INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
TOXICOLOGICAL EVALUATION OF CERTAIN
VETERINARY DRUG RESIDUES IN FOOD
WHO FOOD ADDITIVES SERIES: 43
Prepared by the Fifty-second meeting of the Joint FAO/WHO
Expert Committee on Food Additives (JECFA)
World Health Organization, Geneva, 2000
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.
ISBN 92 4 1660
CONTENTS
Preface
ß-Adrenoceptor blocking agent: Carazolol
Antimicrobial agent: Thiamphenicol
Insecticide: Phoxim
Production aids
Estradiol-17ß, progesterone, and testosterone
Porcine somatotropin
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 Recoimmendations on substances on the agenda and further
information required
PREFACE
The monographs contained in this volume were prepared at the
fifty-second meeting of the Joint FAO/WHO Expert Committee on Food
Additives (JECFA), which met at FAO Headquarters in Rome, Italy, 2-11
February 1999. These monographs summarize the safety data on selected
food additives reviewed by the Committee.
The fifty-second 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. Abbreviations used in the monographs are listed in Annex
2, and the participants in the meeting are listed in Annex 3; 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 residues.
Monographs on residues of the veterinary drugs that were
evaluated at the fifty-second meeting of JECFA will be issued
separately by FAO as Food and Nutrition Paper No. 41/12. The
toxicological monographs in the present publication should be read in
conjunction with the monographs on residues 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.