ANNEX 4
Acceptable Daily Intakes,
other toxicological information,
and information on specifications
Food additives Specifications1 Acceptable Daily
Intake (ADI) and
other toxicological
recommendations
Antioxidants
Butylated hydroxytoluene (BHT) R 0-0.125 mg/kg bw2
tert-Butyl hydroquinone (TBHQ) R 0-0.2 mg/kg bw2
Erythorbic acid and its
sodium salt3 R4 ADI not specified5
Enzyme preparations
alpha-Amylase from Bacillus
stearothermophilus N ADI not specified5
alpha-Amylase from Bacillus
subtilis N ADI not specified5
alpha-Amylase from Bacillus
stearothermophilus
expressed in Bacillus
subtilis N,T ADI not specified5
alpha-Amylase from Bacillus
megaterium expressed in
Bacillus subtilis N,T ADI not specified5
Chymosin A produced from
Escherichia coli K-12 containing
calf prochymosin A gene N,T ADI not specified5
Chymosin B produced from
Aspergillus niger var.
awamori containing calf
prochymosin B gene N,T ADI not specified5
Chymosin B produced from
Kluyveromyces lactis
containing calf
prochymosin B gene N,T ADI not specified5
ANNEX 4 (contd)
Food additives Specifications1 Acceptable Daily
Intake (ADI) and
other toxicological
recommendations
Flavouring agents
Allyl heptanoate N,T 0-0.15 mg/kg bw6
Allyl hexanoate R,T 0-0.13 mg/kg bw6
Allyl isovalerate N,T 0-0.12 mg/kg bw6
trans-Anethole S 0-0.6 mg/kg bw2
(+)-Carvone R 0-1 mg/kg bw
(-)-Carvone R No ADI allocated17
Food colour
Erythrosine R 0-0.1 mg/kg bw
Sweetening agents
Acesulfame potassium S 0-15 mg/kg bw
Trichlorogalactosucrose R 0-15 mg/kg bw
Miscellaneous food additives
Dimethyldicarbonate N Acceptable8
Dioctyl sodium sulfosuccinate R 0-0.25 mg/kg bw2
Gellan gum N ADI not specified5,9
Mineral oil (food grade) R ADI not specified2,5
Contaminant Provisional Tolerable
Weekly Intake (PTWI)
Benzo[a]pyrene PTWI not established10
Ochratoxin A 112 ng/kg bw
ANNEX 4 (contd)
Food additives Specifications only1
Activated carbon R
Citrus red no. 2 W
Diethyl ether R,T
Disodium pyrophosphate R
Glycerol esters of wood rosin R
Lecithin R
Lecithin, partially hydrolyzed R
Mixed carotenoids R,T
Polydimethylsiloxane R
Sucrose acetate isobutyrate R
Tetrasodium pyrophosphate R
Vegetable carbon R11
Xanthan gum R
Notes to Annex 4
1. N, new specifications 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, existing
specifications were withdrawn.
2. Temporary acceptance.
3. This substance was on the agenda under the name "isoascorbic
acid".
4. Existing specifications were revised for erythorbic acid only;
specifications for the sodium salt were not reviewed.
5. 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 that will be stated in the individual
evaluations, the establishment of an ADI expressed in numerical
form is not deemed necessary.
6. The listed values correspond to an allyl alcohol equivalent of
0.05 mg/kg bw, which is the group ADI for the listed allyl
esters. They may be used alone or in pro rata combinations
in such a way that the intake of allyl alcohol does not exceed
this value.
7. The previous temporary ADI was not extended.
8. Acceptable for use as a cold sterilization agent in beverages
when used according to Good Manufacturing Practice up to a
maximum of 250 mg/l.
9. The potential laxative effect of gellan gum at high intakes
should be taken into account when it is used as a food
additive.
10. Insufficient information available to establish a PTWI.
11. Supersedes the earlier tentative specifications for carbon
black published in FAO Food and Nutrition Paper No. 38 (1988).
See Also:
Toxicological Abbreviations