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.
See Also: Toxicological Abbreviations