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    ANNEX 4

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

                                                                        

    Substance                  Specifications1   Acceptable Daily
                                                 Intake (ADI) and
                                                 other toxicological
                                                 recommendations
                                                                        

    Emulsifiers

    Polyglycerol esters of
    fatty acids                      S           0-25 mg/kg body weight2

    Sucrose esters of
    fatty acids                      R           0-10 mg/kg body weight3

    Sucroglycerides                  S           0-10 mg/kg body weight3

    Enzyme preparations

    Enzymes derived from
     Aspergillus niger                S           ADI not specified4

    Flavouring agents

    Benzyl acetate                   S           0-5 mg/kg body weight5
    Cinnamaldehyde                   S           No ADI allocated6
    Dihydrocoumarin                 N,T          No ADI allocated
    Ethyl vanillin                   R           0-5 mg/kg body weight5
    Fumaric acid                     R           ADI not specified7
    Quinine                          R           0-0.9 mg/kg body weight5
                                                                        

                                                                        

    Substance                  Specifications1   Acceptable Daily
                                                 Intake (ADI) and
                                                 other toxicological
                                                 recommendations
                                                                        

    Food colours

    Canthaxanthin                    S           No ADI allocated8
    Carotene preparations
    from natural sources           R,T8          No ADI allocated10
    Curcumin                         S           0-0.1 mg/kg body weight5
    Paprika oleoresin                R           No ADI allocated11
    Tumeric oleoresin                R           No ADI allocated8

    Thickening agents

    Gum Arabic                       R           ADI not specified
    Modified celluloses              S           ADI not specified12

    Miscellaneous food additives

    Ferrous lactate                  N           [0.8 mg/kg body weight13]
    2-Nitropropane                  R,T          No ADI allocated14
    Tannic acid                     R,T          ADI not specified15

    Lactoperoxidase/thiocyanate/
    hydrogen peroxide milk
    preservation system             16           Acceptable17

    Contaminants
    Patulin                                      [7 g/kg body weight]18
    Polychlorinated biphenyls
    (PCBs)                                       PTWI not established19

                                                                        

                                                                        

                               Specifications only

                                                                        

    Carob bean gum                   R

    Citric and fatty acid esters
    of glycerol                      R

    Iron oxides used as food
    colours                          R

    Modified starches                R
                                                                        
    
    Notes

    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.   Applies to polyglycerol esters of fatty acids having an average
         chain length of up to 3 glycerol units.

    3.   Group ADI for sucrose esters of fatty acids and sucroglycerides.

    4.   See p. 76 for definition of "ADI not specified".

    5.   Temporary acceptance.

    6.   The previous temporary ADI was not extended.

    7.   Group ADI for fumaric acid and its salts.

    8.   The previous temporary ADI was not extended.

    9.   Specifications apply to carotenes from both algae and vegetable
         sources.

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

    11.  Self-limiting as a spice extract.

    12.  Group ADI for ethyl cellulose, ethyl hydroxyethyl cellulose,
         hydroxypropyl cellulose, hydroxypropyl methyl cellulose, methyl
         cellulose, methyl ethyl cellulose, and sodium carboxymethyl
         cellulose.  The ability of modified celluloses to produce
         laxative effects should be taken into account when using them as
         food additives.

    13.  Provisional maximum tolerable daily intake (PMTDI) for iron from
         all sources.

    14.  The previous temporary acceptance of 2-nitropropane as a
         fractionating
         solvent in the production of fats and oils was not extended.

    15.  For use as a filtering aid where the application of good
         manufacturing practice ensures that it is removed from food after
         use.

    16.  Existing specifications for sodium thiocyanate were maintained. 
         New specifications for sodium percarbonate were prepared.

    17.  When used according to the draft guidelines produced by the Joint
         FAO/WHO Committee of Government Experts on the Code of Principles
         concerning Milk and Milk Products, this system does not present
         a toxicological hazard.

    18.  Provisional tolerable weekly intake (PTWI).

    19.  The Committee concluded that the no-effect level in studies with
         monkeys was 40 g/kg body weight per day.  Because of the
         limitations of the available data and the ill-defined nature of
         the materials that were used in the feeding studies, it was
         impossible to establish a precise numerical value for a tolerable
         intake.  In particular, the PCB mixtures that were used in the
         studies with monkeys are not entirely the same as the PCB
         mixtures to which humans are exposed in the diet.  However, there
         is no reason to believe that humans would be more sensitive than
         monkeys to the effects of PCBs, and some indication of safe
         exposure levels can provisionally be obtained from the no-effect
         level in the studies with monkeys.





















    See Also:
       Toxicological Abbreviations