ANNEX 4
ACCEPTABLE DAILY INTAKES, OTHER TOXICOLOGICAL INFORMATION, AND
INFORMATION ON SPECIFICATIONS
Substance Specifications1 Acceptable Daily
Intake (ADI) and
other toxicological
recommendations
Emulsifiers
Polyglycerol esters of
fatty acids S 0-25 mg/kg body weight2
Sucrose esters of
fatty acids R 0-10 mg/kg body weight3
Sucroglycerides S 0-10 mg/kg body weight3
Enzyme preparations
Enzymes derived from
Aspergillus niger S ADI not specified4
Flavouring agents
Benzyl acetate S 0-5 mg/kg body weight5
Cinnamaldehyde S No ADI allocated6
Dihydrocoumarin N,T No ADI allocated
Ethyl vanillin R 0-5 mg/kg body weight5
Fumaric acid R ADI not specified7
Quinine R 0-0.9 mg/kg body weight5
Substance Specifications1 Acceptable Daily
Intake (ADI) and
other toxicological
recommendations
Food colours
Canthaxanthin S No ADI allocated8
Carotene preparations
from natural sources R,T8 No ADI allocated10
Curcumin S 0-0.1 mg/kg body weight5
Paprika oleoresin R No ADI allocated11
Tumeric oleoresin R No ADI allocated8
Thickening agents
Gum Arabic R ADI not specified
Modified celluloses S ADI not specified12
Miscellaneous food additives
Ferrous lactate N [0.8 mg/kg body weight13]
2-Nitropropane R,T No ADI allocated14
Tannic acid R,T ADI not specified15
Lactoperoxidase/thiocyanate/
hydrogen peroxide milk
preservation system 16 Acceptable17
Contaminants
Patulin [7 µg/kg body weight]18
Polychlorinated biphenyls
(PCBs) PTWI not established19
Specifications only
Carob bean gum R
Citric and fatty acid esters
of glycerol R
Iron oxides used as food
colours R
Modified starches R
Notes
1. N, new specifications 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. Applies to polyglycerol esters of fatty acids having an average
chain length of up to 3 glycerol units.
3. Group ADI for sucrose esters of fatty acids and sucroglycerides.
4. See p. 76 for definition of "ADI not specified".
5. Temporary acceptance.
6. The previous temporary ADI was not extended.
7. Group ADI for fumaric acid and its salts.
8. The previous temporary ADI was not extended.
9. Specifications apply to carotenes from both algae and vegetable
sources.
10. Insufficient information available on its toxicology and/or
chemical composition to establish an ADI.
11. Self-limiting as a spice extract.
12. Group ADI for ethyl cellulose, ethyl hydroxyethyl cellulose,
hydroxypropyl cellulose, hydroxypropyl methyl cellulose, methyl
cellulose, methyl ethyl cellulose, and sodium carboxymethyl
cellulose. The ability of modified celluloses to produce
laxative effects should be taken into account when using them as
food additives.
13. Provisional maximum tolerable daily intake (PMTDI) for iron from
all sources.
14. The previous temporary acceptance of 2-nitropropane as a
fractionating
solvent in the production of fats and oils was not extended.
15. For use as a filtering aid where the application of good
manufacturing practice ensures that it is removed from food after
use.
16. Existing specifications for sodium thiocyanate were maintained.
New specifications for sodium percarbonate were prepared.
17. When used according to the draft guidelines produced by the Joint
FAO/WHO Committee of Government Experts on the Code of Principles
concerning Milk and Milk Products, this system does not present
a toxicological hazard.
18. Provisional tolerable weekly intake (PTWI).
19. The Committee concluded that the no-effect level in studies with
monkeys was 40 µg/kg body weight per day. Because of the
limitations of the available data and the ill-defined nature of
the materials that were used in the feeding studies, it was
impossible to establish a precise numerical value for a tolerable
intake. In particular, the PCB mixtures that were used in the
studies with monkeys are not entirely the same as the PCB
mixtures to which humans are exposed in the diet. However, there
is no reason to believe that humans would be more sensitive than
monkeys to the effects of PCBs, and some indication of safe
exposure levels can provisionally be obtained from the no-effect
level in the studies with monkeys.
See Also:
Toxicological Abbreviations