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    ANNEX 4

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

                                                                                       

    Food additives                          Specifications1     Acceptable Daily
                                                                Intake (ADI) and
                                                                other toxicological
                                                                recommendations

                                                                                       

    Antioxidants
    Butylated hydroxytoluene (BHT)          R                   0-0.125 mg/kg bw2
    tert-Butyl hydroquinone (TBHQ)          R                   0-0.2 mg/kg bw2
    Erythorbic acid and its 
      sodium salt3                          R4                  ADI not specified5

    Enzyme preparations
    alpha-Amylase from Bacillus 
      stearothermophilus                    N                   ADI not specified5
    alpha-Amylase from Bacillus 
      subtilis                              N                   ADI not specified5
    alpha-Amylase from Bacillus 
      stearothermophilus 
      expressed in Bacillus 
      subtilis                              N,T                 ADI not specified5
    alpha-Amylase from Bacillus 
      megaterium expressed in 
      Bacillus subtilis                     N,T                 ADI not specified5
    Chymosin A produced from
      Escherichia coli K-12 containing 
      calf prochymosin A gene               N,T                 ADI not specified5
    Chymosin B produced from 
      Aspergillus niger var. 
      awamori containing calf 
      prochymosin B gene                    N,T                 ADI not specified5
    Chymosin B produced from
      Kluyveromyces lactis 
      containing calf
      prochymosin B gene                    N,T                 ADI not specified5

                                                                                       

    ANNEX 4 (contd)
                                                                                       

    Food additives                          Specifications1     Acceptable Daily
                                                                Intake (ADI) and
                                                                other toxicological
                                                                recommendations

                                                                                       

    Flavouring agents
    Allyl heptanoate                        N,T                 0-0.15 mg/kg bw6
    Allyl hexanoate                         R,T                 0-0.13 mg/kg bw6
    Allyl isovalerate                       N,T                 0-0.12 mg/kg bw6
    trans-Anethole                          S                   0-0.6 mg/kg bw2
    (+)-Carvone                             R                   0-1 mg/kg bw
    (-)-Carvone                             R                   No ADI allocated17

    Food colour
    Erythrosine                             R                   0-0.1 mg/kg bw

    Sweetening agents
    Acesulfame potassium                    S                   0-15 mg/kg bw
    Trichlorogalactosucrose                 R                   0-15 mg/kg bw

    Miscellaneous food additives
    Dimethyldicarbonate                     N                   Acceptable8
    Dioctyl sodium sulfosuccinate           R                   0-0.25 mg/kg bw2
    Gellan gum                              N                   ADI not specified5,9
    Mineral oil (food grade)                R                   ADI not specified2,5

                                                                                       

                                                                                       

    Contaminant                                                 Provisional Tolerable
                                                                Weekly Intake (PTWI)

                                                                                       

    Benzo[a]pyrene                                              PTWI not established10
    Ochratoxin A                                                112 ng/kg bw

                                                                                       

    ANNEX 4 (contd)
                                                                                       
    Food additives                                              Specifications only1

                                                                                       

    Activated carbon                                            R
    Citrus red no. 2                                            W
    Diethyl ether                                               R,T
    Disodium pyrophosphate                                      R
    Glycerol esters of wood rosin                               R
    Lecithin                                                    R
    Lecithin, partially hydrolyzed                              R
    Mixed carotenoids                                           R,T
    Polydimethylsiloxane                                        R
    Sucrose acetate isobutyrate                                 R
    Tetrasodium pyrophosphate                                   R
    Vegetable carbon                                            R11
    Xanthan gum                                                 R

                                                                                       

    Notes to Annex 4

    1.   N, new specifications 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, existing
         specifications were withdrawn.

    2.   Temporary acceptance.

    3.   This substance was on the agenda under the name "isoascorbic
         acid".

    4.   Existing specifications were revised for erythorbic acid only;
         specifications for the sodium salt were not reviewed.

    5.   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 that will be stated in the individual
         evaluations, the establishment of an ADI expressed in numerical
         form is not deemed necessary.

    6.   The listed values correspond to an allyl alcohol equivalent of
         0.05 mg/kg bw, which is the group ADI for the listed allyl
         esters.  They may be used alone or in  pro rata combinations
         in such a way that the intake of allyl alcohol does not exceed
         this value.

    7.   The previous temporary ADI was not extended.

    8.   Acceptable for use as a cold sterilization agent in beverages
         when used according to Good Manufacturing Practice up to a
         maximum of 250 mg/l.

    9.   The potential laxative effect of gellan gum at high intakes
         should be taken into account when it is used as a food
         additive.

    10.  Insufficient information available to establish a PTWI.

    11.  Supersedes the earlier tentative specifications for carbon
         black published in FAO Food and Nutrition Paper No. 38 (1988).

    






















    See Also:
       Toxicological Abbreviations