INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
SAFETY EVALUATION OF CERTAIN
FOOD ADDITIVES AND CONTAMINANTS
WHO FOOD ADDITIVES SERIES 40
Prepared by:
The forty-ninth meeting of the Joint FAO/WHO Expert
Committee on Food Additives (JECFA)
World Health Organization, Geneva 1998
The International Programme on Chemical Safety (IPCS), established
in 1980, is a joint venture of the United Nations Environment
Programme (UNEP), the International Labour Organisation (ILO),
and the World Health Organization (WHO). The overall objectives of
the IPCS are to establish the scientific basis for assessment of the
risk to human health and the environment from exposure to chemicals,
through international peer-review processes, as a prerequisite for the
promotion of chemical safety, and to provide technical assistance in
strengthening national capacities for the sound management of
chemicals.
The Inter-Organization Programme for the Sound Management of
Chemicals (IOMC) was established in 1995 by UNEP, ILO, the Food and
Agriculture Organization of the United Nations, WHO, the United
Nations Industrial Development Organization and the Organisation for
Economic Co-operation and Development (Participating Organizations),
following recommendations made by the 1992 UN Conference on
Environment and Development to strengthen cooperation and increase
coordination in the field of chemical safety. The purpose of the IOMC
is to promote coordination of the policies and activities pursued by
the Participating Organizations, jointly or separately, to achieve the
sound management of chemicals in relation to human health and the
environment.
Health & Environment International, Ltd., by agreement with WHO,
performed independent literature searches on some of the substances on
which data are summarized in this document in order to ensure that all
relevant toxicological and related information was reviewed.
ISBN 92 4 166040 6
CONTENTS
Preface
Antioxidant
tert-Butylhydroquinone (TBHQ)
Emulsifiers
Microcrystalline cellulose
Sucrose esters of fatty acids and sucroglycerides
Enzyme preparations
alpha-Acetolactate decarboxylase
Maltogenic amylase
Sweetening agent
Maltitol syrup
Miscellaneous substance
Salatrim (short- and long-chain acyltriglyceride molecules)
Substances evaluated using the Procedure for the Safety Evaluation
of Flavouring Agents
Introduction
Saturated aliphatic acyclic linear primary alcohols,
aldehydes and acids
Saturated aliphatic acyclic branched-chain primary alcohols,
aldehydes and acids
Aliphatic lactones
Esters of aliphatic acyclic primary alcohols with branched-chain
aliphatic acyclic acids
Esters of aliphatic acyclic primary alcohols with aliphatic
linear saturated carboxylic acids
Esters derived from branched-chain terpenoid alcohols and
aliphatic acyclic linear and branched-chain
carboxylic acids
Contaminants
Aflatoxins
Annexes
Annex 1 Reports and other documents resulting
from previous meetings of the Joint
FAO/WHO Expert Committee on Food
Additives
Annex 2 Abbreviations
Annex 3 Participants in the forty-ninth meeting
of the Joint FAO/WHO Expert Committee
on Food Additives
Annex 4 Acceptable Daily Intakes, other toxico-
logical information and information
on specifications
Annex 5 Application of a threshold of toxicological
concern in the safety evaluation of certain
flavouring agents
PREFACE
The monographs contained in this volume were prepared at the
forty-ninth meeting of the Joint FAO/WHO Expert Committee on Food
Additives (JECFA), which met in Rome, Italy, 17-26 June 1997. 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-ninth report of JECFA will be published by the World
Health Organization in the WHO Technical Report Series. Terms
abbreviated in the monographs are listed in Annex 2. 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.
Some of the substances listed in this annex were evaluated at the
present meeting for residues only.
Specifications established at the forty-ninth meeting of JECFA
have been issued separately by FAO as Food and Nutrition Paper No. 52,
Add. 5. 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
considered.
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 cited. 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. Special acknowledgement is made to these
advisers. The monographs were edited by Dr P.G. Jenkins, International
Programme on Chemical Safety.
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 to
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 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 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.
This volume contains monographs prepared at the forty-ninth
meeting of the Joint FAO/WHO Expert Committee on Food Additives
(JECFA), which met in Rome, Italy, from 17 to 26 June 1997.
The toxicological monographs in this volume summarize the safety
data on a number of food additives, including the antioxidant tert-
butylhydroquinone, the emulsifiers microcrystalline cellulose and
sucrose esters of fatty acids and sucroglycerides, the enzyme
preparations alpha-acetolactate decarboxylase and maltogenic
amylase, the sweetening agent maltitol syrup, the low-caloried fat
salatrim, a large number of flavouring agents, and aflatoxins. The
data summarized in these monographs served as the basis for the
evaluations performed by the Committee.
This volume and others in the WHO Food Additives Series contain
information that is useful to those who produce and use veterinary
drugs and food additives, government and food regulatory officers,
industrial testing laboratories, toxicological laboratories, and
universities.
See Also:
Toxicological Abbreviations