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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 39





    Prepared by:
    The forty-eighth meeting of the Joint FAO/WHO Expert
    Committee on Food Additives (JECFA)



    World Health Organization, Geneva 1997


    ANNEX 1

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    76.   Principles for the safety assessment of food additives and
    contaminants in food. WHO Environmental Health Criteria, No. 70.
    Geneva, World Health Organization, 1987.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    96.   Compendium of Food Additive Specifications. Joint FAO/WHO Expert
    Committee on Food Additives (JECFA). Combined specifications from 1st
    through the 37th Meetings, 1956_1990. FAO, 1992 (2 volumes).

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    125.  Evaluation of certain veterinary drug residues in food 
    (Forty-seventh report of the Joint FAO/WHO Expert Committee on Food
    Additives). WHO Technical Report Series, in preparation.

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

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

    128.  Evaluation of certain veterinary drug residues in food 
    (Forty-eighth report of the Joint FAO/WHO Expert Committee on Food
    Additives). WHO Technical Report Series, in preparation.

    ANNEX 2


    ABBREVIATIONS USED IN THE MONOGRAPHS


    ADI      acceptable daily intake
    ATCC     American Tissue Culture Collection
    AUC      area under the concentration-time curve
    bw       body weight
    CFR      Code of Federal Regulations (USA)
    cfu      colony-forming units
    DNA      deoxyribonucleic acid
    EEC      European Economic Community
    EPA      Environmental Protection Agency (USA)
    F1       first filial generation
    F2       second filial generation
    FAO      Food and Agricultural Organization of the United Nations
    FDA      Food and Drug Administration (USA)
    GLP      good laboratory practice
    HPLC     high-performance liquid chromatography
    ID50     median inhibitory dose
    JECFA    Joint FAO/WHO Expert Committee on Food Additives
    LD50     median lethal dose
    MIC      minimal inhibitory concentration
    MRL      maximum residue limit
    ND       not determined
    NOEL     no-observed-effect level
    OECD     Organisation for Economic Co-operation and Developoment
    PEG      polyethylene glycol
    QA       quality assurance
    S9       9000  g fraction of rat liver
    SD       standard deviation
    SPF      specific pathogen-free
    T3       triiodothyronine
    T4       thyroxine
    TSH      thyroid-stimulating hormone
    WHO      World Health Organization
    w/w      weight for weight

    ANNEX 3

    Joint FAO/WHO Expert Committee on Food Additives

    Geneva, 18-27 February 1997

    Members

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

    Dr J. Boisseau, Director, Agence nationale du mdicament vtrinaire,
    Fougres, France  (Vice-Chairman)

    Professor A. Boobis, Department of Clinical Pharmacology, Royal
    Postgraduate Medical School, Hammersmith Hospital, London, United
    Kingdom

    Dr G. Boorman, National Institute of Environmental Health Sciences
    Research Triangle Park, NC, USA  (Rapporteur)

    Dr R.L. Ellis, Director, Scientific Research and Oversight Staff, Food
    Safety and Inspection Service, US Department of Agriculture,
    Washington DC, USA  (Rapporteur)

    Dr P.G. Francis, West Horsely, Surrey, United Kingdom

    Dr R.C. Livingston, Director, Office of New Animal Drug Evaluation,
    Center for Veterinary Medicine, Food and Drug Administration,
    Rockville, MD, USA

    Dr J.D. MacNeil, Head, Center for Veterinary Drug Residues, Health of
    Animals Laboratory, Saskatoon, Saskatchewan, Canada

    Dr B.L. Marshall, Counsellor Veterinary Services, New Zealand Embassy,
    Washington DC, USA

    Professor J.G. McLean, Division of Science, Engineering and Design,
    Swinburne University of Technology, Hawthorn, Victoria, Australia
     (Chairman)

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

    Professor J. Palermo-Neto, Departamento de Patologia, Faculdade de
    Medicina Veterinaria e Zootecnia, Universidade de Sao Paulo, Sao
    Paulo, SP, Brazil

    Dr A. Pinter, Deputy Director General, National Institute of Hygiene,
    Budapest, Hungary

    Professor A. Rico, Biochemistry-Toxicology, Physiopathology and
    Experimental Toxicology Laboratory (INRA), National Veterinary School,
    Toulouse, France

    Dr J.L. Rojas Martinez, Chief of Toxicology and Residues Section,
    National Laboratory of Veterinary Services, Ministry of Agriculture
    and Animal Husbandry, San Jos, Costa Rica

    Dr P. Sinhaseni, Department of Pharmacology, Faculty of Pharmaceutical
    Sciences, Chulalongkorn University, Bangkok, Thailand

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

    Dr R. Wells, Director R & D, Australian Government Analytical
    Laboratories, Pymble, NSW, Australia


    Secretariat

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

    Dr P. Chamberlain, Veterinary Medical Officer, Division of Toxicology,
    Office of New Animal Drug Evaluation, Center for Veterinary Medicine,
    Food and Drug Administration, Rockville, MD, USA  (WHO Temporary 
     Adviser)

    Dr G. Gallhoff, European Commission, DGIII/E3, Brussels, Belgium 
     (WHO Temporary Adviser)

    Dr L. Good, Veterinary Medicines Directorate, Addlestone, Surrey,
    United Kingdom  (WHO Temporary Adviser)

    Dr R.J. Heitzman, Newbury, Berkshire, United Kingdom  (FAO 
     Consultant)

    Dr J.L. Herrman, Assessment of Risk and Methodologies, International
    Programme on Chemical Safety, World Health Organization, Geneva,
    Switzerland   (Joint Secretary)

    Professor E. Heseltine, Communication in Science, St Lon-sur-Vzre,
    France  (Editor)

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

    Dr J. Paakkanen, Nutrition Officer, Food and Nutrition Division, Food
    and Agriculture Organization of the United Nations, Rome, Italy 
     (Joint Secretary)

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

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

    Dr G. Roberts, Head, Chemical Products Assessment Section, Therapeutic
    Goods Administration, Commonwealth Department of Health and Family
    Services, Woden, ACT, Australia  (WHO Temporary Adviser)

    Dr S. Sundlof, Director, Center for Veterinary Medicine,Food and Drug
    Adminis-tration, Rockville, MD, USA  (WHO Temporary Adviser)

    Professor F.R. Ungemach, Universitt Leipzig, Veterinarmedizinische
    Fakultat,  Institut fur Pharmakologie, Pharmazie and Toxikologie,
    Leipzig, Germany  (WHO Temporary Adviser)

    ANNEX 4

    Acceptable daily intakes, other toxicological information, and
    information on specifications

    Anthelmintic agents

    Moxidectin

    Acceptable daily intake:      0-2 g per kg of body weight (established at
                                  the forty-fifth meeting of the Committee
                                  (Annex 1, reference 119))
    Residue definition:           moxidectin (MRLs, except for sheep muscle,
                                  were recommended at the forty-fifth meeting
                                  of the Committee (Annex 1, reference 119));
                                  MRLs for sheep muscle were recommended at the
                                  forty-seventh meeting (Annex 1, reference
                                  125; report in preparation))

    Recommended maximum residue limits (MRLs)

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

    Cattle    20a,b     100       50        500
    Sheep     50a       100       50        500
    Deerc     20        100       50        500

    a   At the forty-fifth meeting the Committee noted the very high
        concentration and great variation in the level of residues at the
        injection site over a 49-day period after dosing (Annex 1,
        reference 119).
    b   The present Committee reconsidered the MRL for cattle muscle,
        but on the basis of the available data maintained the previous
        MRL.
    c   Temporary, pending re-evaluation in 1998.


    Thiabendazole

    Acceptable daily intake:            0-100 g per kg of body weight
    Residue definition:                 sum of thiabendazole and 
                                        5-hydroxythiabendazole (MRLs were
                                        recommended at the fortieth meeting of
                                        the Committee (Annex 1, reference 104))

    Recommended maximum residue limits (MRLs)a

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

    Cattle    100       100       100       100                 100
    Pigs      100       100       100       100
    Goats     100       100       100       100                 100
    Sheep     100       100       100       100

    a  These MRLs were established at the fortieth meeting of the
       Committee (Annex 1, reference 104) and were not reconsidered at the
       present meeting.

    Antimicrobial agents

    Ceftiofur

    Acceptable daily intake:            0-50 g per kg of body weight
                                        (established at the forty-fifth meeting
                                        of the Committee (Annex 1, reference
                                        119))
    Residue definition:                 desfuroylceftiofur

    Recommended maximum residue limits (MRLs)

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

    Cattle    1000      2000      6000      2000                100
    Pigs      1000      2000      6000      2000


    Danofloxacin

    Acceptable daily intake:            0-20 g per kg of body weight
    Residue definition:                 danofloxacin

    Recommended maximum residue limits (MRLs)

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

    Cattle    200       400       400       100       
    Pigs      100        50       200       100
    Chickens  200       400       400       100a      

    a Fat/skin in normal proportion


    Dihydrostreptomycin and streptomycin

    Acceptable daily intake:            0-50 g per kg of body weight (group ADI
                                        for combined residues of
                                        dihydrostreptomycin and streptomycin)
    Residue definition:                 sum of dihydrostreptomycin and
                                        streptomycin

    Recommended maximum residue limits (MRLs)a

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

    Cattle    500       500       1000      500                 200
    Pigs      500       500       1000      500       
    Sheep     500       500       1000      500
    Chickens  500       500       1000      500

    a   Temporary MRLs established at the forty-third meeting (Annex 
        1, reference 113) were maintained. The following information is
        required for evaluation in 1999:
        *   validation of the HPLC assay to measure residues of
            streptomycin
        *   studies to determine whether the HPLC and bioassay methods give
            similar results for residues of both drugs using tissues with
            incurred residues

    Enrofloxacin

    Acceptable daily intake:            0-2 g per kg of body weight
    The evaluation of residues was postponed due to late submission of
    data.


    Flumequine

    Acceptable daily intake:            0-30 g per kg of body weight
    Residue definition:                 flumequine

    Recommended maximum residue limits (MRLs)

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

    Cattle       500       1000      3000      1000
    Pigsa        500       1000      3000      1000
    Sheepa       500       1000      3000      1000
    Chickensa    500       1000      3000      1000
    Trouta       500b

    a    MRLs are temporary; the following information is required for
         review in 2000:
         *   studies with radiolabelled flumequine in pigs, sheep,
             chickens, and trout to estimate the ratio of the parent drug
             to total residues
    b    Muscle/skin in normal proportion


    Gentamicin

    The temporary acceptable daily intake established at the forty-third
    meeting of the Committee (Annex 1, reference 113) and temporary
    maximum residue limits recommended at that meeting were extended until
    1998.


    Spiramycin

    Acceptable daily intake:         0-50 g per kg of body weight (established
                                     at the forty-third meeting of the
                                     Committee (Annex 1, reference 113))
    Residue definition:              cattle and chickens: sum of spiramycin and
                                     neospiramycin pigs: spiramycin equivalents
                                     (antimicrobially active residues)

    Recommended maximum residue limits (MRLs)

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

    Cattle       200       600       300       300                 200a
    Pigs         200       600       300       300
    Chickens     200       600       800       300

    a   Recommended at the present meeting; except for cattle milk, all 
        MRLs were established at the forty-seventh meeting of the
        Committee (Annex 1, reference 125; report in preparation).

    Glucocorticosteroid

    Dexamethasone

    Acceptable daily intake:         0-0.015 g per kg of body weight
                                     (established at the forty-second meeting
                                     of the Committee (Annex 1, reference 110))

    Temporary maximum residue limits established at the forty-second and
    forty-third meetings of the Committee (Annex 1, references 110 and
    113; WHO TRS 851, 1995, and TRS 855, 1995) were not extended due to
    non-availability of a method for regulatory monitoring requested by
    the forty-second meeting.

    Insecticides

    Cyfluthrin

    Acceptable daily intake:         0-20 g per kg of body weight
    Residue definition:              cyfluthrin

    Recommended maximum residue limits (MRLs)

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

    Cattle    20        20        20        200                 40


    Fluazuron

    Acceptable daily intake:                0-40 g per kg of body weight
    Residue definition:                     fluazuron

    Recommended maximum residue limits (MRLs)

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

    Cattle    200       500       500       7000

    





















    See Also:
       Toxicological Abbreviations