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
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(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.