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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 45





    Prepared by the
    Fifty-fourth meeting of the Joint FAO/WHO
    Expert Committee on Food Additives (JECFA)



    World Health Organization, Geneva, 2000

    ANNEX 1

    Reports and other documents resulting from previous meetings of the
    Joint FAO/WHO Expert Committee on Food Additives

    1.   General principles governing the use of food additives (First
         report of the Joint FAO/WHO Expert Committee on Food Additives).
         FAO Nutrition Meetings Report Series, No. 15, 1957; WHO Technical
         Report Series, No. 129, 1957 (out of print).

    2.   Procedures for the testing of intentional food additives to
         establish their safety for use (Second report of the Joint
         FAO/WHO Expert Committee on Food Additives). FAO Nutrition
         Meetings Report Series, No. 17, 1958; WHO Technical Report
         Series, No. 144, 1958 (out of print).

    3.   Specifications for identity and purity of food additives
         (antimicrobial preservatives and antioxidants) (Third report of
         the Joint FAO/WHO Expert Committee on Food Additives). These
         specifications were subsequently revised and published as
         Specifications for identity and purity of food additives, Vol. I.
         Antimicrobial preservatives and antioxidants, Rome, Food and
         Agriculture Organization of the United Nations, 1962 (out of
         print).

    4.   Specifications for identity and purity of food additives (food
         colours) (Fourth report of the Joint FAO/WHO Expert Committee on
         Food Additives). These specifications were subsequently revised
         and published as Specifications for identity and purity of food
         additives, Vol. II. Food colours, Rome, Food and Agriculture
         Organization of the United Nations, 1963 (out of print).

    5.   Evaluation of the carcinogenic hazards of food additives (Fifth
         report of the Joint FAO/WHO Expert Committee on Food Additives).
         FAO Nutrition Meetings Report Series, No. 29, 1961; WHO Technical
         Report Series, No. 220, 1961 (out of print).

    6.   Evaluation of the toxicity of a number of antimicrobials and
         antioxidants (Sixth report of the Joint FAO/WHO Expert Committee
         on Food Additives). FAO Nutrition Meetings Report Series, No. 31,
         1962; WHO Technical Report Series, No. 228, 1962 (out of print).

    7.   Specifications for the identity and purity of food additives and
         their toxicological evaluation: emulsifiers, stabilizers,
         bleaching and maturing agents (Seventh report of the Joint
         FAO/WHO Expert Committee on Food Additives). FAO Nutrition
         Meetings Series, No. 35, 1964; WHO Technical Report Series, No.
         281, 1964 (out of print).

    8.   Specifications for the identity and purity of food additives and
         their toxicological evaluation: food colours and some
         antimicrobials and antioxidants (Eighth report of the Joint
         FAO/WHO Expert Committee on Food Additives). FAO Nutrition
         Meetings Series, No. 38, 1965; WHO Technical Report Series, No.
         309, 1965 (out of print).

    9.   Specifications for identity and purity and toxicological
         evaluation of some antimicrobials and antioxidants. FAO Nutrition
         Meetings Report Series, No. 38A, 1965; WHO/Food Add/24.65 (out of
         print).

    10.  Specifications for identity and purity and toxicological
         evaluation of food colours. FAO Nutrition Meetings Report Series,
         No. 38B, 1966; WHO/Food Add/66.25.

    11.  Specifications for the identity and purity of food additives and
         their toxicological evaluation: some antimicrobials,
         antioxidants, emulsifiers, stabilizers, flour treatment agents,
         acids, and bases (Ninth report of the Joint FAO/WHO Expert
         Committee on Food Additives). FAO Nutrition Meetings Series, No.
         40, 1966; WHO Technical Report Series, No. 339, 1966 (out of
         print).

    12.  Toxicological evaluation of some antimicrobials, antioxidants,
         emulsifiers, stabilizers, flour treatment agents, acids, and
         bases. FAO Nutrition Meetings Report Series, No. 40A, B, C;
         WHO/Food Add/67.29.

    13.  Specifications for the identity and purity of food additives and
         their toxicological evaluation: some emulsifiers and stabilizers
         and certain other substances (Tenth report of the Joint FAO/WHO
         Expert Committee on Food Additives). FAO Nutrition Meetings
         Series, No. 43, 1967; WHO Technical Report Series, No. 373, 1967.

    14.  Specifications for the identity and purity of food additives and
         their toxicological evaluation: some flavouring substances and
         non nutritive sweetening agents (Eleventh report of the Joint
         FAO/WHO Expert Committee on Food Additives). FAO Nutrition
         Meetings Series, No. 44, 1968; WHO Technical Report Series, No.
         383, 1968.

    15.  Toxicological evaluation of some flavouring substances and non
         nutritive sweetening agents. FAO Nutrition Meetings Report
         Series, No. 44A, 1968; WHO/Food Add/68.33.

    16.  Specifications and criteria for identity and purity of some
         flavouring substances and non-nutritive sweetening agents. FAO
         Nutrition Meetings Report Series, No. 44B, 1969; WHO/Food
         Add/69.31.

    17.  Specifications for the identity and purity of food additives and
         their toxicological evaluation: some antibiotics (Twelfth report
         of the Joint FAO/WHO Expert Committee on Food Additives). FAO
         Nutrition Meetings Series, No. 45, 1969; WHO Technical Report
         Series, No. 430, 1969.

    18.  Specifications for the identity and purity of some antibiotics.
         FAO Nutrition Meetings Series, No. 45A, 1969; WHO/Food Add/69.34.

    19.  Specifications for the identity and purity of food additives and
         their toxicological evaluation: some food colours, emulsifiers,
         stabilizers, anticaking agents, and certain other substances
         (Thirteenth report of the Joint FAO/WHO Expert Committee on Food
         Additives). FAO Nutrition Meetings Series, No. 46, 1970; WHO
         Technical Report Series, No. 445, 1970.

    20.  Toxicological evaluation of some food colours, emulsifiers,
         stabilizers, anticaking agents, and certain other substances. FAO
         Nutrition Meetings Report Series, No. 46A, 1970; WHO/Food
         Add/70.36.

    21.  Specifications for the identity and purity of some food colours,
         emulsifiers, stabilizers, anticaking agents, and certain other
         food additives. FAO Nutrition Meetings Report Series, No. 46B,
         1970; WHO/Food Add/70.37.

    22.  Evaluation of food additives: specifications for the identity and
         purity of food additives and their toxicological evaluation: some
         extraction solvents and certain other substances; and a review of
         the technological efficacy of some antimicrobial agents.
         (Fourteenth report of the Joint FAO/WHO Expert Committee on Food
         Additives). FAO Nutrition Meetings Series, No. 48, 1971; WHO
         Technical Report Series, No. 462, 1971.

    23.  Toxicological evaluation of some extraction solvents and certain
         other substances. FAO Nutrition Meetings Report Series, No. 48A,
         1971; WHO/Food Add/70.39.

    24.  Specifications for the identity and purity of some extraction
         solvents and certain other substances. FAO Nutrition Meetings
         Report Series, No. 48B, 1971; WHO/Food Add/70.40.

    25.  A review of the technological efficacy of some antimicrobial
         agents. FAO Nutrition Meetings Report Series, No. 48C, 1971;
         WHO/Food Add/70.41.

    26.  Evaluation of food additives: some enzymes, modified starches,
         and certain other substances: Toxicological evaluations and
         specifications and a review of the technological efficacy of some
         antioxidants (Fifteenth report of the Joint FAO/WHO Expert
         Committee on Food Additives). FAO Nutrition Meetings Series, No.
         50, 1972; WHO Technical Report Series, No. 488, 1972.

    27.  Toxicological evaluation of some enzymes, modified starches, and
         certain other substances. FAO Nutrition Meetings Report Series,
         No. 50A, 1972; WHO Food Additives Series, No. 1, 1972.

    28.  Specifications for the identity and purity of some enzymes and
         certain other substances. FAO Nutrition Meetings Report Series,
         No. 50B, 1972; WHO Food Additives Series, No. 2, 1972.

    29.  A review of the technological efficacy of some antioxidants and
         synergists. FAO Nutrition Meetings Report Series, No. 50C, 1972;
         WHO Food Additives Series, No. 3, 1972.

    30.  Evaluation of certain food additives and the contaminants
         mercury, lead, and cadmium (Sixteenth report of the Joint FAO/WHO
         Expert Committee on Food Additives). FAO Nutrition Meetings
         Series, No. 51, 1972; WHO Technical Report Series, No. 505, 1972,
         and corrigendum.

    31.  Evaluation of mercury, lead, cadmium and the food additives
         amaranth, diethylpyrocarbamate, and octyl gallate. FAO Nutrition
         Meetings Report Series, No. 51A, 1972; WHO Food Additives Series,
         No. 4, 1972.

    32.  Toxicological evaluation of certain food additives with a review
         of general principles and of specifications (Seventeenth report
         of the Joint FAO/WHO Expert Committee on Food Additives). FAO
         Nutrition Meetings Series, No. 53, 1974; WHO Technical Report
         Series, No. 539, 1974, and corrigendum (out of print).

    33.  Toxicological evaluation of some food additives including
         anticaking agents, antimicrobials, antioxidants, emulsifiers, and
         thickening agents. FAO Nutrition Meetings Report Series, No. 53A,
         1974; WHO Food Additives Series, No. 5, 1974.

    34.  Specifications for identity and purity of thickening agents,
         anticaking agents, antimicrobials, antioxidants and emulsifiers.
         FAO Food and Nutrition Paper, No. 4, 1978.

    35.  Evaluation of certain food additives (Eighteenth report of the
         Joint FAO/WHO Expert Committee on Food Additives). FAO Nutrition
         Meetings Series, No. 54, 1974; WHO Technical Report Series, No.
         557, 1974, and corrigendum.

    36.  Toxicological evaluation of some food colours, enzymes, flavour
         enhancers, thickening agents, and certain other food additives.
         FAO Nutrition Meetings Report Series, No. 54A, 1975; WHO Food
         Additives Series, No. 6, 1975.

    37.  Specifications for the identity and purity of some food colours,
         enhancers, thickening agents, and certain food additives. FAO
         Nutrition Meetings Report Series, No. 54B, 1975; WHO Food
         Additives Series, No. 7, 1975.

    38.  Evaluation of certain food additives: some food colours,
         thickening agents, smoke condensates, and certain other
         substances. (Nineteenth report of the Joint FAO/WHO Expert
         Committee on Food Additives). FAO Nutrition Meetings Series, No.
         55, 1975; WHO Technical Report Series, No. 576, 1975.

    39.  Toxicological evaluation of some food colours, thickening agents,
         and certain other substances. FAO Nutrition Meetings Report
         Series, No. 55A, 1975; WHO Food Additives Series, No. 8, 1975.

    40.  Specifications for the identity and purity of certain food
         additives. FAO Nutrition Meetings Report Series, No. 55B, 1976;
         WHO Food Additives Series, No. 9, 1976.

    41.  Evaluation of certain food additives (Twentieth report of the
         Joint FAO/WHO Expert Committee on Food Additives). FAO Food and
         Nutrition Meetings Series, No. 1, 1976; WHO Technical Report
         Series, No. 599, 1976.

    42.  Toxicological evaluation of certain food additives. WHO Food
         Additives Series, No. 10, 1976.

    43.  Specifications for the identity and purity of some food
         additives. FAO Food and Nutrition Series, No. 1B, 1977; WHO Food
         Additives Series, No. 11, 1977.

    44.  Evaluation of certain food additives (Twenty-first report of the
         Joint FAO/WHO Expert Committee on Food Additives). WHO Technical
         Report Series, No. 617, 1978.

    45.  Summary of toxicological data of certain food additives. WHO Food
         Additives Series, No. 12, 1977.

    46.  Specifications for identity and purity of some food additives,
         including antioxidant, food colours, thickeners, and others. FAO
         Nutrition Meetings Report Series, No. 57, 1977.

    47.  Evaluation of certain food additives and contaminants
         (Twenty-second report of the Joint FAO/WHO Expert Committee on
         Food Additives). WHO Technical Report Series, No. 631, 1978.

    48.  Summary of toxicological data of certain food additives and
         contaminants. WHO Food Additives Series, No. 13, 1978.

    49.  Specifications for the identity and purity of certain food
         additives. FAO Food and Nutrition Paper, No. 7, 1978.

    50.  Evaluation of certain food additives (Twenty-third report of the
         Joint FAO/WHO Expert Committee on Food Additives). WHO Technical
         Report Series, No. 648, 1980, and corrigenda.

    51.  Toxicological evaluation of certain food additives. WHO Food
         Additives Series, No. 14, 1980.

    52.  Specifications for identity and purity of food colours,
         flavouring agents, and other food additives. FAO Food and
         Nutrition Paper, No. 12, 1979.

    53.  Evaluation of certain food additives (Twenty-fourth report of the
         Joint FAO/WHO Expert Committee on Food Additives). WHO Technical
         Report Series, No. 653, 1980.

    54.  Toxicological evaluation of certain food additives. WHO Food
         Additives Series, No. 15, 1980.

    55.  Specifications for identity and purity of food additives
         (sweetening agents, emulsifying agents, and other food
         additives). FAO Food and Nutrition Paper, No. 17, 1980.

    56.  Evaluation of certain food additives (Twenty-fifth report of the
         Joint FAO/WHO Expert Committee on Food Additives). WHO Technical
         Report Series, No. 669, 1981.

    57.  Toxicological evaluation of certain food additives. WHO Food
         Additives Series, No. 16, 1981.

    58.  Specifications for identity and purity of food additives (carrier
         solvents, emulsifiers and stabilizers, enzyme preparations,
         flavouring agents, food colours, sweetening agents, and other
         food additives). FAO Food and Nutrition Paper, No. 19, 1981.

    59.  Evaluation of certain food additives and contaminants
         (Twenty-sixth report of the Joint FAO/WHO Expert Committee on
         Food Additives). WHO Technical Report Series, No. 683, 1982.

    60.  Toxicological evaluation of certain food additives. WHO Food
         Additives Series, No. 17, 1982.

    61.  Specifications for the identity and purity of certain food
         additives. FAO Food and Nutrition Paper, No. 25, 1982.

    62.  Evaluation of certain food additives and contaminants
         (Twenty-seventh report of the Joint FAO/WHO Expert Committee on
         Food Additives). WHO Technical Report Series, No. 696, 1983, and
         corrigenda.

    63.  Toxicological evaluation of certain food additives and
         contaminants. WHO Food Additives Series, No. 18, 1983.

    64.  Specifications for the identity and purity of certain food
         additives. FAO Food and Nutrition Paper, No. 28, 1983.

    65.  Guide to specifications General notices, general methods,
         identification tests, test solutions, and other reference
         materials. FAO Food and Nutrition Paper, No. 5, Rev. 1,  1983.

    66.  Evaluation of certain food additives and contaminants
         (Twenty-eighth report of the Joint FAO/WHO Expert Committee on
         Food Additives). WHO Technical Report Series, No. 710, 1984, and
         corrigendum.

    67.  Toxicological evaluation of certain food additives and
         contaminants. WHO Food Additives Series, No. 19, 1984.

    68.  Specifications for the identity and purity of food colours. FAO
         Food and Nutrition Paper, No. 31/1, 1984.

    69.  Specifications for the identity and purity of food additives. FAO
         Food and Nutrition Paper, No. 31/2, 1984.

    70.  Evaluation of certain food additives and contaminants
         (Twenty-ninth report of the Joint FAO/WHO Expert Committee on
         Food Additives). WHO Technical Report Series, No. 733, 1986, and
         corrigendum.

    71.  Specifications for the identity and purity of certain food
         additives. FAO Food and Nutrition Paper, No. 34, 1986.

    72.  Toxicological evaluation of certain food additives and
         contaminants. WHO Food Additives Series, No. 20. Cambridge
         University Press, 1987.

    73.  Evaluation of certain food additives and contaminants (Thirtieth
         report of the Joint FAO/WHO Expert Committee on Food Additives).
         WHO Technical Report Series, No. 751, 1987.

    74.  Toxicological evaluation of certain food additives and
         contaminants. WHO Food Additives Series, No. 21. Cambridge
         University Press, 1987.

    75.  Specifications for the identity and purity of certain food
         additives. FAO Food and Nutrition Paper, No. 37, 1986.

    76.  Principles for the safety assessment of food additives and
         contaminants in food. WHO Environmental Health Criteria, No. 70.
         Geneva, World Health Organization, 1987 (out of print). The full
         text is available electronically at www.who.int/pcs.

    77.  Evaluation of certain food additives and contaminants
         (Thirty-first report of the Joint FAO/WHO Expert Committee on
         Food Additives). WHO Technical Report Series, No. 759, 1987 and
         corrigendum.

    78.  Toxicological evaluation of certain food additives. WHO Food
         Additives Series, No. 22. Cambridge University Press, 1988.

    79.  Specifications for the identity and purity of certain food
         additives. FAO Food and Nutrition Paper, No. 38, 1988.

    80.  Evaluation of certain veterinary drug residues in food
         (Thirty-second report of the Joint FAO/WHO Expert Committee on
         Food Additives). WHO Technical Report Series, No. 763, 1988.

    81.  Toxicological evaluation of certain veterinary drug residues in
         food. WHO Food Additives Series, No. 23. Cambridge University
         Press, 1988.

    82.  Residues of some veterinary drugs in animals and foods. FAO Food
         and Nutrition Paper, No. 41, 1988.

    83.  Evaluation of certain food additives and contaminants
         (Thirty-third report of the Joint FAO/WHO Expert Committee on
         Food Additives). WHO Technical Report Series, No. 776, 1989.

    84.  Toxicological evaluation of certain food additives and
         contaminants. WHO Food Additives Series, No. 24. Cambridge
         University Press, 1989.

    85.  Evaluation of certain veterinary drug residues in food
         (Thirty-fourth report of the Joint FAO/WHO Expert Committee on
         Food Additives). WHO Technical Report Series, No. 788, 1989.

    86.  Toxicological evaluation of certain veterinary drug residues in
         food. WHO Food Additives Series, No. 25, 1990.

    87.  Residues of some veterinary drugs in animals and foods. FAO Food
         and Nutrition Paper, No. 41/2, 1990.

    88.  Evaluation of certain food additives and contaminants
         (Thirty-fifth report of the Joint FAO/WHO Expert Committee on
         Food Additives). WHO Technical Report Series, No. 789, 1990, and
         corrigenda.

    89.  Toxicological evaluation of certain food additives and
         contaminants. WHO Food Additives Series, No. 26, 1990.

    90.  Specifications for identity and purity of certain food additives.
         FAO Food and Nutrition Paper, No. 49, 1990.

    91.  Evaluation of certain veterinary drug residues in food
         (Thirty-sixth report of the Joint FAO/WHO Expert Committee on
         Food Additives). WHO Technical Report Series, No. 799, 1990.

    92.  Toxicological evaluation of certain veterinary drug residues in
         food. WHO Food Additives Series, No. 27, 1991.

    93.  Residues of some veterinary drugs in animals and foods. FAO Food
         and Nutrition Paper, No. 41/3, 1991.

    94.  Evaluation of certain food additives and contaminants
         (Thirty-seventh report of the Joint FAO/WHO Expert Committee on
         Food Additives). WHO Technical Report Series, No. 806, 1991, and
         corrigenda.

    95.  Toxicological evaluation of certain food additives and
         contaminants. WHO Food Additives Series, No. 28, 1991.

    96.  Compendium of Food Additive Specifications. Joint FAO/WHO Expert
         Committee on Food Additives (JECFA). Combined specifications from
         1st through the 37th Meetings, 1956-1990. FAO, 1992 (2 volumes).

    97.  Evaluation of certain veterinary drug residues in food
         (Thirty-eighth report of the Joint FAO/WHO Expert Committee on
         Food Additives). WHO Technical Report Series, No. 815, 1991.

    98.  Toxicological evaluation of certain veterinary residues in food.
         WHO Food Additives Series, No. 29, 1991.

    99.  Residues of some veterinary drugs in animals and foods. FAO Food
         and Nutrition Paper, No. 41/4, 1991.

    100. Guide to specifications -- General notices, general analytical
         techniques, identification tests, test solutions, and other
         reference materials. FAO Food and Nutrition Paper, No. 5, Ref. 2,
         1991.

    101. Evaluation of certain food additives and naturally occurring
         toxicants (Thirty-ninth report of the Joint FAO/WHO Expert
         Committee on Food Additives). WHO Technical Report Series No.
         828, 1992.

    102. Toxicological evaluation of certain food additives and naturally
         occurring toxicants. WHO Food Additive Series, No. 30, 1993.

    103. Compendium of food additive specifications: Addendum 1. FAO Food
         and Nutrition Paper, No. 52, 1992.

    104. Evaluation of certain veterinary drug residues in food (Fortieth
         report of the Joint FAO/WHO Expert Committee on Food Additives).
         WHO Technical Report Series, No. 832, 1993.

    105. Toxicological evaluation of certain veterinary drug residues in
         food. WHO Food Additives Series, No. 31, 1993.

    106. Residues of some veterinary drugs in animals and foods. FAO Food
         and Nutrition Paper, No. 41/5, 1993.

    107. Evaluation of certain food additives and contaminants
         (Forty-first report of the Joint FAO/WHO Expert Committee on Food
         Additives). WHO Technical Report Series, No. 837, 1993.

    108. Toxicological evaluation of certain food additives and
         contaminants. WHO Food Additives Series, No. 32, 1993.

    109. Compendium of food additive specifications: Addendum 2. FAO Food
         and Nutrition Paper, No. 52, Add. 2, 1993.

    110. Evaluation of certain veterinary drug residues in food
         (Forty-second report of the Joint FAO/WHO Expert Committee on
         Food Additives). WHO Technical Report Series, No. 851, 1995.

    111. Toxicological evaluation of certain veterinary drug residues in
         food. WHO Food Additives Series, No. 33, 1994.

    112. Residues of some veterinary drugs in animals and foods. FAO Food
         and Nutrition Paper, No. 41/6, 1994.

    113. Evaluation of certain veterinary drug residues in food
         (Forty-third report of the Joint FAO/WHO Expert Committee on Food
         Additives). WHO Technical Report Series, No. 855, 1995, and
         corrigendum.

    114. Toxicological evaluation of certain veterinary drug residues in
         food. WHO Food Additives Series, No. 34, 1995.

    115. Residues of some veterinary drugs in animals and foods. FAO Food
         and Nutrition Paper, No. 41/7, 1995.

    116. Evaluation of certain food additives and contaminants
         (Forty-fourth report of the Joint FAO/WHO Expert Committee on
         Food Additives). WHO Technical Report Series, No. 859, 1995.

    117. Toxicological evaluation of certain food additives and
         contaminants. WHO Food Additives Series, No. 35, 1996.

    118. Compendium of food additive specifications: Addendum 3. FAO Food
         and Nutrition Paper, No. 52, Add. 3, 1995.

    119. Evaluation of certain veterinary drug residues in food
         (Forty-fifth report of the Joint FAO/WHO Expert Committee on Food
         Additives). WHO Technical Report Series, No. 864, 1996.

    120. Toxicological evaluation of certain veterinary drug residues in
         food. WHO Food Additives Series, No. 36, 1996.

    121. Residues of some veterinary drugs in animals and foods. FAO Food
         and Nutrition Paper, No. 41/8, 1996.

    122. Evaluation of certain food additives and contaminants
         (Forty-sixth report of the Joint FAO/WHO Expert Committee on Food
         Additives). WHO Technical Report Series, No. 868, 1997.

    123. Toxicological evaluation of certain food additives. WHO Food
         Additives Series, No. 37, 1996.

    124. Compendium of food additive specifications, addendum 4. FAO Food
         and Nutrition Paper, No. 52, Add. 4, 1996.

    125. Evaluation of certain veterinary drug residues in food
         (Forty-seventh report of the Joint FAO/WHO Expert Committee on
         Food Additives). WHO Technical Report Series, No. 876, 1998.

    126. Toxicological evaluation of certain veterinary drug residues in
         food. WHO Food Additives Series, No. 38, 1996.

    127. Residues of some veterinary drugs in animals and foods. FAO Food
         and Nutrition Paper, No. 41/9, 1997.

    128. Evaluation of certain veterinary drug residues in food
         (Forty-eighth report of the Joint FAO/WHO Expert Committee on
         Food Additives). WHO Technical Report Series, No. 879, 1998.

    129. Toxicological evaluation of certain veterinary drug residues in
         food. WHO Food Additives Series, No. 39, 1997.

    130. Residues of some veterinary drugs in animals and foods. FAO Food
         and Nutrition Paper, No. 41/10, 1998.

    131. Evaluation of certain food additives and contaminants
         (Forty-ninth report of the Joint FAO/WHO Expert Committee on Food
         Additives). WHO Technical Report Series, No. 884, 1999.

    132. Safety evaluation of certain food additives and contaminants. WHO
         Food Additives Series, No. 40, 1998.

    133. Compendium of food additive specifications: Addendum 5. FAO Food
         and Nutrition Paper, No. 52, Add. 5, 1997.

    134. Evaluation of certain veterinary drug residues in food (Fiftieth
         report of the Joint FAO/WHO Expert Committee on Food Additives).
         WHO Technical Report Series, No. 888, 1999.

    135. Toxicological evaluation of certain veterinary drug residues in
         food. WHO Food Additives Series, No. 41, 1998.

    136. Residues of some veterinary drugs in animals and foods. FAO Food
         and Nutrition Paper, No. 41/11, 1999.

    137. Evaluation of certain food additives (Fifty-first report of the
         Joint FAO/WHO Expert Committee on Food Additives). WHO Technical
         Report Series, No. 891, 2000.

    138. Safety evaluation of certain food additives. WHO Food Additives
         Series, No. 42, 1999.

    139. Compendium of food additive specifications, addendum 6. FAO Food
         and Nutrition Paper, No. 52, Add. 6, 1998.

    140. Evaluation of certain veterinary drug residues in food
         (Fifty-second report of the Joint FAO/WHO Expert Committee on
         Food Additives). WHO Technical Report Series, No. 893, in press.

    141. Toxicological evaluation of certain veterinary drug residues in
         food. WHO Food Additives Series, No. 43, 2000

    142. Residues of some veterinary drugs in animals and foods. FAO Food
         and Nutrition Paper, No. 41/12, 2000.

    143. Evaluation of certain food additives and contaminants
         (Fifty-third report of the Joint FAO/WHO Expert Committee on Food
         Additives). WHO Technical Report Series, in press.

    144. Safety evaluation of certain food additives and contaminants. WHO
         Food Additives Series, No. 44, 2000.

    145. Compendium of food additive specifications, addendum 7. FAO Food
         and Nutrition Paper, No. 52, Add. 7, 1999.

    ANNEX 2

    ABBREVIATIONS USED IN THE MONOGRAPHS

    ADI       acceptable daily intake
    AUC       integrated area under the curve of concentration-time
    bw        body weight
    CFU       colony-forming unit
    ED50      median effective dose
    F         female
    F0        parental generation
    F1        first filial generation
    F2        second filial geneartion
    F3        third filial generation
    FAO       Food and Agricultural Organization of the United Nations
    FSH       follicle-stimulating hormone
    GABA      gamna-aminobutyric acid
    GLP       good laboratory practice
    HPLC      high-performance liquid chromatography
    IARC      International Agency for Research on Cancer
    i.p.      intraperitoneal
    IPCS      International Programme on Chemical Safety
    JECFA     Joint FAO/WHO Expert Committee on Food Additives
    JMPR      Joint Meeting on Pesticide Residues
    LC50      median lethal concentration
    LD50      median lethal dose
    LH        luteinizing hormone
    LOEL      lowest-observed-effect level
    M         male
    MEA       6-methyl-8-ergoline-acetonitrile
    MIC50     median inhibitory concentration
    MS        mass spectrometry
    NOEC      no-observed-effect concentration
    NOEL      no-observed-effect level
    NR        not reported
    OECD      Organization for Economic Co-operation and Development
    S9        hepatic microsome fraction
    SPF       specific pathogen-free
    TLC       thin-layer chromatography
    USP       United States Pharmacopeia
    WHO       World Health Organization

    ANNEX 3

    JOINT FAO/WHO EXPERT COMMITTEE ON FOOD ADDITIVES
    Geneva, 15-24 February 2000

     Members 

    Professor A. Anadn, Department of Toxicology & Pharmacology, Faculty
         of Veterinary Medicine, Universidad Complutense de Madrid,
         Madrid, Spain

    Dr L.-E. Appelgren, Professor of Pharmacology, Department of
         Pharmacology and Toxicology, Faculty of Veterinary Medicine, The
         Swedish University of Agricultural Sciences, Uppsala, Sweden

    Dr D. Arnold, Acting Director, Federal Institute for Health Protection
         of Consumers and Veterinary Medicine, Berlin, Germany

    Dr J. Boisseau, Director, National Agency for Veterinary Medicinal
         Products, French Food Safety Agency, Fougres, France
          (Vice-Chairman) 

    Professor A.R. Boobis, Section on Clinical Pharmacology, Division of
         Medicine, Imperial College School of Medicine, Hammersmith
         Campus, London, England  (Rapporteur) 

    Professor L.D.B. Kinabo, Department of Veterinary Physiology,
         Biochemistry, Pharmacology and Toxicology, Sokoine University of
         Agriculture, Morogoro, United Republic of Tanzania

    Dr J.D. MacNeil, Head, Center for Veterinary Drug Residues, Health of
         Animals Laboratory, Canadian Food Inspection Agency, Saskatoon,
         Saskatchewan, Canada  (Rapporteur) 

    Dr J.G. McLean, Professor Emeritus, Swinburne University of
         Technology, Hawthorn, Victoria, Australia  (Chairman) 

    Dr M.A. Miller, Deputy Director, Human Food Safety, Office of New
         Animal Drug Evaluation, Center for Veterinary Medicine, Food and
         Drug Administration, Rockville, MD, USA

    Professor J. Palermo-Neto, Applied Pharmacology and Toxicology
         Laboratory, Department of Pathology, School of Veterinary
         Medicine, University of So Paulo, So Paulo, Brazil

    Dr J.L. Rojas Martnez, Chief, Toxicology and Residues Section,
         National Laboratory of Veterinary Sciences, Ministry of
         Agricultural and Animal Husbandry, San Jos, Costa Rica

    Dr S. Soback, Head, National Residue Laboratory, Kimron Veterinary
         Institute, Ministry of Agriculture, Beit Dagan, Israel

    Dr R.W. Stephany, Head, Laboratory for Residue Analysis, National
         Institute of Public Health and the Environment, Bilthoven,
         Netherlands

     Secretariat 

    Dr F. Aguilar, International Programme on Chemical Safety, World
         Health Organization, Geneva, Switzerland

    Dr S.M.F. Calumpang, National Crop Protection Centre, University of
         the Philippines, Los Baos College Laguna, Philippines  (FAO 
          Consultant) 

    Dr C.E. Cerniglia, Director, Division of Microbiology and Chemistry,
         National Center for Toxicological Research, Food and Drug
         Administration, Jefferson, Arkansas, USA  (WHO Temporary 
          Adviser) 

    Dr R. Ellis, Nutrition Officer, Food Quality Liaison Group, Food
         Quality and Standards Service, Food and Nutrition Division, FAO,
         Rome, Italy  (Joint Secretary) 

    Dr L.G. Friedlander, Center for Veterinary Medicine, Food and Drug
         Administration, Rockville, Maryland, USA  (FAO Consultant) 

    Dr K. Greenlees, Center for Veterinary Medicine, Food and Drug
         Administration, Rockville, Maryland, USA  (WHO Temporary 
          Adviser) 

    Mr D.J. Hamilton, Principal Scientific Officer, Animal and Plant
         Health Service, Department of Primary Industries, Brisbane,
         Australia  (FAO Consultant) 

    Dr J.L. Herrman, Scientist, International Programme on Chemical
         Safety, WHO, Geneva, Switzerland  (Joint Secretary) 

    Dr R.J. Heitzman, Science Consultant, Newbury, Berkshire, England 
          (FAO Consultant) 

    Dr R.C. Livingston, Center for Veterinary Medicine, Food and Drug
         Administration, Rockville, Maryland, USA  (FAO Consultant) 

    Dr K. Mitsumori, Chief, Third Section, Division of Pathology,
         Biological Safety Research Centre, National Institute of Health
         Sciences, Tokyo, Japan  (WHO Temporary Adviser) 

    Professor M.R.A. Morgan, Procter Department of Food Science,
         University of Leeds, Leeds, England  (FAO Consultant) 

    Mr N. Nakashima, International Programme on Chemical Safety, World
         Health Organization, Geneva, Switzerland

    Mrs M.E.J. Pronk, Engineer, Center for Substances and Risk Assessment,
         National Institute of Public Health and the Environment,
         Bilthoven, Netherlands  (WHO Temporary Adviser) 

    Mr D. Renshaw, Principal Scientist: Veterinary Products, Joint
         Ministry of Foof and Fisheries/Department of Health Food
         Standards and Safety Group, Department of Health, London, United
         Kingdom  (WHO Temporary Adviser) 

    Dr L. Ritter, Executive Director, Canadian Network of Toxicology
         Centres, University of Guelph, Guelph, Ontario, Canada
          (WHO Temporary Adviser) 

    Dr G. Roberts, Manager, Chemical Products Assessment Section,
         Therapeutic Goods Administration, Commonwealth Department of
         Health and Aged Care, Woden, Australian Capital Territory,
         Australia  (WHO Temporary Adviser) 

    Dr B. Roestel, Head International Affairs, National Agency for
         Veterinary Medicinal Products, French Food Safety Agency, La
         Haute Marche, France  (FAO Consultant) 

    Dr S. Sundlof, Director, Center for Veterinary Medicine, Food and Drug
         Administration, Rockville, Maryland, USA  (WHO Temporary 
          Adviser) 

    Dr A. Tejada, Pesticide Management Group, Plant Production and
         Protection Division, FAO, Rome, Italy

    Professor F.R. Ungemach, Institute of Pharmacology, Pharmacy and
         Toxicology, Faculty of Veterinary Medicine, University of
         Leipzig, Leipzig, Germany  (WHO Temporary Adviser) 

    Dr Y. Yamada, Food Standards Officer, Joint FAO/WHO Standards
         Programme, Food and Nutrition Division, FAO, Rome, Italy

    Dr R. Wells, Gordon, New South Wales, Australia  (FAO Consultant) 

    Professor J. Zmudzki, Department of Pharmacology and Toxicology,
         National Veterinary Research Institute, Pulawy, Poland
          (FAO Consultant) 

    ANNEX 4

    RECOMMENDATIONS ON COMPOUNDS ON THE AGENDA AND FURTHER INFORMATION
    REQUIRED

    Anthelminthic agent

    Ivermectin

    Acceptable daily intake:      0-1 g/kg bw (established at the
                                  fortieth meeting of the Committee (WHO
                                  TRS 832, 1993))
    Residue definition:           Ivermectin H2B1a

    Recommended maximum residue limits (MRLs)a

                                                      
    Species                                Milk
                                           (g/kg)
                                                      

    Cattle                                 10b
                                                      

    a    The MRLs that were recommended at the thirty-sixth and fortieth
         meetings of the Committee (WHO TRS 799 (1990) and 832 (1993),
         respectively) were not reconsidered and were maintained.
    b    Temporary MRL. Validation data on the analytical method and
         information on other routes of application to cattle to evaluate
         the residues in milk are required for evaluation in 2002.


    Antimicrobial agents

    Flumequine

    Acceptable daily intake:      0-30 g/kg bw (established at the
                                  forty-eighth meeting of the Committee
                                  (WHO TRS 879, 1998))
    Residue definition:           Flumequine

    Recommended maximum residue limits (MRLs)

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

    Cattle      500       500       3000       1000
    Pigs        500       500       3000       1000
    Sheep       500       500       3000       1000
    Chickens    500       500       3000       1000
    Trout       500a
                                                       

    a  For trout muscle including skin in natural proportions.

    Lincomycin

    Acceptable daily intake:      0-30 g/kg bw 
    Residue definition:           Lincomycin

    Recommended maximum residue limits (MRLs)

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

    Cattle      100a      500a      1500a     100a     150
    Pigs        100       500       1500      100
    Sheep       100a      500a      1500a     100a
    Chickensb   100a      500a      1500a     100a
                                                               

    a    The recommended MRLs are temporary. Data comparable to those
         provided for tissues of pigs, which show that lincomycin is the
         major component with significant microbiological activity in
         tissues of cattle, sheep, and chickens, are required for
         evaluation in 2002.
    b    Before considering an MRL for chicken eggs, the Committee would
         wish to see (1) data showing that lincomycin is the major
         component with significant microbiological activity and (2) a
         residue depletion study in which the gas chromatographic-mass
         spectrometry method is used. 


    Oxytetracycline

    Acceptable daily intake:      0-30 g/kg bw (group ADI for
                                  tetracycline, oxytetracycline and
                                  chlortetracycline; established at the
                                  fiftieth meeting of the Committee (WHO
                                  TRS 888, 1999))
    Residue definition:           Oxytetracycline, singly or in
                                  combination with chlortetracycline and
                                  tetracycline

    Recommended maximum residue limits (MRLs)a

                                            
    Species                  Muscle
                             (g/kg)
                                            

    Fish                     200b
                                            

    a    The MRLs that were recommended in cattle, pigs, sheep, poultry,
         and giant tiger prawn (Penaeus monodon) at the fiftieth meeting
         of the Committee (WHO TRS 888, 1999) were not reconsidered and
         were maintained.
    b    Temporary MRL. Residue data and a validated analytical method are
         required for evaluation in 2002. 

    Tilmicosin

    Acceptable daily intake:      0-40 g/kg bw (established at the
                                  forty-seventh meeting of the Committee
                                  (WHO TRS 876, 1996))
    Residue definition:           Tilmicosin

    Recommended maximum residue limits (MRLs)a

                                            
    Species                  Milk
                             (g/kg)
                                            

    Sheep                    Not extendedb
                                            

    a    The MRLs that were recommended for muscle, liver, kidney, and fat
         of cattle, pigs, and sheep at the forty-seventh meeting of the
         Committee (WHO TRS 876, 1998) were not reconsidered and were
         maintained.
    b    The temporary MRL for sheep milk was not extended as results of a
         study with radiolabelled drug in lactating sheep to determine the
         relationship between total residues and parent drug in milk were
         not available.

    Insecticides

    Cyhalothrin

    Acceptable daily intake:      0-2 g/kg bw (temporary)a
    Residue definition:           Cyhalothrin

    Recommended maximum residue limits (MRLs)

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

    Cattleb    20        20       20       400      30
    Pigsb      20        20       20       400
    Sheepb     20        20       20       400
                                                             

    a    Results of appropriate studies to establish a NOEL for
         neurobehavioural effects in laboratory animals are required for
         evaluation in 2002.
    b    The recommended MRLs are temporary because the ADI is temporary.
         In addition, results of the validation of the analytical method
         for sheep liver to demonstrate a limit of quantification of 0.01
         mg/kg are required for evaluation in 2002.

    Cypermethrin

    Acceptable daily intake:      0-50 g/kg bw (established at the
                                  forty-seventh meeting of the Committee
                                  (WHO TRS 876, 1998))
    Residue definition:           Cypermethrin, sum of isomers

    Recommended maximum residue limits (MRLs)

                                                                        
    Species    Muscle     Liver      Kidney       Fat        Milk/Eggs
                                                                        

    Cattlea    Not        Not        Not          Not        Not 
               extended   extended   extended     extended   extended
    Sheepa     Not        Not        Not          Not 
               extended   extended   extended     extended
    Chickensa  Not        Not        Not          Not        Not 
               extended   extended   extended     extended   extended
                                                                        

    a    Since the information required at the forty-seventh meeting of
         the Committee (WHO TRS 876, 1998) was not provided and there was
         no indication that it would be provided in the future, the
         temporary MRLs that had been recommended for cattle, sheep, and
         chickens were not extended.

    alpha-Cypermethrin

    Acceptable daily intake:      0-20 g/kg bw (established at the
                                  forty-seventh meeting of the Committee
                                  (WHO TRS 876, 1998))
    Residue definition:           alpha-Cypermethrin, sum of isomers

    Recommended maximum residue limits (MRLs)

                                                                        
    Species    Muscle     Liver      Kidney       Fat        Milk/Eggs
                                                                        

    Cattlea    Not        Not        Not          Not        Not 
               extended   extended   extended     extended   extended
    Sheepa     Not        Not        Not          Not 
               extended   extended   extended     extended
    Chickensa  Not        Not        Not          Not        Not 
               extended   extended   extended     extended   extended
                                                                        

    a    Since the information required at the forty-seventh meeting of
         the Committee (WHO TRS 876, 1998) was not provided and there was
         no indication that it would be provided in the future, the
         temporary MRLs that had been recommended for cattle, sheep, and
         chickens were not extended.

    Dicyclanil

    Acceptable daily intake:      0-7 g/kg bw 
    Residue definition:           Dicyclanil

    Recommended maximum residue limits (MRLs)

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

    Sheep      200       400      400       150
                                                      

    Permethrin

    Acceptable daily intake:      0-50 g/kg bw (for technical-grade
                                  permethrin with cis:trans ratios of
                                  25:75 to 40:60; established by the 1999
                                  Joint FAO/WHO Meeting on Pesticide
                                  Residues (JMPR) (FAO Plant Production
                                  and Protection Paper, No. 153, 1999)
    Residue definition:           Permethrin, sum of isomers

    Recommended maximum residue limits (MRLs)

         The Committee concluded that the database available to the 1999
    JMPR was not adequate to assess the toxicity of the 80:20 cis:trans
    isomeric mixture proposed for use as a veterinary drug. In the absence
    of an ADI, the Committee was unable to establish MRLs for this
    isomeric mixture of permethrin.

    Trichlorfon

    Acceptable daily intake:      0-20 g/kg bw
    Residue definition:           Trichlorfon

    Recommended maximum residue limits (MRLs)

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

    Cattle    50a      50a      50a      50a      50
                                                          

    a    Guidance value only. Residues of trichlorfon were not detected in
         the depletion studies reviewed by the Committee. MRLs were not
         recommended by the Committee for muscle, liver, kidney, or fat in
         cattle, since no detectable residues should be present in tissues
         from animals treated with trichlorfon when used in accordance
         with good practice in the use of veterinary drugs. The limit of
         quantification may be used as a guide for maximum residue
         concentrations in muscle, liver, kidney, and fat of cattle.


    Production aid

    Melengestrol acetate

    Acceptable daily intake:      0-0.03 g/kg bw
    Residue definition:           Melengestrol acetate

    Maximum residue limits (MRLs)

                                       
    Species      Liver        Fat
                 (g/kg)      (g/kg)
                                       

    Cattle       2a           5a
                                       

    a    Temporary MRL. A practical analytical method for monitoring
         residues of melengestrol at the recommended MRL is required for
         evaluation in 2002. 
    





















    See Also:
       Toxicological Abbreviations