WHO FOOD ADDITIVES SERIES: 52
Food additives evaluated toxicologically
Food additive |
Specificationsa |
Acceptable daily intake (ADI in mg/kg bw) and other toxicological recommendations |
alpha-Amylase from Bacillus licheniformis containing a genetically engineered alpha-amylase gene from B. licheniformis |
N |
ADI "not specified"d |
Annatto extract (solvent-extracted bixin)—"Annatto B"b |
R, T |
0-7 (temporary); for preparations containing not less than 85% pigment (as bixin, of which not more than 2.5% is norbixin)c |
Annatto extract (solvent-extracted norbixin)—"Annatto C" |
R, T |
0-0.4 (temporary); for preparations containing not less than 85% pigment (as norbixin)c |
Annatto extract (oil-processed bixin suspension)—"Annatto D" |
R, T |
No ADI established, since no data on toxicity were available |
Annatto extract (aqueous-processed bixin)—"Annatto E" |
R, T |
0-4 (temporary); for a preparations containing not less than 25% pigment (as bixin, of which not more than 7% is nor bixin)c |
Annatto extract (alkali-processed norbixin)—"Annatto F" |
R, T |
0-0.4 (temporary); for a preparation containing not less than 35% pigment (as norbixin)c |
Annatto extract (alkali-processed norbixin, not acid-precipitated)— "Annatto G" |
R, T |
No ADI established, since no data on toxicity were available |
Curcumin |
R |
0-3 |
Diacetyltartaric and fatty acid esters of glycerol |
— |
0-50 |
D-Tagatose |
R |
0-125 (temporary) |
Laccase from Myceliophthora thermophila expressed in Aspergillus oryzae |
N |
ADI "not specifiedd" |
Mixed xylanase, beta-glucanase enzyme preparation, produced by a strain of Humicola insolens |
N |
ADI "not specifiedd" |
Neotame |
N |
0-2 |
Polyvinyl alcohol |
N |
0-50 |
Quillaia extract (type 1)e |
R |
0-5 |
Quillaia extract (type 2)e |
N |
No ADI established owing to limited information on the qualitative and quantitative composition |
Xylanase from Thermomyces lanuginosus expressed in Fusarium venenatum |
N |
ADI "not specified"d |
a |
N: new specifications prepared; R: existing specifications revised; T: tentative specifications |
b |
To ensure clarity of the text, the Committee adopted for this report the designations B, C, D, E, F, G, as employed in the submitted information, to refer to the different extracts under evaluation |
c |
The ADI is established for the extract as tested biologically and specified. It is not expressed in relation to content of bixin and/or norbixin |
d |
ADI "not specified" is used to refer to a food substance of very low toxicity which, on the basis of the available data (chemical, biochemical, toxicological and other) and the total dietary intake of the substance arising from its use at the levels necessary to achieve the desired effects and from its acceptable background levels 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. An additive meeting this criterion must be used within the bounds of good manufacturing practice, i.e. it should be technologically efficacious and should be used at the lowest level necessary to achieve this effect, it should not conceal food of inferior quality or adulterated food, and it should not create a nutritional imbalance |
e |
Quillaia extract (type 1): saponin content of 20-26%; quillaia extract (type 2): saponin content of 75-90% |
Food Additives considered for specifications only
Food additive |
Specificationsa |
beta-Carotene from Blakeslea trispora |
R |
Magnesium silicate |
R |
Monomagnesium phosphate |
S, T |
Natamycin |
R |
Sucrose esters of fatty acids |
R |
Talc |
R |
Trisodium diphosphate |
R, T |
a |
R: existing specifications revised; S: specifications maintained (revision considered but not required); T: the existing specifications are tentative, information required |
Flavouring agents evaluated by the Procedure for the Safety Evaluation of Flavouring Agents
A. Alicyclic, alicyclic-fused and aromatic-fused ring lactones
Flavouring agent |
No. |
Specificationsa |
Conclusion based on current intake |
4-Hydroxy-4-methyl-5-hexenoic acid gamma-lactone |
1157 |
N |
No safety concern |
(+/-) 3-Methyl-gamma-decalactone |
1158 |
N |
No safety concern |
4-Hydroxy-4-methyl-7-cis-decenoic acid gamma-lactone |
1159 |
N |
No safety concern |
Tuberose lactone |
1160 |
N |
No safety concern |
Dihydromintlactone |
1161 |
N |
No safety concern |
Mintlactone |
1162 |
N |
No safety concern |
Dehydromenthofurolactone |
1163 |
N |
No safety concern |
(+/-)-(2,6,6-Trimethyl-2-hydroxycyclohexylidene)acetic acid gamma-lactone |
1164 |
N |
No safety concern |
Sclareolide |
1165 |
N |
No safety concern |
Octahydrocoumarin |
1166 |
N |
No safety concern |
2-(4-Methyl-2-hydroxyphenyl) propionic acid gamma-lactone |
1167 |
N |
No safety concern |
3-Propylidenephthalide |
1168 |
N |
No safety concern |
3-n-Butylphthalide |
1169 |
N |
No safety concern |
3-Butylidenephthalide |
1170 |
N |
No safety concern |
Dihydrocoumarin |
1171 |
R |
No safety concern |
6-Methylcoumarin |
1172 |
N |
No safety concern |
a |
N: new specifications prepared; R: revised specifications |
B. Aliphatic di- and trienals and related alcohols, acids, and esters
Flavouring agent |
No. |
Specificationsa |
Conclusion based on current intake |
2,4-Pentadienal |
1173 |
N |
No safety concern |
(E,E)-2,4-Hexadien-1-ol |
1174 |
N |
No safety concern |
trans,trans-2,4-Hexadienal |
1175 |
N |
No safety concern |
(E,E)-2,4-Hexadienoic acid |
1176 |
N |
See footnoteb |
Methyl sorbate |
1177 |
N |
No safety concern |
Ethyl sorbate |
1178 |
N |
No safety concern |
2,4-Heptadienal |
1179 |
N |
No safety concern |
(E,E)-2,4-Octadien-1-ol |
1180 |
N |
No safety concern |
trans,trans-2,4-Octadienal |
1181 |
N |
No safety concern |
2-trans,6-trans-Octadienal |
1182 |
N |
No safety concern |
2,4-Nonadien-1-ol |
1183 |
N |
No safety concern |
2,6-Nonadien-1-ol |
1184 |
N |
No safety concern |
2,4-Nonadienal |
1185 |
N |
No safety concern |
Nona-2-trans-6-cis-dienal |
1186 |
N |
No safety concern |
2-trans-6-trans-Nonadienal |
1187 |
N |
No safety concern |
(E,Z)-2,6-Nonadien-1-ol acetate |
1188 |
N |
No safety concern |
(E,E)-2,4-Decadien-1-ol |
1189 |
N |
No safety concern |
2-trans,4-trans-Decadienal |
1190 |
N |
No safety concern |
Methyl (E)-2-(Z)-4-decadienoate |
1191 |
N |
No safety concern |
Ethyl trans-2-cis-4-decadienoate |
1192 |
N |
No safety concern |
Ethyl 2,4,7-decatrienoate |
1193 |
N |
No safety concern |
Propyl 2,4-decadienoate |
1194 |
N |
No safety concern |
2,4-Undecadienal |
1195 |
N |
No safety concern |
trans,trans-2,4-Dodecadienal |
1196 |
N |
No safety concern |
2-trans-6-cis-Dodecadienal |
1197 |
N |
No safety concern |
2-trans-4-cis-7-cis-Tridecatrienal |
1198 |
N |
No safety concern |
a |
N, new specifications prepared |
b |
An ADI of 0-25mg/kg bw was established at the seventeenth meeting. The ADI was maintained and the use of the chemical as a flavouring agent subsumed in the ADI. R: existing specifications revised |
C. Aliphatic branched-chain unsaturated alcohols, aldehydes, acids and related esters
Flavouring agent |
No. |
Specificationsa |
Conclusion based on current intake |
(+/-) 2-Methyl-1-butanol |
1199 |
N |
No safety concern |
3-Methyl-2-buten-1-ol |
1200 |
N |
No safety concern |
2-Methyl-2-butenal |
1201 |
N |
No safety concern |
3-Methyl-2-butenal |
1202 |
N |
No safety concern |
Ammonium isovalerate |
1203 |
N |
No safety concern |
3-Methylcrotonic acid |
1204 |
N |
No safety concern |
trans-2-Methyl-2-butenoic acid |
1205 |
N,T |
No safety concern |
Isobutyl 2-butenoate |
1206 |
N |
No safety concern |
2-Methylallyl butyrate |
1207 |
N |
No safety concern |
4-Methyl-2-pentenal |
1208 |
N |
No safety concern |
2-Methyl-2-pentenal |
1209 |
N |
No safety concern |
2-Methyl-2-pentenoic acid |
1210 |
N |
No safety concern |
2,4-Dimethyl-2-pentenoic acid |
1211 |
N |
No safety concern |
2-Methylheptanoic acid |
1212 |
N |
No safety concern |
Isobutyl angelate |
1213 |
N |
No safety concern |
2-Butyl-2-butenal |
1214 |
N |
No safety concern |
2-Isopropyl-5-methyl-2-hexenal |
1215 |
N |
No safety concern |
2-Ethyl-2-heptenal |
1216 |
N |
No safety concern |
2-Methyl-2-octenal |
1217 |
N |
No safety concern |
4-Ethyloctanoic acid |
1218 |
N,T |
No safety concern |
dl-Citronellol |
1219 |
R |
See footnoteb |
Citronellal |
1220 |
N |
No safety concern |
3,7-Dimethyl-6-octenoic acid |
1221 |
N |
No safety concern |
Rhodinol |
1222 |
N |
No safety concern |
Geraniol |
1223 |
N |
No safety concern |
Nerol |
1224 |
N |
No safety concern |
Citral |
1225 |
R |
See footnoteb |
8-Ocimenyl acetate |
1226 |
N |
No safety concern |
2,6-Dimethyl-10-methylene-2,6,11-dodecatrienal |
1227 |
N |
No safety concern |
3,7,11 -Trimethyl-2,6,10-dodecatrienal |
1228 |
N |
No safety concern |
12-Methyltridecanal |
1229 |
N |
No safety concern |
Farnesol |
1230 |
N |
No safety concern |
a |
N: new specifications prepared; R: existing specifications revised; T: the existing, new or revised specifications are tentative and new information is required |
b |
A group ADI of 0-0.5 mg/kg bw expressed as citral, was established for citral, citronellol, geranyl acetate, linalool and linalyl acetate at the twenty-third meeting. The ADI was maintained and the use of the chemical as a flavouring agent subsumed in the ADI |
D. Aliphatic and aromatic ethers
Flavouring agent |
No. |
Specificationsa |
Conclusion based on current intake |
sec-Butyl ethyl ether |
1231 |
N |
No safety concern |
1 -Ethoxy-3-methyl-2-butene |
1232 |
N |
No safety concern |
1,4-Cineole |
1233 |
N |
No safety concern |
Eucalyptol |
1234 |
N |
No safety concern |
Nerol oxide |
1235 |
N |
No safety concern |
2,2,6-Trimethyl-6-vinyltetrahydropyran |
1236 |
N |
No safety concern |
Tetrahydro-4-methyl-2-(2-methylpropen-1-yl) pyran |
1237 |
N |
No safety concern |
Theaspirane |
1238 |
N |
No safety concern |
Cycloionone |
1239 |
N |
No safety concern |
1,5,5,9-Tetramethyl-13-oxatricyclo (8.3.0.0(4,9)) tridecane |
1240 |
N |
No safety concern |
Anisole |
1241 |
N |
No safety concern |
o-Methylanisole |
1242 |
N |
No safety concern |
p-Methyl anisole |
1243 |
N |
No safety concern |
p-Propylanisole |
1244 |
N |
No safety concern |
2,4-Dimethylanisole |
1245 |
N |
No safety concern |
1-Methyl-3-methoxy-4-isopropyl benzene |
1246 |
N |
No safety concern |
Carvacryl ethyl ether |
1247 |
N |
No safety concern |
1,2-Dimethoxybenzene |
1248 |
N |
No safety concern |
m-Dimethoxybenzene |
1249 |
N |
No safety concern |
p-Dimethoxybenzene |
1250 |
N |
No safety concern |
3,4-Dimethoxy-1 -vinylbenzene |
1251 |
N |
No safety concern |
Benzyl ethyl ether |
1252 |
N |
No safety concern |
Benzyl butyl ether |
1253 |
R |
No safety concern |
Methyl phenethyl ether |
1254 |
N |
No safety concern |
Diphenyl ether |
1255 |
N |
No safety concern |
Dibenzyl ether |
1256 |
R |
No safety concern |
beta-Naphthyl methyl ether |
1257 |
N |
No safety concern |
beta-Naphthyl ethyl ether |
1258 |
N |
No safety concern |
beta-Naphthyl isobutyl ether |
1259 |
N |
No safety concern |
a |
N: new specifications prepared; R: revised specifications |
E. Hydropropenylbenzenes
Flavouring agent |
No. |
Specificationsa |
Conclusions based on current intake |
Isoeugenol |
1260 |
N |
No safety concern |
Isoeugenyl formate |
1261 |
N |
No safety concern |
Isoeugenyl acetate |
1262 |
N |
No safety concern |
Isoeugenyl phenylacetate |
1263 |
N,T |
No safety concern |
Propenylguaethol |
1264 |
N |
No safety concern |
4-Propenyl-2,6-dimethoxyphenol |
1265 |
N |
No safety concern |
Isoeugenyl methyl ether |
1266 |
N |
No safety concern |
Isoeugenyl ethyl ether |
1267 |
N |
No safety concern |
Isoeugenyl benzyl ether |
1268 |
N |
No safety concern |
a |
N, new specifications prepared; T, T, the existing, new or revised specifications are tentative and new information is required |
F. Linear and branched-chain aliphatic unsaturated, unconjugated alcohols, aldehydes, acids and related esters
Flavouring agent |
No. |
Specificationsa |
Conclusion based on current intake |
Isoprenyl acetate |
1269 |
N |
No safety concern |
4-Pentenyl acetate |
1270 |
N |
No safety concern |
3-Hexenal |
1271 |
N |
No safety concern |
3-Hexenyl formate |
1272 |
N |
No safety concern |
Ethyl 5-hexenoate |
1273 |
N,T |
No safety concern |
cis-3-Hexenyl propionate |
1274 |
N |
No safety concern |
cis-3-Hexenyl isobutyrate |
1275 |
N |
No safety concern |
(Z)-3-Hexenyl (E)-2-butenoate |
1276 |
N |
No safety concern |
cis-3-Hexenyl tiglate |
1277 |
N |
No safety concern |
cis-3-Hexenyl valerate |
1278 |
N |
No safety concern |
3-Hexenyl 2-hexenoate |
1279 |
N |
No safety concern |
(Z)-4-Hepten-1-ol |
1280 |
N |
No safety concern |
Ethyl cis-4-heptenoate |
1281 |
N |
No safety concern |
(Z)-5-Octenyl propionate |
1282 |
N |
No safety concern |
(Z,Z) -3,6-Nonadien-1-ol |
1283 |
N |
No safety concern |
(E)-3,(Z)-6-Nonadien-1-ol |
1284 |
N |
No safety concern |
(E,Z)-3,6-Nonadien-1-ol acetate |
1285 |
N |
No safety concern |
9-Decenal |
1286 |
N |
No safety concern |
4-Decenoic acid |
1287 |
N |
No safety concern |
cis-4-Decenyl acetate |
1288 |
N |
No safety concern |
a |
N, new specifications prepared; T, the existing, new or revised specifications are tentative and new information is required |
G. Simple aliphatic and aromatic sulfides and thiols
Flavouring agent |
No. |
Specificationsa |
Conclusion based on current intake |
erythro and threo-3-Mercapto-2-methylbutan-1-ol |
1289 |
N |
No safety concern |
(+/-)2-Mercapto-2-methylpentan-1-ol |
1290 |
N |
No safety concern |
3-Mercapto-2-methylpentan-1-ol (racemic) |
1291 |
N,T |
No safety concern |
3-Mercapto-2-methylpentanal |
1292 |
N |
No safety concern |
4-Mercapto-4-methyl-2-pentanone |
1293 |
N |
No safety concern |
(+/-) Ethyl 3-mercaptobutyrate |
1294 |
N |
No safety concern |
Ethyl 4-(acetylthio)butyrate |
1295 |
N |
No safety concern |
spiro(2,4-Dithia-1-methyl-8-oxabicyclo(3.3.0) octane-3,3'-(1'-oxa-2'-methyl)-cyclopentane) |
1296 |
N,T |
No safety concern |
2-(Methylthio)ethanol |
1297 |
N |
No safety concern |
Ethyl 5-(methylthio)valerate |
1298 |
N |
No safety concern |
2,3,5-Trithiahexane |
1299 |
N |
No safety concern |
Diisopropyl trisulfide |
1300 |
N |
No safety concern |
a |
N, new specifications prepared; T, the existing, new or revised specifications are tentative and new information is required |
Flavouring agents considered for specifications only
No. |
Flavouring agent |
Specificationsa |
No. |
Flavouring agent |
Specificationsa |
42 |
Isoamyl formate |
R |
170 |
n-Amyl heptanoate |
R |
53 |
Citronellyl formate |
R,T |
180 |
Methyl laurate |
R |
54 |
Geranyl formate |
R |
205 |
Methyl 2-methylbutyrate |
R |
55 |
Neryl formate |
R,T |
212 |
2-Methylbutyl 2-methylbutyrate |
R |
56 |
Rhodinyl formate |
R |
|||
57 |
Citronellyl acetate |
R |
237 |
6-Hydroxy-3,7-dimethyloctanoic acid lactone |
R |
60 |
Rhodinyl acetate |
R |
|||
61 |
Citronellyl propionate |
R |
|||
62 |
Geranyl propionate |
R |
244 |
3-Heptyldihydro-5-methyl-2(3H)-furanone |
R |
65 |
Citronellyl butyrate |
R |
|||
66 |
Geranyl butyrate |
R |
272 |
3,7-Dimethyl-1-octanol |
R |
68 |
Rhodinyl butyrate |
R,T |
302 |
2,6-Dimethyl-4-heptanone |
R |
71 |
Citronellyl isobutyrate |
R |
303 |
2,6-Dimethyl-4-heptanol |
R |
73 |
Neryl isobutyrate |
R |
322 |
cis-5-Octen-1-ol |
R |
95 |
Heptanal |
R |
323 |
cis-5-Octenal |
R |
98 |
Octanal |
R |
325 |
cis-6-NonenalR |
R |
101 |
Nonanal |
R |
329 |
9-Undecenal |
R |
104 |
Decanal |
R |
332 |
Linoleic and linolenic acid (mixture) |
R |
107 |
Undecanal |
R |
|||
110 |
Lauric aldehyde |
R |
337 |
Methyl cis-4-octenoateR |
R |
112 |
Myristaldehyde |
R |
338 |
Ethyl cis-4-octenoateR |
R |
117 |
Propyl formate |
R |
346 |
Methyl linoleate & Methyl linolenate (mixture) |
R |
119 |
n-Amyl formate |
R |
|||
124 |
Isobutyl formate |
R |
348 |
2,6-Dimethyl-6-hepten-1-ol |
R |
349 |
2,6-Dimethyl-5-heptenal |
R |
556 |
3-Mercaptohexyl hexanoate |
R |
358 |
Linalyl formate |
R |
|||
360 |
Linalyl propionate |
R |
557 |
1-Mercapto-2-propanone |
R,T |
384 |
beta-Damascone |
R |
559 |
2-Keto-4-butanethiol |
R |
385 |
alpha-Damascone |
R |
568 |
Allyl methyl disulfide |
R |
396 |
Dehydrodihydroionone |
R |
569 |
Methyl 1-propenyl disulfide |
R |
397 |
Dehydrodihydroionol |
R |
570 |
Propenyl propyl disulfide |
R,T |
399 |
Methyl-beta-ionone |
R,T |
571 |
Methyl 3-methyl-1-butenyl disulfide |
R |
409 |
3-Hydroxy-2-pentanone |
R |
|||
410 |
2,3-Pentadione |
R |
583 |
Methyl ethyl trisulfide |
R |
417 |
2,3-Undecadione |
R |
586 |
Allyl methyl trisulfide |
R |
419 |
Ethylcyclo-pentenolone |
R |
590 |
Methyl 2-hydroxy-4-methylpentanoate |
R |
592 |
Citronelloxyacetaldehyde |
R |
|||
422 |
3-Ethyl-2-hydroxy-4-methylcyclopent-2-en-1-one |
R |
603 |
Ethyl 2,4-dioxohexanoate |
R |
423 |
5-Ethyl-2-hydroxy-3-methylcyclopent-2-en-1-one |
R |
604 |
3-(Hydroxymethyl)-2-heptanone |
R |
435 |
Piperitone |
R |
605 |
1,3-Nonanediol acetate (mixed esters) |
R,T |
443 |
l-Menthol ethylene glycol carbonate |
R |
615 |
Butyl ethyl malonate |
R,T |
625 |
Dibutyl sebacate |
R |
|||
465 |
2-Methylthioacetaldehyde |
R |
628 |
Ethyl aconitate (mixed esters) |
R,T |
468 |
4-(Methylthio)butanal |
R |
|||
470 |
2-(Methylthio)methyl-2-butenal |
R |
631.2 |
3-Methyl-2-oxobutanoic acid, sodium salt |
R,T |
471 |
2,8-Dithianon-4-ene-4-carboxaldehyde |
R,T |
632.2 |
3-Methyl-2-oxopentanoic acid, sodium salt |
R,T |
473 |
Methylthiomethyl butyrate |
R |
633.2 |
4-Methyl-2-oxopentanoic acid, sodium salt |
R,T |
479 |
Methyl thiomethyl hexanoate |
R |
668 |
Linalyl cinnamate |
R |
480 |
Ethyl 3-(methylthio) butyrate |
R |
669 |
Terpinyl cinnamate |
R |
704 |
p-Tolyl laurate |
R |
|||
488 |
S-Methyl 4-methylpentanethioate |
R |
735 |
2-Phenylphenol |
R |
737 |
2,3,6-Trimethylphenol |
R |
|||
489 |
S-Methyl hexanethioate |
R |
918 |
Glyceryl monostearate |
R |
495 |
1 -Methylthio-2-propanone |
R |
923 |
Glycerol 5-hydroxydecanoate |
R |
502 |
Di(butan-3-one-1-yl)sulfide |
R |
|||
504 |
S-Methyl benzothioate |
R,T |
924 |
Glycerol 5-hydroxydodecanoate |
R |
519 |
2-Ethylhexanethiol |
R |
937 |
Pyruvaldehyde |
R |
548 |
4-Methoxy-2-methyl-2-butanethiol |
R |
a |
R, existing specifications revised; S, existing specifications were maintained; T, the existing, new, or revised specifications are tentative and new information is required |
Evaluation of a water-treatment agent
Agent |
Specificationsa |
Tolerable daily intake (TDI) and other toxicological recommendations |
Sodium dichloroisocyanurate (NaDCC) |
N |
0-2.0 mg/kgbw for anhydrous NaDCC; applicable for intake from drinking-water treated with NaDCC for the purpose of disinfection |
a N, new specifications prepared
Evaluation of a nutritional source of iron
Source |
Specificationsa |
Toxicological recommendation |
Ferrous glycinate (processed with citric acid) |
N |
Suitable for use as a source of iron for supplementation and fortification, providing that the total intake of iron does not exceed the provisional maximum tolerable daily intake of 0.8mg/kg bwper day |
a N, new specifications prepared
Contaminants
Contaminant |
Tolerable intake and other toxicological recommendations |
Cadmium |
Provisional tolerable weekly intake (PTWI) of 7µg/kg bw (maintained) |
Methylmercury |
Provisional tolerable weekly intake (PTWI) of 1.6µg/kgbw |
See Also: Toxicological Abbreviations