INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
TOXICOLOGICAL EVALUATION OF CERTAIN
VETERINARY DRUG RESIDUES IN FOOD
WHO FOOD ADDITIVES SERIES 38
Prepared by:
The 47th meeting of the Joint FAO/WHO Expert
Committee on Food Additives (JECFA)
World Health Organization, Geneva 1996
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 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 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
Adrenoceptor agonists
Clenbuterol
Xylazine
Antimicrobial agents
Neomycin
Thiamphenicol
Tilmicosin
Insecticides
Cypermethrin and alpha-cypermethrin
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-seventh 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
forty-seventh meeting of the Joint FAO/WHO Expert Committee on Food
Additives (JECFA), which met in Rome, Italy, 4-13 June 1996. These
monographs summarize the safety data on selected veterinary drug
residues reviewed by the Committee. The data reviewed in these
monographs form the basis for acceptable daily intakes (ADIs)
established by the Committee.
The forty-seventh 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.
Residue monographs on the veterinary drugs that were evaluated at
the forty-seventh meeting of JECFA will be issued separately by FAO as
Food and Nutrition Paper No. 41/9. These toxicological monographs
should be read in conjunction with the residue monographs 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 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. 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 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.