IPCS INCHEM Home


    INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY

    WORLD HEALTH ORGANIZATION





    SAFETY EVALUATION OF CERTAIN 
    FOOD ADDITIVES



    WHO FOOD ADDITIVES SERIES: 42





    Prepared by the Fifty-first meeting of the Joint FAO/WHO
    Expert Committee on Food Additives (JECFA)





    World Health Organization, Geneva, 1999
    IPCS - International Programme on Chemical Safety

    ANNEX 4

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

    1.  Food additives

                                                                          

    Substance                    Specificationsa      ADI and other 
    toxicological                                  recommendations
                                                                          

    Enzyme preparations
     alpha-Acetolactase          R                 ADI 'not specified'
      decarboxylase
     Maltogenic amylase          R                 ADI 'not specified'

    Flavouring agents
     trans-Anethole              S                 0-2 mg/kg bw
     Furfural                    N                 No ADIb
     Menthol                     R                 0-4 mg/kg bw

    Food colours
     Curcumin                    R,T               0-1 mg/kg bw 
                                                   (temporary)c

     Riboflavin from genetically N                 0-0.5 mg/kg bw
      modified Bacillus subtilis                   (group ADI with 
                                                   synthetic riboflavin 
                                                   and 
                                                   riboflavin-5'-phosphate)
    Glazing agent
     Mineral oil (medium-        R
      and low-viscosity          
      Class Id                                     0-1 mg/kg bw 
                                                   (temporary) c
      Class IIe and class IIIf                     0-0.01 mg/kg bw 
                                                   (temporary group 
                                                   ADI)c
    Preservatives
     Calcium hydrogen sulfitec   S;T     )
     Calcium metabisulfite       O       )
     Calcium sulfite             O       )
     Potassium hydrogen sulfite  O       )
     Potassium metabisulfitec    R,T     )         Group ADI, 0-0.7
     Potassium sulfitec          R,T     )         mg/kg bwg
     Sodium hydrogen sulfitec    R,T     )
     Sodium metabisulfitec       R,T     )
     Sodium sulfitec             R,T     )
     Sodium thiosulfatec         R,T     )
     Sulfur dioxide              R       )

                                                                          

    Substance                    Specificationsa      ADI and other 
    toxicological                                  recommendations
                                                                          

    Sweetening agent
     Stevioside                  O                 No ADI allocatedb

    Thickening agents
     Carrageenan                 R       )        Group ADI 'not
                                         )        specified' 
                                         )        (temporary)c
     Processed Eucheuma seaweed  R
     Sodium carboxymethyl 
     cellulaose, enzymatically   R                 Group ADI 'not
      hydrolysed                                   specified'h

    Miscellaneous substances
     gamma-Cyclodextrin          N       )         ADI 'not specified' 
                                         )         (temporary)c
     Glucono-delta-lactone       R       )
     Calcium gluconate           R       )
     Magnesium gluconate         R,T     )         Group ADI 'not 
     Potassium gmuconate         R       )         specified'
     Sodium gluconate            R       )
     Polyglycitol syrup          N                 Group ADI 'not 
                                                   specified'i
                                                                          

    a  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
    b  Data were insufficient for establishing an ADI
    c  See Annex 4.
    d  Including P70(H) oil
    e  Including N70(H) and N70(A) oils
    f  Including P15(H), N15(H), and N10(A) oils
    g  The Committee reiterated its recommendation made at the thirtieth
       meeting that, when a suitable alternative method of preservation
       exists, its use should be encourages, particularly in those
       applications (e.g. control of enzymic browning in fresh salad
       vegetables) in which the use of sulfites may lead to high levels
       of acute exposure and which have most commonly been associated
       with life-threatening adverse reactions. Appropriate labelling
       would help to alert individuals who cannot tolerate sulfites.
    h  Included in the group ADI for modified celluloses: ethyl
       cellulose, ethylhydroxyethyl cellulose, hydroxypropyl cellulose,
       hydroxypropyl methyl cellulose, methyl cellulose, methyl ethyl
       cellulose, and sodium carboxymethyl cellulose
    i  Group ADI for materials conforming to the specifications for
       polyglycitol syrup and maltitol syrup

    2.  Substances evaluated using the procedure for the safety evaluation
    of flavouring agents
        A. Flavouring agents evaluated toxicologically and considered for specifications

                                                                                              

    Flavouring agent                         No.      Specificationsa     Conclusions based
                                                                          on current levels
                                                                          of intake
                                                                                              

     Saturated aliphatic acyclic secondary alcohols, ketones, and related saturated and unsaturated 
     esters 

    Acetone                                  0139     N       )
    Isopropyl alcohol                        0277     N       )
    2-Butanone                               0278     N       )           No safety concern
    2-Pentanone                              0279     N       )
    2-Pentanol                               0280     N       )

    3-Hexanone                               0281     N       )
    3-Hexanol                                0282     N       )
    2-Heptanone                              0283     N       )           No safety concern
    2-Heptanol                               0284     N       )
    3-Heptanone                              0285     N       )

    3-Heptanol                               0286     N       )
    4-Heptanone                              0287     N       )           No safety concern
    2-Octanone                               0288     N       )
    2-Octanol                                0289     N       )
    3-Octanone                               0290     N       )

    3-Octanol                                0291     N       )
    2-Nonanone                               0292     N       )
    2-Nonanol                                0293     N       )           No safety concern
    3-Nonanone                               0294     N       )
    3-Decanol                                0295     N       )

    2-Undecanone                             0296     N       )
    2-Undecanol                              0297     N       )
    2-Tridecanone                            0298     N       )           No safety concern
    2-Pentadecanone                          0299     N,T     )
    3-Methyl-2-butanol                       0300     N       )

    4-Methyl-2-pentanone                     0301     N,T     )
    2,6-Dimethyl-4-heptanone                 0302     N,T     )
    2,6-Dimethyl-4-heptanol                  0303     N       )           No safety concern
    Isopropyl formate                        0304     N,T     )
    Isopropyl acetate                        0305     R       )

                                                                                              

    Flavouring agent                         No.      Specificationsa     Conclusions based
                                                                          on current levels
                                                                          of intake
                                                                                              

    Isopropyl propionate                     0306     N       )
    Isopropyl butyrate                       0307     N       )
    Isopropyl hexanoate                      0308     N       )          No safety concern
    Isopropyl isobutyrate                    0309     N       )
    Isopropyl isovalerate                    0310     N       )

    Isopropyl myristate                      0311     N       )
    Isopropyl tiglate                        0312     N       )           No safety concern
    3-Octyl acetate                          0313     N       )
    1-Ethylhexyl tiglate (3-octyl tiglate)   0448     N       )


     Linear and branched-chain aliphatic unsaturated unconjugated alcohols, aldehydes, acids, 
     and related esters

    4-Pentenoic acid                         0314     N       )
    cis-3-Hexen-1-ol                         0315     N       )
    cis-3-Hexenal                            0316     N,T     )           No safety concern
    3-Hexenoic acid                          0317     N       )
    4-Hexen-1-ol                             0318     N       )

    cis-4-Hexenal                            0319     N,T     )
    4-Heptenal                               0320     N       )
    cis-3-Octen-1ol                          0321     N       )           No safety concern
    cis-5-Octen-1-ol                         0322     N       )
    cis-5-Octenal                            0323     N       )

    cis-6-Nonen-1-ol                         0324     N       )
    cis-6-Nonenal                            0325     N       )
    4-Decenal                                0326     N       )          No safety concern
    5&6-Decenoic acid                        0327     N       )
    9-Decenoic acid                          0328     N       )

    9-Undecenal                              0329     N,T     )
    10-Undecenal                             0330     N       )
    10-Undecenoic acid                       0331     N,T     )           No safety concern
    Linoleic acid                            0332     N       )
    Oleic acidb                              0333     N       )

    Methyl 3-hexenoate                       0334     N,T     )
    Ethyl 3-hexenoate                        0335     N       )
    cis-3-Hexenyl cis-3-hexenoate            0336     N       )           No safety concern
    Methyl cis-4-octeboate                   0337     N,T     )
    Ethyl cis-4-octeoate                     0338     N,T     )

                                                                                              

    Flavouring agent                         No.      Specificationsa     Conclusions based
                                                                          on current levels
                                                                          of intake
                                                                                              

    Ethyl cis-4,7-octadienoate               0339     N       )
    Methyl 3-nonenoate                       0340     N       )
    Ethyl trans-4-decenoate                  0341     N,T     )           No safety concern
    Methyl 9-undecenoate                     0342     N,T     )
    Ethyl 10-undecenoate                     0343     N       )

    Butyl 10-undecenoate                     0344     N       )
    Ethyl oleate                             0345     N       )
    Methyl linoleate & methyl                0346     N       )           No safety concern
      linolenate (mix)
    2-Methyl-3-pentenoic acid                0347     N,T     )
    2,6-Dimethyl-6-hepten-1-ol               0348     N,T     )
    2,6-Dimethyl-5-heptenal                  0349     N       )
    Ethyl-2-methyl-3-pentenoate              0350     N,T     )
    Ethyl-2-methyl-4-pentenoate              0351     N       )           No safety concern
    Hexyl-2-methyl-3&4-pentenoate            0352     N,T     )
    Ethyl-2-methyl-3,4-pentadienoate         0353     N,T     )           Evaluation
                                                                          deferredc


     Linear and branched-chain aliphatic unsaturated unconjugated alcohols, aldehydes, acids, 
     and related esters

    Methyl 3,7-dimethyl-6-octenoate          0354     N       )           No safety concern
    2-Methyl-4-pentenoic acid                0355     N       )


     Aliphatic acyclic and alicyclic terpenoid tertiary alcohols and structurally related substances

    Linaloold                                0356     R       )
    Tetrahydrolinalool                       0357     N,T     )
    Linalyl formate                          0358     N       )           No safety concern
    Linalyl acetate                          0359     R       )
    Linalyl propionate                       0360     N       )

    Linalyl butyrate                         0361     N       )
    Linalyl isobutyrate                      0362     N       )
    Linalyl isovalerate                      0363     N       )           No safety concern
    Linalyl hexanoate                        0364     N       )
    Linalyl octanoate                        0365     N       )

    alpha-Terpineol                          0366     N       )
    Terpinyl formate                         0367     N       )
    Terpinyl acetate                         0368     N       )           No safety concern
    Terpinyl propionate                      0369     N       )
    Terpinyl butyrate                        0370     N       )

                                                                                              

    Flavouring agent                         No.      Specificationsa     Conclusions based
                                                                          on current levels
                                                                          of intake
                                                                                              

    Terpinyl isobutyrate                     0371     N,T     )
    Terpinyl isovalerate                     0372     N,T     )
    para-Menth-3-en-1-ol                     0373     N,T     )           No safety concern
    4-Carvomenthenol                         0439     N,T     )
    para-Menth-8-en-1-ol (-terpineol)       0374     N       )

    2-Ethyl-1,3,3-trimethyl-2-norbornanol    0440     N,T     )           No safety concern
    4-Thujanol                               0441     N       )
    Methyl 1-acetoxycyclohexyl ketone        0442     N,T                 Additional data
                                                                          required


     Carvone and structurally related substances

    para-Menthan-2-one                       0375     N       )
    para-Menthan-2-ol                        0376     N       )
    Dihydrocarvone                           0377     N       )           No safety concern
    Dihydrocarveol                           0378     N       )
    Dihydrocarvyl acetate                    0379     N       )

    (+) Carvonee                             0380a    R       )
    (-) Carvone                              0380b    R,T     )
    Carveol                                  0381     N       )           No safety concern
    Carvyl acetate                           0382     N       )
    Carvyl propionate                        0383     N       )


     Ionones and structurally related substances

    -Damascone                              0384     N,T     )
    alpha-Damascone                          0385     N,T     )
    delta-Damascone                          0386     N       )           No safety concern
    Damascenone                              0387     N       )
    alpha-Iononef                            0388     R       )

    -Ionone                                 0389     R       )
    gamma-Ionone                             0390     N       )
    alpha-Ionol                              0391     N       )           No safety concern
    -Ionol                                  0392     N       )
    Dihydro-alpha-ionone                     0393     N       )

    Dihydro--ionone                         0394     N,T     )
    Dihydro--ionol                          0395     N       )
    Dehydrodihydroionone                     0396     N,T     )           No safety concern
    Dehydrodihydroionol                      0397     N,T     )
    Methyl alpha-ionone                      0398     N,T     )

                                                                                              

    Flavouring agent                         No.      Specificationsa     Conclusions based
                                                                          on current levels
                                                                          of intake
                                                                                              

    Methyl--ionone                          0399     N       )           No safety concern
    Methyl-delta-ionone                      0400     N,T                 No safety concern
    Allyl-alpha-ionone                       0401     N                   No safety concern
    1,4-Dimethyl-4-acetyl-1-cyclohexene      0402     N,T                 Not evaluated
    alpha-Irone                              0403     N                   No safety concern

    alpha-iso-Methylionone                   0404     N                   No safety concern


     Aliphatic acyclic and alicyclic alpha-diketones and related substances

    Acetoin                                  0405     N       )
    2-Acetoxy-3-butanone                     0406     N       )
    Butan-3-one-2-yl butanoate               0407     N       )           No safety concern
    Diacetyl                                 0408     N       )
    3-Hydroxy-2-pentanone                    0409     N       )

    2,3-Pentanedione                         0410     N       )
    4-Methyl-2,3-pentanedione                0411     N       )
    2,3-Hexanedione                          0412     N       )           No safety concern
    3,4-Hexanedione                          0413     N       )
    5-Methyl-2,3-hexanedione                 0414     N       )

    2,3-Heptanedione                         0415     N       )
    5-Hydroxy-4-octanone                     0416     N       )
    2,3-Undecadione                          0417     N       )           No safety concern
    Methylcyclopentenolone                   0418     N       )
    Ethylcyclopentenolone                    0419     N       )

    3,4-Dimethyl-1,2-cyclopentanedione       0420     N       )
    3,5-Dimethyl-1,2-cyclopentanedione       0421     N,T     )
    3-Ethyl-2-hydroxy-4-methyl-              0422     N       )           No safety concern
       cyclopent-2-en-1-one                                   )
    5-Ethyl-2-hydroxy-3-methyl-              0423     N       )
       cyclopent-2-en-1-one                                   )
    2-Hydroxy-2-cyclohexen-1-one             0424     N       )

    1-Methyl-2,3-cyclohexadione              0425     N       )
    2-Hydroxy-3,5,5-trimethyl-2-             0426     N       )           No safety concern
       cyclohexen-1-one                                       )

                                                                                              

    Flavouring agent                         No.      Specificationsa     Conclusions based
                                                                          on current levels
                                                                          of intake
                                                                                              

     Menthol and structurally related substances

    Mentholg                                 0427     R       )
    (+) neo-Menthol                          0428     N,T     )
    Menthone                                 0429     N       )           No safety concern
    () Isomenthone                          0430     N       )
    Menthyl acetate                          0431     N       )
    Menthyl isovalerate                      0432     N       )
    (-) Menthyl lactate                      0433     N       )
    para-Menth-1-en-3-ol                     0434     N,T     )           No safety concern
    Piperitone                               0435     N       )
    (-) Menthol ethylene glycol carbonate    0443     N       )

    (-) Menthol 1- and 2-propylene           0444     N       )
       glycol carbonate                                       )
    (-) Menthone 1,2-glycerol ketal          0445     N       )           No safety concern
    () Menthone 1,2-glycerol ketal          0446     N       )
    Monomenthyl succinate                    0447     N       )
                                                                                              

    a   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
    b   The ADIs 'not specified' for calcium, potassium, and sodium salts of oleic acid 
        established at the thirty-third meeting of the Committee (Annex 1, reference 83) 
        were maintained.
    c   The evaluation of this substance was deferred, pending review of a 90-day study 
        of toxicity that was not available at the meeting.
    d   The group ADI of 0-0.5 mg/kg bw established at the twenty-third meeting (Annex 1, 
        reference 50) for citral, geranyl acetate, citronellol, linalool, and linalyl 
        acetate, expressed as citral, was maintained.
    e   The ADI of 0-1 mg/kg bw for (+)-carvone established at the thirty-seventh meeting 
        (Annex 1, reference 94) was maintained.
    f   The group ADI of 0-0.1 mg/kg bw for alpha-ionone and -ionone established at the 
        twenty-eighth meeting (Annex 1, reference 66) was maintained.
    g   An ADI of 0-4 mg/kg bw was established for menthol at the present meeting (see 
        section 1 of this Table). 
    
    B. Flavouring agents considered for specifications only

                                                                         

    Flavouring agent                         No.      Specificationsa
                                                                         

     Saturated aliphatic acyclic branched-chain primary alcohols, 
     aldehydes, and acidsb

    Isobutyl alcohol                         0251     R
    Isobutyraldehyde                         0252     N
    Isobutyric acid                          0253     N
    2-Methylbutyraldehyde                    0254     N
    2-Methylbutyric acid                     0255     N
    2-Ethylbutyraldehyde                     0256     N
    2-Ethylbutyric acid                      0257     N
    3-Methylbutyraldehyde                    0258     N
    Isovaleric acid                          0259     N
    2-Methylpentanal                         0260     N,T
    2-Methylvaleric acid                     0261     N
    3-Methylpentanoic acid                   0262     N
    3-Methyl-1-pentanol                      0263     N
    4-Methylpentanoic acid                   0264     N
    2-Methylhexanoic acid                    0265     N
    5-Methylhexanoic acid                    0266     N
    2-Ethyl-1-hexanol                        0267     N
    3,5,5-Trimethyl-1-hexanol                0268     N
    3,5,5-Trimethylhexanal                   0269     N
    2-Methyloctanal                          0270     N
    4-Methyloctanoic acid                    0271     N,T
    3,7-Dimethyl-1-octanol                   0272     N
    2,6-Dimethyloctanal                      0273     N
    4-Methylnonanoic acid                    0274     N
    2-Methylundecanal                        0275     N


     Aliphatic lactonesb

    4-Hydroxybutyric acid lactone            0219     N
      (gamma-butyrolactone)
    gamma-Valerolactone                      0220     N
    4-Hydroxy-3-pentenoic acid lactone       0221     N
    5-Ethyl-3-hydroxy-4-methyl-2(5H)-        0222     N
      furanone
    gamma-Hexalactone                        0223     N
    delta-Hexalactone                        0224     N
    gamma-Heptalactone                       0225     N
    gamma-Octalactone                        0226     N
    4,4-Dibutyl-gamma-butyrolactone          0227     N
    delta-Octalactone                        0228     N
    gamma-Nonalactone                        0229     R
    Hydroxynonanoic acid, delta-lactone      0230     N

                                                                         

    Flavouring agent                         No.      Specificationsa
                                                                         

    gamma-Decalactone                        0231     N
    delta-Decalactone                        0232     N
    gamma-Undecalactone                      0233     R
    5-Hydroxyundecanoic acid lactone         0234     N
    gamma-Dodecalactone                      0235     N
    delta-Dodecalactone                      0236     N
    6-Hydroxy-3,7-dimethyloctanoic acid      0237     N
      lactone
    delta-Tetradecalactone                   0238     N
    omega-Pentadecalactone                   0239     N,T
    omega-6-Hexadecenlactone                 0240     N
    epsilon-Decalactone                      0241     N,T
    epsilon-Dodecalactone                    0242     N
    4,5-Dimethyl-3-hydroxy-2,5-              0243     N
      dihydrofuran-2-one
    3-Heptyldihydro-5-methyl-2(3H)-furanone  0244     N
    5-Hydroxy-2,4-decadienoic acid           0245     N
      delta-lactone
    5-Hydroxy-2-decenoic acid delta-lactone  0246     N
    5-Hydroxy-7-decenoic acid delta-lactone  0247     N,T
    5-Hydroxy-8-undecenoic acid              0248     N,T
      delta-lactone
    cis-4-Hydroxy(1,4-dodecenoic acid        0249     N,T
      lactone (1,4-dodec-6-enolactone)
    gamma-Methyldecalactone                  0250     N
    Mixture of 5-hydroxy-2-decenoic acid     0276     O
      delta-lactone, 5-hydroxy-2-dodecenoic 
      acid delta-lactone, and 
      5-hydroxy-2-tetradecenoic acid 
      delta-lactone
    4-Hydroxy-3-methyloctanoic acid          0437     N
      gamma-lactone
    5-Hydroxy-2-dodecenoic acid              0438     N
      delta-lactone
                                                                         

    a   N, new specifications prepared; O, no specifications prepared; 
        R, existing specifications revised; T, the existing, new, or revised 
        specifications are tentative and comments are invited
    b   These substances were evaluated at the forty-ninth meeting of JECFA 
        in June 1997.


    3.  Food additives considered for specifications only

                                                                     

    Food additive                            Specificationsa
                                                                     

    Acetone (extraction solvent)             R
    Aluminium powder                         R
    Calcium propionate                       S
    Calcium sorbate                          R
    Canthaxanthin                            R
    Carnauba wax                             R
    Carob bean gum                           R
    Carotenes (algal)                        R
    Caretenes (vegetal)                      R
    Carthamus red                            R
    Carthamus yellow                         R
    Citric acid                              R,T
    Cochineal extract                        R
    Diacetyltartaric and fatty acid          R
      esters of glycerol
    Dichloromethane                          R
    Ethyl-para-hydroxybenzoate               R
    Ferrous gluconate                        R,T
    Ferrous sulfate                          R,T
    Furfuryl alcohol (flavouring agent)      N
    Guar gum                                 R
    Gum arabic                               R
    Hexane                                   R
    4-Hexylresorcinol                        R
    Isobutyl alcohol (extraction solvent)    R
    Methyl-para-hydroxybenzoate              R
    Microcrystalline cellulose               R
    Nitrogen                                 R
    Petroleum jelly                          R
    Polydextroses                            R
    Potassium sorbate                        R
    Propan-2-ol                              R
    Propionic acid                           R
    Propyl-para-hydroxybenzoate              R
    Shellac                                  R
    Sodium sorbate                           O
    Sorbitan monolaurate                     R
    Sucrose esters of fatty acids            R
    Talc                                     R
    Tartaric, acetic, and fatty acid         W
      esters of glycerol, mixed
    Thaumatin                                R,T
    Xanthan gum                              R
                                                                     

    a   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 withdrawn


        4.  Food additives considered for evaluation of national intake assessments

                                                                                                                                           

    Substance                  Conclusions                                                        Recommendations to CCFAC
                                                                                                                                           

    Benzoates                  Intake estimates based on GSFAa levels and range of foods          Review draft GSFA additive levels for:
                               in which use is allowed, integrated with national data on food       Category 1.6.2 Ripened cheese
                               consumption exceed the ADI of 0-5 mg/kg bw for mean                  Category 1.6.4 Processed cheese
                               consumers in the three countriesb that submitted such data.          Category 1.6.5 Cheese analogues
                               In data submitted by nine countriesb, the estimated mean             Category 4.2.2.3 Vegetables in 
                               intake of consumers did not exceed the ADI.                            vinegar or brine
                               High consumers may exceed the ADI, but the available data            Category 9.2.4.2 Crangon crangon 
                               were insufficient to estimate the number of high consumers or          and Crangon vulgaris
                               the magnitude or duration of intake at levels above the ADI.         Category 9.3 Fish products, 
                                                                                                      semi-preserved
                                                                                                    Category 10.2.1 Liquid eggs
                                                                                                    Category 14.1.4.1 Carbonated 
                                                                                                      water-based soft drinks

    Butylated hydroxyanisole   Intake estimates based on GSFAa levels and range of foods          Review draft GSFA additive levels for:
                               in which use is allowed, integrated with national data on food       Category  2 Edible fats and oils
                               consumption, exceed the ADI of 0-0.5 mg/kg bw for mean               Category  4.2.2.2 Dried vegetables
                               consumers in the three countriesb that submitted such data.          Category  4.1.3 Cocoa products
                               In data submitted by 10 countriesb, the estimated mean               Category  8.3.1 Processed 
                               intake of consumers did not exceed the ADI.                            comminuted meat
                               High consumers may exceed the ADI, but the available data            Category  9.2.1 Frozen fish, fillets, and
                               were insufficient to estimate the number of high consumers or          products
                               the magnitude or duration of intake at levels above the ADI.         Category  12.5.1 Ready-to-eat soup 
                                                                                                      and broths
                                                                                                    Category 13.6 Food supplements

    Butylated hydroxytoluene   Intake estimates based on GSFAa levels and range of foods          Review draft GSFA additive levels for:
                               in which use is allowed, integrated with national data on food       Category 2 Edible fats and oils
                               consumption exceed the ADI of 0-0.3 mg/kg bw for mean                Category  5.3 Chewing gum
                               consumers in the three countriesb that submitted such data.          Category 9.2 Fish and fish products
                               In data submitted by 10 countriesb, the estimated mean and
                               high intake of consumers did not exceed the ADI.

                                                                                                                                           

    Substance                  Conclusions                                                        Recommendations to CCFAC
                                                                                                                                           

    Sulfites                   Intake estimates based on GSFAa levels and range of foods          Review draft GSFA additive levels for:
                               in which use is allowed, integrated with national data on food       Category 4.1.2.2 Dried fruits
                               consumption exceed the ADI of 0-0.7 mg/kg bw for mean                Category 4.1.2.5 Jams, jellies, and 
                               consumers in the three countriesb that submitted such data.            marmelades
                               In data submitted by 10 countriesb, the estimated mean               Category 4.1.2.8 Fruit preparations, 
                               intake of consumers did not exceed the ADI.                            including pulp and fruit toppings
                               High consumers may exceed the ADI, but the available data            Category  4.2.2.2 Dried vegetables
                               were insufficient to estimate the number of high consumers or        Category 4.2.2.5 Vegetable, nut, and 
                               the magnitude or duration of intake at levels above the ADI.           seed purees and spreads
                                                                                                    Category 11.1 White and semi-white 
                                                                                                      sugar
                                                                                                    Category 14.1.2.3 Concentrates for 
                                                                                                      fruit juice
                                                                                                    Categories 14.2.3 and 14.2.4 Wines, 
                                                                                                      fruit wines

    tert-Butylhydroquinone     Intake estimates based on GSFAa levels and range of foods          Review draft GSFA additive levels for:
                               in which use is allowed, integrated with national data on food       Category  2 Edible fats and oils
                               consumption exceed the ADI of 0-0.7 mg/kg bw for mean                Category 9.2 Fish and fish products
                               consumers in the three countriesb that submitted such data.          Category 14.1.4.1 Carbonated 
                               In data submitted by six countriesb, the estimated mean                water-based soft drinks
                               intake of consumers did not exceed the ADI.
                               High consumers may exceed the ADI, but the available data
                               were insufficient to estimate the number of high consumers or
                               the magnitude or duration of intake at levels above the ADI.
                                                                                                                                           

    CCFAC, Codex Committee on Food Additives and Contaminants; GSFA, General Standard on Food Additives
    a  Intake estimates derived on the basis of GSFA additive levels integrated with national food consumption data result in gross overestimates
       of actual intake in any one country because the GSFA levels are generally compiled by adopting the highest level of use for any one food
       category submitted by member states or non-governmental organizations. The range of food uses specified in the GSFA is also usually much 
       wider than in national standards.
    b  Eleven countries made submissions: Australia, Brazil, China, Finland, France, India, Japan, New Zealand, Spain, the United Kingdom, and 
       the United States (two countries, Australia and New Zealand, made a joint submission).
        





















    See Also:
       Toxicological Abbreviations