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    WORLD HEALTH ORGANIZATION


    Toxicological evaluation of some food colours, thickening
    agents, and certain other substancse



    WHO FOOD ADDITIVES SERIES NO. 8





    The evaluations contained in this publication were prepared
    by the Joint FAO/WHO Expert Committee on Food Additives which
    met in Geneva, 14-23 April 19751



    World Health Organization, Geneva 1975



    1 Nineteenth Report of the Joint FAO/WHO Expert Committee on Food
    Additives, Wld Hlth Org. techn. Rep. Ser., 1975, No. 576;
    FAO Nutrition Meetings Report Series, 1975, No. 55.

    The monographs contained in the present volume are
    also issued by the Food and Agriculture Organization
    of the United Nations, Rome, as
    FAO Nutrition Meetings Report Series, No. 55A

























    ISBN 92 4 166008 2

    (C) FAO and WHO 1975

    CONTENTS

    INTRODUCTION

    ALLOCATION OF ACCEPTABLE DAILY INTAKES (ADI)

    TOXICOLOGICAL EVALUATION: FOOD COLOURS

    TOXICOLOGICAL EVALUATION: THICKENING AGENTS

    TOXICOLOGICAL EVALUATION: MISCELLANEOUS FOOD ADDITIVES

    THE MONOGRAPHS

         FOOD COLOURS
         Amaranth
         Ferrous gluconate
         Quinoline Yellow

         THICKENING AGENTS

         Gum, carob bean
         Gum, guar
         Gum, tara
         Microcystalline cellulose
         Pectin (amidated)

         MISCELLANEOUS FOOD ADDITIVES

         Dichlorodifluoromethane
         Tertiary butyl hydroquinone (TBHQ)
         Triacetin

    ANNEX 1.    Reports and other documents resulting from previous
         meetings of the Joint FAO/WHO Expert Committee on Food Additives

    ANNEX 2.    Membership of the Nineteenth Joint FAO/WHO Expert
         Committee on Food Additives
    

    INTRODUCTION

         The monographs contained in this document are the result of the
    deliberations of the Joint FAO/WHO Expert Committee on Food Additives
    which met in Geneva, from 14 to 23 April 1975. Since the report1 of
    this meeting contains comments on the same substances, these
    monographs should be read or consulted in conjunction with the report.

         The present monographs follow the standard format adopted by the
    FAO/WHO Expert Committee on Food Additives when dealing with the
    toxicological evaluation of food additives. Each monograph attempts to
    provide, in a condensed form, as full an account as possible of all
    the biochemical and toxicological data made available to the Expert
    Committee on Food Additives at the time of the meeting. Some of the
    substances examined at this meeting have been evaluated in previous
    meetings. Monographs formerly published on the same compounds have
    been incorporated, in a revised form, into the monographs contained in
    this document. References to previous monographs are found in the
    introductory explanation at the beginning of each monograph and a
    comprehensive list of earlier publications is provided in Annex 1 of
    this document.

         As a number of food additives are closely related chemically and
    toxicologically, the Committee at its Seventeenth meeting adopted the
    same position that has been adopted in its seventh and later reports,
    that of a system of grouping additives for purposes of evaluation.
    When a given food additive is related to two or more groups, its level
    in the diet must not exceed the maximum acceptable level for either
    group.

         Any new information and comments on the biological data and their
    evaluation should be addressed to:

    Division of Environmental Health
    Food Additives Unit
    World Health Organization
    Avenue Appia
    1211 Geneva, Switzerland

              

    1    Nineteenth Report of the Joint FAO/WHO Expert Committee on Food
    Additives. FAO Nutrition Meetings Report Series No. 55; Wld Hlth
    Org. techn. Rep. Ser., 1975, No. 576.

    ALLOCATION OF ACCEPTABLE DAILY INTAKES (ADI)

         The acceptable daily intake (ADI) for man, expressed on a body
    weight basis, is the amount of a food additive that can be taken daily
    in the diet, even over a lifetime, without risk.

         An ADI is allocated only to substances for which the available
    data include either the results of adequate short-term and long-term
    toxicological investigations or satisfactory information on the
    biochemistry and metabolic fate of the compound, or both.

         An ADI may be allocated temporarily, pending the provision of
    additional data within a stated period of time. This measure implies
    that the toxicological data are adequate to ensure the safety in use
    of the additive during the time for which the temporary ADI applies. 
    If the additional data requested do not become available within the
    stated period, the temporary ADI may be withdrawn at a future meeting
    of the Committee.

         An ADI without an explicit indication of the upper limit of
    intake ("ADI not specified") may be assigned to substances of very low
    toxicity, especially those that are food constituents or that may be
    considered as foods or normal metabolites in man. The expression "ADI
    not specified" has been adopted by the Joint FAO/WHO Expert Committee
    on Food Additives at its Eighteenth session as a more suitable
    expression than "ADI not limited" previously used. However, an
    additive having an "ADI not specified" must meet the criteria of good
    manufacturing practice for example it should have proven technological
    efficacy and be used at the minimum level of efficacy, it should not
    conceal inferior food quality or adulteration, and it should not
    create a nutritional imbalance.

         The expression "No ADI allocated" is applicable to substances for
    which the available information is not sufficient to establish their
    safety or when the specifications are not adequate to establish their
    identity.

         The expression "Not to be used" is applicable to substances for
    which there is sufficient information on which to base such decision.

         There may be circumstances in which the ADI is not applicable.
    Thus it may be exceeded for special dietary purposes for example, in
    the case of modified celluloses, to reduce the energy content of the
    diet. On the other hand, the ADI for glutamic acid and glutamates does
    not extend to foods for infants under three months old.

         In previous reports a conditional ADI was allocated to a number
    of substances, often in addition to an unconditional ADI. Variations
    in the rules for applying conditional ADIs have given rise to some
    confusion. For this reason, the Committee considers that the
    allocation of conditional ADIs should be abandoned.

         ADIs are intended as guides only and may be exceeded, after
    consultation with experts, in circumstances in which there may be
    important advantages in doing so. In the opinion of the Committee, an
    ADI provides a sufficiently large safety margin to ensure that there
    need be no undue concern about occasionally exceeding it provided the
    average intake over longer periods of time does not exceed it.

    TOXICOLOGICAL EVALUATION: FOOD COLOURS

                                            Acceptable daily
                                            intake for man
    Substances                              (mg/kg bw)

    Amaranth                                0-0.751

    Ferrous gluconate                       Not specified2,3

    Quinoline yellow                        0-0.51

              

    1    Temporary.

    2    The statement "ADI not specified" means, that, on the basis of
    the available data (toxicological, biochemical, and other), the total
    daily intake of the substance, arising from its use or uses at the
    levels necessary to achieve the desired effect and from its acceptable
    background in food, does not, in the opinion of the Committee,
    represent a hazard to health. For this reason, and for the reasons
    stated in individual evaluations, the establishment of an acceptable
    daily intake (ADI) in mg/kg bw is not deemed necessary.

    3    However, the contribution from ferrous gluconate to the total
    dietary gluconic acid intake from all sources should be included in
    the ADI for gluconic acid (0-50 mg/kg body weight).

    TOXICOLOGICAL EVALUATION: THICKENING AGENTS

                                              Acceptable daily
    Substances                                intake for man
                                              (mg/kg bw)

    Gum, carob bean                           Not specified1,2

    Gum, guar                                 Not specified2

    Gum, tara                                 Not specified1,2

    Microcrystalline cellulose                Not specified2

    Pectin (amidated)                         0-251

              

    1    Temporary

    2    The statement "ADI not specified" means that, on the basis of
    the available data (toxicological, biochemical, and other), the total
    daily intake of the substance, arising from its use or uses at the
    levels necessary to achieve the desired effect and from its acceptable
    background in food, does not, in the opinion of the Committee,
    represent a hazard to health. For this reason, and for the reasons
    stated in individual evaluations, the establishment of an acceptable
    daily intake (ADI) in mg/kg bw is not deemed necessary.

    TOXICOLOGICAL EVALUATION: MISCELLANEOUS FOOD ADDITIVES

                                              Acceptable daily
    Substances                                intake for man
                                              (mg/kg bw)

    Dichlorofluoromethane                     0-1.5

    Tertiary butyl hydroquinone               0-0.751

    Triacetin                                 Not specified2

              

    1    Temporary.

    2    The statement "ADI not specified" means that, on the basis of
    the available data (toxicological, biochemical, and other) the total
    daily intake of the substance, arising from its use or uses at the
    levels necessary to achieve the desired effect and from its acceptable
    background in food, does not, in the opinion of the Committee,
    represent a hazard to health. For this reason, and for the reasons
    stated in individual evaluations, the establishment of an acceptable
    daily intake (ADI) in mg/kg bw is not deemed necessary.





















    See Also:
       Toxicological Abbreviations