INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
TOXICOLOGICAL EVALUATION OF CERTAIN
FOOD ADDITIVES AND CONTAMINANTS
WHO FOOD ADDITIVES SERIES 28
Prepared by:
The thirty-seventh meeting of the Joint FAO/WHO Expert
Committee on Food Additives (JECFA)
World Health Organization, Geneva 1991
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.
IPCS gratefully acknowledges the assistance provided by the
International Life Sciences Institute (ILSI) in the form of editing of
the toxicological monographs by Dr L. Fishbein and by providing a
typist and typing facilities for their production.
CONTENTS
Preface
Monograph Format
Antioxidants
Butylated hydroxytoluene (BHT)
Erythorbic acid and its sodium salt
Enzyme Preparations
alpha-Amylase from Bacillus stearothermophilus
alpha-Amylase from Bacillus subtilis
alpha-Amylase from Bacillus stearothermophilus expressed in
Bacillus subtilis
alpha-Amylase from Bacillus megaterium expressed in
Bacillus subtilis
Chymosin A produced from Escherichia coli K-12 containing
calf prochymosin A gene
Chymosin B produced from Kluyveromyces lactis containing
calf prochymosin B gene
Chymosin produced from Aspergillus niger var. awamori
containing calf prochymosin B gene
Flavouring agents
Allyl esters (allyl hexanoate, allyl heptanoate, and
allyl isovalerate)
Trans-anethole
(+)-Carvone and (-)-carvone
Food Colour
Erythrosine
Sweetening agents
Acesulfame potassium
Trichlorogalactosucrose (TGS)
Miscellaneous food additives
Dimethyldicarbonate (DMDC)
Dioctyl sodium sulfosuccinate (DSS)
Gellan gum
Contaminants
Benzo[a]pyrene
Ochratoxin A
Annexes
Annex 1 Reports and other documents resulting
from meeting of the Joint FAO/WHO Expert
Committee on Food Additives
Annex 2 Abbreviations used in the monographs
Annex 3 Participants at thirty-seventh meeting
of the Joint FAO/WHO Expert Committee
on Food Additives
Annex 4 Acceptable daily intakes, other
toxicological recommendations and
information on specifications
Annex 5 Corrigenda to Food Additives Series
No. 26
PREFACE
The monographs contained in this volume were prepared by the
thirty-seventh Joint FAO/WHO Expert Committee on Food Additives
(JECFA), which met in Geneva, Switzerland, 5-14 June 1990. 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 thirty-seventh report of JECFA has been published by the
World Health Organization as WHO Technical Report Series No. 806. 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-seventh meeting of JECFA
will be issued separately by FAO. 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, 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.
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 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/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.
WHO Food Additives Series Volume No. 20, which was
prepared by the twenty-ninth Committee in 1985, through WHO Food
Additives Series Volume 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 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 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
See Also:
Toxicological Abbreviations