ANNEX 4
ACCEPTABLE DAILY INTAKES,
OTHER TOXICOLOGICAL INFORMATION,
AND INFORMATION ON SPECIFICATIONS
Substance Specifications1 Acceptable daily intake
(ADI)in mg/kg body
weight and other
toxicological
recommendations
Emulsifiers
Sucrose esters of fatty acids
and sucroglycerides S 0-16 (group ADI)2
Thermally oxidized soya
bean oil N 0-3
Thermally oxidized soya bean
oil interacted with mono-
and diglycerides of
fatty acids R 0-30
Enzyme preparations
Cellulase from Trichoderma
longibrachiatum R Not specified3
ß-Glucanase from Trichoderma
harzianum R Not specified3
Lysozyme N Acceptable for use in
food processing4
Flavouring substances
trans-Anethole S 0-0.6 (temporary)
Ethyl vanillin R 0-5 (temporary)
Limonene N 0-1.55
Quinine hydrochloride R Current use levels up to
Quinine sulfate S 75 mg/l (as quinine
base) in soft drinks
not of toxicological
concern
Solvents
1,2-Dichloroethane None ADI not allocated
because of evidence of
genotoxicity
and carcinogenicity
Substance Specifications1 Acceptable daily intake
(ADI)in mg/kg body
weight and other
toxicological
recommendations
Dichloromethane R,T Should be limited to
current uses6
Diethylene glycol monoethyl R ADI not allocated
ether because of inadequate
data
Thickening agents
Alginic acid and its ammonium, R Not specified (group
calcium, potassium, and ADI)3
sodium salts
Processed Eucheuma seaweed R,T ADI not allocated
because of inadequate
data
Waxes
Beeswax N Present uses not of
toxicological concern7
Candelilla wax N Present uses not of
toxicological concern8
Carnauba wax N 0-7
Microcrystalline wax N Not specified (group
ADI)9
Paraffin wax R Not specified (group
ADI)9
Shellac N,T Present uses not of
toxicological concern10
Miscellaneous substances
Curcumin R 0-0.1 (temporary)
Furfural R,T ADI not allocated
because of evidence of
genotoxicity
and carcinogenicity11
Substance Specifications1 Acceptable daily intake
(ADI)in mg/kg body
weight and other
toxicological
recommendations
Potassium bromate R,T Not appropriate for use
as a flour-treatment
agent
Naturally-occurring toxicants
Cyanogenic glycosides Safe level of intake
could not be estimated
because of a lack of
quantitative data
Solanine and chaconine Normal levels in
potatoes (20-100 mg
of potatoes) not of
toxicological concern
Substance (considered for specifications only) Specifications1
Aluminium powder R,T
Anoxomer S,T
Calcium stearoyl lactate R
Carbon dioxide S,T
Carob bean gum R
Carotenes (algae) R
Carotenes (vegetable) R
Carthamus red R,T
Dammar gum R
Ethyl hydroxyethyl cellulose S,T
Isomalt R
Lactitol S,T
Mixed carotenoids S,T
Nitrogen R
Pectins R
Sodium stearoyl lactylate R
Sorbitan monolaurate R,T
Sorbitan tristearate R
Sulfur dioxide S,T
Talc R,T
Tannic acid R
Titanium dioxide R
Notes to Annex 4
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. Based on sucrose esters contained in sucrose esters of fatty acids
and sucroglycerides.
3. 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.
4. This enzyme is derived from edible animal tissue commonly used as food;
it may therefore be regarded as food.
5. Applies to total intake of limonene. Food additive intake should not
exceed 0.075 mg/kg of body weight/day, which represents 5% of the maximum
ADI.
6. Should be limited to use as an extraction solvent for spice oleoresins
and the decaffeination of coffee and tea and for food additives in which
previous specifications drawn up by the Committee included residues of
dichloromethane.
7. Beeswax is used as a release and glazing agent in bakery products, a
glazing agent on fresh and frozen fruit, a glazing agent on candy, a
carrier for flavours, and a component of chewing-gum bases.
8. Candelilla wax is used as a glazing agent, a component of chewing gum
base, a surface-finishing agent, and a carrier for flavouring substances.
9. Group ADI for microcrystalline and paraffin waxes for uses listed in the
specifications (chewing-gum base, protective coating, defoaming agent,
and surface-finishing agent).
10. Shellac is used as a coating, glazing, and surface-finishing agent
externally applied to food.
11. The direct addition of furfural to food as a flavouring substance is not
appropriate and its use as a solvent should be restricted to situations
in which alternatives are not available, e.g. for the purification of
food oil by extraction of unsaturated components.
See Also: Toxicological Abbreviations