INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY WORLD HEALTH ORGANIZATION TOXICOLOGICAL EVALUATION OF CERTAIN VETERINARY DRUG RESIDUES IN FOOD WHO FOOD ADDITIVES SERIES 45 Prepared by the Fifty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) World Health Organization, Geneva, 2000 ANNEX 1 Reports and other documents resulting from previous meetings of the Joint FAO/WHO Expert Committee on Food Additives 1. General principles governing the use of food additives (First report of the Joint FAO/WHO Expert Committee on Food Additives). FAO Nutrition Meetings Report Series, No. 15, 1957; WHO Technical Report Series, No. 129, 1957 (out of print). 2. Procedures for the testing of intentional food additives to establish their safety for use (Second report of the Joint FAO/WHO Expert Committee on Food Additives). FAO Nutrition Meetings Report Series, No. 17, 1958; WHO Technical Report Series, No. 144, 1958 (out of print). 3. Specifications for identity and purity of food additives (antimicrobial preservatives and antioxidants) (Third report of the Joint FAO/WHO Expert Committee on Food Additives). These specifications were subsequently revised and published as Specifications for identity and purity of food additives, Vol. I. Antimicrobial preservatives and antioxidants, Rome, Food and Agriculture Organization of the United Nations, 1962 (out of print). 4. Specifications for identity and purity of food additives (food colours) (Fourth report of the Joint FAO/WHO Expert Committee on Food Additives). These specifications were subsequently revised and published as Specifications for identity and purity of food additives, Vol. II. Food colours, Rome, Food and Agriculture Organization of the United Nations, 1963 (out of print). 5. Evaluation of the carcinogenic hazards of food additives (Fifth report of the Joint FAO/WHO Expert Committee on Food Additives). FAO Nutrition Meetings Report Series, No. 29, 1961; WHO Technical Report Series, No. 220, 1961 (out of print). 6. Evaluation of the toxicity of a number of antimicrobials and antioxidants (Sixth report of the Joint FAO/WHO Expert Committee on Food Additives). FAO Nutrition Meetings Report Series, No. 31, 1962; WHO Technical Report Series, No. 228, 1962 (out of print). 7. Specifications for the identity and purity of food additives and their toxicological evaluation: emulsifiers, stabilizers, bleaching and maturing agents (Seventh report of the Joint FAO/WHO Expert Committee on Food Additives). FAO Nutrition Meetings Series, No. 35, 1964; WHO Technical Report Series, No. 281, 1964 (out of print). 8. Specifications for the identity and purity of food additives and their toxicological evaluation: food colours and some antimicrobials and antioxidants (Eighth report of the Joint FAO/WHO Expert Committee on Food Additives). FAO Nutrition Meetings Series, No. 38, 1965; WHO Technical Report Series, No. 309, 1965 (out of print). 9. Specifications for identity and purity and toxicological evaluation of some antimicrobials and antioxidants. FAO Nutrition Meetings Report Series, No. 38A, 1965; WHO/Food Add/24.65 (out of print). 10. Specifications for identity and purity and toxicological evaluation of food colours. FAO Nutrition Meetings Report Series, No. 38B, 1966; WHO/Food Add/66.25. 11. Specifications for the identity and purity of food additives and their toxicological evaluation: some antimicrobials, antioxidants, emulsifiers, stabilizers, flour treatment agents, acids, and bases (Ninth report of the Joint FAO/WHO Expert Committee on Food Additives). FAO Nutrition Meetings Series, No. 40, 1966; WHO Technical Report Series, No. 339, 1966 (out of print). 12. Toxicological evaluation of some antimicrobials, antioxidants, emulsifiers, stabilizers, flour treatment agents, acids, and bases. FAO Nutrition Meetings Report Series, No. 40A, B, C; WHO/Food Add/67.29. 13. Specifications for the identity and purity of food additives and their toxicological evaluation: some emulsifiers and stabilizers and certain other substances (Tenth report of the Joint FAO/WHO Expert Committee on Food Additives). FAO Nutrition Meetings Series, No. 43, 1967; WHO Technical Report Series, No. 373, 1967. 14. Specifications for the identity and purity of food additives and their toxicological evaluation: some flavouring substances and non nutritive sweetening agents (Eleventh report of the Joint FAO/WHO Expert Committee on Food Additives). FAO Nutrition Meetings Series, No. 44, 1968; WHO Technical Report Series, No. 383, 1968. 15. Toxicological evaluation of some flavouring substances and non nutritive sweetening agents. FAO Nutrition Meetings Report Series, No. 44A, 1968; WHO/Food Add/68.33. 16. Specifications and criteria for identity and purity of some flavouring substances and non-nutritive sweetening agents. FAO Nutrition Meetings Report Series, No. 44B, 1969; WHO/Food Add/69.31. 17. Specifications for the identity and purity of food additives and their toxicological evaluation: some antibiotics (Twelfth report of the Joint FAO/WHO Expert Committee on Food Additives). FAO Nutrition Meetings Series, No. 45, 1969; WHO Technical Report Series, No. 430, 1969. 18. Specifications for the identity and purity of some antibiotics. FAO Nutrition Meetings Series, No. 45A, 1969; WHO/Food Add/69.34. 19. Specifications for the identity and purity of food additives and their toxicological evaluation: some food colours, emulsifiers, stabilizers, anticaking agents, and certain other substances (Thirteenth report of the Joint FAO/WHO Expert Committee on Food Additives). FAO Nutrition Meetings Series, No. 46, 1970; WHO Technical Report Series, No. 445, 1970. 20. Toxicological evaluation of some food colours, emulsifiers, stabilizers, anticaking agents, and certain other substances. FAO Nutrition Meetings Report Series, No. 46A, 1970; WHO/Food Add/70.36. 21. Specifications for the identity and purity of some food colours, emulsifiers, stabilizers, anticaking agents, and certain other food additives. FAO Nutrition Meetings Report Series, No. 46B, 1970; WHO/Food Add/70.37. 22. Evaluation of food additives: specifications for the identity and purity of food additives and their toxicological evaluation: some extraction solvents and certain other substances; and a review of the technological efficacy of some antimicrobial agents. (Fourteenth report of the Joint FAO/WHO Expert Committee on Food Additives). FAO Nutrition Meetings Series, No. 48, 1971; WHO Technical Report Series, No. 462, 1971. 23. Toxicological evaluation of some extraction solvents and certain other substances. FAO Nutrition Meetings Report Series, No. 48A, 1971; WHO/Food Add/70.39. 24. Specifications for the identity and purity of some extraction solvents and certain other substances. FAO Nutrition Meetings Report Series, No. 48B, 1971; WHO/Food Add/70.40. 25. A review of the technological efficacy of some antimicrobial agents. FAO Nutrition Meetings Report Series, No. 48C, 1971; WHO/Food Add/70.41. 26. Evaluation of food additives: some enzymes, modified starches, and certain other substances: Toxicological evaluations and specifications and a review of the technological efficacy of some antioxidants (Fifteenth report of the Joint FAO/WHO Expert Committee on Food Additives). FAO Nutrition Meetings Series, No. 50, 1972; WHO Technical Report Series, No. 488, 1972. 27. Toxicological evaluation of some enzymes, modified starches, and certain other substances. FAO Nutrition Meetings Report Series, No. 50A, 1972; WHO Food Additives Series, No. 1, 1972. 28. Specifications for the identity and purity of some enzymes and certain other substances. FAO Nutrition Meetings Report Series, No. 50B, 1972; WHO Food Additives Series, No. 2, 1972. 29. A review of the technological efficacy of some antioxidants and synergists. FAO Nutrition Meetings Report Series, No. 50C, 1972; WHO Food Additives Series, No. 3, 1972. 30. Evaluation of certain food additives and the contaminants mercury, lead, and cadmium (Sixteenth report of the Joint FAO/WHO Expert Committee on Food Additives). FAO Nutrition Meetings Series, No. 51, 1972; WHO Technical Report Series, No. 505, 1972, and corrigendum. 31. Evaluation of mercury, lead, cadmium and the food additives amaranth, diethylpyrocarbamate, and octyl gallate. FAO Nutrition Meetings Report Series, No. 51A, 1972; WHO Food Additives Series, No. 4, 1972. 32. Toxicological evaluation of certain food additives with a review of general principles and of specifications (Seventeenth report of the Joint FAO/WHO Expert Committee on Food Additives). FAO Nutrition Meetings Series, No. 53, 1974; WHO Technical Report Series, No. 539, 1974, and corrigendum (out of print). 33. Toxicological evaluation of some food additives including anticaking agents, antimicrobials, antioxidants, emulsifiers, and thickening agents. FAO Nutrition Meetings Report Series, No. 53A, 1974; WHO Food Additives Series, No. 5, 1974. 34. Specifications for identity and purity of thickening agents, anticaking agents, antimicrobials, antioxidants and emulsifiers. FAO Food and Nutrition Paper, No. 4, 1978. 35. Evaluation of certain food additives (Eighteenth report of the Joint FAO/WHO Expert Committee on Food Additives). FAO Nutrition Meetings Series, No. 54, 1974; WHO Technical Report Series, No. 557, 1974, and corrigendum. 36. Toxicological evaluation of some food colours, enzymes, flavour enhancers, thickening agents, and certain other food additives. FAO Nutrition Meetings Report Series, No. 54A, 1975; WHO Food Additives Series, No. 6, 1975. 37. Specifications for the identity and purity of some food colours, enhancers, thickening agents, and certain food additives. FAO Nutrition Meetings Report Series, No. 54B, 1975; WHO Food Additives Series, No. 7, 1975. 38. Evaluation of certain food additives: some food colours, thickening agents, smoke condensates, and certain other substances. (Nineteenth report of the Joint FAO/WHO Expert Committee on Food Additives). FAO Nutrition Meetings Series, No. 55, 1975; WHO Technical Report Series, No. 576, 1975. 39. Toxicological evaluation of some food colours, thickening agents, and certain other substances. FAO Nutrition Meetings Report Series, No. 55A, 1975; WHO Food Additives Series, No. 8, 1975. 40. Specifications for the identity and purity of certain food additives. FAO Nutrition Meetings Report Series, No. 55B, 1976; WHO Food Additives Series, No. 9, 1976. 41. Evaluation of certain food additives (Twentieth report of the Joint FAO/WHO Expert Committee on Food Additives). FAO Food and Nutrition Meetings Series, No. 1, 1976; WHO Technical Report Series, No. 599, 1976. 42. Toxicological evaluation of certain food additives. WHO Food Additives Series, No. 10, 1976. 43. Specifications for the identity and purity of some food additives. FAO Food and Nutrition Series, No. 1B, 1977; WHO Food Additives Series, No. 11, 1977. 44. Evaluation of certain food additives (Twenty-first report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 617, 1978. 45. Summary of toxicological data of certain food additives. WHO Food Additives Series, No. 12, 1977. 46. Specifications for identity and purity of some food additives, including antioxidant, food colours, thickeners, and others. FAO Nutrition Meetings Report Series, No. 57, 1977. 47. Evaluation of certain food additives and contaminants (Twenty-second report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 631, 1978. 48. Summary of toxicological data of certain food additives and contaminants. WHO Food Additives Series, No. 13, 1978. 49. Specifications for the identity and purity of certain food additives. FAO Food and Nutrition Paper, No. 7, 1978. 50. Evaluation of certain food additives (Twenty-third report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 648, 1980, and corrigenda. 51. Toxicological evaluation of certain food additives. WHO Food Additives Series, No. 14, 1980. 52. Specifications for identity and purity of food colours, flavouring agents, and other food additives. FAO Food and Nutrition Paper, No. 12, 1979. 53. Evaluation of certain food additives (Twenty-fourth report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 653, 1980. 54. Toxicological evaluation of certain food additives. WHO Food Additives Series, No. 15, 1980. 55. Specifications for identity and purity of food additives (sweetening agents, emulsifying agents, and other food additives). FAO Food and Nutrition Paper, No. 17, 1980. 56. Evaluation of certain food additives (Twenty-fifth report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 669, 1981. 57. Toxicological evaluation of certain food additives. WHO Food Additives Series, No. 16, 1981. 58. Specifications for identity and purity of food additives (carrier solvents, emulsifiers and stabilizers, enzyme preparations, flavouring agents, food colours, sweetening agents, and other food additives). FAO Food and Nutrition Paper, No. 19, 1981. 59. Evaluation of certain food additives and contaminants (Twenty-sixth report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 683, 1982. 60. Toxicological evaluation of certain food additives. WHO Food Additives Series, No. 17, 1982. 61. Specifications for the identity and purity of certain food additives. FAO Food and Nutrition Paper, No. 25, 1982. 62. Evaluation of certain food additives and contaminants (Twenty-seventh report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 696, 1983, and corrigenda. 63. Toxicological evaluation of certain food additives and contaminants. WHO Food Additives Series, No. 18, 1983. 64. Specifications for the identity and purity of certain food additives. FAO Food and Nutrition Paper, No. 28, 1983. 65. Guide to specifications General notices, general methods, identification tests, test solutions, and other reference materials. FAO Food and Nutrition Paper, No. 5, Rev. 1, 1983. 66. Evaluation of certain food additives and contaminants (Twenty-eighth report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 710, 1984, and corrigendum. 67. Toxicological evaluation of certain food additives and contaminants. WHO Food Additives Series, No. 19, 1984. 68. Specifications for the identity and purity of food colours. FAO Food and Nutrition Paper, No. 31/1, 1984. 69. Specifications for the identity and purity of food additives. FAO Food and Nutrition Paper, No. 31/2, 1984. 70. Evaluation of certain food additives and contaminants (Twenty-ninth report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 733, 1986, and corrigendum. 71. Specifications for the identity and purity of certain food additives. FAO Food and Nutrition Paper, No. 34, 1986. 72. Toxicological evaluation of certain food additives and contaminants. WHO Food Additives Series, No. 20. Cambridge University Press, 1987. 73. Evaluation of certain food additives and contaminants (Thirtieth report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 751, 1987. 74. Toxicological evaluation of certain food additives and contaminants. WHO Food Additives Series, No. 21. Cambridge University Press, 1987. 75. Specifications for the identity and purity of certain food additives. FAO Food and Nutrition Paper, No. 37, 1986. 76. Principles for the safety assessment of food additives and contaminants in food. WHO Environmental Health Criteria, No. 70. Geneva, World Health Organization, 1987 (out of print). The full text is available electronically at www.who.int/pcs. 77. Evaluation of certain food additives and contaminants (Thirty-first report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 759, 1987 and corrigendum. 78. Toxicological evaluation of certain food additives. WHO Food Additives Series, No. 22. Cambridge University Press, 1988. 79. Specifications for the identity and purity of certain food additives. FAO Food and Nutrition Paper, No. 38, 1988. 80. Evaluation of certain veterinary drug residues in food (Thirty-second report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 763, 1988. 81. Toxicological evaluation of certain veterinary drug residues in food. WHO Food Additives Series, No. 23. Cambridge University Press, 1988. 82. Residues of some veterinary drugs in animals and foods. FAO Food and Nutrition Paper, No. 41, 1988. 83. Evaluation of certain food additives and contaminants (Thirty-third report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 776, 1989. 84. Toxicological evaluation of certain food additives and contaminants. WHO Food Additives Series, No. 24. Cambridge University Press, 1989. 85. Evaluation of certain veterinary drug residues in food (Thirty-fourth report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 788, 1989. 86. Toxicological evaluation of certain veterinary drug residues in food. WHO Food Additives Series, No. 25, 1990. 87. Residues of some veterinary drugs in animals and foods. FAO Food and Nutrition Paper, No. 41/2, 1990. 88. Evaluation of certain food additives and contaminants (Thirty-fifth report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 789, 1990, and corrigenda. 89. Toxicological evaluation of certain food additives and contaminants. WHO Food Additives Series, No. 26, 1990. 90. Specifications for identity and purity of certain food additives. FAO Food and Nutrition Paper, No. 49, 1990. 91. Evaluation of certain veterinary drug residues in food (Thirty-sixth report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 799, 1990. 92. Toxicological evaluation of certain veterinary drug residues in food. WHO Food Additives Series, No. 27, 1991. 93. Residues of some veterinary drugs in animals and foods. FAO Food and Nutrition Paper, No. 41/3, 1991. 94. Evaluation of certain food additives and contaminants (Thirty-seventh report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 806, 1991, and corrigenda. 95. Toxicological evaluation of certain food additives and contaminants. WHO Food Additives Series, No. 28, 1991. 96. Compendium of Food Additive Specifications. Joint FAO/WHO Expert Committee on Food Additives (JECFA). Combined specifications from 1st through the 37th Meetings, 1956-1990. FAO, 1992 (2 volumes). 97. Evaluation of certain veterinary drug residues in food (Thirty-eighth report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 815, 1991. 98. Toxicological evaluation of certain veterinary residues in food. WHO Food Additives Series, No. 29, 1991. 99. Residues of some veterinary drugs in animals and foods. FAO Food and Nutrition Paper, No. 41/4, 1991. 100. Guide to specifications -- General notices, general analytical techniques, identification tests, test solutions, and other reference materials. FAO Food and Nutrition Paper, No. 5, Ref. 2, 1991. 101. Evaluation of certain food additives and naturally occurring toxicants (Thirty-ninth report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series No. 828, 1992. 102. Toxicological evaluation of certain food additives and naturally occurring toxicants. WHO Food Additive Series, No. 30, 1993. 103. Compendium of food additive specifications: Addendum 1. FAO Food and Nutrition Paper, No. 52, 1992. 104. Evaluation of certain veterinary drug residues in food (Fortieth report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 832, 1993. 105. Toxicological evaluation of certain veterinary drug residues in food. WHO Food Additives Series, No. 31, 1993. 106. Residues of some veterinary drugs in animals and foods. FAO Food and Nutrition Paper, No. 41/5, 1993. 107. Evaluation of certain food additives and contaminants (Forty-first report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 837, 1993. 108. Toxicological evaluation of certain food additives and contaminants. WHO Food Additives Series, No. 32, 1993. 109. Compendium of food additive specifications: Addendum 2. FAO Food and Nutrition Paper, No. 52, Add. 2, 1993. 110. Evaluation of certain veterinary drug residues in food (Forty-second report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 851, 1995. 111. Toxicological evaluation of certain veterinary drug residues in food. WHO Food Additives Series, No. 33, 1994. 112. Residues of some veterinary drugs in animals and foods. FAO Food and Nutrition Paper, No. 41/6, 1994. 113. Evaluation of certain veterinary drug residues in food (Forty-third report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 855, 1995, and corrigendum. 114. Toxicological evaluation of certain veterinary drug residues in food. WHO Food Additives Series, No. 34, 1995. 115. Residues of some veterinary drugs in animals and foods. FAO Food and Nutrition Paper, No. 41/7, 1995. 116. Evaluation of certain food additives and contaminants (Forty-fourth report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 859, 1995. 117. Toxicological evaluation of certain food additives and contaminants. WHO Food Additives Series, No. 35, 1996. 118. Compendium of food additive specifications: Addendum 3. FAO Food and Nutrition Paper, No. 52, Add. 3, 1995. 119. Evaluation of certain veterinary drug residues in food (Forty-fifth report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 864, 1996. 120. Toxicological evaluation of certain veterinary drug residues in food. WHO Food Additives Series, No. 36, 1996. 121. Residues of some veterinary drugs in animals and foods. FAO Food and Nutrition Paper, No. 41/8, 1996. 122. Evaluation of certain food additives and contaminants (Forty-sixth report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 868, 1997. 123. Toxicological evaluation of certain food additives. WHO Food Additives Series, No. 37, 1996. 124. Compendium of food additive specifications, addendum 4. FAO Food and Nutrition Paper, No. 52, Add. 4, 1996. 125. Evaluation of certain veterinary drug residues in food (Forty-seventh report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 876, 1998. 126. Toxicological evaluation of certain veterinary drug residues in food. WHO Food Additives Series, No. 38, 1996. 127. Residues of some veterinary drugs in animals and foods. FAO Food and Nutrition Paper, No. 41/9, 1997. 128. Evaluation of certain veterinary drug residues in food (Forty-eighth report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 879, 1998. 129. Toxicological evaluation of certain veterinary drug residues in food. WHO Food Additives Series, No. 39, 1997. 130. Residues of some veterinary drugs in animals and foods. FAO Food and Nutrition Paper, No. 41/10, 1998. 131. Evaluation of certain food additives and contaminants (Forty-ninth report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 884, 1999. 132. Safety evaluation of certain food additives and contaminants. WHO Food Additives Series, No. 40, 1998. 133. Compendium of food additive specifications: Addendum 5. FAO Food and Nutrition Paper, No. 52, Add. 5, 1997. 134. Evaluation of certain veterinary drug residues in food (Fiftieth report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 888, 1999. 135. Toxicological evaluation of certain veterinary drug residues in food. WHO Food Additives Series, No. 41, 1998. 136. Residues of some veterinary drugs in animals and foods. FAO Food and Nutrition Paper, No. 41/11, 1999. 137. Evaluation of certain food additives (Fifty-first report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 891, 2000. 138. Safety evaluation of certain food additives. WHO Food Additives Series, No. 42, 1999. 139. Compendium of food additive specifications, addendum 6. FAO Food and Nutrition Paper, No. 52, Add. 6, 1998. 140. Evaluation of certain veterinary drug residues in food (Fifty-second report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, No. 893, in press. 141. Toxicological evaluation of certain veterinary drug residues in food. WHO Food Additives Series, No. 43, 2000 142. Residues of some veterinary drugs in animals and foods. FAO Food and Nutrition Paper, No. 41/12, 2000. 143. Evaluation of certain food additives and contaminants (Fifty-third report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series, in press. 144. Safety evaluation of certain food additives and contaminants. WHO Food Additives Series, No. 44, 2000. 145. Compendium of food additive specifications, addendum 7. FAO Food and Nutrition Paper, No. 52, Add. 7, 1999. ANNEX 2 ABBREVIATIONS USED IN THE MONOGRAPHS ADI acceptable daily intake AUC integrated area under the curve of concentration-time bw body weight CFU colony-forming unit ED50 median effective dose F female F0 parental generation F1 first filial generation F2 second filial geneartion F3 third filial generation FAO Food and Agricultural Organization of the United Nations FSH follicle-stimulating hormone GABA gamna-aminobutyric acid GLP good laboratory practice HPLC high-performance liquid chromatography IARC International Agency for Research on Cancer i.p. intraperitoneal IPCS International Programme on Chemical Safety JECFA Joint FAO/WHO Expert Committee on Food Additives JMPR Joint Meeting on Pesticide Residues LC50 median lethal concentration LD50 median lethal dose LH luteinizing hormone LOEL lowest-observed-effect level M male MEA 6-methyl-8ß-ergoline-acetonitrile MIC50 median inhibitory concentration MS mass spectrometry NOEC no-observed-effect concentration NOEL no-observed-effect level NR not reported OECD Organization for Economic Co-operation and Development S9 hepatic microsome fraction SPF specific pathogen-free TLC thin-layer chromatography USP United States Pharmacopeia WHO World Health Organization ANNEX 3 JOINT FAO/WHO EXPERT COMMITTEE ON FOOD ADDITIVES Geneva, 15-24 February 2000 Members Professor A. Anadón, Department of Toxicology & Pharmacology, Faculty of Veterinary Medicine, Universidad Complutense de Madrid, Madrid, Spain Dr L.-E. Appelgren, Professor of Pharmacology, Department of Pharmacology and Toxicology, Faculty of Veterinary Medicine, The Swedish University of Agricultural Sciences, Uppsala, Sweden Dr D. Arnold, Acting Director, Federal Institute for Health Protection of Consumers and Veterinary Medicine, Berlin, Germany Dr J. Boisseau, Director, National Agency for Veterinary Medicinal Products, French Food Safety Agency, Fougères, France (Vice-Chairman) Professor A.R. Boobis, Section on Clinical Pharmacology, Division of Medicine, Imperial College School of Medicine, Hammersmith Campus, London, England (Rapporteur) Professor L.D.B. Kinabo, Department of Veterinary Physiology, Biochemistry, Pharmacology and Toxicology, Sokoine University of Agriculture, Morogoro, United Republic of Tanzania Dr J.D. MacNeil, Head, Center for Veterinary Drug Residues, Health of Animals Laboratory, Canadian Food Inspection Agency, Saskatoon, Saskatchewan, Canada (Rapporteur) Dr J.G. McLean, Professor Emeritus, Swinburne University of Technology, Hawthorn, Victoria, Australia (Chairman) Dr M.A. Miller, Deputy Director, Human Food Safety, Office of New Animal Drug Evaluation, Center for Veterinary Medicine, Food and Drug Administration, Rockville, MD, USA Professor J. Palermo-Neto, Applied Pharmacology and Toxicology Laboratory, Department of Pathology, School of Veterinary Medicine, University of Sœo Paulo, Sœo Paulo, Brazil Dr J.L. Rojas Martínez, Chief, Toxicology and Residues Section, National Laboratory of Veterinary Sciences, Ministry of Agricultural and Animal Husbandry, San José, Costa Rica Dr S. Soback, Head, National Residue Laboratory, Kimron Veterinary Institute, Ministry of Agriculture, Beit Dagan, Israel Dr R.W. Stephany, Head, Laboratory for Residue Analysis, National Institute of Public Health and the Environment, Bilthoven, Netherlands Secretariat Dr F. Aguilar, International Programme on Chemical Safety, World Health Organization, Geneva, Switzerland Dr S.M.F. Calumpang, National Crop Protection Centre, University of the Philippines, Los Baños College Laguna, Philippines (FAO Consultant) Dr C.E. Cerniglia, Director, Division of Microbiology and Chemistry, National Center for Toxicological Research, Food and Drug Administration, Jefferson, Arkansas, USA (WHO Temporary Adviser) Dr R. Ellis, Nutrition Officer, Food Quality Liaison Group, Food Quality and Standards Service, Food and Nutrition Division, FAO, Rome, Italy (Joint Secretary) Dr L.G. Friedlander, Center for Veterinary Medicine, Food and Drug Administration, Rockville, Maryland, USA (FAO Consultant) Dr K. Greenlees, Center for Veterinary Medicine, Food and Drug Administration, Rockville, Maryland, USA (WHO Temporary Adviser) Mr D.J. Hamilton, Principal Scientific Officer, Animal and Plant Health Service, Department of Primary Industries, Brisbane, Australia (FAO Consultant) Dr J.L. Herrman, Scientist, International Programme on Chemical Safety, WHO, Geneva, Switzerland (Joint Secretary) Dr R.J. Heitzman, Science Consultant, Newbury, Berkshire, England (FAO Consultant) Dr R.C. Livingston, Center for Veterinary Medicine, Food and Drug Administration, Rockville, Maryland, USA (FAO Consultant) Dr K. Mitsumori, Chief, Third Section, Division of Pathology, Biological Safety Research Centre, National Institute of Health Sciences, Tokyo, Japan (WHO Temporary Adviser) Professor M.R.A. Morgan, Procter Department of Food Science, University of Leeds, Leeds, England (FAO Consultant) Mr N. Nakashima, International Programme on Chemical Safety, World Health Organization, Geneva, Switzerland Mrs M.E.J. Pronk, Engineer, Center for Substances and Risk Assessment, National Institute of Public Health and the Environment, Bilthoven, Netherlands (WHO Temporary Adviser) Mr D. Renshaw, Principal Scientist: Veterinary Products, Joint Ministry of Foof and Fisheries/Department of Health Food Standards and Safety Group, Department of Health, London, United Kingdom (WHO Temporary Adviser) Dr L. Ritter, Executive Director, Canadian Network of Toxicology Centres, University of Guelph, Guelph, Ontario, Canada (WHO Temporary Adviser) Dr G. Roberts, Manager, Chemical Products Assessment Section, Therapeutic Goods Administration, Commonwealth Department of Health and Aged Care, Woden, Australian Capital Territory, Australia (WHO Temporary Adviser) Dr B. Roestel, Head International Affairs, National Agency for Veterinary Medicinal Products, French Food Safety Agency, La Haute Marche, France (FAO Consultant) Dr S. Sundlof, Director, Center for Veterinary Medicine, Food and Drug Administration, Rockville, Maryland, USA (WHO Temporary Adviser) Dr A. Tejada, Pesticide Management Group, Plant Production and Protection Division, FAO, Rome, Italy Professor F.R. Ungemach, Institute of Pharmacology, Pharmacy and Toxicology, Faculty of Veterinary Medicine, University of Leipzig, Leipzig, Germany (WHO Temporary Adviser) Dr Y. Yamada, Food Standards Officer, Joint FAO/WHO Standards Programme, Food and Nutrition Division, FAO, Rome, Italy Dr R. Wells, Gordon, New South Wales, Australia (FAO Consultant) Professor J. Zmudzki, Department of Pharmacology and Toxicology, National Veterinary Research Institute, Pulawy, Poland (FAO Consultant) ANNEX 4 RECOMMENDATIONS ON COMPOUNDS ON THE AGENDA AND FURTHER INFORMATION REQUIRED Anthelminthic agent Ivermectin Acceptable daily intake: 0-1 µg/kg bw (established at the fortieth meeting of the Committee (WHO TRS 832, 1993)) Residue definition: Ivermectin H2B1a Recommended maximum residue limits (MRLs)a Species Milk (µg/kg) Cattle 10b a The MRLs that were recommended at the thirty-sixth and fortieth meetings of the Committee (WHO TRS 799 (1990) and 832 (1993), respectively) were not reconsidered and were maintained. b Temporary MRL. Validation data on the analytical method and information on other routes of application to cattle to evaluate the residues in milk are required for evaluation in 2002. Antimicrobial agents Flumequine Acceptable daily intake: 0-30 µg/kg bw (established at the forty-eighth meeting of the Committee (WHO TRS 879, 1998)) Residue definition: Flumequine Recommended maximum residue limits (MRLs) Species Muscle Liver Kidney Fat (µg/kg) (µg/kg) (µg/kg) (µg/kg) Cattle 500 500 3000 1000 Pigs 500 500 3000 1000 Sheep 500 500 3000 1000 Chickens 500 500 3000 1000 Trout 500a a For trout muscle including skin in natural proportions. Lincomycin Acceptable daily intake: 0-30 µg/kg bw Residue definition: Lincomycin Recommended maximum residue limits (MRLs) Species Muscle Liver Kidney Fat Milk (µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg) Cattle 100a 500a 1500a 100a 150 Pigs 100 500 1500 100 Sheep 100a 500a 1500a 100a Chickensb 100a 500a 1500a 100a a The recommended MRLs are temporary. Data comparable to those provided for tissues of pigs, which show that lincomycin is the major component with significant microbiological activity in tissues of cattle, sheep, and chickens, are required for evaluation in 2002. b Before considering an MRL for chicken eggs, the Committee would wish to see (1) data showing that lincomycin is the major component with significant microbiological activity and (2) a residue depletion study in which the gas chromatographic-mass spectrometry method is used. Oxytetracycline Acceptable daily intake: 0-30 µg/kg bw (group ADI for tetracycline, oxytetracycline and chlortetracycline; established at the fiftieth meeting of the Committee (WHO TRS 888, 1999)) Residue definition: Oxytetracycline, singly or in combination with chlortetracycline and tetracycline Recommended maximum residue limits (MRLs)a Species Muscle (µg/kg) Fish 200b a The MRLs that were recommended in cattle, pigs, sheep, poultry, and giant tiger prawn (Penaeus monodon) at the fiftieth meeting of the Committee (WHO TRS 888, 1999) were not reconsidered and were maintained. b Temporary MRL. Residue data and a validated analytical method are required for evaluation in 2002. Tilmicosin Acceptable daily intake: 0-40 µg/kg bw (established at the forty-seventh meeting of the Committee (WHO TRS 876, 1996)) Residue definition: Tilmicosin Recommended maximum residue limits (MRLs)a Species Milk (µg/kg) Sheep Not extendedb a The MRLs that were recommended for muscle, liver, kidney, and fat of cattle, pigs, and sheep at the forty-seventh meeting of the Committee (WHO TRS 876, 1998) were not reconsidered and were maintained. b The temporary MRL for sheep milk was not extended as results of a study with radiolabelled drug in lactating sheep to determine the relationship between total residues and parent drug in milk were not available. Insecticides Cyhalothrin Acceptable daily intake: 0-2 µg/kg bw (temporary)a Residue definition: Cyhalothrin Recommended maximum residue limits (MRLs) Species Muscle Liver Kidney Fat Milk (µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg) Cattleb 20 20 20 400 30 Pigsb 20 20 20 400 Sheepb 20 20 20 400 a Results of appropriate studies to establish a NOEL for neurobehavioural effects in laboratory animals are required for evaluation in 2002. b The recommended MRLs are temporary because the ADI is temporary. In addition, results of the validation of the analytical method for sheep liver to demonstrate a limit of quantification of 0.01 mg/kg are required for evaluation in 2002. Cypermethrin Acceptable daily intake: 0-50 µg/kg bw (established at the forty-seventh meeting of the Committee (WHO TRS 876, 1998)) Residue definition: Cypermethrin, sum of isomers Recommended maximum residue limits (MRLs) Species Muscle Liver Kidney Fat Milk/Eggs Cattlea Not Not Not Not Not extended extended extended extended extended Sheepa Not Not Not Not extended extended extended extended Chickensa Not Not Not Not Not extended extended extended extended extended a Since the information required at the forty-seventh meeting of the Committee (WHO TRS 876, 1998) was not provided and there was no indication that it would be provided in the future, the temporary MRLs that had been recommended for cattle, sheep, and chickens were not extended. alpha-Cypermethrin Acceptable daily intake: 0-20 µg/kg bw (established at the forty-seventh meeting of the Committee (WHO TRS 876, 1998)) Residue definition: alpha-Cypermethrin, sum of isomers Recommended maximum residue limits (MRLs) Species Muscle Liver Kidney Fat Milk/Eggs Cattlea Not Not Not Not Not extended extended extended extended extended Sheepa Not Not Not Not extended extended extended extended Chickensa Not Not Not Not Not extended extended extended extended extended a Since the information required at the forty-seventh meeting of the Committee (WHO TRS 876, 1998) was not provided and there was no indication that it would be provided in the future, the temporary MRLs that had been recommended for cattle, sheep, and chickens were not extended. Dicyclanil Acceptable daily intake: 0-7 µg/kg bw Residue definition: Dicyclanil Recommended maximum residue limits (MRLs) Species Muscle Liver Kidney Fat (µg/kg) (µg/kg) (µg/kg) (µg/kg) Sheep 200 400 400 150 Permethrin Acceptable daily intake: 0-50 µg/kg bw (for technical-grade permethrin with cis:trans ratios of 25:75 to 40:60; established by the 1999 Joint FAO/WHO Meeting on Pesticide Residues (JMPR) (FAO Plant Production and Protection Paper, No. 153, 1999) Residue definition: Permethrin, sum of isomers Recommended maximum residue limits (MRLs) The Committee concluded that the database available to the 1999 JMPR was not adequate to assess the toxicity of the 80:20 cis:trans isomeric mixture proposed for use as a veterinary drug. In the absence of an ADI, the Committee was unable to establish MRLs for this isomeric mixture of permethrin. Trichlorfon Acceptable daily intake: 0-20 µg/kg bw Residue definition: Trichlorfon Recommended maximum residue limits (MRLs) Species Muscle Liver Kidney Fat Milk (µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg) Cattle 50a 50a 50a 50a 50 a Guidance value only. Residues of trichlorfon were not detected in the depletion studies reviewed by the Committee. MRLs were not recommended by the Committee for muscle, liver, kidney, or fat in cattle, since no detectable residues should be present in tissues from animals treated with trichlorfon when used in accordance with good practice in the use of veterinary drugs. The limit of quantification may be used as a guide for maximum residue concentrations in muscle, liver, kidney, and fat of cattle. Production aid Melengestrol acetate Acceptable daily intake: 0-0.03 µg/kg bw Residue definition: Melengestrol acetate Maximum residue limits (MRLs) Species Liver Fat (µg/kg) (µg/kg) Cattle 2a 5a a Temporary MRL. A practical analytical method for monitoring residues of melengestrol at the recommended MRL is required for evaluation in 2002.
See Also: Toxicological Abbreviations