INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
TOXICOLOGICAL EVALUATION OF CERTAIN
FOOD ADDITIVES AND CONTAMINANTS
WHO FOOD ADDITIVES SERIES 35
The 44th meeting of the Joint FAO/WHO Expert
Committee on Food Additives (JECFA)
World Health Organization, Geneva 1996
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 166035 X
Butylated hydroxytoluene (BHT)
Glycerol ester of wood rosin
Sucrose esters of fatty acids and sucroglycerides
Mineral oils and waxes
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, 14-23 February 1995
Annex 4 Acceptable Daily Intakes, other toxicological
information, and information on specifications
Annex 5 A procedure for the safety evaluation of
flavouring substances (Paper by Dr I.C. Munro,
CanTox Inc., Mississauga, Ontario, Canada)
The monographs contained in this volume were prepared by the
forty-fourth Joint FAO/WHO Expert Committee on Food Additives (JECFA),
which met in Rome, Italy, 14-23 February 1995. 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
The forty-fourth report of JECFA has been published by the World
Health Organization as WHO Technical Report Series No. 859. 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-fourth meeting of JECFA
has been published by FAO as FAO Food and Nutrition Paper 52, Add. 3.
These toxicological monographs should be read in conjunction with the
specifications and the report.
Reports and other documents resulting from previous meetings of
JECFA 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 residue monographs and toxicological monographs,
such as those contained in this volume, on substances that they have
The toxicological monographs contained in this volume are based
upon working papers that were prepared by Temporary Advisers. A
special acknowledgement is given at the beginning of each monograph to
those who prepared these working papers.
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. The monographs were edited by Dr H.
Galal-Gorchev, Geneva, Switzerland.
From 1972 to 1975 the toxicological monographs prepared by JECFA
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.
WHO Food Additives Series No. 20, which was prepared by the
twenty-ninth Committee in 1985, through WHO Food Additives Series
No. 24, which was prepared by the thirty-third Committee in 1988, were
published by the Cambridge University Press. Beginning with WHO Food
Additives Series No. 25, which was prepared by the thirty-fourth
Committee, WHO has been 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 supports 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
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,