ANNEX 4
ACCEPTABLE DAILY INTAKES, OTHER TOXICOLOGICAL
RECOMMENDATIONS, AND INFORMATION ON SPECIFICATIONS
ADI for man and other
Substance Specifications1 toxicological
recommendations
A. Food additives
Enzyme preparations
alpha-Amylase from A. oryzae N,T Acceptable2
Protease from A. oryzae R,T Acceptable2
Amyloglucosidases from A. niger N,T 0-1 mg/kg b.w.3
beta-Glucanase from A. niger N,T 0-1 mg/kg b.w.3
hemi-Cellulase from A. niger N,T 0-1 mg/kg b.w.3
Pectinases from A. niger N,T 0-1 mg/kg b.w.3
Protease from A. niger O 0-1 mg/kg b.w.3
beta-Glucanase from T. harzianum N,T 0-0.5 mg/kg b.w.3,4
Cellulase from T. reesei N,T 0-0.3 mg/kg b.w.3,4
Cellulase from P. funiculosum N,T No ADI allocated3
Pectinase from A. alliaceus O No ADI allocated3
Flavouring agents
trans-Anethole S 0-2.5 mg/kg b.w.4
Benzyl acetate S 0-5 mg/kg b.w.4
Smoke flavourings N,T Provisional acceptance6
Food colours
Beet red R ADI "not specified"7
Canthaxanthin R 0-0.05 mg/kg b.w.4
Carbon black R,T No ADI allocated5,8
Carotenes (algae) N,T9 No ADI allocated5
Carotenes (vegetable) N,T9 No ADI allocated5
Citranaxanthin R No ADI allocated5
Xanthophylls (mixed carotenoids) N,T10 No ADI allocated5
Xanthophylls (Tagetes extract) N,T10 No ADI allocated5
ACCEPTABLE DAILY INTAKES, OTHER TOXICOLOGICAL
RECOMMENDATIONS, AND INFORMATION ON SPECIFICATIONS (cont'd)
ADI for man and other
Substance Specifications1 toxicological
recommendations
Miscellaneous food additives
Ferrous gluconate S 0.8 mg/kg b.w.11
Glutamic acid and its salts R ADI "not specified"7,12
4-Hydroxymethyl-2,6-ditert-
butylphenol W No ADI allocated5
Polydextroses S ADI "not specified"7
Tannic acid R,T ADI "not
specified"4,7,13
B. Contaminants
Aflatoxins - Lowest practicable
level14
Specifications only1
Activated carbon R
alpha-Amylase and glucoamylase from A. oryzae R,T
beta-Carotene, synthetic R
Brilliant black BN S
Caramel colours R
Carthamus yellow R
Chlorophylls R
Chlorophylls, copper complexes R
Chlorophyllins, copper complexes, sodium and
potassium salts R
Hydrogenated glucose syrups R,T15
Insoluble polyvinylpyrrolidone S
Paprika oleoresin R
Patent blue V R
Polyethylene glycols R
Polyglycerol esters of fatty acids S
Ponceau 4R S
Potassium bromate R
Potassium dihydrogen citrate R
Riboflavin R
Riboflavin 5'-phosphate, sodium R
Sucrose esters of fatty acids S
Talc S
Triammonium citrate S
Xylitol R,T
Notes to Annex 4
1. N, new specifications prepared; 0, 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. Acceptable for use in food processing. These enzymes are derived
from microorganisms that are traditionally accepted as
constituents of foods or are normally used in the preparation of
foods. These products are regarded as foods and, consequently,
considered acceptable, provided that satisfactory chemical and
microbiological specifications can be established.
3. Based on the percentage of T.O.S. (total organic solids); %
T.O.S. = 100 - (A + W + D), where A = % ash, W = % water, and
D = % diluent and carrier.
4. Temporary acceptance.
5. Insufficient information available on its toxicology and/or
chemical composition to establish an ADI.
6. Analytical and compositional data, including data on variability,
are required; further safety studies on a well-defined spectrum
of smoke flavourings are desired. Benzo(a)pyrene should not
exceed 10 µg per kg.
7. 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.
8. The use of carbon black from hydrocarbon sources in food contact
materials is provisionally accepted.
9. The previous specifications for carotenes (natural) were
withdrawn.
10. The previous specifications for xanthophylls were withdrawn.
11. Provisional maximum tolerable daily intake (PMTDI) for iron.
12. Group ADI for L-glutamic acid and its ammonium, calcium,
magnesium, monosodium, and potassium salts.
13. For use as a processing aid.
14. Presence in food should be reduced to irreducible levels. An
irreducible level is defined as that concentration of a substance
that cannot be eliminated from a food without involving the
discarding of that food altogether, severely compromising the
ultimate availability of major food supplies.
15. This specification also covers dry, food grade maltitol, which is
the substance listed on the agenda of this meeting.