ANNEX 4
ACCEPTABLE DAILY INTAKES, OTHER TOXICOLOGICAL INFORMATION, AND INFORMATION ON SPECIFICATIONS
Acceptable Daily Intake (ADI) and other toxicological recommendations
Substance Specifications1 Acceptable Daily Intake
Antioxidants
Dodecyl gallate R 0-0.05 mg/kg bw (temporary)2
Octyl gallate R 0-0.1 mg/kg bw (temporary)2
Propyl gallate R 0-1.4 mg/kg bw
Flavouring agents
Benzyl acetate S 0-5 mg/kg bw (group ADI)2,3
2-Ethyl-1-hexanol N 0-0.5 mg/kg bw
d-Limonene R Not specified4
alpha-Methylbenzyl alcohol N 0-0.1 mg/kg bw
Quinine hydrochloride R } Current use levels of up to 100 mg/l
Quinine sulfate R } (as quinine base) in soft drinks not of toxicological concern
Flavour enhancers
Disodium-5'-guanylate R } Not specified4
Disodium-5'-inosinate R }
Food colours
Carotenes (algal) R No ADI allocated because of inadequate data
Carotenes (vegetable) R Acceptable, provided the level of use does not exceed the level
normally found in vegetables
Sweetening agents
Maltitol S } Not specified4
Maltitol syrup R }
Saccharin S 0-5 mg/kg bw
Substance Specifications1 Acceptable Daily Intake
Thickening agents
Konjac flour N,T2 Not specified (temporary)2,4
Processed Eucheuma seaweed R 0-20 mg/kg bw (temporary)2
Propylene glycol alginate R,T2 0-70 mg/kg bw
Miscellaneous substances
ß-Cyclodextrin N,T2 0-6 mg/kg bw (temporary)2
Sodium iron EDTA N,T2 Provisionally considered to be safe in food
fortification programmes5
Sucrose acetate isobutyrate R 0-10 mg/kg bw (temporary)2
Urea N Use at levels of up to 3% in chewing gum not of
toxicological concern
Contaminant Provisional Tolerable Weekly Intake (PTWI)
Cadmium 7 µg per kg of body weight
Chloropropanols Levels in hydrolyzed vegetable proteins should
(3-chloro-1,2-propanediol and be reduced as far as technologically possible
1,3-dichloro-2-propanol)
Lead 25 µg/kg bw
Substances considered for specifications only
Substance Specifications1
Alginic acid R
Ammonium alginate R
Ammonium polyphosphate R
alpha-Amylase from Bacillus stearothermophilus R
alpha-Amylase from Bacillus subtilis R
alpha-Amylase and glucoamylase from Aspergillus oryzae R,T2
Calcium alginate R
Carmines R
Cochineal extract (formerly cochineal and carminic acid) R
Disodium pyrophosphate R
Erythrosine R
Ethyl hydroxyethyl cellulose S,T2
ß-Glucanase from Aspergillus niger, var. R
Hexane S,T2
Lecithin R
Lecithin, partially hydrolyzed S
2-Nitropropane S,T2
Oxystearin S,T2
Petroleum jelly S,T2
Potassium alginate R
Sodium alginate R
Sucralose (formerly trichlorogalactosucrose) R
Tetrasodium pyrophosphate R
Trichloroethylene S,T2
Xanthan gum R
Notes to Annex 4
1. N, new specifications were 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. Details of further toxicological studies and other information required for
certain substances are given in Annex 3 to the Report of the 41st meeting of
JECFA (WHO Technical Report Series, in preparation).
3. Group ADI with benzyl alcohol, benzaldehyde, benzoic acid, and benzoate salts.
4. 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 was not deemed necessary.
5. The Committee provisionally concluded that sodium iron EDTA
(ethylenediaminetetraacetate) meeting the tentative specifications prepared at
the meeting does not present a safety problem when used in supervised food
fortification programmes in iron deficient populations.
See Also: Toxicological Abbreviations