INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
TOXICOLOGICAL EVALUATION OF CERTAIN
FOOD ADDITIVES AND CONTAMINANTS
WHO FOOD ADDITIVES SERIES 32
Prepared by:
The forty-first meeting of the Joint FAO/WHO Expert
Committee on Food Additives (JECFA)
World Health Organization, Geneva 1993
The International Programme on Chemical Safety (IPCS) is a
joint venture of the United Nations Environment Programme, the
International Labour Organisation, 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 the IPCS include the development 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 166032 5
CONTENTS
INTRODUCTION
PREFACE
MONOGRAPH FORMAT
ANTIOXIDANTS
GALLATES
FLAVOURING SUBSTANCES
BENZYL ACETATE
2-ETHYL-1-HEXANOL
ALPHA-METHYLBENZYL ALCOHOL
FLAVOUR ENHANCERS
DISODIUM 5'-GUANYLATE AND DISODIUM 5'-INOSINATE
FOOD COLOURS
CAROTENES FROM NATURAL SOURCES (ALGAL AND VEGETABLE)
SWEETENING AGENTS
MALTITOL AND MALTITOL SYRUP
SACCHARIN AND ITS SALTS
THICKENING AGENTS
KONJAC FLOUR
PROCESSED EUCHEUMA SEAWEED
PROPYLENE GLYCOL ALGINATE
MISCELLANEOUS SUBSTANCES
ß-CYCLODEXTRIN
SODIUM IRON EDTA
SUCROSE ACETATE ISOBUTYRATE
UREA
CONTAMINANT
CHLOROPROPANOLS
ANNEXES
ANNEX 1
ANNEX 2
ANNEX 3
ANNEX 4
PREFACE
The monographs contained in this volume were prepared by the
forty-first Joint FAO/WHO Expert Committee on Food Additives (JECFA),
which met in Geneva, Switzerland, from 9 to 18 February 1993. These
monographs summarize the safety data on selected food additives and
contaminants reviewed by the Committee. The data reviewed in these
monographs form the basis for acceptable daily intakes (ADIs)
established by the Committee.
The forty-first report of JECFA will be published by the World
Health Organization in the WHO Technical Report Series. 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 at the forty-first meeting of JECFA
will be published in the FAO Food and Nutrition Paper series. These
toxicological 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 and Contaminants and the
Codex Committee on Residues of Veterinary Drugs in Foods, regarding
the safety of food additives, residues of veterinary drugs, naturally
occurring toxicants, and contaminants in food. Committees serve this
function by preparing reports of their meetings and publishing
specifications or residues monographs and toxicological monographs,
such as those contained in this volume, on substances that they have
considered.
Many proprietary unpublished reports are referenced in this
volume. These were voluntarily submitted to the Committee, generally
by producers of the food additives under review, and in many cases
these reports represent the only safety data available on these
substances. The working papers used by the Committee to develop the
monographs in this volume were developed by Temporary Advisers based
on all the data that had been submitted, and all these studies were
available to the Committee as it made its evaluations and finalized
the monographs.
From 1972 to 1975 the toxicology monographs prepared by Joint
FAO/WHO Expert Committees on Food Additives were published in the WHO
Food Additives Series; between 1975 and 1985 this series was available
in the form of unpublished WHO documents provided by the Organization
upon request. WHO Food Additives Series Volume No. 20, prepared by
the twenty-ninth Committee in 1985, through WHO Food Additives Series
Volume No. 24, prepared by the thirty-third Committee in 1988, were
published by the Cambridge University Press. Beginning with WHO Food
Additives Series No. 25, prepared by the thirty-fourth Committee, WHO
has produced these volumes as priced documents.
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 the 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 the IPCS concerning
the legal status of any country, territory, city, or area or its
authorities, nor concerning the delimitation of its frontiers or
boundaries. The mention of specific companies or of certain
manufacturers' products implies neither that they are endorsed nor
recommended by those organizations in preference to others of a
similar nature that are not 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.
MONOGRAPH FORMAT
Note: Monographs in this document generally follow the format
presented below. All monographs may not, however, require the use of
each heading, and in some monographs the format has been modified to
better present data about several substances.
1. EXPLANATION
2. BIOLOGICAL DATA
2.1 Biochemical aspects
2.1.1 Absorption, distribution and excretion.
2.1.2 Biotransformation
2.1.3 Effects on enzymes and other biochemical
parameters
2.2 Toxicological studies
2.2.1 Acute toxicity studies
2.2.2 Short-term toxicity studies
2.2.2.1-2.2.2.X Species tested
2.2.3 Long-term/carcinogenicity studies
2.2.4 Reproduction studies
2.2.5-2.2.X Special studies
2.3 Observations in humans
3. COMMENTS
4. EVALUATION
5. REFERENCES