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        ANNEX 4

    Acceptable daily intakes, other toxicological information, and information on specifications

                                                                                                  

    Substance                     Specifications    Acceptable daily intake (ADI) in mg/kg of
                                                    body weight and other toxicological
                                                    recommendations
                                                                                                  

    Antioxidants
      Dodecyl gallate             R                 No ADI allocateda
      Octyl gallate               R                 No ADI allocateda
      Propyl gallate              R                 0-1.4

    Emulsifier
     Glycerol ester of wood       R                 0-25
      rosin

    Flavouring agents
      Ethyl esters
        Ethyl formate             R                 No safety concern at current levels of intakeb
        Ethyl acetate             R                 No safety concern at current levels of intakeb
        Ethyl propionate          N                 No safety concern at current levels of intakeb
        Ethyl butyrate            R                 No safety concern at current levels of intakeb
        Ethyl pentanoate          N                 No safety concern at current levels of intakeb
        Ethyl hexanoate           N                 No safety concern at current levels of intakec
        Ethyl heptanoate          R                 No safety concern at current levels of intakeb
        Ethyl octanoate           N                 No safety concern at current levels of intakeb
        Ethyl nonanoate           R                 No safety concern at current levels of intakeb
        Ethyl decanoate           N                 No safety concern at current levels of intakeb
        Ethyl undecanoate         N,T               No safety concern at current levels of intakeb
        Ethyl dodecanoate         R                 No safety concern at current levels of intakeb
        Ethyl tetradecanoate      N                 No safety concern at current levels of intakeb
        Ethyl hexadecanoate       N                 No safety concern at current levels of intakeb
        Ethyl octadecanoate       N,T               No safety concern at current levels of intakeb
                                                                                                  

    ANNEX 4  (Con't)
                                                                                                  

    Substance                     Specifications    Acceptable daily intake (ADI) in mg/kg of
                                                    body weight and other toxicological
                                                    recommendations
                                                                                                  

      Isoamyl alcohol and isoamyl esters
        Isoamyl alcohol           N                 No safety concern at current levels of intakeb
        Isoamyl formate           N                 No safety concern at current levels of intakeb
        Isoamyl acetate           R                 No safety concern at current levels of intakec
        Isoamyl propionate        N                 No safety concern at current levels of intakeb
        Isoamyl butyrate          R                 No safety concern at current levels of intakeb
        Isoamyl hexanoate         N                 No safety concern at current levels of intakeb
        Isoamyl octanoate         N,T               No safety concern at current levels of intakeb
        Isoamyl nonanoate         N,T               No safety concern at current levels of intakeb
        Isoamyl isobutyrate       N                 No safety concern at current levels of intakeb
        Isoamyl isovalerate       N                 No safety concern at current levels of intakeb
        Isoamyl 2-methylbutyrate  N,T               No safety concern at current levels of intakeb

      Allyl esters
        Allyl propionate          N,T               No safety concern at current levels of intaked
        Allyl butyrate            N                 No safety concern at current levels of intaked
        Allyl hexanoate           R                 No safety concern at current levels of intakee
        Allyl heptanoate          R                 No safety concern at current levels of intaked
        Allyl octanoate           N                 No safety concern at current levels of intaked
        Allyl nonanoate           N                 No safety concern at current levels of intaked
        Allyl isovalerate         R                 No safety concern at current levels of intaked
        Allyl sorbate             N,T               No safety concern at current levels of intaked
        Allyl 10-undecanoate      N                 No safety concern at current levels of intaked
        Allyl tiglate             R                 No safety concern at current levels of intaked
        Allyl 2-ethylbutyrate     N                 No safety concern at current levels of intaked
        Allyl cyclohexane         N,T               No safety concern at current levels of intaked
          acetate
        Allyl cyclohexane         R                 No safety concern at current levels of intaked
          propionate
        Allyl cyclohexane         N,T               No safety concern at current levels of intaked
          butyrate
                                                                                                  

    ANNEX 4  (Con't)
                                                                                                  

    Substance                     Specifications    Acceptable daily intaked (ADI) in mg/kg of
                                                    body weight and other toxicological
                                                    recommendations
                                                                                                  

      Allyl esters (con't)
        Allyl cyclohexane         N,T               No safety concern at current levels of intaked
          valerate
        Allyl cyclohexane         N,T               No safety concern at current levels of intaked
          hexanoate
        Allyl phenylacetate       N,T               No safety concern at current levels of intaked
        Allyl phenoxyacetate      N                 No safety concern at current levels of intakef
        Allyl cinnamate           N,T               No safety concern at current levels of intaked
        Allyl anthranilate        N,T               No safety concern at current levels of intakef
        Allyl 2-furoate           N,T               Evaluation not completedg

    Sweetening agent
      Alitame                     R                 0-1h

    Thickening agent
      Konjac flour                R                 ADI 'not specified' for food additive usesi

    Miscellaneous substances
      Benzyl acetate              R
      Benzyl alcohol              R                 0-5 (group ADI)
      Benzaldehyde                R
      Benzoic acid and            R
        its salts
      Sucrose acetate             R                 0-20
        isobutyrate

    Contaminant                   Toxicological recommendation

    Aflatoxins                    Evaluation not completedj
                                                                                                  

    ANNEX 4  (Con't)
                                                                   

    Substance (considered for                    Specifications
    specifications only)
                                                                   

    Isomalt                                           R
    Lactitol                                          R
    Maltitol                                          R
    Maltitol syrup                                    R
    Mannitol                                          R
    Sorbitol                                          R
    Sorbitol syrup                                    R
    Xylitol                                           R
    Benzyl benzoate                                   R
    Ethanol                                           R
    Acesulfame K                                      R
    Ammonium hydroxide                                R
    Annatto extracts (oil- and alkali-extracted)      R
    Annatto extracts (solvent-extracted)              N
    Calcium dihydrogen phosphate                      R
    Citric acid                                       R
    Cyclohexylsulfamic acid                           R
    Calcium cyclamate                                 R
    Sodium cyclamate                                  R
    Enzyme-hydrolysed carboxymethyl cellulose         Ok
    Enzyme-treated starches                           S,Tl
    Gellan gum                                        R
    Hydrochloric acid                                 R
    Lactic acid                                       R
    Microcrystalline cellulose                        R
    Propylene glycol                                  R
    Propylene glycol esters of fatty acids            R,Tm
                                                                   
    ANNEX 4  (Con't)
                                                                   

    Substance (considered for                    Specifications
    specifications only)
                                                                   

    Sodium polyphosphate, glassy                      R
    Sodium metaphosphate, insoluble                   N
    Calcium stearoyl 2-lactylate                      R
    Sodium stearoyl 2-lactylate                       R
    Stearyl tartrate                                  R
    Tartaric, acetic and fatty acid esters of         N,Tn
      glycerol, mixed
    Triacetin                                         R
                                                                   

    N, new specifications prepared; O, no 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; W, existing
    specifications were withdrawn
    
    a  The temporary ADI was not extended because the additional studies
       on the pharmacokinetics and metabolism of dodecyl, octyl, and
       propyl gallate requested at the forty-first meeting of the
       Committee (WHO Technical Report Series No. 837) were not available.

    b  This flavouring agent is in structural class I; the conclusions are
       based on a 'yes' answer at step 2 and a 'no' answer at step 3 of
       the approach described in Annex 5 of WHO Food Additives Series
       No.35 (1996).

    c  This flavouring agent is in structural class I; the conclusions are
       based on 'yes' answers at steps 2, 3, and 4 of the approach
       described in Annex 5 of WHO Food Additives Series No.35 (1996).

    d  This flavouring agent is in structural class II; the conclusions
       are based on 'no' answers at steps 2 and 3 of the approach
       described in Annex 5 of WHO Food Additives Series No. 35 (1996). A
       revised step 6 was applied, in which the Committee determined that
       an adequate margin of safety existed between the NOEL
       (no-observed-effect level) and current levels of intake.

    e  This flavouring agent is in structural class II; the conclusions
       are based on a 'no' answer at step 2 and a 'yes' answer at step 3
       using the approach outlined in Annex 5 of WHO Food Additives Series
       No. 35 (1966). It was evaluated on the basis of available toxicity
       data.

    f  This flavouring agent is in structural class III; the conclusions
       are based on 'no' answers at steps 2 and 3 of the approach
       described in Annex 5 of WHO Food Additives Series No. 35 (1996). A
       revised step 6 was applied, in which the Committee determined that
       an adequate margin of safety existed between the NOEL and current
       levels of intake.

    g  The evaluation was not completed pending consideration of step 7
       of the approach described in Annex 5 of WHO Food Additives Series
       No. 35 (1996) at the next Expert Committee meeting when food additives
       and contaminants are evaluated.

    h  The results of an on-going study of tolerance to repeated doses of
       alitame in diabetic subjects should be submitted for assessment
       when available.

    i  Includes uses as a thickener, emulsifier, stabilizer, gelling
       agent, texturizing, and glazing agent.

    j  The evaluation could not be completed at the present meeting. The
       Committee recommended that assessment of the carcinogenic potency
       and estimates of the risks presented by aflatoxins be continued at
       the next meeting of the Expert Committee when food additives and
       contaminants are evaluated.

    k  The Committee considered a suggestion for specifications for
       carboxymethyl cellulose, enzyme-hydrolysed, but because it was
       understood that the product was not yet on the market, the
       Committee deferred the establishment of specifications until the
       additive is known to be commercially available.

    l  The tentative specifications for enzyme-treated starches were on
       the agenda for revision; however, as no new information was
       received, the Committee maintained the existing specifications as
       tentative and requested new information for evaluation in 1997.
       Unless this information is received the specifications will be
       withdrawn.

    m  The Committee revised the specifications for propylene glycol
       esters of fatty acids and designated them as tentative, requesting
       a method of assay for the total ester content for evaluation in
       1997.

    n  The Committee noted that the specifications for tartaric, acetic,
       and fatty acid esters of glycerol, mixed, in FAO Nutrition Meetings
       Report Series No. 40 A, B, C (1967) were old and rudimentary, and
       therefore new tentative specifications were prepared. These were
       designated as tentative, and information on methods of manufacture
       was requested for evaluation in 1997 in order to distinguish this
       material from diacetyltartaric and fatty acid esters of glycerol.
    





















    See Also:
       Toxicological Abbreviations