INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
TOXICOLOGICAL EVALUATION OF CERTAIN
VETERINARY DRUG RESIDUES IN FOOD
WHO FOOD ADDITIVES SERIES: 43
Prepared by the Fifty-second meeting of the Joint FAO/WHO
Expert Committee on Food Additives (JECFA)
World Health Organization, Geneva, 2000
IPCS - International Programme on Chemical Safety
ANNEXES
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, 19561990. 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, 1988.
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 press.
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, in preparation.
137. Evaluation of certain food additives (Fifty-first report of the
Joint FAO/WHO Expert Committee on Food Additives). WHO Technical
Report Series, in press.
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, in preparation.
ANNEX 2
ABBREVIATIONS USED IN THE MONOGRAPHS
acute RfD acute reference dose
ADI acceptable daily intake
AUC integrated area under the curve of plasma
concentration-time
bw body weight
COMT carechol-O-methyltransferase
CYP cytochrome P450
DHT 5 alpha-dihydrotestosterone
ER estrogen receptor
ERKO estrogen receptor knockout
F female
F0 parental generation
F1 first filial generation
F2 second filial geneartion
F3 third filial generation
fa fraction of an oral dose available to act on
microorganisms in the colon
FAO Food and Agricultural Organization of the United
Nations
GABA gamma-aminobutyric acid
GLP good laboratory practice
GSFA General Standard for Food Additives
HPLC high-performance liquid chromatography
IARC International Agency for Research on Cancer
IC50 median inhibitory concentration
Ig immunoglobulin
JECFA Joint FAO/WHO Expert Committee on Food Additives
LC50 median lethal concentration
LD50 median lethal dose
M male
MCC mass of colonic content
MIC minimum inhibitory concentration
MRL maximum residue limit
NADP nicotinamide adenine dinucleotide phosphate
NADPH reduced form of NADP
ND not determined
NOEL no-observed-effect level
NR not reported
8-OHdG 8-hydroxy-2'-deoxyguanosine
QA quality assurance
S9 hepatic microsome fraction
sf safety factor
SHBG sex hormone-binding globulin
T3 triiodothyronine
T4 thyroxine
ANNEX 3
Joint FAO/WHO Expert Committee on Food Additives
Rome, 2-11 February 1999
Members
Dr F.Z. AliAbadi, Pharmacokinetics Unit, Veterinary Diagnostic Cntre
and Pharmaceutical and Biological products Quality Control
Laboratories, Veterinary organization of Iran, Tehran, Iran
Professor L.-E. Appelgren, 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.D. Baggot, Depart,ent of Preclinical Veterinary Studies, Faculty
of Veterinary Science, University of Zimbabwe, Harare, Zimbabwe
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 G. Boorman, National Institute of Environmental Health Sciences,
Research Triangle Park, North Carolina, USA
Dr R. Ellis, Scientific Research and Oversight, Office of Public
Health and Science, US Department of Agriculture, Washington DC, USA
( Rapporteur)
Dr LD.B. Kinabo, Department of Veterinary Physiology, Biochemistry,
Pharmacology and Toxicology, Sokoine University of Agriculture, Chuo
Kikuu, Marogoro, United Republic of Tanzania
Dr J. MacNeil, Center for Veterinary Drug Residues, Health of Animals
Laboratory, Canadian Food Inspection Agency, Saskatoon, Saskatchewan,
Canada
Professor J.G. McLean, South Melbourne, Victoria, Australia (Chairman)
Dr M.A. Miller, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine, Food and Drug Administration, Rockville,
Maryland, 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
Dr A.M. Montes Nino, Buenos Aires, Argentina
Professor J. Palermo-Neto, Department of Pathology, Faculty of
Veterinary Medicine, University of Sao Paulo, Sao Paulo, Brazil
Dr R.W. Stephany, Laboratory for Residue Analysis, National Institute
of Public Health and the Environment, Bilthoven, The Netherlands
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 S. Franceschi, Epidemiology Unit, Aviano Cancer Centre, Aviano,
Italy ( WHO Temporary Adviser)
Dr D.W. Gaylor, National Center for Toxicological Research, Food and
Drug Administration, Jefferson, Arkansas, 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 J. Leighton, Division of Oncology Drug Products, Food and Drug
Administration, Rockville, Maryland, USA ( WHO Temporary Adviser)
Dr R.C. Livingston, Center for Veterinary Medicine, Food and Drug
Administration, Rockville, Maryland, USA ( FAO Consultant)
Dr D.B. McGregor, Unit of Carcinogen Identification and Evaluation,
International Agency for Research on Cancer, Lyon, France
( WHO Temporary Adviser)
Dr K. Mitsumori, Division of Pathology, Biological Safety Research
Centre, National Institute of Health Sciences, Tokyo, Japan
( WHO Temporary Adviser)
Dr M.R.A. Morgan, Department of Biochemistry, Institute of Food
Research, Colney, Norwich, United Kingdom ( FAO Consultant)
Mr N. Nakashima, International Programme on Chemical Safety, World
Health Organization, Geneva, Switzerland
Dr P. Olsen, Head, Pathology Section, Institute of Food Safety and
Toxicology, Danish Veterinary and Food Administration, Soborg, Denmark
( WHO Temporary Adviser)
Ir M. Pronk, Centre for Substances and Risk Assessment, National
Institute of Public Health and the Environment, Bilthoven, Netherlands
( WHO Temporary Adviser)
Dr L. Ritter, Canadian Network of Toxicology Centres, Department of
Environmental Biology, University of Guelph, Guelph, Ontario, Canada
( WHO Temporary Adviser)
Dr B. Roestel, National Agency for Veterinary Medicines, National
Centre of Veterinary and Food Studies, Fougères, France
( FAO Consultant)
Dr S. Soback, National Residue Laboratory, Kimron Veterinary
Institute, Ministry of Agriculture, Beit Dagan, Israel
( FAO Consultant)
Dr S. Sundlof, Center for Veterinary Medicine, Food and Drug
Administration, Rockville, Maryland, 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, Residue Chemistry Team, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine, Food and Drug
Administration, Rockville, MD, USA ( FAO Consultant)
Dr J. Weatherwax, Food Quality Liaison Group, Food Quality and
Standards Service, Food and Nutrition Division, Food and Agricultural
Organization of the United Nations, Rome, Italy ( Joint Secretary)
Dr R. Wells, Gordon, New South Wales, Australia ( FAO Consultant)
Dr J. Zmudzki, Department of Pharmacology and Toxicology, National
Veterinary Research Institute, Pulawy, Poland ( FAO Consultant)
ANNEX 4
RECOMMENDATIONS ON SUBSTANCES ON THE AGENDA AND FURTHER INFORMATION
REQUIRED
ß-Adrenoceptor-blocking agent
Carazolol
Acceptable daily intake: 0-0 1 µg/kg bw (established at the
forty third meeting of the Committee
(WHO TRS 855, 1995))
Acute RID: 0-0 1 µg/kg bw
Residue definition: Carazolol
Recommended maximum residue limits (MRLs)a
Species Muscle Liver Kidney Fat
(µg/kg) (µg/kg) (µg/kg) (µg/kg)
Pigs 5 25 25 5b
a Recommended at the forty-third meeting of
the Committee (WHO TRS 855, 1995) Residues
of carazolol at the injection site two
hours after treatment may result in an
intake that exceeds the acute RfD. Therefore,
unless appropriate measures can be taken to
ensure that residues at the injection site
do not exceed the acute RfD, the use of
carazolol during the transport of animals
to slaughter is inconsistent with safe use
of the drug.
b Fat/skin
Anthelminthic agent
Doramectin
Acceptable daily intake: 0-0.5 µg/kg bw (established at the
forty-fifth meeting of the Committee
(WHO TRS 864, 1996))
Residue definition: Doramectin
Recommended maximum residue limits (MRLs)a
Species Muscle Liver Kidney Fat
(µg/kg) (µg/kg) (µg/kg) (µg/kg)
Cattleb 20 100 30 150
Pigs 5 100 30 150
a The Committee noted the high concentrations
of residues at the infections sites
b Recommended at the forty fifth meeting of
the Committee (WHO TRS 864 1996)
Antimicrobial agents
Dihydrostreptomycin/streptomycin
Acceptable daily intake: 0-50 µg/kg bw (established at the forty-eighth
meeting of the Committee (WHO TRS 879, 1998))
Residue definition: Sum of the concentrations of dihydrostreptomycin
and streptomycin
Recommended maximum residue limits (MRLs)
Species Musclea Livera Kidneya Fata Milk
(µg/kg) (µg/kg) (µg/kg) (µg/kg)
Cattle 600 600 1000 600 200b
Pigs 600 600 1000 600
Sheep 600 600 1000 600
Chickens 600 600 600 600
1 The Committee was aware of more sensitive analytical methods for
dihydrostreptomycin and streptomycin in edible tissue and requested
that additional analytical methods be made available to the Committee
for evaluation in 2001.
2 Temporary. The following information is required for evaluation in 2001:
1. A validated analytical method to quantify both compounds in milk at
low concentrations
Neomycin
Acceptable daily intake: 0-60 µg/kg bw (established at the
forty seventh meeting of the Committee
(WHO TRS 876, 1998))
Residue definition: Neomycin
Recommended maximum residue limits (MRLs)
Species Muscle Liver Kidney Fat Milk Eggs
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg)
Cattle 500a 15 000 20 000 500a 500a
Pigs 500a 500a 500b 500a
Sheep 500a 500a 500b 500a
Goats 500a 500a 500b 500a
Turkeys 500a 500a 500b 500a
Ducks 500a 500a 500a 500a
Chicken 500a 500a 500a 500a 500a
a Recommended at the forty-third meeting of the Committee (WHO TRS 855 1995)
b Recommended at the forty-seventh meeting of the Committee (WHO TRS 876, 1998)
Thiamphenicol
Acceptable daily intake: 0-5 µg/kg bw
Residue definition: Sum of thiamphenicol
and thiamphenicol
conjugates, measured as
thiamphenicol
Recommended maximum residue limits (MRLs)
Species Muscle Liver Kidney Fat
(µg/kg) (µg/kg) (µg/kg) (µg/kg)
Cattlea Withdrawn Withdrawn Withdrawn Withdrawn
Pigsb 50 100 500 50
Chickensa Withdrawn Withdrawn Withdrawn Withdrawn
Fishb 50
a The previous temporary MRLs for cattle and chicken were
withdrawn as the data required by the forty-seventh
meeting of the Committee (WHO TRS 876 1998) were not provided
b Temporary. The following information is required for evaluation
in 2002:
1. A radiolabel depletion study in pigs to determine the
relationship between free thiamphenicol, thiamphenicol
conjugates and total residues in all tissues
2. A validated analytical method for use in all animal
tissues which incorporates an enzymatic hydrolysis
step allowing the determination of the sum of
thiamphenicol and thiamphenicol conjugates as free
thiamphenicol
Insecticides
Deltamethrin
Acceptable daily intake: 0-10 µg/kg bw (established by the 1982 Joint FAO/WHO
Meeting on Pesticide Residues (FAO Plant Production and
Protection Paper 46, 1983))
Residue definition: Deltamethrin
Recommended maximum residue limits (MRLs)
Species Musclea Liver Kidney Fat Milka Eggsa
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg)
Cattle 30 50 50 500 30
Sheep 30 50 50 500
Chicken 30 50 50 500 30
Salmon 30
1 No residues were detected MRLs are for guidance only and are based on two
times the limit of quantification of the analytical method
Phoxim
Acceptable daily intake: 0-4 µg/kg bw
Residue definition: Phoxim
Recommended maximum residue limits (MRLs)a
Species Muscle Livera Kidneya Fata Milk
(µg/kg) (µg/kg) (µg/kg) (µg/kg)
Cattle 50 50 50 400 10
Pigs 50 50 50 400
Sheep 50 50 50 400
Goats 50 50 50 400
a Temporary. The following information is required for evaluation in 2002:
1. Radiolabel studies to relate the marker residue to the
total residue in ruminants and pigs after topical
application of the formulated product
2. Residue studies in accordance with Good Laboratory Practice
with the current recommended treatments in cattle and sheep
3. Validation of available analytical methods for phoxim
residues in tissues of cattle sheep, and goats and in
milk from cattle
Production aids
Estradiol-17ß, progesterone, and testosterone (see Annex 1)
Acceptable daily intakes
Estradiol-17ß: 0-0.05 µg/kg bw
Progesterone: 0-30 µg/kg bw
Testosterone: 0-2 µg/kg bw
Maximum residue limits: MRLs 'not specified"a in cattle muscle,
liver, kidney, and fat
a The 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
Porcine somatotropin
Acceptable daily intake: ADI 'not specifieda' (applies to the three
products evaluated at the meeting)
Maximum residue limit: MRLs 'not specified'b in pig muscle,
liver, kidney, and fat (applies to the
three products that were evaluated at the
present meeting)
a The available data on the toxicity and intake of the veterinary
drug indicate a large margin of safety for consumption of residues
in loud 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 See footnote under estradiol-17ß, progesterone and testosterone
Tranquilizing agent
Azaperone
New information on the method of analysis in tissues of pigs was
reviewed. Insufficient characterization of the specificity, accuracy,
and reproducibility of the method was provided The Committee
recommended that the method be improved and, after further
development, be forwarded to the Codex Committee on Residues of
Veterinary Drugs in Foods for consideration.
See Also:
Toxicological Abbreviations