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    ANNEX 4

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

                                                                     ADI for man and other
    Substance                                   Specifications1      toxicological
                                                                     recommendations
                                                                                              

    A. Food additives

    Enzyme preparations

      alpha-Amylase from A. oryzae              N,T                  Acceptable2
      Protease from A. oryzae                   R,T                  Acceptable2
      Amyloglucosidases from A. niger           N,T                  0-1 mg/kg b.w.3
      beta-Glucanase from A. niger              N,T                  0-1 mg/kg b.w.3
      hemi-Cellulase from A. niger              N,T                  0-1 mg/kg b.w.3
      Pectinases from A. niger                  N,T                  0-1 mg/kg b.w.3
      Protease from A. niger                    O                    0-1 mg/kg b.w.3
      beta-Glucanase from T. harzianum          N,T                  0-0.5 mg/kg b.w.3,4
      Cellulase from T. reesei                  N,T                  0-0.3 mg/kg b.w.3,4
      Cellulase from P. funiculosum             N,T                  No ADI allocated3
      Pectinase from A. alliaceus               O                    No ADI allocated3

    Flavouring agents

      trans-Anethole                            S                    0-2.5 mg/kg b.w.4
      Benzyl acetate                            S                    0-5 mg/kg b.w.4
      Smoke flavourings                         N,T                  Provisional acceptance6

    Food colours

      Beet red                                  R                    ADI "not specified"7
      Canthaxanthin                             R                    0-0.05 mg/kg b.w.4
      Carbon black                              R,T                  No ADI allocated5,8
      Carotenes (algae)                         N,T9                 No ADI allocated5
      Carotenes (vegetable)                     N,T9                 No ADI allocated5
      Citranaxanthin                            R                    No ADI allocated5
      Xanthophylls (mixed carotenoids)          N,T10                No ADI allocated5
      Xanthophylls (Tagetes extract)            N,T10                No ADI allocated5
                                                                                              

    ACCEPTABLE DAILY INTAKES, OTHER TOXICOLOGICAL
    RECOMMENDATIONS, AND INFORMATION ON SPECIFICATIONS (cont'd)
                                                                                              

                                                                     ADI for man and other
    Substance                                   Specifications1      toxicological
                                                                     recommendations
                                                                                              

    Miscellaneous food additives

      Ferrous gluconate                         S                    0.8 mg/kg b.w.11
      Glutamic acid and its salts               R                    ADI "not specified"7,12
      4-Hydroxymethyl-2,6-ditert-
        butylphenol                             W                    No ADI allocated5
      Polydextroses                             S                    ADI "not specified"7
      Tannic acid                               R,T                  ADI "not
                                                                     specified"4,7,13

    B. Contaminants

      Aflatoxins                                -                    Lowest practicable
                                                                     level14
                                                                                              

                                                                                              

    Specifications only1
                                                                                              

    Activated carbon                                       R
    alpha-Amylase and glucoamylase from A. oryzae          R,T
    beta-Carotene, synthetic                               R
    Brilliant black BN                                     S
    Caramel colours                                        R
    Carthamus yellow                                       R
    Chlorophylls                                           R
    Chlorophylls, copper complexes                         R
    Chlorophyllins, copper complexes, sodium and
      potassium salts                                      R
    Hydrogenated glucose syrups                            R,T15
    Insoluble polyvinylpyrrolidone                         S
    Paprika oleoresin                                      R
    Patent blue V                                          R
    Polyethylene glycols                                   R
    Polyglycerol esters of fatty acids                     S
    Ponceau 4R                                             S
    Potassium bromate                                      R
    Potassium dihydrogen citrate                           R
    Riboflavin                                             R
    Riboflavin 5'-phosphate, sodium                        R
    Sucrose esters of fatty acids                          S
    Talc                                                   S
    Triammonium citrate                                    S
    Xylitol                                                R,T
                                                                                              
    
    Notes to Annex 4

    1.   N, new specifications prepared; 0, specifications not prepared;
         R, existing specifications revised; S, specifications exist,
         revision not considered or not required; T, the existing, new or
         revised specifications are tentative and comments are invited;
         and W, previously established specifications withdrawn.

    2.   Acceptable for use in food processing. These enzymes are derived
         from microorganisms that are traditionally accepted as
         constituents of foods or are normally used in the preparation of
         foods. These products are regarded as foods and, consequently,
         considered acceptable, provided that satisfactory chemical and
         microbiological specifications can be established.

    3.   Based on the percentage of T.O.S. (total organic solids); %
         T.O.S. = 100 - (A + W + D), where A = % ash, W = % water, and
         D = % diluent and carrier.

    4.   Temporary acceptance.

    5.   Insufficient information available on its toxicology and/or
         chemical composition to establish an ADI.

    6.   Analytical and compositional data, including data on variability,
         are required; further safety studies on a well-defined spectrum
         of smoke flavourings are desired. Benzo(a)pyrene should not
         exceed 10 g per kg.

    7.   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.

    8.   The use of carbon black from hydrocarbon sources in food contact
         materials is provisionally accepted.

    9.   The previous specifications for carotenes (natural) were
         withdrawn.

    10.  The previous specifications for xanthophylls were withdrawn.

    11.  Provisional maximum tolerable daily intake (PMTDI) for iron.

    12.  Group ADI for L-glutamic acid and its ammonium, calcium,
         magnesium, monosodium, and potassium salts.

    13.  For use as a processing aid.

    14.  Presence in food should be reduced to irreducible levels. An
         irreducible level is defined as that concentration of a substance
         that cannot be eliminated from a food without involving the
         discarding of that food altogether, severely compromising the
         ultimate availability of major food supplies.

    15.  This specification also covers dry, food grade maltitol, which is
         the substance listed on the agenda of this meeting.
    





















    See Also:
       Toxicological Abbreviations