ANNEX 4 ACCEPTABLE DAILY INTAKES, OTHER TOXICOLOGICAL RECOMMENDATIONS, AND INFORMATION ON SPECIFICATIONS ADI for man and other Specifications1 toxicological recommendations A. Food additives Antioxidants Butylated hydroxyanisole (BHA) R 0-0.3 mg/kg b.w.2 Butylated hydroxytoluene (BHT) R 0-0.125 mg/kg b.w.2 Dodecyl gallate R No ADI allocated3 Octyl gallate R No ADI allocated3 Propyl gallate R 0-2.5 mg/kg b.w. Tertiary butylhydroquinone (TBHQ) R 0-0.2 mg/kg b.w.2 Tocopherol, dl-alpha- R ) ) 0.15-2 mg/kg b.w.4,5 Tocopherol, d-alpha-concentrate N ) Flavouring agents d-Carvone R ) ) 0-1.0 mg/kg b.w.2,3 l-Carvone R ) Food colours Brown FK R No ADI allocated3 Curcumin R 0-0.1 mg/kg b.w.2 Erythrosine R 0-0.6 mg/kg b.w.2 ADI for man and other Specifications1 toxicological recommendations Fast Green FCF R 0-25 mg/kg b.w. Lithol rubine BK R No ADI allocated3 Turmeric oleoresin O 0-0.3 mg/kg b.w.2 Sweetening agents Mannitol R ADI "not specified"6 Thickening agents Ethylhydroxyethyl cellulose S 0-25 mg/kg b.w.7 Karaya gum S 0-20 mg/kg b.w.2 Processed Euchuema seaweed N,T No ADI allocated3 Tara gum R ADI "not specified"6 Xanthan gum R ADI "not specified"6 Miscellaneous food additives Glucono-delta-lactone R ADI "not specified"6 Hydrocarbon waxes N,T8 No ADI allocated3 Mineral oil R,T ADI "not specified"2,6 Petroleum jelly N,T No ADI allocated3 Polyvinylpyrrolidone (PVP) R 0-50 mg/kg b.w. Sodium aluminium phosphate, acidic S 0-0.6 mg/kg b.w.5,9 Sodium aluminium phosphate, basic S ADI for man and other Specifications1 toxicological recommendations Sulfur dioxide and sulfites R,T10 0-0.7 mg/kg b.w. Talc R,T ADI "not specified"6 B. Contaminants Lead (children and infants) - 25 µg/kg b.w.11 Specifications only1 Blackcurrant extract N,T Calcium disodium ethylenediaminetetraacetate R Carob bean gum R,T Citric and fatty acid esters of glycerol R,T Heptanes R Lecithin R,T Lecithin, partially hydrolysed N,T Potassium malate solutions, DL- W Sodium dihydrogen citrate R Sodium fumarate R Sodium malate, DL- R Tocopherol concentrate, mixed N Turmeric colour N,T Notes to Annex 4 1. N, new specifications prepared; O, 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new or revised specifications are tentative and comments are invited; and W, previously established specifications withdrawn. 2. Temporary acceptance. 3. Insufficient information available to establish an ADI. 4. The lower value represents the daily dietary allowance recommended by the US National Academy of Sciences/National Research Council. The upper value represents the maximum value for the ADI. 5. ADI applies to the two listed compounds, alone or in combination. 6. 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. 7. Group ADI for modified celluloses. 8. New tentative specifications for paraffin wax were prepared. 9. Group temporary ADI for aluminium salts expressed as aluminium. 10. Revised tentative specifications for sulfur dioxide were prepared. 11. Provisional tolerable weekly intake (PTWI).
See Also: Toxicological Abbreviations