INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
SAFETY EVALUATION OF CERTAIN
FOOD ADDITIVES
WHO FOOD ADDITIVES SERIES: 42
Prepared by the Fifty-first meeting of the Joint FAO/WHO
Expert Committee on Food Additives (JECFA)
World Health Organization, Geneva, 1999
IPCS - International Programme on Chemical Safety
This publication is a contribution to the International Programme on
Chemical Safety.
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 assessing 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 United Nations 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.
CONTENTS
Preface
Flavouring agents
trans-Anethole
Furfural
Menthol
Food colour: Riboflavin from genetically modified Bacillus subtilis
Preservative: Sulfur dioxide and sulfites
Sweetening agent: Stevioside
Thickening agents
Carrageenan
Processed Eucheuma seaweed
Sodium carboxymethyl cellulose, enzymatically hydrolysed
Miscellaneous substances
gamma-Cyclodextrin
Glucono-delta-lactone and the calcium, magnesium, potassium,
and sodium salts of gluconic acid
Polyglycitol syrups
Safety evaluations of groups of related substances
evaluated by the Procedure for the Safety Evaluation
of Flavouring Agents
Introduction
General aspects of metabolism
Saturated aliphatic acyclic secondary alcohols, ketones,
and related saturated and unsaturated esters
Linear and branched-chain aliphatic unsaturated, unconjugated
alcohols, aldehydes, acids, and related esters
Aliphatic acyclic and alicyclic terpenoid tertiary alcohols
and structurally related substances
Carvone and structurally related substances
Ionones and structurally related substances
Aliphatic acyclic and alicyclic a-diketones and related
alpha-hydroxyketones
Substances structurally related to menthol
Assessments of the intake of specific food additives
Benzoates
Butylated hydroxyanisole (BHA)
Butylated hydroxytoluene (BHT)
Sulfites
tert-Butylhydroquinone (TBHQ)
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 Participants in the fifty-first meeting of the
Joint FAO/WHO Expert Committee on
Food Additives
Annex 4 Acceptable daily intakes, other toxicological
information, and information on specifications
PREFACE
The monographs contained in this volume were prepared at the
fifty-first meeting of the Joint FAO/WHO Expert Committee on Food
Additives (JECFA), which met at WHO Headquarters in Geneva,
Switzerland, 9-18 June 1998. These monographs summarize the safety
data on selected food additives reviewed by the Committee.
The fifty-first report of JECFA will be published by the World Health
Organization in the WHO Technical Report Series. Reports and other
documents resulting from previous meetings of JECFA are listed in
Annex 1. The participants in the meeting are listed in Annex 3 of the
present publication; a summary of the conclusions of the Committee is
given in Annex 4. Some of the substances listed in Annex 4 were
evaluated at the meeting only for specifications.
Specifications that were developed at the fifty-first meeting of JECFA
have been issued separately by FAO as Food and Nutrition Paper No. 52
Add.6. The toxicological monographs in the present publication should
be read in conjunction with the specifications and the report.
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 referenced. These were
voluntarily submitted to the Committee by various producers of the
food additives under review and in many cases represent the only data
on safety available on those substances. The Temporary Advisers based
the working papers they developed on all of the data that were
submitted, and all of these reports were available to the Committee
when it made its evaluations. The monographs were edited by E.
Heseltine, Lajarthe, 24290 St Léon-sur-Vézère, France.
The preparation and editing of the monographs included in this
volume were 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.
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 properties of the compounds evaluated in this
publication 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.