INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
TOXICOLOGICAL EVALUATION OF CERTAIN
FOOD ADDITIVES AND NATURALLY OCCURRING TOXICANTS
WHO FOOD ADDITIVES SERIES 30
Prepared by:
The thirty-ninth 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.
CONTENTS
Preface
Monograph Format
Emulsifier
Thermally oxidized soya bean oil and thermally
oxidized soya bean oil interacted with mono- and
diglycerides of fatty acids
Enzyme preparations
Cellulase derived from Trichoderma longibrachiatum
Lysozyme
Flavouring substances
Limonene
Quinine
Solvents
1,2-Dichloroethane
Dichloromethane
Diethylene glycol monoethyl ether
Thickening agent
Alginic acid and its ammonium, calcium,
potassium and sodium salts
Waxes
Beeswax
Candelilla wax
Carnauba wax
Microcrystalline wax and paraffin wax
Shellac
Miscellaneous substances
Furfural
Potassium bromate
Naturally occurring toxicants
Cyanogenic glycosides
Solanine and chaconine
Annexes
Annex 1 Reports and other documents
resulting from previous meetings
of the Joint FAO/WHO Expert
Committee on Food Additives
Annex 2 Abbreviations used in the
Monographs
Annex 3 Joint FAO/WHO Expert Committee
on Food Additives, Rome,
3-12 February 1992
Annex 4 Recommendations on compounds
on the agenda
PREFACE
The monographs contained in this volume were prepared by the
thirty-ninth Joint FAO/WHO Expert Committee on Food Additives (JECFA),
which met in Rome, Italy, 3-12 February 1992. These monographs
summarize the safety data on selected food additives and naturally
occurring toxicants reviewed by the Committee. The data reviewed in
these monographs form the basis for acceptable daily intakes (ADIs)
established by the Committee.
The thirty-ninth report of JECFA has been published by the World
Health Organization as WHO Technical Report Series No. 828. 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-ninth meeting of JECFA
have been published in FAO Food and Nutrition Paper 52. 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 accomplish
this task 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. 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 in the WHO
Food Additives Series; after 1975 this series was available in the
form of unpublished WHO vi documents provided upon request to the
Organization. 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 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. All monographs may not, however, require the
use of each heading.
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