ANNEX 4
Acceptable daily intakes, other toxicological information, and information on specifications
Substance Specifications Acceptable daily intake (ADI) in mg/kg of
body weight and other toxicological
recommendations
Antioxidants
Dodecyl gallate R No ADI allocateda
Octyl gallate R No ADI allocateda
Propyl gallate R 0-1.4
Emulsifier
Glycerol ester of wood R 0-25
rosin
Flavouring agents
Ethyl esters
Ethyl formate R No safety concern at current levels of intakeb
Ethyl acetate R No safety concern at current levels of intakeb
Ethyl propionate N No safety concern at current levels of intakeb
Ethyl butyrate R No safety concern at current levels of intakeb
Ethyl pentanoate N No safety concern at current levels of intakeb
Ethyl hexanoate N No safety concern at current levels of intakec
Ethyl heptanoate R No safety concern at current levels of intakeb
Ethyl octanoate N No safety concern at current levels of intakeb
Ethyl nonanoate R No safety concern at current levels of intakeb
Ethyl decanoate N No safety concern at current levels of intakeb
Ethyl undecanoate N,T No safety concern at current levels of intakeb
Ethyl dodecanoate R No safety concern at current levels of intakeb
Ethyl tetradecanoate N No safety concern at current levels of intakeb
Ethyl hexadecanoate N No safety concern at current levels of intakeb
Ethyl octadecanoate N,T No safety concern at current levels of intakeb
ANNEX 4 (Con't)
Substance Specifications Acceptable daily intake (ADI) in mg/kg of
body weight and other toxicological
recommendations
Isoamyl alcohol and isoamyl esters
Isoamyl alcohol N No safety concern at current levels of intakeb
Isoamyl formate N No safety concern at current levels of intakeb
Isoamyl acetate R No safety concern at current levels of intakec
Isoamyl propionate N No safety concern at current levels of intakeb
Isoamyl butyrate R No safety concern at current levels of intakeb
Isoamyl hexanoate N No safety concern at current levels of intakeb
Isoamyl octanoate N,T No safety concern at current levels of intakeb
Isoamyl nonanoate N,T No safety concern at current levels of intakeb
Isoamyl isobutyrate N No safety concern at current levels of intakeb
Isoamyl isovalerate N No safety concern at current levels of intakeb
Isoamyl 2-methylbutyrate N,T No safety concern at current levels of intakeb
Allyl esters
Allyl propionate N,T No safety concern at current levels of intaked
Allyl butyrate N No safety concern at current levels of intaked
Allyl hexanoate R No safety concern at current levels of intakee
Allyl heptanoate R No safety concern at current levels of intaked
Allyl octanoate N No safety concern at current levels of intaked
Allyl nonanoate N No safety concern at current levels of intaked
Allyl isovalerate R No safety concern at current levels of intaked
Allyl sorbate N,T No safety concern at current levels of intaked
Allyl 10-undecanoate N No safety concern at current levels of intaked
Allyl tiglate R No safety concern at current levels of intaked
Allyl 2-ethylbutyrate N No safety concern at current levels of intaked
Allyl cyclohexane N,T No safety concern at current levels of intaked
acetate
Allyl cyclohexane R No safety concern at current levels of intaked
propionate
Allyl cyclohexane N,T No safety concern at current levels of intaked
butyrate
ANNEX 4 (Con't)
Substance Specifications Acceptable daily intaked (ADI) in mg/kg of
body weight and other toxicological
recommendations
Allyl esters (con't)
Allyl cyclohexane N,T No safety concern at current levels of intaked
valerate
Allyl cyclohexane N,T No safety concern at current levels of intaked
hexanoate
Allyl phenylacetate N,T No safety concern at current levels of intaked
Allyl phenoxyacetate N No safety concern at current levels of intakef
Allyl cinnamate N,T No safety concern at current levels of intaked
Allyl anthranilate N,T No safety concern at current levels of intakef
Allyl 2-furoate N,T Evaluation not completedg
Sweetening agent
Alitame R 0-1h
Thickening agent
Konjac flour R ADI 'not specified' for food additive usesi
Miscellaneous substances
Benzyl acetate R
Benzyl alcohol R 0-5 (group ADI)
Benzaldehyde R
Benzoic acid and R
its salts
Sucrose acetate R 0-20
isobutyrate
Contaminant Toxicological recommendation
Aflatoxins Evaluation not completedj
ANNEX 4 (Con't)
Substance (considered for Specifications
specifications only)
Isomalt R
Lactitol R
Maltitol R
Maltitol syrup R
Mannitol R
Sorbitol R
Sorbitol syrup R
Xylitol R
Benzyl benzoate R
Ethanol R
Acesulfame K R
Ammonium hydroxide R
Annatto extracts (oil- and alkali-extracted) R
Annatto extracts (solvent-extracted) N
Calcium dihydrogen phosphate R
Citric acid R
Cyclohexylsulfamic acid R
Calcium cyclamate R
Sodium cyclamate R
Enzyme-hydrolysed carboxymethyl cellulose Ok
Enzyme-treated starches S,Tl
Gellan gum R
Hydrochloric acid R
Lactic acid R
Microcrystalline cellulose R
Propylene glycol R
Propylene glycol esters of fatty acids R,Tm
ANNEX 4 (Con't)
Substance (considered for Specifications
specifications only)
Sodium polyphosphate, glassy R
Sodium metaphosphate, insoluble N
Calcium stearoyl 2-lactylate R
Sodium stearoyl 2-lactylate R
Stearyl tartrate R
Tartaric, acetic and fatty acid esters of N,Tn
glycerol, mixed
Triacetin R
N, new specifications prepared; O, no 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; W, existing
specifications were withdrawn
a The temporary ADI was not extended because the additional studies
on the pharmacokinetics and metabolism of dodecyl, octyl, and
propyl gallate requested at the forty-first meeting of the
Committee (WHO Technical Report Series No. 837) were not available.
b This flavouring agent is in structural class I; the conclusions are
based on a 'yes' answer at step 2 and a 'no' answer at step 3 of
the approach described in Annex 5 of WHO Food Additives Series
No.35 (1996).
c This flavouring agent is in structural class I; the conclusions are
based on 'yes' answers at steps 2, 3, and 4 of the approach
described in Annex 5 of WHO Food Additives Series No.35 (1996).
d This flavouring agent is in structural class II; the conclusions
are based on 'no' answers at steps 2 and 3 of the approach
described in Annex 5 of WHO Food Additives Series No. 35 (1996). A
revised step 6 was applied, in which the Committee determined that
an adequate margin of safety existed between the NOEL
(no-observed-effect level) and current levels of intake.
e This flavouring agent is in structural class II; the conclusions
are based on a 'no' answer at step 2 and a 'yes' answer at step 3
using the approach outlined in Annex 5 of WHO Food Additives Series
No. 35 (1966). It was evaluated on the basis of available toxicity
data.
f This flavouring agent is in structural class III; the conclusions
are based on 'no' answers at steps 2 and 3 of the approach
described in Annex 5 of WHO Food Additives Series No. 35 (1996). A
revised step 6 was applied, in which the Committee determined that
an adequate margin of safety existed between the NOEL and current
levels of intake.
g The evaluation was not completed pending consideration of step 7
of the approach described in Annex 5 of WHO Food Additives Series
No. 35 (1996) at the next Expert Committee meeting when food additives
and contaminants are evaluated.
h The results of an on-going study of tolerance to repeated doses of
alitame in diabetic subjects should be submitted for assessment
when available.
i Includes uses as a thickener, emulsifier, stabilizer, gelling
agent, texturizing, and glazing agent.
j The evaluation could not be completed at the present meeting. The
Committee recommended that assessment of the carcinogenic potency
and estimates of the risks presented by aflatoxins be continued at
the next meeting of the Expert Committee when food additives and
contaminants are evaluated.
k The Committee considered a suggestion for specifications for
carboxymethyl cellulose, enzyme-hydrolysed, but because it was
understood that the product was not yet on the market, the
Committee deferred the establishment of specifications until the
additive is known to be commercially available.
l The tentative specifications for enzyme-treated starches were on
the agenda for revision; however, as no new information was
received, the Committee maintained the existing specifications as
tentative and requested new information for evaluation in 1997.
Unless this information is received the specifications will be
withdrawn.
m The Committee revised the specifications for propylene glycol
esters of fatty acids and designated them as tentative, requesting
a method of assay for the total ester content for evaluation in
1997.
n The Committee noted that the specifications for tartaric, acetic,
and fatty acid esters of glycerol, mixed, in FAO Nutrition Meetings
Report Series No. 40 A, B, C (1967) were old and rudimentary, and
therefore new tentative specifications were prepared. These were
designated as tentative, and information on methods of manufacture
was requested for evaluation in 1997 in order to distinguish this
material from diacetyltartaric and fatty acid esters of glycerol.
See Also:
Toxicological Abbreviations