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    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, Fougres, 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-Lon-sur-Vzre, 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, Fougres, 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

    -Adrenoceptor-blocking agent

    Carazolol
                                                                   

    Acceptable daily intake:    0-0 1 g/kg bw (established at the 
                                forty third meeting of the Committee
                                (WHO TRS 855, 1995))
    Acute RID:                  0-0 1 g/kg bw
    Residue definition:         Carazolol

    Recommended maximum residue limits (MRLs)a
                                                                   

    Species    Muscle   Liver     Kidney    Fat
              (g/kg)   (g/kg)   (g/kg)   (g/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 g/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
             (g/kg)   (g/kg)   (g/kg)   (g/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 g/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
                  (g/kg)    (g/kg)    (g/kg)    (g/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 g/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
                 (g/kg)    (g/kg)    (g/kg)    (g/kg)    (g/kg)   (g/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 g/kg bw

    Residue definition:        Sum of thiamphenicol
                               and thiamphenicol
                               conjugates, measured as
                               thiamphenicol

    Recommended maximum residue limits (MRLs)
                                                                     
    Species      Muscle        Liver        Kidney        Fat
                 (g/kg)       (g/kg)      (g/kg)       (g/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 g/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
                 (g/kg)    (g/kg)    (g/kg)    (g/kg)  (g/kg)  (g/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 g/kg bw
    Residue definition:       Phoxim

    Recommended maximum residue limits (MRLs)a
                                                                  
    Species    Muscle     Livera     Kidneya    Fata       Milk
               (g/kg)    (g/kg)    (g/kg)    (g/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-17, progesterone, and testosterone (see Annex 1)

    Acceptable daily intakes
               Estradiol-17:      0-0.05 g/kg bw
               Progesterone:       0-30 g/kg bw
               Testosterone:       0-2 g/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-17, 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