislead the consumer.

When a product is deemed to have a characterizing flavor it must appear as part of or immediately following the product identity statement (21 CFR §101.22). Under this regulation, if a product’s label, by word, vignette, or design, makes a prominent representation with respect to a primary recognizable flavor, then such flavor is deemed to be a characterizing flavor. The characterizing flavor regulations are very detailed and specific and different rules apply depending upon whether the flavor is entirely natural, entirely artificial, or a combination thereof. The most debated issues have been with respect to interpreting the general characterizing ingredient requirements for diluted juice products. In 1974, the FDA proposed a regulation to establish common or usual name regulations with guidelines and requirements for diluted juices rather than developing standards of identity. Such common or usual name regulations have been developed for some (e.g., ‘diluted orange juice beverages’), but not all, juices. Under current regulations, beverages that purport to contain juice (fruit or vegetable) must declare the percentage of juice (volume/volume basis) (21 CFR §101.30). Included in the requirement are non-carbonated and carbonated beverages, full-strength (100%) juices, concentrated juices, diluted juices, and juices that purport to, but do not, contain juice. ‘Purporting to contain juice’ is interpreted by label statements, by pictures of fruits or vegetables on the label, or by consumer expectations (e.g., taste or appearance). The percentage juice declaration must be on the information panel (see Chapter 3), near the top, in easily legible bold type, and may be stated either with or without the name of the fruit or vegetable (e.g., ‘contains 100% juice’; ‘100% juice’; or ‘100% Apple Juice’). Only beverages that are 100% juice may be called ‘juice’, while diluted juices must have a qualifying term (e.g., ‘beverage’, ‘drink’ or ‘cocktail’) or with a name using the form ‘diluted’ (e.g., ‘diluted apple juice’).

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The percentage juice declaration is adequate for single source juices diluted with water. However, it was not adequate for multi-juice blends where it is common practice to dilute a dominant flavored juice (e.g. raspberry) with a bland, less expensive juice (e.g. apple). Consumers could potentially be misled by a 100% juice label declaration (when the product is not 100% raspberry juice). In fact, the characterizing ingredient (raspberry juice) may prominently appear in the product identity while the consumer would have to scrutinize the ingredient list for the apple juice. Because of these concerns, additional criteria were developed for multi-juice beverages. In general, manufacturers have the following choices: • When declared as part of the product identity, the names of juice used in multi-juice beverages must be in descending order of predominance (by volume) (e.g. Apple, Pear and Raspberry Juice Drink), unless the named juice is used for flavor (e.g. RaspberryFlavored Apple and Pear Juice). • When the label represents one or more but not all the juices (except in the ingredient list), then the name must indicate that more juices are present (e.g., ‘Apple Juice Blend’; ‘Apple Juice in a Blend of Two Other Fruit Juices’). • When the label of a multi-juice beverage names one or more, but not all, the juices in the beverage, and if the named juice is present in minor amounts, manufacturers must either: – state that the product is ‘flavored’ with that juice (e.g. raspberry-flavored juice blend) provided that the term ‘juice’ is not used other than in the ingredient list, and the beverage does not otherwise give the impression they contain juice, or – declare the amount of the juice in a five percent range (e.g. juice blend, two to seven percent raspberry juice).

General ingredient/additive declaration requirements The ingredient list An ingredient statement (ingredient list) is required on all foods that contain one or more ingredient (including all standardized foods). The ingredient list requirements apply to all packaged foods, industrial ingredients, institutional and food service products. The ingredient list shall be placed on the same panel as the name and address of the manufacturer, packer or distributor (either the principal display panel or the information panel) and shall meet the type size, prominence, and clarity requirements for labeling therein (see Chapter 3). The type size shall be such that it is at least 1/16th inch as measured by the lower case ‘o’ or, if all caps are used, the capital ‘O’ and that it is prominent, conspicuous, and easy to read (with certain exemptions to allow for smaller packages). An example of the ingredient list and its location is presented in Fig. 5.1. Listing of ingredients Ingredients shall be listed in descending order of predominance (by weight) and declared by their common or usual name. The order of predominance shall be based on the amount of the ingredients used in formulation rather than the amount in the finished product. Minor ingredients (present at 2% or less by weight) may be listed at the end of the ingredient statement and without regard to order of predominance if preceded by the phrase ‘Contains 2% or less of each of the following: . . . . . . . ..’ Naming of ingredients The common or usual name of a food ingredient may be obvious (e.g. ‘salt’ or ‘sugar’) and is used instead of the scientific name (e.g. ‘sodium chloride’ or ‘sucrose’). For some

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Tomato

SOUP Nutrition Facts NET. WT. 12ozs

INGREDIENTS: TOMATO, WATER, HIGH FRUCTOSE CORN SYRUP, WHEAT FLOUR, SALT, SPICE, CITRIC ACID.

Any Soup Company, Somewhere, N69 5JC

Fig. 5.1

The location of the ingredient list in the information panel of a food label.9

ingredients, tradition of use is used to establish the common or usual name. For example, the name ‘starch’ may be used to identify corn starch, because of traditional use. Other starches must be identified by source (i.e. potato starch, rice starch). Similarly, the term ‘flour’ on an ingredient statement refers to white flour from wheat while others are designated by source (i.e. rye flour, corn flour). In many cases, the common or usual name of a food ingredient is established by a regulation or a standard. For example, common or usual names of food additives, GRAS substances, and color additives have been established through regulations promulgated for their use. When food products are used as ingredients in other foods, they must be listed by the appropriate name as described in product naming regulations (see Section 3.4). If such ingredient is a standardized food, it must be listed by the name established in the standard and, further, conform in every respect to the established standard of identity.

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Table 5.2

Examples of collective or generic names for food ingredients7

Ingredients

Alternative or generic name(s)

Skim milk, concentrated skim milk, reconstituted skim milk, and non-fat dry milk

‘Skim milk’ or ‘non-fat milk’

Milk, concentrated milk, reconstituted milk, and dry whole milk

‘Milk’

Sweetcream buttermilk, concentrated sweetcream buttermilk, reconstituted sweetcream buttermilk, and dried sweetcream buttermilk Butteroil and anhydrous butterfat

‘Buttermilk’

‘Butterfat’

Whey, concentrated whey, reconstituted whey, and dried whey

‘Whey’

Dried whole eggs, frozen whole eggs, and liquid whole eggs

‘Eggs’

Dried egg whites, frozen egg whites, and liquid egg whites

‘Egg whites’

Dried egg yolks, frozen egg yolks, and liquid egg yolks

‘Egg yolks’

The general rule for most ingredients is that the name declared on the label be a specific and not a collective or generic name [21 CFR §101.4(2)(b)]. However, collective or generic listing is specifically allowed for some ingredients with similar composition (see Table 5.2) where the consumer is not likely to be misled. These ingredients may be listed by either their specific name or by the collective name shown. Multi-component ingredients An ingredient composed of two or more components may be listed in one of two ways [21 CFR §101.4(b)(2)]. The first option is to list the common or usual name of the ingredient in the ingredient list in the place where it would normally appear followed immediately by a parenthetical sub-listing of its ingredients, also in order of predominance. For example: • ‘Ingredients: potato chips (potatoes, salt, oil)’ • ‘Ingredients: tomato puree (water, tomato paste)’.

An alternative option is to incorporate each of the separate sub-ingredients into the ingredient list (in the proper order of predominance by weight) for the entire finished product, without listing the name of the multi-component ingredient. Additional specific requirements Water Water added in the reconstitution of ingredients, formulation, or making of a food product is considered to be an ingredient and must be identified on the ingredient list. Water may also be added as part of the processing and handling procedure. Such added

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water may be either an ingredient or a processing aid and defined as an incidental additive (see below). For example, water added to facilitate formulation but removed during processing (e.g. water added to dough, but which is removed during baking of cereal products) would be considered a processing aid and not an ingredient. The general rule is that added water must be declared in the ingredient list to the extent that it exceeds the amount necessary to bring any concentrated or dehydrated ingredient of a food up to single strength. Reconstituted juices If used as an ingredient in another food, reconstituted juices made from concentrate must be identified in the ingredient list by either of two formats. For example: • Ingredients: ‘concentrated apple juice and water’ • Ingredients: ‘water and concentrated pear juice’.

Vegetable powders Vegetable powders must be declared by their specific common or usual name in the ingredient list. For example: • ‘Ingredients: celery powder’ • ‘Ingredients: tomato powder’.

Bacteria cultures When used as a food ingredient (e.g. cheese, yogurt), bacteria cultures may simply be declared by the word ‘cultured’ followed by the name of the substrate in the ingredient list. For example: • ‘Ingredients: made from cultured skim milk’ • ‘Ingredients: made from cultured buttermilk’.

Nutritional ingredients in fortified foods Vitamins and minerals (when added to fortified foods and dietary supplements) are listed in the ingredient list in the following order (21 CFR §101.36): vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, thiamin, riboflavin, niacin, folate, biotin, pantothenic acid, calcium, iron, phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, chloride, sodium and potassium. Qualifying synonyms may be added in parentheses following the name of the nutrient. For example: • ‘Ingredients: vitamin C (ascorbic acid), thiamin (vitamin B1), riboflavin (vitamin B2)’.

Fats and oils When a fat or oil is used as a food ingredient, it must be declared by its common or usual name (e.g. soybean oil, or lard) in the ingredient list. Hydrogenated or partially hydrogenated oils must be appropriately identified (e.g. ‘hydrogenated corn oil’, or ‘partially hydrogenated safflower oil’). For food products which are formulated by blending from more than one source of fats and oils, there are several options for the ingredient list. Each fat or oil may simply be listed separately in order of predominance. For example: • ‘Ingredients: soybean oil, lard’

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A second option is to list them collectively as ‘. . . . (animal, marine or vegetable) shortening’ or ‘blend of . . . . (animal fat, marine oil or vegetable oil)’. However, such collective listing must be followed by a parenthetic sub-listing of the individual products in the blend in order of predominance. For example: • ‘Ingredients: vegetable shortening (partially hydrogenated soybean oil and palm oil)’ • ‘Ingredients: blend of animal fats (butterfat, lard).

Manufacturers frequently change from one source of fat or oil, thus the regulations allow the use of the phrase ‘may contain one or more of the following’ to precede a listing of fats or oils (in order of predominance) and alternative (‘and/or’) labeling. The use of ‘or’ allows for only one of the listed oils being present, while ‘and/or’ implies that one or more listed products is used [21 CFR §101.4(b)(14)]. These options are only permitted for food products that contain relatively small quantities of added fat or oil ingredients (i.e. not the predominant ingredient) and only if the manufacturer is unable to predict which fat or oil ingredient will be used. Examples of such fat and oil ingredient labeling are as follows: • ‘Ingredients: vegetable oil (may contain one or more of the following: corn oil, soybean oil, palm oil)’ • ‘Ingredients: vegetable oil (contains one or more of the following: corn oil, soybean oil, or palm oil)’ • ‘Ingredients: vegetable oil (contains one or more of the following: corn oil, soybean oil, and/or palm oil)’.

Colors, flavors, and spices Spices may be listed in the ingredient list by their specific common or usual name, or they may be generically listed as ‘spices’ (21 CFR §101.22). Similarly, flavor additives from natural sources may be specifically listed in the ingredient list by their common or usual name or by the terms ‘flavor’, ‘flavoring’, ‘natural flavor ‘ or ‘natural flavoring’. However, if the substance is classed as a flavor enhancer (see below), it must be listed specifically by the common or usual name. Artificial flavors used in a food product must be declared on the ingredient list as ‘artificial flavors’. For example: • ‘Ingredients: spices, natural flavor and artificial flavor’.

The ingredient listing requirements for colors depend upon the source of the color. FDA-certified colors and their lakes (or non-soluble form) must be listed specifically by complete or abbreviated name for all food products except butter, cheese, and ice cream. Mixtures of colorings may be listed as ‘artificial color’ followed by a parenthetical sublisting of the certified colors. Examples of ingredient listing for FDA-certified colors are as follows: • ‘Ingredients: FD&C Yellow No. 5’ • ‘Ingredients: Yellow 5’ • ‘Ingredients: artificial color (including Yellow 6, Red 40)’.

Other color additives (non-certified colors) may be listed either by their specific common or usual name (e.g. ‘caramel coloring’ or ‘colored with caramel’), ‘artificial color’, ‘artificial color added,’ or ‘color added’. Spices which also provide color must be declared either by the specific common or usual name (e.g. ‘paprika’, ‘turmeric’, ‘saffron’) or by the term ‘spice and coloring’.

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The required identification of artificial flavors and colors is also applied to bulk foods, such as produce. The declaration must be plainly visible on the bulk container or other appropriate device, or counter card or sign at retail display. Functional additives or ingredients Substances for a functional purpose are termed functional additives and ingredients (e.g. leavening agents, yeast nutrients, dough conditioners, firming agents, emulsifiers, stabilizers, and acidulants or acidifiers). These functional additives may be declared in the ingredient list using a collective or generic term followed by a parenthetical phrase listing the specific ingredients used for that function or, conversely, by the common or usual name followed by a sublisting. Further, functional ingredients may be listed collectively using the terms ‘or’, ‘and’ or ‘and/or’ to allow flexibility in changing formulations without changing label declaration statements [21 CFR §101.4(b)(16) through (18)]. Examples of functional additive listing is as follows: • • • •

‘Ingredients: ‘Ingredients: ‘Ingredients: ‘Ingredients:

soy lecithin (emulsifier)’ or ‘ingredients: emulsifier (soy lecithin)’ citric acid (acidifier)’ or ‘ingredients: acidifier (citric acid)’ leavening (baking soda, sodium aluminum phosphate)’ stabilizer (mono and diglycerides, and/or guar gum)’.

Chemical preservatives When a chemical preservative is added to food, the ingredient list must include both the common or usual name and the function of the preservative using terms such as ‘preservative’, ‘to retard spoilage’, ‘to protect flavor’, ‘to preserve (or retain) freshness’, ‘a mold inhibitor’, or ‘to promote color retention’. Functional additives or ingredients clearly in use for other functional properties, but which may also act as preservatives (e.g. natural acidulants such as vinegar and juice concentrates) are exempted from using the supplemental descriptive statement. Examples of chemical preservative listing are as follows: • ‘Ingredients: ascorbic acid (to promote color retention)’ • ‘Ingredients: tocopherols (a natural antioxidant)’ • ‘Ingredients: sorbic acid (to retain freshness)’.

Protein hydrolysates Protein hydrolysates, manufactured by hydrolysis of protein materials using acid or enzyme treatment, are added to foods for a variety of functions. The source of these additives is highly varied as they arise from animal protein sources (i.e. casein, meats) as well as vegetable protein sources (i.e. wheat, corn, soybean). Generally used as flavorings and/or flavor enhancers, these multifunctional additives also provide nutrition and functionality (i.e. leavening agents, stabilizers). Previously, the general terms ‘hydrolyzed vegetable protein’, ‘hydrolyzed animal protein’, ‘hydrolyzed milk protein,’ or simply ‘hydrolyzed protein’ were permitted for ingredient declaration. Such generalized labeling has been confusing to the consumer and controversial in that it did not provide sufficient information to consumers with special dietary requirements for health, religious, or cultural reasons. Further, as it has been unclear whether these additives are flavorings or flavor enhancers, some manufacturers had been listing them simply as ‘flavorings’ or ‘natural flavors’ without further identification which created further confusion to the consumer. The FDA has recently concluded that protein hydrolysates, while added for other functions, nearly always function as flavor enhancers as well and,

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therefore, must be declared by their common or usual name (e.g. specific protein source identified) in the ingredient list. For example: • ‘Ingredients: hydrolyzed soy protein’ • ‘Ingredients: hydrolyzed casein’.

Caseinates Caseinates are milk proteins which are widely used for their desirable functional (e.g. emulsification) and nutritional properties in formulated foods including dairy substitutes or foods labeled ‘non-dairy’. As many consumers choose non-dairy products because of allergenic sensitivities and other health reasons, the simple listing of caseinates by their common or usual name in the ingredient list of products labeled ‘non-dairy’ may not sufficiently identify the milk source of this protein. Therefore, current regulations require further identification of casein as a milk derivative when used in foods that claim to be non-dairy. For example: • ‘Ingredients: caseinate (a milk derivative)’.

Incidental additives Incidental additives, substances that have no technical or functional effect in the food and are present at insignificant levels, do not have to be declared on the ingredient list [21 CFR §101.100(a)(3)]. Manufacturers should consult the regulations with regard to the defined level of a specific additive which is considered incidental. Incidental additives include: • processing aids which are added to food during processing but removed to an insignificant level in some manner before it is packaged; • substances that are converted into constituents normally present in the food; • substances which are added for a technical or functional processing effect, but are present in the finished food at insignificant levels and do not have any technical or functional effect in the finished food; • substances migrating to food from equipment or packaging materials which are approved as a food additive and present at an insignificant level.

The exemption from ingredient declaration for incidental additives has come under attack from consumer groups desiring more complete disclosure. Examples of controversial incidental additives are the sulfiting agents, used primarily as antioxidants to prevent or reduce enzymatic and/or nonenzymatic browning of fruits and vegetables, and as microbial inhibitors in wine. The types of sulfiting agents used include: sulfur dioxide, sodium sulfite, sodium and potassium bisulfite, or sodium and potassium metabisulfite. Sulfite sensitivity, especially in asthmatics, results in a wide range of symptoms and can be life-threatening in severe cases.12 Therefore, under current regulations, sulfiting agents specifically used as preservatives must be listed on the label regardless of the level in the finished product. Sulfites used in food processing, but not serving as preservatives in the final food, must be declared if present at 10 ppm or higher. Regulations further prohibit the use of sulfiting agents on fresh produce intended to be sold or served raw to consumers, for example in salad bars and grocery stores. Additional ingredient declaration concerns and requirements Warning labels for specific ingredients As required by the Saccharin Study and Labeling Act of 1977, food products containing saccharin must bear the following statement: Use of This Product May be Hazardous to

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Your Health. This Product Contains Saccharin Which Has Been Determined to Cause Cancer in Laboratory Animals. The statement must be conspicuous, in legible type in contrast to the typography, layout and color, and as near as possible to the name of the food. Notice must also be provided in retail establishments where the food is held for sale, but not for immediate consumption. The artificial sweetener, aspartame (e.g. NutrasweetTM), was approved for safe use in foods in 1981.2 However, phenylalanine, a component of aspartame, is not effectively metabolized by certain people including those with the genetic disease phenylketonuria (PKU), those with advanced liver disease, and pregnant women with hyperphenylalanine (high levels of phenylalanine in the blood). Therefore, the warning statement, Phenylketonurics–Contains Phenylalanine, is required on all food products containing aspartame. Irradiated food ingredients The processing of foods through the use of irradiation techniques is clearly defined as a food additive under FDCA, Sec. 201.13 Further, under FDCA, Sec. 402(a)(7), a food which has been irradiated without conformity to a food additive regulation, is considered adulterated. Thus, approval of irradiation is done on a case by case basis. Such approval has been granted for several applications including growth and maturation inhibition and pest disinfestation in fresh foods, microbial destruction in dehydrated enzyme preparations, aromatic vegetable substances including many spices and some natural color additives (e.g. turmeric and paprika), pork carcasses, and ground beef. The regulations require that irradiated foods must be identified at wholesale and retail with the international Radura logo and with either of the following statements: ‘treated with irradiation’ or ‘treated by irradiation’. Manufacturers may add qualifying terminology such as ‘to control spoilage’ or ‘to extend shelf-life’. The labeling requirements apply only to a food that has been irradiated (firstgeneration) and does not apply to a food which contains an irradiated ingredient (secondgeneration). Thus, foods which contain irradiated ingredients do not have to bear the symbol nor the special labeling statement. The exemption from special labeling for second generation foods has been of concern to some consumer groups. In response to these concerns, the FDA has issued an Advance Notice of Proposed Rulemaking (ANPR)14 in which the labeling issues for irradiated foods as well as possible labeling revisions are discussed. Glutamates When present in its free form, the glutamic acid or glutamate can enhance the flavor of foods. The sodium salt of glutamic acid, monosodium glutamate (MSG), has been used as a flavor enhancer for more than 2000 years. The FDA considers MSG as a GRAS substance.15 Due to questions as to the potential relationship of glutamates with certain neurological responses, this widely used food additive has been the topic of debate for many years. Pressures from consumer groups calling for special label declaration of glutamates in food led the FDA to contract the Federation of American Societies for Experimental Biology (FASEB) to review available scientific data as to the safety of MSG. The 1995 FASEB report reaffirmed the FDA’s assertion of the safety of MSG and related substances as food ingredients. Under current FDA regulations,15 MSG, when added to a food, must be identified by its common or usual name (monosodium glutamate) in the ingredient list. However, issues related to glutamate declaration continue to be controversial in the United States.

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Various petitions have been filed with the FDA asking for additional labeling requirements with regard to glutamates. These include requiring warning labels stating that MSG may be harmful to certain consumers, requiring mandatory listing of MSG in the ingredient list for manufactured and processed foods that naturally contain free glutamate, and allowing ‘No MSG’ labeling for food products which do not contain added MSG. In 1993, the FDA informally proposed to add a parenthetical qualifying phrase (contains glutamates) to the common or usual names of certain protein hydrolysates (e.g. hydrolyzed soy protein (contains glutamates)) in the ingredient list. In an ANPR,16 several issues were presented including a proposal that foods which contain significant amounts of free glutamate declare ‘glutamate’ in the ingredient declaration and options for allowances and restrictions on ‘No MSG’ labeling. However, the agency has, to date, not finalized any rules for additional labeling requirements for MSG or free glutamates. Further, since consumers frequently use the term MSG to mean all free glutamate, the FDA considers foods labeled ‘No MSG’ or ‘No Added MSG’ to be misleading on such products that contain free glutamates in their ingredients (e.g. hydrolyzed protein).15 Ingredients derived by biotechnology Food biotechnology (broadly described as the application of biological techniques to improve certain attributes of food crops and herbicide-tolerant crops, animals, and microorganisms) has been in use for many years in traditional fermented food. Such technology has resulted in a diverse array of food ingredients including enzymes, flavors, amino acids, sweeteners, thickeners, antioxidants, preservatives, colors, and other substances. Special labeling statements have not traditionally been required for these ingredients. However, development of food ingredients using more advanced biotechnology techniques such as genetic engineering, genetic manipulation, gene technology and/or recombinant dexoyribose nucleic acid (DNA) technology have raised consumer concerns and questions with regard to the need for additional labeling. This technology has collectively been termed ‘genetically modified organisms’ (GMOs) or ‘genetically engineered food’ (GEF). The first regulation for the use of a recombinant DNA-produced food ingredient was the affirmation of fermentation-derived chymosin (rennet) for cheese manufacture as a GRAS substance.16 Genetically modified tomato (Calgene’s FLAVR SAVRTM) introduced in 1994 has also received GRAS status.2,17 In addition, recombinant bovine somatotropin (rBST) has been given approval in the United States as a treatment in dairy cows to boost production, and genetically modified, pest resistant crops are in the marketplace. In 1992 the FDA published a policy statement18 for foods derived from new plant varieties. In general, the agency has been carefully considering issues raised regarding safety, allergenicity, and labeling of biotechnology derived substances. Substances derived from genetic engineering must meet the same stringent safety requirements as conventional additives in that they must either be affirmed as GRAS or approved under the food additive regulation process. With regard to labeling, the FDA has been under considerable pressure from various groups to require a special label to identify genetically modified foods or ingredients. However, the agency has held to its current policy that no additional labeling is required for these ingredients unless they are listed in such a way as to be false or misleading. Further, the use of labeling to describe products which do not contain these ingredients (e.g. ‘GMO-free’, ‘No GMO ingredients’, ‘rBSTfree’) has also not been accepted because of the difficulty in proving such statements. However, special labeling may be required in the following situations:

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• If the composition of the GEF differs significantly from its conventional counterpart, or if the use of a GMO-derived ingredient results in a significant change, additional labeling to inform the consumer may be required; • If the GEF or GMO-derived ingredients contain an allergen, special labeling to alert sensitive consumers may be required.

Potentially allergenic ingredients Undeclared food allergens have become a major concern and have been the subject of numerous food product recalls in the United States in recent years. To date, the FDA has not formally defined allergens, but has provided examples of foods which are commonly associated with allergenic response.18,19 Further, due to concerns that certain allergenic ingredients may be inadvertently excluded from specific label declaration, the FDA published a warning letter to manufacturers on the topic.20 In this letter, the agency clearly reaffirms its concerns regarding the need for declaration of potentially allergenic ingredients on food labels, and acknowledges that potentially allergenic substances may be exempt from declaration under current regulations (e.g. incidental additive exemption and collective labeling for spices, flavorings, and colorings). The agency further reaffirms that, to be considered an incidental additive and exempt from listing, both elements of the incidental additive definition must be met (i.e. the substance is present at an insignificant level and does not have a technical or functional effect in the food). For example, egg white (a potential allergen) may be used at levels deemed insignificant as a binder in breaded fish, but the ingredient is not an incidental additive because it is used for a functional effect. The FDA has asked manufacturers to examine closely their product formulations that may contain known allergens, to examine their manufacturing practices for potential cross-contamination of allergens from one food to another, and, further, to voluntary declare the presence of potentially allergenic substances (regardless of qualifying for incidental additive exemption). Where appropriate, the name of the ingredient may be accompanied by a qualifying parenthetical statement (e.g. processing aid) for clarity. Voluntary listing of allergenic ingredients in colors, flavors, or spices is also encouraged whereby manufacturers may simply list the ingredient at the end of the ingredient list. Some manufacturers are currently labeling products with the statement ‘may contain . . . . . . . . (name of allergen)’. (See also Section 12.3.)

5.3.2 Food Safety and Inspection Service (FSIS) In principle, general ingredient labeling requirements under the US Department of Agriculture/Food Safety and Inspection Service (FSIS) are similar to those of the FDA regulations described above. Further, most of the FDA requirements for ingredient listing have been adopted into FSIS regulations. However, there is one notable difference between the agencies in that that all labels of FSIS-regulated products must be preapproved by the agency. FSIS ingredient and additive declaration requirements are codified under 9 CFR §31721 and in the USDA ‘Labeling Policy Book’.22 An edited version of the detailed FSIS regulations is also available.23 FSIS has adopted several standards of identity for meats and poultry and have also defined informally food products under their jurisdiction in the Labeling Policy Book22 and additional policy memoranda. These regulations describe in great detail the permitted ingredients and additives. In addition, specific naming requirements for products which contain characterizing ingredients and for ingredients used in foods are provided.

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General ingredient/additive declaration requirements The ingredient list The FSIS requires full ingredient labeling on all products (including standardized products). Ingredients must be listed by their common or usual name or by a name defined under regulations. According to 9 CFR §317.2(f): The list of ingredients shall show the common or usual names of the ingredients arranged in the descending order of predominance, except as otherwise provided. Composite ingredients statements When it is necessary to use a multi-ingredient product (e.g. pepperoni from various sources with differing formulations) as an ingredient, a composite ingredient list may be used. Such a statement may identify all the ingredients that may be present from all the various formulations provided such ingredients are minor and do not have a bearing on the overall characteristics or value of the product. An example of a composite label is as follows: • ‘Ingredients: pepperoni (pork, beef, water, salt, spices, sodium nitrite. May also contain lactic acid, starter culture, sugar, and sodium ascorbate)’.

Additional specific requirements The following includes examples of some additional FSIS labeling requirements22–24 which apply when certain ingredients are used or when a processing step is used which changes composition in meat and poultry products. • Added juice or solution. If a meat or poultry product is cooked in an impervious bag which contains free flowing juice that is not drained, the product name shall reflect the presence of the solution or juice (e.g. ‘Roast beef contains up to 12% solution’). • Alcohol products. Alcoholic beverages (wine, beer, sherry, etc.) used as ingredients in meat and poultry products do not require sublisting on the label. • Alpha-tocopherol. If pump-cured bacon is treated on the surface with d- or d1-alphatocopherol, the product name must be qualified with a parenthetical phrase to identify the substance(s) and method of application (e.g. ‘sprayed with a solution of vegetable and vitamin E’, ‘dipped in corn oil and d-alpha-tocopherol’). • Aspartame. This sweetener is not acceptable as a direct ingredient in meat and poultry products, but is acceptable as an ingredient of components (e.g. cereals, dry bases, fillings, etc.) used in these products. If such ingredient is used, the warning statement discussed previously must be present. • Aspic. When aspic is used as an ingredient it must be sublisted in the ingredient list with a parenthetical phrase (e.g. Aspic (meat juices, tomato juices)). • Autolyzed yeast. When permitted for use, this flavoring may be either listed as ‘autolyzed yeast’ or ‘autolyzed yeast extract’ in the ingredient list. • Batters. If a batter is used, the ingredient list must show the ingredients in proper order (e.g. water, flour, etc.). • Beef consomme´. The beef ingredient in beef consomme´ can be listed alternatively as ‘beef stock’ or ‘beef broth’ in the ingredient list. • Beef testicles or beef fries are not permitted as an ingredient in meat products. • Binders. When permitted, and if they comprise more than 3% of the formula, binders (e.g. gelatin) must be included in the product name as a qualifying phrase (e.g. ‘gelatin added’).

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• Catsup. When permitted in meat products, catsup shall be listed in the ingredient list as either ‘catsup’ or ‘tomato catsup’ (with sublisting). When used in beef patties it must appear in the product name (e.g. ‘Beef patties with catsup’). • Cheese. When ‘cheese’ is declared in the ingredient list, cheddar cheese must be used. Other cheeses must be declared by name when used. • Chili products. When chili products are used as ingredients, several alternative ingredient declaration options are allowed: the terms ‘chili’ or ‘chili con carne’ may be used interchangeably, chili peppers may be listed as ‘red pepper’, ‘cayenne pepper’, or ‘spice’. • Cracker meal. When cracker meal is permitted, it may be listed in the ingredient list of meat and poultry products without sublisting of ingredients. • Dipped in hot vegetable oil. Products prepared in such a manner must bear a product name which is qualified with the specific vegetable oil used (e.g. ‘Browned in cottonseed oil’). • Increased weight in cooking. Cooked corned beef and cooked cured pork products whose weights after cooking exceed the weight of the fresh product, must reflect this in the product name (e.g. ‘cooked corned beef and . . . . . % water’ or similar descriptor to account for additional ingredients). • Mechanically separated. When used in meat and meat products, mechanically separated meat must be declared as ‘mechanically separated beef or pork’. Similarily, mechanically separated poultry must be declared as ‘mechanically separated chicken or turkey’. • Tenderizers. Products tenderized with proteolytic enzymes (e.g. bromelin, papain) must bear the statement ‘Tenderized in a solution of water and bromelin’ or ‘Tenderized in a solution of eater and papain’. • Wine, MSG, nitrates and nitrites are not allowed in meat and poultry products designated as baby and toddler foods.

Negative labeling Another area where FSIS and FDA ingredient labeling regulations differ is in negative labeling (for processors who wish to declare that products do not contain certain ingredients). The FDA informally addresses such label statements and allows them only when they are not false or misleading, but has not promulgated negative labeling regulations. In contrast, FSIS regulations either specifically allow or specifically disallow the use of negative labeling statements. Negative labeling statements are allowed under FSIS if: • it is not clear from the product name that the ingredient is not present; • the processor can demonstrate that the statements are beneficial for health, religious preference, or other reasons; • such claims call attention to the absence of an ingredient because it is prohibited by regulation (e.g. no preservatives).

Examples of allowed negative labeling include: ‘no beef’, ‘no artificial anything’. In contrast, the terminology ‘chemical free’ or ‘no chemicals’ is not allowed. The claim, ‘no hormones added’ is not allowed on pork or poultry labels unless it is followed by the statement, ‘Federal regulations prohibit the use of hormones’. The terminology, ‘no hormones administered’ may be approved on beef product labels if sufficient justification is provided. Similarily, ‘no antibiotics added’ may be approved on meats and poultry labels (with sufficient justification provided).

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In summary, when preparing an ingredient list, the general rule is that all ingredients of the product must be declared in descending order of predominance. Any deviations from this general rule must be authorized by one of the specific exemptions set forth in the regulations, or must be in accord with one of the alternative ways of declaring certain ingredients. Finally, as is the case with every aspect of a food label, the ingredient list must not be false or misleading in any particular.

5.4

References

1. Vetter JL, Food Laws and Regulations, Manhattan, KS, Am. Inst. of Baking, 1996. 2. Noah L and Merrill RA, ‘Starting from scratch?: Reinventing the Food Additive Approval Process’, Boston Univ Law Rev, 1998 78 (2) 329–443. 3. US Dept. of Health and Human Serv., Food and Drug Admin., Center for Food Safety and Appl. Nutr., www.cfsan.fda.gov. 4. Food and Drug Admin., Center for Food Safety and Appl. Nutr., ‘Food Labeling; General Provisions; Nutrition Labeling; Label Format; Nutrient Content Claims; Health Claims; Ingredient Labeling; State and Local Requirements; and Exemptions; Final Rule,’ 6 Jan. 1993, Federal Register, 58: 2067–2099. 5. US Dept. of Agriculture, Food Safety and Insp. Serv., www.fsis.usda.gov. 6. Food Safety and Inspection Service (FSIS), ‘Nutrition Labeling of Meat and Poultry Products; Final Rule,’ 6 Jan. 1993, Federal Register, 58: 632–685. 7. Food and Drug Admin., Center for Food Safety and Appl. Nutr., ‘Food Labeling; Subpart A – General Provisions; Food; Designation of Ingredients,’ US Government Printing Office, Washington, DC, Code of Federal Regulations 21(2), Part 101.4. 8. Food and Drug Admin., Center for Food Safety and Appl. Nutr., ‘A Food Labeling Guide: Chapter I – General Food Labeling Requirements,’ 1997, http://vm.cfsan.fda.gov/~dms/flg-1.html. 9. Food and Drug Admin., Center for Food Safety and Appl. Nutr., ‘A Food Labeling Guide: Chapter IV – Ingredient List,’ 1997, http://vm.cfsan.fda.gov/~dms/flg-4.html. 10. Food and Drug Admin., Center for Food Safety and Appl. Nutr., 1999, FDA Backgrounder, The Food Label, http://vm.cfsan.fda.gov/fdnewlab.html. 11. Segal M, ‘Ingredient Labeling: What’s in a Food?,’ May 1993, FDA Consumer, http://vm.cfsan.fda.gov/ fdac/special/foodlabel/ingred.html. 12. Papazian R, ‘Sulfites: Safe for Most, Dangerous for Some,’ Dec. 1996, FDA Consumer, http:// vm.cfsan.fda.gov/~dms/fdsulfit.html. 13. Diehl JF, ‘Government Regulations of Irradiated Foods,’ In: Safety of Irradiated Foods, 2nd edition, New York, NY, Marcel Dekker, Inc, 1995. 14. Food and Drug Admin., Center for Food Safety and Appl. Nutr., ‘Irradiation in the Production, Processing, and Handling of Food,’ Adv. Notice of Proposed Rulemaking, 17 February 1999, Federal Register, 64(31) 7834–7837. 15. Food and Drug Admin., Center for Food Safety and Appl. Nutr., FDA Backgrounder, ‘FDA and Monosodium Glutamate (MSG),’ 1995, www.cfsan.fda.gov. 16. Food and Drug Admin., Center for Food Safety and Appl. Nutr., ‘Food Labeling; Declaration of free glutamate in food,’ Adv. Notice of Proposed Rulemaking, Federal Register 61: 48102–48110, 12 Sept. 1996. 17. Maryanski JH, ‘FDA’s Policy for Foods Developed by Biotechnology,’ Am Chem Soc Symp Series No. 605, 1995. 18. Food and Drug Admin., Center for Food Safety and Appl. Nutr., ‘Statement of Policy: Foods Derived from New Plant Varieties,’ Federal Register 29 May 1992, 57: 22984–23005. 19. Food and Drug Admin., Center for Food Safety and Appl. Nutr., ‘Food Allergies: Rare But Risky,’ May 1994, FDA Consumer, http://vm.cfsan.fda.gov/~dms/wh-alg1.html. 20. Shank FR, ‘Notice to Manufacturers: Label Declaration of Allergenic Substances in Foods,’ 10 June 1996, http:/vm.cfsan.fda.gov/~lrd/allerg7.html. 21. US Dept. of Agriculture, Food Safety and Insp. Serv., ‘Labeling, Marking Devices and Containers,’ US Government Printing Office, Washington, DC, Code of Federal Regulations 9(2) Part 317. 22. Anonymous, ‘International Meat Inspection Consultants – Food Labeling Guide,’ Brookeville, MD, International Meat Inspection Consultants (IMIC), www.thefoodtrainer.com. 23. US Dept. of Agriculture, Food Safety and Insp. Serv., US Government Printing Office, FSIS Labeling Policy Book. 24. US Dept. of Agriculture, Food Safety and Insp. Serv., ‘Meat and Poultry Labeling Terms,’ Feb. 1999, www.fsis.usda.gov/oa/pubs/labterm.html.

6 Durability indication: European Union A. Mro¨hs, Bund fu¨r Lebensmittelrecht und Lebensmittelkunde e.V., Bonn

6.1

Introduction

Until 1978 there was no general requirement for a minimum durability date on food labels in Europe. Without harmonised European legislation on food labelling, Member States had established different provisions which varied significantly. Most of the Member States asked for some kind of date indication, but differences existed not only about the products which were covered but also about the date itself. Some countries, e.g. Luxembourg, allowed manufacturers to indicate a code instead of an open declaration of the date. Differences also existed on whether to declare only the year, the month and the year, or a specific date with day, month and year. But also the character of the date itself was different. In some countries it was the date of production, in others the date of packaging or the best-before date, the use-by date or even a sell-by date was required.1 As early as 1976 the European Commission submitted a proposal for a Directive on food labelling2 to harmonise the difficult and contradictory area of food labelling in Europe. This was to guarantee the functioning of the Common Market and the free circulation of goods within the European Community. But as the differences with regard to labelling in the various Member States were significant, the negotiations on the labelling Directive were difficult. The date indication was one of the main discussion points. While France was in favour of a use-by date and Belgium wanted a date of production on the one hand, the UK, Ireland and Denmark were in favour of a flexible solution on the other hand, and Germany supported a best-before date. At this stage the Recommended International General Standards for the Labelling of Prepackaged Foods of the FAO/WHO Codex Alimentarius Commission had a great impact on the work on the European labelling Directive. The basic consent of the Member States resulting from this fact considerably facilitated the negotiations on the propositions submitted by the EC Commission.3 The Codex Standard preferred the bestbefore date,4 and only if this date was not suitable because of the specific character of the product, the production date, packaging date or final sell-by or use-by date should be considered.

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The ‘Council Directive on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer (79/112/EEC)’ was adopted on 18 December 1978 (OJ No L 33, 8.2.1979, p. 1). After several amendments in the following years a codified version of the Directive (2000/13/EC), hereinafter referred to as ‘Labelling Directive’ was adopted on 20 March 2000 (OJ No L 109, 6.5.2000, p. 29).5 It requires in Article (Art.) 9 the indication of the date of minimum durability of foodstuffs. As there was no common position between the Member States on the regulation of short-life products, this area was left to the Member States (Amendment in 1989, see Section 6.6).

6.2

The legal situation

6.2.1 Which products are covered by Art. 9? All products to be delivered as such to the ultimate consumer including foodstuffs intended for supply to restaurants, hospitals, canteens and other similar mass caterers with the following exceptions (Art.1 paragraph (para.) 1 and 2, Art. 3 para. 5): 1.

2. 3.

In the case of products without prepackaging or foodstuffs which are packed on the sales premises at the consumer’s request or prepackaged for direct sale, please check national regulations as this is left to Member States (Art. 12). Foodstuffs which from the microbiological point of view are highly perishable (these are discussed separately in Sections 6.6 to 6.9. – Fresh fruit and vegetables, including potatoes, which have not been peeled, cut or similarly treated. This derogation shall not apply to sprouting seeds and similar products such as legume sprouts, – wines, liqueur wines, sparkling wines, aromatised wines and similar products obtained from fruits other than grapes, and beverages falling within CN codes 2206 00 91, 2206 00 93 and 2206 00 99* and manufactured from grapes or grape musts, – beverages containing ten per cent or more by volume of alcohol, – soft drinks, fruit juices, fruit nectars and alcoholic beverages in individual containers of more than five litres, intended for supply to mass caterers, – bakers’ or pastry cooks’ wares which, given the nature of their content, are normally consumed within 24 hours of their manufacture, – vinegar, – cooking salt, – solid sugar, – confectionery products consisting almost solely of flavoured and/or coloured sugars, – chewing gums and similar chewing products, – individual portions of ice-cream.

6.2.2 Definition of the minimum durability date The minimum durability date means the date until which the foodstuff retains its specific properties when properly stored. This does neither mean that after that date the product is no longer fit for consumption nor that the product loses its specific properties at that date. * The corresponding heading in the Harmonised System to the above-mentioned CN codes is 22.06 (Act of Accession of Austria, Finland and Sweden).

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But after the minimum durability date additional checks are needed to decide whether the product can be put on the market or not. Guidelines on how dates should be calculated and presented are discussed in Section 6.10. 6.2.3 Specific properties The specific properties of a product are defined by the nutritional value and by the value for enjoyment and usefulness. This means the product does not retain its specific properties if it has changed so much that it is diminished in nutritional value, usefulness or enjoyment. The nutritional value of a foodstuff is determined by all substances which play a role in nutrition, e.g. protein, carbohydrates, fat, vitamins and minerals, etc. Factors for enjoyment given by a product are mainly taste and smell but also appearance. The usefulness of a product is reflected by its technological properties, mainly the fitness to use the product in further preparations such as baking, cooking and so on. 6.2.4 Proper storage The minimum durability date of the product depends on proper storage and must be determined in relation to those conditions. Manufacturers cannot expect extreme ways of storing by the consumer, but have to take into account what is reasonable for customers. This covers, for example, storage in the refrigerator. Further conditions can reasonably be expected for storage in retail. Proper storage is in any case what is customary for specific products such as cool storage for juices or certain meat products. If non-customary storage is taken as the basis for the minimum durability date, a description of the storage condition is necessary (Art. 9, para. 3, last sentence). 6.2.5 Form of date marking Table 6.1 shows the three forms of minimum durability dates. 6.2.6 Description of the storage conditions A description of the storage conditions which must be observed if the product is to keep for the specified period is necessary ‘if need be’. The phrase ‘if need be’ in Art. 9 is not Table 6.1

Forms of minimum durability indications and their prerequisites

Prerequisites

Form of minimum durability indication

Foodstuffs which will not keep for more than three months

‘best before’ followed by the indication of the day and the month*

Products which will keep for more than three months but not more than 18 months

‘best before end’ followed by the indication of the month and the year*

Products which will keep for more than 18 months

‘best before end’ followed by the indication of the year*

* In any case it is necessary to use the wording ‘best before . . .’ when the date includes an indication of the day and ‘best before end . . .’ in other cases. It is not necessary that the date itself follows, but also a reference to where the date is given on the labelling is sufficient.

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further defined in the Directive, and Member States interpret it variously as meaning ‘conditions other than customary for the product’ or ‘conditions other than ambient’. In Germany, for example, this means that this indication is not always necessary although the minimum durability is always connected to special storage conditions and temperatures. Additional information has only to be indicated if not customary and unusual storage conditions are required. On the other hand, the UK Food Labelling Regulations 1996 are interpreted as a mandatory requirement to state any storage conditions other than ambient.

6.3

Manufacturers’ responsibilities

Usually the manufacturer has to indicate the minimum durability date and is responsible for the correctness of the date. A wrong date is misleading information in the sense of Art. 2 para. 1 of the Labelling Directive. Therefore manufacturers have to check carefully the probable durability of foodstuffs on the basis of general experience on the one hand and storage tests on the other hand. As the minimum durability is a case-by-case decision, which can be different from product to product and from manufacturer to manufacturer because of different raw materials, different production methods, different packaging, etc., it is in the end a technological decision how to decide on the date (see Chapter 13). If there are complaints about the minimum durability date in more than single cases, the manufacturer has to check the correctness again. The manufacturer who originally indicated the date on the label has the exclusive right to amend the minimum durability date.

6.4

The product on its way to the consumer

The manufacturer/producer who is responsible for the minimum durability date has to monitor the product on the way to the consumer in order to check whether the date calculation is correct. After the minimum durability date, additional checks are necessary to decide whether the product is fit for consumption and can be put on the market. If food sold after the expiry of a minimum durability date causes injury to the consumer, the fact that the minimum durability date had expired may be taken into account in any civil proceedings under consumer protection civil law. Article 9 of the Labelling Directive gives no direct responsibilities to the retail sector. Nevertheless the retail sector has to take care that the products are properly stored. But even in cases of a given description for the storage condition which must be observed, retailers are not obliged to store the product in the way mentioned by Art. 9. However, if due to different storage conditions or improper storage by the retailer the minimum durability date proves to be false, this is the retailer’s responsibility in contravening the Labelling Directive by misleading labelling (Art. 2 misleading the consumer with wrong dates). The consumer should also take care to store products properly. After the minimum durability date (best-before), he should check carefully whether the product is still fit for consumption (in many cases it will be) and decide for himself whether to eat the product or not. This does not apply to microbiologically highly perishable foods which should never be consumed after their ‘use-by’ durability dates (see also Section 6.8).

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Varied application in the EU

A different application of the rules on minimum durability date is given in Denmark where products have to be taken from the shelves after the minimum durability date. This interpretation seems to be not in line with the wording and the spirit of the minimum durability provisions, which are based on the Recommended International General Standards for the Labelling of Prepackaged Foods of the FAO/WHO Codex Alimentarius Commission. However, during the negotiations on Art. 9, a declaration of the Council and the Commission to the minutes stated that Member States do have the right to prohibit the marketing of products after the expiry of the minimum durability date.6

6.6

Special provision for short-life products: introduction

With the amendment of the Labelling Directive in 1989,7 the use-by date was introduced for products, which from the microbiological point of view, are highly perishable. This area was left to the Member States in the original Labelling Directive from 1978. A harmonised provision was now adopted as ‘in the interests of a better protection of public health a stricter system of dating should be used in preference thereto in the case of foodstuffs which, from the microbiological point of view, are highly perishable’.

6.7

The legal situation: use-by date

Article 10 (originally Article 9a) of the Labelling Directive requires a use-by date instead of the date of minimum durability for foodstuffs which, from the microbiological point of view, are highly perishable and are therefore likely to constitute an immediate danger to human health after a short period. To decide which products are covered is a difficult task in the EU. During the negotiations on the adoption of this provision there were already discussions on what is highly perishable and whether there was a need to fix dates for a better understanding of this term. It was clear that Member States had very different views on what is highly perishable so a general wording was chosen to come to a common position. There is no general rule, therefore, about a time limit which defines what ‘highly perishable’ means. The interpretation in the Member States varies from one or two days up to nine or ten days or even longer. The legislation makes it clear that the reasons for the perishability have to be microbiological ones so that products which are perishable for other reasons, e.g. oxidation, are not covered. The second criterion which has also to be fulfilled is that, because of their perishability from a microbiological point of view, these products are likely to constitute an immediate danger to human health after a short period. The decision on whether a product is covered on this basis has to be taken case by case. It has to consider not only the product itself but also the production method, hygiene conditions in production, etc. Moreover the storage and retail conditions have to be taken into account. The manufacturer may assume that the stated storage conditions will be observed when deciding whether the product falls under Art. 10.

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The use-by date has to be given with the wording, which is laid down in the different languages of the Member States, and has to be followed either by the date itself or a reference to where the date is given on the labelling. Article 10 para. 3 provides that the date shall consist of the day, the month and possibly the year in that order and shall not be given in a coded form. It is also necessary to give a description of the storage conditions which must be observed. In most cases this will refer to refrigerated storage, sometimes specifying a particular temperature, and may include additional instructions such as storage away from light or moisture.

6.8

Products with use-by date on their way to the consumer

After the use-by date has been reached, the product must not be marketed under any circumstances. It may be that the product is perfectly safe, but marketing is still prohibited. Manufacturers and retailers have to take the products from the shelves and destroy them. The consumer should also not consume the product after that date.

6.9 Varied interpretations of ‘use-by’ provisions in EU Member States The provisions on the use-by date are open to varied interpretation especially on the terms ‘highly perishable’ and ‘immediate danger to human health’. Therefore the range of products which are considered to be covered by this requirement differs from country to country. In the end manufacturers are responsible for deciding whether their products are covered and a use-by date is the correct indication.

6.10

Guidelines on how dates should be calculated and presented

6.10.1 Guidelines on calculation of dates For ‘use-by’ products, the date will be a matter of only several days from the date of manufacture and will be determined mainly by microbiological considerations and the interpretation in the Member State concerned. For other products, the date should be selected on the basis of determination or estimation of the shelf-life of the product under the stated storage conditions. Are there European codes of practice? Following a survey of the international branch organisations in Europe, there seems to be a general European agreement on date marking only for soluble (instant) coffee. According to the Association of Soluble Coffee Manufacturers of the European Community (AFCASOLE), instant coffee, after being appropriately packed, has a virtually unlimited shelf-life. However, in order to avoid any unfair competition, the following agreement was made within AFCASOLE in March 1986: • shelf-life was 2 years at least; • the cut off point for production should be: • January–June: label end of ‘current year + 2’ • June–December: label end of ‘current year + 3’

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AFCASOLE mentioned, however, that today almost all the products bear an indication of day, month and year (which can be used as the batch code) and therefore label beyond the initially agreed requirements. For other product categories European codes of practice play a role as far as they lay down characteristics of products, hygiene requirements, etc., and these can be important parameters for the specific properties of the products.

6.10.2 How should dates be presented? The presentation of the minimum durability date as well as the use-by date has to follow the general rules of the Labelling Directive, especially Art. 13. This means the date labelling shall appear on the prepackaging or on a label attached thereto. • It has to be easy to understand. • It must be located in a conspicuous place in such a way as to be easily visible, clearly legible and indelible. • It shall not in any way be hidden, obscured or interrupted by other written or pictorial matter. • It shall appear in the same field of vision together with the name under which the product is sold and the net quantity. In cases of alcoholic beverages with more than 1.2% alcohol by volume, it must appear together with the declaration of the alcohol content.

6.11

Future trends

Labelling in the European Union is a more and more difficult subject as labelling requirements are increasing. On the other hand consumer understanding is poor in many cases. Therefore it is necessary to reform the food labelling requirements in general to make them clearer and more easily understood. Among the main indications which are used by consumers are the use-by and the best-before dates. This should be taken into account when the Labelling Directive is revised. Nevertheless the understanding of the dates and their different meanings may be increased as well as ways of presenting the dates. To make the declaration easier to understand without using the different Member States’ languages on a multilingual package, one might think about the introduction of symbols for the use-by and the best-before phrases. Furthermore, consumers need to appreciate the difference between those two dates. Many consumers use both dates as a use-by date, which is wrong. The best-before date is not an expiry date. Products may be consumed and remain perfectly safe and wholesome also after that date. This information is also important for consumers to know. Therefore better consumer information and education about labelling requirements and the durability indication is also necessary in future.

6.12

Sources of further information and advice

6.12.1 Further literature Horst M, ‘Auslegungsfragen zu §7 Abs. 4 LMKV’, ZLR 1983 (2) 223–230. Horst M, ‘Die neue Lebensmittel-Kennzeichnungs-VO – ein halbes Jahr nach

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Inkrafttreten – Ausgewa¨hlte Auslegungsfragen’, ZLR 1982 (3) 193–215. Klein G, Rabe HJ and Weiss H, Lebensmittelrecht auf CD-ROM: Textsammlung, Hamburg, Behr, 1996 (Grundwerk), 8th update 1999. Ruf F, ‘Das Mindesthaltbarkeitsdatum bei Lebensmitteln – Lebensmittelchemische und rechtliche Aspekte’, ZLR 1983 (2) 121–145. Zipfel W and Rathke KD, Lebensmittelrecht, Munich, C.H. Beck, 1954 (Grundwerk), 100th update 1998.

6.12.2 Further advice National food and drink industry federations in the EU: Bund fu¨r Lebensmittelrecht und Lebensmittelkunde e.V. (BLL) Godesberger Allee 142–8 D-53175 Bonn Tel.: +49 / 228 81 99 30 Fax: +49 / 228 37 50 69 Food and Drink Federation (FDF) 6 Catherine Street London WC2B 5JJ Tel.: +44 / 207 836 24 60 Fax: +44 / 207 836 05 80 ANIA – Association Nationale des Industries Agro-Alimentaires 155, Boulevard Haussmann F-75008 Paris Tel.: +33 / 1 538 38 600 Fax: +33 / 1 456 19 664 Confederation of Danish Industries Dansk Industri H. C. Andersens Boulevard 18 DK-1787 Kopenhagen V Tel.: +45 / 33 77 30 18 Fax: +45 / 33 77 34 20 and/or branch organisations Institut fu¨r Lebensmittelwissenschaft und -information GmbH (ILWI) Godesberger Allee 142–8 D-53175 Bonn Tel.: +49 / 228 81 99 30 Fax: +49 / 228 37 34 27 Leatherhead Food RA Randalls Road Leatherhead Surrey KT22 7RY Tel.: +44 / 1372 37 67 61 Fax: +44 / 1372 38 62 28

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6.13 1. 2. 3. 4. 5. 6. 7.

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References

Tolkmitt HB, ‘Allgemeine Kennzeichnungsgebote in 15 europa¨ischen Staaten’, ZLR 1978 (4) 550–567. Commission Proposal of 30 March 1976 of a Council Directive on the approximation of the laws of the Member States relating to labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer, OJ No C 91, 22.4.1976, p. 3. Eckert D, ‘Die EG-Kennzeichnungsrichtlinie’, ZLR 1979 (2) 163–197. FAO/WHO, ALINORM 78/22: Report of the 12th Session of the Codex Alimentarius Commission, para. 130. All quoted Articles without further indications are those of the Labelling Directive in the codified version of Directive 2000/13/EC. Eckert D, ‘Die EG-Kennzeichnungsrichtlinie’, ZLR 1979 (2) 163–197. Council Directive of 14 June 1989 amending Directive 79/112/EEC on the approximation of the laws of the Member States relating to labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer (89/395/EEC), OJ No L 186, 30.6.1989, p. 17.

7 Durability indication: United States R. A. LaBudde, North Carolina State University and Least Cost Formulations, Ltd.

7.1

Introduction

‘Durability indication’, or ‘shelf-life dating’ or ‘open dating’, as it is generally called in the United States, is the presentation on a product package of a date which indicates to the consumer the time at which the food no longer possesses some attributes of ‘freshness’ that would have been otherwise expected. In order for a durability indication to be made on a product label, the concept of ‘shelf-life’ must be articulated first. In 1981, the National Food Processors Association defined ‘shelf-life’ as follows: ‘A product is within its shelf-life when it is neither misbranded nor adulterated, when the product quality is generally accepted for its purported use by its consumers, and so long as the container retains its integrity with respect to leakage and protection of the contents.’1 This definition includes elements of safety, quality, regulation and packaging. In Canada, currently ‘durable life’ is defined as ‘the period, starting on the day a food is packaged for retail sale, that the food will retain its normal wholesomeness, palatability and nutritional value, when it is stored under conditions appropriate for that product.’2 This definition includes nutrition and storage conditions, but omits packaging. These two attempts to define ‘shelf-life’ epitomize the continuing regulatory and scientific confusion surrounding this term.

7.2

History

As with many other inventions of our modern world, the concept of ‘shelf-life’ arose primarily from the logistical effort of World War II.3 The question of storage stability and durability of military food rations has been a fruitful area of research for food science since that time, and has been responsible for many key technical innovations, not the least of which has been the development of food irradiation as a preservative.4,5 A brief scan of the bibliographic references of Section 7.10 shows the depth, breadth and longevity of research in this area. In the consumer-oriented 1960s and 1970s, the concept of ‘open dating’ arose, in which a non-coded date understandable to the consumer was marked on

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the package.6 Since that time, open-code dating of durability has become mandatory on a number of products in many States and voluntarily included on many others.7,8 This chapter will discuss primarily the philosophical and regulatory background in the United States of durability indications on the package. Chapter 13 will cover in depth the scientific definition of ‘shelf-life’ and how it is measured experimentally.

7.3

Terminology

Although in time the North American Free Trade Agreement (NAFTA) will undoubtedly force the use of specific terms for durability indications throughout the continent, currently no universal terms exist. In Canada, the term ‘durable life’ is used for the period, and the package is marked for the consumer with ‘best before’ used on the label.2 In the United States, there are no federal regulations on the subject of durability indications, with the sole exception of infant formula (21 CFR 107.20). In addition, minimum shelf-lives (7 yr) are required for meat-based military rations (9 CFR 98.2). Although federal regulations are largely absent, a number of States have promulgated local rules on the subject. Furthermore, many manufacturers have voluntarily supplied open dating information in the interest of promoting sales. Because of the absence of national standards on terminology and presentation, currently a wide range of styles of durability indications are used on consumer food packages. A trip to the grocer shows a can of soup using the term ‘Recommend use by date on can end’, with the date presented as ‘Nov 00’. A box of breakfast cereal states ‘Better if used before April 25, 2000’. A box of pasta recommends ‘Best before Sep 15 00’. A fresh orange juice carton has simply the expiry date of ‘02 May’ embossed on its closure. Margarine says simply ‘Jun 09 00’, an expiry date. A carton of dairy half-andhalf states ‘Sell by May 11’. Sour cream says simply ‘27 Mar 00’. A carton of eggs says firmly ‘Exp April 26’. Fresh deli potato salad is marked ‘Mar 29 00’, an expiry date. Fresh meat is labelled ‘Sell by Mar 15 00’. Many brands and foods contain no open-code dating at all. Some list only the date of packaging. This plethora of synonymous terms, coupled with the increasing public interest in food safety issues, has led to a vast confusion among consumers regarding the meaning of these terms, their impact on food safety, and their usefulness in providing guidance for safe consumption. Recognizing this, in 1997 the Food and Drug Administration (FDA) issued model language to be used in labelling refrigerated foods.9 Foods are broken into three classes. ‘Group A’ foods are those (‘Potentially Hazardous Food’, or ‘PHF’) which must be kept refrigerated for food safety. ‘Group B’ foods are those shelf-stable until the package is breached. ‘Group C’ foods are those that are safe even after opening and even after temperature abuse, but may be refrigerated solely to protect quality. These foods have a pH  4.6, or Aw  0.85 or have dependable chemical barriers, such as salt, acid or antimicrobials. FDA suggests an additional package declaration of ‘IMPORTANT Must Be Kept Refrigerated To Maintain Safety’ for Group A foods, ‘IMPORTANT Must Be Refrigerated After Opening To Maintain Safety’ for Group B foods, and ‘Refrigerate for Quality’ for Group C foods.

7.4

Conflicting purposes of durability indications

The underlying notion of durability indications or shelf-life is that of product ‘spoilage’. Unfortunately, the meaning of ‘spoilage’, like that of ‘beauty’, lies in the eyes of the

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beholder. Different interpretations are placed on the word by producers, consumers and regulators.10 In order to add some structure to the following discussion, ‘critical spoilage’ will be defined here as the loss of a critical property, or more than one major property, of a food to an extent that renders it unfit for the purpose intended (sale or consumption). Unfitness may be due to development of a hazard, loss of standard of identity or adulteration. Loss of a critical property includes both loss of a positive benefit (such as appearance or nutrition) or gain of a negative property (such as pathogen growth or syneresis). Properties may be microbiological, physical, chemical or organoleptic. From a food quality point of view, many features of a food are subject to deterioration after packing. These include, among others: • • • • • • • •

appearance (mottled, withered) colour (loss, unexpected) flavour (loss, undesirable) aroma (loss, undesirable) mouthfeel (change) texture (change) syneresis (‘purge’, ‘weeping’) nutrition (loss).

Generally speaking, loss of these quality properties corresponds to loss of the regulatory ‘standard of identity’ or consumer expectations of the product. Because of this, a producer will determine the end of shelf-life of his product to be the point at which the product starts to become unacceptable to consumers and difficult to sell. From a food safety point of view, risks of hazards develop from loss of hurdles, passage of time and growth of pathogens and contaminants. Some of these include: • • • •

biological growth (pathogenic) toxin accumulation (microbiological) chemical (solvent leaching, interactions, metal leaching) physical (hardening, package degradation).

Regulators take a different view from producers about loss of quality attributes or risks to food safety. These are viewed either as economic adulteration (loss of standard of identity or fitness of purpose intended) or contamination (wholesomeness or adulteration). Although there are few Federal regulations in the United States requiring open dating of foods, all properties of the product (including nutrient declaration and any claims) must be maintained throughout the period the product is offered for sale. If the product fails to do so, it would be considered misbranded and subjected to enforcement actions (see, for example, 21 CFR 201(n), 21 CFR 114.80, 21 CFR 114.100). Meat and poultry products are regulated by the US Department of Agriculture (USDA), not the FDA. USDA-regulated products are much more tightly controlled in both composition and in labelling. Permission to mark packages with dates is specifically given by regulation, at 9 CFR 317.5(b)(9)(xii) for meat and 9 CFR 381.133(b)(9)(xii) for poultry. Under 9 CFR 317.8(b)(32), the allowed use of dates on packages of meat products is subject to the following restrictions: A calendar date may be shown on labeling when declared in accordance with the provisions of this subparagraph:

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(i) The calendar date shall express the month of the year and the day of the month for all products and also the year in the case of products hermetically sealed in metal or glass containers, dried or frozen products, or any other products that the Administrator finds should be labeled with the year because the distribution and marketing practices with respect to such products may cause a label without a year identification to be misleading. (ii) Immediately adjacent to the calendar date shall be a phrase explaining the meaning of such date, in terms of ‘packing’ date, ‘sell-by’ date, or ‘use before’ date, with or without a further qualifying phrase, e.g., ‘For Maximum Freshness’ or ‘For Best Quality’, and such phrases shall be approved by the Administrator as prescribed in §317.4. Similar restrictions are given for poultry products at 9 CFR 381.129(c). Because durability indications have been viewed in the past by regulators in the United States as a promotional, logistic or quality issue, over the last ten years the FDA and USDA have been shifting their stance from safeguarding the consumer from economic adulteration to increasing protection of food safety. To this end, both the FDA and USDA have taken the position, upheld in Federal courts, that the presence of certain pathogenic bacteria in specific types of foods is equivalent to a contaminating adulterant, which justifies enforcement action. This has been the basis of widespread compliance testing programs for E. coli O157:H7 in ground beef, Staphylococcus aureus in dry sausage, and Listeria monocytogenes and Salmonella in a wide range of foods. These pathogens are controlled at a ‘zero tolerance’ level, the true level of which is actually determined by the sampling scheme and analytical method used. When concern increases, the regulators take more sensitive samples, as the USDA has done with E. coli O157:H7 in ground beef. In October 1997 the sample size was increased from one test of 25 g to five tests of 325 g, with the requirement kept the same that no test should result positive for the pathogen. As a consequence, recalls of ground beef based upon compliance testing of E. coli O157:H7 multiplied three-fold compared to the previous year. Finally, consumers generally view loss of quality as loss of safety. Changes in colour, odor or taste are viewed as danger signals, as are syneresis and texture changes. The consumer wishes products to be labelled with durability indicators along the lines of ‘Discard after’ rather than ‘Use by’. The different viewpoints of the producer, the regulator and the consumer as to the purpose and meaning of durability indicators has led to great confusion in the United States, particularly in the absence of uniform Federal regulations on the subject.

7.5

Cost of durability indications

The conflicts in viewpoint of producer, consumer and regulator concerning the practical setting of durability indications can be resolved by describing the issue in the language of risk assessment. Just as in most practical, real-world problems, durability indications represent a compromise between two types of losses. The first type (Type I) is the producer’s loss. Setting any limit on shelf-life at all, or especially one which is too short, results in wastage of food which is pulled from shelves and discarded while it would otherwise remain on sale. This is a major factor in determining the world’s available food supply,11 and is currently borne entirely by the producer or distributor.

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The second (Type II) is a combination of the consumer’s loss and its implications for the producer. Setting no durability indication, or one which is too long, allows the food to spoil before sale or before consumption. If consumer-detectable spoilage occurs, future loss of business or complaints result for the producer (i.e., loss of ‘goodwill’ or market share), as well as the loss of product. If the spoilage is not consumer-detectable, foodborne illness may result, with costs to society and to the producer through lawsuits and recalls. In addition, regulatory compliance testing is becoming increasingly burdensome to the producer through the cost of recalls and negative publicity. Although perhaps overly simplistic, consider the following cost- or risk-assessment model. Suppose the probability of spoilage Ps by time t obeys a simple first-order rate model with characteristic (exponential) time Ts with a lag time Ls:12–15 Ps …t† ˆ 1

exp f …t

Ls †=Ts g

…t  Ls †

‰7:1Š

In addition, assume the growth rates for regulatory detection (Pr) and foodborne disease infectivity (median infectious dose) (PID50) are also given by such first-order rate expressions: Pr …t† ˆ 1

exp f …t

Lr †=Tr g

…t  Lr †

‰7:2Š

PID50 …t† ˆ 1

exp f …t

LID50 †=TID50 g

…t  LID50 †

‰7:3Š

respectively. Further assume the proportion of units sold per period
t is a constant fraction of those remaining unspoiled and unsold at time t: Psold …t† ˆ
t=Tsales

‰7:4Š

(In practice, these probability distributions and rates would be obtained from measurements and models, such as those described in Chapter 13.) Let the costs of the product, lost business, recall and food-borne disease be denoted respectively by Cp, Clb, Cr and Cfbi. In addition, let the probability of contamination of product with pathogens be denoted by Pc, the probability of sampling discovery by regulators by Pr, and the probability of infection (given the ID50) by Pfbi. If N …t† denotes then fraction of packages which remain unsold and unspoiled, Ns(t) denotes the cumulative fraction of packages which spoiled before being sold, Nr(t) denotes the cumulative fraction of regulatory samples occurring and Nfbi(t) denotes the cumulative fraction of infectious packages occurring, all at time t, then N …t ‡
t† ˆ N …t†

N …t† Ps …t†
t

fN …t†=Tsales g
t

Ns …t† ˆ N …t† Ps …t†
t Nr …t† ˆ fN …t† ‡ Ns …t†g Pc Pr
t Nfbi …t† ˆ N …t† Pc PID50 Pfbi
t

‰7:5Š ‰7:6Š ‰7:7Š ‰7:8Š

where the sum is from time zero to t and
t is a numerical integration time step, small compared with Ts. A crude model for the combined producer cost per unit of production is then Ctotal ˆ N …t† Cp ‡ Ns …t† fCp ‡ Clb g ‡ Nr …t† Cr ‡ Nfbi …t† Cfbi

‰7:9Š

where the first term evaluates the Type I loss, and the second through fourth expressions evaluate the Type II losses. This equation presupposes that: • all unsold, unspoiled product is discarded at time t (first term); • spoiled product is lost cost, and lost business is proportional to it appearing on the shelf (second term);

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regulatory sampling is based on both unsold and spoiled product; product must be contaminated to have recall (third term) or illness cost (fourth term); spoiled product is not consumed; only a fraction of contaminated packages are regulatory sampled (Pr); and only a fraction of infectious packages cause disease (Pfbi).

Although the model in Eq. [7.9] is simple and contains a large number of arguable assumptions, it does contain sufficient structure to show the qualitative features of the real-world problem. As the selected dated shelf-life t is increased, the first term drops and the others increase. As the dated shelf-life t is reduced, the first term increases while the others drop. This suggests an optimum point in between at which to position the durability indication. For convenience, assume time is measured in units of Ts (i.e., Ts = 1). A reasonable example consists of choosing Ls = 0.25, Tr = 1.5, Lr = 0.375, TID50 = 3.0, LID50 = 0.75 and Tsales = 0.3125. Compatible estimates for Pc, Pr and Pfbi might be 0.1%, 1% and 5%, respectively. Finally, assume the cost of lost product Cp is $0.60, the additional lost business cost Clb is $0.60 (= 1  Cp), the cost associated with a regulatory recall is $100,000, and the cost of a food-borne illness outbreak is $500,000. With these estimates, the model in Eq. [7.9] has a shallow minimum at t = 0.90, where the total lost cost is $0.069 per unit of production (see Fig. 7.1). The wasted product cost (first term) amounts to $0.027 per unit at this point, and the spoiled and lost business costs are equal at $0.013 per unit. The cost of recall risk is $0.010 and the food-borne illness cost is $0.006. As expected, the cost of wasted product, spoiled product and consumer reaction dominate. The wise producer would normally choose the time t for durability indication

Fig. 7.1 Cost per unit vs. chosen durability indication for Cr = $100,000 and Cfbi = $500,000. Curves are obtained from the model given in Eq. [7.9]. Note the shallow minimum in total cost at a durability indication of 0.90.

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that caused the total cost Ctotal in Eq. [7.9] to be a minimum. For the values given, the curve is sharply decreasing initially with t (Fig. 7.1), hence the conventional wisdom which suggests pushing the durability indication as far out in time as possible. Unfortunately for producers in the United States, the regulatory and legal climate has changed for the worse during the last few years. An outbreak of E. coli O157:H7 in alfalfa sprouts16 has all but destroyed the industry in the United States. A similar outbreak soon after in ground beef17 resulted in the closure of the operating plant and the largest food recall in US history. Recently, a major outbreak of listeriosis in frankfurters18 was initially estimated to cost between $50 million and $70 million by the manufacturer, although the cost will undoubtedly be higher, particularly if goodwill damage to the holding company’s publicly traded stock is considered. While not all of these outbreaks can be attributed to shelf-life issues, they have permanently changed both the regulatory and legal landscapes in the United States. The Cr and Cfbi costs above may now have to be revised upwards by as much as 10–100 times for specific hazards. Producers have sensed this, particularly in the meat industry, where one response to recent events has been to cut shelf-life estimates one or two weeks on packages of pasteurized product (about 10–25%). For comparison, Fig. 7.2 shows the cost curves obtained when Cr and Cfbi are increased ten times to $1,000,000 and $5,000,000, respectively. In this case the optimum cost moves from the previous t = 0.90 down to 0.65 (a substantial drop of 28%). The total cost at this minimum almost doubles from $0.069 previously to $0.132 under the new regime. This cost is almost entirely due to wasted product ($0.069) and recalls ($0.045).

Fig. 7.2 Cost per unit vs. chosen durability indication for Cr = $1,000,000 and Cfbi = $5,000,000. Curves are obtained from the model given in Eq. [7.9]. Note the sharp minimum in total cost at a durability indication of 0.65.

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7.6

Guidelines for durability indications

Chapter 13 provides a detailed discussion of the measurement of product shelf-lives and associated index criteria. Only a very brief discussion of this issue will be given here. There is an enormous range of food product types manufactured, and any criteria used must necessarily be adapted to the particular properties of the individual product involved. Although the cutoff values used to specify shelf-life vary widely, the principle remains in common that the cutoff point is positioned at the first point in time that a significant shift in properties occurs. This shift is measured by comparing the product at the beginning and at the end of its shelf-life.

7.6.1 Criteria Many producers set their shelf-lives for durability indications based on simple sensory evaluation of products at staged intervals. Typically, a case of companion packages is stored at conditions approximating those at retail, and samples are removed at the beginning and at incremental periods of 10–25% of expected shelf-life. The samples are evaluated by sensory review and the allowed shelf-life based on this information. Other producers attempt to associate shelf-lives with more directly measurable variables. The simplest of these is total heterotrophic plate counts for spoilage bacteria, where the so-called ‘index of spoilage’ is usually quantified at 8 on a log CFU/g or log CFU/ml scale. The durability indication would normally be positioned at log CFU = 7, slightly below the index for full spoilage. This is the point at which sensory attributes first clearly start changing. This method is used for products with relatively short shelf-lives, which are kept refrigerated, such as processed or ground meats, fish, etc. The ‘index of spoilage’ is also approximately the point at which slime becomes visible, if sufficient sugars or starches are available to the flora. A value of log CFU/ml = 4 or 4.3 is frequently used as an endpoint for fresh milk. A practical alternative to direct microbiological measurement of vacuum-packaged products, such as processed meats, is measurement by pH shift, since spoilage is typically by lactic acid bacteria. A pH change of 0.20–0.25 units from beginning of life would typically denote end of life. It is often the case that a specific parameter for a particular class of product supplies the limiting factor in determining shelf-life. For example, some products, such as fresh meats, have shelf-lives which are determined more by colour than by any other attribute. Consumers have been conditioned to expect the bright red colour of oxymyoglobin in fresh meat, and brownish metmyoglobin colour as symptomatic of old meat. This is a particular problem in ground meats, since the incorporated oxygen together with extensive flora rapidly exhausts the biochemical protection of colour. Colour is also used to determine shelf-lives of tomato-based sauces. Products which are low-moisture and high in fat content, such as potato chips (crisps) or margarine have shelf-lives determined mainly by the onset of oxidative rancidity.19,20 This is normally measured chemically by the peroxide, anisidine, ‘Totox’ (a combination of peroxide and anisidine values) or thiobarbituric acid (‘TBA’) values.21 Fresh fish are an example of a product whose spoilage may first become noticeable by odour. Sensory scales are available for classifying the degree of spoilage.22 Presence of histamine (the source of scombrotoxicity) can also be tested for,23 although this would denote a point obviously beyond normal shelf-life. Evolution of CO2 gas has also been proposed for setting refrigerated fish shelf-life.24

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Vitamin C (ascorbic acid) is helpful in assessing the shelf-life of dry breakfast cereals and some other products, given its lability during long storage. Other measurable quantities useful in establishing shelf-lives of long shelf-life products (such as those aseptically processed) include the amounts of solvents or metals absorbed from packaging. 7.6.2 Methodology Before committing to a durability indication for any product, it is essential the issue be approached with the proper managerial and engineering methodology.28–31 The first step is to identify requirements. What is the purpose of the durability indication on the package? What is it intended to accomplish? Are there any risks to placing the information on the package? Are there risks associated with leaving it off’ What will happen if the indication is incorrect? The second step is to analyze requirements. What is the functional dependence of associated risks and requirements on the shelf-life selected? This analysis should take into account the worst possible storage condition scenarios. The topic of proper worstcase storage conditions is an important one which has unfortunately received little attention over the years, except for military rations.32 (In discussing substitute versions of standardized foods in 1995, the FDA defined shelf-life as ‘the time the product exists in a wholesome condition under acceptable handling practices’ (60 FR 67477). No definition of ‘acceptable handling practices’ was given.) The third step is to assess risks and benefits, and make a decision as to the criteria and measurables to use together with their acceptable ranges. The fourth step is to carry out an experimental study to validate the concept and the shelf-life to be dated. The fifth step is to implement the concept, at least on a test market basis, under the regime of normal (vs. pilot plant) production, distribution and storage. The sixth step is to verify the proper functioning of the dating policy and its proper position relative to unacceptable spoilage. The final step is to review and revalidate the durability indication model in the wake of any significant changes in product materials, process, storage or handling.

7.7

Telltale indicators

The use of physical, chemical or biochemical time-temperature monitors to record storage conditions or to estimate end of shelf-life has undergone extensive development over the last three decades.33–45 The attempt to make surrogate indicators for predicted product life has finally passed from a research problem in food science to a reality in industry.46 Initially, simple temperature recorders were used. Later, open-loop predictors were proposed that estimated shelf-life based on underlying microbial or biochemical models. Recently, closed-loop direct measurement indicators have become available that actually react to conditions in the package rather than relying upon dead reckoning.47–49 Technology has even progressed to the point that biochemical indicators attached to semiconductors are being developed to indicate electronically the presence of specific bacteria or chemicals. This subject will be covered further in depth in Chapter 13.

7.8

Future trends

Until recently the driving force for durability indications has been marketing benefits and proper logistical control of product in the distribution system. Increasingly, however, the

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consumer and regulatory environment in the United States, and throughout the world, is becoming dominated by the issue of food safety. With the promulgation of the ‘Mega-Reg’ in 1996 (61 FR 38868), all meat and poultry products under Federal inspection in the United States must be produced under the auspices of a Hazard Analysis and Critical Control Point (HACCP) plan (9 CFR 417). In fact, no plant will be approved for inspection in the future unless such a plan exists (9 CFR 304.3, 381.22). In addition to these USDA regulations, the FDA requires all seafood processors to have such a HACCP plan for operations (21 CFR 123.6). This places meat and seafood processors under a similar burden of food safety guarantee that has long existed for aseptically processed (‘canned’) products (9 CFR 310.24, 21 CFR 113, 21 CFR 114). In addition, the FDA has also proposed mandatory HACCP plans for manufacturers of fruit and vegetable juices (63 FR 20449). In the presence of a HACCP or other food safety engineering plan, the concept of durability indications takes on new meanings and risks. Certainly in the case of the pasteurized and refrigerated (‘potentially hazardous’) foods, the idea of unlimited, or even unspecified, shelf-life is antithetical to the logic of HACCP. Any hazard analysis extended to the point of consumption of the food must take into account the duration and conditions of storage up to that point. In the current regulatory and legal environment, a case could be made for negligence and associated punitive damages if a durability indication were not included on the package. How else is the consumer to know the product may have become unsafe to eat? Concomitant with the increasing severity of the regulatory position on food safety in the United States in the last few years are the increasing legal costs of recalls and foodborne disease outbreaks. The nearly $100 million cost of the recent listeriosis outbreak is enough to bankrupt all but the very largest companies. In fact, another recall for Listeria contamination in processed meats at about the same time and same location was cited by a different company in its seeking bankruptcy protection immediately thereafter. In refrigerated foods, psychrotrophic pathogens, such as Listeria monocytogenes, Yersinia enterocolitica and sometimes Aeromonas hydrophila, are believed almost always to present a safety hazard when a lengthy time has elapsed even under cold storage conditions.50,51 In seafood, psychrophilic, non-proteolytic Clostridium botulinum presents a similar risk,52 particularly in smoked fish where spoilage is less obvious. Vibrio parahaemolyticus psychrotrophic strains are also becoming important.50 These emerging pathogens are virulent or toxigenic and cause serious illness, particularly in immunosuppressed populations. Slight cross-contamination from the raw to cooked sides of processing, followed by lengthy storage may be sufficient to provide an infectious dose without evident signs of spoilage.53–56 This problem is exacerbated by the apparent widespread incidence of these pathogenic contaminants in the current food supply,57–61 particularly in food produced from animals. A paradigm for the change in regulatory policy in this regard is the recent handling of the issue of Salmonella Enteritidis in fresh shell eggs by the USDA.62 After establishing the societal significance of this pathogen in ova intacta, the USDA proceeded to alter its policy concerning the storage and handling of fresh eggs. In particular, labels of fresh eggs must now warn consumers they must be kept refrigerated (7 CFR 59.50). The USDA also changed its grading policy so that eggs older than 30 days are no longer eligible to be Grade A shield and must therefore be used industrially rather than sold at retail. This effectively sets a shelf-life on refrigerated fresh eggs of no more than 30 days, although currently only about one-third of this market is graded in the United States.

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The increasing importance of irradiative pasteurization will also cause profound changes in the way durability indications are determined and displayed. The future may also hold a necessity for dual durability indications: one which specifies the shelf-life of the intact package stored in distribution (viz., the current ‘sellby’ type of date), and the second which informs the consumer of the safe duration of storage after the package is breached. An example might be: ‘Sell by Apr 15 00. Discard 10 days after opening package.’ The current ‘best used before’ type of labelling does not satisfy HACCP food safety requirements.

7.9

Summary

So far in the United States, durability indications have been subject to little Federal regulation, and are not required for many products. Open dating of shelf-lives has been applied to products primarily for marketing and logistical reasons. Consequently, a great diversity of label display methods are currently in place. Food safety issues driven by large-scale food-borne illness outbreaks in the United States are changing the Federal regulatory environment with respect to this issue. In the future, the mandates for risk assessment and HACCP planning will inevitably result in a prescription for open and uniform durability indications for at least all potentially hazardous foods, and this will probably occur within the next five years.

7.10

Sources of further information and advice

Anonymous, Code of Federal Regulations, Part 21 (Food and Drugs), Washington, US Govt. Printing Office, 1999. (Available on-line at: http://www.access.gpo.gov/nara/cfr/ cfr-table-search.html) Anonymous, Code of Federal Regulations, Part 9 (Animals and Animal Products), Washington, US Govt. Printing Office, 1999. (Available on-line at: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html) Anonymous, ed., Shelf-life: A Key to Sharpening Your Competitive Edge: Proceedings, February 18, 1981, Washington, Food Processors Institute, 1981. Anonymous, Shelf Life of Foods: Guidelines for its Determination and Prediction, London, Inst. Food Science and Technology, 1993. Charalambous G, ed., Handbook of Food and Beverage Stability: Chemical, Biochemical, Microbiological and Nutritional Aspects, Orlando, Fla., Academic Press, 1986. Charalambous G, ed., The Shelf Life of Foods and Beverages: Proceedings of the 4th International Flavor Con-ference, Rhodes, Greece, 23–26 July 1985, Developments in Food Science 12, Amsterdam, Elsevier, 1986. Charalambous G, ed., Shelf Life Studies of Foods and Beverages: Chemical, Biological, Physical and Nutritional Aspects, Developments in Food Science 33, Amsterdam, Elsevier, 1993. Eskin N A M and Robinson D S, eds, Food Shelf Life Stability, Boca Raton, CRC Press, 1999. Jankowski J, Shelf Life: Modern Package Design, 1920–1945, San Francisco, Chronicle Books, 1992. Kroll D, Shelf Life Technology for Processed Foods, Norwalk, Conn., Business Communications Co., 1995.

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Labuza TP, Shelf-Life Dating of Foods, Westport, Conn., Food & Nutrition Press, 1982. Labuza TP and Szybist LM, Current Practices and Regulations Regarding Open-Dating of Food Products, Working Paper 99-01, Dept. Food Science and Nutritition, Univ. Minn., 1999. (Available on-line at: http://trfic.umn.edu.publ.html.) Man CMD and Jones AA, eds., Shelf-Life Evaluation of Foods, London, Chapman & Hall, 1994. National Conference on Weights and Measures, ‘Uniform Open Code Regulation’, Uniform Laws and Regulations Adopted by the National Conference on Weights and Measures, National Institute of Science and Technology Handbook 130, Washington, DC, US Government Printing Office, 1984–1997. Pintauro N, Food Additives to Extend Shelf Life, Park Ridge, NJ, Noyes Data Corp., 1974. Puolanne E, ed., Shelf Life of Meat Products: Symposium, May 15, 1981, Helsinki, University of Helsinki, 1981. Redd JB et al., Quality Control Manual for Citrus Processing Plants, vol. 3, Auburndale, Fla., AgScience, 1992. Robson JN, ‘Storage and shelf-life’, Proc R Soc London, B Biol Sci, 1975 191(1102) 185–191. Taub IA and Singh PR, eds., Food Storage Stability, Boca Raton, CRC Press, 1998. US Patent and Trademark Office, Full-text searchable patent database. (Available on-line at: http://www.uspto.gov/patft/index.html.)

7.11

References

1. Moshy RJ, ‘Shelf life: food science considerations’, Shelf-Life: A Key to Sharpening Your Competitive Edge, Washington, DC, Food Processors Institute, 1981. 2. Anonymous, Guide to Food Labelling and Advertising, Section 2.10, Canadian Food Inspection Agency, 1996. (Available on-line at: http://www.cfia-acia.agr.ca/english/ppc/label/contents.html) 3. Porter WL, ‘Storage life prediction under noncontrolled environmental temperatures: product-sensitive environmental call-out’, Shelf-Life: A Key to Sharpening Your Competitive Edge, Washington, DC, Food Processors Institute, 1981. 4. Thayer DW, ‘Extending shelf-life of poultry and red meat by irradiation processing’, J Food Protection, 1993 56(10) 831–833, 846. 5. Roberts WT and Weese JO, ‘Shelf life of ground beef patties treated by gamma irradiation’, J Food Protection, 1998 61(10) 1387–1389. 6. Anonymous, Open Shelf-Life Dating of Food, Washington, US Govt. Printing Office, 1979. 7. Anonymous, ‘Open shelf-life dating of food’, Food Technology, 1981 35(2) 89–96. 8. Dahlberg AC, ‘Influence of dating milk containers on retailing milk in New York City food stores’, Bulletin 927, Cornell University Agricultural Experiment Station, Ithaca, NY, 1958. 9. Anonymous, ‘Guidance on labeling of foods that need refrigeration by consumers’, Federal Register, 1997 62(36) 8248–8252. 10. Evans FJ, ‘Shelf life problems from the point of view of enforcement and the consumer’, Proc Inst Food Sci Technol UK, 1978 30(3) 43–46. 11. Bourne MC, ‘The World problem of post harvest food losses’, Nutr-Health, 1982 1(1) 24–28. 12. Wilson LA, ‘Kinetics of flavor changes in foods’, Physical and Chemical Properties of Foods, ed Okos MR, St. Joseph, Mich., American Society of Agricultural Engineers, 1986. 13. Labuza TP and Fu B, ‘Growth kinetics for shelf-life prediction: theory and practice’, J. Indust Micro, 1993 12 309–323. 14. Taoukis P and Labuza TP, ‘Summary: integrative concepts’, Chap. 17, Food Chemistry, 3rd edn, ed Fennema O R, New York, Marcel Dekker, 1996. 15. Taoukis P, Labuza TP and Sagy S, ‘Kinetics of food deterioration and shelf-life prediction’, Food Engineering Handbook, ed Sagy S and Rotstein K, Denver, CRC Press, 1997, 363–405. 16. Como-Sabetti K et al., ‘Outbreaks of Escherichia coli O157:H7 Infection Associated with Eating Alfalfa Sprouts – Michigan and Virginia, June–July 1997’, MMWR, 1997 46(32) 741–744. 17. Shillam P et al., ‘Escherichia coli O157:H7 Infections Associated with Eating a Nationally Distributed Commercial Brand of Frozen Ground Beef Patties and Burgers – Colorado, 1997’, MMWR, 46(33) 777–778. 18. Anonymous, ‘Multistate outbreak of listeriosis – United States, 1998’, MMWR, 1998 47(50) 1085–1086.

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19. St. Angelo AJ ed, Lipid Oxidation in Food, ACS Symposium Series 500, Washington, DC, American Chemical Society, 1991. 20. Gray JI, Gomaa EA and Buckley DJ, ‘Oxidative quality and shelf-life of meats’, Meat Sci, 1996 43(suppl) S111–S123. 21. Stauffer CE, Fats and Oils, St. Paul, Minn., Eagan, 1996. 22. Gibson DM, ‘Preservation technology and shelf-life of fish and fish products’, Shelf-Life Evaluation of Foods, ed Man CMD and Jones AA, London, Chapman & Hall, 1994. 23. Rodriguez-Jerez JJ et al., ‘Histamine, putrescine and cadaverine formation in Spanish semipreserved anchovies as affected by time/temperature’, J Food Sci, 59(5) 993–997. 24. Chew SY and Hsieh YHP, ‘Rapid CO2 evolution method for determining shelf-life of refrigerated catfish’, J Food Sci, 1998 63(5) 768–771. 25. Hall MN, ‘The shelf-life of canned foods’, Nutr Food Sci, 1979 (59) 2–5. 26. Mannheim C and Passy N, ‘Internal corrosion and shelf-life of food cans and methods of evaluation’, CRC Crit Rev Food Sci Nutr, 1982 17(4) 371–407. 27. McKernan B, ‘Shelf life aspects of processed food in aluminum cans’, Act Rep Res Dev Assoc Mil Food Packag Syst, 1974 26(2) 64–69. 28. Sacharow S, ‘How to measure shelf-life in food packaging’, Prepared Foods, 1986 155(7) 93, 96. 29. Labuza TP and Schmidl MK, ‘Use of sensory data in the shelf-life testing of foods: principles and graphical methods for evaluation’, Cereal Foods World, 1988 33(2) 193–206. 30. Curiale MS, ‘Limiting Growth: Microbial Shelf-Life Testing’, Food Prod Design, 1998 Feb 72–83. 31. Labuza TP and Fu B, ‘Shelf life testing: procedures and prediction methods’, Frozen Food Quality, ed Hong YC, Denver, CRC Press, 1997, 377–415. 32. Shaw CP, ‘Food stabilization and shelf-life indices for military subsistence feeding in environmental extremes’, Act Rep Res Dev Assoc Mil Food Packag Syst, 1996/1997 48/49(2/1) 307–314. 33. Wells JH and Singh RP, ‘Performance evaluation of time-temperature indicators for frozen food transport’, J Food Sci, 1985 50(2) 369–371. 34. Fields SC and Prusik T, ‘Shelf life estimation of beverage and food products using bar coded timetemperature indicator labels’, Devel Food Sci, 1986 12 85–96. 35. Wells JH and Singh RP, ‘Application of time-temperature indicators in monitoring changes in quality attributes of perishable and semi-perishable foods’, J Food Sci, 1988 53(1) 148–152. 36. Wells JH and Singh RP, ‘A kinetic approach to food quality prediction using full-history time-temperature indicators’, J Food Sci, 1988 53(6) 1866–1871. 37. Obst J, ‘Tags may help track food shelf-life’, Minn Sci Agric Station Univ Minn, 1989 44(1) 3. 38. Taoukis PS and Labuza TP, ‘Applicability of time-temperature indicators as shelf-life monitors of food products’, J Food Sci, 1989 54(4) 783–788. 39. Taoukis PS and Labuza TP, ‘Reliability of time temperature indicators as food quality monitors under nonisothermal conditions’, J Food Sci, 1989 54(4) 789–793. 40. Malcata FX, ‘The effect of internal thermal gradients on the reliability of surface mounted full-history time-temperature indicators’, J Food Process Preserv, 1990 14(6) 481–497. 41. Sherlock M et al., ‘A systematic evaluation of time-temperature indicators for use as consumer tags’, J Food Protection, 1991 54(11) 885–889. 42. Shellhammer TH and Singh RP, ‘Monitoring chemical and microbial changes of Cottage cheese using a full-history time-temperature indicator’, J Food Sci, 1991 56(2) 402–405. 43. Fu B, Taoukis PS and Labuza TP, ‘Predictive microbiology for monitoring spoilage of dairy products with time-temperature integrators’, J Food Sci, 1991 56(5) 1209–1215. 44. Fu B and Labuza TP, ‘Considerations of the application of time temperature integrators for food distribution’, J Food Distrib Res, 1992 23(1) 9–17. 45. Fu B and Labuza TP, ‘The use of time-temperature indicators as an indicator of abuse of MAP products’, Principles of Modified Atmosphere and Sous-Vide Product Packaging, ed Farber J and Dodds KL, Lancaster, Penn., Technomic, 1994, 385–404. 46. Arons RP et al., ‘Time-temperature integrating indicator device’, US Patent, 1997 #5 667 303. 47. Harewood P, ‘Detection of fish spoilage by colourimetry’, US Patent, 1998 #5 744 321. 48. Horan TJ, ‘Method for determining bacterial contamination in food package’, US Patent, 1998 #5 753 285. 49. Woodaman JG, ‘Detection of contaminants in food’, US Patent, 1999 #5 869 341. 50. Marth EH, ‘Extended shelf-life refrigerated foods: microbiological quality and safety’, Food Technol, 1998 52(2) 57–62. 51. Doyle MP, ‘Extending the shelf-life of refrigerated foods: for better or worse?’, Food Technol, 1998 52(2) 20. 52. Peck MW et al., ‘Effect of heat treatment on survival of, and growth from, spores of nonproteolytic Clostridium botulinum at refrigeration temperatures’, Applied Environ Micro, 1995 61(5) 1780–1785. 53. Pearson LJ and Marth EH, ‘Listeria monocytogenes – threat to a safe food supply: A review’, J Dairy Sci, 1990 73(4) 912–928. 54. Hudson JA et al., ‘Growth of Listeria monocytogenes on some vacuum packaged processed meats’, J Food Protection, 1994 55(1) 4–7.

124 55. 56. 57. 58. 59. 60. 61. 62.

Food labelling Beumer RR et al., ‘Growth of Listeria monocytogenes on sliced cooked meat products’, Food Micro, 1996 13(4) 333–340. Notermans S et al., ‘Studies on the risk assessment of Listeria monocytogenes’, J Food Protection, 61 244–248. MacGowan AP et al., ‘The occurrence and seasonal changes in the isolation of Listeria spp. in shop bought food stuffs, human faeces, sewage and soil from urban sources’, Int J Food Microbiol, 1994 21(4) 325– 334. Kozak J et al., ‘Prevalence of Listeria monocytogenes in foods: Incidence in dairy products’, Food Control, 1996 7(4–5) 215–221. de Simon M, Tarrago C and Ferrer MD, ‘Incidence of Listeria monocytogenes in fresh foods in Barcelona (Spain)’, Int J Food Microbiol, 1992 16(2) 153–156. de Simon M and Ferrer MD, ‘Initial numbers, serovars and phagevars of Listeria monocytogenes isolated in prepared foods in the city of Barcelona (Spain)’, Int J Food Microbiol, 1998 44(1–2) 141–144. Heinitz ML and Johnson JM, ‘The incidence of Listeria spp., Salmonella spp., and Clostridium botulinum in smoked fish and shellfish’, J Food Protect, 1998 61 318–323. Baker AJ et al., ‘Salmonella Enteritidis Risk Assessment: Shell Eggs and Egg Products’, Federal Register, 1998 63(133) 37512–37513. (Available on-line at: http://www.fsis.usda.gov/ophs/risk/)

8 Nutrition information: European Union L. Insall, Food and Drink Federation, London

8.1

Introduction: key issues in presenting nutrition information

Increasing interest in the relationship between diet and health has led to an ever sharper focus on the nutritional aspects of the food supply. Interest in nutrition, in respect of both total diet and individual foods, is second only to concern about food safety, and is sometimes confused with the safety aspects of the food supply. Some commentators blame the nutritional content of the diet for a wide range of health problems such as obesity, cardiovascular disease and certain cancers, that is, long-term chronic diseases as opposed to the type of short-term acute illnesses usually associated with food safety problems. Nutrition information is, therefore, an aspect of a very broad debate, often highly politicised, about the nutritional quality of the modern food supply, and specifically about the contribution to the modern diet, and therefore the health of the population, made by the food manufacturing industry. In terms of issues, the provision of nutrition information ranks very high in the diet and health debate. The United Kingdom has possibly been more absorbed by this subject than most other European Member States, a reflection, perhaps, of the cultural attitude towards food as fuel and the growing obsession with fitness and body form in a population inclining towards obesity. Where food has traditionally been enjoyed as one of life’s great pleasures, notably France, the most important factor is what the product tastes like, not the ‘vital statistics’ of its content. Nevertheless, the link between food and health is now acknowledged as a matter of considerable importance to the EU as a whole and is the subject of a major review, with the ultimate aim of introducing dietary guidelines throughout the EU. The UK experience is therefore likely to be mirrored to a greater or lesser extent in other Member States and UK practices and consumer research are used here as an illustration of issues of wider relevance on which other Members States may not yet have published data. The provision of nutrition information, as with the provision of any other form of information, is an enabling mechanism which allows the purchaser to make an informed choice about the product he or she is considering buying. The degree of interest in this particular segment of the mass of information printed on a food label is a matter which

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will be discussed in greater detail in Section 8.4, but there are several issues which a manufacturer will need to consider in deciding whether or not to include nutrition information on the label: • • • • • •

Is it required by legislation/what are the regulatory requirements? Can I conform with these? Will it be helpful to my customers/do they require this information? Are my competitors providing nutrition information? Will it give me an advantage over my competitors to provide nutrition information? Is there space on the label?

There may be trade-offs and these will need to be weighed in the balance, but two essential points should be borne in mind: (a) the provision of nutrition information on label is voluntary, unless a claim is made; (b) approximately 80% of prepacked foods manufactured in the UK carry nutrition labelling, so not to do so is the exception rather than the rule. The strict and detailed regulatory requirements which govern the presentation of nutrition information are set out in the next section, and it will be clear from a provisional glance that providing this information inevitably has cost implications, at least at the outset, unless the product is very simple and the values can be taken from a published source, such as McCance and Widdowson.1 The formulaic nature of the required presentation may appear unnecessarily prescriptive, but there is good reason for this. The underlying purpose of the current legislation was to encourage the provision of nutrition information in a prescribed format which would allow consumers to compare the nutritional content of various products. The effectiveness of this policy is another issue which will be discussed in greater detail in a later section, but it is not arbitrary and reflects the complexity of negotiating legislation on a contentious issue to cover a large trading block made up of more than a dozen European Member States with diverse geographic and cultural backgrounds, and thus differences in local food supply and eating patterns. Of the many factors governing food choice, of which price is likely to be quite high on most people’s lists, nutrition information may not figure strongly for many. But the enormous number and variety of food products available on the market nowadays, including imports of exotic foods and ingredients from all over the world, resulting from the increasing interest in ethnic dishes generated by long-haul travel and TV cooks, not to mention new ranges of products inspired by these developments, means that the consumer needs ever greater knowledge and information to allow him or her to choose from this vast range. At point of purchase it is the food label which provides the information that will enable the consumer to make the choice between products. If diet and health are important to the consumer, the provision of nutrition information on the pack may be a deciding factor between purchasing the product and leaving it on the shelf, or, alternatively, a more careful study of the nutrition panel later in the home may influence a repeat purchase. A further influence on the provision (or not) of nutrition information may be the intermediate customer, namely the retailer, rather than the end consumer. The major UK supermarket chains exert an enormous influence on the highly competitive retail market for food and thus on food production. All major retailers stock a wide range of ‘own label’ products, manufactured to their own specification by a variety of food manufacturers. The specification will cover not only the composition of the product

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but also the details of the food label. This will almost certainly include ‘full’ nutrition labelling, i.e. the ‘Big 4’ and ‘Little 4’ nutrients (see next section) and possibly additional, supplementary voluntary information, which is discussed in detail in Sections 8.4 and 8.5. A manufacturer will need to consider whether or not he is producing supermarket ‘own label’ products and the competitiveness of his own branded goods if he is selling alongside them. Most retailers also carry a range of ‘healthy’ products, in which the composition is strictly formulated to meet specified nutrition criteria such as reduced fat content, lower sodium content, lower calorie, high fibre or any combination of these. They will invariably carry ‘full’ nutrition information. Consumers interested in a healthier diet may well look unfavourably at branded products which appear similar in content but do not offer nutrition information. Even if they are not specifically interested in this information they may wonder ‘Have they got something to hide?’. In the UK, this has become a general accusation of consumer groups against those manufacturers who choose, for whatever reason, not to provide nutrition information. In addition to retailer pressure and consumer demands, there is the added factor of government policy. Governments are the legislators and therefore have the power to regulate if they perceive a need or cannot achieve their aims by other means. Successive UK governments have placed diet and its influence on health under sharp focus in an effort to reduce the incidence of non-communicable disease, with the accent on prevention and the ultimate aim being to reduce the pressure and cost on the National Health Service of treating avoidable conditions. The factors influencing such diseases are recognised as multifarious and complex, but food is an easy target and food labels a visible, and therefore quantifiable, marker of change. Nutrition information is therefore an area of considerable government interest and is kept constantly under review. The majority of food manufacturers support the provision of information which helps consumers make an informed choice about the products presented to them. This includes the provision of nutrition information. For as long as a voluntary regime continues, the decision as to whether or not to provide nutrition information is largely a commercial one, assessed against some of the factors mentioned above, and others which will be touched on later. The arguments for change will be discussed in detail later, but first let us consider in detail the requirements of the existing legislation.

8.2

EU nutrition legislation

8.2.1 Background Legislation on nutrition labelling was developed as a means of providing consumers with information about the nutrient content of the foods they were choosing in a standardised format recognisable across the European Community, thereby also promoting the freedom of movement of goods in the Single Market. An essential part of the philosophy behind the Nutrition Labelling Directive, the principle EU legislative instrument in this area,2 was the growing recognition of the link between diet and health and the need to encourage consumers to make an informed choice about the foods they consume. It was considered that knowledge of the basic principles of nutrition and the provision of nutrition labelling would contribute significantly in this and act as a tool in the nutrition education of the public. To this end, it was deemed that the information provided should be simple and easily understood, with a standardised format which would allow comparison of one product with another.

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Thus the dual principles underlying EU legislation on nutrition labelling are consumer information and education, and the removal of technical barriers to trade. As usual in the development of harmonised legislation, one of the driving forces was the divergence in national legislation which risked causing reciprocal barriers to trade after completion of the Single Market on 31 December 1992. In the UK there was no specific legislation on nutrition information, but the Food Advisory Committee (FAC), whose advice carries considerable weight, had issued guidelines on nutrition labelling, which had been widely adopted by the industry. The Ministry of Agriculture, Fisheries and Food (MAFF) indicated its intention to introduce national legislation on the compulsory indication of fat content. This spurred the Commission into pushing its own proposals forward, on the basis that the UK’s freedom to legislate in this area was constrained by its Community obligations under the Food Labelling Directive, 79/112/ EEC. Work on European harmonisation began in 1988, when the Commission put forward two linked proposals, one on compulsory nutrition labelling and the other setting out what that labelling should be. The Directive eventually adopted in 1990, Directive 90/496/EEC on nutrition labelling for foodstuffs, did not require compulsory labelling, except where a claim is made, and focused more on the nature and format of the labelling, about which it goes into great detail. Interestingly, for a piece of legislation for which one of the primary aims is the provision of information regarded as being of benefit to the consumer, it is a highly technical Directive, unlikely to be understood by anyone without some knowledge of food science or food legislation, and ideally both. To understand and use it requires detailed analysis. Its main provisions are detailed in Section 8.2.2.

8.2.2 Provisions of the current legislation Format The provision of nutrition labelling is voluntary, unless a nutrition claim is made, e.g. ‘reduced fat’, ‘high fibre’, ‘low sodium’. If nutrition information is given, it must be in one of two formats: either or

Group 1 information: energy, protein, carbohydrate and fat (in that order) Group 2 information: energy, protein, carbohydrate, sugars, fat, saturates, fibre and sodium (in that order).

These formats are commonly referred to as ‘The Big 4’ and ‘The Big 4 plus little 4’. Quantities must be given per 100 g or 100 ml of the food or drink, or per 100 g/100 ml and per serving. The Directive requires that the information be given in one place, in tabular format, with the numbers aligned if space permits. Declarations may also be made in respect of vitamins and minerals, provided they are listed in the Annex of the Directive and are present in ‘significant amounts’, currently defined as 15% of the Recommended Daily Amount (RDA), supplied per 100 g or 100 ml of the food, or per package if the package contains only a single portion. The vitamins and minerals currently listed and their RDAs are given in Table 8.1. A declaration may also be given in respect of one or more of the following: • starch • polyols • mono-unsaturates

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Table 8.1 Vitamin/mineral

RDA

Vitamin/mineral

RDA

Vitamin A Vitamin D Vitamin E Vitamin C Thiamin Riboflavin Niacin Vitamin B6 Folacin

800 g 5 g 10 mg 60 mg 1.4 mg 1.6 mg 18 mg 2 mg 200 g

Vitamin B12 Biotin Pantothenic acid Calcium Phosphorus Iron Magnesium Zinc Iodine

1 g 0.15 mg 6 mg 800 mg 800 mg 14 mg 300 mg 15 mg 150 g

• polyunsaturates • cholesterol

but if a declaration is made in respect of polyunsaturates, mono-unsaturates or cholesterol, the amount of saturates must also be given. Calculation of energy value For the purpose of calculating the energy value for these nutrients, the Directive specifies the values on which they are to be calculated by means of the following conversion factors: • • • • • •

Carbohydrate (except polyols) Polyols Protein Fat Alcohol (ethanol) Organic acid

4 kcal/g 2.4 kcal/g 4 kcal/g 9 kcal/g 7 kcal/g 3 kcal/g

17 10 17 37 29 13

kJ/g kJ/g kJ/g kJ/g kJ/g kJ/g

Definitions The Directive, like most pieces of legislation, has to define what it refers to so all the nutrients that a manufacturer might want to put a number beside are defined scientifically. So, for example, the Directive states that: ‘‘‘protein’’ means the protein content calculated by using the formula: protein = total Kjeldahl nitrogen  6.25’, and ‘‘‘saturates’’ means fatty acids without double bond’. Hence the earlier comment that it is a Directive written for the food scientist rather than the average consumer. The Directive also defines ‘average value’. This is necessary because the composition of foods is subject to natural variation due, for example, to variations in cultivar, weather, growing location, conditions and practices (for crops) and in breed, seasonality, rearing conditions and practices (for animal-derived materials). The Directive therefore states that: ‘‘‘average value’’ means the value which best represents the amount of the nutrient which a given food contains, and reflects allowances for seasonal variability, patterns of consumption and other factors which may cause the actual value to vary’. Declared Values These are the average values of the nutrients, as defined above, based on: • the manufacturer’s analysis of the food; • a calculation from the known or actual average values of the ingredients used; • a calculation from generally established and accepted data.

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The amounts declared must be for the food as sold. However, where appropriate they may relate to the foodstuff after preparation, provided that sufficiently detailed instructions for preparation are given and the information relates to the food as prepared for consumption. The Directive provides for the use of the Standing Committee procedure in the event of discrepancies being found between the declared values and those established during the course of official analysis. The Standing Committee is convened from experts from all Member States who will adjudicate on the matter(s) placed before them. In the United Kingdom, the term ‘typical’ is preferred to ‘average’ and is more generally used being a more representative indication of value than the average. Nutrition claims As stated earlier, the provision of nutrition information is voluntary unless a claim is made. So, for example, if a claim is made that a product is ‘low in fat’, at least Group 1 information must be given. Very often the full Group 2 information is given, but this would only be compulsory if the claim were for one of the ‘Little 4’ nutrients, so ‘saturated fat’ rather than ‘fat’. The Directive defines as a nutrition claim: any representation and any advertising message which states, suggests or implies that a foodstuff has particular nutrition properties due to the energy (calorific value) it • provides, • provides at a reduced or increased rate or • does not provide and/or due to the nutrients it • contains, • contains in reduced or increased proportions or • does not contain. Only generic advertising is excluded from this, so if a producer decided to launch a campaign to persuade people to eat more fresh green vegetables and claimed that green vegetables are low in fat, he would not have to include the nutrition information alongside his images of leafy greens. The issue of nutrition claims is a separate sub-set of rules, codes and developments and is explored in more detail in Chapter 10. Timescale The Directive entered into force in September 1990 and required that trade in products complying with the Directive be permitted by 1 April 1992 and that products not complying with the Directive be prohibited with effect from 1 October 1993. The Directive also required that, eight years from its notification, the Commission would submit to the European Parliament and the Council a report on the application of the Directive and any appropriate proposals for amendment. This review, due in autumn 1998, has not yet taken place. This is discussed further in Section 8.6.

8.2.3 Implementation Most legislation is only as good as its implementation and enforcement. This has been mixed in the case of the Nutrition Labelling Directive. Some Member States were tardy

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in implementing it into their national legislation and some, the UK being a prime example, did it so clumsily that it would have been a deterrent to use had the Directive itself not already been familiar to most UK food and drink manufacturers and its provisions already widely used on a voluntary basis. Reports from elsewhere in Europe suggest that national implementing rules, which invariably entail a degree of interpretation, have indeed been a deterrent factor and have acted as a disincentive to provide nutrition information voluntarily. The UK’s record of some 80% of manufactured food and drink products voluntarily carrying nutrition information remains a matter of surprise, admiration and consternation in other Member States. UK implementation of the Nutrition Labelling Directive is via the Food Labelling Regulations 1996 (as amended). These are complex Regulations covering all the essentials of food labelling from batch marking to medicinal claims. Implementation of the Nutrition Labelling Directive, which took place in 1994, carried with it the usual burden of complexity that comes with turning the positive approach of EU legislation (you are not allowed to do it unless the Directive says so) into the negative style of UK Regulations (you can do what you like unless the Regulations state that ‘No person shall . . .’). The transposition of Article 4.1 of Directive 90/496/EEC, which states simply that Where nutrition labelling is provided, the information to be given shall consist of either group 1 or group 2 in the following order: Group 1 (a) energy value; (b) the amounts of protein, carbohydrate and fat. Group 2 (a) energy value; (b) the amounts of protein, carbohydrate, sugars, fat, saturates, fibre and sodium. became in Schedule 6A Part I of The Food Labelling (Amendment) Regulations 1994, a half-page single table listing both Group 1 and Group 2 nutrients, plus all the additional nutrients allowed to be mentioned, such as polyols under carbohydrates and polyunsaturates under fats, with a complex set of cross-references to Part II of the Schedule and subsequent paragraphs of Part I to explain the two separate groups and how they should be set out. No wonder MAFF needed to issue explanatory guidance notes to accompany the amendment to the Regulations.3 An additional complexity for manufacturers operating outside the UK has been differences in interpretation, and enforcement, of the legislation in other Member States. This lack of uniformity in approach to implementation of EU legislation is by no means unique to nutrition labelling, but particular aspects of its implementation and enforcement in some Member States appear to have acted as a disincentive to manufacturers to provide nutrition information. For example, for the first five years after adoption of the Directive, a declaration of one of the ‘Little 4’, e.g. saturates or fibre, did not carry the obligation to provide full Group 2 information, whether or not the declaration of the nutrient was triggered by a claim, although after 6 October 1995 it did. Some Member States never offered this distinction, whilst elsewhere the additional onus of having to provide all Group 2 information obliged some manufacturers to withdraw information on single ‘Little 4’ nutrients which they had previously provided. Another complexity is that of unresolved issues such as the lack of an agreed EU definition of dietary fibre. The UK’s adherence to the Englyst method of analysis and a definition of fibre as non-starch polysaccharides from plant cell walls only has hitherto left UK food manufacturers out of step with the rest of Europe (except Ireland), which favours

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the Association of Analytical Chemists’ (AOAC International) method of analysis and includes lignin and resistant starch in the values for dietary fibre. While the United Kingdom has recently shown a willingness to take a pragmatic approach to this contentious issue by giving preferred status to the AOAC International method of analysis and setting a ‘Guideline Daily Amount’ for intake of fibre as measured by this method (as opposed to the Dietary Reference Value set by COMA),4 an agreed European definition and recommended method of analysis is long overdue and urgently required. Article 1.4(j) of Directive 90/ 496/EEC states that ‘‘‘fibre’’ means the material to be defined in accordance with the procedure laid down in Article 10 and measured by the method of analysis to be determined in accordance with that procedure’. Article 10 refers to the Standing Committee procedure described above. However, the matter was referred to the EU Scientific Committee for Food (SCF), an appropriate authority to pronounce on such an important matter. Unfortunately, the SCF has so far been unable to reach agreement on a definition of dietary fibre, which becomes ever more complex as nutrition science moves on. It is an unsatisfactory situation which the European Commission should seek to resolve.

8.3

Manufacturers’ responsibilities

Clearly if a manufacturer decides to provide nutrition information, he must comply with the legislation, and if he wishes to make a nutrition claim on the product, he must give the nutrition information for that nutrient and all the others within the grouping. The above should provide a useful guide as to what is required, but it is important to check the precise requirements of the legislation in the country, or countries, in which the product is to be marketed. In the UK, the relevant legislation is the (now consolidated) Food Labelling Regulations 1996 (as amended). If marketing elsewhere in Europe, it is advisable to check the detail of the implementing legislation in each Member State, though provided the provisions of the Nutrition Labelling Directive are complied with, the manufacturer is unlikely to fall foul of national implementation rules. If providing nutrition information, it is important that it is accurate. Not only is it a legal requirement that any labelling information must be accurate and not misleading, but periodically consumer organisations run checks on the values given for the various nutrients and publicise embarrassing inaccuracies. Changes in values will inevitably occur with any changes in composition, so labelling information will need to be changed at the same time as the recipe. Whilst this may appear obvious, minor changes might easily be overlooked in terms of potential impact on nutrition information. It is important to establish the values accurately, preferably by periodical analysis, or by using a wellestablished database. Though expensive, recent analytical results would be indicative to any enforcement officer that the manufacturer had acted responsibly in the event of there being a dispute. Seasonal variation is provided for, but gross inaccuracy in terms of nutrient content and declared values is not, and reliance on published data may not suffice for more complex compositions. As in any other area of food legislation, a dialogue with the enforcement authorities, in the UK via the Home Authority,* is generally helpful, * The Home Authority Principle is defined by LACOTS, the Local Authorities Co-ordinating Body on Food and Trading Standards, as ‘An authority where the relevant decision making base of an enterprise is located. It may be the place of the Head Office, or Factory, service centre or place of importation.’ The purpose of this principle is to prevent infringements by offering advice at source and by encouraging enforcement authorities and enterprises to work in liaison with the Home Authority so as to encourage consultation and minimise duplication of effort and inconsistency in approach. LACOTS is seeking to promote this principle throughout the European Union.

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particularly for manufacturers who are unsure about their obligations, or about the precise requirements of the law. If, for example, the shape or size of the packaging precludes the inclusion of nutrition information in the recommended format, an opinion from the Home Authority on the acceptability of the alternative, proposed before the product is placed on the market, should reduce the potential for complaint afterwards. The manufacturer also has an obligation to ensure that the label is understandable in the market(s) in which the product is sold. Fortunately this requirement has not yet extended to ensure that the consumer understands the nutrition information per se, only the language in which it is provided. This is important for products sold throughout the EU where multilingual packaging is used. Regrettably it cannot be assumed that consumers throughout the EU understand the nutrition information if given in the language of the country of manufacture, even though it is set out in a recognised format and order of nutrients. If other aspects of the label are translated into the language of the Member State in which the product is being marketed, so must be the nutrition panel. This can be off-putting because of space, for which reason some manufacturers have, for many years, advocated a system of symbols for the nutrients which would be recognisable throughout Europe, and even internationally, but this has yet to be taken on board. Finally, but importantly, the manufacturer has a responsibility to his customers. They may well express interest in the nutritional attributes of the product, whether or not nutrition information is provided. Many manufacturers and retailers produce leaflets to help explain nutrition labelling and how it can help them to choose a balanced diet. Manufacturers who do not produce their own leaflets can helpfully refer their customers to some of the organisations and resources referred to in Section 8.7.

8.4

Consumer expectations

It is a long-held view of the UK food and drink manufacturing industry that nutrition labelling alone cannot educate the consumer to select a healthy balanced diet, but that it should provide the cornerstone of any nutrition education policy. Research has shown that relatively few consumers actually read the nutrition information provided, and even fewer of them understand it. Nevertheless, consumer organisations clamour for more and more information, at least Group 2 nutrition labelling, and on a mandatory basis. The view of food manufacturers is that it is not always possible to meet all the expectations of consumers, either because they are not justified or because they are not feasible. For example package sizes vary. Cornflake packets provide ample space for all the requisite compulsory labelling information plus voluntary declarations, recipe suggestions, marketing offers and more besides. Individual chocolate bars and yoghurt pots do not. In addition, there are cost implications in the provision of nutrition information from analytical testing to packaging design and the manufacturer may not feel these additional costs are justified against the likely level of interest and consumer benefit in providing additional information. In this context, research conducted by the UK Consumers’ Association in 1995 revealed some interesting results.5 A survey conducted in March/April 1995 questioned consumers on a number of issues about food purchases. The research was both qualitative and quantitative, the qualitative research consisting of four discussion groups held with women responsible for choosing and buying food. The quantitative research involved personal interviews with a representative sample of 1,454 people in Great Britain aged

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Table 8.2

What shoppers look for5 Most important

1. 2. 3. 4. 5. 6. 7. 8. 9.

Price/value for money Quality Nutrition/how healthy it is Family’s/personal preference How quick/easy to prepare How fattening it is Brand name/label Special diet for medical reasons Ethical/religious considerations

N = 1454 (%)

Important at all (more than one answer) N = 1454 (%)

34 21 16 12 5 4 3 3 1

87 77 61 53 33 33 28 10 3

over 15 years – people responsible for choosing food and doing any of the food shopping. Respondents were asked which of certain attributes were important to them when shopping for food. The results are shown in Table 8.2. Taking points 3, 6 and 8 as relevant to nutrition, diet and health, 23% of respondents consider this the most important aspect when shopping for foods, and a much higher number of some importance, even though nutrition and health ranked third after price/ value for money and quality. 86% of those asked recognised a nutrition information panel, though of these only 42% took notice of it, with 33% stating that it was what they took most notice of. Clearly, nutrition panels are very familiar and the circumstances in which nutrition information panels are used are of note: • • • • • •

36% 34% 26% 15% 15% 14%

when buying food not bought very often or never bought before; when comparing two different makes or types of the same product; when checking the nutrition claims made on the front of the pack; never use this information; every time food is bought that has this information on it; have never seen this information.

The statements shown in Table 8.3 make interesting reading both for nutritionists and marketing departments. For the purposes of this chapter we shall focus on the third, fourth and final points and the preferences expressed by those who participated in the survey for presentation of the nutrition panel and the aspects and terms of the current format they found difficult to understand: the easiest to use were those which were clearer/easiest to read (e.g. large print/good for poor eyesight – 50%); good layout (general) (e.g. simple, clearer, neater, ordered (in a column), etc. – 22%); easy to understand (9%). Other points mentioned were highlighting/bold print; distinguishes between medium and high; shows value per 100 g; familiar/used to it/seen most often. The most difficult to use were those with poor layout (e.g. crammed together, jumbled, a muddle, words run together, cluttered, etc. – 41%); difficult to read/indistinct/small print (34%); not tabulated/itemised/in columns (9%); hard to pick out a particular piece of information (4%). Table 8.4 lists a number of terms on a nutrition information panel that were found to be confusing.

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Table 8.3 Results of questionnaire where respondents were asked about their level of agreement with statements about information given on food labels (N = 1,454)5

1. 2. 3. 4. 5. 6. 7.

I believe all of the health messages and claims that appear on products nowadays I never believe the nutrition claims on food packaging and always check the label for more information I find it difficult to work out from the nutrition information panel on food products what is good for me and what is not Nutrition information panels should be laid out in the same way for all food products Claims are a quick and easy way of seeing how healthy a food product is Health messages and nutrition claims should all be regulated It is important that nutrition information is shown on all food products

Table 8.4

Agree (%)

Neither (%)

Disagree (%)

33

17

48

47

24

27

49

18

32

90

7

3

54

17

25

84

10

3

88

8

3

Nutrition information: consumer confusion5

% RDA kJ kcals Sodium Saturates Per 100 grams Per serving

80% 53% 41% calories (2%) 14% 11% 8% 7%

Leaving aside the 88% desire for nutrition information on all food products against the 42% who actually take any notice of it, the provision of nutrition information is evidently the expectation and the norm. The next hurdle is making it helpful and meaningful to consumers.5 Alongside the results of the UK Consumers’ Association’s research, we shall also consider the Nutrition Labelling Study Report prepared for the UK Ministry of Agriculture, Fisheries and Foods (MAFF) by Research Services Ltd and published in April 1995.6 The purpose of this study was to conduct a quantitative survey on consumers’ awareness of nutrition labelling on food products, with the main objective of finding out the extent to which consumers use and understand this type of information. This was particularly timely in terms of baseline information as the new Regulations on nutrition labelling, i.e. implementation of the Nutrition Labelling Directive, entered into force in March 1995. The study looked at the level of use of nutrition labelling; any problems in its presentation; and dietary habits, including changes in dietary patterns and what consumers thought they should be eating more or less of. The areas examined were: • The level of usage of nutrition labelling, including level of awareness; who uses nutrition labelling; the nutrients respondents were aware of/looked for on the label; use of 100 g or per serving information and which was most useful; how the labelling was

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used, i.e. to compare different foods or to assess the nutritional profile of individual foods and whether this was in the context of an individual meal or the whole diet. • Any problems with the way in which the nutrition information was presented, including whether or not the nutrients shown were understood, i.e. energy, sodium, protein, etc., and the relationship between carbohydrate and sugar, fat and saturates; whether the units and other terms were understood, i.e. kilojoules, kilocalories, calories, grams, percent RDA; could consumers understand the relationship between per 100 g and per portion information? Were consumers able to compare nutrient levels in different products on a 100 g and per portion basis? And were consumers able to make judgements about products across the range of nutrients, i.e. products that may be high in fat but differ in their content of saturates? • The type of diet followed at the moment, including special dietary requirements; changes in diet over the last few years; what people think they should be eating more or less of. A nationally representative sample of 1,000 interviews was used, following an initial qualitative phase for which actual knowledge was tested in a hall test situation. Those interviewed had to be personally responsible for shopping for food for the household or play a significant part in choosing what food was to be bought for themselves or their household. Further tests were incorporated to distinguish between those who were ‘nutritionally aware’ and those who were less well informed. Most respondents were aware of nutrition labelling when asked about the information which could be found on foods, 62% mentioning nutrients whilst only 45% mentioned ingredients. The sample was more likely to look for nutrition labelling than look for the ingredients. Nutrition labelling was found to be the primary source of information about the content of foods. Around half the sample claimed to take this information into account when buying or using foods. People who were health conscious were more likely to take nutrition labelling into account than any other subgroup. Within the nutrition panel, the information of most interest was fat levels (68%). About half those who looked at labels looked for energy levels, whilst sugar, protein and fibre were of less interest. Overall, ‘per serving’ information was preferred to ‘per 100 g’ information (65% of those who looked at labels preferred per serving information against 21% preferring per 100 g information). However, the perceived usefulness of the ‘per 100 g’ information increased among respondents who could understand labels and had a high knowledge of nutrition. Respondents were most likely to use nutrition information to compare two brands of the same product (49% of those who looked at labels claimed this). They were less likely to use it to compare two different products (only 15% claimed this). They were slightly more likely to use the information to assess products in terms of their whole diet rather than see how products fitted in with the rest of the meal. The sample was equally divided between those who considered nutrition information useful and those who did not. However, certain subgroups believed it to be more helpful than others. A large majority (68%) of those who were health conscious considered the information useful. The researchers stated ‘if it is the aim of nutrition labelling to be helpful to those who want to use it, it would make sense to see this group as the ‘‘target group’’, therefore a result of over two-thirds finding nutrition information useful seems encouraging.’ Some 53% of females compared to 44% of males claimed nutrition information to be quite useful or very useful. Younger age groups were more likely to

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find the information useful (62% of 16 to 34 year olds, 51% of 35 to 44 year olds, 48% of 45 to 64 year olds and 33% of those aged 65+), as were those from higher social grades (60% of ABs, 53% of C1s, 48% of C2s, 43% of DEs). Other subgroups which found the information more useful were those with children in the household (57%); those whose education finished at the age of 19 or over (65%); those who were working (55%); those who were in the household with someone who had a special diet (60%); and those with high nutritional knowledge (61%). Suggestions for improvement, apart from ‘make it easier to understand’, were generally in terms of making the print larger and giving more explanation of what the names and numbers meant. With regard to understanding of the nutrients, fat was the most widely recognised nutrient and the one which respondents considered they knew most about. 89% claimed to know something about fat, and the vast majority stated that fat should be cut down on. When comparing two products, over half the respondents cited a lower level of fat as a healthier difference. By comparison, saturates, polyunsaturates and monounsaturates were less well recognised or understood. A proportion of the sample was aware of the need to cut down on saturates and increase polyunsaturates intake. However, compared with the number of respondents looking at fat levels on labels, very few claimed to look for saturate levels. When comparing two products, a very small number cited a lower level of saturates being a healthier difference. The researchers concluded ‘it appears that there is a need for people to be made more aware of the implications of high saturate intake’. Carbohydrate was very widely recognised, but around 25% of the sample claimed not to be sure what it was. Some 27% of respondents claimed carbohydrate intake should be increased whilst 17% believed intake should be reduced. When comparing two products, opinion was divided as to whether carbohydrate should be looked for in higher or lower levels. Fat, sugars, protein, fibre and energy were all more likely to be looked for on a nutrition label than carbohydrate. Sugar and starch were at least as well recognised as carbohydrate, sugar being understood and looked for more than carbohydrate itself. The vast majority of the sample believed sugar levels should be reduced. However, respondents were also far more likely to believe that starch intake should be reduced. The researchers concluded ‘there is a need to educate people on the healthiness of this nutrient’. Protein was widely recognised, but as with carbohydrate, about a quarter of the sample were not sure what it was. The majority of respondents agreed that intake of protein was beneficial and, when comparing two products, about half of them cited a higher level of protein as a healthier difference. Fibre was better recognised and understood than the ‘Big 4’ nutrients, protein and carbohydrate. Some 84% of the sample claimed to know something about fibre. Over two thirds of the sample believed fibre intake should be increased, and around half of the sample cited a higher level of fibre to be a healthier difference when comparing two products. Energy was perceived by respondents as ‘calories’. Most respondents (67%) claimed to know something about energy although, again, about a quarter of the sample were not sure what it was. After fat, it was the item of most interest on the nutrition label. The term ‘sodium’ was much less well understood than ‘salt’. Some 62% of respondents felt salt intake should be reduced, compared with 22% believing that sodium should be reduced. Sodium levels were rarely inspected by those who looked at nutrition labels. A majority of the sample mentioned a lower level of sodium being beneficial when there was a substantial difference in sodium levels between two products. Only

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15% of the sample gave the same answers when comparing salt and sodium levels between two products, suggesting that relatively few respondents were able to equate sodium levels with salt levels. ‘Calories’ was a term recognised by almost all the sample, and most respondents correctly defined it as a measure of energy. By comparison, the terms ‘kilocalories’ and ‘kilojoules’ were less well recognised and understood. Grams were recognised and correctly defined as a measure of weight by the vast majority of respondents. Few claimed to be aware of the term ‘percentage RDA’, only about one in ten being able to define this term correctly. As far as visualising what amount of food constitutes 100 g, the sample’s performance was generally quite poor, though this was dependent upon the foodstuff in question. Where respondents were given three different amounts of the food to choose from, 28% of the sample gave the correct answer for fish fingers, 30% gave the correct answer for digestive biscuits and 16% gave the correct answer for raisins. When asked to read figures from a nutrition label, or make comparisons of nutrient levels between two labels, almost a third of respondents were unable to answer each time. When no calculation was required, the majority of the sample could read ‘per 100 g’ or ‘per packet’ information from a label. The declaration ‘of which saturates’ or ‘of which sugars’ was understood as well as any other part of the label. Calorific information confused some respondents, bringing the proportion of those who could read this particular information down to around 50%. If a simple calculation was required, less than half of the sample were able to obtain the correct answer. This also applied when comparing nutrient levels between two labels. Most people did not have the ability to make the necessary calculations in their head to convert ‘per 100 g’ information into information for the whole packet, either when comparing two products or when assessing one product. The researchers wanted to test how well respondents could assess the product’s healthiness taking into account all as opposed to individual nutrients. In comparisons between two products, respondents were good at recognising the healthier product when the healthier differences between the products were to do with the most well known nutrients, for example lower in fat, higher in fibre, higher in protein. Respondents were less likely to recognise the healthier product when the healthier differences between the products involved nutrients which were less well known, for example, lower in saturates, lower in sodium. Few respondents claimed to be in a household with someone who had special dietary requirements, the most common being a slimming diet which was mentioned by one in ten respondents. However, most individuals claimed to have changed their diet over the last few years, reasons to do with being healthier being the most commonly given. The foods people were most likely to believe they should be eating less of were fatty foods and sweet things. In terms of what the sample felt they should be eating more of, the most likely responses were fruit and vegetables. The researchers concluded ‘most respondents claimed to be concerned about the healthiness of foods although less than half claimed to always choose a healthier food. A strong feeling for enjoying the foods they were eating emerged.’ Geographically, respondents in Wales and southern England performed better than those in the Midlands and the north of England. Respondents from Scotland and Northern Ireland were relatively less well informed. The results of this research galvanised the food industry, both retail and manufacturing, into seeking ways of providing nutrition information in a manner which would be more helpful to consumers.

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Further research commissioned and conducted in the UK by the Institute of Grocery Distribution (IGD) in 1996 showed that of those consumers who use the nutrition information on the label, most focus on energy, and to a lesser extent fat, slightly at odds with the RSL Report. The research also indicated that many consumers have little knowledge of how much energy, in terms of kcal or kJ, they need per day and little idea of what guideline targets are with respect to fat. As indicated in the previously listed research results, few understood the meaning of the term ‘saturates’, especially in the given format where it is indicated under fats as ‘of which . . .’, and the concept of kilojoules was not understood at all. Most respondents said that ‘per serving’ information was generally found to be more helpful than ‘per 100 g/100 ml’, though the latter was useful when making comparisons between products at point of sale. As a result of this research, proposals were drawn up for highlighting calories and fat on the nutrition label, and the UK Ministry of Agriculture, Fisheries and Foods (MAFF) and Department of Health (DH) were consulted about Guideline Daily Amounts of calories and fat, and values were agreed for both men and women. Various formats were tested on consumers and, as a result, a scheme for supplementary voluntary nutrition labelling was launched in February 1998.7 The details of this scheme are set out in Section 8.5.

8.5

Voluntary codes

Since the advent of the European Nutrition Labelling Directive and an agreed regulatory basis for the provision of nutrition information, itself voluntary unless a claim is made, there has been little scope for voluntary codes, except a general recommendation to UK manufacturers to provide at least Group 1 information (Food and Drink Federation), and a general understanding that manufacturers and retailers should do as much as possible to assist consumers to understand and use the information on the pack by providing leaflets, customer helplines and other sources of assistance. This is part of any major food business. Feedback from consumers informs businesses about what their customers want and expect and the results of the UK consumer research outlined in Section 8.4 above came as no great surprise to the food industry. Some major UK retailers had already begun to highlight information about specific nutrients below the standard nutrition panel in response to dietary advice in the ‘Health of the Nation’ White Paper8 recommendations to reduce consumption of fat, and especially saturated fat, and to reduce levels of obesity. In pursuit of UK government strategy in respect of nutrition goals, a Nutrition Task Force (NTF) was established to consider a range of aspects which might assist in improving consumers’ eating habits including, unsurprisingly, the use of nutrition information. A group of experts drawn from the Nutrition Task Force and Food Advisory Committee (NTF/FAC Working Party) commissioned the consumer research project, described above, which concluded that current nutrition information was not helpful to many consumers. The industry began to look at the possibilities, within the constraints of the existing legislation, for providing additional voluntary nutrition labelling as a tool to help consumers choose a healthy diet. The initiative was formalised in May 1995 under the auspices of the Institute of Grocery Distribution (IGD), a research organisation which draws its membership from every stage of the food supply chain and has links with a number of consumer associations.

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The existing scientific, consumer and company research was reviewed, including that described in Section 8.4, and new research commissioned to identify a labelling format for food products which would provide consumers with information to enable them to gain an improved understanding of the amount of fat and energy they consume in their daily diets. The objective was that the labelling format should provide relevant information and the nutrition information be expressed in a format useful to the consumer: it should help them to understand and manage the type and balance of nutrients (fat and energy) they were consuming in their diet. The information should be clear and simple to understand, for which reason the study focused on three nutrients in order not to confuse consumers with overly complex or detailed information. The choice of nutrients, fat, saturates and calories, resulted from the identification by the NTF/FAC Working Party, endorsed by the FAC, that such a focus would be a significant step forward in providing supplementary nutrition labelling, and that simpler supplementary nutrition labels would assist more consumers in selecting healthy diets. A two-step research programme was conducted. Step one was qualitative research (five focus groups) which explored consumer attitudes towards nutrition labelling and provided guidance for the design of the major quantitative research. Step 2, the quantitative research, covered 2,300 adult consumers in a nationally representative study to assess the performance of a number of nutrition labelling formats. The research was designed to assess consumers’ ability to use the label, i.e. their performance, rather than their preference for, different labelling formats. The main findings of the research were as follows: • Current levels of nutrition understanding are low. • Current nutrition information is too complicated, frustrating and often illegible. • Fat and calories were the most monitored nutrients, followed by protein and sugar, with fibre and sodium stimulating little concern. • Many people only monitor the nutritional quality of their food if they are dieting or ill. • The terms carbohydrate, saturates and sodium were not understood. • Kilojoules are perceived as irrelevant to adult consumers. • Consumers’ ability to assess accurately the calorie content in foods was quite good. However, their ability to assess accurately the fat content in foods was poor. Products were rated as high or low in fat with very few intermediate assessments. • Nutrition information is read whilst in the supermarket. • There was genuine support for guideline daily amounts. Consumers felt that this was new information which helped them to place nutrition information in context, making the whole label more valuable and useful. • Consumers preferred the use of whole numbers to decimal places and could not understand the relevance of having the information expressed to a tenth of a gram. • ‘Per serving’ information was preferred over ‘per 100 g’, although the ‘per 100 g’ information was used when comparing the nutrient content of similar products at the point of purchase.

The IGD’s guidance on Voluntary Nutrition Labelling was formulated after thorough analysis and discussion of the research results. The concept of Guideline Daily Amounts (GDAs) was central to the labelling formats tested and the underlying purpose of the supplementary voluntary nutrition information, i.e. to assist consumers in choosing a healthier diet in line with ‘Health of the Nation’ recommendations. A number of companies were already promoting daily ‘amounts’ for fat and calories in company literature, and it clearly made sense to work to a common standard to avoid confusing

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consumers. The GDAs recommended by the IGD were agreed following discussion with MAFF and the DH. They are based on the predicted daily consumption of an average consumer eating a diet conforming to Committee on Medical Aspects of Food Policy (COMA) recommendations. They are not intended as targets to aim for, but guidance to assist consumers in their understanding of their daily consumption of calories, fat and saturates. The recommended Guideline Daily Amounts are: Each day

Women

Men

Calories Fat Saturates

2000 70 g 20 g

2500 95 g 30g

It was recognised that consumer understanding of saturates is low, but the GDA was provided for those companies which choose to offer this information. There are four other recommendations. Firstly, additional on-pack information needs to be provided. In line with the research results which indicated that consumers were most interested in fat and calorie content, and on a per serving basis, the IGD recommends that this information be illustrated independently of the nutrition panel in a separate box. Table 8.5 shows an example of nutrition information, and Table 8.6 illustrates a per serving example. Where this is not possible because of the pack size or layout, it is suggested that this information be highlighted in colour within the nutrition panel. The ‘per serving’ measures must be stated and be appropriate to consumers, who show a preference for household units, e.g. per teaspoon, per half pack, per biscuit, per slice. The next recommendation is that the column order in the nutrition information panel should be changed so that ‘per serving’ information comes before the ‘per 100 g’ information. Table 8.5

Nutrition information

Typical values

per 100 ml

Energy Protein Carbohydrates of which Sugars Fat of which Saturates Fibre Sodium

280 KJ 67 kcal 3.2 g 4.8 g 4.8 g 3.9 g 2.6 g 0.0 g 0.1 g

Table 8.6

Per serving Per serving (A cup)

67 calories

3.9 g fat

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The IGD also recommended that a consumer education programme is required to improve consumer understanding about saturates and their role in the diet. Companies are recommended to use Group 2 nutrition information thereby ensuring that saturates appear on the label. The final recommendation concerns legibility. The IGD referred to its June 1994 publication ‘Packaging Legibility – Recommendations for Improvements’ as guidance to assist consumers to read the information provided. The scheme has been widely adopted on UK supermarket ‘own label’ products. Uptake on branded foods has been less enthusiastic, for two reasons. First, the recommended supplementary format is, strictly speaking, illegal. This was recognised by the IGD, which stated in the published Guidelines: MAFF point out that, in the strictest interpretation of the current legislation, this information would likely fall within the definition of ‘nutrition information’ in Article 1(4)(a). Under Article 4, which sets out the order in which information should be given and the eighth Whereas clause, which prohibits any other form of nutrition labelling than that specified in the Directive, the presentation of fat and calories as recommended by the IGD Nutrition Group would be prohibited. However, LACOTS supports nutrition labelling which assists consumers to make informed dietary choices and takes the view that the IGD recommendations go some way to achieving this aim and therefore welcomes the IGD recommendations. Whilst noting the current legal constraints, local authorities will carefully consider pragmatic approaches which will benefit consumers. In the longer term LACOTS strongly supports changes to existing legislation to enable alternative forms of information to be given. Second, most major food producers operate in a European environment and package and market accordingly. The supplementary information, especially the Guideline Daily Amounts, would not necessarily be appropriate to consumers elsewhere in Europe, and would almost certainly fall foul of local enforcement authorities. Many UK manufacturers have therefore opted not to display the supplementary information on the pack, but to include it in their company leaflets and promotional literature. The IGD is committed to reviewing the effectiveness of the supplementary voluntary labelling, and to considering other nutrients. Sodium is currently under discussion.

8.6

Future trends

The application of the Nutrition Labelling Directive and its usefulness to consumers has remained under constant review since it entered into force. The anticipated arrival of the formal deadline of October 1998 for the European Commission to provide its report and any proposals for amendment provided an additional focus, as did the Commission’s 1997 Green Paper on The General Principles of Food Law in the European Union. The review of the Directive is now more than a year overdue and it is high time to consider proposals for change.

8.6.1 Proposals for changes to the legislation In the light of experience and research into consumer use and understanding of nutrition information, the UK food and drink manufacturing industry’s response to the

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need for change could be summed up in two words: simplification and flexibility. Most prepacked food and drink products sold in the UK already carry at least Group 1 information, and many provide Group 2 information. This reflects a genuine desire to take positive steps towards educating and informing consumers about the nutritional value of the products they consume. The Nutrition Labelling Directive is therefore perceived as a useful piece of legislation which could, if appropriate supporting education programmes were put in place, help consumers to construct a healthy balanced diet from the wide variety of products available to them. The legislation in its present form is not over-burdensome to industry, which sees no need for fundamental change. There is, however, scope for improvement in the light of experience, and indeed technological development, and some of the areas which might usefully be reviewed are as follows. Format Greater flexibility with Group 2 information would encourage more manufacturers to provide it. Where label space is at a premium, lists of nutrients with ‘O’ against them appear to waste it. So if the figure for the ‘Big 4’ nutrient is zero, the inclusion of the ‘Little 4’ nutrient appears superfluous, e.g. Fat –

of which saturates

0 0

Definitions Technological advances necessitate a review of the definitions of several of the nutrients. For example the definition of carbohydrate encompasses substances such as polydextrose but, although a carbohydrate, polydextrose is only partially metabolisable and also demonstrates fibre-type properties. Moreover, the energy conversation factor of 4 kcal/g is far in excess of the acknowledged energy contribution of polydextrose: 1 kcal/g. Similarly fat replacers are now entering the market to meet the demand for lower energy foods. A substance such as olestra, already approved by the US Food and Drug Administration, is a lipid and, although not metabolisable, would be defined by the Directive as a fat and attract an energy conversion factor of 9 kcal. This would clearly be a nonsense as the substance passes straight through the gut and provides no energy at all. Fibre has long been a bone of contention and despite years of discussion, the Commission has still failed to provide an agreed EU definition or method of analysis (see Section 8.2.3), although with the UK recognition of AOAC method of analysis, this may be resolved in the not-too-distant future. Simplification and flexibility A concept enshrined in the Directive is that nutrition information should be simple and easily understood. Highlighting specific information believed to be of most use to consumers, as recommended by the IGD, and removing any unnecessary clutter, would therefore appear to be a step in the right direction. Many manufacturers would prefer to make nutrition information available on a ‘per serving’ basis with 100 g/100 ml as an option, rather than the other way round. As indicated above, this has already been shown to be preferred by consumers, who sometimes have difficulty in calculating the information for the amount of the product they would actually consume, especially if it is not a simple multiple or fraction of 100 g/ 100 ml.

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Manufacturers would also like the flexibility to respond to consumer requests for additional information, which often occur on a short-term basis following media focus on a particular nutrient, such as the Willett study9 which raised concerns about trans-fatty acids (TFAs). Currently there is no provision for such a declaration, though care would need to be taken not to encourage over-reaction to a ‘scare’ provoked by poor interpretation of a scientific report or a badly conducted study. Manufacturers would also support the use of symbols to denote both macro- and micro-nutrients which would overcome any language problems and encourage more use of nutrition information on multilingual packs. Simplification of the vitamin and mineral declarations would also be welcomed. The use of common synonyms is thought to be more helpful to consumers than the biochemical names prescribed in the Directive, e.g. folic acid rather than folacin; and vitamin B1 instead of thiamin. The range of declarable micronutrients should also be extended to include important minerals such as selenium and chromium. It might also be helpful to be able to declare them in amounts other than 15% of the RDA per 100 g/ml or per serving, as a product might be an important source of a vitamin or mineral in terms of daily consumption but not meet the ‘per serving’ requirement, e.g. bread and milk.

8.6.2 Voluntary or mandatory? The debate on whether nutrition labelling should be on a voluntary or mandatory basis has been going on since before the Directive was adopted. Many consumer groups call for nutrition information to be mandatory on all prepacked foods and drinks. Arguably this should not present UK industry with any great difficulties as nutrition labelling is already provided voluntarily on about 80% of products, but what about the other 20%? First, it should be remembered that no information comes without a price or a tradeoff. Consider the amount of compulsory labelling on any food product: the name of the food; the supplier; a full list of ingredients; a sell-by or ‘best before’ date; storage instructions; cooking or usage instructions to name but a few. Information overload can be off-putting. Consider then the cost of providing the nutrition information: working out the values for each product, monitoring and checking by analysis, formatting on the label and repeating this procedure wherever a change in the product is made. Even finding space on which to put the information may require new packaging design. Most people would agree that products which contribute a major source of the daily food intake might usefully provide nutrition information. But what about those products which are eaten only occasionally, possibly as a special treat, or which are used only in small amounts such as cake decorations, or only as an accompaniment, such as condiments? And should not more focus be placed on the general change in eating patterns and the tendency to consume more of our food outside the home, in restaurants and other catering establishments? At present the Directive concerns nutrition labelling of ‘foodstuffs to be delivered as such to the ultimate consumer’. It also applies to foodstuffs supplied to restaurants, hospitals, canteens and other similar mass caterers, but how often do we see nutrition declarations on a menu or on any food sold loose over the counter? In any future trends, perhaps there is a need to reconsider the primary purpose of nutrition information and whether or not current practice is actually achieving it. Consumer information and consumer education are not necessarily the same thing. The primary purpose of the food label is to inform the consumer, not to educate, but the information, as indicated in Section 8.4, is of little or no use without some pre-existing knowledge. Responsibility for providing this background knowledge has always been

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shared between government, consumer and health organisations, the media and the trade, but appears not yet to have fully achieved its aim. It would appear that the lead needs to come from government, in the United Kingdom specifically from the newly established Food Standards Agency, which has responsibility for food labelling and consumer information. If the provision of nutrition information is to assist consumers to choose a more healthy, balanced diet, they must first know what that diet should consist of, then how to use nutrition information to help achieve it. Consistency and simplicity in the messages would be a good start, followed by consistency and simplicity on the label. The growing use of electronic information, including in-store, offers opportunities not previously dreamt of. If such a medium can provide each individual consumer with every iota of information he or she wishes to know about any product, why try to cram more and more on the label? Perhaps future policy should gravitate towards providing only the more essential information on the label, and giving interested consumers quick and easy access to any other nutrition information they may wish to know via another medium. The debate on diet and health will continue indefinitely. Arguments over the provision of nutrition information will probably do likewise.

8.7

Sources of further information and advice

British Nutrition Foundation, High Holborn House, 52–54 High Holborn, London SW1V 6RQ. Telephone +44 (0)20 7404 6504. British Dietetic Association, 7th Floor, Elizabeth House, 22 Suffolk Street, Queensway, Birmingham B1 1LS. Telephone +44 (0)121 616 4900. Camden and Chorleywood Food RA, Chipping Campden, GL55 6LD. Telephone +44 (0)386 840319. Food & Drink Federation, 6 Catherine Street, London WC2B 5JJ. Telephone +44 (0)20 7836 2460. Institute of Grocery Distribution, Grange Lane, Letchmore Heath, Watford, Herts WD2 8DQ. Telephone +44 (0)1923 857141. Leatherhead Food RA, Randalls Road, Leatherhead, KT22 7RY. Telephone +44 (0)372 376761. MAFF Food Standards and Labelling Division, Ergon House, 17 Smith Square, London SW1P 3JR. Telephone: +44 (0)20 7238 6463 (from April 2000: Food Standards Agency).

8.8 1. 2. 3. 4. 5. 6. 7. 8. 9.

References McCance and Widdowson’s The Composition of Foods, Fifth Edition, The Royal Society of Chemistry and Ministry of Agriculture, Fisheries and Food, 1991. Official Journal of the European Communities, No. L 276/40-44, 6 October 1990. MAFF Guidance Notes on Nutrition Labelling, 1994, MAFF, London. Dietary Reference Values for Food Energy and Nutrients for the United Kingdom, Report of the Panel on Dietary Reference Values of the Committee on Medical Aspects of Food Policy, HMSO, 1991. Consumers’ Association Nutrition Labelling Research, Brief Summary of Quantitative Survey, 1995 (tables reproduced by kind permission of the Consumers’ Association). Nutrition Labelling Study Report, Research Services Limited (RSL), MAFF J1366, April 1995. Voluntary Nutrition Labelling Guidelines to Benefit the Consumer – Supplementary to legislative nutrition labelling requirements, Institute of Grocery Distribution, 1998. The Health of the Nation – a strategy for health, HMSO, 1992. Willett, WC, Stampfer, MJ, Manson, JE, Colditz, GA, Speizer, FE, Rosner, BA, Sampson, LA and Hennekens, CH (1993). Intake of trans fatty acids and risk of coronary heart disease among women. Lancet 341, 581–585.

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8.9

Further reading

MAFF Foodsense Leaflet ‘Use Your Label: Making Sense of Nutrition Information’ MAFF 1996. Council Directive of 24 September 1990 on nutrition labelling for foodstuffs (90/496/EEC), Official Journal of the European Communities No. L276/40-44, 6 October 1990. Department of Health, Guidelines on Educational Materials concerned with Nutrition, HMSO, London 1996. The Food Labelling Regulations 1996, Statutory Instrument 1996 No. 1499, HMSO London.

9 Nutrition information: United States T. A. Altman, Professional Fluency, Chicago

This discussion outlines the basic requirements for providing nutrition information on packaging for most food products sold in the United States. Two types of labels are specified: ‘Nutrition Facts’ labels for conventional foods, and ‘Supplement Facts’ labels for dietary supplement products. Both are intended to present consistent, reliable information about the basic nutrients in consumer products. The US regulatory agencies have established separate rules restricting manufacturer claims about a product’s nutrient content or health benefits (e.g., ‘low sodium’ or ‘fat free’); those are discussed in Chapter 11. Note, however, that making such a claim mandates that the labeling provide the nutrition information discussed here (even if the product would otherwise be exempt from these rules).

9.1

Key principles of US labeling requirements

Generally speaking, all food products sold to consumers must provide nutrition information. In some cases, exemptions are provided for small businesses; furthermore, special provisions apply to foods sold in bulk or to single-ingredient, raw products (e.g., steaks or fresh fruit).

9.1.1 Legislation leads to rule changes In the United States, most nutrition labeling requirements are derived from language in the Federal Food, Drug, and Cosmetic Act (FDCA), as revised in 1990 by the Nutrition Labeling and Education Act (NLEA). The statute authorizes the Food and Drug Administration (FDA) to administer rules ensuring that nutrition labels on most food products are accurate and consistent. When the NLEA was adopted in 1990, it represented the first major overhaul of federal food labeling statutes since 1938. The US laws governing red meat and poultry (i.e., the Federal Meat Inspection Act (FMIA) and the Federal Poultry Inspection Act (PPIA)) were not amended by the NLEA. However, because the US Department of Agriculture (USDA) elected to establish its own

148

Food labelling

nutrition information policies closely resembling the FDA regulations, meat and poultry is subject to requirements similar to the rules governing all other food and seafood products. FDA publishes rules . . . For many years, the FDA has required that basic information be presented on product labels, including the name of the food, manufacturer information, statements of ingredients, and net quantity of contents (see Chapter 5 for details on declaring ingredients). After passage of the NLEA, the FDA was forced to revamp its regulations to establish a separate program governing the presentation of comprehensive nutrition information to the consumer: • The agency published a comprehensive set of regulations on January 6, 1993 to implement the NLEA provisions. The FDA’s requirements appear in 21 CFR Part 101 of the federal regulations. Throughout this chapter, citations to specific sections of the FDA rules are noted in square brackets as ‘regulatory references.’ • The 1994 passage of the Dietary Supplement Health and Education Act (DSHEA) required the FDA to revise some of its policies. As discussed in Section 9.4, the agency has issued separate labeling requirements for products containing supplements of vitamins, minerals, herbs, and other substances.

. . . and FSIS follows Nutrition labeling for meat and poultry products is governed by the USDA’s Food Safety Inspection Service (FSIS) – see Chapter 3 for a discussion of the legal framework for US requirements. Among other things, FSIS requires meat and poultry product labels to inform consumers about quality and content. Meat and poultry are subject to labeling requirements that closely resemble those administered by FDA. FSIS first adopted new nutrition information rules on January 6, 1993 – at that time, the agency simply incorporated FDA’s rules by reference, rather than formally publish regulations. However, based on feedback concerning the difficulty of referring back and forth between the FSIS and FDA rules, on January 3, 1995 FSIS published its own complete set of nutrition labeling regulations. The agency’s requirements are published at 9 CFR Parts 317 and 381 of the federal regulations. Throughout this chapter, citations to specific FSIS rules are noted in square brackets as ‘regulatory references.’

9.1.2 Nutrition facts While ‘food labeling’ might refer to naming a product or listing ingredients, ‘nutrition labeling’ means providing information on labels as specifically mandated by NLEA. Figure 9.1 shows a sample label for a typical product, including requirements for typefaces and sizes. Unless an alternative format is allowed, or a product is exempt, this type of label must appear on any food product offered to consumers. Typically, ‘label’ refers to any printed material placed upon a food container. The FDCA defines it as ‘a display of written, printed, or graphic matter upon the immediate container of any article’ [Section 201(k)]. Labeling is defined to mean ‘all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article’ [FDCA Section 201(m)]. FSIS regulations clarify that stickers are considered part of a label.

Nutrition Information: United States

Fig. 9.1

149

Basic formatting for ‘nutrition facts’ labels.

Methods for calculating specific nutrient values for label declarations are discussed in Section 9.2. Formatting requirements and exemptions are discussed in Section 9.3, and separate provisions for labeling dietary supplement products are discussed in Section 9.4. Principal display and information panels Product labeling requirements other than for Nutrition Facts labels are outside the scope of this discussion. However, two basic labeling concepts – the principal display panel and the information panel – are important for presenting nutrition information: • Principal display panel – On a food package, the PDP is the section most likely to be displayed under conditions of ordinary retail sale: the portion typically presented to the consumer. If a package has another surface that could also serve as the PDP, it is considered an ‘alternate PDP.’ Nutrition information required on the PDP must be duplicated on all alternate PDPs. • Information panel – This is the panel immediately to the right of the PDP (or an alternate PDP), as observed by the consumer. If the right-hand panel is too small to display the required information, the next right-hand panel may serve as the information panel. Note that, if the top of a container serves as the PDP, the information panel is any panel adjacent to the PDP (assuming there is no alternate).

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Food labelling

Required information is placed on either the PDP or the information panel. However, if a package has available surface area larger than 40 square inches, but the two panels still do not accommodate the information, any alternate panel may be used for the nutrition information [regulatory references: 21 CFR §§101.1–101.2, 101.9(j); 9 CFR §§317.2, 381.116].

9.2

Making nutrient declarations

‘Nutrition Facts’ labels typically provide information on: (1) (2) (3) (4) (5)

serving size, number of servings in the container or package, total calories per serving and calories from fat (per serving), quantities of certain primary nutrients (expressed in grams or milligrams), and ‘percent daily values’ for those nutrients, plus percent daily values for vitamins and minerals.

Nutrition information is provided for a product as packaged (although some singleingredient, raw products are labeled on an as-cooked basis). Labels may include ‘dual’ declarations for the product on both an as-packaged and as-prepared basis, as long as cooking instructions are provided. In addition, when a packing medium is not usually consumed (e.g., the juice in a jar of olives), label declarations should be based on the drained solids content.

9.2.1 Declaring number of servings Determining serving size – and number of servings per package – is a fundamental step in preparing nutrition labels. ‘Serving’ or ‘serving size’ is the amount of food customarily consumed by someone at least four years of age. For products formulated for infants or toddlers, a serving is the amount consumed by an infant less than one year old, or by a toddler 1–3 years old. Serving sizes Manufacturers must determine serving sizes using values established in the regulations – these are referred to as reference amounts customarily consumed (RACC). The RACCs are listed according to product category, and are published by FDA at 21 CFR §101.12(b) and by FSIS at 9 CFR §§317.312(b), 381.412(b). Serving sizes are expressed in common household measures, along with metric equivalents. In addition to per-serving information, a label may include a second set of numbers declaring the information based on 100 g, 100 ml, 1 oz, or 1 fl oz as packaged or purchased. Note that serving sizes for meal-type products are declared as the entire package contents [regulatory references: 21 CFR §101.13(l) and 9 CFR §§317.313(l), 381.413(l)]. Both the FDA and FSIS provide guidelines for determining serving size in certain special situations, such as when products are sold in discrete units (e.g. frozen pizza), in bulk (e.g. muffin mix), or in variety packs (e.g. a cheese sampler). For instance, the serving size for a product sold in large, discrete units would be declared based on the fractional portion most nearly approximating the RACC (e.g. ‘1/4 pizza’). Other special cases are also addressed; for example, when two foods are packaged together, with the

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main ingredient a discrete unit or a bulk product (such as cake mix and frosting, or a pizza with sauce), a serving may represent a portion of the main item plus proportioned accompanying ingredients. Serving sizes must be declared in common household measures, followed by metric equivalents in parentheses. Regulatory requirements are summarized in 21 CFR §101.9(b) and 9 CFR §§317.309(b), 381.409(b). Note that: • For household measures, if an unusual unit (e.g., ‘slice’) is used, serving size may also be expressed in English units (e.g., ounces). This value would be declared by placing a ‘/’ after the metric quantity: serving size = 2 slices (56 g/2 oz). • When declaring metric equivalents, fluid amounts should be expressed in milliliters (ml), and all other quantities should be declared in grams (g). • When labeling a single-serving container, if the metric quantity is already provided on the PDP as part of the net-weight statement, it is not required (unless nutrition information is required on a drained-weight basis).

Number of servings Once serving size has been determined, the number of servings per container must be declared. The regulations specify that the number of servings be rounded to the nearest whole number, with some exceptions: • If the number of servings is between two and five, the value should be rounded to the nearest half-serving, and declared as follows: ‘about 3.5 servings.’ • If serving size is expressed on a drained-solids basis, and the value varies because of natural variations, declare the typical number of servings per container (e.g., ‘usually 4 servings of [product name]).

9.2.2 Declaring nutrient information Both the FDA and FSIS specify which nutrients may be declared on nutrition labeling. Some nutrients (e.g., sodium) are mandatory, while others (e.g. polyunsaturated fat) are voluntary. However, food components not specifically identified in the regulations may not be included. Information on non-listed nutrients must be provided outside the Nutrition Facts label. The regulations specify the order in which declared nutrients must appear. The nutrients that are required on nutrition labels are listed below; acceptable synonyms are shown in parentheses. Note that the highlighted names should appear in bold type on the label, and that the % of vitamin A present as beta-carotene may be declared voluntarily [regulatory references: 21 CFR §101.9(c), 9 CFR §§317.309(c) and 381.409(c)]. Nutrients that may be declared voluntarily are listed in Table 9.1. • • • • • • • • •

Calories (or total calories or calories) Calories from fat Fat, total (or total fat) Saturated fat (or saturated) Cholesterol Sodium Carbohydrate, total (or total carbohydrate) Dietary fiber Sugars

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Food labelling Table 9.1

Nutrients that may be declared voluntarily

Basic nutrients

Vitamins and minerals*

Calories from saturated fat Stearic acid Polyunsaturated fat Monounsaturated fat Potassium Soluble fiber Insoluble fiber Sugar alcohol Other carbohydrate

Vitamin D Vitamin E Vitamin K Thiamin Riboflavin Niacin Vitamin B6 Folate Vitamin B12 Biotin Pantothenic acid Phosphorus Iodine Magnesium Zinc Selenium Copper Manganese Chromium Molybdenum Chloride

* If added as supplements, or if claims are made about these vitamins or minerals, nutrition label declarations are required. Regulatory references: 21 CFR §101.9(c); 9 CFR §§317.309(c), 381.409(c)

• • • • •

Protein Vitamin A Vitamin C Calcium Iron

Beneath the serving-size declarations, values are listed for ‘calories’ and ‘calories from fat.’ These are provided on a per-serving basis, using 5- or 10-calorie increments, depending on the declared value. Zero declarations are allowed if the per-serving level is below five calories. The FDA plans to begin requiring that the amount of trans-fatty acids in foods or dietary supplements be included when determining how to declare saturated fats. The agency intends to require that, when trans-fatty acids are present, the product labeling refer to a footnote at the bottom of the nutrition label – the footnote would indicate the number of grams of trans-fatty acids present in a serving of the product. This proposal was published on 17 November 1999 (64 FR 627 46). If finalized, this action would revise regulations in 21 CFR §§101.9, 101.13, 101.14, 101.36, 101.62. It would also revise the requirements for making nutrient content or health claims about reduced saturated fat levels, and would allow claims for ‘trans-fat free’ products – specifics for making such claims are discussed in Chapter 11. Declaring nutrients by weight Information on key nutrients follows the calorie declarations. Most nutrients must be declared on a weight-per-serving basis in grams or milligrams, as shown in the sample

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labels – as opposed to calories, for which no weight is given, or vitamins and minerals, for which only percent daily values are provided (see Figs 9.1–9.3). For each nutrient, the regulations specify which units to use (mg or g), and a level beneath which declarations of ‘zero’ are allowed. ‘Rounding’ rules are also provided: for example, when sodium is present at levels between 5 and 140 mg per serving, declarations are to be made in increments of 5 mg; above 140 mg per serving, an increment of 10 mg is specified [21 CFR §101.9(c), 9 CFR §§317.309(c) and 381.409(c)]. Percent daily values As noted earlier, for vitamins and minerals, so-called percent daily values (%DVs) are listed on the labels, but not the nutrient amounts by weight. Procedures for determining %DV are outlined below. Daily reference values (DRVs) For most basic nutrients, the regulations specify daily reference values (DRVs) based on a reference caloric intake of 2,000 calories. These are published for the purpose of calculating and then declaring %DV. • For a nutrient with an established DRV, the amount of that item in the product is divided by the applicable DRV and multiplied by 100; the result (i.e., the %DV) is expressed to the nearest whole percent.

Fig. 9.2 Alternative tabular and linear displays for nutrition facts.

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Fig. 9.3

‘Nutrition facts’ dual display (two forms of product).

• In a case where no DRV has been established (e.g., when declaring sugars), the %DV column is left blank. • A %DV is not required for protein unless the product label makes a claim about protein, or the product is intended for use by infants or children younger than four years old [21 CFR §101.9(c)(7)(i); 9 CFR §§317.309(c)(7)(i), 381.409(c)(7)(i)]. • The current DRVs are listed in Table 9.2 [21 CFR §101.9(c)(7)(i); 9 CFR §§317.309(c)(7)(i), 381.409(c)(7)(i)].

Reference daily intakes (RDIs) For vitamins and minerals, the FDA and FSIS have adopted reference daily intakes (RDIs) for the purpose of calculating percent daily values. Current RDIs are listed in

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155

Daily reference values (DRVs)

Nutrient

DRV

Fat Saturated fatty acids Cholesterol Total carbohydrate Fiber Sodium Potassium Protein

65 g 20 g 300 mg 300 g 25 g 2400 mg 3500 mg 50 g

These synonyms are allowed: vitamin C – ascorbic acid, thiamin – vitamin B1, riboflavin – vitamin B2, and folate – either folic acid or folacin. Regulatory references: 21 CFR §101.9(c)(9); 9 CFR §§317.309(c)(9), 381.409(c)(9)

Table 9.3. The listing indicates the order in which vitamins and minerals are to be declared on nutrition labeling (except on dietary supplements). As shown in Table 9.4, the regulations specify how values for vitamins and minerals should be rounded for presentation on labeling. Table 9.3

Reference daily intakes (RDIs) for vitamins and minerals

Substances required on labeling Vitamin A Vitamin C Calcium Iron

5,000 International units 60 mg 1,000 mg 18 mg

Required if added to the product, or if a claim is made Vitamin D Vitamin E Vitamin K Thiamin Riboflavin Niacin Vitamin B6 Folate Vitamin B12 Biotin Pantothenic acid Phosphorus Iodine Magnesium Zinc Selenium Copper Manganese Chromium Molybdenum Chloride

400 International units 30 International units 80 g 1.5 mg 1.7 mg 20 mg 2.0 mg 400 g 6 g 300 g 10 mg 1,000 mg 150 g 400 mg 15 mg 70 g 2.0 mg 2.0 mg 120 g 75 g 3,400 mg

Regulatory references: 21 CFR §101.9(c)(8); 9 CFR §§317.309(c)(8), 381.409(c)(8)

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Food labelling Table 9.4

Rounding rules for declaring vitamins and minerals

Level at which nutrient is present (% of RDI)

Declare % daily value to the nearest increment

50

0* 2 5 10

* Nutrients below 2% of RDI not required. Declare as zero, or state: ‘Contains less than 2 percent of the daily value of this (these) nutrient(s).’ Label declaration not required for vitamin A, vitamin C, calcium, or iron present below 2% of RDI: state: ‘Not a significant source of . . . . . . . . . . . . (omitted nutrients).’ Regulatory references: 21 CFR §101.9(c)(8)(iii); 9 CFR §§317.309(c)(8)(iii), 381.409(c)(8)(iii)

9.2.3 A footnote Finally, a footnote is required to explain that the labeled nutrient information is based on a 2,000 calorie diet. Below the list of vitamins and minerals, the following statement is required: ‘Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs.’ The footnote is accompanied by a dual listing of nutrient values, where the first column reflects a 2,000 calorie diet, and the other reflects 2,500 calorie levels.

9.3

Format requirements and exemptions: conventional foods

Unless a regulatory exemption is available, all food products must provide nutrition information consistent with the FDA and FSIS labeling rules. The typical format, illustrated in Fig. 9.1, was discussed earlier. Alternative formats are discussed below, followed by exemptions specifically allowed by the FDA or FSIS.

9.3.1 Alternative formats The ‘Nutrition Facts’ format does not always accommodate unusual package shapes and sizes, nor is it ideal for products containing insignificant amounts of key nutrients. FDA and FSIS allow alternative formats in these cases, as discussed below. Examples are shown in Figs 9.2 and 9.3. • Tabular display: where continuous vertical space is insufficient (see Fig. 9.2) [21 CFR 101.9(d)(11); 9 CFR §§317.309(d)(11), 381.409(d)(11)]. • Aggregate display: where a package contains individually packaged foods, intended for consumption separately, or the package is used interchangeably for similar products [21 CFR 101.9(d)(13); 9 CFR §§317.309(d)(13), 381.409(d)(13)]. • Dual display: where the labeling presents information for two forms of the food (e.g., as purchased vs. as prepared), combinations (e.g., dry and ‘with milk’), or different units, such as slices and grams (see Fig. 9.3) [21 CFR §101.9(b), (e), (h)(4); 9 CFR §§317.309(b), (c)(8), (e), 381.409(b), (c)(8), (e)]. • Simplified format: (1) where the food contains insignificant amounts of seven specified nutrients (for FDA-regulated products), or (2) when nutrients other than calories, total fat, sodium, total carbohydrate, and protein are present in insignificant amounts (for USDA-regulated products).

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Additional accommodations may be made for small packages. For instance, tiny packages may be exempted from labeling as long as an address or telephone number is provided. In addition, information may sometimes be placed on a different part of the label if space is insufficient [21 CFR 101.9(d)(11), 9 CFR §§317.309(d)(11), 381.409(d)(11)]. For larger packages, where the PDP and information panel still cannot accommodate the required information, an alternate panel that can readily be seen by consumers may be used. The space needed for vignettes and other non-mandatory information on the PDP may be considered in determining the sufficiency of available space, but non-mandatory text on the information panel will not be considered in determining this sufficiency [21 CFR §101.9(j)(17)].

9.3.2 Exemptions and exceptions In some cases, the regulations completely exempt a product from the labeling requirements; in others, exceptions are made to formatting requirements. Exemptions for single-ingredient, raw products are discussed later in this chapter. FDA exemptions Key exemptions provided by FDA in 21 CFR §101.9 are summarized in Table 9.5. Most of these are based on FDA’s interpretation of the NLEA, which, among other things, provides a small-business exemption for products sold by firms with annual food sales below $50,000. Table 9.5

Overview of FDA’s labeling exemptions*

Foods without significant nutrients • Contain insignificant amounts of all components required on labeling (e.g., coffee beans, food colors) [(j)(4)] Special foods • Infant formula labeled under 21 CFR Part 107 [(j)(7)] • Medical foods as defined in the Orphan Drug Act [(j)(8)(i)–(v)] Small Business • Products sold to customers with annual sales below $500,000, or food sales below $50,000 [(j)(1)(i)] • Low-volume products sold by a firm with fewer than 100 employees, and for which annual US sales are below 100,000 units [(j)(18)] Products not sold to consumers • Shipped in bulk, intended for use in manufacturing other foods, or processed off-site [(j)(9)] Products consumed in retail establishments • Food served in restaurants, not served to the consumer in the package in which received [(j)(2)(i)–(v)] • Food sold to consumers, but not for immediate consumption, and processed in a retail establishment (e.g., independent bakery) [(j)(3)(i)–(v)] Small Packages • Packages with total available area less than 12 square inches. Must provide an address or telephone number for consumers. [(j)(13)(i)] *Regulatory references to 21 CFR §101.9 are shown in square brackets. Note: Exemptions are invalid if a product bears a nutrition or health claim, or provides other nutrition information on labeling or in advertising.

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Congress provided another exemption for ‘low-volume’ food products when it passed the NLEA Amendments of 1993. To qualify, the manufacturer must file an annual claim with the FDA; units sold and employee head-count must fall below specified thresholds. In 21 CFR §101.9(j)(18), the FDA formally specifies how to qualify for the exemption. In addition to the format alternatives discussed previously, FDA makes certain other exceptions in 21 CFR §101.9. These include labeling for: • Dietary supplements: Label according to 21 CFR §101.36. (See Section 9.4.) • Products for infants and children: Various exceptions apply; e.g., labels should not declare calories from fat [21 CFR §101.9(c)(1)(ii)–(iii), (c)(2)(i)–(iii), and (c)(3)(j)(5)(i)]. (See Table 9.5.) • Eggs: If a shell-egg carton lid conforms to the shape of the product, nutrition information may be presented beneath the lid, or in an insert visible when the carton is opened [21 CFR §101.9(j)(14)].

FSIS exemptions Meat and poultry product nutrition labeling exemptions provided by FSIS are summarized below, including a small-business exemption based on number of employees and production volume. However, these are invalid if the product label makes a nutrient content claim or health claim, or if nutrition information is included in any context on labeling or in advertising. (Regulatory references to 9 CFR §317.400 and §381.500 are shown in square brackets.) • Products not sold to consumers – Includes products intended for further processing, custom products, and export items [(a)(2)–(a)(6)]. • Small business – If a single-plant facility or multi-plant firm employing fewer than 500 people produces less than 100,000 pounds of a given product, the product is exempt from nutrition labeling (where ‘product’ is defined as a formulation, not including distinct flavors not significantly altering the nutritional profile, sold in any size package) [see (a)(1)–(7)]. • Retail items – Ready-to-eat products prepared and served at retail are usually exempt [(a)(7)]. • Children’s products – Products made specifically for children younger than two years must be labeled in accordance with §§317.400(c)(2) and 381.500(c)(2); the label should not declare calories from fat, stearic acid, or cholesterol [(c)(1)]. • Small packages – Small items may be exempt [(a)(4)]. Packages with available surface area less than 12 square inches are exempt if an address or telephone number is provided [(d)(1)–(2)].

Single-ingredient, raw products Special labeling policies apply to single-ingredient, raw products; compliance with the conventional rules would simply be impractical for many of these products. The NLEA requires that the FDA administer a voluntary program for labeling raw fruits, vegetables, and fish. These items are exempt from mandatory nutrition labeling as long as retailers participate in the FDA’s program. FSIS has also established voluntary guidelines for labeling single-ingredient, raw meat or poultry items [see 9 CFR §§317.300 and 381.400]. Under the voluntary programs, nutrition information may be provided at the point of purchase, rather than on packages, by posting a sign, providing brochures, or through some other means (e.g. posters). The information must appear in close proximity to product displays.

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The agencies have outlined guidelines for labeling single-ingredient, raw fruits, vegetables, fish, meat products, and poultry products [21 CFR §101.45 and 9 CFR §§317.345, 381.445]. • The nutrition information should conform to the formats applicable under the mandatory programs. • Information for fruits and vegetables must be based on the raw, edible portion; data on fish are to be provided on an as-cooked basis, using no breading or seasonings. The FDA has published specific values for producing nutrition information on these products [see 21 CFR Part 101, Appendices C and D]. • For meat and poultry products regulated by FSIS, the nutrition information may be given on either an as-consumed or an as-packaged basis.

As long as the agencies determine that the activities of retailers and producers represent ‘significant participation’ in this program, single-ingredient, raw products are exempt from mandatory nutrition labeling. Both the FDA and FSIS conduct biannual surveys of retail establishments to assess the level of conformance with the guidelines. ‘Substantial compliance’ means that at least 60% of the food retailers sampled in a given survey are providing nutrition information satisfying the voluntary guidelines; thus far, government surveys have confirmed substantial compliance. Additional considerations • Prior label approval by FSIS – Traditionally, FSIS has required that it approve label designs before they are used. However, minor revisions often qualify for so-called generically approved labeling. This streamlined approval may apply only if the product makes no claims pertaining to quality, nutrients, or geographical origin. • Restaurants – Products prepared and/or served in restaurants and other retail establishments, or in institutions, often qualify for exemptions or special formatting requirements. The FDA has published regulations specifically concerning restaurant foods in §101.10.

9.4

Dietary supplement labeling

While the FDA was developing its new nutrition labeling program, many questions arose concerning how the rules should apply to dietary supplements of vitamins, minerals, herbs, and other substances. These products fall somewhere between traditional foods and medical drugs; some policies on food labeling simply did not accommodate the special characteristics of dietary supplements.

9.4.1 DSHEA Everything changed during October 1994, when Congress enacted the Dietary Supplement Health and Education Act (DSHEA). Among other things, the new legislation defined ‘dietary supplements’, provided flexibility in labeling these products, and allowed statements characterizing the level of ingredients for which no RDI or DRV has been established. The FDA responded by publishing a new set of regulations governing package labeling for supplement products. The agency distinguishes between ‘dietary supplements’ and ‘conventional foods’, regardless of the physical form of a product. The FDA

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no longer prohibits supplement manufacturers from giving prominence to a product ingredient that is not a vitamin or mineral. The agency’s provisions in 21 CFR §101.36 specify procedures for: label format [paragraphs (b)–(e)]; listing nutrients by weight, whether or not an RDI or DRV has been established for the dietary ingredient in question [(b)(2)–(3)]; labeling proprietary blends [(b)(4)]; alternative means of compliance [(f)]; and small-business exemptions and other exceptions [(h)(1)].

9.4.2 Supplement facts The FDA’s regulatory requirements follow the basic concepts for nutrition labeling of conventional food products, but the labels instead present ‘Supplement Facts.’ Some sample labels are shown in Figs 9.4–9.6: • Servings – Serving sizes are declared, but the serving size is expressed using a term appropriate for the product in question (e.g., capsule, teaspoonful). ‘Servings per container’ are also declared. • Declarations — In 21 CFR §101.36(b)(2), the FDA lists 14 ingredients that must be listed on supplement labels; these consist of calories, fats, carbohydrates, fiber, sugars, protein, vitamins, sodium, calcium, and iron. If these are present at ‘zero’ levels, (e.g., for vitamins and minerals, below 2% of the RDI), they do not have to be declared. Certain other ingredients must be declared if claims are made about them, as with labeling for conventional foods. • Sources – The source of an ingredient may be identified by its common name [e.g., ‘calcium (as calcium carbonate)’]. • Insufficient space – Some exceptions to type-size and other formatting requirements apply to small packages and to packages with high numbers of declared ingredients. • Small business – The FDA exempts small businesses with total annual sales below $500,000, or annual food sales below $50,000. No nutrition information, health claims, or nutrient content claims may be made on product labels or in advertising.

Fig. 9.4

Typical ‘supplement facts’ label.

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Weights and daily values If a product contains one or more vitamins or minerals for which FDA has established a daily value, the amounts (by weight) must be listed according to the order specified in §101.36(b)(2)(B). For these substances, the percent daily value (%DV) must be declared. • The %DV is calculated by dividing the amount of each §101.36(b)(2)-dietary ingredient by the RDI and multiplying by 100; numbers are given to the nearest whole percent. However, if the ingredient is present at an amount significant enough to be listed on the label, although the rounded, nearest whole %DV equals zero, the label should state ‘Less than 1%’ or ‘ 50 grams as prepared), and a reduced caloric claim requires it to be 25% lower than a reference value of a product in the same category. The ‘free of’ claim is one that is confusing to consumers because the product may not be entirely free of ‘x’. An example is a commercial ‘fat free’ butter substitute that has these words on the front label, whereas the Nutrition Facts statement shows it contains approximately 0.5 g of fat which is the allowed upper limit for a fat free claim and that it has five calories from fat [21 CFR 101.60(b)(1)(i)]. For specific nutrient claims, such as ‘an excellent source of vitamin C’, 21 CFR 101.62 requires the product to have at least 20% of the RDI or DRV whereas when claiming the product as a good source, there must be between 10% and 19% of the value. The regulations also have preclusions that disallow the use of a content claim for one nutrient when other nutrients present in the food would make the product have less of a health benefit. For example, one can claim a lite sodium product only if the sodium reduction is > 50% and the fat content is less than 3 g per serving (21 CFR 101.56). Importantly, the FDA revoked many standards of identity (formulas) for foods, including those for most dairy products, based on petitions from both industry and consumer organizations, such that terms like ‘skim’ now are consistent with the new labeling practices, that is, lower fat milk now has to provide the percentage fat content on the front label panel. USDA’s final rules governing nutrition labeling of meat and poultry products (now 9 CFR part 317, 320 and 381), states that FSIS’s nutrition labeling final regulations for meat and poultry products as authorized by the Federal Meat Inspection Act, the Wholesome Meat Act and the Poultry Products Inspection Act, will parallel to the extent possible, the FDA’s nutrition labeling regulations promulgated under the Nutrition Labeling and Education Act. Consequently, USDA labeling in the marketplace is almost identical to FDA-labeled products. USDA’s regulations provide for ‘voluntary nutrition labeling on single-ingredient, raw meat and poultry products and by establishing mandatory nutrition labeling for all other meat and poultry products, with certain exceptions’. USDA accepted most of the FDA’s nutrient-content claim definitions but had a problem with lipids, simply because meat and poultry by nature contribute significantly to lipid intake. USDA therefore emphasized additional adjectival descriptors such as ‘lean’ and ‘extra lean’. For example, 9 CFR 317.362 states, ‘The term ‘‘lean’’ may be used on the label or in labeling of a meat product, provided that the product contains less than 10 g fat, less than 4 g saturated fat and less than 95 mg cholesterol per

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100 g and per Reference Amount Customarily Consumed (RACC) for individual foods, and per 100 g and labeled serving size for meat-type products’ (21 CFR 317 sec. 313 et seq.). It should be noted that the FDA also has ‘lean’ claims [21 CFR 101.62 (e)(2)] for meal products or main dish products (such as a frozen dinner) which requires less than 10 g total fat, less than 4 g saturated fat and less than 95 mg of cholesterol in a serving. Extra lean claims require less than 5 g total fat, less than 2 g saturated fat and less than 95 mg cholesterol in a serving.

11.3

Disease-specific claims or disease-prevention claims

Up until 1993, FDA regulations [21 CFR 101.9(I)(1)] prevented any food label from bearing a disease-specific/disease-prevention or health-related claim. If it did, the FDA considered the product to be a drug, defined as any article which ‘is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals’ [FFDCA Section 201(g)]. Thus in the case mentioned earlier, NutriLab, Inc. v. Schweiker, the government seized a NutriLab product, a starch blocker, because it was intended to affect the structure/function of the body in the prevention of a disease, obesity. On 6 January 1993 and after numerous amendments, the FDA’s final rules for diseasespecific/disease-prevention claims were issued (21 CFR 101.14; 58 FR 44036; 18 August 1993, 59 FR 24232; 10 May 1994, 62 FR 15390; 1 May 1997). Under these rules one may petition the FDA to issue a regulation to approve a ‘health claim’, but the FDA will issue such a regulation only when it determines, based on the totality of publicly available scientific evidence, including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles, that there is significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence, that is, that there is a national health risk and that the ingredient has been shown scientifically to reduce that risk [21 CFR 101.14(b)]. In addition to this very high standard of scientific proof that the FDA will require to issue such a regulation, an approved ‘health claim’ may be used in labeling for any product that meets the conditions set forth in the regulation, not just the petitioner’s product.9,10 It should be noted that in 63 FR 14349 (25 April 1998) the FDA revised the food labeling definition of healthy to permit processed fruits and vegetables and standardized enriched cereal grain products (to which iron, thiamin, niacin and riboflavin have been added, in the appropriate levels) that conform to bear this term. Note that since this chapter was written a soy claim was added. The model health claims which appear in 21 CFR 101.71 et seq. are as follows. 1. Calcium and osteoporosis ‘Regular exercise and a healthy diet with enough calcium helps teen and young adult white and Asian women maintain good bone health and may reduce their high risk of osteoporosis later in life’ (21 CFR 101.72; 58 FR 2665; 6 January 1993). In order to make the claim on the label the food must satisfy the following specific nutritional standards: • The food must be ‘high’ in calcium. • The calcium must be assimilable. • Dietary supplements must meet United States Pharmacopeia (USP) standards for disintegration and dissolution, or if no USP standard applies, appropriate assimilability under the conditions of use must be stated on the product label.

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• The food or supplement must not contain more phosphorus than calcium on a weight per weight basis.

2. Dietary lipids and cancer ‘Development of cancer depends on many factors. A diet low in total fat may reduce the risk of some cancers’ (21 CFR 101.73; 58 FR 2787; 6 January 1993). In order to make the claim on the label the food must satisfy the following specific nutritional standards: • The food must meet the requirements for a ‘low fat’ food. • Fish and game meat may meet the requirements for ‘extra lean’ instead of ‘low fat’.

3. Sodium and hypertension: ‘Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors’ (21 CFR 101.74; 58 FR 2820; 6 January 1993). In order to make the claim on the label the food must satisfy the following specific nutritional standard: • The food shall meet the requirements of a ‘low sodium’ food.

4. Dietary saturated fat and cholesterol and risk of coronary heart disease ‘Development of heart disease depends upon many factors, but its risk may be reduced by diets low in saturated fat and cholesterol and healthy lifestyles’ (21 CFR 101.75; 58 FR 2739; 6 January 1993). In order to make the claim on the label the food must satisfy the following specific nutritional standards: • The food must meet the requirements for a ‘low saturated fat’, ‘low cholesterol’, and ‘low fat’ food. • Fish and game meat may meet the requirements for ‘extra lean’ instead of ‘low fat’ food.

5. Fiber-containing grain products, fruits and vegetables and cancer ‘Low fat diets rich in fiber-containing grain products, fruits and vegetable may reduce the risk of some types of cancer, a disease associated with many factors’ (21 CFR 101.76; 58 FR 2537; 6 Janaury 1993). In order to make the claim on the label the food must satisfy the following specific nutritional standards: • The food must meet the requirements for a ‘low fat’ food. • The food must meet the requirements for a ‘good source’ of dietary fiber without fortification. • The food must be, or contain, a grain product, fruit or vegetable.

6. Fruits, vegetables and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease ‘Diets low in saturated fat and cholesterol and rich in fruits, vegetables and grain products that contain some types of dietary fiber, particularly soluble fiber, may reduce the risk of heart disease, a disease associated with many factors’ (21 CFR 101.77; 58 FR 2552; 6 January 1993). In order to make the claim on the label the food must satisfy the following specific nutritional standards: • The food must meet the requirements for a ‘low saturated fat’, ‘low cholesterol’, and ‘low fat’ food.

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• The food must contain at least 0.6 g soluble fiber per reference amount customarily consumed without fortification. The content of soluble fiber must be declared on the nutrition information panel. • The food must be or contain a grain product, fruit or vegetable.

7. Fruits and vegetables and cancer ‘Low fat diets rich in fruits and vegetables (foods that are low in fat and may contain dietary fiber, vitamin A and vitamin C) may reduce the risk of some types of cancer, a disease associated with many factors. Broccoli is high in vitamins A and C and it is a good source of dietary fiber’ (21 CFR 101.78; 58 FR 2552; 6 January 1993). In order to make the claim on the label the food must satisfy the following specific nutritional standards: • The food must meet the requirements of a ‘low fat’ food. • The food must qualify as a ‘good source’ of vitamin A, vitamin C or dietary fiber without fortification. • The food must be or contain a fruit or vegetable.

8. Folate and neural tube defects ‘Healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord birth defect’ (21 CFR 101.79; 61 FR 8752; 15 April 1996). In order to make the claim on the label the food must satisfy the following specific nutritional standards: • The food shall meet or exceed the requirements for a ‘good source’ of folate (i.e., provides 10 to 19% of the daily value per reference amount of food). • Dietary supplements shall meet the United States Pharmacopeia (USP) standards for disintegration and dissolution, except that if there are no applicable USP standards, the folate in the dietary supplements shall be shown to be bioavailable under the conditions of use stated on the product label. • The food shall not contain more than 100% of the RDI for vitamin A as retinol or preformed vitamin A and vitamin D per serving or per unit.

9. Dietary sugar alcohol and dental caries For packages with total surface area available for labeling of less than 15 square inches: ‘Useful only in not promoting tooth decay’. For packages with total surface area available for labeling of 15 or more square inches: ‘Frequent between meal consumption of foods high in sugars and starches promotes tooth decay. The sugar alcohols in (name of food) do not promote tooth decay’ (21 CFR 101.80; 61 FR 43433). It should be noted that sugar free (sorbitol) chewing gum manufacturers had been using the claim ‘Does not promote tooth decay’ for almost 30 years with no interference from the FDA. The promulgation of this claim thus gave regulatory credence to this practice. In order to make the claim on the label the food must satisfy the following specific nutritional standards: • The sugar alcohol in the food must be xylitol, sorbitol, mannitol, maltitol, isomalt, lactitol, hydrogenated starch hydrolysates, hydrogenated glucose syrups, erythritol or a combination of these. • The food must contain less than 0.5 g of sugar per reference amount customarily consumed and per labeled serving.

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• The sugar-alcohol containing food must not lower plaque pH below 5.7 by bacterial fermentation either during consumption or up to 30 minutes after consumption as measured by in vivo tests.

10. Soluble fiber from certain foods and risk of coronary heart disease ‘Diets low in saturated fat and cholesterol that include soluble fiber from (name of whole oat or psyllium source and if, desired, the name of the food product) may reduce the risk of heart disease’ (21 CFR 101.81; 61 FR 296; 4 January 1996, 62 FR 15343; 31 March 1997, 63 FR 8103; 18 February 1998).10 It should be noted that with respect to soluble fiber, 21 CFR 101.17 warns that the label should state that the consumer should consume adequate quantities of water if the fiber source is from psyllium. One should also note that the oat health claim was promulgated first and when the psyllium claim was finalized, the two were combined, thus in effect there are actually 11 promulgated final health claim regulations found in the Federal Register. In order to make the claim on the label the food must satisfy the following specific nutritional standards: • The food product must contain one or more of the whole oat foods: oat bran, rolled oats or whole oat flour, and the whole oat foods shall contain at least 0.75 g of soluble fiber per reference amount customarily consumed of the food product; or psyllium husk (as defined in the regulations), and the pysllium food shall contain at least 1.7 g of soluble fiber per reference amount customarily consumed of the food product. • The amount of soluble fiber must be declared in the nutrition label. • The food must meet the requirements for a ‘low saturated fat’, ‘low cholesterol’, or ‘low fat’ food.

11.

Soy protein and risk of coronary heart disease (see below)

None of the above health claims can be made under 21 CFR 101.14(a)(5) if the product contains:  13 g of total fat,  4 g of saturated fat,  60 mg of cholesterol or  480 mg of sodium, per reference amount customarily consumed and per labeled serving size. For meal-type products, similar claims can be made but the above restrictions are  26 g of total fat,  8 g of saturated fat,  120 mg of cholesterol and  960 mg of sodium per labeled serving. For main dish products, these levels are  19.5 g fat,  6 g saturated fat,  90 mg cholesterol, or  720 mg sodium per labeled serving. It should be noted that the CFR for each claim contains all the FR notice references. For those interested in the scientific basis used to establish each claim they should obtain these FR notices. Very importantly, the FDA also issued the so called ‘jelly bean’ rule [21 CFR 101.14(e)(6)] precluding adding an ingredient to a food so as to be able to make a health claim, if the original food contains less than 10% of the RDI or DRV for vitamins A and C, iron, calcium, protein, or dietary fiber before supplementing. The FDA has suggested this requirement is problematic and could be modified in the future to allow claims for some vitamin-fortified foods. This rule does not apply to dietary supplements. Finally in 21 CFR 101.71, the FDA has stated specifically that since there was no significant scientific agreement there can be no claims made (yet) for dietary fiber and cancer (58 FR 53296; 1993), dietary fiber and cardiovascular disease (58 FR 53298; 1993), antioxidants and cancer (58 FR 53302; 1993), zinc and immune function and omega 3-fatty acid and cardiovascular disease (58 FR 53304; 1993). Because the timetable was vague as to the time period in which the FDA had to publish a final regulation on any health claim once it was first published, the dietary

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supplement industry sued (Nutritional Health Alliance v. Shalala, 953 F.Supp. 526; S.D. N. Y. 1997). This forced the FDA to promulgate 62 FR 12579, 17 March 1997) and 62 FR 28230, 22 February 1997) in which they agreed to a 270-day time period between initial FR proposal and final regulation with two possible 90-day extensions. Furthermore, several courts overturned parts of 21 CFR 101.71 dealing with the above ban on claims for dietary fiber and colorectal cancer [21 CFR 101.71(c)], the antioxidant vitamins and cancer, omega-3 fatty acids and coronary heart disease [21 CFR 101.71(e)] and a claim in [21 CFR 101.79(c)(a)(i)(g)] regarding a statement that the effectiveness of a specified amount of folate per serving from one particular source for reducing risk of neural tube defects was better than another source (61 FR 8752, 8760; 1996; Pearson and Shaw v. Shalala, 164 F.3d 650; DC Cir. 1999; National Council for Improved Health v. Shalala, 122 F.3d 878; 10th Cir. 1997; Nutritional Health Alliance v. Shalala, 144 F.3d 220, 2d Cir. 1998; Circuit 98-5043; US Appl. Lexis 464). The legal overturning of the regulations was directed towards dietary supplements but it appears it may also apply to conventional foods. The Court said that fears that claims would be misleading could be addressed effectively through disclaimers, rather than through suppression of the claim. Thus, the Courts in these cases found that both foods and dietary supplements could carry a disclaimer if a health claim is made. Allowing the ‘disclaimer’ along with the health claim would therefore result in non-violation of the First Amendment, permiting commercial free speech. The agency was directed to reconsider these health claims and provide guidance on what information is needed to meet the ‘significant scientific agreement’ standard for approval of health claims, as to not do so would be in violation of the First Amendment related to commercial free speech (59 FR 395, 405, 422–23; 1994). Thus the Courts said to the FDA that the disclaimer could carry the burden as to the level of scientific support for the claim as opposed to against the claim. The Court was concerned, however, that this could lead to consumer confusion. The Court also reiterated that if the FDA denied a claim, it would be subject to review by the Court. In addition, in any earlier case (Pearson v. Shalala, 14 F.Supp 2d.10 D.C. 1998), the issue of improper procedures with respect to promulgation of the regulations under the APA were raised, but the Courts felt that the time line to get approval was appropriate. Other instances in which part of these regulations were challenged include (1) National Council for Improved Health v. Shalala (122 F.3d 878; 884–85; 10th Cir. 1997) in which the case against the government was thrown out on the basis that there was no particular injury to the parties; and (2) Nutritional Health Alliance v. Shalala (144 F.3d 220, 225–227; 953 F.Supp. 526 (S.D.N.Y.); 1997 2nd Cir. 1998 cert. denied; U.S.L.W. 3113–3122, 7 December 1998] in which the case was thrown out on the basis of it being unripe for adjudication since the challengers did not try to go through the normal regulatory proposal procedure even though that could take up to 540 days as noted above. For a good review of the implication of commercial free speech on dietary supplement claims see Sidale (1993).11 These cases thus support the principle that one can have appropriate health claims and structure/function claims on both conventional foods and dietary supplements, if they qualify. Structure function claims require a different type of wording but must also be truthful and not misleading and will be discussed later in this chapter. Note that in a Federal Trade Commission (FTC) action on advertising (American Home Products Corp. v. FTC, 695 F. 2d 681, 684, 696–702; 3d Cir. 1983) the FTC required the advertiser of an unsubstantiated claim to have a disclaimer that said the claim was open to substantial question. Since 10 November 1999 (63 FR 62977) the FDA has also allowed a health claim about the role soy protein may have in reducing the risk of coronary heart disease (CHD) on the

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labels and labeling of food containing soy protein. This proposal is based on the agency’s determination that soy protein, as part of a diet low in saturated fat and cholesterol, may reduce the risk of CHD. In proposing this health claim, the FDA concluded that foods containing protein from the soybean as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease by lowering blood total cholesterol and LDLcholesterol. The amino acid content in soy protein is different from that of animal protein and most other vegetable proteins, and appears to alter the synthesis and metabolism of cholesterol in the liver. Because soy protein occurs in or can be added to a wide variety of foods and beverages, it is possible to eat soy protein-containing products as many as four times a day (three meals and a snack), according to the FDA. Studies show 25 g of soy protein per day have a cholesterol lowering effect. Therefore, for a food to qualify for the health claim, each serving of the food must contain at least 6.25 g of soy protein, or one quarter of the 25 g amount shown to have a cholesterol lowering effect. This claim is different from the structure function claim of ‘Benefits cholesterol’ on BenecolÕ, a margarine like product now being marketed as a conventional food in the United States. Since 1995 BenecolÕhas been sold in Finland and targeted to those patients with cardiovascular disease. Clinical research demonstrated that regular use of the product in place of butter or other margarines will reduce LDL cholesterol. BenecolÕ is a canola oilbased margarine that includes sitostanol ester (1.5 g per serving), an esterified alcohol derived from pine oil, a by-product of the wood pulp industry. Its mode of action is through the inhibition of cholesterol absorption in the gastrointestinal tract. It was allowed for introduction into the US market as a food after some objections by the US FDA which were satisfied by having the manufacturer self declare the sitostanol ester as Generally Recognized As Safe (GRAS). Additionally, another margarine-product containing plant sterols, called ‘Take ControlTM’, was allowed to be marketed as a conventional food as of May 1999 in the US. In this case, Unilever (through T.J. Lipton) also used the self declaration allowance to deem a soy lipid sterol as a GRAS substance so it could be added to foods. Both of these products carry structure function claims, ‘Benefits cholesterol’ or ‘Helps maintains healthy cholesterol levels’. A further interesting point relating to claims arose on 5 February 1999 when the Bureau of Alcohol Tobacco and Firearms (BATF) approved statements for wine labels that referred to health effects of wine consumption. The statements were amended versions of those submitted over three years ago by the Coalition for Truth and Balance, an ad hoc group of 12 US wineries. Use of the labels is voluntary. The two BATF approved statements are: ‘The proud people who made this wine encourage you to consult your family doctor about the health effects of wine consumption’ and ‘To learn the health effects of wine consumption, send for the Federal Government’s Dietary Guidelines for Americans, Center for Nutrition Policy and Promotion, USDA, 1120 20th Street, NW, Washington DC 20036 or visit its website’. As noted in their press release from BATF, under existing law, BATF can only deny labeling statements, if they are false or misleading and since these were not and more importantly they were not direct health claims, the statements were allowed after they had done a survey on wine drinkers. BATF does not intend to go through the FR public notice process for this action. They will, however, seek federal legislation to strengthen their authority over alcoholic beverages. According to the definition in the FFDCA, drink is food and thus should be regulated by the FDA. However, since BATF already has inspectors in alcoholic beverage manufacturing facilities and the presence of alcohol inhibits pathogenic growth, the FDA began in 1938 to defer all authority to them, although the FDA could still seize

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adulterated product. In 1974 the FDA asked BATF to issue ingredient labeling requirements for alcoholic beverages. Since they refused, the FDA terminated their memorandum of understanding with BATF in 1975 (40 FR 54536) and were going to pursue such practice. The alcoholic beverage industry sued to prevent this (Brown Forman Distillers v. Mathews, 436 F.Supp 5, 1976; Brown Forman Distillers v. Califono, DC West KY, 1979) and won the action to prevent the FDA from doing so. In 1980 BATF did propose labeling requirements (46 FR 40538) but withdrew the proposal in 1982 (48 FR 11884) after significant objection by the liquor industry. On 25 May 1994 (59 FR 27144) the Food Safety and Inspection Service (FSIS) of the USDA announced a proposed rule on, ‘Nutrition Labeling; Health Claims on Meat and Poultry Products’. The rule proposed to amend the Federal meat and poultry products inspection regulations by proposing requirements for permitting the use of health claims on the labeling of meat and poultry products that characterize the relationship of a substance (food or food component) to a disease or health-related condition. The rule also proposed regulations establishing a labeling application process for such health claims. On 22 April 1998 (63 FR 19852) FSIS decided to withdraw the proposal announcing it had become obselete because of changes made by the FDA in its original final rule and in its subsequent rule-making on health claims. FSIS intends to propose a more comprehensive document on health claims regulations for meat and poultry products that will parallel those regulations issued by the FDA for other foods. It appears that most consumers find the new labels easier to understand, but considerable concern about label accuracy remains. In many cases, consumers are downright suspicious of health or other claims, particularly because of the plethora of often-conflicting health claims they are subjected to in the media based on analysis of research studies showing opposing effects of various foods, ingredients or nutrients, e.g. the positive or negative value of drinking coffee. Many believe that the label information is at the discretion of the manufacturer and that such information is not strictly regulated by the FDA. At best, one can reasonably conclude that implementation of the NLEA has been only a modest success in terms of education, in spite of the enormous efforts devoted to its implementation.12 In some regards, the FDA has been a bit overzealous in implementing the wording in the labeling for disease-specific claims. For example, consider the regulation for calcium and osteoporosis. Most manufacturers would simply like to claim that ‘calcium helps prevent osteoporosis’, when their food product contains a reasonable amount of calcium. However, the FDA regulation provides several model label statements that they anticipate should be used. One such model for foods exceptionally high in calcium and that can be used for most calcium supplements states: ‘Regular exercise and a healthy diet with enough calcium helps teen and young adult white and Asian women maintain good bone health and may reduce their high rate of osteoporosis later in life. Adequate calcium intake is important, but daily intakes above about 2,000 mg are not likely to provide any additional benefit’. Given the limited space on food labels, the statement is too long. In addition it ignores the large population of African-American women who also might benefit from use of calcium and an Asia-American group objected to it on the basis it discriminated against Asian women. Thus, there are not a lot of disease-specific claims being made in the marketplace at present. For the most part, the American public seems nutritionally illiterate, and they will remain so until our schools make nutritional education an integral part of health and science education. The food label does not substitute for such education although it can be used as a means in the process. This brings up another interesting twist in the US legal

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system as was noted earlier. Since about the 1950s, the government seized food products if pamphlets, flyers, books, etc., were in close proximity to the product and such material contained disease-related claims specific to the product. The US targeted this mainly on supplement products (for example US v. Kordel, 335–345; 69 S.Ct. 106; 1948; US v. Kordel, 397 US 1; 90 S.Ct. 763; 1970). Since the last case mentioned, the FDA has had little action in this area although it remains as a sword of Damocles on promotional material in close proximity to the product when held for sale. This promotional material was also considered in DSHEA as will be seen.

11.4

FDA Modernization Act of 1997

The Food and Drug Administration Modernization Act (FDAMA) amended the FFDCA to ‘allow an alternative procedure for a nutrient content claim or a health claim that is the subject of a published authoritative statement by a scientific body of the United States Government with official responsibility for public health protection or research directly relating to human nutrition (such as the National Institutes of Health or the Centers for Disease Control and Prevention) or the National Academy of Sciences.’ The person who wants to use the claim must give the FDA at least 120 days prior notice, including the exact claim to be used, a copy of the authoritative statement and a balanced representation of the scientific literature related to the claim. The FDAMA authorized the FDA to exercise its discretion to allow use of the new nutrient content claim at the time that the FDA publishes the FR proposal to permit use of the claim for public comment. This authority could also be used to remove an existing claim at the proposal stage. With regard to this new method for health claims, the claim must be stated in a manner such that the claim is an accurate representation of the authoritative statement, and in a manner that the claim enables the public to comprehend the information provided in the claim and to understand the relative significance of such information in the context of a total daily diet. The FDA published the regulations pursuant to this as a guidance document in 63 FR 32102, 11 June 1998). This document is available in the Compliance Policy Guides Manual (CPGM). Because of concern by Congress about these rules, the FDA published a proposed regulation for this process on 21 January 1999 (64 FR 3250) which would comprise 21 CFR 101.90. The health claim may be made only if the food does not contain a nutrient in an amount which increases the risk to persons in the general population and/or the risk of a disease or health-related condition which is diet-related, taking into account the significance of the food in the total daily diet. In addition, the health claim may not be false or misleading in any particular, which includes a prohibition on failure to reveal facts that are ‘material in the light of’ the claim. The FDA will continue to be the final arbiter about whether such a health claim may be made because the claim may be made only until, either (a) the FDA issues a regulation prohibiting or modifying the claim or finding that the requirements to make the claim have not been met, or (b) a District Court of the United States finds, in an enforcement proceeding, that the requirements to make the claim have not been met. In addition, the FDA has the authority to make a proposed health claim regulation effective immediately upon the date of publication of the proposal.4,13 Finally, FDAMA revised the requirement for referral statements. Previously referral statements such as ‘see side panel for nutrition information’ on the front panel of a food label were made whenever a disease prevention claim or a nutrient descriptor claim was

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made for a food. Under FDAMA this will no longer be true. Such a referral statement will be required only if the FDA makes a determination that the food contains a nutrient at a level that increases the risk of disease. This provision will significantly reduce label clutter, and significantly increase the incentive for useful nutrition information in labeling.

11.5

Medical foods

One type of food product which may bear a ‘disease claim’ is the medical food. A medical food is defined as a food that is specially formulated for the feeding of a patient who has a special medically-determined nutrient requirement, the dietary management of which cannot be achieved by the modification of the normal diet alone, and the food is labeled to be used under the supervision of a physician or under medical supervision (Orphan Drug Act 1988 (Pub. L. 100-290)). The medical food’s label and labeling may bear information about its usefulness for the dietary management of a disease or medial condition for which distinctive nutritional requirements, based on recognized scientific principles are established by medical evaluation [21 CFR 101.9(j)(8)].1,14–16 A food is subject to this exemption only if: • it is a specially formulated and processed product (as opposed to a naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding by tube; • it is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically-determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone; • it provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation; • it is intended to be used under medical supervision; and • it is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instruction on the use of the medical food [21 CFR 101.9(j)(8)].

If a food qualifies as a medical food, it is exempt from the pre-approval requirements that otherwise generally apply for FDA approval of health claims and nutrient content claims used in labeling. It is also not a drug even though it is used in the management of a disease (e.g., low phenylalanine products for those with phenylketonuria disease). A company that is responsible for a medical food must possess data that are sufficient to show that no claim made on the label or in other labeling is either false or misleading in any particular manner. However, there is no requirement to notify the FDA that one is manufacturing or marketing a medical food or to obtain FDA approval or even notify the FDA with respect to the use of medical food labeling claims. A medical food is not authorized to bear a claim to cure, mitigate, treat or prevent a disease such a claim would create drug status for the product. Instead, a medical food is permitted to make a claim to address a patients’ special dietary needs that exist because of a disease. This type of claim is distinguished from a claim to treat the disease. The distinction should be kept in mind in developing any labeling claims for a medical food.1,15

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Typical medical food products include foods useful in the treatment of: • • • • •

genetic disorders (e.g., phenylketonuria, celiac disease, maple syrup urine disease) stress conditions (e.g., surgery, chemotherapy, radiation therapy, burns) cancer and HIV/AIDS patients neurological disorders (e.g., Alzheimer’s Disease) gastrointestinal disorders (e.g., Crohn’s disease, ulcerative colitis)

11.6

Dietary Supplement Health and Education Act of 1994

Beginning in the early 1950s, the FDA became increasingly concerned about what they felt were illegal label and formulation claims on vitamin and mineral products. In 1973, they promulgated an especially threatening regulation to the dietary supplement industry which resulted in a strong Congressional lobby effort to change the law (38 FR 2143, 2152, 19 January 1973 and 38 FR 20708; 38 FR 20730, 2 September 1973). In addition, the industry had several portions of the regulations overturned in court, dealing with limits or levels of addition of ingredients (National Nutritional Foods Association v. FDA, 504 F.2d 761, 2d Cir 1974 and National Nutritional Foods Association v. Kennedy, 572 F.2d 377; 2d Cir. 1978). Because of this the FDA was forced to withdraw ‘all’ of the above regulations (44 FR 16005, 16 March 1979). Congress also acted, upon the urging of Senator Proxmire of Wisconsin, by passing the Vitamin-Mineral Amendment of 1976 which prohibited the FDA from imposing any limits on the level of safe vitamins and minerals in dietary supplements, from classifying them as drugs, and from limiting any combination thereof. This very hard hand slapping forced the issue and the FDA discontinued pursuing dietary supplement manufacturers. However, when NLEA was passed, the FDA again began to stake their claim on these products. The FDA published several regulations suggesting that NLEA applied (58 FR 33700, 18 June 1993; 58 FR 53296, 14 October 1993; 59 FR 395, 4 January 1994). During the period between 1992 and 1994, there was again extensive pressure on Congress by the industry to amend NLEA and the FFDCA to preclude any FDA action on dietary supplements which included vitamins, mineral, specific metabolic compounds and herbal supplements. On 7 October 1992, Congress passed an amendment to the FFDCA (Dietary Supplement Act 1992, Pub. L. 102–571; 106 Stat. 4491, 4500) to create a moratorium which inhibited the FDA from applying NLEA requirements on dietary supplements. Following passage of this Act, until passage of the Dietary Supplement Health and Education Act of 1994, many US Senators and House of Representatives claimed to be receiving more mail, more phone calls, and generally more constituent pressure on this subject than on anything else, including health care reform, abortion or the budget deficit.17 Not surprisingly, given all this pressure, Congress eventually passed the Dietary Supplement Health and Education Act (DSHEA) of 1994 (Pub. L. 102–571). The House of Representatives approved the measure by unanimous consent on 7 October 1994 and the Senate approved it, also by unanimous consent on 8 October 1994. The President signed it into law on 25 October 1994.16 The FDA has published 25 FR notices pursuant to this law, some of which have been finalized as regulations. The new law, like virtually all legislation and the regulations pursuant to it (62 FR 49826; 62FR 49883; 62 FR 41886; 49859; 63 FR 23633) is a compromise. It does not include all of the restraints on FDA regulation of dietary supplements that the sponsors

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had originally wanted. Furthermore, it imposes some significantly new requirements for such products. Nevertheless, viewed as a whole, this legislation is a very favorable development for those who want to sell or consume a free range of dietary supplements including vitamins, minerals, herbs, other botanicals, amino acids and other similar dietary substances as mentioned earlier. The latter could be any compound in any metabolic pathway. Dietary supplements are now defined by Sec. 201(ff) of the FFDCA as amended by the DSHEA, as products intended to be ingested in the form of a tablet, capsule, powder, softgel, gelcap or liquid droplet (or, if not in such form, are not represented for use as a conventional food or as a sole item of a meal or the diet) and which contains one or more of the following dietary ingredients: a vitamin, mineral, herb or other botanical, amino acid or other dietary substance for use to supplement the diet by increasing the total dietary intake, including a concentrate, metabolite, constituent, extract, or combination of any of the above.3 Thus under Section 3(c) of DSHEA, a food containing an added supplemental ingredient, can be sold as a dietary supplement as long as it does not claim to be a food and does state on the front panel that it is a dietary supplement. This thus supersedes the 1976 Vitamin Mineral Amendment which disallowed a food from the category [Section 411(c)(3) of the FFDCA]. To further distinguish the product as a dietary supplement, nutrition labeling with the panel shown in Figure 11.1 was deleted, but a new type of panel was required called ‘Supplement Facts’, an example of which is shown in Figure 11.2. Thus a chicken soup-like product with added echinacea can be sold as a dietary supplement if it states on the front panel of the label ‘a hot liquid preparation with echinacea’ suggesting that it is not a food but rather an item to supplement the diet and the front panel also has the required words ‘Dietary Supplement’. It should also be noted that the FDA additionally promulgated several definitions in 62 FR 49868 23 September 1997) including descriptors such as ‘high potency’ and the definitions for ‘high in antioxidants’, claims that might be used on the front principal display panel.

Fig. 11.2 An example of a ‘Supplement Facts’ panel.

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While an unapproved health claim is generally not permitted on the label or other labeling of a food (including a dietary supplement) unless the claim meets the FDA approved health claims or FDAMA4 requirements previously discussed, for dietary supplement products only, there is an exception that permits four types of statements of nutritional support to be made on the label or in other labeling. These statements of nutritional support are as follows: 1. 2. 3. 4.

a statement that claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States; a statement that describes the role of a nutrient or dietary ingredient intended to affect the structure or function of the body in humans; a statement that characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function; and a statement that describes general well-being from consumption of a nutrient or dietary ingredient.3,17,18

Any of the above four types of statements of nutritional support may be made in labeling for a dietary supplement without the approval of a health claim regulation under 21 CFR 101.71, if the manufacturer has substantiation that such statement is truthful and not misleading. In addition the labeling must carry a prominent disclaimer which states that: ‘This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.’ The manufacturer must notify the FDA no later than 30 days after the first marketing of the dietary supplement with a structure/function statement that such a statement is being made.3,16 Of further importance, FFDCA, Section 403(B) et seq. made it clear that the FDA should not use the Kordel decision mentioned earlier to prevent separate published material from being sold. This new section thus allows publications to be in close proximity, but physically separated from the product. It also requires that such printed material should present a balanced view of the available scientific literature on the dietary supplement. The publication also cannot promote a particular manufacturer or brand of a dietary supplement and this cannot be subverted by applying a sticker to the publication or on the product. Most importantly Section 403(B)(c) puts the burden on the FDA to establish proof that the material is false or misleading. The new claims allowed for dietary supplements are generally referred to as ‘structure/ function’ claims. More than 3800 statements of nutritional support have now been filed with the FDA by companies that have told the agency that they are using such a statement in labeling. The FDA has responded to a few hundred, through a ‘courtesy letter’, in those instances where the agency believes that the claims were improper ‘disease’ claims. The firm is told either to drop the claim or to contact the FDA Drug Center for more information. Obviously in these cases the FDA feels the claims make the product a drug, and thus it is illegal since the product has not gone through the drug approval process and thus the product is both adulterated and misbranded. To provide guidance to industry, in April 1998, the FDA proposed a rule stating criteria to determine when a structure/function claim for a dietary supplement constitutes an impermissible disease claim (63 FR 23624).19 The proposal generated more the 100,000 comments from manufacturers, trade associations, health care professional, consumers, Congress and other federal, state and local governmental agencies. The overwhelming majority of the respondents were highly critical of the proposal. The proposed rule first expands FDA’s definition of disease to be: ‘any deviation from, impairment of, or interruption of the normal structure or function of any part, organ or

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system (or combination thereof) of the body that is manifested by a characteristic set of one or more signs or symptoms, including laboratory or clinical measurement that are characteristic of a disease’. The FDA states in the preamble that the laboratory or clinical measurements that are characteristic of a disease include elevated cholesterol fraction, uric acid, blood sugar and glycosylated hemoglobin and that characteristic signs of disease include elevated blood pressure or intraocular pressure. The agency then proposed ten criteria for identifying disease claims that would be impermissible for a dietary supplement unless the products were to comply with drug requirements or with an applicable health claim regulation. Note that these were finalized in 65 FR999-1050.20 1. Claimed effect on a specific disease or class of diseases The FDA’s examples of such claims (disease claims) include: protection against the development of cancer; reduces the pain and stiffness associated with arthritis; decreases the effect of alcohol intoxication; alleviates constipation. Claims that the FDA acknowledges would not be disease claims include: helps promote urinary tract health; helps maintain cardiovascular function and a healthy circulatory system; helps maintain intestinal flora; promotes relaxation. 2. Claimed effect on signs or symptoms The second type of disease claim identified by the FDA is a claim of an effect on signs or symptoms (presenting symptoms) that are recognizable to the health care professional or consumers as being characteristic of a specific disease or of a number of different specific diseases. Examples of these claims are: improves urine flow in men over 50 years old; lowers cholesterol; reduces joint pain; relieves headache. Examples of claims that the FDA acknowledges are not disease claims because the signs or symptoms are not by themselves sufficient to characterize a specific disease or diseases include reduces stress and frustration; improves absentmindedness. The FDA also states that if the context did not suggest treatment or prevention of a disease, a claim that a substance helps maintain normal function would not ordinarily be a disease claim. The agency gives as examples of these appropriate claims: helps maintain a healthy cholesterol level that is already within the normal range; helps maintain regularity. However, the agency was concerned that the only reason for maintaining normal function is to prevent a specific disease or diseases associated with abnormal function. 3. Claimed effect on a consequence of a natural state that presents a characteristic set of signs or symptoms These are claims about certain natural states (pregnancy, aging, menstrual cycle) that are not diseases but are sometimes associated with abnormalities that are characterized by a specific set of signs or symptoms that are recognizable to health care professionals or consumers as constituting an abnormality of the body. The FDA gives as examples of these abnormalities: toxemia of pregnancy; premenstrual syndrome; abnormalities associated with aging such as presbyopia; decreased sexual function; Alzheimer’s disease; or hot flushes. Examples of claims that the FDA acknowledges would not be disease claims are, for example, for men over 50 years old; to meet nutritional needs during pregnancy. 4. Claimed effect on disease through name of products, claims about ingredients in product, citation of publication, use of disease term, illustrations Examples of names of products that the FDA feels would constitute a disease claim include Carpaltum (carpal tunnel syndrome); Raynaudin (Raynaud’s phenomenon);

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Hepatacure (liver problems). Names that the FDA states do not imply an effect on disease include: Cardiohealth and Heart Tabs. A claim that a dietary supplement contains an ingredient that has been regulated primarily by the FDA as a drug and is well known to consumers for its use in preventing or treating a disease (e.g. aspirin, digoxin and laetrile) would be a disease claim. Citing a title of a publication or other reference, if the title refers to a disease use, would be a disease claim. Pictures, vignettes, symbols or other illustrations that suggest an effect on disease are also said by the FDA to be disease claims. The FDA gives the following as examples: electrocardiogram tracings; pictures of organs that suggest prevention or treatment of a disease state; the prescription symbol (Rx); or any reference to prescription use. 5. Claims that products belong to a class of products intended to diagnose, mitigate, treat, cure or prevent disease This category includes identifying a product as antibiotic, antimicrobial laxative, antiseptic, analgesic, antidepressant, antiviral, vaccine or diuretic. In contrast, the FDA states that acceptable identifiers would be: rejuvenative; revitalizer; adaptogen. 6. Claim that product is substitute for therapy product These include claims that a product has the same effect as that of a recognized drug or disease therapy, for example, Herbal Prozac. Prozac is an approved prescription drug used for depression. 7. Claim that product augments a particular therapy or drug action These are claims that a product should be used as an adjunct to a recognized drug or disease therapy in the treatment of disease. For example, a claim for use as part of your diet when taking insulin to help maintain a healthy blood sugar level. 8. Claim that product has a role in body’s response to disease or to a vector of disease These are claims that a product augments the body’s own disease-fighting capabilities. Examples include: supports the body’s antiviral capabilities; supports the body’s ability to resist infection. This category also includes claims that a product is intended to affect the body’s ability to kill or neutralize pathogenic microorganisms, or to mitigate the consequences of the action of pathogenic microorganisms on the body (i.e. the signs and symptoms of infection). In contrast, the FDA states that an example of an acceptable claim in this area would be ‘supports the immune system’. 9. Claimed effect on adverse events associated with disease therapy These are claims that a product treats, prevents or mitigates adverse events that are associated with a medical therapy or procedure and manifested by a characteristic set of signs or symptoms. Examples of these disease claims identified by the FDA are: reduces nausea associated with chemotherapy; helps avoid diarrhea associated with antibiotic use; to aid patients with reduced or compromised immune function such as patients undergoing chemotherapy. On the other hand the FDA acknowledges that ‘helps maintain healthy intestinal flora’ would be an acceptable claim for a dietary supplement. Such a claim can be found on quite a number of fermented dairy based dietary supplements which contain bifidobacteria.

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10. ‘Catch- all’ provision The FDA states that any claim that otherwise suggests an effect on a disease or diseases is also a disease claim. Note that the final rules appear in 21 CFR 101.93. One month after the publication of the above proposed regulation on structure/function claims (20 May 1999) the FDA issued a notice to Pharmanex Inc. (Siam Valley, CA) that their dietary supplement product, Cholestin, was a drug and therefore misbranded. At that time, the product label stated that it could reduce both total cholesterol and LDL cholesterol by 10%. Cholestin is a fermented red yeast rice product that was imported from China where it was used to both color foods and in Traditional Chinese Medicine (TCM). The yeast fermentation produces a compound, mevinolin, exactly the same compound as a drug called MevacorÕ (lovastatin). This was manufactured by Merck and approved in 1987 to inhibit cholesterol synthesis in the liver and thereby reduce cholesterol levels in the blood. In 1998, the FDA asked the Bureau of Customs to prevent (blocklist) the major ingredient at all ports of entry into the US, thus preventing Pharmanex from getting their raw material to manufacture their dietary supplement. Subsequently Pharmanex sued the United States (Pharmanex v. Shalala, case 2:97 CV 0262K DC Utah) to overturn that decision. On 16 February 1999 the DC agreed and overturned the FDA decision, declaring that Cholestin is a dietary supplement on the basis that ‘DSHEA, 21 USC Section 321(ff)(3)(B)(I) declares that a dietary supplement does not include . . . an article that is approved as a new drug under Section 355 . . . which was not before such approval . . . marketed as a dietary supplement or as a food’. Thus the Courts ruled that this section only applies to new drugs and Cholestin is a dietary supplement which was used as such in China before passage of DSHEA. What this says is that a dietary supplement may contain a substance with drug-like activity, but if that substance was being used or marketed as a supplement by one party prior to DSHEA, the fact that it was also marketed as a drug by another party prior to that time does not make the supplement a drug. This case followed the standard set by Fmali Herb, Inc. v. Heckler (715 F.2d 1383; DCNC, 15 September 1983). Before Fmali, the FDA held that foods, herbs, and botanicals not consumed in the US before passage of the 1958 Food Additives Amendment were either unapproved food additives or, if not such, then the company introducing it had to either get a GRAS declaration or go through the food additive process. In 1973, the FDA thus prevented a sassafras herb tea from being marketed because it contained safrole, an unapproved food additive that was a carcinogen (US v. Select Natural Herb Tea, Civ #73-1370 RF; D.C. Cal; 15 July 1973). The Fmali case essentially overturned the block-list the FDA instituted on a Korean herb (renshrenfenwang-jiang) on the basis that the Food Additives Amendment did not apply only to the US, that is, if a product was consumed safely somewhere in the world before 1958, it can be imported into the US. It should also be noted that the FDA instituted a new self affirmation process for GRAS declaration (62 FR 18938; 17 April 1997) which has not been finalized. Thus some new, never before used, herb would have to be declared GRAS before its use in food or it could be more easily introduced as a new dietary ingredient under DSHEA, as will be mentioned below. Note that the FDA intends to appeal the Pharmanex decision to the Circuit Court. This certainly makes the decision of what is a drug versus a dietary supplement in the US market very confusing and in limbo. As a final note to this section, the current laws and regulations and their interpretation has created a watershed for new products. It is not clear from DSHEA or the relevant

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regulations what data the product must have in order to substantiate the claim on the label [21 CFR 101.9(c)]. The current feeling is that claims are being made based on single research articles or fairly uncontrolled in-house clinical studies, perhaps returning us to the climate of the 1950s. In addition, under DSHEA a manufacturer of a dietary supplement may use any ingredient in the product as long as they notify the FDA 75 days before its use (62 FR 49886 now in 21 CFR 190.6). Moreover, these ingredients are exempted from the GRAS or the food additive definition, including the Delaney Clause (Section 409(c)(3)(a) which in itself prevents use of potential carcinogens as ingredients [Section 201(s)(6)]. Furthermore, DSHEA requires that the burden of proof on safety exist with the FDA [see Section 402(f)(1)(D)]; i.e. the manufacturers are not required to prove safety before introduction into the marketplace. Thus, ingredients that are not approved for use as a food additive (see Section 409 of the FFDCA) can be added to a dietary supplement as long as the manufacturer has some data in their files as to its safety and toxicity. For example, the compound stevioside, a sweetener extracted from the leaves of chrysanthemum species, although petitioned for, has not been approved for use in foods, but is now found in several dietary supplements in the US market. Thus based on the Fmali case, the leaves of the stevia plant could be imported and used in a dietary supplement, but using the effective compound in a purified form (stevioside) would be illegal since the compound has neither GRAS or an approved food additive status unless petitioned for (e.g. the soy oil sterol mentioned earlier). It is also likely that stevioside could be declared as a new dietary supplement ingredient under 21 CFR 190.6 and be used in supplements.

11.7

Controversy over labeling

There is some controversy, as mentioned earlier, over whether the labeling of a food other than a dietary supplement may include a structure/function claim. The FDCA recognized that a food may be intended to affect the structure or any function of the body. Accordingly, it has long been felt that a food may make a label claim or other labeling representation about its dietary impact on the structure or function of the human body, provided that the particular claim used does not also suggest that the food will cure, mitigate, treat, or prevent disease (which would give it drug status) and provide further that the claim does not trigger some other requirement for FDA pre-clearance. In practice, the FDA generally has tolerated a few claims of this type over the years, without asserting that the claim creates drug status or is a health claim. For example, claims that calcium helps build strong bones, protein helps build strong muscles and bread builds strong bodies in 12 ways have been made in food labeling and have been tolerated by the FDA as appropriate claims about the impact of a food on the structure or function of the body. As noted before, the same was true about certain sorbitol containing chewing gums that claimed ‘does not promote tooth decay’. This latter claim was legitimized when the FDA allowed this as one of the ten approved health claims. To make the situation even more confusing, on 7 December 1998 the US Supreme Court declined to review a US 2nd Circuit Court of Appeals decision on the FDA prohibition of the ‘health claims’ on dietary supplements (Nutritional Health Alliance v. Shalala, 953 F.Supp 526; S.D.N.Y.; 1997). The Court basically upheld the practice that although such a claim is within the Constitutional allowance of commercial free speech, if the FDA felt there was not significant scientific agreement of the benefit, for a product in particular, then they can deny the use of the claim.

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In principle, these structure/function claims can be extended to other truthful and nonmisleading statements. For example, it would appear to be potentially defensible to claim that a substance in a food helps maintain a normal, healthy cardiovascular system without triggering either drug status or requirements for approval of a health claim. However, there is some uncertainty about how far this type of structure/function claim can be pushed before the FDA will assert either drug status or an unapproved health claim status. A preamble statement on the FDA’s final labeling rules on dietary supplements, in the Federal Register of 23 September 1997 (62 FR 49860) stated: FDA points out that the claim that cranberry juice cocktail prevents the reoccurrence of urinary tract infections is a claim that brings the product within the ‘drug’ definition whether it appears on a conventional food or on a dietary supplement because it is a claim that the product will prevent disease. However, a claim that cranberry products help to maintain urinary tract health may be permissible on both cranberry products in conventional food form and dietary supplement form if it is truthful, not misleading and derives from the nutritional value of cranberries. If the claim derives from the nutritive value of cranberries, the claim would describe an effect of a food on the structure or function of the body and thus fall under one exception to the definition for the term drug. The claim is not a health claim because no disease is mentioned explicitly or implicitly.20 The FDA’s statements in this regard may not be entirely consistent with governing law, regulations or the Court’s varied interpretations. There is at least some basis for concluding that a food can have other uses, as acknowledged by the courts with respect to prunes and coffee in Nutrilab v. Schweiker. The major food trade associations are in favor of an interpretation that would treat conventional food in the same regulatory manner as dietary supplements in this respect. This then brings up the vision that the grocery store will eventually supplant the medical care system and the pharmacy.

11.8

Advertising and the Federal Trade Commission (FTC)

Information and claims about a food in the print or electronic media is considered to be advertising, while information on the food label is labeling. This was resolved in 1938 by the Wheeler-Lea Act (52 Stat 111) and reaffirmed in 1966 with the Fair Packaging and Labeling Act (Pub. L. 89–755; 80 Stat 1296) which excluded food labeling from being considered advertising. The prior sections covered the laws and regulations with respect to labeling which is under the aegis of misbranding under the FFDCA or the Wholesome Meat Act. Advertising is covered under the Federal Trade Commission Act (15 USC 52– 56) passed in 1914 and amended many times. The Act created a stand alone commission, the FTC, to deal with unfair and deceptive practices in advertising, thus control of advertising goes beyond mere ‘truth’; it also includes ‘unfairness’. There are no requirements for pre-clearance of advertising claims by the FTC. Instead, the FTC maintains that an advertiser should be in possession of a reasonable basis of substantiation for an advertising claim from the time that the claim is first made. (No allowance to claim now and then substantiate later.) Under its current policies and practices, the FTC would assert that an advertiser should be in possession of competent and reliable scientific evidence to substantiate a claim of health-related benefit. Competent and reliable scientific evidence means tests, analyses, research studies, or

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other evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results. This is exactly the question the Courts made in several of the FDA cases discussed earlier, i.e. what level of science constitutes substantiation? The FTC maintains that an advertiser should possess substantiation for all objective claims that it makes, whether explicit or implicit. The FTC sometimes alleges that an objective claim has been made implicitly and should have been substantiated, although the surprised advertiser does not believe that the alleged claim was made at all.21–23 Insofar as a company repeats in advertising particular claims that are appropriate under the FDA’s rules for use in labeling, the company is likely to be in compliance with the FTC’s standards for advertising. In particular, the FTC has stated that it would not likely question the use in advertising of a health claim or a nutrient content claim covered by an FDA regulation.24 In addition, if a company has sufficient data to substantiate other types of health-related claims for FDA purposes, the data are likely to satisfy the FTC. Occasionally, it may be possible to include in advertising a claim that is not necessarily appropriate for use in labeling. For example, a company may have sufficient data to substantiate a health claim but the claim has not been approved by the FDA for use in labeling. Because there are no requirements for FTC pre-clearance of health claims used in advertising, the company could use the claim in advertising if the claim can be adequately substantiated. The FTC has recently published a guidance document for industry with respect to advertising dietary supplements, which reaffirm the above principles.25 One key difference in FTC actions is the cease and desist principle [FTC Act Section 6(f)]. In a rather complicated process, if the FTC finds fault with a company and the company agrees to this fault, the company can agree to cease and desist from using the same advertisement in the future. This action and acceptance then becomes no admission of guilt. FTC cease and desist decisions are published in the Federal Register. Several interesting cases include: FTC vs ITT Continental Baking (36 FR 18521; 1971) for advertising of a thin-sliced bread useful for weight reduction; FTC vs TJ Lipton (38 FR 18366; 1973) for advertising of gelatin as nutritious; and more recently FTC vs Body Gold (62 FR 11201; 11 March 1997) for advertising of a dietary supplement based on chromium for weight loss.

11.9

The future

Although the complex set of US laws may seem unduly restrictive, there is clearly a trend towards allowing more information to be available to the consumer, on some basis of substantiation. As the demand from the consumer rises and is recognized by the US Congress, the FDA will undoubtedly have to adapt its regulatory policies to accommodate unique foods. The market will only then continue to increase in dollar value and size.

11.10

Further reading

For additional reading on interpretation of the Food Drug and Cosmetic Act that relates to health claims and dietary supplements see:

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203

Hutt PB and Hutt II, PB, ‘A history of government regulation of adulteration and misbranding of food’. Food Drug Cosmetic Law Journal 39(2): 1–73, 1984. Hutt PB, ‘Government regulation of health claims in food labeling and advertising’. Food Drug Cosmetic Law Journal 41(3): 52–63, 1986. Hutt PB and Merrill RA, Food and Drug Law: Cases and Materials, 2nd edition, Mineola Press, New York, 1991.

11.11

References

1. US Congress. 100th Congress. Orphan Drug Amendments of 1988. Pub. L. 100-290. Amendment of Section 526(a)(1) of the Federal Food, Drug and Cosmetic Act, 21 USC 360bb(ax1). Library of Congress, Washington, DC, 1988. 2. US Congress. 101st Congress. Nutrition Labeling and Education Act of 1990. Pub. L. 101-535. Amendment of Section 403 of the Federal Food, Drug and Cosmetic Act, 21 USC 343. Library of Congress, Washington, DC, 1990. 3. US Congress. 103rd Congress. Dietary Supplement Health and Education Act of 1994. Pub. L. 103-417. 108 Stat/4325-4335, Library of Congress, Washington, DC, 1994. 4. US Congress. 105th Congress. Food and Drug Administration Modernization Act of 1997. Pub. L. 105115. 111 Stat. 2296, Library of Congress, Washington, DC, 1997. 5. FDA. ‘Food labeling regulations implementing the Nutrition Labeling and Education Act of 1990, final rule, opportunity for comments.’ Fed Register 58 2066–2963, 1993. 6. FDA. ‘Food labeling; mandatory status of nutrition labeling and nutrient content revisions; format for nutrition label.’ Fed Register 58 2079, 1993. 7. FDA. ‘Food labeling; establishment of date of application.’ Fed Register 58 2070, 1993. 8. FDA. ‘Food labeling; serving sizes. Final rule.’ Fed Register 58 2070, 1993. 9. FDA. ‘Labeling: General requirements for health claims for food. Proposed rule’. Fed. Reg. 56:6053760689, 1991. 10. FDA. ‘Authorized Health Claims.’ 21 Code of Federal Regulations, 1999, Part 101.72(e)–101.81. 11. Sidale M, ‘Dietary supplements and commercial free speech’. Food and Drug Law Journal 48: 441–455, 1993. 12. Owe S, ‘Functional foods: Consumers are ready, are we?’ Society for Nutrition Education symposium, Montreal, Quebec, 26 July 1997. 13. Hutt PB, ‘A guide to the FDA Modernization Act of 1997’. Food Technology, 52(5): 54, 1998. 14. Hattan DG and Mackey D, ‘A review of medical foods: Enterally administered formulations used in the treatment of disease and disorders’. Food Drug Cosmetic Law J. 44: 479–501, 1989. 15. Schmidl MK and Labuza TP, ‘Medical food. A scientific status summary by the Institute of Food Technologists Expert Panel on Food Safety and Nutrition’. Food Technology 46: 87–96, 1992. 16. Mueller C and Nestle M, ‘Regulation of Medical Foods: Toward a Rational Policy’. Nutrition in Clinical Practice 10: 8–15, 1995. 17. McNamara SH, ‘Dietary supplement legislation enhances opportunities to market nutraceutical-type products’. Journal of Nutraceuticals, Functional & Medical Foods, 1: 47–59, 1997. 18. Nesheim MC, ‘The regulation of dietary supplement’. Nutrition Today, 33(2) 62–68, 1998. 19. FDA. ‘Regulations on statements made for dietary supplements concerning the effect of the product on the structure or function of the body; proposed rule and dietary supplements: Comments on report of the commission on dietary supplement labels’. Fed. Reg. 63:23624-23632,1998. 20. FDA. ‘Regulations on statements made for dietary supplements concerning the effect of the product on the structure or function of the body; final rules’. 65 Fed. Reg. 999, 2000. 21. FDA. ‘Food labeling regulation, amendments; food regulation uniform compliance date; and new dietary ingredient premarket notification; final rules’. Fed. Reg. 62: 49826-49868,1997. 22. Federal Trade Commission Act. Part 5, 12, 1984. 23. Consolidated Book Publishers Inc., v. Federal Trade Commission, 53 F.2d 942, cert. denied, 286 US. 553, 1931. 24. FTC. ‘Food advertising enforcement policy statement’. 59 Fed. Reg. 28388, 1994. 25. FTC. ‘Business guide for dietary supplement industry released by FTC staff’. FTC File No. 974506, Washington, DC, 1998.

12 Special issues in food labelling

12.1 Good design in food labelling E. J. Whiteley, Institute of Grocery Distribution, Watford 12.1.1 Introduction Good design is achieved by considering every aspect of the product and how it satisfies the users of that product. With regard to illustrating labelling information there are two basic requirements. First, that the information is appropriate to the user, and second that it is easy to read. This section specifically considers ways in which to improve the presentation of information on food and grocery packaging to ensure it is legible. There is increasing competition for limited space. There are conflicting challenges, new labelling legislation, retailing trends, changing demographics and consumer demands all require more label information, both statutory and voluntary in a finite space. To consider these challenges and address the needs of consumers, the Institute of Grocery Distribution (IGD) a research and education body drawing membership from the total UK grocery supply chain, established a working group in 1994. The working group consisted of technical experts from the food and grocery industry and representatives from consumer groups, as well as from Moorfields Eye Hospital, The Royal National Institute for the Blind and Age Concern. The IGD working group developed guidelines1 to improve the legibility of labels. The guidelines were developed with the UK in mind, but the design principles outlined are of general application. This section is adapted from, and mainly based on, those guidelines.

12.1.2 The challenge The diversity of products in the marketplace, the complex interaction of legibility factors, the legislative framework, changing demographics and the physical constraints of pack sizes means that there is no perfect formula to improve legibility. This section summarises the challenges facing industry in achieving good design examining two areas: legal requirements and demographics.

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Legal requirements The legislative food labelling requirements in the EU and its Member States are extensive and complex and involve displaying a considerable amount of information in a way that is easy to understand, legible and not liable to mislead. Moreover, there are layout constraints: the legally required matter must not in any way be hidden, obstructed or interrupted by other written or pictorial matter, and the product name, durability indication, storage instructions and quantity declaration must appear in the same field of vision. The EU requirements are to be found in a number of EU Directives. Reference should be made to Chapter 2 for details of these. For the US labelling requirements, reference should be made to Chapter 3. In addition to legally required information, the following major trends have given rise to the need for still more information to be displayed on labels: • move to self service (the pack must illustrate the products’ benefits to the customer rather than the shop keeper) • food safety (statutory guarantees of product safety, date marking, source, storage and cooking instructions) • dramatic expansion of the types of products on offer (products sourced from overseas and new products requiring special preparations, storage information) • multinational characteristics of suppliers and markets (information to be displayed in a variety of languages) • consumer concerns (organic, healthy, more environmentally friendly, genetic modification, etc., the packaging must inform customers) • allergens as a food safety issue (label warning of their presence) • environment (packaging minimisation) • technological developments (bar codes are now fundamental to the efficient operating of the supply chain) • economic climate (special offers, competitions to be displayed on pack) • new cooking methods (increased ownership of microwaves requiring cooking instructions to be displayed on pack) • household size decreasing (smaller pack sizes) • increased demand for convenience (ingredients, nutrition and preparation implications).

Thus a myriad of statutory and voluntary information must be displayed effectively on packs. The competition for space is challenging. This section contains guidelines on managing the presentation of on-pack information so as to optimise legibility and intelligibility. Demographics Predictions by the Office of Population Censuses and Surveys (OPCS) indicate that over the next five decades there will be an explosion in the numbers of people aged over 60 in the UK. The increase in numbers of elderly people is an opportunity for business development. In recognising the needs of this important sector of the population two main facts should be understood: 1.

A significant proportion of these consumers will be affluent and control greater spending power than is traditionally recognised in this age group. Social, demographic and economic changes have created an empowered, large and important market force.

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The older one becomes, the greater the probability of experiencing deterioration of eyesight, hearing or experiencing some form of arthritis. All three of these ailments gradually affect one’s ability to carry out comfortably everyday tasks. However, they do not affect one’s desire to be independent and able to carry out everyday tasks encountering minimal difficulties.

The Royal National Institute for the Blind estimate that there are 970,000 people in the UK whose vision is such that they could be registered blind or partially sighted, 90% of whom are over the age of 60. Visual deterioration is intrinsically linked with the ageing process. The total number of people requiring glasses in the UK is estimated to be 26 million with a further 1.8 million people wearing contact lenses.2 Industry should aim to improve the situation for these consumers by enhancing the legibility of labels. By improving legibility, potentially 45% of the population could benefit. This is by no means a minority issue. Thus, demographic factors add to, and will increasingly add to, the importance of improving legibility of label information.

12.1.3 Improving legibility The visually impaired are not an homogeneous group of people and there is in existence a multitude of eye defects, each impinging on different legibility functions. To complicate things further, legibility of print is dependent on a number of technical factors, all of which interact closely, such as print size, colour, contrast, typography and layout. To provide a clearer approach to improving legibility, each design factor is discussed separately. If information is meant to be read it is essential to make the appropriate selection of layout, design, typography and print features. Label designers should follow the principles given in this chapter and test the final designs on consumers. Print size Legibility is not dependent solely on type size; however, it is recognised as the largest contributor to legibility. Medical specialists recommend a print size of 16–18 point. Clearly this is impractical for packaging where, on a finite surface, a great deal of information must be displayed. • A minimum of 6 point is recommended: this is the recommended minimum point size • A minimum of 12 point is recommended for warnings and food safety information:

Do not drink It is acknowledged that some packs are physically too small to accommodate even a 6 point size. In such cases other factors that influence legibility (i.e. choice of colour, type font and layout) must be addressed more critically. Type font There are thousands of type fonts available and each has a different relationship with type size. Choice of specific fonts is a matter for the individual designer, but the following principles should be observed: • Use sans serif fonts for text less than 6pt size. Fancy types by their nature can compromise legibility (Fig. 12.1). They should be used for main feature type only where the size can support their use. • Select a print colour that clearly contrasts with the background.

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Fig. 12.1 Type fonts.

Colour and contrast Colour selection is somewhat subjective and is already a complex procedure when used to promote a brand image. Choice of specific colours is a matter for the individual designer, but the following principles should be observed: • Avoid using reflective surfaces where print size is small as they reflect light making print difficult to read. • Ensure that a clear contrast in colour between background and type is achieved. • White on a dark background (reversed type) is preferable as the eye responds to light. However in cases where the surface area available restricts the size of print to less than 12 point do not use reversed type unless you can achieve an excellent print resolution. • Dark print on a light background is effective. • Avoid using shades of red and green together; some people are red/green colour blind: for example, 12% of the male population in the UK have a genetically determined colour vision problem. • Strong colours work better than pastel shades for rapid identification. The ability to differentiate between things that contrast poorly with their background deteriorates with age. Subtle contrasts are the enemy of legibility. • Avoid shadowing the text. This can cause difficulties for people with visual defects.

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Layout All text presentation should take into account the print size, colour and typeface principles given above and also consider the following points. • Long lines across the whole pack length should be avoided as long lines of small text are difficult to read. The optimal range to be comfortably read is 50 characters. Long lines can be avoided through the use of boxes of text. • Hyphens detract from legibility. • Lines of text too close together can deter effective backtracking of text by the reader; spacing between lines of text improves legibility. • Right justification of text impinges on legibility and should be avoided. • Boxes, bullet points and colour differentiation can aid legibility of text. • The selective use of bold and italic typeface can enhance legibility. Careful selection of typeface, type size, and colour must be considered before using italics and bold, which, when used on some typefaces, can be very difficult to read. • A mixture of upper and lower case is easier to read than a panel of all upper case because people get their reading cues from the peaks and troughs of the letters. • Sub-sectioning within boxes of text can improve clarity if the space is available.

Overall pack layout Different consumers find different pieces of information important when making their product choice and to complicate the situation further it is likely that the priority of information changes for different types of product. Therefore, it is difficult to prioritise the importance of different sections of on-pack information, and impossible to agree a standard template across industry. To enable customers to locate the information in which they are particularly interested, the different sections of information should be easily identifiable. This is best achieved by boxing specific data and using brief, legible headings (see Fig. 12.2). The box position, shape and size should then be planned into the total surface area determined by what buyers, marketers and manufacturers see as priority customer information for the particular product.

Fig. 12.2 Overall pack layout.

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The box areas should be coloured contrasting to the background colour of the pack. This ensures they stand our as units of information. The best practice is to use a contrasting or lightened version of the main pack colour for each box. The ideal selection is black print on a white background. Selection should be made dependent on the total design aesthetics; however, the importance of colour contrast cannot be overstated. The use of clear headings within the box assists consumers with locating the information that is of importance to them. Legibility of box headings is improved by keeping them short and sub-boxing can be effective if space is available. This practice ensures that even if space is restricted and type face has to be small the customer can quickly and more easily locate the information they specifically require without having to scan all the information on the pack. Within the box the best selection of type colour, type size, typeface and layout must be achieved for the surface area available. Preparation instructions Diagrams are a useful form of illustrating preparation information (see Fig. 12.3). Simple icons are very helpful to visually impaired people, particularly if they are in general use and have clear outlines. Many fail because they attempt to do too much. Cooking times should be displayed beneath the illustration with text placed to the right for more detailed instruction. All this should be arranged clearly in a box. Date marking The date mark on products is the piece of information most sought after by consumers. The date code tends to be applied by on-line systems and often legibility can be compromised by this method of application. Companies should review the quality of date marks on their product portfolio and adopt the following principles: • • • •

clear contrast of print and background is achieved black print on a white background is effective print size should be a minimum of 12 point where a batch code is also applied, ensure that a separation of both pieces of information is achieved.

Fig. 12.3 The use of diagrams in preparation instructions.

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12.1.4 Summary The increasing competition for space makes optimising the surface area of grocery packaging a design challenge. In addition, the changing demographics in the UK population place different requirements on UK industry. Improved legibility of labels is a key requirement of the ageing population. A working group consisting of industry experts and representatives from consumer organisations reviewed the situation in 1994 and developed practical recommendations to assist companies in addressing these challenges. The guidelines were developed with UK in mind, but the design principles are of general application. There are clear steps that can be taken to improve the legibility of pack information. Companies should ensure that appropriate selection of print size, font, colour and layout of information as detailed in this section are adopted, and also that they test new designs on consumers.

12.1.5 1. 2.

References

IGD, Packaging Legibility – Recommendations for Immediate Improvement, 1994. KeyNote Ophthalmic Goods and Services Eighth Edition 1993.

12.1.6

Further reading

British Food Journal, The Clarity of Food Labels, Vol 95 Number 8 1993. HMSO Food Advisory Committee Report on its Review of Food Labelling and Advertising 1990. HMSO Food Labelling Survey England & Wales 1990. IGD Packaging Openability Recommendations for Immediate Improvements 1993

12.2 Multi-language requirements Jean-Paul Kern, Mars Incorporated, McLean 12.2.1 Introduction The problem of accommodating legally-required information on a food package in more than one language is not new. Canada, with two official languages – French and English – has long required label information to be given in both. However, multi-language labelling has become a much wider problem in the European Community, where a food product may need to be marketed in the same packaging in several (or indeed, all) Member States. This entails accommodating a greatly increased amount of information in a finite amount of space. There is a clear conflict between the principle of free movement of goods within the European Community and consumer interests requiring that food products be labelled in the local language of the country of marketing. Even if applied indiscriminately to domestic and imported products, national language requirements are likely to create barriers to intraCommunity trade, entailing the additional labelling of products and thus, additional costs. This section looks at how the European Community has addressed the problem. EC food law is based on the principle of mutual recognition, under which any food lawfully manufactured and sold in one Member State must be admitted to the markets of all others. However, this principle is subject to harmonising legislation covering matters which are regulated as a matter of public policy. Language requirements for the labelling of food products are regulated in this way, in order to protect consumers. The basic Community legislation concerning foodstuffs to be delivered to the ultimate consumer is contained in the General Food Labelling Directive (Directive 79/112/EEC).

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The provision setting out language requirements was originally Article 14, which obliged Member States to prohibit the sale of foodstuffs in their territories unless either detailed compulsory particulars1 appear on products in a language easily understood by the purchaser, or other measures had been taken to ensure that the purchaser was informed. It was expressly provided that such particulars could be indicated in more than one language. On 27 January 1997, the European Parliament and Council adopted Directive 97/4/EC, which repeals the second paragraph of Article 14 of the General Food Labelling Directive, replacing it with a new Article 13a. The new Article 13a amends the Article 14 position in the following respects: • the language used must be easily understood by the ‘consumer’ (rather than the ‘purchaser’); • the possibility of informing the consumer by means of other measures, such as designs, symbols or pictograms, is limited to measures which have been officially approved at EC level; and • Member States may stipulate the language to be used for the compulsory particulars on the labels of products marketed in the territory. If they do so, they must choose between the 11 official Community languages.

Since 14 August 1998, Member States have been required to allow trade in products labelled in accordance with Article 13a, and from 14 February 2000 they are required to prohibit trade which does not conform with the amendment. In addition to the provisions set out in the General Food Labelling Directive, several other Directives also contain provisions setting out linguistic requirements for labelling (which are discussed further below). It should be noted that the scope of the Article 13a/ 14 linguistic requirements and those imposed by the above mentioned Directives is limited, insofar as they apply only to the labelling of foodstuffs intended for the ultimate consumer and concern only certain compulsory particulars. Since EC legislation does not fully harmonise the language requirements applicable to the labelling of food products, Member States are at liberty to impose additional language requirements, if they so wish. Such requirements must, however, comply with the EC Treaty rules on the free movement of goods. The European Court of Justice (ECJ) has reconfirmed that national language requirements are capable of constituting a barrier to intra-Community trade if, for example, they result in additional labelling costs.2 Article 28 of the EC Treaty (former Article 30) prohibits national rules which forbid or restrict the import of goods, unless the rules can be justified on one of the public policy grounds set out in Article 30 (former Article 36). They include health protection, public policy and public morality. The ECJ has also extended the grounds set out in Article 30 to include consumer protection and fair trade. Member States do not, however, have complete freedom to restrict trade simply on the basis that, for example, their national law is designed to protect consumers. The level of protection required must not be excessive or unreasonable and it must be necessary and proportionate to the objective pursued.3 Moreover, the language requirements must apply without distinction. They cannot be applied solely to imported products, so that products from the Member State concerned are at an advantage compared with products coming from other Member States.4 The application of Article 28 has been restricted considerably by the ECJ’s judgment in the Keck case.5 There the court decided that Article 28 does not apply to national restrictions concerning commercial activity generally, provided the rules are equally

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applicable to both domestic and imported products. However, the court specifically stated that national rules requiring a product to be labelled in a certain way do fall within the scope of Article 28.6

12.2.2 What must be translated? Article 13a/14 of the General Food Labelling Directive establishes linguistic requirements for labelling only in respect of the following compulsory particulars mentioned in Articles 3 and 4(2) of the General Food Labelling Directive: (1) (2) (3) (5) (4) (5) (6)

the name under which the product is sold; the list of ingredients; in the case of prepackaged foodstuffs, the net quantity; the quantity of certain ingredients;7 the ‘use-by’ date; any special storage conditions or conditions of use; the name or business name and address of the manufacturer or packager, or of a seller established within the Community;8 (7) particulars of the place of origin or provenance, if failure to give such particulars might mislead the consumer to a material degree in this respect; and (8) instructions for use, if it would be impossible to make appropriate use of the foodstuff without such instructions. Additional linguistic requirements are also required under the following Directives: • • • • • • • • • • • • • • •

Directive Directive Directive Directive Directive Directive 6(6)); Directive Directive Directive Directive Directive Directive Directive Directive Directive

76/118 on Dehydrated Milk (Article 7a (2)); 88/344 on Extraction Solvents (Article 7(4)); 83/417 on Lactoproteins (Caseins and Caseinates) (Article 4(2)); 88/388 on Flavourings (Article 9a (3)); 89/107 on the General Framework for Additives (Article 10); 89/109 on Materials in and Articles in Contact with Foodstuffs (Article 90/496 on Nutritional Labelling (Article 7(2)); 91/321/EEC (Article 7) on Infant Formulae; 94/54/EC (Article 1) on Packaging Gases; 96/5/EC (Article 7) on Baby Foods; 96/8/EC (Article 5) on Foods for Energy-restricted Diets; 96/21/EC (Article 1) on Sugars and Sweeteners; 1139/98 (Article 2(3)) on the Labelling of GMOs; 1999/2/EC (Article 6) on Food Irradiation; and 1999/21/EC (Article 4) on Dietary Foods for Special Medical Purposes.

It will also be necessary to check what other information must, in accordance with any applicable national legislation, be translated into a national language. The issue of what additional information Member States may require to be translated on imported products was addressed in Colim.9 The ECJ ruled that, in the absence of full harmonisation of language requirements applicable to information appearing on imported products, such a requirement must be restricted to the information which the Member State concerned has made compulsory and which cannot be appropriately conveyed to consumers by means other than translation.10 It is for traders to decide whether to make further noncompulsory information available in the language of the consumer.11

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12.2.3 The choice of language Article 13a of the General Food Labelling Directive requires that the compulsory particulars appear in ‘a language easily understood’ by the ‘consumer’ (Article 14 referred to the ‘purchaser’). Article 13a.2 provides that these particulars must now appear in one of the 11 official languages of the Community and has thus excluded the possible use of regional languages (such as Welsh or Catalan), in respect of the compulsory particulars, although these were previously allowed under Article 14. It has been argued that the ECJ’s rulings on the meaning of the term, ‘a language easily understood’ have tended to favour the free movement of goods, by permitting some flexibility in the choice of language used for labelling.12 The Court could have interpreted the term to require labelling in the language of the linguistic region, in order to guarantee a high level of consumer protection. The Court itself made this point when the issue arose in Piageme I. It observed that, ‘the language of the linguistic region is the language which seems to be the most easily understood’.13 However, it nonetheless chose to interpret Article 14 as primarily intended to eliminate the differences between national provisions which hinder the free movement of goods, deducing this from the recitals to the General Food Labelling Directive.14 In Piageme I it was therefore held that, ‘a language easily understood’, precludes national measures requiring the exclusive use of the language of the linguistic region in which the foodstuffs are marketed, without allowing the possibility of using another language easily understood by purchasers or of ensuring that the purchaser is informed by other means. Moreover, such requirements were found to be measures having an effect equivalent to a quantitative restriction on imports, prohibited by Article 30 EC Treaty (now Article 28 EC). In Piageme II,15 the Court went further, holding that national measures merely requiring the use of the language of the region, without excluding the parallel use of other languages, are equally precluded under Article 14.16 The ECJ has emphasised that it is ultimately for the national court to assess whether the information supplied can be understood.17 However, this leaves national courts faced with the vexed question of whether any language other than that of the linguistic region will be ‘easily understood’. The Court addressed this problem in Piageme II, conceding that, in practice, proper understanding of labelling by consumers will usually be ensured by the use of the languages of the State or region in which the product is marketed. Nonetheless, it held that the relevant issue is the comprehensibility of the labelling, rather than the use by consumers of a particular language, so that some foreign expressions may fall within the meaning of a ‘language easily understood’.18 The Commission has also addressed this issue in a Communication issued following Piageme I.19 It believes that the concept must be left to the discretion of the Member States but observes that exceptions to the use of the local language can be made in three categories of cases. First, where expressions used are generally known to the consumer (e.g. ‘made in’). Second, where the terms are untranslatable, and finally, where words used can be easily understood due to similarity of spelling (e.g. coffee, lychees, mangos, puree and soya). Ultimately, the lack of clarity on this issue means that there is no certainty for manufacturers as to whether certain expressions in a foreign language will ultimately be deemed to be ‘easily understood’. Overall, however, it appears that a foreign language will be deemed to be ‘easily understood’ in relatively few cases. This situation cannot be regarded as promoting market openness. These problems also arise with regard to the language of labelling particulars which are not compulsory under EC legislation. Such national measures will be subject to

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Article 28 of the EC Treaty (former Article 30 EC), as explained above. In this context, the ECJ held in Colim that, in the absence of full harmonisation of language requirements applicable to information appearing on imported products, the Member States may adopt national measures requiring such information to be given in the language of the area in which the products are sold or in another language which may be readily understood by consumers in that area, provided that those national measures apply without distinction to all national and imported products and are proportionate to the objective of consumer protection which they pursue. They must, in particular, be restricted to information which the Member State makes mandatory and which cannot be appropriately conveyed to consumers by means other than translation.20

12.2.4 Where should the translation be placed? The ECJ held in Goerres that all the compulsory labelling particulars specified in Directive 79/112 must appear on the product label. It reasoned that the aim of Article 14 (to inform and protect consumers) will not be attained unless consumers have access to the compulsory particulars both at the time of purchase and of consumption. Moreover, it pointed out that the ultimate consumer is not always the purchaser. A supplementary sign placed next to the product in the shop is not therefore sufficient to ensure that the ultimate consumer is informed and protected. Similarly, information supplied at the sales point or as part of a wide-ranging advertising campaign will not suffice.21

12.2.5 Can a translation be replaced by means of other measures? The ECJ has recognised on several occasions that the compulsory particulars set out in the General Food Labelling Directive can appear as designs, symbols or pictograms, rather than in a ‘language easily understood’ by the consumer.22 The use of symbols may represent a workable alternative, avoiding the translation problems which the use of language entails. However, the replacement of Article 14 by Article 13a has limited the scope of this approach to labelling, insofar as it provides that in respect of the compulsory particulars, only measures which have been approved at Community level23 are allowed as an alternative to language. So far, none has been approved.

12.2.6 Marketing of multilingually labelled foodstuffs Multilingual labelling is expressly permitted by Article 13a/14 and is increasingly used by food manufacturers marketing products on a pan-European basis. It is one of the tools which can be used by manufacturers to take advantage of the Single Market in food products. Given that labelling must be easy to understand, easily visible, clearly legible and indelible, particular care has to be taken in using multilingual labelling. The problems of legibility and space on the product label arising from the use of multilingual labelling have, however, been compounded by the currently confused state of EC food labelling legislation. Where Member States cannot agree on a solution to a particular problem, labelling is often used as the means of reaching a compromise. As a result, the essential objective of giving consumers correct and clear information about the product, its ingredients and how it should be prepared, has been lost in a welter of

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hopelessly detailed requirements which confuse consumers and which manufacturers find difficult to fit on product labels, especially if they are provided in more than one language. As Europe enlarges, there is clearly a need for a new approach to food labelling which identifies what information it is essential to place on pack, in order to provide sufficient information to enable the consumer to make an informed choice, and what information would be better provided by other means such as databases, information lines, retail trade information systems, the Internet, etc. This would rectify the situation we have today, where food labels often lead to consumer confusion and suspicion, and in many cases create barriers to the EC’s Single Market, which increase operating costs and consumer prices unnecessarily. Food labels should provide consumers with clear and comprehensive information which creates confidence in EU food and should facilitate the marketing of food products throughout the Community.

12.2.7

References

1. These compulsory particulars are specified in Articles 3 and 4(2) Directive 79/112/EEC. 2. Case C-51/93 Meyhui v Schott Zwiesel Glaswerke [1994] ECR I-3879, para 13, and cited in Case C-33/97, Colim NV v Biggs Continent Noord NV [1999], para 36. 3. Case C-51/93 Meyhui NV v Schott Zwiesel Glaswerke AG [1994] para 10, and followed in Case C-33/97, Colim NV v Biggs Continent Noord NV [1999], para 40. 4. Case C33/97, Colim NV v Biggs Continent Noord NV [1999], para 43. 5. Joined cases C-267/91 and C268/91 Keck and Mithouard [1993]. 6. Keck (see n. 5 above) para 16 and cited in Colim (see n. 4 above). 7. Required in accordance with Article 1.2 of Directive 97/4/EC, which amends Article 3(1) of the General Food Labelling Directive. 8. Although, in respect of butter produced in their territory, Member States are authorised to require only an indication of the manufacturer, packager or seller. 9. Colim (see n. 4 above). 10. Colim (see n. 4 above), para 44. 11. Colim (see n. 4 above), para 42. 12. Schilling T, ‘The labelling of foodstuffs in a language easily understood by purchasers’, EFLR 1/96. 13. Case C-369/89, Piageme and others v BVBA Peeters (Piageme I) [1991], para 14. 14. Piageme I (see n. 13 above), para 15. 15. Case C-85/94 Piageme v Peeters (Piageme II) [1995], 12 October 1995. 16. Piageme II, para 19 followed in Case C-385/96, Goerres [1998], para 21. 17. Piageme II (see n. 15 above), Case C-385/96, Goerres [1998], para 20. 18. Piageme II (see n. 15 above), para 29. Guidance is also given in the ‘Interpretative Commission Communication concerning the use of languages in the marketing of foodstuffs in the light of the judgment in the Peeters case’, COM (93) 532 final, p. 6. 19. Interpretative Commission communication concerning the use of languages in the marketing of foodstuffs in the light of the judgment in the Peeters case, COM (93) 532 final, 10 November 1993. 20. Colim (see n. 4 above), para 44. 21. Case C-385/96, Goerres [1998], paras 24–25, following Piageme II (see n. 15 above). 22. Piageme II (see n. 15 above) para 27 et seq; Case C-385/96, Goerres [1998], para 20; Colim (see n. 4 above), para 41. 23. In accordance with the procedure laid down in Article 17 of the General Food Labelling Directive.

12.3 Food allergen labelling J. Ralph Blanchfield, Food Science, Food Technology and Food Law Consultant 12.3.1 Introduction The problem of food allergens is part of the wider problem of adverse reactions to foods, including those resulting from microbial and chemical food poisoning, psychological aversions and specific non-allergenic responses. An allergy is an immune response,

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leading to the formation of immunoglobulin E (IgE) antibodies. These, through a series of biochemical reactions, result in the release of histamine, leucotrienes and other substances into the tissues from the body’s mast cells, which reside in the eyes, skin, respiratory system and intestinal system. Allergy requires an initial sensitisation which may often occur in childhood. Once sensitised, repeat exposure causes full-blown allergic reaction. Repeat exposure is usually either because the person is unaware of being allergic to a particular substance or because of unawareness of the presence of a known allergic substance. An allergic reaction may be triggered by a minute amount of allergen. Allergic reactions may range from relatively short-lived discomfort to anaphylactic shock and possible death (and not only from the well-publicised peanut, see for example Nordlee et al.).1 Different people are allergic to different substances e.g. house dust mites, pollen, cat fur, paint and various foods. An estimate in the United Kingdom suggests a total of 15 million sufferers from allergies to various substances (more than 1 in 4 of the population) of which 3 million are allergic to house dust mites. A food allergy is an immune response to a food or a substance, normally a protein or glycoprotein, in a food naturally, or by contamination, or produced by processing, cooking or digestion. Dealing with at least the major serious food allergens has become recognised in recent years as an important food safety issue.

12.3.2 Major serious allergens (MSAs) Over 170 foods have been documented in the scientific literature as causing allergic reactions. Clearly it would be impossible to deal with all of these, and for practical purposes the food manufacturer has to concentrate his attention on dealing effectively with ‘major serious allergens’ (MSAs). What does the term signify? It certainly includes the so-called ‘big eight’, namely milk, eggs, soy, wheat, peanuts, shellfish, fruits and tree nuts, which reportedly between them account for over 90% of allergies.2 It could also include the so-called ‘second eight’, namely sesame seeds, sunflower seeds, cottonseed, poppy seed, molluscs, beans other than green beans, peas and lentils. Additionally, latex, tartrazine and sulphites should be treated as MSAs. There has been considerable confusion about whether the oils (e.g. of peanut, tree nuts, cottonseed) are allergenic. In the past there was an unsupported assumption that they must be; then an equally unsupported view that oil does not contain protein and therefore they cannot be. In 1997, papers on peanut oils by Hourihane et al.3 and tree nut oils by Teuber et al.,4 showed that unrefined oils were allergenic but refined oils were not. However, a later paper by Olszewski et al.5 reported the presence of protein allergens in refined peanut oil. The obvious explanation of the contradiction between the results of Hourihane et al. and Olszewski et al. is that they were using two different samples of refined peanut oil, which in turn suggests the conclusion that the unqualified term refined peanut oil cannot be assumed to mean non-allergenicity. This suggests that unless the oil is an analytically-monitored, highly refined and designated non-allergenic, peanut oil should be treated as allergenic. ‘Dealing effectively’ means taking due care to prevent or minimise the avoidable presence of MSAs, and warning on the label of the presence of any MSA that is unavoidably present. The ‘due care’ and the label warning are inseparable. Labelling cannot be effectively considered except in the context of both knowledge by the individual and precautions by the manufacturer.

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12.3.3 Knowledge on the part of the individual No form of warning about the presence of an allergen in a food can be effective for an individual unless he or she is aware of what are the foods or food substances to which he/ she is allergic. This information cannot be derived from any source except that individual and his/her medical adviser. People who think that they suffer from a food allergy owe it to themselves to undergo tests to determine if it is a true allergy, and if so, what the substance is that causes it.

12.3.4 Precautions by food manufacturers While not detracting from the responsibility of sufferers (and their medical advisers) to identify the particular foods or food substances to which they are allergic, there is need for due diligence by manufacturers in considering the use of major serious allergens as ingredients, in warning of the presence or potential presence of such allergens in products, and in preventing adventitious cross-contamination of products with allergens present in other manufactured products. This is not only a duty of care and an integral part of due diligence, but an essential means of minimising the risk of being subject to a product liability claim, and the risk of having to recall cross-contaminated products. As companies now successfully operating such a policy have found, it is far from easy to introduce and implement. The new development of such a policy requires nothing less than a change in the company ‘culture’, an allocation of very substantial funds and resources, and a concentrated and sustained effort by everyone led by the Board; and its application and maintenance thereafter requires ongoing effort. That it is possible to achieve has been demonstrated by the development and effective implementation of such a policy by a number of companies. The first task is to win the understanding and commitment of the Board itself, and that needs both the dedicated effort of a sufficiently senior and sufficiently knowledgeable champion and the presentation and adoption of a plan. Part of the work of implementing the plan, however, is the difficult and ongoing task of training all concerned – general managers, buyers, production managers, quality managers, engineers, supervisors, operators, cleaners – to understand the importance of the plan and the need to carry out conscientiously the measures that it contains. Existing or proposed new product formulations should be carefully examined to see whether there is a possibility of excluding MSAs. Of course, in many cases an MSA is essential to characterise the food, and in such cases label warning must suffice (see below). In some cases, however, where MSAs are present as non-characterising ingredients, it may be possible to effect a substitution. Likewise, a similar approach should be made to MSAs in compound ingredients comprising less than 25% of the total weight (and thereby – at the time of writing – not required by UK or EU law to be individually named in the ingredients list). If it is necessary to include an MSA in such a compound ingredient, then the MSA should be named. The adventitious presence of an MSA in a product may arise in two main ways: • by accidental mis-formulation • by cross-contamination by an MSA from a contaminated ingredient or from a different product.

Mis-formulation resulting in the inclusion of an MSA (or any other ingredient) not in the product formulation should be prevented by proper attention to the formulation development and control provisions of good manufacturing practice. Cross-contamina-

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tion of a product by an MSA from a different product may arise due to residues in shared equipment, airborne dust, or the incorporation of re-work material without consideration of the allergen problem. In companies producing on more than one site, or in different buildings on the same site, serious consideration should be given to raw material storage segregation and production segregation. Where the latter is not possible, separate production equipment should be used if possible. Where shared production equipment between one or more MSA-free products and an MSA-containing product is unavoidable, the MSA-containing product should be run as the last production of the day, immediately before cleaning (for example, on a shared production line for mixed breakfast cereals, one of which contains nuts, the product containing nuts should be run last; an alternative approach might be to package the nut component separately elsewhere, in sealed pouches, which could then be put into the container, leaving it to the purchaser to mix them in or not, according to personal choice). However, it should be recognised that cleaning afterwards, especially in a plant producing dry products, will not necessarily guarantee against small quantities of trapped material waiting to be ‘carried over’ into the first product to go through thereafter, and segregation may be the only acceptable solution. The same applies to small quantities of MSA in airborne dust. Any re-work material incorporated into a product must not include ingredients that are not ingredients of that product. This, therefore, would prohibit the use of any re-work material that may contain an MSA not in the formulation of that product.

12.3.5 Label warnings of the presence of MSAs Against the foregoing background, appropriate label warnings to the potential purchaser are necessary. Distinctive labelling cannot encompass every one of the 170+ foods documented as causing allergic reactions (or most food labels would have to carry numerous warnings and all impact would be lost). Nor should labelling be regarded as obviating the responsibilities of sufferers (and their medical advisers) to identify the particular foods or food substances to which they are allergic, or the responsibilities of manufacturers referred to above. Labelling deficiencies resulting in allergic reactions may arise (a) because an MSA may be present but not named when in a compound ingredient; (b) because a known MSA is not recognised by its designation in an ingredients list, for example, declared ‘vegetable oil’ may be unrefined peanut oil; and few, if any, consumers, knowing that they are allergic to milk protein would realise the significance of ‘calcium caseinate’ in an ingredients list; and (c) because an MSA that is present and named is unnoticed due to the smallness of print on many ingredients lists. Likewise few, if any, consumers would know that ‘gum base’, named as an ingredient of chewing gum, may include latex. To minimise risk there is a clear need to provide some kind of label warning regarding the presence of any of the MSAs. In some obvious cases some manufacturers do give warning voluntarily, both as a measure of public safety and as a measure of selfprotection. However, this could inevitably lead to a multiplicity of methods leading to confusion, and there may be a case for standardising by devising a regulation laying down how it should be done. This is likely to occur as a result of the European Union review of labelling taking place in 1998–99, and elsewhere via Codex Alimentarius. In the meantime the following suggestions were put forward by the Institute of Food Science & Technology6 in 1997 to minimise confusion. The proposals were subsequently incorporated in 1998 in the IFST Good Manufacturing Practice Guide.7

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More recently, both the UK Food and Drink Federation (FDF)8 and the Leatherhead Food Research Association (LFRA)9 have issued guidance advice to manufacturers, and the Institute of Grocery Distribution (IGD) is attempting to promote and co-ordinate an agreed consistent approach by maufacturers and retailers. Inclusion of the name of an MSA in an ingredients list should not be regarded as adequate warning. The presence or potential presence of an MSA should be separately stated, in a prominent and easily legible way, where it will be seen clearly by a potential purchaser under normal conditions of display. Where a product contains one or more MSAs, whether as individual ingredient(s) or as component(s) in a compound ingredient, the presence of the MSA should be stated (for example, ‘Contains PEANUT’). The terminology should be clearly understandable by the lay person. Thus where calcium caseinate is the MSA concerned, the warning should read ‘Contains MILK PROTEIN’. It would be helpful to the purchaser to add to this category of warning the words ‘to which some people may be allergic’. Where a product nominally free from MSAs is produced on a production line shared with an MSA-containing product, a suitable warning might be, for example, ‘May contain traces of PEANUT’. Again the additional words, ‘to which some people may be allergic’ would be helpful. Where a product nominally free from MSAs is produced in the same factory building as an MSA-containing product, a suitable warning might be, for example, ‘Produced in a factory where PEANUT is also handled’. In the cases of tartrazine or sulphites, the relevant warning statement should refer to the additive both by name and E number. In Europe, from January 2000, under a variety of circumstances, quantitative ingredients declaration (QUID) for some ingredients will be mandatory. This applies to any ingredient given ‘special emphasis’ on the label. The naming of an ingredient in an allergen warning could be interpreted as special emphasis. However, in the UK the official Guidance Notes on interpretation of the QUID provisions specifically exempt the naming of ingredients in allergy warnings. Warnings should be given not only on retail pack labels but also on labels of bulk packs for use in delicatessens and in catering so that the information can be passed onto customers. The precautions by retailers in respect of prepacked own-label products are those as if they were themselves the manufacturer. In regard to prepacked branded products, retailers need to satisfy themselves that appropriate label warnings are given. However, retailers have special responsibilities in regard to foods that are sold from open containers, e.g. on delicatessen counters. When such foods contain MSAs, the warnings should be clearly displayed immediately by the foods in question. In catering (food service) warnings should be given on menus or displayed alongside self-service foods, and special training and up-to-date information should be given to staff to enable them correctly to answer customer questions about the presence or absence of allergens.

12.3.6 1. 2. 3.

References

Nordlee J A et al. (1995b) ‘Anaphylaxis from undeclared walnut in commercially processed cookies’, J. Allergy Clin. Immunol., 91, 154. Bush R K (1997) Paper presented at the Institute of Food Technologists Annual Meeting, Orlando, June. Hourihane J O et al. (1997) ‘Randomised, double blind, crossover challenge study of allergenicity of peanut oils in subjects allergic to peanuts’, British Medical Journal, 12 April, 314, 1084–8.

Special issues in food labelling 4. 5. 6. 7. 8. 9.

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Teuber S S et al. (1997) ‘Allergenicity of gourmet nut oils processed by different methods’, J. Allergy Clin. Immunol., April, 99 (4), 502–7. Olszewski A et al. (1998) ‘Isolation and characterization of proteic allergens in refined peanut oil’, Clin. Exp. Allergy, 28 (7), 850–9. IFST Position Statement on Food Allergens, 12 September 1997, and updated version, 16 June 1999. Institute of Food Science & Technology, London. Blanchfield J R, ed. (1998) ‘Dealing with Food Allergens’ Chapter 30 in Food and Drink – Good Manufacturing Practice: A Guide to its Responsible Management, 4th edn. Institute of Food Science & Technology, London. Food Allergens Advice Notes (1998). Food and Drink Federation, Scientific and Regulatory Affairs Division. Leesof M, ed. (1997) Food Allergy Issues for the Food Industry, Leatherhead Food Research Association.

12.4 Genetically modified foods and ingredients M. J. Sadler, Institute of Grocery Distribution, Watford 12.4.1 Introduction In Europe, adoption of the principle of informed consumer choice has led to increasingly comprehensive measures, initially voluntary and then by legislation, to provide distinctive labelling of genetically modified (GM) foods. In contrast, the Food and Drug Administration (FDA) in the USA has, despite increasing pressure, refused to require distinctive labelling where GM foods are substantially equivalent to the non-GM versions. Consideration of the development and current position of distinctive labelling of GM foods in this section is therefore based on European experience and is largely illustrated by the UK experience. Three products from genetically modified plants have been available in recent years in the UK. The first is a specific variety of tomato pure´e produced in California that has been sold as an own-label product in two retailers. This is the only genetically modified whole food product to be sold in the UK, and it was introduced in 1996. Though not legally required, clear labelling was provided on the front of the product explaining that it was produced from genetically modified tomatoes. The two other introductions have been Round-up Ready Soya and Bt Maize. These are both varieties of commodity crops that are imported into the UK. Initial requirements for labelling genetically modified foods or ingredients produced from them were set out in the Novel Foods Regulations.1 The approach adopted was that of substantial equivalence. However, because of the potential for adverse consumer reaction within the EU to the introduction of genetically modified commodity crops, more detailed requirements for labelling (1139/98)2 were developed. Round-up Ready Soya and Bt Maize were introduced before the EU Labelling Regulations (1139/98) were agreed. The UK food industry therefore adopted voluntary labelling with the aim of meeting consumer demands for labelling. This section will review the development and the principles of the EU labelling requirements, their adoption in the UK, how the label information should be presented, further developments of the regulation, and the problems encountered in adopting the labelling legislation in the light of consumer reaction to the introduction of GM crops. 12.4.2 Industry’s responsibilities Labelling genetically modified foods and ingredients was addressed in the EU Novel Foods and Novel Food Ingredients Regulation (258/97)1 that came into force in May 1997. The principle of labelling was on the basis of substantial equivalence, a tool that has been used extensively in the safety assessment of GM foods. This approach was

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developed by the World Health Organization (WHO)3 and Organisation for Economic Cooperation and Development (OECD)4 and involves any comparison of a GM food with its conventional counterpart; the differences between them becomes the subsequent focus of the safety assessment. Article 8 of the Novel Foods Regulation requires labelling where, in comparison to an existing, equivalent food: • foods and food ingredients derived from genetically modified plants or organisms (GMOs) are no longer equivalent • additional material is present that may have adverse health implications (e.g. allergens) • additional material is present that may give rise to ethical concerns, or • foods contain or consist of GMOs.

Round-up Ready Soya and Bt Maize were introduced to the food supply in 1997. As they were approved before the Novel Foods Regulation came into force, a separate regulation (1813/97)5 was issued bringing them within the scope of 258/97. There was initially no legal requirement to label ingredients from these two crops. However, because of the potential for adverse consumer reaction within the EU to the introduction of GM soya and maize, voluntary labelling proposals were developed by a number of Member States. It was recognised that this could present a barrier to trade. The Commission therefore agreed to adopt more detailed requirements for labelling. Commission proposals for detailed labelling rules for Round-up Ready Soya and Bt Maize were issued in Autumn 1997. Voluntary labelling in the UK The UK food industry agreed guidelines for the voluntary labelling of products in November 1997. IGD Voluntary Guidelines for Communication and Labelling6 formed the basis of labelling. These were developed by a cross-sector group involving manufacturers, retailers, the food service sector, consumer groups, scientific bodies, and biotechnology companies. The principle of the guidelines was to label products that contained modified DNA, whether the DNA was active (intact) or not. Labelling commenced in January 1998, when the proportion of Round-up Ready Soya grown in the United States had increased to 15%. However, in practice, some companies started to remove GM ingredients from products through sourcing non-GM soya, or through the reformulation of products to remove soya ingredients altogether. 12.4.3 Presenting information on labels – Labelling Regulation 1139/98 Regulation 1139/982 was published in May 1998 and came into force in the following September. In developing the regulation it was recognised that the basis of labelling needs to be meaningful to consumers. In view of this, labelling is based on the principle that the presence of genetically modified DNA renders foods and food ingredients from genetically modified soya and maize ‘no longer equivalent’ to those from traditional crops. In practice, this regulation has signalled a move away from the approach of substantial equivalence. Where modified DNA has been destroyed by processing, the foods and food ingredients are considered equivalent unless modified protein is present, and in this case do not require labelling. The labelling regulation requires that: • ingredients containing modified DNA should be labelled with the wording ‘produced from genetically modified soya/maize’

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• the wording should be displayed either in brackets after the ingredient in the ingredients list, or as a footnote indicated by an asterisk • where an ingredient is already listed as being produced from soya or maize the footnote can be abbreviated to ‘genetically modified’; the asterisk should be directly attached to the word ‘soya’ or ‘maize’ • products should be labelled even if they do not have an ingredients list • labelling applies to compound ingredients that are less than 25% of the final product • claims that a product is made from non-genetically modified ingredients can be made on a voluntary basis.

Labelling does not apply to food additives, flavourings or extraction solvents as these are considered under other legislation. The draft proposals included the provision for ‘may contain’ labelling, particularly with reference to commodity crops. However, the regulation does not allow this form of labelling. The Commission opted instead to investigate the concept of a threshold level to allow for accidental mixing of GM crops with segregated supplies of traditional non-GM crops. The assumption is that the labelling rules for these two crops will form the basis for future genetically modified crops that are approved. In the UK, the enabling regulations also include the provision for labelling to apply to foods sold loose, and foods sold through the food service sector. This came into force on 19 September 1999. Consumers can be informed that products contain genetically modified soya or maize through declarations on menus, notices or tickets, or the information can be given verbally by staff provided that there is a system in place to keep staff informed of product contents.

12.4.4 Recent and future trends Proposals for a de minimis threshold of 1% have been agreed by the Commission (49/ 2000).7 This will allow for the presence of GM material at levels below 10% to avoid the requirement for labelling. To enable the threshold level to be enforced the need to develop quantitative analytical techniques has also been recognised by the Commission. An EU ring trial to validate two methods for the quantitative detection of genetically modified material is planned. The concept of a list of ingredients that would not require labelling was also put forward by the Commission as part of the labelling regulation. Advice has been sought from the Scientific Committee on Food and relevant evidence from analysis has been put forward. A proposal is awaited from the Commission. The main purpose of this approach is that the ingredients listed will not require testing each time they are used to prove they are free of genetically modified DNA or protein. Likely candidates for inclusion are hydrolysed maize starches and refined oils. Ingredients from genetically modified crops approved in the future can be added to the list, subject to provision of the required analytical data. Additives, flavourings and extraction solvents, though previously excluded from the labelling regulation now require labelling where they contain GM material (50/2000).8 Labelling is on the basis of detectability of modified DNA or protein.

12.4.5 Key problems Round-up Ready Soya has been generally more of an issue for industry than Bt Maize, as Europe is relatively self-sufficient in maize and Bt Maize is mainly used for animal feed. Soya, by contrast, is mainly imported from the USA, and is used in a variety of food products.

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The key problem concerning the introduction of Round-up Ready Soya in Europe has been lack of segregation from the conventional crop in the USA. This has arisen from a combination of three main factors: • the absence of any US requirement for distinctive labelling of foods containing GM soya or maize • the absence of significant consumer awareness of concern (not unconnected with the absence of label indication); and • the large scale and manner in which soya and maize are harvested, stored, transported and processed as commodities.

Soya ingredients are used in an estimated 60% of processed foods, and it is estimated that in 1999 30% of soya in the USA was the Round-up Ready resistant variety. As the crop has not been segregated, where soya is used in products consumers are no longer able to exercise choice over whether or not to eat GM soya. Consumers were also concerned that not all ingredients from soya were being labelled, including some additives (e.g. lecithin) and those not containing DNA, e.g. soya oil. In view of this, retailers developed a policy of labelling all derivatives from GM soya. However, in view of growing consumer concerns about GM foods in general, manufacturers and retailers have acted to alleviate these concerns by reformulating products to remove soya ingredients, and by sourcing supplies of non-genetically modified soya. Hence labelling products has become a secondary issue to removing GM soya from products. In taking this route to meet consumers’ demands, it is essential to ensure traceability of non-GM supplies and supplier verification in order to have a due diligence defence. Within the catering sector there has been no previous experience of labelling foods and dishes to the extent that is required for GM ingredients. The requirement to assess whether ingredients and products used contain GM ingredients has caused difficulties for caterers. However, once procedures are in place, this may pave the way for labelling or the provision of information about other sensitive ingredients, e.g. allergens. The UK food industry has generally followed the recommendation in the IGD labelling guidelines, not to make claims that individual products do not contain genetically modified ingredients. The long-term value of ‘negative’ claims is questionable, and there has been little support within the UK food industry for this approach. There is also the issue of accuracy of terms, with products that make claims for ‘GM-free’ having a different proposition to products that are unlabelled (i.e. use of ‘nonGM’ ingredients). In Germany, proposed legislation for making a voluntary claim that products are made ‘without genetic engineering’ is very strict. It requires that products must not consist of, be produced from, or contain, substances produced using gene technology. For example there must be no use of genetically modified animal feed or medicines, with proof that these are absent. The EU is expected to publish proposals for GM-free labelling shortly.7 However, companies in the UK have publicly announced policies to remove GM soya and maize from all of their product range. This has involved sourcing non-GM soya, and in some cases the removal of soya ingredients from products. Before the legal threshold was agreed, companies were working to a 0.1% threshold for the presence of GM soya or maize in the identity preserved non-GM stream, based on analytical testing and documentation for traceability. The impact of the legal threshold will therefore be minimal as the level has been set above that which the market is demanding. The agreement of a validated analytical method will also be crucial. The level of the threshold

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that is being worked to will influence the methodology chosen; that is, at a threshold of 1% there are a variety of methods available, but at 0.1% there are fewer available methods. 12.4.6 1. 2. 3. 4. 5. 6. 7. 8.

References

Regulation EC No 258/97 of the European Parliament and of the Council concerning Novel Foods and Novel Foods Ingredients. Official Journal of the European Communities L 43/1; 14.2.97. EC. Council Regulation (EC) No 1139/98 concerning the compulsory indication of the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Directive 79/112/EEC. EU, 1998. WHO. Report of a Joint FAO/WHO Consultation on Biotechnology and Food Safety. Geneva: WHO, 1996. OECD. Safety evaluation of foods produced by modern biotechnology – concepts and principles. Paris: OECD, 1993. EC Commission Regulation (EC) No 1813/97 of the 19 September 1997, concerning the compulsory indication on the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Directive 79/112/EEC. L257/7. EU, 1997. IGD. Communication and labelling guidelines for genetically modified foods. Watford: IGD, 1997. Regulation EC No 49/2000 – OJ L6 11.1.2000, p. 13. Regulation EC No 50/2000 – OJ L6 11.1.2000, p. 15.

12.5 Irradiated foods and ingredients G. W. Gould, Consultant 12.5.1 Introduction Irradiation of food was first suggested as long ago as the early 1900s. A 1905 UK patent concerns the use of ionizing radiation ‘to bring about an improvement in the condition of foodstuffs.’ The US Department of Agriculture suggested that X-rays be used to inactivate trichinae in pork in 1921. However, it was not until the 1950s that the increased availability of suitable isotopes, together with President D. Eisenhower’s ‘Atoms for Peace’ programme, triggered major international collaborations on food irradiation. Safety became a key issue in these programmes following the classification of food irradiation as a food additive by the US Food and Drug Administration (FDA). A major 24-country International Programme in the Field of Food Irradiation (IFIP) commenced in 1970, supported by the Food and Agriculture Organisation of the United Nations (FAO), the International Atomic Energy Agency (IAEA), and the Organisation for Economic Cooperation and Development (OECD), and advised by the World Health Organisation (WHO). Data from this and related programmes formed the basis of the conclusions of FAO/IAEA/WHO Expert Committees on the Wholesomeness of Irradiated Food (JECFI) in 19761 and 1980.2 JECFI concluded that ‘the irradiation of any food up to an overall average dose of 10 kilogray (kGy) presents no toxicological hazard; hence, toxicological testing of foods so treated is no longer required and introduces no special nutritional or microbiological problems.2 This was reaffirmed by a JECFI that met in 1992,3 and led to the Codex Alimentarius Commission adopting the Codex General Standard for Irradiated Foods and the Recommended International Code of Practice for the Operation of Radiation Facilities for the Treatment of Food in 1983.4 In 1994, the WHO stated that ‘irradiated food produced in accordance with good manufacturing practice can be considered safe and nutritionally adequate’.3 In 1997, a joint FAO/IAEA/WHO Study Group examined toxicological, nutritional, microbiological, and radiation chemical data and further concluded that there is no need for an upper dose limit to be imposed for food irradiation.5 The Study Group recommended that steps

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be taken to establish the technological guidelines implied by these conclusions and to incorporate them in Codex Alimentarius standards. At present, 41 countries allow the irradiation of about 100 different foods or classes of foods,6 either on an unconditional or a restricted basis.7 However, acceptance of irradiated foods by consumers is slow to develop in many countries, so that tonnages of irradiated foods remain low with a few exceptions, e.g. about 60 000 tonnes of irradiated spices and dried vegetable seasonings have been produced in a number of countries, including about 30 000 tonnes in the USA. In the former USSR, some 400 000 tonnes of grain were irradiated annually for disinfestation, and in Japan, about 20 000 tonnes of potatoes for inhibition of sprouting.

12.5.2 The use of irradiation Ionizing radiations employed for food processing include -radiation from the radioactive isotope Co60, -radiation (electrons) with a maximum energy of 10 Mev (million electron volts) from machine sources and, to a much lesser extent, X-rays with a maximum energy of 5 Mev from machine sources. The absorbed dose of radiation is defined in terms of the energy absorbed by the substance irradiated. The SI unit of dose is the gray (Gy), which is 1 joule kg 1 . Food irradiation doses are generally quoted in kilograys (kGy). The gray replaces the previous unit, the rad. 1 Gy = 100 rad 1 kGy = 100 krad 10 kGy = 1 Mrad (1 million rad) The dose received varies within a product depending on its geometry and the particular processing technique. Dose uniformity is defined as the ratio of maximum to minimum absorbed dose. The ratio Dmax/Dmin is termed the ‘overdose ratio.’ A ratio of 1.5 is a typical figure.8 Technological objectives of food irradiation include improvement of safety, particularly of meat and poultry and some seafoods, reduction of spoilage, disinfestation, and delay of ripening of fruits and vegetables. Typical doses employed to meet these objectives are indicated in Table 12.1.

12.5.3 The legal background Following the various JECFI meetings,1,2 their conclusions and recommendations were used to derive an international standard by the Codex Alimentarius Commission (CAC) of the joint FAO/WHO Food Standards Programme. The CAC adopted a ‘Codex General Standard for Irradiated Foods’ and a ‘Recommended International Code of Practice for Operation of Radiation Facilities used for Treatment of Food’.4 The Codex Standard was recommended by the CAC to all its 130 or so member countries for acceptance in 1984. The Standard provided the stimulus for national authorities to introduce regulations for food irradiation. Beginning in the early 1980s, a number of advanced countries introduced regulations following the principles of the Codex Standard, including Canada, Denmark, France, The Netherlands, the United Kingdom and the United States. Likewise, some developing countries introduced early legislation to allow and control food irradiation, again based predominantly on the Codex Standard, e.g. Bangladesh, Brazil, Chile, PR China, India, Republic of Korea, Thailand, and others.

Special issues in food labelling Table 12.1

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Major technological objectives of food irradiation and typical doses employed

Technological objective Extend storage life by inhibiting sprouting, e.g. of potatoes. onions, garlic

Typical dose range (kGy) 0.05–0.15

Delay ripening of fruits, e.g.of mangoes, papayas

0.2–0.5

Prevent post-harvest storage losses due to insects, e.g. in cereals, flour, fresh and dried fruits

0.2–1.0

Inactivate parasites in meat, e.g. Trichinella in pork

0.03–6.0

Extend chill or ambient shelf life, e.g of meat, poultry, fish, fruits, and some vegetables by inactivating spoilage bacteria, yeasts, and moulds

0.5–5.0

Improve safety by inactivating non-sporing food poisoning bacteria including Salmonella serovars, Escherichia coli, Listeria monocytogenes, Campylobacter species, Vibrio species, e.g. in meat, poultry, shrimps and prawns

3.0–7.0

Reduce microbial levels in minor food ingredients, e.g. dried herbs and spices

5.0–10.0

Shorten drying times through the depolymerization of pectin, cellulose and starch, e.g. for dehydration of vegetables, fruits and legumes

3.0–10.0

Sterilize foods by inactivating spore forms of bacteria

25–50

Most countries’ national legislation requires the licensing of food irradiation facilities with associated examination and auditing to ensure proper controls and record-keeping. Most countries that allow food irradiation approve it on a product-by-product or food category-by-food category basis following demonstration of a clear technological need.

12.5.4 General labelling requirements In 1981 the joint FAO/IAEA/WHO Expert Committee2 recommended that it was not necessary, on scientific grounds, to label irradiated foods. However, it is widely recognized in most countries that labelling is necessary in order to inform the consumer if a product has been irradiated, and to indicate the purpose. Consequently, in those countries that allow food irradiation, it has become common to include some form of words such as ‘irradiated’, ‘treated with ionizing radiation’, ‘treated with ionizing energy’, ‘protege par ionisation’, etc. As recommended by IAEA in 19939 the particular form of words must be displayed prominently and close to the name of the product. Use of the green ‘Radura’ symbol (see Figure 12.4) has become recognised internationally and is required, in addition to the worded statement, in some countries, e.g. the USA, Canada, and The Netherlands. IAEA recommended that labels on packs of retail foods should contain an additional statement explaining the specific purpose for which the radiation is applied, for example to ensure hygienic quality, to extend fresh shelf-life, etc.10 In some countries, food irradiation was allowed but, following the original recommendations of the 1981 JECFI,

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Food labelling

Fig. 12.4 The Radura symbol. The green symbol is used to indicate clearly that a food has been treated with ionizing radiation.

labelling was not required originally, e.g. in China and South Africa. The current situation is summarized in Table 12.2 and commented on below. The framework against which individual country requirements should be interpreted is the Codex General Standard for Labelling of Prepackaged Food,11 adopted in 1991, and quoted from below. Section 5.2.1 The label of a food which has been treated with ionizing radiation shall carry a written statement indicating that treatment in close proximity to the name of the food. The use of the international food irradiation symbol is optional but when it is used, it shall be in close proximity to the name of the food. Section 5.2.2 When an irradiated product is used as an ingredient in another food, this shall be so declared in the list of ingredients. Section 5.2.3 When a single ingredient product is prepared from a raw material which has been irradiated, the label of the product shall contain a statement indicating the treatment. However, an ICGFI Statement on Labelling of Irradiated Foods in 1998 recommended small changes, namely that: the term ‘irradiated’ or equivalent wording need not be more prominent but shall not be less prominent than the ingredient statement. The irradiation statement may also be used to indicate the benefit of the treatment. Codex should consider the principle that the irradiated ingredient be so indicated if it amounts to more than some specified proportion of the product. ICGFI continues to discuss further modifications, e.g. in 1999,10 to relax the need for specific wording by the introduction, within Section 5.2.1, of the words: ‘Any factually correct phrase indicating the purpose or benefit of the treatment may be included in this statement’. In Section 5.2.2 (for an irradiated ingredient used in another food): ‘at a level that would require its unirradiated counterpart to be declared in the list of ingredients, then the modifying term ‘irradiated’ shall be included and shall be displayed at least as prominently as the ingredient name’. In Section 5.2.3 (for a single ingredient product): ‘that had been irradiated to a dose higher than is needed for sprout inhibition or insect

Special issues in food labelling Table 12.2 Country

229

Labelling requirements for irradiated foods in different countries10 Key phrase on label Symbol required ‘Irradiat,’ ‘Ionize’ ‘Radurize’ on label*

Argentina Bangladesh Belgium Brazil Canada China, PR Chile Cuba Costa Rica Croatia Czech Rep

‡ ‡ ‡** ‡ ‡

Denmark Finland France Hungary India Indonesia Israel Italy Japan Mexico Netherlands Norway Phillipines South Africa Switzerland Thailand UK USA

‡ ‡

Labelling of ingredients

‡ ‡ ‡

if above 10% if above 5%

‡ ‡ ‡ ‡

‡ ‡

‡ ‡ ‡ ‡** ‡ ‡ ‡

‡ ‡

‡ ‡** ‡ ‡****

‡ ‡

‡ ‡

‡ ‡

***

‡

if above 2% (herbs and spices), 10% (food industry raw materials) if above 5%

‡

‡

‡

if above 10% if above 5% ‡

* Symbol must be accompanied by a suitable phrase ** Statement of purpose of irradiation required *** Statement not yet specified **** Statement not required to be more prominent than the declaration of ingredients

disinfestation, the label of the product shall contain a statement’, and: ‘Any factually correct phrase indicating the purpose or benefit of the treatment may be included in this statement.’

12.5.5 Individual country requirements Although all based on the Codex Standard, there remain country-by-country variations in the labelling requirements for irradiated foods, especially for the labelling of foods containing irradiated ingredients. Table 12.2 summarizes the situation at the time of writing, assembled by the IAEA for the most recent meetings of the International Consultative Group on Food Irradiation (ICGFI).10 In the European Union, the two branches of the Community’s legislative authority (the European Parliament and the European Council) agreed a framework Directive laying down general provisions for irradiated foods, including labelling, based on the Codex

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Food labelling

Standards. The Directive (1999/2/EC) was agreed on 22 February 199912 and includes the following labelling requirements, in Article 6: The labelling of foodstuffs treated with ionizing radiation shall be governed by the following provisions: 1.

2.

3.

in the case of products intended for the ultimate consumer and mass caterers: (a) if the products are sold as items, the words ‘irradiated’ or ‘treated with ionising radiation’ shall appear on the label as provided for in 5(3) of Directive 79/112/EEC. In the case of products sold in bulk, these words shall appear together with the name of the product on a display or notice above or beside the container in which the products are placed; (b) if an irradiated product is used as an ingredient, the same words shall accompany its designation in the list of ingredients. In the case of products sold in bulk, these words shall appear together with the name of the product on a display notice above or beside the container in which the products are placed; (c) by way of derogation from Article 6(7) of Directive 79/112/EEC, the same words shall be required in order to indicate the irradiated ingredients used in compound ingredients in foodstuffs, even if these constitute less than 25% of the finished product; in the case of products not intended for the ultimate consumer and mass caterers: (a) the words provided for in the previous paragraph shall be used to indicate treatment of both the foods and the ingredients contained in a non-irradiated foodstuff; (b) either the identity and address of the facility which carried out the irradiation or its reference number as provided for in Article 7 shall be indicated; the indication of treatment shall in all cases be given on the documents which accompany or refer to irradiated foodstuffs’.

However, as indicated by their absence from Table 12.2, a number of EU countries continue to ban food irradiation, e.g. Germany, with the exception that certain spices, radiation-processed in France only, that may be marketed in any Member State of the EU or European Economic Area, may thereafter be imported into Germany. In Sweden, irradiation of foodstuffs is prohibited with the exception of spices labelled in accordance with labelling directive 79/112/EEC. In South Africa, which has a long history of food irradiation, all containers of irradiated foodstuffs must now be labelled with the Radura symbol together with one of the words ‘Irradiated’, ‘Radurised’, ‘Bestraal’, or ‘Geraduriseerd’ directly below the symbol. Foodstuffs containing more than 10% of an irradiated ingredient must be so labelled, though the Radura symbol may be omitted. Where bulk containers of irradiated foodstuffs are opened at the point of sale, a notice with the above information must be displayed prominently in immediate proximity to the foodstuff. Food irradiation is not allowed in Australasia. However, the Australia New Zealand Food Authority is currently receiving comments from the public, the food industry, and professional groups in New Zealand regarding a proposed draft standard for foods treated with irradiation, including requirements for clear labelling.

Special issues in food labelling

231

In the United States, labelling regulations13 are continuing to evolve, particularly because of concerns about pathogens such as Escherichia coli O157:H7, as well as Salmonella, and Listeria monocytogenes. These concerns have encouraged the USDA to allow American plants to irradiate red meats.14 Surveys have indicated that about 80% of consumers would be likely to purchase a food product labelled ‘irradiated to kill harmful bacteria.’ Under the proposals, the Food Safety and Inspection Service (FSIS) suggests that meat products be labelled with the green Radura symbol and a suitable statement. The symbol must be placed ‘prominently and conspicuously’ in conjunction with the required statement, which must appear next to the product name. The size of the irradiation disclosure does not have to be larger than the ingredient statement. For multiingredient foods, such as sausage, it is proposed that an ingredient statement, for ingredient X for example, would read ‘irradiated X’ or ‘X, treated by irradiation.’ Some level of negative industry reaction to these proposals is likely. In Canada, the Radura symbol must be displayed (see Table 12.2), along with the words ‘treated with radiation,’ ‘treated by irradiation,’ or ‘irradiated,’ or a written statement that has the same meaning.15 In the United Kingdom, the Food (Control of Irradiation) Regulations16,17 cleared seven catagories of food for irradiation, and made provision for labelling. Under the Food Labelling Regulations (1996), irradiated foods and ingredients must be identified with the words ‘irradiated,’ or ‘treated with ionizing radiation’ (see Table 12.2).

12.5.6 Irradiated ingredients The Codex recommendations on labelling with respect to irradiated ingredients are given above. However, the regulations introduced in different countries differ greatly in their interpretation of the recommendations, particularly regarding the level of ingredient necessary to require labelling. The country-by-country situation is summarized in Table 12.2, from where it can be seen that some countries simply require labelling if an irradiated ingredient is used (e.g. Belgium, India, Israel, UK), whereas others require labelling if more than a certain minimum proportion of irradiated inredients are used (e.g. 2% for spices and seasonings, and 10% for food raw materials in the Czech Republic; 5% in Denmark and Thailand; 10% in Canada and South Africa; 5% in Chile). The European Directive for irradiated foods12 includes the requirement for labelling ‘even when the ingredient constitutes less than 1% of the finished product’. It is in order to rationalize the situation that the ICGFI is discussing the introduction of the new phrases into Section 5.2.2 of the Codex General Standard (quoted in Section 12.5.5 above).

12.5.7 Labelling problems Major labelling problems have included the diversity of regulatory requirements in different countries. However, following the general adoption of the Codex Standard, the EU Directive and the North American initiatives, a greater degree of harmonization is evident in those countries that permit the irradiation of foods. There are now a number of analytical procedures for the detection of irradiated foods, so that authorities can determine whether or not a particular food has been irradiated, and therefore whether labelling is required. However, none of the techniques is foolproof, and determination of the dose of radiation that a food has received is even more difficult. The most influential problem regarding labelling in most countries remains public reaction. This varies from relative acceptance by consumers in some countries (e.g.

232

Food labelling

France, South Africa) on the one hand, to deep reluctance to accept irradiated foods, and therefore extremely negative reaction to any proposed form of labelling (e.g. Germany).

12.5.8 Future trends After a very long period of research into the positive aspects of food irradiation, and its safety, public debate and consumer views have been the main controlling factors promoting or impeding its introduction in different countries. At the same time, acceptance by governments has steadily grown around the world. It is increasingly recognized that irradiation has a potentially substantial role to play, along with other technologies, to help feed the world’s increasing population. Major expanding applications include: assurance of the hygienic quality of foods of animal origin and spices; as a quarantine treatment to overcome barriers to trade; to protect grain and other stored products from insect infestation; and, in combination with other processing procedures, as a low energy requiring process to maintain food quality. The positive conclusion in 1993 of the Uruguay Round of the GATT Multilateral Trade Negotiations, especially the adoption of the Agreement on the Application of Sanitary and Phytosanitary Measures in 1993, added further incentive to international trade in irradiated foods.6 In particular in developed countries, rising levels of morbidity and mortality resulting from food poisoning are seemingly difficult to arrest, and are becoming of increasing public concern. Although known for many years, public realization that irradiation could quickly and greatly reduce food poisoning has been slow, but there is now evidence that consumer acceptance for such important food hygiene measures is growing. The debate has resulted in universal requirements for clear labelling, and it is certain that there will continue to be steady movement towards international harmonization.

12.5.9 Sources of further information and advice The International Atomic Energy Agency (IAEA) is the major source of information on food irradiation worldwide, and regularly generates up-to-date summaries of international regulations regarding labelling. The Joint FAO/IAEA Division of Nuclear Techniques in Food and Agriculture and the International Consultative Group on Food Irradiation (ICGFI) can be contacted at: Wagamerstrasse 5 PO Box 100 A-1400 Vienna Austria Tel: +43 1 2600-21638 Fax: +43 1 26007 ICGFI home page: http://www/iaea.org/icgfi Major coverage of all technical aspects of food irradiation is given in the major three volume publication: eds. Josephson ES and Peterson MS, Preservation of Food by Ionizing Radiation, Vols I–III, Boca Raton Fa. CRC Press 1983 and in Urbain WM, Food Irradiation, New York, Academic Press, 1982. Safety aspects of irradiated foods are fully dealt with in: Diehl JF, Safety of Irradiated Foods, 2nd ed. New York, Marcel Dekker, 1995.

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233

An alphabetical reference guide to food irradiation, uses, safety, terms employed, etc., is given in: Wilkinson VM and Gould GW, Food Irradiation: a Reference Guide, Abington, Woodhead Publications Ltd, 1998.

12.5.10

References

1. WHO Report of a Joint FAO/WHO/IAEA Expert Committee, Wholesomeness of Irradiated Food, WHO Technical Report Series No. 604, 1977. 2. WHO Report of a Joint FAO/WHO/IAEA Expert Committee, Wholesomeness of Irradiated Food, WHO Technical Series No. 659, 1981. 3. WHO Review of the Safety and Nutritional Adequacy of Irradiated Food, Report of a WHO Consultation, Geneva, WHO, 1994. 4. FAO, Codex General Standard for Irradiated Foods and Recommended International Code of Practice for the Operation of Radiation Facilities used for the Treatment of Foods. CODEX STAN 106-1983. In CODEX ALIMENTARIUS-General Requirements, 2nd ed. Rome, FAO, 1992. 5. Joint FAO/IAEA/WHO Study Group on High Dose Irradiations. Weekly Epidemiol Rec, Jan 16, 1998. 6. Loaharanu P, ‘Food irradiation: current status and future prospects’, in Gould GW, ed. New Methods of Food Preservation, Glasgow, Blackie Academic and Professional, pp. 90–112, 1995. 7. Patterson M and Loaharanu P, ‘Irradiation’, in Lund BM, Baird-Parker AC and Gould GW ed. The Microbiological Safety and Quality of Food, Gaithersburg MD, Aspen Publishers Inc, pp. 65–100, 2000. 8. ACINF, The Safety and Wholesomeness of Irradiated Foods. Advisory Committee on Irradiated and Novel Foods, London, HMSO, 1986. 9. IAEA, Irradiation of poultry meat and its products. A compilation of technical data for its authorization and control. Geneva, IAEA-TECDOC-685, pp. 76–77, 1993. 10. ICGFI, Labelling of Irradiated Foods. 14th, 15th and 16th Meetings of the International Consultative Group on Food Irradiation, Vienna, IAEA, 1997, 1998 and 1999. 11. FAO, Codex General Standard for the Labelling of Prepackaged Foods. CODEX-STAN 106-1985 as amended in 1991. 12. Directive 1999/2/EC of the European Parliament and of the European Council of 22 February 1999 on the approximation of the laws of Member States concerning foods and food ingredients treated with ionising radiation. Off J Eur Com L66, 16–25, 1999. 13. FDA, ‘Irradiation in the production, processing and handling of food; final rule’. Fed Reg 55FR 14415, 18 April 1990. 14. ‘Red meat irradiation proposal is compatible with HACCP, calls for less stringent labelling’. Food Chem News, Feb 22, 18–19, 1999. 15. Canadian Food and Drug Regulations CRC, C.870, 1998. 16. The Food (Control of Irradiation) Regulations 1990, SI 2490, London, HMSO, 1991. 17. Guidelines on the Food (Control of Irradiation) Regulations 1990, London, HMSO, 1991.

12.6 Label problems for blind and visually impaired people J. Ralph Blanchfield, Food Science, Food Technology and Food Law Consultant 12.6.1 Outline of the problem This is a brief account of efforts to solve what has proved so far to be an intractable problem – how can blind and visually-impaired people (VIPs) gain access to information on food labels, especially that crucial to food safety? When the VIP arrives home with a variety of food packages, what is each one? Should it be stored in the larder, refrigerator or freezer? How long can it safely be kept? How should it be prepared/cooked for eating? Similar questions arise when it is a matter of (literally) blind selection of an item from home storage for consumption. Many VIPs live alone; even those who have the help of a sighted person at times often do not have it at a convenient time. While they often receive in-store help in selection of purchases, a scheme which enabled them to cope at home that could also help them to shop independently would provide an extra advantage. Such a scheme must involve a system to convert printed label information into a form perceivable by VIPs. The possibilities of such a scheme were extensively researched in 1991–1995 by a Joint

234

Food labelling

Working Group (JWG) instigated by the Institute of Food Science & Technology (IFST), also involving the Royal National Institute for the Blind (RNIB), the Guide Dogs for the Blind Association (GDBA) and the British Computer Association of the Blind (BCAB), with representatives from the Ministry of Agriculture, Fisheries and Food, the Article Number Association and Campden & Chorleywood Food Research Association.

12.6.2 Potential methods Braille The Group started by listing the criteria that any method must fulfil – some obvious, some less so – and began examining potential methods. Initial thought that the latter could be a choice of braille or very large print were invalidated by the information from RNIB that, of around one million blind and partially-sighted people in the United Kingdom, only about half can read very large print and a maximum of only 20,000 can read braille. In the region of half a million can read neither. It quickly became clear that the only possibility was a scheme based on substituting sound for vision, i.e. acquiring the printed information in electronic form and converting it into speech. This, of course, would not help those who were deaf as well as blind; but a scheme which helped most of those concerned was better than no scheme. The technology already existed for synthesising speech from electronic data. The problem was to find a method for acquisition of the label data. Optical character recognition The Group investigated the possibility of using optical character recognition (OCR) textscanning, a technique using a flat-bed or hand-held scanner, well-established as a means of importing printed text or graphics directly into computer files. This method would not only avoid the creation and updating of a massive database of information, but would have many valuable uses for VIPs, far beyond its use in connection with food labels. However, this proved to be non-viable for the purpose. Even when scanning a perfectly flat page, reasonably accurate acquisition by a hand-held scanner needs an even speed of movement of the scanner across the page and a very steady hand, which many blind people living alone and who may be elderly would not have. Even the best text scanning produced typographical errors which speech synthesis renders as gibberish. Then there are the problems of presenting the scanner squarely to the text when one cannot see it; of the complex mixtures of graphics and varying fonts, typefaces and sizes encountered, sometimes with text running in two directions; of variations in colour contrast and gloss; of the wide variety of shapes of food packs, including cylinders, tubes, truncated cones, flexible packs of various shapes and nominal planes which are uneven; and of the difficulty of selecting only brief information when required. Even with possible future advances in scanning technology, this technique did not seem to be a solution to label data acquisition. Other scanning methods Many ideas for other approaches were considered, some depending on universal adoption of an additional device on all food packs (an extra bar code or a hologram, or a scannable complex of ‘allophones’, in each case with all the product information coded in it). The Group took the realistic view that such universal adoption would not happen except in the event of some presently-unforeseeable commercial imperative, such as that which led to the (quite slow) introduction of present bar codes; and therefore rejected additional pack device schemes.

Special issues in food labelling Table 12.3

235

Criteria that must ideally be fulfilled by an acceptable system

Factor

Requirements

Cliente`le

Must cater for VIPs including those without sighted assistance, who can read neither braille nor large print.

Ease of use

Must be compact, lightweight, easily portable and usable by VIPs.

Locations of use

Must be usable in any food shop (whether large supermarket or small corner store) without causing disruption, and in the home at any time from arriving home with the foods until they are required for use.

Foods covered

Must apply to imported as well as UK-manufactured food products, whether branded or own-label.

Data provided

Must provide all relevant information relating to a food, and in a uniform way.

Data acquisition

Must be able either to ‘read’ the information on any food package/label or instantly to obtain from a database all relevant information about any selected food product, in either case delivered in the form of speech.

Database update

If accessing a database is used, the database must be updatable at frequent intervals to accommodate new products.

Data selection

Must be capable of providing a choice, selected by simple and easily operated means, of brief information (product identity, where to store the food and how long it can safely be kept) or full information about the food.

Cost

The whole system (including hardware and software) must be made available to VIPs at a cost within their means, whether by subsidy, sponsorship or other means.

Table reprinted, from, Food Control 1993, 4(4), Blanchfield, J R ‘Food Labelling for the Visually Impaired’, pp. 178–180, with permission from Elsevier Science.

Scanning and database methods By elimination, the remaining option was to use existing bar codes on food packs, the scanning of which would address a database and retrieve the relevant information to convert to speech. This enabled further elaboration of the criteria to be fulfilled, as shown in Table 12.3. Ideally all the information on food products (except ‘best before’ or ‘use-by’ dates, which of course would require a different bar code for each day’s production of a product) would be in a database, accessed by reading a product bar code, and delivered to the user as synthesised speech. For the user, in one of several schemes, it would involve a hand-held bar code scanner operated by a single button, a shoulder-slung equivalent of a portable CD player with speech module, and an earplug. With an experimental set-up and a small database of products and product information, this was shown to be feasible and it even proved possible to train a completely blind person to find and scan the bar code without undue difficulty. Beyond that lay the problems of translating the model system into a commercially available unit, designing, compiling and updating the database, and the economics and logistics of making it accessible. Contrary to much popular belief, the normal bar code contains no information but manufacturer and product identity. When scanned at a retail check-out, it triggers the

236

Food labelling

extraction, from the retailer’s own in-store database, of that and other information for printout on the till receipt, while simultaneously subtracting one unit from the stock control total for that product in the database. Such databases do not contain detailed label information. The proposed system would, therefore, have to be provided with a database containing information that exists scattered among tens of thousands of food product labels/packages and scattered in the records of thousands of food manufacturers, may largely exist in the combined records of the largest retailer groups, but does not currently exist in any publicly or privately existing database or compilation. As the system cannot provide the ‘best before’ or ‘use-by’ date, any database would have instead to be provided with ‘Use within x days (months, years) of purchase’ data relevant to the type of product. Particularly for more perishable products with ‘use-by’ dates, as there is no way for the system to know how near the purchase date is to the ‘useby’ date, the ‘use within . . .’ information in the database for each product would have to be on a prudent basis. The undoubtedly daunting prospect of compiling and updating such a huge database prompted suggestions of individual databases of a small number of products, perhaps on ‘smart cards’, on the basis that most people’s regularly purchased food products number somewhere in the 100–200 range. On examination, however, there were innumerable snags, not least the mind-boggling prospect of compiling, issuing and updating a vast number of individually tailored databases (from what source but a central huge database?), or the even more mind-boggling alternative suggestion that the VIPs would compile their own databases (how?) or have a sighted next-door neighbour do it for them. If a database could be provided, there follow the very considerable problems of translating the model system into a commercially available, low cost, easily operable unit, and of overcoming a variety of detail complications (such as the rate at which new products come into the shops, and the fact that there are rare instances where the same bar code may be used by retailer A for his own-label product B, as retailer C uses for his own-label product D); of designing, compiling and updating the database; and of the economics and logistics of making the system accessible to VIPs, most of whom are below average income for their age-group, and many of whom have only small savings. Discussion with the major supermarket groups and a major food market research organisation to establish, in principle, whether a scheme could be developed to utilise existing databases at least to provide product identity, led to the discovery that all use abbreviations, which are inconsistent between the groups, inconsistent from store to store within a group, and even inconsistent within a store – and such abbreviations are rendered by speech-conversion as gibberish. It remains to be seen whether the concept will ever be put into practice, even to achieve the limited objective of product identity. The main purpose of IFST and the JWG had been to arrive at a potential scheme for which the science was already there and the technology to put it into effect was available or within reach. The IFST involvement was through voluntary spare-time effort by working food scientists and technologists. To bring the concept to fruition and maintain it, however, would require, on the part of the food manufacturing and retailing industries, the electronics and computer industries and government, a great deal of goodwill, ingenuity, and resources of effort, information and money. The purpose of this account is to indicate avenues already explored and the (so far) intractable difficulties to be overcome. It may be that the recent I-Label initiative (see Chapter 14, page 264) will, in the course of time, provide an addressable database, at least for information on products handled by major retailers.

13 Determining shelf-life C. M. D. Man, South Bank University, London

13.1

What do we mean by ‘shelf-life’?

13.1.1 Introduction Shelf-life is an important property of food. The UK Institute of Food Science and Technology (IFST) defines shelf-life as the period of time during which the food product will (i) remain safe; (ii) be certain to retain desired sensory, chemical, physical and microbiological characteristics; (iii) comply with any label declaration of nutrition data, when stored under the recommended conditions.1 It is clear, therefore, that practically everyone involved in the supply, storage and consumption of food should have an interest in the shelf-life of food. And, if a food product, for whatever reasons, fails to meet any of the criteria given in the IFST’s definition, the consequences could be very grave indeed. Whether or not a food product will be successful commercially depends a lot on its ability to generate repeated purchase. If the quality of a food product becomes unacceptable before the end of its shelf-life, consumers are unlikely to be encouraged to buy it again. This is particularly so if there are already competing products available. The situation will be even more severe if the product becomes unsafe within its shelf-life. Even if the manufacturer can mount an effective and timely product recall, significant costs will have been incurred not to mention the likely effect on the reputation of the company. Worse still, if the product were to cause food poisoning or death, it could mean the end of the company as a business. In addition, it is very probable that the company would have to face prosecutions by the enforcement agency and/or litigation brought by relatives of the victims. In view of these potential consequences, it is inconceivable that any responsible food business, be it an importer, packer, manufacturer, distributor or retailer, will not take the shelf-life of its products seriously and do everything possible to determine them accurately.

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Food labelling

Basically, the responsibility of determining the correct shelf-life rests with the manufacturer who makes the product or in the case of fresh produce and dry foods, the packer who packs the product. Of course, others, such as the raw materials supplier, can also play an important part in the establishment of the optimum shelf-life. Retailers, too, have a greater responsibility towards determining the shelf-lives of their own-labelled products than those of branded ones. The stating of a shelf-life on a food product, an indication of its minimum durability, is a legal requirement – a mandatory food labelling requirement within the European Union (EU). It does form a contract between a food company and its customers that, provided the food is stored according to the recommended storage conditions, it should last at least as long as its stated shelf-life. In order to be confident of its statement, the company will need to have done the necessary work in determining the correct shelf-life; the stating of a product shelf-life does imply that this is so. Given that all the other parties have played their parts, consumers do have a vital role to play as well. The latter includes handling the food properly, and storing and using it according to instructions so that it can be enjoyed as intended. No amount of scientific work and testing can assure the reproducibility of the shelf-life of a food product if it were to be abused by the consumer. The consumer must acknowledge this and act accordingly. This is particularly critical in the case of products that are designed for multiple use. Everyday food products such as tomato ketchup and vegetable fat spread now carry instructions such as ‘refrigerate after opening’ and ‘store in the refrigerator’, respectively. Clearly, if these products are to survive their best before dates, consumers must follow closely the storage instructions provided on the packs.

13.1.2 The ways food deteriorates and spoils There are a few foods and drinks, such as some cheeses and wines, the acceptability of which, though not indefinitely, is known to improve on storage (i.e. ageing) but they are the exceptions. Other than these, it is a fact of life that the quality and acceptability of most food decrease on storage, even under optimum conditions. It is now known that there are many factors which affect how long a food lasts, i.e. how long its shelf-life is going to be. These factors are usually divided into two types, namely, intrinsic and extrinsic factors. Intrinsic factors are raw materials, product formulation and composition, product make-up, water activity value, pH value and acidity, and composition of inside-pack atmosphere. Extrinsic factors are processing, hygiene, packaging materials and systems, storage, distribution and retail display. These independent factors may interact in practice and their combined effect can be synergistic or antagonistic. As pointed out before, the consumer factor, the handling and use by the consumer, is very much a poorly-studied factor which can adversely affect the shelf-life of food. Table 13.1 gives examples of important parameters of the intrinsic and extrinsic factors affecting the shelf-life of food. While in reality more than one factor may be at work, it is unusual to see all the factors, both intrinsic and extrinsic, having some significant influence on the shelf-life of a food product. Understanding the nature and behaviour during storage of a food product will assist in the identification of the relevant factors affecting its shelf-life. Once identified, these factors will need to be controlled so that the intended shelf-life can be assured and maintained consistently. For instance, the shelf-life of a low-acid canned food that has been given an adequate scheduled heat process is often very long. However, this shelf-life can only be maintained if the microbiological quality of the ingredients used is within agreed and acceptable limits. If, for whatever reasons, ingredients with

Determining shelf-life Table 13.1

Intrinsic

Intrinsic and extrinsic factors and examples of important parameters Factors

Parameters

Raw materials Product formulation Product make-up Water activity value pH value and acidity

Microbiological counts Presence and level of preservative Presence of a moisture barrier Equilibrium relative humidity (%) Presence and level of organic acid, e.g. acetic acid

Composition of inside-pack atmosphere Extrinsic

239

Processing Hygiene Packaging materials and systems Storage, distribution and retail display

Carbon dioxide (%) Severity of thermal processing Environmental microbial counts; effectiveness of plant cleaning and disinfection Water vapour transmission rate of the materials; use of aseptic system Duration of storage, conditions of distribution and display, e.g. environmental temperature, type and intensity of light, etc.

microbial loads higher than the maximum acceptable limits (i.e. out-of-specification/substandard ingredients), were used, then it is unlikely that the designated shelf-life will be kept. In a similar way, poor plant hygiene and ineffective cleaning and disinfection regimes are known to have caused an aseptically processed and packaged soft drink to ferment and spoil before its best before date, resulting in substantial financial loss to the company concerned.2 Besides identifying the major factors affecting the shelf-life of a food product, it is important to know the mechanism by which it deteriorates or spoils, although in some cases, this may not be possible, or at best the mechanism can only be understood poorly. Nevertheless, much knowledge of food deterioration has been gained and most food spoilage can be explained by one or more of the following mechanisms: • • • • •

moisture/water vapour transfer physical transfer other than that of moisture/water vapour chemical/biochemical changes light-induced changes microbiological changes

Many food products are sensitive to transfer of moisture or water vapour. Depending on the nature of the product, either a gain or loss of moisture (or water vapour) can reduce the acceptability of the food and limit its shelf-life in due course. There are many examples of food products that behave in this manner. These include fresh leafy vegetables which become wilted and unattractive as they continue to lose moisture to the atmosphere, and sweet biscuits which begin to lose their characteristic crunchiness as they pick up moisture from the atmosphere. In both cases, suitable packaging can be employed to slow down the transfer process but a complete elimination of the transfer is usually either not feasible or prohibitively expensive. Even products such as powdered malted chocolate drink, that have been processed and formulated to give a very long shelf-life (up to two years under ambient conditions) will eventually cake as a result of gradual moisture pick-up, losing their free-flowing property after continued use over a long period of time. This kind of deterioration is not confined to ambient storage; it also

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occurs at chilled as well as frozen conditions, albeit at a much reduced rate. Thus the wafer component in an ice cream cone, an ice cream sandwich or similar product will become soggy and chewy as a result of water vapour transfer from the ice cream unless a barrier, usually in the form of a fat-based chocolate-like coating, has been applied to the surface of the wafer component in direct contact with the ice cream. Moisture/water vapour changes, too, can induce food deterioration by other mechanisms such as mould growth (e.g., in an ambient packaged fruit pie) or oxidation (e.g., in intermediate moisture foods). Due consideration, therefore, must be given to the possibility of interactions between different mechanisms, giving rise to mixed and/or cascading effects. Most food products are packaged in some way and their quality and hence shelf-life can be affected by the packaging materials with which they are in contact as well as by the barrier properties of the materials. This is particularly significant with plastics materials and can lead to, for example, a gradual loss of carbon dioxide (i.e. pressure and fizziness) over time from carbonated soft drinks causing these products to become stale and flat. Flavour/aroma compounds in foods, too, are known to be absorbed by polymeric packaging materials. This phenomenon, called flavour scalping, can result in loss of flavour intensity or the development of an unbalanced flavour profile, either of which may reduce the perceived product quality and consumer acceptance. Much research has been conducted to investigate flavour scalping phenomena in food products; it is hoped this will eventually lead to shelf-life problems associated with them being minimised or eliminated in the future.3 Packaging materials, especially plastics, also contribute towards packaging migration which may give rise to off-flavour and/or safety problems. Indeed, in the UK (and in other Member States of the EU), such migration in food is controlled by the Materials and Articles in Contact with Food Regulations 1987 and their subsequent amendments. Premature termination of shelf-life as a result of the product picking up offflavour from the transport/storage environment can cause enormous difficulty as the exact source of contamination is often dependent on the environment and not easy to trace.4 Most chemical and biochemical reactions that occur in foods, both during processing and subsequent storage, are undesirable and have a definite impact on the shelf-life of the food in question. Examples of these reactions include lipolytic/hydrolytic rancidity, oxidative rancidity, chemical hydrolysis, Maillard reaction (non-enzymic browning) and product/packaging interactions. Depending on the product involved, these reactions often result in deleterious changes in the colour, flavour or texture of the food, limiting its shelf-life. In general, two types of colour changes can occur in foods: those due to pigment degradation and those due to discoloration reactions. All natural pigments are unstable; the extent of degradation and hence colour loss depends on the conditions to which the food is exposed during processing and storage. In order to achieve the required shelf-life, the most common solution is to add a permitted artificial colour that is usually more stable in the food in order to compensate for the loss of the natural colour. The causes of discoloration reactions in foods are varied, so are the end products of these reactions. Blackening of cook-chilled potatoes, which is unappealing, has been shown to be caused by complex formation between phenolic compounds and ferrous ion in the presence of air. Brown discolorations, often due to the reaction between reducing sugars and aminoacids (Maillard reaction), can occur in dehydrated fruits and vegetables. Pinking in readycooked white meat (e.g. turkey) combined with part-cooked vegetables is known to be due to the formation of nitrosomyoglobin which is pink in colour. Resolving shelf-life problems such as these will require an adequate understanding of the underlying mechanism as the solution is often product-specific.

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Rancidity and rancid flavour formation, on the other hand, are mainly associated with oils and fats and fatty foods, although in some cases, the oil/fat does not need to be present at a particularly high level as in the case of instant potato powder. One of the better known product/packaging interactions is that which takes place in food products of intermediate acidity (pH 4.0–5.5) packed in plain tinplate cans. During storage, the food acquires varying amounts of tin from the can surface by corrosion processes which are promoted by factors such as the presence of oxidising agents (e.g. headspace oxygen), nitrate and sulphur dioxide. In the UK, the Tin in Food Regulations 1992 impose a maximum tin content of 200 mg/kg in food packed in this way. This level of tin has since become a logical end point by which the shelf-life of this type of canned foods may be set. When the tin contents of the latter have been found to exceed the legal limit, the only option open to the manufacturer/retailer may be a voluntary product recall in order that its reputation and the well-being of its customers can be safeguarded.5,6 Besides lipid oxidation, there are other shelf-life limiting changes that are induced by light. The most well known of these is the degradation of certain vitamins, notably ascorbic acid and riboflavin. In products where the levels of such vitamins are given as nutrition information, it is common industry practice that overages are used to ensure that the label declarations regarding the levels of the various vitamins added are complied with up to the best before date, at least for the unopened pack.7 Recently, it has been shown in model food systems that the situation can be extremely complex and the estimation of residual vitamin levels difficult to make when there are more than one vitamin present.8 Where appropriate, the exclusion of light by the use of suitable packaging materials remains an effective means of protecting vitamins in food from early degradation. While the microbiological changes in products such as fermented foods (e.g. fermented sausages) and some functional foods (e.g. bioyoghurt containing Bifidus essensisÕ cultures) are beneficial and encouraged, microbiological changes that result in spoilage or food poisoning are to be avoided. Consequently, a main objective of all methods of food preservation, both traditional and modern, is to achieve microbiological safety and stability in the food to be preserved. It is worth remembering, as already mentioned, that microbiological spoilage can arise unexpectedly due to changes caused by a different mechanism such as moisture migration in a multicomponent food product. The use of an exotic ingredient too, such as fresh herbs, in an otherwise microbiologically stable product like potato crisps has resulted in unusual shelf-life problems. It is now generally recognised that the responsible application of good manufacturing practice (GMP) principles which incorporate the use of an appropriate food control system based on the internationally agreed principles of hazard analysis critical control point (HACCP) is the most cost-effective way of assuring microbiological safety in food.9 Of course, the same approach can be adopted to assure chemical and physical safety as well as to build quality and the required shelf-life into a food product. Not only is understanding the predominant mechanism of deterioration in a food product fundamental to the determination of its shelf-life, but it is also important to the maintenance and increasingly, the extension of a product’s shelf-life. The successful use, in recent years, of combined preservation methods to give significantly longer shelf-lives, such as washing, chilling and modified atmosphere packaging of ready-to-eat fresh salads, and pasteurisation, chilling and microfiltration of milk, is testimony to the good understanding of the deteriorative mechanisms in these products. Temperature, the important environmental factor that affects food quality and shelflife, has a major influence on all the above mechanisms. Microorganisms have different

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optimum temperatures for growth such that very different microflora can colonise a given food at different temperatures. Temperature can affect the rates of diffusion of moisture, gases and vapours and in general, it tends to speed up the rates of chemical reactions including those that are detrimental to the shelf-life of foods. The latter, in essence, is the basis of accelerated shelf-life determination based on the use of elevated storage temperatures to be discussed later. The importance of temperature consideration in the determination and extension of shelf-life cannot be overemphasised.

13.2

Introducing the main categories of product

In the context of shelf-life determination and for the sake of simplicity, food products may be grouped into different categories in respect of the lengths of their shelf-lives under specified conditions. This classification, however, is not absolute. Some products within a category may have shorter-than-average shelf-lives (e.g. fresh sandwiches), and in a different category, others could have longer shelf-lives but for commercial reasons (e.g. potato crisps). Also, for a given food, the combination of the preservation and processing methods used can have a profound influence on the shelf-life of the end product. For instance, freshly squeezed orange juice has a few days refrigerated shelf-life only; mildly pasteurised orange juice has a slightly longer refrigerated shelf-life; canned or bottled orange juice has a much longer shelf-life at ambient temperature and concentrated orange juice has the longest shelf-life of all when frozen and stored at 20ºC.

13.2.1 Products with a short shelf-life This category includes products with a shelf-life of a few days to a few weeks. Many of the products within this category have to be kept refrigerated between 0ºC and +8ºC in order that their shelf-lives can be maintained.10 These include many of the prepared and ready-to-cook as well as ready-to-eat meals and main dish accompaniments, milk and dairy products, fresh cream desserts, fresh sandwiches, meat and fish products, and vacuum-packed and modified-atmosphere-packed delicatessen products. Because they are microbiologically highly perishable (i.e without temperature control, they may support the growth of pathogenic bacteria or the production of their toxins), within the EU, they are legally required to carry a ‘use-by’ date together with any special storage conditions or conditions of use. There are ambient representatives within this category, however. These are, for instance, the different types of bread, packaged cakes and pastries which, though of a short shelf-life, are in the main to be stored under ambient conditions. And, since staling and other forms of non-microbial deterioration are the usual shelf-life problems rather than microbiological changes with the exception of mould growth, baked goods in the EU carry a ‘best before’ and not a ‘use-by’ date.

13.2.2 Products with a medium shelf-life This category includes products with a shelf-life of a few months to a year. Products within this category include those that can be stored under ambient conditions as well as some that need to be refrigerated. Examples of the former are speciality flat breads that are packed in a protective atmosphere (e.g. pittas), savoury snack foods (e.g. potato crisps, cereal bars, biscuits, chocolate confectionery and soft drinks); examples of the

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latter are the different types of vegetable fat spreads that are to be kept refrigerated throughout their shelf-lives. In the EU, all products within this category carry a ‘best before’ date.

13.2.3 Products with a long shelf-life This category includes products with a shelf-life of a year or longer. Products within this category include those that are ambient shelf-stable and commercially sterile because they have been adequately heat-processed either conventionally or aseptically, those that have been preserved compositionally (e.g. fruit preserves and vinegar-containing sauces), those that have been adequately dehydrated (e.g. breakfast cereals), and those that are frozen and stored as such (e.g. frozen vegetables and ice cream). Almost as a rule, when correctly stored, products within this category are microbiologically stable and nonmicrobial changes are the main reasons that cause their shelf-lives to end eventually. Within the EU, they all carry a ‘best before’ date as an indication of their minimum durability. As mentioned earlier, while the sensory/eating quality of most food products invariably deteriorates after manufacture, albeit very slowly in the case of products with a long shelf-life, the quality of some cheeses and wines actually improves on maturation. Nevertheless, once the optimum quality of these products has been reached, be it a fuller body, a richer flavour or a combination of much desired attributes, a definite shelf-life will follow, which can range from medium to long, depending on the product.

13.3

Principal ways of determining and estimating shelf-life

Broadly speaking, there are two principal ways of determining the shelf-life of a food product. These are direct determination and indirect estimation and prediction. As seen later, both have their advantages and limitations. During the development of a new product or the modification of an existing one, either approach or both can be employed generating valuable and complementary information about the shelf-life of the product being studied. It must be emphasised that the success and validity of both ways of shelflife determination crucially depend on the correct identification of the factors affecting the shelf-life of the product in question. These factors in turn govern the type(s) of mechanism by which the process of deterioration eventually reveals itself, either as microbiological, biochemical/chemical, physical or sensory changes or a combination of them. The point in time at which these changes have caused the product to become unacceptable for safety, quality or any other reason is the end of its shelf-life and has to be determined. This determination, carried out either directly or indirectly, is primarily the central and common objective of all shelf-life studies. While the actual work involved in the determination or estimation of shelf-life is understandably product-specific, the activity itself is undoubtedly an essential part of every product development programme. Naturally, if the latter is to do with line extension or a modification of an existing product (e.g. recipe improvement), the amount of work required may be much less than that for a totally new one. Nonetheless, the ability to carry out such work depends on the availability of relevant and up-to-date technical expertise and facility. Clearly, it is far more cost-effective and convenient in the long run to have available in-house these resources than to purchase them from an outside service organisation every time a shelf-life determination is needed. Obviously, as shelf-life

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determination is such an integral part of product development, the life-blood of every food company, it makes sense, both technically and commercially, for every food business to possess its own shelf-life determination capability. Moreover, by carrying out the work itself, a food business will have produced valuable objective evidence in the form of project briefs, documented experimental protocols, laboratory results, records of shelf-life data and the like to prove, should the need arise, that it has taken the necessary precautions and exercised all due diligence insofar as establishing the shelf-lives of its products goes. Indeed, a high level of confidence in product safety and an adequate and reproducible shelf-life do not happen by chance. Proper and correct determination of shelf-life ensures that safety and the required quality will be built into a product, a worthwhile investment that will reward the company with continued success in the marketplace.

13.3.1 Direct determination of shelf-life As expected, this approach to determining shelf-life involves keeping the product being studied under controlled storage conditions until it has become unacceptable. Like all shelf-life determinations, conducted by whatever ways, the main objectives here are to obtain accurate information about the changes in product safety and quality over time, and to establish as reliably as practicable at what point in time these changes cause the product to be unacceptable to the consumer. In general, the selected storage conditions should include both fixed condition environments and environments with simulated or fluctuating conditions. The actual storage conditions will depend on the product being investigated as well as the amount of knowledge a company has about the projected distribution chain through to end use. Ideally, fixed conditions should cover all of the following conditions: • optimum conditions: the most desirable conditions of temperature, humidity, light and so on; storage under these conditions should provide the most optimistic shelf-life data • typical or average conditions: the conditions most commonly experienced by the product; storage under these conditions should provide shelf-life data that apply to the bulk of production most of the time • worst case conditions: the most extreme conditions that the product is likely to encounter; storage under these conditions should provide the most conservative shelflife data which, if used to assign a shelf-life, should give it a margin of safety ensuring that product failures due to insufficient shelf-life are highly unlikely in practice.

In determining shelf-life directly, a number of fixed conditions are commonly used: • frozen: 18ºC or lower (relative humidity is usually near 100%) • refrigerated: 0 to +5ºC, with a maximum of +8ºC (relative humidity is usually very high) • temperate: 25ºC, 75% relative humidity • tropical: 37ºC, 95% relative humidity.

As an illustration, for determining the shelf-life of a packaged cake in the UK, temperatures of 30ºC (and 75% relative humidity), 21ºC and 15ºC may be used as the worst case, typical and optimum conditions, respectively. By including a worst case condition that is likely to be encountered during the summer months, a shelf-life can be set that will reduce the chance of mould growth right through the year to a minimum. Alternatively, a longer shelf-life based on the typical condition may be assigned to the

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product, which is reduced specially for the summer months to a mould-free shelf-life, achieving the same objective. Very often, control products need to be available alongside the products being stored to enable comparisons to be made. There are a number of possibilities. Fresh products can be made or obtained every time a comparison is required or products stored under optimum conditions can be used as controls since they are expected to deteriorate at a slower rate. For products that do not change appreciably when frozen and are unaffected by thawing, freezing can be a very practical and convenient way of keeping products as controls. While fixed storage conditions are easy to set up, simulated or fluctuating conditions are more difficult to create, both because of the special facility demanded and of the detailed knowledge required concerning the conditions the product will face from the point it leaves the factory through to consumer use. Basically, simulated or fluctuating storage makes use of a programmed storage facility that creates a set of artificial conditions (e.g. lighting coming on and off on a regular basis) that mimic the real-life conditions experienced by the product. Obviously, such a facility will be expensive to set up and also, if there are gaps in the knowledge about the real-life conditions, inaccurate shelf-life data will result. Because of these and other reasons, simulated storage is less common than fixed condition storage for the direct determination of shelf-life. All shelf-life determinations begin with an evaluation of the product with respect to food safety. This is because an unsafe product can never be a quality product and determining the shelf-life of such a product can hardly be a useful exercise. And, since sensory evaluation which can involve product tasting is inevitable at some stage, establishing that the product is safe to eat at the earliest opportunity is vitally important. Nowadays, the most useful and powerful tool for assuring food safety is the one based on the internationally recognised HACCP principles. Details concerning the application of HACCP principles are beyond the scope of this chapter. Suffice it to say that when used correctly, the HACCP technique is a preventative, systematic and comprehensive food safety assurance tool which is as effective in identifying and assessing food pathogens as in dealing with harmful chemicals (e.g. cleaning chemicals) and foreign objects (e.g. sharp broken stones in canned fruit). Thus, with few exceptions (such as microbiological challenge testing), laboratory analyses and examinations can rarely be used on their own to provide the necessary confidence in the safety of a food product. Once the safety of a product has been evaluated and confirmed, determination of its shelf-life can follow. The direct determination of shelf-life invariably involves storing a sufficient number of samples of a food product under fixed conditions (e.g. 0 to +5ºC for chilled foods or 19 to 23ºC for a savoury snack) and evaluating their quality at appropriate intervals until such time as the product has been judged to be unacceptable, that is, it has reached the end of its shelf-life in respect of the storage conditions used. It cannot be overemphasised that correct identification of the shelf-life limiting factor(s), and hence an adequate understanding of the mechanism by which the product loses its quality, are crucial to the success of any shelf-life determination. Together they point to the relevant quality parameter(s) to be measured, which can be used to monitor the decline in quality as shelf-life progresses. The actual quality assessment will depend on the product but most certainly will include evaluation of some or all of its organoleptic quality attributes like appearance, texture, flavour and taste. A schematic representation of the direct determination of shelf-life is given in Fig. 13.1.

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Fig. 13.1 The direct determination of shelf-life – a schematic representation.

13.3.2 Indirect estimation and prediction of shelf-life The direct determination of shelf-life is only really practicable and applicable to products belonging to the short and medium shelf-life categories. There are reasons for this. Many product development activities, particularly those of new product development, and maybe even the decision to continue or abandon development, are inextricably linked with the outcome of shelf-life determination; it is unrealistic to employ the direct approach which may go on for two years or longer. Also, by definition, the direct way of determining shelf-life involves the use of pre-defined and controlled storage conditions. If, for whatever reasons, shelf-life data for different storage conditions have to be obtained, the determination will need to be repeated under the new set of conditions. These, together with competitive, economic and other reasons, have meant that an alternative (i.e. indirect) and invariably quicker way of determining shelf-life is necessary. Of course, if the product being studied is very similar to existing products already in production, educated guess and expert judgement based on in-house productspecific expertise as well as up-to-date knowledge in food science and technology can often be sufficient for arriving at an estimate of the shelf-life. It is good practice too, for a food company to retain representative samples regularly from production and keep them for their designated shelf-life under specified conditions even in the case of long shelf-life products; but this is not shelf-life determination per se and will not be discussed further. Unlike the direct way of determining shelf-life, the indirect approach tends to be far more product dependent and specific in its application. To date, there have been a number of ways of determining shelf-life indirectly and they are outlined below. Accelerated shelf-life determination As mentioned earlier (Section 13.1.2), one of the ways to speed up shelf-life determination is to accelerate the rate of deterioration by storing the food product in question at an elevated temperature. The data obtained are then extrapolated to normal storage conditions by using the Arrhenius equation. Thus, it has been established that storage at 37ºC results in an approximate four-fold increase in tin pick-up rate in foods packed in plain tinplate cans.11 Difficulty in extrapolation can arise, for example, if different mechanisms of deterioration are in operation at the different storage temperatures (i.e. ambient and elevated). A concise discussion of the various practical problems related to the use of accelerated shelf-life determination is given elsewhere.1 Of

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course, when the pattern of quality changes is the same during normal and accelerated storage as exemplified by a recent study comparing normal and accelerated storage of commercial orange juice packed in one litre TetraBrikTM,12 shelf-life changes in this case for a period of six to eight months at room temperature can be reproduced by 1–2 weeks’ accelerated storage resulting in significant saving of time. Accelerated shelf-life testing is by no means restricted to the use of elevated storage temperatures. Products such as mayonnaise, whose shelf-life are dependent on stability of the emulsion, may be subject to controlled shaking under specified conditions. Any structural instability, the consequence of a particular formulation for instance, which can take a long time to show up under normal conditions, can often be accentuated by using an accelerated procedure that has been validated. Use of mathematical models The use of mathematical models as a more rapid, economical, and therefore alternative way to the direct determination of shelf-life is not new. The safe thermal processing of many canned foods has been based for more than 70 years on models for microbial inactivation developed by Esty and Meyer in the 1920s.13 Over the years, a number of models have been developed and successfully used; a few examples of which are now described. The Preservation Index (PI) This is an empirical model put forward by Dakin14 that can be used to predict the stability of unpasteurised pickles and sauces. This model basically states that the minimum acetic acid content necessary to achieve the satisfactory preservation of all pickles and sauces is 3.6%, calculated as a percentage of the volatile constituents of the product. The index is represented by the following relationship: Preservation index ˆ (total acetic acid acidity  100†=…100

total solids†

The index applies essentially to traditional unpasteurised pickles and sauces only. It does not necessarily apply to more modern products which tend to contain less acetic acid (or vinegar), sugar and salt. Also, an index lower than 3.6% does not always mean instability if the product happens to contain a natural preservative and/or is to be heat-treated. The CIMSCEE model Included in this code, written by the Comite´ des Industries des Mayonnaises et Sauces Condimentaires de la Communaute´ Economique Europe´enne (CIMSCEE), are two formulae which can be used to establish safety and stability for sauces containing acetic acid derived from vinegar or directly used.15 The formulae are: 15:75…1

†…total acetic acid%† ‡ 3:08…salt%† ‡ …hexose%†

‡0:5…disaccharide%† ‡ 40…4:0

pH† ˆ s

for any sauce based on acetic acid, if the value of this formula (s) exceeds 63, safety from microbial pathogens is assured. 15:75…1 †…total acetic acid%† ‡ 3:08…salt%† ‡ …hexose%† ‡0:5…disaccharide%† ˆ  for any sauce based on acetic acid, if the value of this formula () exceeds 63, microbial spoilage should not occur. (1 ) is the proportion of the total acetic acid which is undissociated and is related to the pH of the sauce and the pKa of acetic acid.

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Like the PI, the CIMSCEE formulae have limited applications. They are mainly used for assessing shelf-life of ambient stable, low pH products and do not give accurate predictions for products which contain preservatives (natural or added) or in which factors such as water activity are shelf-life limiting. Estimation of mould-free shelf-life (MFSL) of cakes Based on a considerable amount of experimental work carried out at the former Flour Milling and Baking Research Association (FMBRA) in the UK, the following expressions have been established and can be used to estimate the MFSL of cakes stored at 27ºC and 21ºC respectively,16 provided their equilibrium relative humidities (ERHs) are known: Log10 MFSL (days at 27 C) ˆ 6:42 Log10 MFSL (days at 21 C) ˆ 7:91

…0:065  ERH%† …0:081  ERH%†

Since 1991, these calculations have been very much simplified by the launch of the ERH Calc program by FMBRA (now part of Campden and Chorleywood Food Research Association (CCFRA)), enabling the estimation of MFSLs of bakery products to be made using an IBM or compatible PC even before development work commences. A recent report suggests that the MFSLs of some 80% of cakes produced in the UK are now estimated by using this program.17 Square root model Proposed by Ratkowsky and co-workers,18 the square root model is a simple twoparameter empirical equation for the temperature dependence of microbial growth up to the optimum temperature (Topt): p k ˆ b…T Tmin † where k is the specific growth rate determined frompthe growth curve of the organism in question, b is the slope of the regression line of k versus temperature, T is the test temperature (in either ºC or K) and Tmin is the notional p microbial growth temperature where the regression line cuts the temperature axis at k ˆ 0. Ratkowsky et al.18,19 were able to show that the equation described accurately the growth rate data of many organisms. Fu and Labuza later reported that the square root model was the best model for describing the growth (covering lag phase and exponential phase) of Pseudomonas fragi in a simulated milk, when compared with the Arrhenius, Davey, linear and exponential models based on the criteria of r2 and mean square error (MSE).20 (r2, the coefficient of determination, is a measure of the amount of variation about the mean explained by the model and MSE is a measure of the experimental error.) Other models A large quantity of literature is also available on the modelling of shelf-life of packaged foods whose shelf-lives are limited by non-microbial mechanisms of deterioration such as moisture and oxygen-related changes.21 The majority of published models for these food products typically require prior knowledge of some critical level of moisture or oxygen that results in the product becoming unacceptable. Models have been built which make use of the kinetic rate equation. The latter, when combined with a suitable moisture sorption isotherm, can be used to model moisture mediated changes in foods.22 Modelling of shelf-life for packaged foods that are susceptible to oxidative deterioration is generally

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more complicated than that for moisture sensitive products. Models that describe other modes of food deterioration are also available. McMurrough et al. have developed a model that can be used to predict the shelf-life of lager beer and demonstrated, at least on pilot scale, that colloidal instability and formation of protein-polyphenol haze can be minimised while optimising shelf-life using this composition model for stability.23 In all cases, however, it is clear that the complexity of foods makes model validation with experimentally determined data crucial to any successful prediction of shelf-life. Use of predictive microbiological models Largely as a result of research work conducted in the UK, USA, continental Europe and Australia, predictive microbiological models that can predict not only microbial growth, but also survival and non-thermal inactivation have recently become available. Within the UK, a large research project (1989–1994), initiated and funded by the UK Ministry of Agriculture, Fisheries and Food (MAFF), has resulted in the production of Food MicroModel, a software package that will predict the growth, survival and thermal death of the major food pathogens and a number of food-spoilage organisms in a wide range of foods. The current package consists of 29 models, each of which is organism-specific.24 For some of the pathogens there are more than one model within the package, thus enabling the user to choose a model that closely reflects the food for which the prediction is being made. All models within Food MicroModel have been shown to generate predictions relevant to most food groups. In the USA, the United States Department of Agriculture (USDA) has also produced a predictive pathogen modelling program which is available free on the Internet (http://www.arserrc.gov/mfs/pathogen.htm). The program consists of a number of models, including gamma irradiation models for Salmonella typhimurium, E. coli 0157:H7 and ‘normal’ flora in meats. Predictive microbiological models, however, do have their limitations. In general, they give predictions based on the controlling factors used to create them. Consequently, if factors other than those used in the models are at work, predictions will be incorrect. Also, there is no facility for extrapolation of predictions to conditions beyond the limits of factors within which the models have been built. It is advisable to confirm all predictions using appropriate challenge tests and to seek advice from an experienced food microbiologist at the earliest opportunity. Because of the unequivocal need to assure microbiological safety in foods, the majority of predictive microbiological models have been based on food-borne pathogens. More recently, mathematical models for predicting microbial spoilage have also become available.25–27 The ‘Forecast’ system, available as an enquiry service from CCFRA, consists of a number of growth models of spoilage organisms, namely, Enterobacteriaceae, Pseudomonas species, Bacillus species, yeasts and lactic acid bacteria.27 It is understood that work is underway to enhance and expand the ‘Forecast’ system and it is likely that other sector/commodity-specific models will be developed to meet the increasing demand for rapid, accurate, reliable and cost-effective predictions of microbial shelf-life.

13.4

Future trends

While the direct approach will remain an established way of determining shelf-life, the trend is undoubtedly towards the use of models, in particular, predictive models if they are available. The development of the global consumer market, the need to develop

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products in very short times, and the ever-increasing need for food companies to use precious resources effectively are just a few of the reasons that have made predictive modelling of safety and shelf-life attractive and necessary. The use of predictive microbiological models to aid the application of HACCP principles to food manufacture is already taking place. This is a new phase in the development of HACCP, which will ensure good quality, systematic and objective information on which correct and sound decisions concerning microbial hazards can be based. As computer-based aids to HACCP are now a reality,28,29 HACCP studies integrated with predictive microbiology are expected to become popular. Brief mention has already been made regarding the possibility of different mechanisms of deterioration interacting in a food product (Section 13.1.2). While most shelf-life determinations, either direct or indirect, tend to concentrate on a single predominant mechanism, the reality is that a number of different mechanisms may be operating, leading to a competitive situation depending on the prevalent conditions. There is growing recognition that the optimisation of product shelf-life with respect to safety, nutrition, sensory quality and minimum unit cost will be highly beneficial from a commercial perspective.30 The spectacular growth of personal computers with everincreasing power and sophistication will in time encourage such optimisation through the judicious use of experimental design, data analysis and modelling programs, for the benefit of all.

13.5

Sources of further information and advice

The vast amount of information relating to the shelf-life of foods, both in the primary as well as secondary literature, has demonstrated the continuing importance of this field of food science and technology. Improvement in the scientific understanding of the storage behaviour of foods and drinks through advances in food science will undoubtedly lead to new possibilities for progress in the development of the scientific principles of shelf-life determination. This, in turn, will impact on the practice of shelf-life determination, bringing about more comprehensive approaches, more rapid and reliable methodologies and techniques as well as more accurate predictions in the future. The following sections outline some of the better known sources of information about the shelf-life of foods. These, however, are not intended to be exhaustive, perhaps revealing only the tip of the iceberg of information that is now available. Also, on-line sources of food science and technology information (e.g. Leatherhead Food Research Association’s FoodlineÕ databases) as well as the Internet are clearly becoming popular as they are comprehensive, up-do-date and easy to use especially when specific information regarding shelf-life is being sought.

13.5.1 Major journals in food science and technology Many original research papers on the shelf-life of foods appear from time to time in the primary literature, covering different aspects of shelf-life and reflecting the continued interest in the subject. Some of the well-known journals are : International Journal of Food Science and Technology (ISSN 0950-5423) This is the food science and technology journal of the IFST (UK), published by Blackwell Science Ltd. It offers a bi-monthly forum for original research papers in food science and

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technology. The journal is strongly science-based and is of wide interest to all involved in food science and technology. Food Research International (http://www.elsevier.nl/locate/foodres) This is the food science journal of the Canadian Institute of Food Science and Technology (CIFST). It offers a forum for the communication of original research in food science and is published in ten issues per year. Journal of Food Science (ISSN 0022-1147) This is the scientific publication of the American Institute of Food Technologists (IFT). It publishes peer-reviewed original research and critical reviews of all basic and applied aspects of food science for food scientists and other interested professionals. The journal is published bi-monthly.

13.5.2 Major references Over the years, a number of references on the subject of shelf-life have become available. These have tended to be multi-authored references, reflecting the many-faceted and multidisciplinary nature of the subject area. The following are a few useful titles. Shelf Life of Foods – Guidelines for its Determination and Prediction (ISBN 0 905365 11 1) This is a publication of the IFST (UK). It was written on behalf of the Institute by an ad hoc working group consisting of members of the Institute. It gives concise and useful advice to food business managers on the principles of shelf-life determination and prediction, at every point in the food chain. The booklet, some 70 pages in length, also explains the factors influencing the shelf-life of foods and the various mechanisms of deterioration in foods, which form the basis of the scientific principles essential to all evaluations of shelf-life of foods. Appendix 4 contains a list of useful references. Shelf Life Studies of Foods and Beverages – Chemical, Physical and Nutritional Aspects31 (ISBN 0 444 89459 4) This is a substantial reference (1204 pages) consisting of 40 chapters covering the shelflives of many foods (e.g. mushrooms), food products (e.g. extruded products) and beverages (e.g. tea, coffee). It is an update of a similar title, published seven years earlier, from the same editor and publisher. The bibliography is extensive. Shelf Life Evaluation of Foods32 (ISBN 0 7514 0033 5) This reference (321 pages) concentrates primarily on the shelf-life of foods, although much of what is covered, particularly that on the principles of shelf-life evaluation, is equally applicable to drinks. The book, divided into two parts, begins with five chapters reviewing the principles of shelf-life evaluation and goes on, in ten chapters, to illustrate these principles using a number of selected food products. Technical Manual No. 28: Evaluation of Shelf Life for Chilled Foods33 This document, first produced in 1990 by the CFDRA Shelf Life Working Party, was part-revised in 1997. It is intended to be used as an outline structure for the evaluation of shelf-life of chilled foods including ingredients and products for retail sale.

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13.5.3 Conferences and meetings Because of the importance of the subject, conferences, seminars and meetings on the various aspects of shelf-life are usually very popular and well subscribed. The IFST (UK) and the Society of Chemical Industry jointly publish a Food Science and Technology Meetings ‘yellow pages’ four times a year, which contains information about meetings to be held mainly, but not exclusively, in the UK. Similarly, the European Federation of Food Science and Technology (EFFoST) produces a regular calendar of food science, technology and engineering meetings in Europe and major international events. During the past nine years, for example, two useful and well attended meetings have been held in the UK at the CCFRA. They are: • Shelf-life – problems, technology and solutions, 19–20 March 1991 • Ambient stable foods: an essential guide, 27 November 1998

Publications34,35 emanating from these meetings have since become valuable additions to the growing volume of information on the shelf-life of foods.

13.6

References

1. IFST, Shelf Life of Foods – Guidelines for its Determination and Prediction, London, Institute of Food Science and Technology, 1993. 2. Hongkong Standard, ‘Vitasoy faced with $66m bill for recall’, Hong Kong, 29 January 1996. 3. Nielsen T and Ja¨gerstad M, ‘Flavour scalping by food packaging’, Trends in Food Science and Technology, 1994 5 353–356. 4. The Globe and Mail, ‘Smarties recall announced’, Toronto, 21 August 1993. 5. The Daily Telegraph, ‘Product Recall – Tesco Canned Italian Premium Chopped Tomatoes’, 21 November 1998. 6. The Daily Telegraph, ‘Product Recall – Tesco Italian Long Cut Spaghetti in Tomato Sauce’ (410 g cans), 3 February 1999. 7. Berry Ottaway P, ‘Stability of vitamins in food’, in: The Technology of Vitamins in Food, ed. Berry Ottaway P, 90–113, Glasgow, Blackie Academic and Professional, 1993. 8. Pacquette C, Stability of Selected Water-soluble Vitamins in Model Systems, PhD Thesis, London, South Bank University, 1998. 9. Codex Committee on Food Hygiene, HACCP System and Guidelines for its Application, Annex to CAC/ RCP 1-1969, Rev. 3, in: Codex Alimentarius Food Hygiene Basic Texts, Rome, Food and Agriculture Organisation of the United Nations, World Health Organisation, 1997. 10. Department of Health, A Guide to the General Temperature Control Regulations, London, 1996. 11. Ellis M, Personal communication, 1996. 12. Petersen MA, Tønder D and Poll L, ‘Comparison of normal and accelerated storage of commercial orange juice – changes in flavour and content of volatile compounds’, Food Quality and Preferences, 1998 9(1/2) 43–51. 13. Walker SJ, ‘The principles and practice of shelf-life prediction for microorganisms’, in: Shelf Life Evaluation of Foods, eds Man CMD and Jones AA, 40–51, Glasgow, Blackie Academic and Professional, 1994. 14. Binstead R, Devey JD and Dakin JC, Pickle and Sauce Making, 3rd edn, London, Food Trade Press, 1971. 15. Anon., Code for the Production of Microbiologically Safe and Stable Emulsified and Non-emulsified Sauces Containing Acetic Acid, CIMSCEE, 1991. 16. Jones HP, ‘Ambient packaged cakes’, in: Shelf Life Evaluation of Foods, eds. CMD Man and Jones AA, 179–201, Glasgow, Blackie Academic and Professional, 1994. 17. Young L, ‘Setting the shelf-life in new product development context – for cakes and biscuits’, in: Ambient Stable Foods: An Essential Guide, Chipping Campden, CCFRA, 1998. 18. Ratkowsky DA, Olley J, McMeekin TA and Ball A, ‘Relationship between temperature and growth rate of bacterial cultures’, J. Bacteriol., 1982 149 1–5. 19. Ratkowsky DA, Lowry RK, McMeekin TA, Stokes AN and Chandler, RE, ‘Model for bacterial culture growth rate throughout the entire biokinetic temperature range’, J. Bacteriol., 1983 154 1222–1226. 20. Fu B and Labuza TP, ‘Shelf life prediction: theory and application’, Food Control, 1993 4(3) 125–133. 21. Floros JD and Gnanasekharan V, ‘Shelf life prediction of packaged foods’, in: Shelf Life Studies of Foods and Beverages – Chemical, Biological, Physical and Nutritional Aspects, ed. Charalambous G, 1081– 1118, Holland, Elsevier Science Publishers BV, 1993.

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22. Labuza TP and Hyman CR, ‘Moisture migration and control in multi-domain foods’, Trends in Food Science and Technology, 1998 9 47–55. 23. McMurrough I, Madigan D, Kelly R and O’Rourke T, ‘Haze formation and shelf-life prediction for lager beer’, Food Technology 1999 53(1) 58–62. 24. Anon., Food MicroModel Version 3.0, Surrey, Food MicroModel Ltd., 1999. 25. Zwietering M , Wijtzes T, de Wit JC and Van’t Riet K, ‘A decision support system for prediction of the microbial spoilage in foods’, J. Food Protection, 1992 55 973–979. 26. McClure PJ, Blackburn C de W, Cole MB. Curtis PS, Jones JE, Legan JD, Ogden ID, Peck MW, Roberts TA, Sutherland JP and Walker SJ, ‘Modelling the growth, survival and death of microorganisms in foods’, Int. J. Food Microbiol, 1994 23, 265–275. 27. Everis L, ‘Predicting microbial shelf-life CIMSCEE and FORECAST’, in: Ambient Stable Foods: An Essential Guide, Chipping Campden, CCFRA, 1998. 28. Smedley P, Development of Computer Based Aids to Hazard Analysis Critical Control Point (HACCP), PhD Thesis, London, South Bank University, 1997. 29. Mortimore S and Wallace C, HACCP A Practical Approach, 2nd edn, Maryland, Aspen Publishers, 1998. 30. Tucker G and Holdsworth D, ‘Optimisation of quality factors for foods thermally processed in rectangular containers’, in: Process Engineering in the Food Industry – 2. Convenience Foods and Quality Assurance, eds. Field RW and Howell JA, London, Elsevier Applied Science, 1990. 31. Charalambous G (ed), Shelf Life Studies of Foods and Beverages – Chemical, Biological, Physical and Nutritional Aspects, Holland, Elsevier Science Publishers BV, 1993. 32. Man CMD and Jones AA (eds), Shelf Life Evaluation of Foods, Glasgow, Blackie Academic and Professional, 1994. 33. CCFRA Shelf Life Working Party, Evaluation of Shelf Life for Chilled Foods, Technical Manual No. 28, Chipping Campden, CCFRA, 1997. 34. CFDRA, Shelf Life – Problems, Technology and Solutions, Chipping Campden, symposium held at CFDRA on 19–20 March 1991. 35. CCFRA, Ambient Stable Foods: An Essential Guide, Chipping Campden, meeting held at CCFRA on 27 November 1998.

14 Instructions for storage and use K. G. Anderson, Consultant and Visiting Professor, University of North London

14.1

Introduction

Other than where a foodstuff is commonly used and its characteristics readily understood and appreciated by the consumer, there is a considerable burden of responsibility on the manufacturer or distributor to ensure that it is accompanied by clear instructions for its storage and use. Whatever the precise legal requirement it seems entirely reasonable that clear, unambiguous instructions for use should appear prominently on a pack, making it plain to an intending purchaser or user just what will be required to prepare the food. The responsible labelling of products with instructions for storage and use has become of increasing importance and frequently needs to be recognised on a global basis. That which will stand up to the mid-day temperature in Kuwait will not necessarily withstand the freezing conditions in Alaska without suffering some loss in quality. Various legislation governs requirements for storage and use and instructions relating thereto. For example, in the European Union (EU) by the EU Council Directive 70/112/ EEC as amended, and in the UK by: • Legislation made under the Food Safety Act 1990, particularly the Food Labelling Regulations • The Trade Descriptions Act 1968 • Product Liability legislation • Health & Safety legislation.

There are also various Codes of Practice, Guidelines, etc. in existence, for example those relating to frozen foods, organic foods, canned soups, emulsified and non-emulsified sauces, etc., a number of which include aspects of labelling and storage. More recent UKapplicable Codes of Practice are mentioned in Appendix III of the 4th edition of IFST’s Good Manufacturing Practice Guide. It is recommended that current information is sought from an appropriate trade association or other advisory body on specific product areas. Statutory codes also exist and may be relevant. Internationally, the work of FAO/ Codex Alimentarius Commission should be referred to and is covered elsewhere in this book.

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14.1.1 Food labelling regulations Labelling law generally requires that, as in the case of the UK Food Labelling Regulations 1996, foods are marked or labelled with any special storage conditions or conditions of use, and in certain cases, instructions for use. This is generally where failure to provide such instructions would make it difficult to make appropriate use of the food. In this respect consideration should be given to the intended and likely market as it is quite possible that a use readily appreciated in one part of the world or in one community would be a complete mystery in another. There may be special requirements for particular circumstances of use, such as in vending machines, where, for example, notice of reheating instructions may be required if not provided on the packaging of the food in question. Instructions for use for concentrates, dry mixes or similar destined to be made up into another food by the addition of other substances should include a clear indication of every other substance to be used and its manner of addition if significant.

14.1.2 Trade descriptions The UK Trade Descriptions Act 1968 covers, among other things, fitness for purpose, and while in the vast majority of situations foods will be controlled under legislation specific to food, it can happen that a Trade Descriptions Act offence could arise where, for example, damage arose from the mis-use of packaging due to inadequate instructions for use. Examples might be the exploding of a can in an oven through failure to puncture the lid, or damage due to reflection or tracking in a microwave oven due to failure to remove metal foil. Appropriate warnings should be included in instructions for use. The Trade Descriptions Act may be applied to pet foods where general food laws do not apply but where the general need of truthfulness and fitness for purpose is called into account. While there is plenty of legislation on animal feeds, there is little on general pet foods and customer need for information on their use may be significant and should be borne in mind.

14.1.3 Product liability legislation Product liability legislation basically requires products to be safe, and where damage has occurred, circumstances may dictate whether any action is brought as a result of trade description infringement or of product liability for the damage. Hence it behoves the food business to consider both possibilities and ensure that instructions are adequate for foreseeable circumstances. It is for such reasons that one sometimes sees instructions such as ‘do not re-use’ on a food container. In the case of both trade descriptions and product liability there may a further involvement with other consumer protection legislation such as the Sale of Goods Act and the fitness for purpose requirement under that.

14.1.4 Health & Safety legislation (including COSHH) At first sight it may be obvious that some requirements in the area may need to form part of the instructions for storage or use. However, where a food can give rise to a health hazard or to damage to property for example, information may have to be provided. Such situations may be exemplified by reference to the need to remove or pierce packaging materials before conventional or microwave heating, by advising the use of acid-resistant

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vessels for cooking or storing high-acid products, and by stressing the need for caution (and possibly protection) when handling potentially hazardous food materials or ingredients such as certain spices or extracts. There is also the question of warning of the presence or possible presence of materials which may produce an adverse reaction in some consumers. The UK legislation on the Control of Substances Hazardous to Health (COSHH) requires that information is provided on the nature of hazards, precautions that need to be taken, and remedial measures or treatments necessary in the event of an accident. This can apply to some food ingredients for manufacturing and catering purposes in relation to their storage and use. This would apply, for example to strong acids, curing salts, proteolitic enzymes such as papain, horseradish oil and so forth. Some materials such as sugar, flour, and instant beverage powders can present explosion hazards and again warning may need to be given. Definitive information in these circumstances may often be provided in accompanying documentation rather than specifically on a label. In one situation known to the writer an extremely serious mixing error happened just because of a colour change on bulk packaging when a semi-literate worker, used to relying on the packaging colour as an indicator of content, failed to distinguish between ‘-ate’ and ‘-ite’ in the chemical ingredient name.

14.1.5 Due diligence and manufacturers’ responsibilities The need to exercise due diligence and take reasonable precautions to ensure food safety is all part of good manufacturing practice (GMP), and in the UK is an allowable defence under the Food Safety Act if it can be demonstrated. While it is a responsibility often taken up in whole or part by the distributor, especially where own-label or distributor’s own brands (DOB) are involved, it is not to be lost sight of in giving instructions for storage or use. Failure to give adequate instruction or advice to the consumer could well be considered lack of due diligence were food poisoning or other hazard to result. Part of due diligence is to recognise that instructions should be presented in a manner that can be followed by all anticipated consumers, some of whom may have only a very limited knowledge of domestic science.

14.1.6 Other considerations Other considerations may include the need for any special instructions relating to ethical, religious or political aspects or to special physiological or nutritional circumstances. For instance, it may be appropriate to give advice on limiting the use and hence consumption of high energy or high salt foods in particular circumstances, or their use in circumstances not intended by the manufacturer. The writer can recall patients presenting with red urine as a result of beeturia from excessive beetroot consumption and children suffering from excess salt intake resulting from the consumption of stock cubes as sweets in the school playground. Where promotions are linked with product labelling, information on the promotional item may usefully be provided, while recipes and cookery advice should always be verified for their efficacy and acceptability using a variety of common cooking methods, e.g. gas, electric and microwave ovens. Reference has been made to other factors relating to date marking which might need consideration, and these relate to the post-purchase status of the product and the storage and use conditions which it is likely to encounter both in general terms and in relation to

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durability. Having complied with the basic requirements of the Food Labelling Regulations, such other factors to which the responsible manufacturer or distributor should give careful consideration include instructions relating to • • • • • • •

post-opening post-freezing re-freezing cooking reheating use in recipes clarity of language

and these are considered further below. Nutrition information and health claims are the subjects of other chapters, although it is worth mentioning here that circumstances of storage and use which might affect nutritional properties should be taken into account. Finally, a word on pictorial matter, which can be very valuable in conveying information and in illustating the way in which a food might be presented. It is, however, important that this should not mislead, not only with regard to content and quality, but also to quantiy, ease of preparation and convenience of use.

14.2

Risk categorisation

Food and drink products can be divided into categories with reference to the potential risk, usually of microbiological food poisoning, that they present to the consumer. Commonly, products may be regarded as low, medium and high risk according to their composition, processing, packaging, and method of distribution and storage. For example, sugar, sugar confectionery, flour, most dry goods, etc., would be regarded as low-risk as they would not support the growth of pathogenic organisms other than in circumstances of extreme abuse such as wetting or contamination with dangerous substances. High-risk foods are generally regarded as those which allow the growth of pathogenic microflora to a dangerous degree if abused, notably in terms of any time/ temperature constraints that should be applied. There is rightly a very high level of responsibility on the manufacturer and distributor in this respect, which must culminate in provision of the best possible information to the consumer or customer for the storage and use of the food. As recommended elsewhere a hazard analysis should be applied, and the risk assessment carried through to the point of consumption.

14.3

Clarity of language

Wherever possible information and instructions should be written in language that is as simple and easily understood as possible. Due regard should be given to the use of diagrams and other pictorial images if these can make the requirements easier to understand. Particularly, this can often apply to instructions for opening the container, especially where the packaging is relatively novel. Depending on the market envisaged, and especially if likely to have appeal to some ethnic groups, it may be desirable to offer information in more than one language. Checks should be made to see if there is any special requirement for print size for the country of destination, but there is none at

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present for the EU for instructions for storage or use although there is for quantity declaration. There is, however, a legibility requirement, and although not specifically laid down, information should generally be presented in contrasting colours and of a print size and quality to allow it to be read in reasonable light by those of normal vision (with glasses if worn). The positioning of the information should also be given consideration, and particularly ease of reading instructions while preparing the food and whether any field of vision constraints apply for the intended market. It can be most irritating to have an opened package in front of one only to find that a vital piece of information is on the base, or worse still, has been binned with the outer packaging. Some cooking instructions annoyingly appear on the underside of a label so that important information cannot be accessed without opening the package.

14.4

Date marking (appropriate durability indication)

Date marking, covered in detail in Chapter 6, is an important consideration and encompasses the EU requirements for indication of minimum durability for the product. In the UK this is evidenced by a ‘Best before’ date in the case of foods which may display quality defects if not consumed by the date given but which are not likely to be injurious to health if consumed thereafter, and by a ‘Use by’ date if they may become hazardous if not used by the stated date, usually because of microbiological spoilage with risk of growth of pathogenic organisms. These marking requirements are prescribed in the Food Labelling Regulations 1996 (SI No 1499) s.20–22. For the ‘best before’ date the Regulations require an indication of the date up to and including that to which the food can reasonably be expected to retain its specific properties if properly stored and of any storage conditions which need to be observed. To some extent this has resulted in an understating of the likely acceptable shelf-life of foods and an overstating of requirements for storage, manufacturers and distributors feeling obliged to label in accordance with a worst-case scenario. The date must be expressed in terms of day, month and year (in that order) unless it has a life of less than three months in which case it may be expressed as day and month only; or, where it will have a life of more than 18 months it can be provided as month and year only, or year only. In either case the words ‘best before’ must be extended to read ‘best before end’ The date and any storage instructions may appear separately from the words ‘best before’ or ‘best before end’ provided that those words are followed by a reference to where that information does appear, e.g. ‘see base of carton’ or ‘see cap’. With regard to the ‘use by’ date, similar considerations apply for order and crossreferencing and for indicating storage conditions which need to be observed. The options for date indication are only for day, month and year or day and month. Some foods are exempt from the need to bear an indication of minimum durability. Enforcement authorities in the UK regard the display of goods for sale beyond the ‘use by’ date very seriously for obvious public health reasons, and there have been numerous prosecutions in respect of this since the Regulations came into force. Reference may also be made to the MAFF Guidance Notes on the Food Labelling Regulations 1996 which contain guidance on the rules generally governing the labelling of foods and also cover some additional labelling requirements applying to specific foods only.

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Storage and post-opening storage

The storage of products by the consumer subsequent to purchase can be highly variable and experience tells of everything from emergency stores being laid down as ballast in a cabin cruiser to the inappropriate chill storage of tropical fruits. The biology of still-live food components needs to be considered as do such matters as fat melting points/solidifying temperatures, freeze-thaw stability, shelf-life constraints and the like. There is a general safeguard used by producers, of applying the umbrella advice ‘store in a cool, dry place’ or similar to safeguard against redress when problems arise. Similar thoughts can be in mind regarding ‘refrigerate after opening’, sometimes applied on the better-safe-than-sorry principle.

14.5.1 Immediate storage The first consideration should be of what advice is necessary for immediate storage presuming that the preceding distribution chain has been covered satisfactorily. This may range from none for everyday familiar goods such as common salt, sugar, flour and bread to that for keeping frozen, chilled, or whatever. In all events, due regard must be given to the factors which influence product life so that these may be taken into account in determining instructions for storage. For example, some foods are susceptible to quality deterioration on exposure to light, as exemplified by an increased rate of oxidative rancidity, vitamin loss and bleaching or fading of colour. Obviously, in such cases where the packaging does not offer sufficient protection, the advice ‘store in the dark’ or ‘keep away from strong light’ is desirable.

14.5.2 Post-opening storage What is to happen after the consumer has opened the package but not used it all up? Clearly he or she may very well need guidance on what to do with it. Should it be discarded, refrigerated, consumed within so many days, transferred to a more suitable container for storage, can it be frozen? Etc. If it is an ingredient how should it be stored and for how long? Do the storage conditions alter the shelf-life originally intended? In some circumstances additional treatment may be advised, such as the addition of a small quantity of olive oil to opened olives in brine to minimise the growth of scum yeast after opening or the use of a special closure, as for wine bottles.

14.6

Freezing, treatment post-freezing and re-freezing

Sensible advice may be offered on freezing techniques for some foods, including the simple advice ‘not suitable for freezing’. If the food can be frozen it is prudent to give an indication of the time within which it should be frozen after purchase, e.g. ‘Keep refrigerated and if freezing, freeze on day of purchase’. As foods do not always divide well when frozen and do not re-freeze well either, portion control freezing at domestic level may be advised to minimise wastage for the consumer. It may be appropriate to offer advice on suitability of packaging, e.g. clingfilm, foil, plastic boxes, etc.

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14.6.1 Post-freezing Many chill products give the information ‘suitable for freezing’. Where this is so, then appropriate instructions for subsequent use should be provided. Some products may be better cooked straight from frozen, as in the case where rapid heating quickly sets soluble protein to maintain the required texture, but others benefit from thawing thoroughly before re-heating or cooking. It is not likely that instructions for use as a chill product will be the same for best results from frozen and hence further guidance can be useful.

14.6.2 Re-freezing Most products do not re-freeze well and microbiological hazard may be increased with re-freezing. Again appropriate instructions should be given, e.g. ‘DO NOT RE-FREEZE’.

14.7

Cooking and reheating

14.7.1 Cooking This is really all too obvious at first sight. However it may be necessary to give instructions for the plethora of cooking systems and methods that abound today, or maybe do not abound at all. The writer was surprised himself at being asked for instructions for making tea in a microwave oven, but apparently this can be the only method of heating food in some single-person accommodation and for students in some circumstances. Other considerations are not only gas vs. electricity, but whether fan-assisted or not and a whole variety of microwave and combination functions. More on microwave instructions is given below.

14.7.2 Reheating Many products are not entirely consumed or used up at first sitting and so it is important for the consumer to be told whether or not the product can be reheated satisfactorily and whether any special precautions are needed.

14.8

Microwaveable foods

With microwave cooking, for the UK, due heed should be given to the MAFF recommendations on labelling with instructions that relate to the power of the oven, and the use of the symbol system is advocated and may very well be applied in principle elsewhere. The Voluntary Agreement on the Categorisation of Domestic Microwave Ovens for Heating Small Foods Loads and the Consequent Labelling of Domestic Microwave Ovens and Foods was the result of a MAFF working party of all interested parties and an agreement with oven manufacturers on categorising power outputs was reached in August 1990 with an agreement on labelling being reached in September 1991. Most ovens are now marked in accordance with the agreed symbol by sign, letter and wattage, and foods are normally labelled with reference to at least two of the heating bands for coking instructions. The heating ratings are given in Table 14.1 and symbols are illustrated in Figs 14.1 and 14.2.

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Food labelling Table 14.1 Heating categories of domestic microwave ovens for use in heating small food loads (based on power output into a 350 g water load) Heating category

Power output into 350 g water (watts)

E D C B A

741–800 681–740 621–680 561–620 500–560

Note: Minimum dimensions: height, 13.8 mm; width, 23.4 mm.

Fig. 14.1 Example of symbol for use on domestic microwave ovens.

Note: Minimum dimensions: height, 2.76 mm; width, 3.24 mm.

Fig. 14.2 Symbol for use on labels for microwaveable foods.

Foods and food products can behave very variably in microwave ovens with symptoms varying from uneven temperature to actual ignition, and reference can be made to the MAFF Microwave Science Series of publications for more information. The series is not listed in the references, but information on titles may be obtained from MAFF Microwave Science Series, London, SE99 7TW, and the titles are listed by MAFF Publications, London SE99 7TP.

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The above refers only to domestic microwave ovens, those produced for catering purposes having different characteristics. Not only have microwave ovens developed significantly of recent years so that inclusion of browning and other conventional oven attributes has become common, but also packing materials have advanced to become interactive in the system. Where such packaging material (which tends to focus or dispel the microwave energy) is used the importance of giving the right cooking instructions cannot be overstressed. Safety is another consideration with microwaved foods and appropriate warning may be necessary to prevent the consumer becoming burned or scalded. Advice recommending the use of a microwaveable cooking vessel can be provided if felt necessary.

14.9

Use in recipes

There have been occasions when a food intended for consumption as such has been used instead as an ingredient in another dish and hence not subjected to the preparation regime originally expected. This needs to be thought about, and the potential difficulty may be best appreciated through example. In one example a dry vending soup mix was used in a slow cooker more-or-less as a flavour enhancer. Now the mix would not be sterile, but the hot water from the vending machine would deal with any vegetative microorganisms, and the soup would be consumed before any spores could germinate. In a completely different situation never imagined by the manufacturer, growth of both could take place with resulting problems. Another example is the transfer of some strongly acid pickle into a much milder product where, with dilution of the acidity, hitherto inhibited acid-tolerant organisms were able to ferment the food.

14.10

Special circumstances

There are some situations where the special circumstances of use should stimulate special instructions being given.

14.10.1 Vending machines Products for use in vending machines may require instructions or information to be given in a form that can be displayed on the outside of the machine itself. In addition advice on storage and loading may be required and information provided on throw weights and yields of drinks and drink components (whitener, sugar), water temperature, freeing of interlocks and cleaning procedures.

14.10.2 Portion control and ready-to-use packs For some portion control, ready-to-use packs and similar, information may be required on various aspects of storage and use, and for the catering sector stock rotation guidance may be very useful, if not a specific customer requirement. Again, advice on matters such as water temperature, e.g. to minimise plastic cup distortion and release of monomers, will be appropriate in some circumstances.

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14.10.3 Vulnerable environments Occasionally foods may be at risk of being stored in vulnerable environments. Examples of this would be where absorption of foreign flavours or taints could arise, infestation could readily occur, or where relative humidity could be high and the product prone to moisture absorption. In such cases it may be sensible to reinforce normal storage instructions accordingly.

14.11

Future trends

Now is the time for crystal ball gazing. ‘For the best results from the ball allow it to reach room temperature before using and expose to a good source of light. For more information refer to our instructions on our hypothetical Web site.’ Well, www data availability is one thing coming to meet the ever increasing consumer demand for more information and is expanding along with Internet shopping. Already we have the I-Label labelling service from one company offering a facility for supermarkets to provide online information on products. That Web site is and some retailers and manufacturers are offering such a service through that or other channels. This also offers the opportunity of including information on presence or absence of allergens and other information for which there may not be space. The editor and the writer would very much like to see an effective system developed for provision of food labelling information to the visually impaired, a need which they have been conscious of for a number of years. Food safety will continue to be of major concern, and time/temperature indicators are likely to come to the fore with some sort of signalling system to indicate when a food is no longer safe to use. Redox indicators may indicate the state of oxidation of a food and such parameters coupled together and with others indicating microbial growth may form the basis of real shelf-life indicators. We can anticipate the continuing development of interactive and intelligent packaging which will help maintain product quality and means of electronic data transfer allowing storage and cooking equipment to be specifically programmed. Remote selection of ready-to-eat meals for consumption on arrival home will mean even tighter controls for the suppliers of such food and the equipment for using it. Who knows, we may even get built-in temperature indicators on our fridges, which themselves may have to alter to be able to cope with a variety of required storage conditions.

14.12

Sources of further information and advice

This is not an attempt to provide an exhaustive list of sources of information, but rather to give some pointers as to where it might be found. Clearly fundamental is the Legislation itself – as published by the relevant authorities and including Codex documents. Other sources, including access to legislation may be provided from the following reference publications, research, professional, enforcement and trade organisations: Butterworth’s Law of Food and Drugs, Butterworth-Heinemann, Oxford, OX2 8DP. Campden & Chorleywood Food Research Association, Chipping Campden, Gloucestershire, GL55 6LD.

Instructions for storage and use

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CIAA (Confe´de´ration des industries agro-alimentaires de l’UE), Avenue des Arts, 43-B1040 Bruxelles, Belgium. Food & Drink Federation, 6 Catherine Street, London, WC2B 5JJ. Institute of Food Science & Technology, 5, Cambridge Court, 210 Shepherds Bush Road, London, W6 7NL. Leatherhead Food Research Association, Randalls Road, Leatherhead, Surrey, KT22 7RY. Local Authorities’ Co-ordinating Body on Food and Trading Standards (LACOTS ), 10 Albert Embankment, London, SE1 7SP. Practical Food Law Manual, Sweet & Maxwell, London, NW3 3PF.

14.13

Bibliography

The Food Labelling Regulations 1996 (SI No 1499) as amended, The Stationery Office, 1996. Listing of Codes of Practice applicable to Foods, IFST, London (1993). Food and Drink: Good Manufacturing Practice – A Guide to its Responsible Management, 4th Edition, Ed. Blanchfield J R, IFST, London (1998). Guidance Notes on the Food Labelling Regulations 1996, MAFF, Food Labelling and Standards Division, Ergon House c/o Nobel House, 17 Smith Square, London, SW1P 3JR. Shelf Life of Foods – Guidelines for its Determination and Prediction, IFST, London (1993). The Trade Descriptions Act 1968, The Stationery Office 1968.

15 The role of traceability in food labelling C. Morrison, Youngs Bluecrest Seafoods Ltd, Grimsby

15.1

The key objectives of traceability

Traceability and systems associated with the ability to link a finished food product with its ingredients and processing have always formed a key part of any good manufacturing practice and quality assurance scheme. Without such schemes in place, it would be very difficult to substantiate any on-pack marketing claims, for example ‘Organic’; to provide due diligence in the event of a Public Enforcement challenge or to minimise the quantities involved in the event of a recall. There has been significant growth in both global sourcing and manufacturing, along with centralisation of food production into specialist sites, in recent years. As a result, large volumes of raw materials and ingredients will be sourced from suppliers around the world and converted into equally large volumes of finished product for global distribution. In these circumstances, traceability is especially important to the manufacturer, whether international, national or regional. It is also clear that, in order to be proactive in meeting ever-increasing consumer demands for clear labelling and transparency, traceability will gain in importance. Traceability schemes will always need to go beyond any legislative requirements. This, in turn, will lead to improved process controls and good manufacturing practices (GMP). The absolute need for a fully documented traceability system within the food chain has never been stronger, building from the late 1980s through to the millennium. Two issues in particular, the BSE crisis, followed by the genetically modified organisms (GMO) debate, can best illustrate this. Initial loss of confidence of consumers in British beef arising from the BSE crisis was further exacerbated by the extended ban on all exports. This very much centred around issues of lack of adequate government-controlled cattle traceability schemes. British retailers tackled this problem for their home markets by instigating their own traceability systems and assured labelling schemes, which were heavily promoted in advertising and in-store leaflet campaigns. The Meat and Livestock Commission (MLC) also established a national traceability scheme for beef and beef products,1 which could be translated into on-pack quality claims for manufacturers and retailers participating in the scheme. While

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Food labelling

BSE was fundamentally a food safety issue, it is now widely perceived that the GMO debate is one of consumer choice, transparency and ethical labelling. Traceability is an indispensable aspect, whether to meet developing labelling legislation within the EU in this area, or to justify labelling claims of ‘GM-free’ (see Section 12.4). In consideration of the way in which two recent problems affect the food industry, and the globalisation of manufacturing and supply, it is possible to identify some key objectives required from a traceability scheme.2 • Compliance with international and national traceability coding legislation as appropriate. • Development of agriculture traceability schemes for commodities and ‘organics’ – ability to make marketing claims – ability to make health and other claims. • Definition and control of ingredients – comprehensive specifications – ability to avoid the need for negative claims e.g. ‘may contain nut traces’. • Improved process control and GMP – comprehensive process control specifications – comprehensive final product standards – improved quality and consistency – due diligence systems enhanced – ability to minimise recall losses. • Improved consumer perception – transparency – confidence – loyalty.

15.2

Legal requirements concerning traceability coding

The Codex General Standard for the labelling of prepackaged foods3 encompasses the key elements of traceability, and these are adopted by most national Governments in their own legislation (see Chapters 2 and 3). They include: • name of food • date marking requirements: date of manufacture, date of packaging, sell-by date, date of minimum durability, use-by date • lot identification mark • name and address of manufacturer, packer, distributor, importer, exporter or vendor • country of origin, if omission would mislead or deceive the consumer.

Within the EU, for example, the above requirements have been captured in both specific and general legislation including the ‘Lot’ Marking Directive, the Labelling Directive and the various vertical hygiene Directives such as the meat and meat products, fish and fish products, milk and milk products and the Quick Frozen Foods Directive. It is possible to encompass some of the above specific requirements of traceability into one form, if by doing so, none of the essential information is lost. For example, a lot mark has to be applied to the packaging, or to any accompanying commercial documents for non-prepackaged goods in an easily visible, clearly legible and indelible form. The format and system is not prescribed, but must be preceded by the letter ‘L’ if not obviously a lot code.

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269

Fig. 15.1 Durability dates.

The minimum durability date, i.e. the ‘best before’ or ‘use-by’ date for highly perishable foodstuffs, can therefore substitute for the lot mark since they can also indicate a period of production. The positioning of the date of minimum durability must appear in the same field of view as the name of the food along with the weight or volume and certain other requirements. However, it is acceptable to put the actual date and any relevant storage and handling conditions elsewhere on the package so long as it is stated where (see Fig. 15.1). In addition to lot marking and durability coding, the vertical EU hygiene regulations covering fish, meat, and meat products, poultry and dairy products all require that the foodstuff packaging and any inner wrapping is labelled with a health mark, giving the official approval number for the production plant, and types of product covered. The information is required to be contained within an oval in most instances and includes: • the initial letters of the approving Member State country in capitals • the reference code for the approval number for the producing factory below the country code • the initials for the Community e.g. EEC, CEE (see Fig. 15.2)

The exact format will vary according to circumstance and product type, Directive and approved status, but a central register is maintained for them all, which is available to Health Enforcement Officers across the EU via the Internet. Whilst this approval number is not applied strictly for traceability, it has been used for this purpose, most recently during the problem of dioxin contamination of animal feeds in Belgium in mid-1999.

Fig. 15.2 An EU health mark.

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Food labelling

15.3

Wider aspects of traceability coding

The legal obligations of traceability coding are to facilitate free movement of foodstuffs across borders and to ensure correct product identification in the event of a Public Enforcement recall for health and safety reasons. The manufacture and/or the owner of the food product will need to ensure that the quantity of product involved in a recall is kept to a minimum. For example, a ‘lot’ is a batch of foodstuffs produced under essentially the same conditions. This can be translated, for a long shelf-life product, as the minimum durability code of ‘Best Before End’ – June 2001, i.e. a month’s production as described above. It follows, therefore, that supplementary coding further defining the batch is advisable. Just as for the lot mark, or durability code, a batch code should be clearly legible and easy to find, particularly for consumers when reporting a problem to the product manufacturers. This is equally applicable to holders of stock, in the event of a recall or withdrawal, in order to ensure only affected product is returned and sales of unaffected stock continues. Typically, the code will be close to the durability code as illustrated in Fig. 15.3. In this example: Best Before End W B N 273 8

Sep99

is a 12 month shelf-life, i.e. produced during October 1998 is producing factory identifier is the specific production line. is hour code is Julian calendar day is last digit of year 1998

Traditionally, coding equipment had to be set up by placing individual letters and numbers into a printing block. This meant that codes could probably be changed only once per day or per shift. New technology inkjet and laser systems are now able to encode and print significant amounts of information, including the durability code and the production codes, down to the minute if required. Similarly, the outer distribution cases into which packed product is placed, can be batch coded to the hour as can the pallet on which the cases are stacked. It is therefore possible to locate a problem to a very specific batch, thereby minimising the number of recalled items, providing, of course, data on the issue is available. There is no point in having this end-of-line fine detail, of course, if it is not paralleled by an equivalent level of sophistication backwards through the production process, and all the way back to the raw materials and packaging materials and forwards through the distribution chain.

Fig. 15.3 A batch code.

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271

A computerised traceability system will accomplish this speedily, although it is perfectly possible to provide the same information through a paperwork system. In the event of a recall, however, a computerised system will generate in hours what might take many people days to accomplish.

15.4 A modern computerised production and management control system Production control systems contain details of each product recipe at a number of levels starting with the individual ingredients, each identified by a unique code (see Fig. 15.4). They may then track intermediate operations or recipe levels, e.g. preparation of a spices batch, through to the sauce batch, a cooked chicken piece through to combination and completion of the product by depositing in a foil tray, the placing of trays into cartons, then distribution cases and finally stacking on a pallet. Such systems are driven by a sales forecast, from which the production plan is determined along with product batch sizes, standard yields and the purchase order plan for ingredients. In order for such a system to work, it requires access to complete details of unique product specifications, ingredients, packaging components and approved suppliers. Ideally the specification system should be linked directly to the management control system. In this way any approved changes flow automatically through the system for information from a specific date so that there can never be any question about what was used on or about the changeover date. Many processes within the total operation may also be computerised and records of results could also be integrated into the main system. Figure 15.5 outlines a product traceability flow sequence for a process from raw materials receipt to delivery to distribution store. In this instance, all of the information concerning the raw material receipt is contained within a hand-held computer. Records of the intake, such as order number, followed by quality attributes, such as weights, are entered directly into the hand-held computer. Comparison with standards is made automatically and the pass/fail can then be downloaded into the main system. It is also possible to apply bar coding to this system so that samples can be sent to laboratories with unique codes. Where microbiological or analytical release is required, this could again be completed via the laboratory’s Laboratory Management Information System (LIMS), or equivalent system using the bar code reference applied to the samples for analysis, again with results loaded directly into the main system. A similar approach can be applied within, for example, batch weighing of ingredients. It is possible to apply a bar code to each ingredient linked to its unique computer code. As each is weighed on a computerised weighing system, a bar code sticker is generated for the container according to the recipe weight. The components are then bar-scanned into the next stage of the process, so ensuring that no item is left out. This principle applies for all process records right through to final on-pack coding and quantities delivered to store. Typically, for legal compliance, records have to be kept for a minimum of three years, so it can be envisaged how much archive space has to be provided for a large production unit using a paperwork recording system compared to an electronic system as described. An area of traceability not yet described is the on-pack bar coding required by many retailers. The system used is known as ‘Article Numbering and Symbol Marking’ and is administered by the International Article Numbering Association.4 In Europe a 13-digit EAN (originally European, but now international Article Number) bar code has been applied (EAN-13), while in the United States and Canada a

Fig. 15.4 A typical computerised production and management control system.

Fig. 15.5 Product traceability flow.

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Fig. 15.6 Bar code symbols (Source: Bar Coding: recommendations for best practice (conclusions of ‘MR BIG’ (the major retailers Bar code Integrity Group)), published by the Institute of Grocery Distribution – November 1997 ISBN: 1 898044 40 6).

12-digit UPC code (UPC-A) is used. The 12-digit code can be read in Europe but the 13digit code will become the standard. An 8-digit code (EAN-8) may also be used when a retailer has its own brand as this set of numbers is unique to the retailer (see Fig. 15.6). The 13 digits of EAN-13 correspond to the thick, thin and spacing characteristics of the bar code which is electronically scanned. The first two digits refer to the administration association issuing the bar code, followed by five digits for the company, five digits for the unique product description and the final digit is for checking purposes. For product packed into distribution cases, i.e. traded units, there are two different coding systems in use: • ITF-14 which is a basic bar code symbol, which identifies the product and number of sales units per case. • EAN-128 which is designed to encode supplementary data as well as item identification such as: – use-by/best before dates – measurements – batch and serial numbers.

EAN-128 is seen as a more flexible and integrated system than ITF-14 or EAN-13. It is gaining greater acceptance across Europe and is a standard which UK retailers require suppliers to meet. Finally, for pallets of traded units in distribution, there is an ANA code based on EAN-128, known as the Transport Unit Bar Code Symbol. It can be seen from the preceding descriptions of bar coding that a high level of traceability can be achieved already through this system and this will improve with time. Already some major manufacturing companies are able to link directly into Point of Sale Scanning Information at retailer store level (see Fig. 15.7). Within the UK, retailers, through the Major Retailers Bar Code Integrity Group, are currently embarked on a project in conjunction with the Article Numbering Association (UK) Ltd, known as ‘Mr Big’. The purpose of this initiative is that ‘Total quality in the use of EAN bar code symbols is achieved when the right place reads correctly every time’. The project has

The role of traceability in food labelling

275

Point of sale

Distribution

Stock check

Warehouse

Order new stock

Factory

Fig. 15.7 Bar codes in the supply chain (Source: Bar Coding: recommendations for best practice (conclusions of ‘MR BIG’ (the major retailers Bar code Integrity Group)), published by the Institute of Grocery Distribution – November 1997 ISBN: 1 898044 40 6).

issued best practice guidelines covering such issues as the presentation, size, positioning and print quality of bar codes.

15.5

Use of care lines on product packaging in traceability

The care line concept has developed rapidly over the past seven years and is now used by many major manufacturers on their brands. Previously, a Consumer Guarantee of Satisfaction would be included on the pack along with the address of consumer services department to contact in the event of a problem. The care line offers a much more proactive and interactive communications route for consumers. It can be suggested onpack, for instance, that in addition to phoning on quality satisfaction matters, they also seek more information about other products, for instance through recipe cards. Most of all, it enables a gentle interrogation of the consumer to establish the actual batch codes and traceability information, since very often, when responding by post mail, they will send the bar code only, which whilst identifying the product exactly, will not identify the batch at this time.

15.6

Applying traceability systems when problems arise

The ability to recognise and respond rapidly to a problem is essential in any management system. This allows the impact and potential losses to be contained to a minimum. Quality systems such as ISO 90005 require regular management review of complaints and problems together with records and corrective actions taken. Any due diligence defence or mitigation would also require evidence of a similar nature. Most larger food manufacturers have a consumer services department, which together with the technical department, will handle consumer quality, safety issues and interactions with the customers and Public Enforcement bodies such as governmental bodies, e.g. Food Standards Agency (FSA) MAFF, Department of Health (DH), Environmental Health (EHO) and Trading Standards (TSO) in the UK. Other contacts may also come into the company head office via employees, or in the event of threats, via the police, media or extortionist.

276

Food labelling

To determine the scope of any reported complaint, a recording system and analytical process is required, which would encompass investigation, rapid report back and risk assessment where necessary. Such a system is outlined in Fig. 15.8, which is based on a consumer services department as the central function, initially co-ordinating the complaints received and responding back to the complainant, or in the case of serious complaints, instigating further investigation which may result in the involvement of the internal crisis management team. Within the EU the implications of Food Safety Regulations, General Product Safety Regulations and product liability legislation will have to be considered in these circumstances.6–8

15.6.1 The trace Where the crisis management team is called together and, after assessing the available information, the team instigates a recall, there will be two important tasks to carry out: identifying all affected stock and communicating the recall (see Fig. 15.9). Stock identification is essentially a collation of information, based on date code information, of the affected product, through to the implicated process or ingredient as appropriate (see Fig. 15.10). Once this information has been collated and customers likely to be holding stock identified, a decision as to how far to ‘widen the net’ to include codes either side as a safeguard needs to be taken. Nothing could dent customer or consumer confidence more than to have to instigate a second recall later for the same problem.

15.6.2 Communications During the run-up to the recall, a recall notice will have been planned. First and foremost within the notice will be the clear details of product identification, i.e. all of the on-pack traceability features, followed by details of the problem and recommendations of actions to take: • • • • • • • • •

full product description – brand, name, pack size identification codes – computer codes, bar codes, batch codes, best before dates features to distinguish from similar products nature of problem reassurance and steps to take if product already consumed how to return/dispose of product how to claim potential links to other products/issues potential links to previous company’s issues.

15.7

Summary

The key objectives for a comprehensive traceability scheme have been described. • In the EU laws requiring clear on-pack batch ‘lot’ marking and durability codes have been strengthened or introduced over the past 10 years. This has served to increase the free movement of foodstuffs and trade, but also to facilitate product recalls for safety reasons. • Manufacturers and brand owners have generally improved their traceability schemes well beyond legal requirements. This has been both to minimise losses in the event of

Fig. 15.8 Flow diagram for co-ordination of complaints.

Fig. 15.9 Crisis management.

Fig. 15.10 Traceability and computerised management systems.

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Food labelling

a recall, and also as part of increasingly efficient management control systems. This has been aided by advances in modern technology and computerised systems. • Consumer demands for greater transparency in labelling, coupled with more sophisticated products, products with particular nutritive, environmental, or ethical attitudes, are resulting in a proliferation of label claims, necessitating ever more authenticity verification, in turn placing increasing demands on traceability.

15.8 1. 2. 3. 4. 5. 6. 7. 8.

References

Meat and Livestock Commission, MLC traceability for beef and beef products, MLC, Milton Keynes, 1900. Moe T. ‘Perspectives on Traceability in Food Manufacture’, Food Science and Technology – Trends in Food Science and Technology, 1998, 9, 211–214. Codex General Standard for the labelling of prepackaged foods. (World-wide Standard) CODEX STAN 11985 (Rev.1-1991) From FAO/WHO Food Standards Programme Codex Alimentarius Volume 1A 1995 (2nd Ed). Article Numbering Association (UK), Article numbering and symbol marking operating manual, London, 1900, Web: http://www.e.centre.org.uk British Standards Institution, ISO9000, Quality Management and Quality Assurance Standards: Part 1 – Guidelines for selection and use, 1994; Part 2 – Generic guideline for the application if ISO9001, ISO9002 and ISO9003, 1997, London. General Product Safety Directive 92/59/EEC, 1992. Product Liability Directive 85/374/EEC 25th July 1985. Christopher Hodges, M. Tyler and H. Abbot, Product Safety Sweet and Maxwell, 1900.

Index

accelerated shelf-life determination 246–7 added water in cured meat products code 29 additives 6–7 declaration in EU 65–79 additional declarations 70, 71–2 exemptions 70 declaration in US 81–100 additional requirements 90–7, 98–100 general requirements 88–90, 98 special requirements 85–8 sold as such 73–5 adverse events associated with disease therapy 198 advertising 201–2 agricultural produce 40–1 see also under individual types alcoholic beverages 98, 190–1 allergens 97, 216–20 allergies 6, 216–17 alpha-tocopherol 98 Article Numbering and Symbol Marking 271–5 aspartame 95, 98 aspic 98 Australasia 230 authorised officers 23–4 autolyzed yeast 98 average value 129 bacteria, spoilage by 114, 115–17, 118, 120, 241–2 bacteria cultures 91 bar coding traceability 271–5 visual impairment 233–6 batch code 270 batters 98 beef 98

Belgium 166, 167–8, 175 Benecol 190 best-before date 101, 107, 259 see also durability indication ‘Big 4’ 128 binders 98 biochemical changes 240–1 biotechnology 96–7 see also genetically modified foods blind people 233–6 see also visual impairment body’s disease-fighting capabilities 198 braille 233–4 BSE crisis 267–8 Bt maize 221, 222, 223, 224 Bureau of Alcohol, Tobacco and Firearms (BATF) 52, 63, 190–1 business sales 73–5 cakes 248 calcium 185–6, 191 calories 152 Canada 230 cancer 186, 187 carbohydrate 137 care lines 275 caseinates 94 category names 69 catsup 99 characterizing ingredients 87–8 cheese 99 chemical changes 240–1 chemical preservatives 93 children 11 chili products 99 chocolate products 72 cholesterol 186, 190

282

Index

Cholestin 199 CIMSCEE model 247–8 citation of publication 197–8 cocoa products 72 Code Administration Body (CAB) 174 Code of Federal Regulations (CFR) 51, 182 codes of practice 23, 29, 75, 106–7 Codex Standards 19, 37 EU legislation and 33–4 irradiated foods 225, 226–7, 228–9 UK criteria and 39, 45–7 coding equipment 270 collective names 90 colour additives 83, 92 label design 208 colour changes 240 Common Agricultural Policy (CAP) 32, 43 marketing regulations 40–1 common/usual names 86–7 communications, recall 276 complaints/problems 275–6, 277–9 compliance management 162–3 compound ingredients 54, 67, 90, 98 computerized production and management control system 271–5 conferences and meetings 252 Conseil national de l’alimentation (CNA) 166, 168–9 consumers 3–4, 104 expectations and nutrition information 133–9 needs 5–11 Consumers’ Association 133–5 content claims 56–7, 180, 183–4 contrast 208 Control of Substances Hazardous to Health (COSHH) legislation 257 cooking 261 coronary heart disease (CHD) 186–7, 188, 189–90 costs of durability indication 114–17 country of origin 10, 56 courts, US 51–2, 181 cracker meal 99 crisis management 276, 278 criteria claims 45–7 durability indication 118–19 critical spoilage 113 daily reference values (DRVs) 153–4, 155, 161, 182 daily values (percent) 153, 161 databases 235–6 date marking 103, 210, 259 see also durability indication declared values 129–30 demographics 206–7 dental caries 187–8 design 205–11

deterioration mechanisms 238–42 see also spoilage dietary fibre 131–2, 137, 186–7, 188 Dietary Supplement Health and Education Act 1994 (DSHEA) 84–5, 148, 159–60, 194–200 dietary supplements 159–62, 163, 175, 188–9, 195, 200–1 direct determination of shelf-life 244–6 disclaimers 189 discoloration reactions 240 disease risk reduction claims 167 disease-specific/disease prevention claims see health claims due diligence 18–19, 76, 257 durability indication 9, 36, 102–3, 259, 269 EU 101–9 calculation 106–7 date marking 103, 210, 259 presentation 107 US 111–23 see also shelf-life E numbers 2, 7 E. coli 114 eggs 120 endorsements 10 energy 137 energy value 129 enforcement 4–5, 13–14, 22–9 compliance management 162–3 US agencies 52, 63 see also under individual agencies enjoyment 103 environmental consciousness 7 established common/usual name regulations 87 European Union (EU) 2, 21 declaration of ingredients and additives 35–6, 65–79 durability indication 101–9 functional labelling 16 GM foods 41–3, 66, 68, 71, 221, 222–4 irradiated foods 229–30 labelling requirements 31–47 legislation and Codex Standards 33–4 multi-language requirements 211–16 nutrition and health claims 37–9, 130, 165–77 nutrition information 37–9, 125–46, 175 organisation of EU legislation 32–3 traceability coding 268–9 exceptions 157–9 exemptions EU 68, 70 US 157–9 Expert Authority 174 extrinsic factors 238–9 Fair Packaging and Labeling Act 1966 (FPLA) 50, 83

Index fats 91–2, 136, 137, 186 Federal Alcohol Administration Act 50 Federal Food, Drug and Cosmetic Act 1938 (FDCA) 49, 82–3, 179–80 Federal Meat Inspection Act 49–50 Federal Register (FR) 51, 180–2 Federal Trade Commission (FTC) 50, 201–2 Federal Trade Commission Act 50 fibre 131–2, 137, 186–7, 188 fish 158–9 fish content code 29 flavour scalping 240 flavourings 69–70, 92–3 flexibility 143–4 folate 187 Food Advisory Committee (FAC) 15, 28, 39, 128, 173 food allergies 6, 217 see also allergens food-borne disease 115–17, 120 food composition 5 food composition Directives 39–40 Food and Drug Administration (FDA) 8, 49, 51, 52, 63, 148, 180 compliance management 162–3 disease prevention claims 185–92, 196–200 exemptions 157–8 GM foods 8, 96, 221 ingredients and additives 82–5, 85–97 nutrition and health claims 57, 185–92, 194, 196–200, 200–1 Food and Drug Modernization Act 1997 (FDAMA) 192–3 Food Labelling Directive 25, 31–2, 34–7, 65 durability indication 101–4, 105–6 Food Labelling Regulations 1996 (FLR) 14, 17, 25, 27, 131, 256, 259 Food MicroModel 249 Food Research International 251 Food Safety Act 1990 14, 17, 18, 19, 25 enforcement 22–4 Food Safety and Inspection Service (FSIS) 52, 63, 148, 191 compliance management 162–3 exemptions 158 ingredients and additives 85, 97–100 prior label approval 159 Food Standards Agency 22, 75, 145 footnote 156 ‘Forecast’ system 249 formats for nutrition information EU 128–9, 140, 143 US 148–50, 156–7 fortified foods 91 France 166, 168–9 freezing 260–1 freshness 9 see also durability indication; shelf-life fruit juices 72, 87–8, 91 fruits 186–7

283

functional additives and ingredients 93 functional foods 85, 166, 175–6, 179 functional labelling 16 functions of food labels 1–2 General Product Safety Regulations 1994 17 generally regarded as safe (GRAS) declaration 199 generic names 90 genetically modified (GM) foods 2–3, 7–8, 221–5, 267–8 EU requirements 41–3, 66, 68, 71, 221, 222–3 ingredients 66, 68, 71, 96–7, 221–5 US requirements 8, 63–4, 96–7 geographic origin 10, 56 glutamates 95–6 grain products 186–7 see also maize, GM guidance 17–18 Guidance Notes 75 Guideline Daily Amounts (GDAs) 140–1 guidelines 75 durability indication 118–19 handling information 9–10 Hazard Analysis and Critical Control Point (HACCP) principles 120, 245, 250 health 5–7 health claims 6 ambiguous legislation 28 code of practice 29 EU 165–77 substantiation 28–9, 174–5 US 57–63, 179–203 disease-specific claims 180, 185–92 impermissible 196–9 health effect claims 167 health mark 269 health and safety legislation 256–7 healthy eating pattern claims 167 ‘healthy’ products 127 herbs 199 Home Authority Principle 24–5 hormone treated cattle 3 hydrolysates, protein 93–4 hypertension 186 I-Label initiative 236, 264 illustrations 197–8, 215, 258 immediate storage 260 implementation 130–2 incidental additives 94 increased weight in cooking 99 index of spoilage 118 indirect estimation and prediction of shelf-life 246–9 information panel 149–50 ingredient list 35, 88, 89 ingredients claims about in dietary supplements 197–8

284

Index

ingredients (continued) EU requirements 35–6, 65–79 exemptions from listing 68 GM 66, 68, 71, 96–7, 221–5 irradiated 231 quantitative declaration (QUID) 35–6, 37, 66, 72–3, 77, 220 sold as such 73–5 US requirements 53–4, 81–100 additional requirements 90–7, 98–100 general declaration requirements 88–90, 98 special ingredient specifications 85–8 Institute of Food Science and Technology (IFST) 219, 239 Institute of Grocery Distribution (IGD) 139, 140–2, 205 International Journal of Food Science and Technology 250–1 intrinsic factors 238–9 irradiation 8, 95, 225–33 jams and jellies 71–2 ‘jelly bean’ rule 188 Joint Health Claims Initiative (JHCI) 173 Journal of Food Science 251 juices, fruit 72, 87–8, 91 juices/solutions, added 98 Labelling Regulation 1139/98 42–3, 66, 222 labelling requirements EU 31–47 US 49–64 language 78 choice of 214–15 clarity 258–9 multi-language requirements 211–16 layout 209 legal cases 179, 181, 184, 188–92, 194, 199–200, 202 legibility 71, 207–10 legislation and regulations 4, 13–14, 19–21 ambiguous 27–8 design 206 EU durability indication 102–4, 105–6 ingredients and additives 66–75 labelling requirements 31–47 nutrition information 127–32, 142–4 see also under individual Directives factors influencing rule-making process 20–1 guiding principles 19–20 irradiation 226–31 main requirements of 20 manufacturers and 16–17 storage and use 256–7 traceability coding 268–9 US ingredients and additives 82–5 labelling requirements 49–64 nutrition and health claims 179–203

nutrition information 147–8 see also under individual Acts light-induced changes 241 lipids, dietary 186 list of ingredients 35, 88, 89 literacy, limited 11 ‘Little 4’ nutrients 128, 131 local authorities 22–3 Local Authorities Co-ordinating Body on Food and Trading Standards (LACOTS) 17–18, 24, 29 long shelf-life products 243 losses 114–17 lot mark 268–9 maize, GM 42, 66, 68, 222, 223, 224 major serious allergens (MSAs) 217, 218–20 warnings of presence 219–20 mandatory nutrition labelling 144–5 manufacturers 4 needs 13–19 precautions and allergens 217–19 responsibilities additives and ingredients 76–7, 85–100 durability indication 104 EU 76–7, 104, 132–3 GM foods and ingredients 221–2 nutrient information 132–3 storage and use 257 US 85–100 marketing environment 25–6 multilingually labelled foodstuffs 215–16 mathematical models 247–9 meat products 72, 85, 99, 113–14, 158–9, 184–5, 191 mechanically separated meat 99 medical foods 193–4 medicines 176 medium shelf–life products 242–3 methodology 119 microbial changes/spoilage 114, 115–17, 118, 120, 241–2 microbiological models, predictive 249 microbiologically highly perishable foods 105–6 microwaveable foods 261–3 milk products 41, 72 minerals 91, 127, 128, 144, 154–6 minimum durability date see durability indication Ministry of Agriculture, Fisheries and Food (MAFF) 38–9, 128, 261–2 Nutrition Labelling Study Report 135–8 moisture transfer 239–40 monosodium glutamate (MSG) 95–6 mould-free shelf-life (MFSL) 248 ‘Mr Big’ project 274–5 multi-component ingredients 54, 67, 90, 98 multi-language requirements 211–16 mutual recognition principle 211

Index names 27–8 category names for additives 69 common/usual 86–7 disease claims 197–8 EU requirements 35 ingredients 88–90 US requirements 52–3 natural states 197 negative claims 224 negative labelling 99 net quantity 36, 54–5 Netherlands 166, 169–70, 175 neural tube defects 187 new technologies 7–8, 20–1 see also genetically modified foods non-prepacked foods 70–1 ‘not me first’ syndrome 25–6 novel foods 41–3, 66 Novel Foods Regulation 41–2, 66, 221 number of servings 151 nutraceuticals (functional foods) 85, 166, 175–6, 179 nutrient content claims 56–7, 180, 183–4 nutrient function claims 167 nutrient modification claims 184 Nutrition Centre (Netherlands) 169–70 nutrition claims EU 37–9, 130, 165–77 US 179–203 Nutrition Facts labels 147, 148–56, 183 nutrition information 5–6 definitions of nutrients 129, 143 EU 37–9, 125–46, 175 key issues in presenting 125–7 US 55–6, 91, 147–64 Nutrition Labeling and Education Act 1990 (NLEA) 83–4, 147, 148, 180, 182 Nutrition Labelling Directive 37–9, 127–32, 175 implementation 130–2 proposals for changes to 142–4 Nutrition Labelling Study Report 135–8 Nutrition Task Force (NTF) 139 nutritional support, statements of 196 nutritional value 103 oils 91–2 open dating 111–12 see also durability indication optical character recognition (OCR) 234 osteoporosis 185–6, 191 overall pack layout 209–10 ‘own label’ products 126–7 pack layout 209–10 packaging 240, 241 pathogenic bacteria 114, 115–17, 118, 120 ‘per serving’ information 141, 143 percent daily values (%DVs) 153, 161 Pharmanex 199 pictorial matter 198, 215, 258

285

pigment degradation 240 portion control 263 position of information 71, 259 post-freezing 261 post-opening storage 260 poultry products 85, 158–9, 184–5, 191 Poultry Products Inspection Act 49–50 predictive microbiological models 249 prepacked foods 34–7 preparation instructions 10, 210 preservation index (PI) 247 preservatives, chemical 93 prevention 166–7 principal display panel (PDP) 52, 149–50 print size 207 prior label approval 159 processing methods 7–8 product liability legislation 256 product traceability flow sequence 271, 273 production and management control system 271–5 production methods 7–8 proprietary ingredient blends 162 protein 137 protein hydrolysates 93–4 public analysts 23–4 quantitative ingredients declaration (QUID) 35–6, 37, 66, 72–3, 77, 220 Radura symbol 228, 231 rancidity 241 raw products 158–9 ready-to-use packs 263 reassembled meat products code 29 recall 276, 278 recipes 10, 263 recombinant DNA (rDNA) techniques 7–8 recommended daily amounts (RDAs) 128, 129 reconstituted juices 91 reference daily intakes (RDIs) 154–6, 161, 182 referral statements 192–3 re-freezing 261 regulatory compliance 162–3 see also legislation and regulations reheating 261 responsible agent 54 restaurants 159 retailers 4, 104 risk assessment and durability indication 114–17 categorisation 258 rounding rules 155–6 Roundup Ready Soya 221, 222, 223–4 saccharin 94–5 Saccharin Study and Labeling Act 1977 83 Salmonella Enteritidis 120 saturated fat 186 scanning 234–6 seals 10

286

Index

self-knowledge, and allergies 217 serving sizes 150–1, 160, 183 shelf-life 111, 237–53 categories of product 242–3 determining and estimating 243–9 see also durability indication short shelf-life products 105–6, 242 simplification 143–4 signs and symptoms 197 single-ingredient, raw products 158–9 small business 158, 160 sodium 137–8, 186 soluble fibre 186–7, 188 South Africa 230 soy protein 189–90 soya, GM 42, 66, 68, 221, 222, 223–4 Spain 166, 170–1 specific properties 102, 103 spices 92–3 spoilage 112–13 costs and durability indication 115–17 index of 118 mechanisms 238–42 spreadable fats 41, 72, 77 square root model 248 standard panels 15 standardized foods 86–7 statements of nutritional support 196 stevioside 200 stock identification 276, 279 see also traceability storage durability indication and 103–4 instructions 9–10, 255–65 strict liability regime 18 structure/function claims 180, 189, 190, 196–200, 200–1 substantial equivalence 43 substantiation of health claims 28–9, 174–5 sugar alcohol 187–8 sulfiting agents 94 Supplement Facts labels 147, 160–2, 195 supplements, dietary 159–62, 163, 175, 188–9, 195, 200–1 Sweden 166, 171–2 symbols 198, 215 symptoms 197 Tariff Act 50 technological innovation 7–8, 26–7 see also genetically modified foods telltale indicators 9, 119, 264 temperature 241–2 tenderizers 99 therapy, disease 198 time/temperature indicators 9, 119, 264 tomato pure´e, GM 221 tooth decay 187–8

traceability 267–80 applying the system when problems arise 275–6, 277–9 trade descriptions 256 Trade Descriptions Act 1968 14, 19, 256 translation of information 213, 215 type font 207–8 understanding of nutrients 137–8 United Kingdom (UK) 231 GM foods 222 nutrition and health claims 38–9, 45–7, 166, 173–4, 175 United States (US) 3, 78 court system 51–2, 181 durability indication 111–23 enforcement agencies 52, 63 see also under individual agencies health claims 57–63, 179–203 ingredients and additives 53–4, 81–100 irradiated foods 231 labelling requirements 49–64 legislative and rule-making process 50–2, 180–2 nutrition claims 179–203 nutrition information 55–6, 91, 147–64 United States Department of Agriculture (USDA) 113–14, 184, 249 use, instructions for 10, 255–65 use-by date 101, 105–6, 107, 259 see also durability indication usefulness 103 vegetable oil 99 vegetable powders 91 vegetables 186–7 vending machines 263 visual impairment 11, 207, 233–6 Vitamin-Mineral Amendment 1976 194 vitamins 91, 127, 128, 144, 154–6 degradation 241 voluntary labelling 64 GM foods 222 nutrition information 139–42, 144–5 vulnerable environments 264 warnings 94–5 presence of MSAs 219–20 water 67, 90–1 added in cured meat products 29 water vapour transfer 239–40 weight increased in cooking 99 nutrients by 152–3, 161 wine labels 190 yeast, autolyzed 98