INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY WORLD HEALTH ORGANIZATION TOXICOLOGICAL EVALUATION OF CERTAIN FOOD ADDITIVES AND CONTAMINANTS WHO FOOD ADDITIVES SERIES 20 Prepared by: The 29th meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) World Health Organization, Geneva 1985 The International Programme on Chemical Safety (IPCS), established in 1980, is a joint venture of the United Nations Environment Programme (UNEP), the International Labour Organisation (ILO), and the World Health Organization (WHO). The overall objectives of the IPCS are to establish the scientific basis for assessment of the risk to human health and the environment from exposure to chemicals, through international peer-review processes, as a prerequisite for the assistance in strengthening national capacities for the sound management of chemicals. The Inter-Organization Programme for the Sound Management of Chemicals (IOMC) was established in 1995 by UNEP, ILO, the Food and Agriculture Organization of the United Nations, WHO, the United Nations Industrial Development Organization and the Organisation for Economic Co-operation and Development (Participating Organizations), following recommendations made by the 1992 UN Conference on Environment and Development to strengthen cooperation and increase coordination of the policies and activities pursued by the Participating Organizations, jointly or separately, to achieve the sound management of chemicals in relation to human health and the environment. Published by the Press Syndicate of the University of Cambridge The Pitt Building, Trumpington Street, Cambridge CB2 1RP 32 East 57th Street, New York, NY 10022, USA 10 Stamford Road, Oakleigh, Melbourne 3166, Australia (c) World Health Organization 1987 First published 1987 Printed in Great Britain at the University Press, Cambridge British Library cataloguing in publication data Joint FAO/WHO Expert Committee on Food additives, Meeting (29th : 1985: Geneva) Toxicological evaluation of certain food additives and contaminants. - (WHO Food Additives series; 20) 1. Food additives - Toxicology 2. Food contamination 3. Food poisoning I. Title II. Series 363.1'92 RA1258 Library of Congress cataloging in publication data available ISBN 0 521 34347 X The preparation of this document was supported by the International Programme on Chemical Safety (IPCS), Geneva, Switzerland. CONTENTS Preface Enzyme Preparations and Enzyme Immobilizing Agents Carbohydrase (alpha-amylase) from B. lichenformis Glucose isomerase (immob.) from A. missouriensis Glucose isomerase (immob.) from B. coagulans Glucose isomerase (immob.) from S. olivaceus Glucose isomerase (immob.) from A. olivochromogens Glucose isomerase (non-immobilized & immob.) from S. rubiginosus Polyethylenimine and ethylenimine Flour treatment agent Chlorine Food colours Brown FK Caramel colours, Classes I, II, II, and IV Fast Green FCF Sweetening Agents Hydrogenated Glucose Syrups Isomalt Thaumatin Thickening Agent Tragacanth Gum Annexes Annex 1 Reports and other documents resulting from previous meetings of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Annex 2 Abbreviations used in the monographs Annex 3 1985 JECFA participants Annex 4 Acceptable daily intakes and information on specifications PREFACE The monographs contained in this volume were prepared by the twenty- ninth Joint FAO/WHO Expert Committee on Food Additives (JECFA), which met in Geneva, Switzerland, 3-12 June 1985. These monographs summarize the safety data on selected food additives and contaminants reviewed by the Committee. Generally, the compounds on which monographs were prepared are those on which substantial safety data exist. The data reviewed in these monographs form the basis for acceptable daily intakes (ADIs) established by the Committee. The twenty-ninth report of JECFA has been published by the World Health Organization as WHO Technical Report Series, No. 733. The participants in the meeting are listed in Annex 3 of the present publication and a summary of the conclusions of the Committee is included as Annex 4. Specifications established by the twenty-ninth JECFA have been issued separately by FAO under the title Specifications for the identity and purity of certain food additives, FAO Food and Nutrition Paper, No. 34. These toxicology monographs should be read in conjunction with the specifications and the report. Reports and other documents resulting from previous meetings of the Joint FAO/WHO Expert Committee on Food Additives are listed in Annex 1. JECFA serves as a scientific advisory body to FAO, WHO, their Member States, and the Codex Alimentarius Commission, primarily through the Codex Committee on Food Additives, regarding the safety of food additives and contaminants in food. Committees accomplish this task by preparing reports of their meetings and publishing specifications and toxicological monographs, such as those contained in this volume, on substances that they have considered. The toxicological monographs contained in this volume are based upon working papers that were prepared by temporary advisers in advance of the 1985 JECFA meeting. A special acknowledgement is given to those who prepared these working papers: Dr C.L. Galli, Professor of Experimental Toxicology, University of Milan, Milan, Italy; Dr S.I. Shibko, Associate Director of Regulatory Evaluation, Center for Food Safety and Applied Nutrition, Food and Drug Administration, Washington, DC, USA; and Dr Ronald Walker, Professor of Biochemistry, University of Surrey, Guildford, Surrey, England. Many proprietary unpublished reports are referenced. These were voluntarily submitted to the Committee by various producers of the food additives under review and in many cases these reports represent the only safety data available on these substances. The temporary advisers based the working papers they developed on all the data that were submitted, and all these studies were available to the Committee when it made its evaluations. From 1972 to 1975 the toxicology monographs prepared by Joint FAO/WHO Expert Committees on Food Additives were published by WHO in the WHO Food Additives Series; after 1975 this series became available only in the form of unpublished WHO documents provided on request by the Organization. Henceforth their publication by Cambridge University Press should ensure that these monographs are more widely known and available. The preparation and editing of the monographs included in this volume have been made possible through the technical and financial contributions of the Participating Institutions of the International Programme on Chemical Safety (IPCS), which support the activities of JECFA. IPCS is a joint venture of the United Nations Environment Programme, the International Labour Organisation, and the World Health Organization, which is the executing agency. One of the main objectives of IPCS is to carry out and disseminate evaluations of the effects of chemicals on human health and the quality of the environment. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the organizations participating in IPCS concerning the legal status of any country, territory, city, or area or 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 those organizations in preference to those of a similar nature that are not so mentioned. Any comments or new information on the biological or toxicological data on the compounds reported in this document should be addressed to: Joint WHO Secretary of the Joint FAO/WHO Expert Committee on Food Additives, International Programme on Chemical Safety, World Health Organization, Avenue Appia, 1211 Geneva 27, Switzerland.
See Also: Toxicological Abbreviations