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    TOXICOLOGICAL EVALUATION OF CERTAIN FOOD ADDITIVES



    WHO FOOD ADDITIVES SERIES 10





    The evaluations contained in this document were prepared by the
    Joint FAO/WHO Expert Committee on Food Additives*
    Rome, 21-29 April 1976



    Food and Agriculture Organization of the United Nations

    World Health Organization




    *Twentieth Report of the Joint FAO/WHO Expert Committee on Food
    Additives, Geneva, 1976, WHO Technical Report Series No. 599, FAO Food
    and Nutrition Series No. 1.

    CONTENTS

    INTRODUCTION

    ALLOCATION OF ACCEPTABLE DAILY INTAKES (ADI)

    TOXICOLOGICAL EVALUATION: FOOD COLOURS

    THE MONOGRAPHS

         Butylated hydroxyanisole
         Butylated hydroxytoluene
         Diethylene glycol monoethyl ether
         Gallates, dodecyl, octyl, propyl
         Glycerol and glycerol diacetate
         Menthol
         Mineral oil (food grade)
         Natamycin (Pimoricin(R))
         Nitrites, sodium and potassium salts
         Sucrose esters of fatty acids and sucroglycerides
         Trichloroethylene

    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 Twentieth 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 Rome from 21 to 29 April 1976. 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 Safety Unit
         World Health Organization
         Avenue Appia
         1211 Geneva, Switzerland

              

    1  Twentieth Report of the Joint FAO/WHO Expert Committee on Food
    Additives. FAO Nutrition Meetings Report Series No. 1 Wld Hlth
    Org. techn. Rep. Ser., 1976, 599

    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)

    butylated hydroxyanisole                          0-0.51,2
    butylated hydroxytoluene                          0-0.51,2
    diethylene glycol monoethyl ether                 No ADI allocated
    gallates, totecyl, octyl, propyl                  0-0.21,3
    glycerol                                          Not specified4
    glycerol diacetate                                Not specified4
    menthol                                           0-0.2
    mineral oil (food grade)                          Not specified4
    nitrites, sodium and potassium salts              0-0.21,5
    natamycin (PimencinR)                             0-0.3
    sucrose esters of fatty acids                     0-2.56
    sucroglycerides                                   0-2.56
    trichloroethylene                                 No ADI allocated7

              

    1    Temporary.

    2    As BHA, BHT, or the sum of the two chemicals.

    3    Applicable to individual gallates or their sum. (Note: n-octyl
         gallate should not be used in beverages.)

    4    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.

    5    Food for babies less than six months old should not contain
         added nitrites.

    6    As sucrose esters of fatty acids, sucroglycerites, or the sum
         of both.

    7    The permitted use as an extractant is withdrawn.





















    See Also:
       Toxicological Abbreviations