INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
TOXICOLOGICAL EVALUATION OF CERTAIN
FOOD ADDITIVES AND CONTAMINANTS
WHO FOOD ADDITIVES SERIES 26
Prepared by:
The 35th meeting of the Joint FAO/WHO Expert
Committee on Food Additives (JECFA)
World Health Organization, Geneva 1990
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.
CONTENTS
Preface
Monograph Format
Emulsifiers
Sucrose esters of fatty acids sucroglycerides
Flavouring agents
Benzyl acetate
Ethyl vanillin
Quinine hydrochloride
Food colours
Canthaxanthin
Thickening agents
Gum arabic
Modified celluloses
Miscellaneous food additives
2-Nitropropane
Contaminants
Patulin
Annexes
Annex 1 Reports and other documents resulting
from meetings of the Joint FAO/WHO
Expert Committee on Food Additives
Annex 2 Abbreviations used in the monographs
Annex 3 Thirty-fifth JECFA meeting participants
Annex 4 Accceptable daily intakes, other
toxicological recommendations and
information on specifications
PREFACE
The monographs contained in this volume were prepared by the
thirty-fifth Joint FAO/WHO Expert Committee on Food Additives (JEFCA),
which met in Rome, Italy, 29 May-7 June 1989. These monographs
summarize the safety data on selected food additives and a contaminant
reviewed by the Committee. The data reviewed in these monographs form
the basis for acceptable daily intakes (ADIs) established by the
Committee.
The thirty-fifth 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 thirty-fifth meeting of JEFCA
will be issued separately by FAO under the title, Specifications for
the identity and purity of certain food additives 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.
JEFCA 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
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 and/or presented by temporary
advisers in advance of the 1988 JECFA meeting. A special
acknowledgement is given to those who prepared these working papers,
Dr Ronald Walker, Professor of Biochemistry, University of Surrey,
Guildford, Surrey, England; Drs D. Benz, I. Chen, C.B. Johnson, M.
Bleiberg, J. Griffiths, K. Edelman and H. Irausquin, Division of
Toxicological Review and Evaluation, Center for Food Safety and
Applied Nutrition, Food and Drug Administration, Washington, DC, USA;
Dr C.L. Galli, Professor of Toxicology, University of Milan, Italy;
Drs D.L. Grant, E. Vavasour, S.G. Gilbert, E.M. Kovacs, P. Nawrot and
T. Kemeny, Bureau of Chemical Safety, Foods Directorate, Health and
Welfare Canada, Ottawa, Canada; and Dr G.J. van Esch, the Netherlands.
Many proprietary unpublished reports are referenced. These were
voluntarily submitted to the Committee by various producers of the
veterinary drugs 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 obtained, 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 in the WHO
Food Additives Series; after 1975 this series was available in the
form of unpublished WHO documents provided upon request to the
Organization. Beginning with WHO Food Additives Series No. 20, which
was prepared by the twenty-ninth Committee in 1985 until WHO Food
Additives Series No. 24, which was prepared by the thirty-third
Committee in 1988, volumes in this series were published by the
Cambridge University Press. Beginning with WHO Food Additives Series
No. 25, which was prepared by the thirty-fourth Committee, WHO is
producing 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, 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 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: Each monograph in this document follows the general
format presented below. Each heading may not, however, be applicable
to all monographs.
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 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
Level causing no toxicological effect
Estimate of acceptable daily intake
Further work or information
Required for substances given a temporary ADI
Desired
5. REFERENCES
See Also:
Toxicological Abbreviations