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
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.
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, in press.
123. Toxicological evaluation of certain food additives. WHO Food
Additives Series, No. 37, 1996.
124. Compendium of food additives 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, in preparation.
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, in preparation.
ANNEX 2
ABBREVIATIONS USED IN THE MONOGRAPHS
ADI acceptable daily intake
ATCC American Tissue Culture Collection
AUC area under the concentration-time curve
bw body weight
CFR Code of Federal Regulations (USA)
cfu colony-forming units
DNA deoxyribonucleic acid
EEC European Economic Community
EPA Environmental Protection Agency (USA)
F1 first filial generation
F2 second filial generation
FAO Food and Agricultural Organization of the United Nations
FDA Food and Drug Administration (USA)
GLP good laboratory practice
HPLC high-performance liquid chromatography
ID50 median inhibitory dose
JECFA Joint FAO/WHO Expert Committee on Food Additives
LD50 median lethal dose
MIC minimal inhibitory concentration
MRL maximum residue limit
ND not determined
NOEL no-observed-effect level
OECD Organisation for Economic Co-operation and Developoment
PEG polyethylene glycol
QA quality assurance
S9 9000 × g fraction of rat liver
SD standard deviation
SPF specific pathogen-free
T3 triiodothyronine
T4 thyroxine
TSH thyroid-stimulating hormone
WHO World Health Organization
w/w weight for weight
ANNEX 3
Joint FAO/WHO Expert Committee on Food Additives
Geneva, 18-27 February 1997
Members
Dr D. Arnold, Deputy Director, Federal Institute for Health Protection
of Consumers and Veterinary Medicine, Berlin, Germany
Dr J. Boisseau, Director, Agence nationale du médicament vétérinaire,
Fougères, France (Vice-Chairman)
Professor A. Boobis, Department of Clinical Pharmacology, Royal
Postgraduate Medical School, Hammersmith Hospital, London, United
Kingdom
Dr G. Boorman, National Institute of Environmental Health Sciences
Research Triangle Park, NC, USA (Rapporteur)
Dr R.L. Ellis, Director, Scientific Research and Oversight Staff, Food
Safety and Inspection Service, US Department of Agriculture,
Washington DC, USA (Rapporteur)
Dr P.G. Francis, West Horsely, Surrey, United Kingdom
Dr R.C. Livingston, Director, Office of New Animal Drug Evaluation,
Center for Veterinary Medicine, Food and Drug Administration,
Rockville, MD, USA
Dr J.D. MacNeil, Head, Center for Veterinary Drug Residues, Health of
Animals Laboratory, Saskatoon, Saskatchewan, Canada
Dr B.L. Marshall, Counsellor Veterinary Services, New Zealand Embassy,
Washington DC, USA
Professor J.G. McLean, Division of Science, Engineering and Design,
Swinburne University of Technology, Hawthorn, Victoria, Australia
(Chairman)
Dr M.A. Miller, Deputy Director for Human Food Safety, Office of New
Animal Drug Evaluation, Center for Veterinary Medicine, Food and Drug
Administration, Rockville, MD, USA
Professor J. Palermo-Neto, Departamento de Patologia, Faculdade de
Medicina Veterinaria e Zootecnia, Universidade de Sao Paulo, Sao
Paulo, SP, Brazil
Dr A. Pinter, Deputy Director General, National Institute of Hygiene,
Budapest, Hungary
Professor A. Rico, Biochemistry-Toxicology, Physiopathology and
Experimental Toxicology Laboratory (INRA), National Veterinary School,
Toulouse, France
Dr J.L. Rojas Martinez, Chief of Toxicology and Residues Section,
National Laboratory of Veterinary Services, Ministry of Agriculture
and Animal Husbandry, San José, Costa Rica
Dr P. Sinhaseni, Department of Pharmacology, Faculty of Pharmaceutical
Sciences, Chulalongkorn University, Bangkok, Thailand
Dr S. Soback, Head, National Residue Laboratory, Kimron Veterinary
Institute, Ministry of Agriculture, Beit Dagan, Israel
Dr R. Wells, Director R & D, Australian Government Analytical
Laboratories, Pymble, NSW, Australia
Secretariat
Dr C.E. Cerniglia, Director, Division of Microbiology, National Center
for Toxicological Research, Food and Drug Administration, Jefferson,
AR, USA (WHO Temporary Adviser)
Dr P. Chamberlain, Veterinary Medical Officer, Division of Toxicology,
Office of New Animal Drug Evaluation, Center for Veterinary Medicine,
Food and Drug Administration, Rockville, MD, USA (WHO Temporary
Adviser)
Dr G. Gallhoff, European Commission, DGIII/E3, Brussels, Belgium
(WHO Temporary Adviser)
Dr L. Good, Veterinary Medicines Directorate, Addlestone, Surrey,
United Kingdom (WHO Temporary Adviser)
Dr R.J. Heitzman, Newbury, Berkshire, United Kingdom (FAO
Consultant)
Dr J.L. Herrman, Assessment of Risk and Methodologies, International
Programme on Chemical Safety, World Health Organization, Geneva,
Switzerland (Joint Secretary)
Professor E. Heseltine, Communication in Science, St Léon-sur-Vézère,
France (Editor)
Dr K. Mitsumori, Chief, Third Section, Division of Pathology,
Biological Safety Research Centre, National Institute of Health
Sciences, Tokyo, Japan (WHO Temporary Adviser)
Dr J. Paakkanen, Nutrition Officer, Food and Nutrition Division, Food
and Agriculture Organization of the United Nations, Rome, Italy
(Joint Secretary)
Ir M.E.J. Pronk, Centre for Substances and Risk Assessment, National
Institute of Public Health and the Environment, Bilthoven, Netherlands
(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, Head, Chemical Products Assessment Section, Therapeutic
Goods Administration, Commonwealth Department of Health and Family
Services, Woden, ACT, Australia (WHO Temporary Adviser)
Dr S. Sundlof, Director, Center for Veterinary Medicine,Food and Drug
Adminis-tration, Rockville, MD, USA (WHO Temporary Adviser)
Professor F.R. Ungemach, Universitœt Leipzig, Veterinarmedizinische
Fakultat, Institut fur Pharmakologie, Pharmazie and Toxikologie,
Leipzig, Germany (WHO Temporary Adviser)
ANNEX 4
Acceptable daily intakes, other toxicological information, and
information on specifications
Anthelmintic agents
Moxidectin
Acceptable daily intake: 0-2 µg per kg of body weight (established at
the forty-fifth meeting of the Committee
(Annex 1, reference 119))
Residue definition: moxidectin (MRLs, except for sheep muscle,
were recommended at the forty-fifth meeting
of the Committee (Annex 1, reference 119));
MRLs for sheep muscle were recommended at the
forty-seventh meeting (Annex 1, reference
125; report in preparation))
Recommended maximum residue limits (MRLs)
Species Muscle Liver Kidney Fat Eggs Milk
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/l)
Cattle 20a,b 100 50 500
Sheep 50a 100 50 500
Deerc 20 100 50 500
a At the forty-fifth meeting the Committee noted the very high
concentration and great variation in the level of residues at the
injection site over a 49-day period after dosing (Annex 1,
reference 119).
b The present Committee reconsidered the MRL for cattle muscle,
but on the basis of the available data maintained the previous
MRL.
c Temporary, pending re-evaluation in 1998.
Thiabendazole
Acceptable daily intake: 0-100 µg per kg of body weight
Residue definition: sum of thiabendazole and
5-hydroxythiabendazole (MRLs were
recommended at the fortieth meeting of
the Committee (Annex 1, reference 104))
Recommended maximum residue limits (MRLs)a
Species Muscle Liver Kidney Fat Eggs Milk
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/l)
Cattle 100 100 100 100 100
Pigs 100 100 100 100
Goats 100 100 100 100 100
Sheep 100 100 100 100
a These MRLs were established at the fortieth meeting of the
Committee (Annex 1, reference 104) and were not reconsidered at the
present meeting.
Antimicrobial agents
Ceftiofur
Acceptable daily intake: 0-50 µg per kg of body weight
(established at the forty-fifth meeting
of the Committee (Annex 1, reference
119))
Residue definition: desfuroylceftiofur
Recommended maximum residue limits (MRLs)
Species Muscle Liver Kidney Fat Eggs Milk
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/l)
Cattle 1000 2000 6000 2000 100
Pigs 1000 2000 6000 2000
Danofloxacin
Acceptable daily intake: 0-20 µg per kg of body weight
Residue definition: danofloxacin
Recommended maximum residue limits (MRLs)
Species Muscle Liver Kidney Fat Eggs Milk
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/l)
Cattle 200 400 400 100
Pigs 100 50 200 100
Chickens 200 400 400 100a
a Fat/skin in normal proportion
Dihydrostreptomycin and streptomycin
Acceptable daily intake: 0-50 µg per kg of body weight (group ADI
for combined residues of
dihydrostreptomycin and streptomycin)
Residue definition: sum of dihydrostreptomycin and
streptomycin
Recommended maximum residue limits (MRLs)a
Species Muscle Liver Kidney Fat Eggs Milk
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/l)
Cattle 500 500 1000 500 200
Pigs 500 500 1000 500
Sheep 500 500 1000 500
Chickens 500 500 1000 500
a Temporary MRLs established at the forty-third meeting (Annex
1, reference 113) were maintained. The following information is
required for evaluation in 1999:
* validation of the HPLC assay to measure residues of
streptomycin
* studies to determine whether the HPLC and bioassay methods give
similar results for residues of both drugs using tissues with
incurred residues
Enrofloxacin
Acceptable daily intake: 0-2 µg per kg of body weight
The evaluation of residues was postponed due to late submission of
data.
Flumequine
Acceptable daily intake: 0-30 µg per kg of body weight
Residue definition: flumequine
Recommended maximum residue limits (MRLs)
Species Muscle Liver Kidney Fat Eggs Milk
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/l)
Cattle 500 1000 3000 1000
Pigsa 500 1000 3000 1000
Sheepa 500 1000 3000 1000
Chickensa 500 1000 3000 1000
Trouta 500b
a MRLs are temporary; the following information is required for
review in 2000:
* studies with radiolabelled flumequine in pigs, sheep,
chickens, and trout to estimate the ratio of the parent drug
to total residues
b Muscle/skin in normal proportion
Gentamicin
The temporary acceptable daily intake established at the forty-third
meeting of the Committee (Annex 1, reference 113) and temporary
maximum residue limits recommended at that meeting were extended until
1998.
Spiramycin
Acceptable daily intake: 0-50 µg per kg of body weight (established
at the forty-third meeting of the
Committee (Annex 1, reference 113))
Residue definition: cattle and chickens: sum of spiramycin and
neospiramycin pigs: spiramycin equivalents
(antimicrobially active residues)
Recommended maximum residue limits (MRLs)
Species Muscle Liver Kidney Fat Eggs Milk
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/l)
Cattle 200 600 300 300 200a
Pigs 200 600 300 300
Chickens 200 600 800 300
a Recommended at the present meeting; except for cattle milk, all
MRLs were established at the forty-seventh meeting of the
Committee (Annex 1, reference 125; report in preparation).
Glucocorticosteroid
Dexamethasone
Acceptable daily intake: 0-0.015 µg per kg of body weight
(established at the forty-second meeting
of the Committee (Annex 1, reference 110))
Temporary maximum residue limits established at the forty-second and
forty-third meetings of the Committee (Annex 1, references 110 and
113; WHO TRS 851, 1995, and TRS 855, 1995) were not extended due to
non-availability of a method for regulatory monitoring requested by
the forty-second meeting.
Insecticides
Cyfluthrin
Acceptable daily intake: 0-20 µg per kg of body weight
Residue definition: cyfluthrin
Recommended maximum residue limits (MRLs)
Species Muscle Liver Kidney Fat Eggs Milk
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/l)
Cattle 20 20 20 200 40
Fluazuron
Acceptable daily intake: 0-40 µg per kg of body weight
Residue definition: fluazuron
Recommended maximum residue limits (MRLs)
Species Muscle Liver Kidney Fat Eggs Milk
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/l)
Cattle 200 500 500 7000