ANNEX 4
Acceptable Daily Intakes, other toxicological information, and
information on specifications
Acceptable Daily Intake (ADI)
in mg per kg of body weight and
Substance Specificationsa other toxicological
recommendations
Antioxidants
Butylated hydroxytoluene (BHT) S 0-0.3
tert-Butylhydroquinone (TBHQ) R 0-0.2 (temporary)b
Carrier solvent
Diethylene glycol monoethyl ether S No ADI allocatedc
Colour stabilizer
4-Hexylresorcinol N Treatment of crustaceans is not of
toxicological concernd
Emulsifiers
Dioctyl sodium sulfosuccinate S 0-0.1
Glycerol ester of wood rosin R No ADI allocatede
Sucrose esters of fatty acids and S 0-20 (temporary group ADI)b,f
sucroglycerides
Flavouring agent
Ethyl vanillin S 0-3
Food colours
Canthaxanthin R 0-0.03
Curcumin S 0-1 (temporary)b
Glazing agents
Microcrystalline waxg R 0-20 (group ADI)h
Mineral oil (revised and divided
into two Groups):
Mineral oil (high viscosity)i R 0-20
Mineral oil (medium and low R
viscosity)
Class Ij 0-1 (temporary)b
Class IIk and Class IIIl 0-0.01 (temporary group ADI)b
Paraffin waxm W ADI withdrawnn
Sweetening agent
Alitame N No ADI allocatedo
Acceptable Daily Intakes, other toxicological information, and
information on specifications (cont'd)
Acceptable Daily Intake (ADI)
in mg per kg of body weight and
Substance Specificationsa other toxicological
recommendations
Thickening agent
Processed Eucheuma seaweed R 0-20 (temporary)b
Miscellaneous substances
ß-Cyclodextrin R 0-5
Nitrate Rp 0-3.7 (expressed as nitrate ion)q
Nitrite Rr 0-0.06 (expressed as nitrite ion)s
Potassium bromate R Use as a flour-treatment agent is
not appropriate
Contaminant Tolerable Intake in µg per kg of body weight
Ochratoxin A PTWI (Provisional Tolerable Weekly Intake): 0.1
Patulin PMTDI (Provisional Maximum Tolerable Daily Intake): 0.4
Notes
aN, new specifications prepared; R, existing specifications
revised; S, specifications exist, revision not considered or not
required; and W, existing specifications were withdrawn.
bFurther work is required (see WHO Technical Report Series,
No. 859).
cAdequate long-term feeding studies were not available. In view of
significant potential intake of this substance, an ADI could not be
allocated.
dTreatment of crustaceans at concentrations up to 50 mg per liter,
resulting in a residual level of approximately 1 mg per kg in the
edible portion, is not of toxicological concern.
eBecause of a lack of adequate long-term toxicity/carcinogenicity
and reproductive toxicity studies with glycerol esters of wood rosin,
an ADI could not be allocated. At a minimum, studies demonstrating the
metabolic stability and non-bioavailability of glycerol esters of wood
rosin under conditions resembling those in the human gastrointestinal
tract would be required to permit further evaluation of this material.
fTemporary group ADI for the sucrose ester content of sucrose esters
of fatty acids and sucroglycerides.
gIncluding HMPW (high-melting-point wax) and HSW (high-sulfur wax.).
hSince both waxes fall within the same specifications, a group ADI
was allocated to HMPW and HSW.
iIncluding P100(H) oil.
jIncluding P70(H) oil.
kIncluding N70(H) and N70(A) oils.
lIncluding P15(H), N15(H) and N10(A) oils.
mIncluding LMPW (low melting point wax) and IMPW (intermediate-
melting-point wax).
nThe previous ADI "not specified" for paraffin wax was withdrawn,
because toxicological effects were observed at all dose levels.
oAn ADI could not be allocated because of deficiencies in the
carcinogenicity studies in rats.
Notes contd.
pThe specifications were revised for both potassium nitrate and
sodium nitrate.
qBecause nitrate may be converted into nitrite in significant
amounts and infants below the age of 3 months are more vulnerable to
the toxicity of nitrite than adults, the ADI does not apply to such
infants. The Committee was aware that vegetables are an important
potential source of intake of nitrate. However, in the light of the
well-known benefits of vegetables and the lack of data on the possible
effects of vegetable matrices: on the bioavailability of nitrate, the
Committee considered it inappropriate to compare exposure to nitrate
from vegetables directly with the ADI and hence to derive limits for
nitrate in vegetables directly from it.
rThe specifications were revised for both potassium nitrite and
sodium nitrite.
sThe ADI applies to all sources of intake. Nitrite should not be used
as an additive in food for infants below the age of 3 months. The ADI
does not apply to such infants.