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        ANNEX 4

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

    Acceptable Daily Intake (ADI) and other toxicological recommendations

                                                                                                                               

    Substance                        Specifications1    Acceptable Daily Intake

                                                                                                                               

    Antioxidants
      Dodecyl gallate                       R           0-0.05 mg/kg bw (temporary)2
      Octyl gallate                         R           0-0.1 mg/kg bw (temporary)2
      Propyl gallate                        R           0-1.4 mg/kg bw

    Flavouring agents
      Benzyl acetate                        S           0-5 mg/kg bw (group ADI)2,3
      2-Ethyl-1-hexanol                     N           0-0.5 mg/kg bw 
      d-Limonene                            R           Not specified4
      alpha-Methylbenzyl alcohol            N           0-0.1 mg/kg bw 
      Quinine hydrochloride                 R }         Current use levels of up to 100 mg/l
      Quinine sulfate                       R }         (as quinine base) in soft drinks not of toxicological concern

    Flavour enhancers
      Disodium-5'-guanylate                 R }         Not specified4
      Disodium-5'-inosinate                 R }

    Food colours
      Carotenes (algal)                     R           No ADI allocated because of inadequate data
      Carotenes (vegetable)                 R           Acceptable, provided the level of use does not exceed the level
                                                        normally found in vegetables

    Sweetening agents
      Maltitol                              S }         Not specified4
      Maltitol syrup                        R }
      Saccharin                             S           0-5 mg/kg bw
                                                                                                                               

                                                                                                                               

    Substance                        Specifications1    Acceptable Daily Intake

                                                                                                                               

    Thickening agents
      Konjac flour                        N,T2          Not specified (temporary)2,4
      Processed Eucheuma seaweed            R           0-20 mg/kg bw (temporary)2
      Propylene glycol alginate           R,T2          0-70 mg/kg bw

    Miscellaneous substances
      -Cyclodextrin                      N,T2          0-6 mg/kg bw (temporary)2
      Sodium iron EDTA                    N,T2          Provisionally considered to be safe in food
                                                        fortification programmes5
      Sucrose acetate isobutyrate           R           0-10 mg/kg bw (temporary)2
      Urea                                  N           Use at levels of up to 3% in chewing gum not of
                                                        toxicological concern
                                                                                                                               

                                                                                            

    Contaminant                             Provisional Tolerable Weekly Intake (PTWI)

                                                                                            

    Cadmium                                 7 g per kg of body weight

    Chloropropanols                         Levels in hydrolyzed vegetable proteins should
        (3-chloro-1,2-propanediol and       be reduced as far as technologically possible
        1,3-dichloro-2-propanol)

    Lead                                    25 g/kg bw
                                                                                            

    Substances considered for specifications only

                                                                                            

    Substance                                                      Specifications1

                                                                                            

    Alginic acid                                                           R
    Ammonium alginate                                                      R
    Ammonium polyphosphate                                                 R
    alpha-Amylase from Bacillus stearothermophilus                         R
    alpha-Amylase from Bacillus subtilis                                   R
    alpha-Amylase and glucoamylase from Aspergillus oryzae               R,T2
    Calcium alginate                                                       R
    Carmines                                                               R
    Cochineal extract (formerly cochineal and carminic acid)               R
    Disodium pyrophosphate                                                 R
    Erythrosine                                                            R
    Ethyl hydroxyethyl cellulose                                         S,T2
    -Glucanase from Aspergillus niger, var.                               R
    Hexane                                                               S,T2
    Lecithin                                                               R
    Lecithin, partially hydrolyzed                                         S
    2-Nitropropane                                                       S,T2
    Oxystearin                                                           S,T2
    Petroleum jelly                                                      S,T2
    Potassium alginate                                                     R
    Sodium alginate                                                        R
    Sucralose (formerly trichlorogalactosucrose)                           R
    Tetrasodium pyrophosphate                                              R
    Trichloroethylene                                                    S,T2
    Xanthan gum                                                            R
                                                                                            

    Notes to Annex 4

    1.   N, new specifications were 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.   Details of further toxicological studies and other information required for
         certain substances are given in Annex 3 to the Report of the 41st meeting of
         JECFA (WHO Technical Report Series, in preparation).

    3.   Group ADI with benzyl alcohol, benzaldehyde, benzoic acid, and benzoate salts.

    4.   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 was not deemed necessary.

    5.   The Committee provisionally concluded that sodium iron EDTA
         (ethylenediaminetetraacetate) meeting the tentative specifications prepared at
         the meeting does not present a safety problem when used in supervised food
         fortification programmes in iron deficient populations.





















    See Also:
       Toxicological Abbreviations