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    ANNEX 4

    Acceptable Daily Intakes, other toxicological information, and
    information on specifications
                                                                                                  

                                                             Acceptable Daily Intake (ADI)
                                                             in mg per kg of body weight and
    Substance                              Specificationsa   other toxicological
                                                             recommendations
                                                                                              

    Antioxidants
      Butylated hydroxytoluene (BHT)       S                 0-0.3
      tert-Butylhydroquinone (TBHQ)        R                 0-0.2 (temporary)b

    Carrier solvent
      Diethylene glycol monoethyl ether    S                 No ADI allocatedc

    Colour stabilizer
      4-Hexylresorcinol                    N                 Treatment of crustaceans is not of
                                                             toxicological concernd
    Emulsifiers
      Dioctyl sodium sulfosuccinate        S                 0-0.1
      Glycerol ester of wood rosin         R                 No ADI allocatede
      Sucrose esters of fatty acids and    S                 0-20 (temporary group ADI)b,f
        sucroglycerides

    Flavouring agent
      Ethyl vanillin                       S                 0-3

    Food colours
      Canthaxanthin                        R                 0-0.03
      Curcumin                             S                 0-1 (temporary)b

    Glazing agents
      Microcrystalline waxg                R                 0-20 (group ADI)h
      Mineral oil (revised and divided
      into two Groups):
      Mineral oil (high viscosity)i        R                 0-20
      Mineral oil (medium and low          R
        viscosity)
        Class Ij                                             0-1 (temporary)b
        Class IIk and Class IIIl                             0-0.01 (temporary group ADI)b
    Paraffin waxm                          W                 ADI withdrawnn

    Sweetening agent
      Alitame                              N                 No ADI allocatedo
                                                                                              

    Acceptable Daily Intakes, other toxicological information, and
    information on specifications (cont'd)
                                                                                              

                                                             Acceptable Daily Intake (ADI)
                                                             in mg per kg of body weight and
    Substance                              Specificationsa   other toxicological
                                                             recommendations
                                                                                              

    Thickening agent
      Processed Eucheuma seaweed           R                 0-20 (temporary)b

    Miscellaneous substances
      -Cyclodextrin                       R                 0-5
      Nitrate                              Rp                0-3.7 (expressed as nitrate ion)q
      Nitrite                              Rr                0-0.06 (expressed as nitrite ion)s

      Potassium bromate                    R                 Use as a flour-treatment agent is
                                                               not appropriate


                                                                                              

    Contaminant             Tolerable Intake in g per kg of body weight
                                                                                              

    Ochratoxin A            PTWI (Provisional Tolerable Weekly Intake): 0.1
    Patulin                 PMTDI (Provisional Maximum Tolerable Daily Intake): 0.4
                                                                                              
    
    Notes

    aN, new specifications prepared; R, existing specifications
    revised; S, specifications exist, revision not considered or not
    required; and W, existing specifications were withdrawn.

    bFurther work is required (see WHO Technical Report Series,
    No. 859).

    cAdequate long-term feeding studies were not available. In view of
    significant potential intake of this substance, an ADI could not be
    allocated.

    dTreatment of crustaceans at concentrations up to 50 mg per liter,
    resulting in a residual level of approximately 1 mg per kg in the
    edible portion, is not of toxicological concern.

    eBecause of a lack of adequate long-term toxicity/carcinogenicity
    and reproductive toxicity studies with glycerol esters of wood rosin,
    an ADI could not be allocated. At a minimum, studies demonstrating the
    metabolic stability and non-bioavailability of glycerol esters of wood
    rosin under conditions resembling those in the human gastrointestinal
    tract would be required to permit further evaluation of this material.

    fTemporary group ADI for the sucrose ester content of sucrose esters
    of fatty acids and sucroglycerides.

    gIncluding HMPW (high-melting-point wax) and HSW (high-sulfur wax.).

    hSince both waxes fall within the same specifications, a group ADI
    was allocated to HMPW and HSW.

    iIncluding P100(H) oil.

    jIncluding P70(H) oil.

    kIncluding N70(H) and N70(A) oils.

    lIncluding P15(H), N15(H) and N10(A) oils.

    mIncluding LMPW (low melting point wax) and IMPW (intermediate-
    melting-point wax).

    nThe previous ADI "not specified" for paraffin wax was withdrawn,
    because toxicological effects were observed at all dose levels.

    oAn ADI could not be allocated because of deficiencies in the
    carcinogenicity studies in rats.

    Notes  contd.

    pThe specifications were revised for both potassium nitrate and
    sodium nitrate.

    qBecause nitrate may be converted into nitrite in significant
    amounts and infants below the age of 3 months are more vulnerable to
    the toxicity of nitrite than adults, the ADI does not apply to such
    infants. The Committee was aware that vegetables are an important
    potential source of intake of nitrate. However, in the light of the
    well-known benefits of vegetables and the lack of data on the possible
    effects of vegetable matrices: on the bioavailability of nitrate, the
    Committee considered it inappropriate to compare exposure to nitrate
    from vegetables directly with the ADI and hence to derive limits for
    nitrate in vegetables directly from it.

    rThe specifications were revised for both potassium nitrite and
    sodium nitrite.

    sThe ADI applies to all sources of intake. Nitrite should not be used
    as an additive in food for infants below the age of 3 months. The ADI
    does not apply to such infants.
    





















    See Also:
       Toxicological Abbreviations