INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
TOXICOLOGICAL EVALUATION OF CERTAIN
VETERINARY DRUG RESIDUES IN FOOD
WHO FOOD ADDITIVES SERIES 41
Prepared by:
The 50th meeting of the Joint FAO/WHO Expert
Committee on Food Additives (JECFA)
World Health Organization, Geneva 1998
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 Report 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 Report 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 Report 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 Report 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 Report
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 Report Series, No. 45, 1969; WHO Technical Report Series, No.
430, 1969.
18. Specifications for the identity and purity of some antibiotics.
FAO Nutrition Meetings Report 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 Report 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 Report 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 Report 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 Report Series,
No. 51, 1972; WHO Technical Report Series, No. 505, 1972, and
corrigendum.
31. Evaluation of mercury, lead, cadmium and the food additives
amaranth, diethylpyrocarbonate, 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 Report 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 Report 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 flavour 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 Report 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 antioxidants, 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, 1997.
123. Toxicological evaluation of certain food additives and
contaminants. 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, No. 876, in press.
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 press.
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, in press.
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, in preparation.
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, in preparation.
ANNEX 2
ABBREVIATIONS USED IN THE MONOGRAPHS
ADI acceptable daily intake
ATCC American Tissue Culture Collection
AUC area under the concentrationœtime curve
BLV bovine leukaemia virus
BSE bovine spongiform encephalopathy
bw body weight
CAEV caprine arthritis encephalitis virus
CCFA D-cycloserine, cefotoxin, and fructose agar
CFU colony-forming units
CYP cytochrome P450 isoenzyme
d day
DNA deoxyribonucleic acid
ED Euclidian distance
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)
GABA gamma-aminobutyric acid
GLP good laboratory practice
GST-P+ gluathione S-transferase placental form-positive
HIV human immunodeficiency virus
HPLC high-performance liquid chromatography
ID50 median inhibitory dose
IDDM insulin-dependent type I diabetes mellitus
IGF-I insulin-like growth factor
JECFA Joint FAO/WHO Expert Committee on Food Additives
LD50 median lethal dose
MIC minimal inhibitory concentration
MRL maximum residue limit
NCCLS National Committee for Clinical Laboratory Standards
ND not determined
NDEA N-nitrosodiethylamine
NOEL no-observed-effect level
OECD Organisation for Economic Co-operation and Developoment
PEG polyethylene glycol
QA quality assurance
rbST recombinant bovine somatotropin
RIA radioimmunoassay
S9 9000 × g fraction of rat liver
SD standard deviation
SPF specific pathogen-free
T3 triiodothyronine
T4 thyroxine
TSH thyroid-stimulating hormone
VPI Virginia Polytechnic Institute and State University
WHO World Health Organization
w/w weight for weight
ANNEX 3
Joint FAO/WHO Expert Committee On Food Additives
Rome, 17-26 February 1998
Members
Dr L.-E. Appelgren, Professor of Pharmacology, Department of
Pharmacology and Toxicology, Faculty of Veterinary Medicine, The
Swedish University of Agricultual Sciences, Biomedical Centre,
Uppsala, Sweden
Dr D. Arnold, Deputy Director, Federal Institute for Health,
Protection of Consumers and Veterinary Medicine, Berlin, Germany
Dr J. Boisseau, Director, National Agency for Veterinary Medicines,
National Centre of Veterinary and Food Studies, Fougères, France
(Chairman)
Professor A.R. Boobis, Section on Clinical Pharmacology, Division of
Medicine, Imperial College School of Medicine, Hammersmith Campus,
London, United Kingdom
Dr R. Ellis, Director, Scientific Research and Oversight, Office of
Public Health and Science, US Department of Agriculture, Washington
DC, USA (Rapporteur)
Dr R. Livingston, Center for Veterinary Medicine, Food and Drug
Administration, Rockville, MD, USA
Professor J.G. McLean, South Melbourne, Victoria, Australia
(Vice-Chairman)
Dr J. MacNeil, Head, Center for Veterinary Drug Residues, Health of
Animals Laboratory, Canadian Food Inspection Agency, Saskatoon,
Saskatchewan, Canada
Dr J. Rojas Martinez, Chief, Toxicology and Residue Section, National
Laboratory of Veterinary Sciences, Ministry of Agriculture and Animal
Husbandry, San José, Costa Rica
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 (Rapporteur)
Professor E.S. Mitema, Department of Public Health, Pharmacology and
Toxicology, Faculty of Veterinary Medicine, College of Agriculture and
Veterinary Sciences, University of Nairobi, Kabete, Kenya
Professor J. Palermo-Neto, Dean, Department of Pathology, Faculty of
Veterinary Medicine, University of Sao Paulo, Sao Paulo, Brazil
Dr A. Pintér, National Institute of Environmental Health, Budapest,
Hungary
Dr P. Sinhaseni, Deputy Director for Research, Institute of Health
Research, Chulalongkorn University, Bangkok, Thailand
Dr S. Soback, Head, National Residue Laboratory, Kimron Veterinary
Institute, Ministry of Agriculture, Beit Dagan, Israel
Dr R. Wells, Gordon, NSW, Australia
Secretariat
Dr C. E. Cerniglia, Director, Division of Microbiology and Chemistry,
National Center for Toxicological Research, Food and Drug
Administration, Jefferson, AR, USA (WHO Temporary Adviser)
Dr P. Chamberlain, Toxicologist, Division of Human Food Safety, Office
of New Animal Drug Evaluation, Center for Veterinary Medicine, Food
and Drug Administration, Rockville, MD, USA (WHO Temporary Adviser)
Dr S.D. Chernausek, Endocrinology, Childrens Hospital Medical Center,
Cincinnati, OH, USA (WHO Temporary Adviser)
Dr R. Fuchs, Head, Department of Experimental Toxicology and
Ecotoxicology, Institute for Medical Research and Occupational Health,
Zagreb, Croatia (WHO Temporary Adviser)
Dr E.A.M. Good, Veterinary Medicines Directorate, Addlestone, Surrey,
United Kingdom (WHO Temporary Adviser)
Dr M.K. Hansen, Consumer Policy Institute, Consumers Union, Yonkers,
NY, USA (WHO Temporary Adviser)
Dr R. Heitzman, Compton, Newbury, Berks, United Kingdom (FAO
Consultant)
Dr J.L. Herrman, Scientist, Assessment of Risk and Methodologies,
International Programme on Chemical Safety, World Health Organization,
Geneva, Switzerland (Joint Secretary)
Mrs E. Heseltine, Communication in Science, Lajarthe,
Saint-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)
Professor C.E. Nord, Chairman, Department of Immunology, Microbiology,
Pathology and Infection Diseases, Karolinska Institutet, Huddinge
University Hospital, Huddinge, Sweden (WHO Temporary Adviser)
Dr P. Olsen, Head, Pathology Section, Institute of Food Safety and
Toxicology, Danish Veterinary and Food Administration, Sœborg, Denmark
(WHO Temporary Adviser)
Dr J. Paakkanen, Food Quality Liaison Group, Food Quality and
Standards Service, Food and Nutrition Division, Rome, Italy
(Joint Secretary)
Dr M. 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, Professor, Department of Environmental Biology, 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 B. Roestel, National Agency for Veterinary Medicines, National
Centre of Veterinary and Food Studies, Fougères, France (FAO
Consultant)
Dr R.C. Sills, Head, Molecular Pathology, National Institute of
Environmental Health Sciences, Research Triangle Park, NC, USA (WHO
Temporary Adviser)
Dr S. Sundlof, Director, Center for Veterinary Medicine, Food and Drug
Administration, Rockville, MD, USA (WHO Temporary Adviser)
Professor F.R. Ungemach, Institute of Pharmacology, Pharmacy and
Toxicology, Faculty of Veterinary Medicine, University of Leipzig,
Leipzig, Germany (WHO Temporary Adviser)
Dr N. Weber, Leader, Residue Chemistry Team, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine, Food and Drug
Administration, Rockville, MD, USA (FAO Consultant)
ANNEX 4
Recommendations on compounds on the agenda and further toxicological
studies and other information required
Anthelminthic agents
Eprinomectin
Acceptable daily intake: 0-10 µg/kg bw
Residue definition: Eprinomectin B1a
Recommended maximum residue limits (MRLs)
Species Muscle Liver Kidney Fat Milk
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/L)
Cattle 100 2000 300 250 20
Febantel, fenbendazole, and oxfendazole
Acceptable daily intake: 0-7 µg/kg bw (group ADI for febantel,
fenbendazole, and oxfendazole)
Residue definition: Determined as the sum of fenbendazole,
oxfendazole, and oxfendazole sulfone,
expressed as oxfendazole sulfone equivalents
Recommended maximum residue limits (MRLs)
Species Muscle Liver Kidney Fat Milk
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/L)
Cattle 100 500 100 100 100
Horses 100 500 100 100
Pigs 100 500 100 100
Goats 100 500 100 100
Sheep 100 500 100 100 100
Moxidectin
Acceptable daily intake: 0-2 µg/kg bw (established at the forty-fifth
meeting of the Committee (Annex 1, reference
119))
Residue definition: Moxidectin
Recommended maximum residue limits (MRLs)
Species Muscle Liver Kidney Fat
(µg/kg) (µg/kg) (µg/kg) (µg/kg)
Cattlea 20b 100 50 500
Sheepa 50 100 50 500
Deer 20 100 50 500
a Recommended at the forty-fifth meeting of the Committee (Annex
1, reference 119), except for sheep muscle, which was recommended
at the forty-seventh meeting (Annex 1, reference 125)
b At the forty-fifth meeting (Annex 1, reference 119), the
Committee noted the very high concentration and great variation
in the level of residues at the injection site in cattle over a
49-day period after dosing.
Antimicrobial agents
Gentamicin
Acceptable daily intake: 0-20 µg/kg bw
Residue definition: Gentamicin
Recommended maximum residue limits (MRLs)
Species Muscle Liver Kidney Fat Milk
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/L)
Cattle 100 2000 5000 100 200
Pigs 100 2000 5000 100
Procaine benzylpenicillin
Acceptable daily intake: Residues of benzylpenicillin and procaine
benzylpenicillin should be less than 30 µg of
penicillin per person per day.
Residue definition: Benzylpenicillin
Recommended maximum residue limits (MRLs)
Speciesa Muscle Liver Kidney Milk
(µg/kg) (µg/kg) (µg/kg) (µg/L)
Cattle 50 50 50 4
Pigs 50 50 50
Chickens 50 50 50
a Procaine benzylpenicillin is also used in horses, sheep,
turkeys, rabbits, quail, and pheasants. Owing to lack of
information, MRLs could not be established for those species.
Sarafloxacin
Acceptable daily intake: 0-0.3 µg/kg bw
Residue definition: Sarafloxacin
Recommended maximum residue limits (MRLs)
Species Muscle Liver Kidney Fat
(µg/kg) (µg/kg) (µg/kg) (µg/kg)
Chickens 10 80 80 20
Turkeys 10 80 80 20
Spectinomycin
Acceptable daily intake: 0-40 µg/kg bw (established at the
forty-second meeting of the Committee (Annex
1, reference 110))
Residue definition: Spectinomycin
Recommended maximum residue limits (MRLs)
Species Muscle Liver Kidney Fat Milk Eggs
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/L) (µg/kg)
Cattle 500 2000 5000 2000 200
Pigs 500 2000 5000 2000
Sheep 500 2000 5000 2000
Chickens 500 2000 5000 2000 2000
Chlortetracycline, oxytetracycline, and tetracycline
Acceptable daily intake: 0-30 µg/kg bw (group ADI for oxytetracycline,
chlortetracycline, and tetracycline)
Residue definition: Parent drug
Recommended maximum residue limits (MRLs)a
Species Muscle Liver Kidney Milk Eggs
(µg/kg) (µg/kg) (µg/kg) (µg/L) (µg/kg)
Cattle 200 600 1200 100
Pigs 200 600 1200
Sheep 200 600 1200 100
Poultry 200 600 1200 400
Fishb,c 200
Giant prawnb 200
(Penaeus monodon)
a Singly or in combination
b Applies only to oxytetracycline
c Temporary, pending evaluation of use pattern of oxytetracycline
in aquaculture
Antiprotozoal agents
Diclazuril
Acceptable daily intake: 0-30 µg/kg bw
Residue definition: Diclazuril
Recommended maximum residue limits (MRLs)
Species Muscle Liver Kidney Fat
(µg/kg) (µg/kg) (µg/kg) (µg/kg)
Sheep 500 3000 2000 1000
Poultry 500 3000 2000 1000a
Rabbits 500 3000 2000 1000
a Skin or fat
Imidocarb
Acceptable daily intake: 0-10 µg/kg bw
Residue definition: Imidocarb
Recommended maximum residue limits (MRLs)a
Species Muscle Liver Kidney Fat Milk
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/L)
Cattle 300 2000 1500 50 50
a Temporary. Studies of residue depletion in lactating and non-
lactating cattle given recommended subcutaneous doses of
unlabelled imidocarb and analysis of samples by the proposed
regulatory method with enzymatic digestion are required for
evaluation in 2001. If MRLs are to be recommended for sheep, a
study of residue depletion with the recommended dose and route of
administration is required.
Nicarbazin
Acceptable daily intake: 0-400 µg/kg bw
Residue definition: N,N'-Bis(4-nitrophenyl)urea
Recommended maximum residue limits (MRLs)
Species Muscle Liver Kidney Fat or skin
(µg/kg) (µg/kg) (µg/kg) (µg/kg)
Chickens (broilers) 200 200 200 200
Glucocorticosteroid
Dexamethasone
Acceptable daily intake: 0-0.015 µg/kg bw (established at the
forty-second meeting of the Committee
(Annex 1, reference 110))
Maximum residue limits: The forty-second and forty-third
meetings of the Committee recommended
temporary MRLs of 0.5 µg/kg in muscle,
0.5 µg/kg in kidney, and 2.5 µg/kg in
liver of cattle, horses, and pigs and
0.3 µg/L in cattle milk based on an ADI
of 0-0.015 µg/kg bw. The MRLs were
temporary because there was no adequate
method to determine compliance with the
MRLs. The Committee requested data on
the performance of the analytical method
for evaluation at its forty-eight
meeting, but no data were received. The
Committee decided to withdraw the
temporary MRLs for dexamethasone because
of lack of an adequate analytical method
for enforcement of the MRLs. The present
Committee reviewed the documentation for
a high-performance liquid
chromatography-mass spectrometry method
for measuring dexamethasone residues in
tissues and milk. The Committee
concluded that the proposed method does
not meet the required performance
characteristics for identification and
quantification of residues in incurred
tissues. MRLs could not be recommended
because a suitable method for residue
analysis was not available.
Production aid
Bovine somatotropins
Acceptable daily intake: Not specifieda (applies to
somagrebove, sometribove, somavubove,
and somidobove)
Maximum residue limits: Not specified in cattle milk and edible
tissuesb (applies to somagrebove,
sometribove, somavubove, and somidobove)
a ADI 'not specified' means that available data on the toxicity
and intake of the veterinary drug indicate a large margin of
safety for consumption of residues in food when the drug is used
according to good practice in the use of veterinary drugs. For
that reason and for the reasons stated in the individual
evaluation, the Committee concluded that use of the veterinary
drug does not represent a hazard to human health and that there
is no need to specify a numerical ADI.
b MRL 'not specified' means that available data on the identity
and concentration of residues of the veterinary drug in animal
tissues indicate a wide margin of safety for consumption of
residues in food when the drug is used according to good practice
in the use of veterinary drugs. For that reason and for the
reasons stated in the individual evaluation, the Committee
concluded that the presence of drug residues in the named animal
product does not present a health concern and that there is no
need to specify a numerical MRL.
Tranquilizing agent
Azaperone
Acceptable daily intake: 0-6 µg/kg bw
Residue definition: Sum of concentrations of azaperone and
azaperol
Recommended maximum residue limits (MRLs)
Species Muscle Liver Kidney Fat
(µg/kg) (µg/kg) (µg/kg) (µg/kg)
Pigs 60 100 100 60
See Also:
Toxicological Abbreviations