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Principles for the Safety Assessment of Food Additives and Contaminants in Food

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J U L 1987 Environmental Health Criteria 70 -S St : Principles for the Safety Assessment of Food Additives and Contaminants in Food Published under the joint sponsorship of the United Nations Environment Programme, the International Labour j Organisation, and the World Health Organization in collaboration with the Food and Agriculture Organization of the United Nations WORLD HEALTH ORGANIZATION GENEVA 1987 Other titles available in the ENVIRONMENTAL HEALTH CRITERIA series include: Mercury Aquatic (Marine and Polychlorinated Biphenyls and Freshwater) Biotoxins Terphenyls Heptachlor Lead Paraquat and Diquat Oxides of Nitrogen Endosulfan Nitrates, Nitrites, and Quintozene N-Nitroso Compounds Tecnazene Principles and Methods for Chlordecone Evaluating the Toxicity of Mirex Chemicals, Part 1 Camphechlor Photochemical Oxidants Guidelines for the Study of Sulfur Oxides and Suspended Genetic Effects in Human Particulate Matter Populations DDT and its Derivatives Summary Report on the Carbon Disulfide Evaluation of Short-Term Tests Mycotoxins for Carcinogens (Collaborative Noise Study on In Vitro Tests) Carbon Monoxide Dimethyl Sulfate Ultraviolet Radiation Acrylamide Tin and Organotin Compounds Trichloroethylene Radiofrequency and Microwaves Guide to Short-Term Tests for Manganese Detecting Mutagenic and Arsenic Carcinogenic Chemicals Hydrogen Sulfide Toluene Selected Petroleum Products Asbestos and Other Natural Chlorine and Hydrogen Mineral Fibres Chloride Ammonia 22 Ultrasound Ethylene Oxide Lasers and Optical Radiation Propylene Oxide Titanium Principles of Toxicokinetic Selected Radionuclides Studies Styrene Selenium Guidelines on Studies in Principles for Evaluating Health Environmental Epidemiology Risks from Chemicals During Acrylonitrile Infancy and Early Childhood: 2,4-Dichlorophenoxyacetic The Need for a Special Approach Acid (2,4-D) Principles for the Assessment Principles for Evaluating of Neurobehavioural Toxicology Health Risks to Progeny Chromium Associated with Exposure 1,2-Dichloroethane to Chemicals during Pregnancy Organophosphorus Insecticides Tetrachloroethylene - A General Introduction Methylene Chloride Carbamate Pesticides - Epichlorohydrin A General Introduction Chiordane Butanols - Four Isomers Extremely Low Frequency Kelevan (ELF) Fields Tetradifon Fluorides and Fluorine This report contains the collective views of an in- ternational group of experts and does not necessarily represent the decisions or the stated policy of the United Nations Environment Programme, the Interna- tional Labour Organisation, the World Health Organization, or the Food and Agriculture Organi- zation of the United Nations Environmental Health Criteria 70 PRINCIPLES FOR THE SAFETY ASSESSMENT OF FOOD ADDITIVES AND CONTAMINANTS IN FOOD Published under the joint sponsorship of the United Nations Environment Programme, the International Labour Organisation, and the World Health Organization in collaboration with the Food and Agriculture Organization of the United Nations / S \6 ). ei World Health Organization -r - Geneva, 1987 The International Programme on Chemical Safety (IPCS) is a joint senture at the United Nations Environment Programme, the International Labour Organisa- tion, and the World Health Organization. The main objective of the IPCS is to carry out and disseminate evaluations of the effects of chemicals on human health and the quality of the environment. Supporting activities include the development of epidemiological, experimental laboratory, and risk-assessment methods that could produce internationally comparable results, and the development of manpower in the field of toxicology. - Other activities carried out by IPCS include the develop- ment of know-how for coping with chemical accidents.,coordination of laboratory testing and epidemiological studies, and promotion of research on the mechanisms of the biological action of chemicals. ISBN 92 4 154270 5 World Health Organization 1987 Publications of the \Vor]d Health Organization enjoy copyright protection in accordance with the provisions of Protocol 2 of the Universal Copyright Conven- tion. For rights of reproduction or translation of WHO publications, in part or in 1010, application should be made to the Office of Publications, World Health Organization, Geneva, Switzerland. The World Health Organization welcomes such applications. The designations employed and the presentation of the material in this publica- tion do not imply the expression of any opinion whatsoever on the part of the Secretariat of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. The mention of specific companies or of certain manufacturers' products does not imply that they are endorsed or recommended by the World Health Organiza- tion in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. SSN 020-563X PRINTED IN FENEAND 8671 21 - vAylylAtA - 55110 -3- CONTENTS PRINCIPLES FOR THE SAFETY ASSESSMENT OF FOOD ADDITIVES AND CONTAMINANTS IN FOOD FORE VORD 11 PREFACE ........................ 12 1. INTRODUCTION 15 2, HISTORICAL BACKGROUND ................ l 2.1 Introduction .................. is 2.2 Periodic review 21 2.2.1 Concept of periodic review 21 2.2.2 Mechanism of periodic review 23 CRITERIA FOR TESTING AND EVALUATION ......... 25 3.1 Criteria for testing requirements 25 3.1.1 Estimating exposure ........... 26 3,1,2 Predicting toxicity from chemical structure ............... 27 3.1.3 Other factors to consider when develop- ing criteria 28 3.2 Priorities for testing and evaluation 29 3.3 Quality of data 30 CHEMICAL COMPOSITION AND THE DEVELOPMENT OF SPECIFICATIONS 32 4.1 Identity and purity 32 4.2 Reactions and fate of food additives and contaminants in food .............. 33 4.3 Specifications ................. 34 TEST PROCEDURES AND EVALUATION 39 5.1 End-points in experimental toxicity studies 39 5.1.1 Effects with functional manifestations 40 5.1.2 Non-neoplastic lesions with morpho- logical manifestations 41 5.1.3 Neoplasms ................ 42 3.1.4 Reproduction/developmental toxicity . 46 5.1.5 In vitro studies 48 5.2 The use of metabolic and pharnacokinetic studies in safety assessment .......... 50 -4- Page 5.2.1 Identifying relevant animal species . 51 5.2.2 Determining the mechanisms of toxicity 53 5.2.3 Metabolism into normal body constituents .............. 54 5.2.4 Influence of the gut microflora in safety assessment ............ 56 5.2.4.1 Effects of the gut microflora on the chemical ........ 56 5.2.4.2 Effects of the chemical on the gut microflora ......... 59 5.3 Influence of age, nutritional status, and health status on the design and interpretation of studies ................... 59 5.3.1 Age ................... 60 5.3.1.1 History ........... 60 5.3.1.2 Usefulness of studies involving in utero exposure ...... 64 5.3.1.3 Complications of aging ..... 65 5.3.2 Nutritional status ........... 65 53.3 Health status .............. 68 5.3.4 Study design .............. 68 5.4 Use of human studts in safety evaluation . 70 5.4.1 Epidemiological studies ......... 72 54.2 Food intolerance ............ 73 5.5 Setting the ADI ................ 75 55.1 Determination of the no-observed-effect level ................. 77 5.5.2 Use of the safety factor ........ 78 5.5.3 Toxicological versus physiological responses ................ 82 5.5.4 Group AD1s .............. 82 5.5.5 Special situations ........... 83 5.5.6 Comparing the ADI with potential exposure ................ 84 6. PRINCIPLES RELATED TO SPECIFIC GROUPS OF SUbSTANCES 86 6.1 Substances consumed in small amounts ......86 6,1.1 Food contaminants ............86 6.1.2 Food flavouring agents .........88 6.2 Substances consumed in large amounts ......92 6.2.1 Chemical composition, specifications, and impurities .............93 6.2.2 Nutritional studies ...........94 6.2.3 Toxicity studies ............95 6.2.4 Foods from novel sources ........97 -5- Page REFERENCES 100 ANNEX I. GLOSSARY ................. 110 ANNEX II. STATISTICAL ASPECTS OF TOXICITY STUDIES . 115 REFERENCES TO ANNEX II ................. 134 ANNEX III. GUIDELINES FOR THE EVALUATION OF VARIOUS GROUPS OF FOOD ADDITIVES AND CONTAM- INANTS .................. 135 REFERENCES TO ANNEX III ................. 144 ANNEX IV. EXAMPLES OF THE USE OF METABOLIC STUDIES IN THE SAFETY ASSESSMENT OF FOOD ADDITIVES ................. 145 REFERENCES TO ANNEX IV ................. 152 ANNEX V. APPROXIMATE RELATION OF PARTS PER MILLION IN DIET TO MG/KG PER DAY ......... 156 ANNEX VI. REPORTS AND OTHER DOCUMENTS RESULTING FROM MEETINGS OF THE JOINT FAO/I1O EXPERT COMMITTEE ON FOOD ADDITIVES ........ 158 INDEX .......................... 166 6- WHO TASK GROUP ON UPDATING THE PRINCIPLES FOR THE SAFETY ASSESSMENT OF FOOD ADDITIVES AND CONTAMINANTS IN FOOD 1985 and/or 1986 JECFA Members Dr H. Blumenthal, Division of Toxicology, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, Washington DC, USA c,d Dr I. Chakravarty, Department of Biochemistry and Nutrition, All India Institute of Hygiene and Public Health, Calcutta, India C Dr W.H.B. Denner, Food Composition and Information Unit, Food Sciences Division, Ministry of Agri- culture, Fisheries and Food, London, United Kingdom C Dr A.H. El-Sebee, Pesticides Division, Faculty of Agriculture, Alexandria University, Alexandria, Egypt C Professor P.E. Fournier, Hôpital Fernand-Widol
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