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    ANNEX 4

    ACCEPTABLE DAILY INTAKES,
    OTHER TOXICOLOGICAL INFORMATION,
    AND INFORMATION ON SPECIFICATIONS
    
                                                                                               

    Substance                                 Specifications1        Acceptable daily intake
                                                                     (ADI)in mg/kg body
                                                                     weight and other
                                                                     toxicological
                                                                     recommendations
                                                                                               

    Emulsifiers
        Sucrose esters of fatty acids
            and sucroglycerides                     S                0-16 (group ADI)2
        Thermally oxidized soya
            bean oil                                N                0-3
        Thermally oxidized soya bean
            oil interacted with mono-
            and diglycerides of
            fatty acids                             R                0-30

    Enzyme preparations
        Cellulase from Trichoderma
            longibrachiatum                         R                Not specified3
        -Glucanase from Trichoderma
            harzianum                               R                Not specified3
        Lysozyme                                    N                Acceptable for use in
                                                                        food processing4

    Flavouring substances
     trans-Anethole                                 S                0-0.6 (temporary)
     Ethyl vanillin                                 R                0-5 (temporary)
     Limonene                                       N                0-1.55
     Quinine hydrochloride                          R                Current use levels up to
     Quinine sulfate                                S                   75 mg/l (as quinine
                                                                        base) in soft drinks
                                                                        not of toxicological
                                                                        concern

    Solvents
        1,2-Dichloroethane                          None             ADI not allocated
                                                                        because of evidence of
                                                                        genotoxicity
                                                                        and carcinogenicity
                                                                                               

                                                                                               

    Substance                                 Specifications1        Acceptable daily intake
                                                                     (ADI)in mg/kg body
                                                                     weight and other
                                                                     toxicological
                                                                     recommendations
                                                                                               

    Dichloromethane                                 R,T              Should be limited to
                                                                        current uses6

    Diethylene glycol monoethyl                     R                ADI not allocated
        ether                                                           because of inadequate
                                                                        data

    Thickening agents
        Alginic acid and its ammonium,              R                Not specified (group
            calcium, potassium, and                                     ADI)3
            sodium salts

        Processed Eucheuma seaweed                  R,T              ADI not allocated
                                                                        because of inadequate
                                                                        data

    Waxes
        Beeswax                                     N                Present uses not of
                                                                        toxicological concern7

        Candelilla wax                              N                Present uses not of
                                                                        toxicological concern8

        Carnauba wax                                N                0-7

        Microcrystalline wax                        N                Not specified (group
                                                                        ADI)9

        Paraffin wax                                R                Not specified (group
                                                                     ADI)9

        Shellac                                     N,T              Present uses not of
                                                                     toxicological concern10

    Miscellaneous substances
        Curcumin                                    R                0-0.1 (temporary)
        Furfural                                    R,T              ADI not allocated
                                                                        because of evidence of
                                                                        genotoxicity
                                                                        and carcinogenicity11
                                                                                               

                                                                                               

    Substance                                 Specifications1        Acceptable daily intake
                                                                     (ADI)in mg/kg body
                                                                     weight and other
                                                                     toxicological
                                                                     recommendations
                                                                                               

        Potassium bromate                           R,T              Not appropriate for use
                                                                        as a flour-treatment
                                                                        agent

    Naturally-occurring toxicants
        Cyanogenic glycosides                                        Safe level of intake
                                                                        could not be estimated
                                                                        because of a lack of
                                                                        quantitative data

        Solanine and chaconine                                       Normal levels in
                                                                        potatoes (20-100 mg
                                                                        of potatoes) not of
                                                                        toxicological concern
                                                                                               

                                                                                  

    Substance (considered for specifications only)         Specifications1
                                                                                  

    Aluminium powder                                       R,T
    Anoxomer                                               S,T
    Calcium stearoyl lactate                               R
    Carbon dioxide                                         S,T
    Carob bean gum                                         R
    Carotenes (algae)                                      R
    Carotenes (vegetable)                                  R
    Carthamus red                                          R,T
    Dammar gum                                             R
    Ethyl hydroxyethyl cellulose                           S,T
    Isomalt                                                R
    Lactitol                                               S,T
    Mixed carotenoids                                      S,T
    Nitrogen                                               R
    Pectins                                                R
    Sodium stearoyl lactylate                              R
    Sorbitan monolaurate                                   R,T
    Sorbitan tristearate                                   R
    Sulfur dioxide                                         S,T
    Talc                                                   R,T
    Tannic acid                                            R
    Titanium dioxide                                       R
                                                                                  

    Notes to Annex 4

    1.    N, new specifications prepared; R, existing specifications revised;
          S, specifications exist, revision not considered or not required;
          and T, the existing, new, or revised specifications are tentative and
          comments are invited.

    2.    Based on sucrose esters contained in sucrose esters of fatty acids
          and sucroglycerides.

    3.    ADI "not specified" means that, on the basis of the available data
          (chemical, biochemical, toxicological, and other), the total daily intake
          of the substance arising from its use 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 that
          reason, and for the reasons stated in the individual evaluations, the
          establishment of an ADI expressed in numerical form is not deemed
          necessary.

    4.    This enzyme is derived from edible animal tissue commonly used as food;
          it may therefore be regarded as food.

    5.    Applies to total intake of limonene. Food additive intake should not
          exceed 0.075 mg/kg of body weight/day, which represents 5% of the maximum
          ADI.

    6.    Should be limited to use as an extraction solvent for spice oleoresins
          and the decaffeination of coffee and tea and for food additives in which
          previous specifications drawn up by the Committee included residues of
          dichloromethane.

    7.    Beeswax is used as a release and glazing agent in bakery products, a
          glazing agent on fresh and frozen fruit, a glazing agent on candy, a
          carrier for flavours, and a component of chewing-gum bases.

    8.    Candelilla wax is used as a glazing agent, a component of chewing gum
          base, a surface-finishing agent, and a carrier for flavouring substances.

    9.    Group ADI for microcrystalline and paraffin waxes for uses listed in the
          specifications (chewing-gum base, protective coating, defoaming agent,
          and surface-finishing agent).

    10.   Shellac is used as a coating, glazing, and surface-finishing agent
          externally applied to food.

    11.   The direct addition of furfural to food as a flavouring substance is not
          appropriate and its use as a solvent should be restricted to situations
          in which alternatives are not available, e.g. for the purification of
          food oil by extraction of unsaturated components.





















    See Also:
       Toxicological Abbreviations