INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
Toxicological evaluation of certain veterinary drug
residues in food
WHO FOOD ADDITIVES SERIES 39
Prepared by:
The forty-eighth meeting of the Joint FAO/WHO Expert
Committee on Food Additives (JECFA)
World Health Organization, Geneva 1997
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.
CONTENTS
Preface
Anthelmintic agent
Thiabendazole
Antimicrobial agents
Danofloxacin
Dihydrostreptomycin and streptomycin
Enrofloxacin
Flumequine
Insecticides
Cyfluthrin
Fluazuron
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-eighth meeting of the Joint
FAO/WHO Expert Committee on Food Additives
Annex 4 Acceptable daily intakes, other toxicological information,
and information on specifications
Annex 5 Corrigendum
PREFACE
The monographs contained in this volume were prepared at the
forty-eighth meeting of the Joint FAO/WHO Expert Committee on Food
Additives (JECFA), which met at WHO Headquarters in Geneva,
Switzerland, 18œ27 February 1997. These monographs summarize the
safety data on selected veterinary drug residues reviewed by the
Committee.
The forty-eighth 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. Terms abbreviated in the monographs are listed in Annex 2,
and 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 residues.
Monographs on residues of the veterinary drugs that were
evaluated at the forty-eighth meeting of JECFA will be issued
separately by FAO as Food Nutrition Paper No. 41/10. 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 nine previous meetings of the Committee to consider residues
of veterinary drugs in food (Annex 1, references 80, 85, 91, 97, 104,
110, 113, 119, and 125) had been held in response to the
recommendations of the Joint FAO/WHO Expert Consultation held in 1984.
The present meeting was convened in response to the recommendation
made at the forty-seventh meeting of the Committee that meetings on
this subject should be held annually (Annex 1, reference 125). The
Committeeœs purpose was to provide guidance to FAO and WHO Member
States and to the Codex Alimentarius Commission on public health
issues pertaining to residues of veterinary drugs in foods of animal
origin.
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
veterinary drugs 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 Professor
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.