Food additives evaluated toxicologically
Food additive |
Specificationsa |
Acceptable daily intake (ADI) in mg/kg |
Alitame |
R |
0–1 mg/kg bwb |
Cross-linked sodium carboxy cellulose |
N |
Included in the group ADI ‘not specified’c with methyl other modified celluloses |
Mineral oils (low- and medium-viscosity) |
||
Class Id |
R |
0–10 mg/kg bw |
Class IIe and Class IIIf |
R |
0–0.01 mg/kg bw (group ADI) (temporary)g |
Nitrite |
S |
0–0.07 mg/kg bw (expressed as nitrite ion) |
Nitrate |
S |
0–3.7 mg/kg bw (expressed as nitrate ion) |
Salatrim (short- and long-chain acyltriglyceride molecules) |
R |
Adequate information was not available to evaluate safety and nutritional effects. |
a |
N, new specifications prepared; R, existing specifications revised; S, existing specifications were not considered. |
b |
ADI was established at the forty-sixth meeting (WHO Technical Report Series, No. 868, 1997). Evaluation of a 90-day study of teolerance in patients with diabetes was postponed. |
c |
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 that meets 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 its effect, it should not conceal food of inferior quality or adulterated food, and it should not create a nutritional imbalance. |
d |
Including P70(H) oil. |
e |
Including N70(H) and N70(A) oils. |
f |
Including P15(H), N15(H), and N10(A) oils |
g |
See Annex 3. |
Food additive considered for specifications only
Food additive |
Specificationsa |
Amyloglucosidase from Aspergillus niger, var. |
R |
aR, existing specifications revised
Substances evaluated by the Procedure for the Safety Evaluation of Flavouring Agents
A. Alicyclic primary alcohols, aldehydes, acids and related esters
Flavouring agent |
No. |
Specificationsa |
Conclusions based on current intake |
Cyclohexanecarboxylic acid |
961 |
N |
No safety concern |
Methyl cyclohexanecarboxylate |
962 |
N |
No safety concern |
Ethyl cyclohexanecarboxylate |
963 |
N |
No safety concern |
Cyclohexaneethyl acetate |
964 |
N |
No safety concern |
Cyclohexaneacetic acid |
965 |
N |
No safety concern |
Ethyl cyclohexanepropionate |
966 |
N |
No safety concern |
2,2,3-Trimethylcyclopent-3-en-1-yl acetaldehyde |
967 |
N |
No safety concern |
cis-5-Isopropenyl-cis-2-methylcyclopentan-1-carboxaldehyde |
968 |
N |
No safety concern |
Campholene acetate |
969 |
N |
No safety concern |
alpha-Campholenic alcohol |
970 |
N |
No safety concern |
para-Menth-1-en-9-al |
971 |
N |
No safety concern |
1-para-Menthen-9-yl acetate |
972 |
N |
No safety concern |
para-Mentha-1,8-dien-7-al |
973 |
N |
No safety concern |
para-Mentha-1,8-dien-7-ol |
974 |
N |
No safety concern |
para -Mentha-1,8-dien-7-yl acetate |
975 |
N |
No safety concern |
1,2,5,6-Tetrahydrocuminic acid |
976 |
N |
No safety concern |
2,6,6-Trimethylcyclohexa-1,3-dienyl methanal |
977 |
N |
No safety concern |
2,6,6-Trimethyl-1-cyclohexen-1-acetaldehyde |
978 |
N |
No safety concern |
2,6,6-Trimethyl-1&2-cyclohexen-1-carboxaldehyde |
979 |
N |
No safety concern |
2-Formyl-6,6-dimethylbicyclo[3.1.1]hept-2-ene(Myrtenal) |
980 |
N |
No safety concern |
Myrtenol |
981 |
N |
No safety concern |
Myrtenyl acetate |
982 |
N |
No safety concern |
6,6-Myrtenyl formate |
983 |
N |
No safety concern |
Santalol (alpha and beta) |
984 |
N |
No safety concern |
Santalyl acetate (alpha and beta) |
985 |
N |
No safety concern |
10-Hydroxymethylene-2-pinene |
986 |
N |
No safety concern |
a N, new specifications prepared
B. Phenethyl alcohol, aldehyde, acid and related acetals and esters
Flavouring agent |
No. |
Specificationsa |
Conclusions based on current intake |
Phenethyl alcohol |
987 |
N |
No safety concern |
Phenethyl formate |
988 |
N |
No safety concern |
Phenethyl acetate |
989 |
N |
No safety concern |
Phenethyl propionate |
990 |
N |
No safety concern |
Phenethyl butyrate |
991 |
N |
No safety concern |
Phenethyl isobutyrate |
992 |
N |
No safety concern |
Phenethyl 2-methylbutyrate |
993 |
N |
No safety concern |
Phenethyl isovalerate |
994 |
N |
No safety concern |
Phenethyl hexanoate |
995 |
N |
No safety concern |
Phenethyl octanoate |
996 |
N |
No safety concern |
Phenethyl tiglate |
997 |
N |
No safety concern |
Phenethyl senecioate |
998 |
N |
No safety concern |
Phenethyl phenylacetate |
999 |
N |
No safety concern |
Acetaldehyde phenethyl propyl acetal |
1000 |
N |
No safety concern |
Acetaldehyde butyl phenethyl acetal |
1001 |
N |
No safety concern |
Phenylacetaldehyde |
1002 |
N |
No safety concern |
Phenylacetaldehyde dimethyl acetal |
1003 |
N |
No safety concern |
Phenylacetaldehyde glyceryl acetal |
1004 |
N |
No safety concern |
Phenylacetic acid |
1007 |
N |
No safety concern |
Methyl phenylacetate |
1008 |
N |
No safety concern |
Ethyl phenylacetate |
1009 |
N |
No safety concern |
Propyl phenylacetate |
1010 |
N |
No safety concern |
Isopropyl phenylacetate |
1011 |
N |
No safety concern |
Butyl phenylacetate |
1012 |
N |
No safety concern |
Isobutyl phenylacetate |
1013 |
N |
No safety concern |
Isoamyl phenylacetate |
1014 |
N |
No safety concern |
Hexyl phenylacetate |
1015 |
N |
No safety concern |
3-Hexenyl phenylacetate |
1016 |
N |
No safety concern |
Octyl phenylacetate |
1017 |
N |
No safety concern |
Rhodinyl phenylacetate |
1018 |
N |
No safety concern |
Linalyl phenylacetate |
1019 |
N |
No safety concern |
Geranyl phenylacetate |
1020 |
N |
No safety concern |
Citronellyl phenylacetate |
1021 |
N |
No safety concern |
Santalyl phenylacetate (alpha and beta) |
1022 |
N |
No safety concern |
para-Tolylacetaldehyde |
1023 |
N |
No safety concern |
para-Isopropylphenylacetaldehyde |
1024 |
N |
No safety concern |
Methyl para-tert-butylphenylacetate |
1025 |
N |
No safety concern |
Phenoxyacetic acid |
1026 |
N |
No safety concern |
Ethyl (para-tolyloxy)acetate |
1027 |
N |
No safety concern |
2-Phenoxyethyl isobutyrate |
1028 |
N |
No safety concern |
Sodium 2-(4-methoxyphenoxy)propanoate |
1029 |
N |
No safety concern |
a N, new specifications prepared
C. Sulfur-containing heterocyclic compounds
Flavouring agent |
No. |
Specificationsa |
Conclusions based on current intake |
Thiamine hydrochloride |
1030 |
N |
No safety concern |
4-Methyl-5-thiazoleethanol |
1031 |
N |
No safety concern |
Thiazole |
1032 |
N |
No safety concern |
2-(1-Methylpropyl)thiazole |
1033 |
N |
No safety concern |
2-Isobutylthiazole |
1034 |
N |
No safety concern |
4,5-Dimethylthiazole |
1035 |
N |
No safety concern |
2,4,5-Trimethylthiazole |
1036 |
N |
No safety concern |
2-Isopropyl-4-methylthiazole |
1037 |
N |
No safety concern |
4-Methyl-5-vinylthiazole |
1038 |
N |
No safety concern |
2,4-Dimethyl-5-vinylthiazole |
1039 |
N |
No safety concern |
Benzothiazole |
1040 |
N |
No safety concern |
2-Acetylthiazole |
1041 |
N |
No safety concern |
2-Propionylthiazole |
1042 |
N |
No safety concern |
4-Methylthiazole |
1043 |
N |
No safety concern |
2-Ethyl-4-methylthiazole |
1044 |
N |
No safety concern |
4,5-Dimethyl-2-isobutyl-3-thiazoline |
1045 |
N |
No safety concern |
2-Isobutyl-4,6-dimethyldihydro-1,3,5-dithiazine and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine (mixture) |
1046 |
N |
No safety concern |
2-Isopropyl-4,6-dimethyl and 4-isopropyl-2,6-dimethyldihydro-1,3,5-dithiazine (mixture) |
1047 |
N |
No safety concern |
2,4,6-Triisobutyl-5,6-dihydro-4H-1,3,5-dithiazine |
1048 |
N |
No safety concern |
2,4,6-Trimethyldihydro-4H-1,3,5-dithiazine |
1049 |
N |
No safety concern |
5-Methyl-2-thiophenecarboxaldehyde |
1050 |
N |
No safety concern |
3-Acetyl-2,5-dimethylthiophene |
1051 |
N |
No safety concern |
2-Thienylmercaptan |
1052 |
N |
No safety concern |
2-Thienyl disulfide |
1053 |
N |
No safety concern |
2-Ethoxythiazole |
1056 |
N |
No safety concern |
2-Methyl-5-methoxythiazole |
1057 |
N |
No safety concern |
4,5-Dimethyl-2-ethyl-3-thiazoline |
1058 |
N |
No safety concern |
2-(2-Butyl)-4,5-dimethyl-3-thiazoline |
1059 |
N |
No safety concern |
a N, new specifications prepared
D. Sulfur-substituted furan derivatives
Flavouring agent |
No. |
Specificationsa |
Conclusions based on current intake |
2-Methyl-3-furanthiol |
1060 |
N |
No safety concern |
2-Methyl-3-(methylthio)furan |
1061 |
N |
No safety concern |
2-Methyl-5-(methylthio)furan |
1062 |
N |
No safety concern |
2,5-Dimethyl-3-furanthiol |
1063 |
N |
No safety concern |
Methyl 2-methyl-3-furyl disulfide |
1064 |
N |
No safety concern |
Propyl 2-methyl-3-furyl disulfide |
1065 |
N |
No safety concern |
Bis(2-methyl-3-furyl) disulfide |
1066 |
N |
No safety concern |
Bis(2,5-dimethyl-3-furyl) disulfide |
1067 |
N |
No safety concern |
Bis(2-methyl-3-furyl) tetrasulfide |
1068 |
N |
No safety concern |
2-Ethanethoic acid, S-(2-methyl-3-furanyl) ester |
1069 |
N |
No safety concern |
2,5-Dimethyl-3-furan thioisovalerate |
1070 |
N |
No safety concern |
2,5-Dimethyl-3-thiofuroylfuran |
1071 |
N |
No safety concern |
Furfuryl mercaptan |
1072 |
N |
No safety concern |
S-Furfuryl thioformate |
1073 |
N |
No safety concern |
S-Furfuryl thioacetate |
1074 |
N |
No safety concern |
S-Furfuryl thiopropionate |
1075 |
N |
No safety concern |
Furfuryl methyl sulfide |
1076 |
N |
No safety concern |
Furfuryl isopropyl sulfide |
1077 |
N |
No safety concern |
Methyl furfuryl disulfide |
1078 |
N |
No safety concern |
Propyl furfuryl disulfide |
1079 |
N |
No safety concern |
2,2'-(Thiodimethylene)difuran |
1080 |
N |
No safety concern |
2,2'-(Dithiodimethylene)difuran |
1081 |
N |
No safety concern |
2-Methyl-3-, 5- or 6-(furfurylthio)pyrazine |
1082 |
N |
No safety concern |
S-Methyl thiofuroate |
1083 |
N |
No safety concern |
4-[(2-Furanmethyl)thio]-2-pentanone |
1084 |
N |
No safety concern |
3-[(2-Methyl-3-furyl)thio]-4-heptanone |
1085 |
N |
No safety concern |
2,6-Dimethyl-3-[(2-methyl-3-furyl)thio]-4-heptanone |
1086 |
N |
No safety concern |
4-[(2-Methyl-3-furyl)thio]-5-nonanone |
1087 |
N |
No safety concern |
Ethyl 3-(furfurylthio)propionate |
1088 |
N |
No safety concern |
2-Methyl-3-thioacetoxy-4,5-dihydrofuran |
1089 |
N |
No safety concern |
2-Methyl-3-tetrahydrofuranthiol |
1090 |
N |
No safety concern |
2,5-Dimethyl-3-tetrahydrofuranthiol, cis and trans isomers |
1091 |
N |
No safety concern |
2,5-Dimethyl-3-thioacetoxy-tetrahydrofuran, cis and trans isomers |
1092 |
N |
No safety concern |
a N, new specifications prepared
E. Alicyclic ketones, secondary alcohols and related esters
Flavouring agent |
No. |
Specificationsa |
Conclusions based on current intake |
3,3,5-Trimethyl cyclohexanol |
1099 |
N |
No safety concern |
Cyclohexanone |
1100 |
N |
No safety concern |
Cyclopentanone |
1101 |
N |
No safety concern |
2-Methylcyclohexanone |
1102 |
N |
No safety concern |
3-Methylcyclohexanone |
1103 |
N |
No safety concern |
4-Methylcyclohexanone |
1104 |
N |
No safety concern |
1-Methyl-1-cyclopenten-3-one |
1105 |
N |
No safety concern |
2-Hexylidene cyclopentanone |
1106 |
N |
No safety concern |
3-Methyl-2-cyclohexen-1-one |
1107 |
N |
No safety concern |
2,2,6-Trimethylcyclohexanone |
1108 |
N |
No safety concern |
2-sec-Butylcyclohexanone |
1109 |
N |
No safety concern |
4-Isopropyl-2-cyclohexenone |
1110 |
N |
No safety concern |
Tetramethylethylcyclohexenone (mixture of isomers) |
1111 |
N |
No safety concern |
Isophorone |
1112 |
N |
No safety concern |
3-Methyl-5-propyl-2-cyclohexen-1-one |
1113 |
N |
No safety concern |
3-Methyl-2-(2-pentenyl)-2-cyclopenten-1-one |
1114 |
N |
No safety concern |
Isojasmone |
1115 |
N |
No safety concern |
(E)-2-(2-Octenyl)cyclopentanone |
1116 |
N |
No safety concern |
2-(3,7-Dimethyl-2,6-octadienyl)cyclopentanone |
1117 |
N |
No safety concern |
a N, new specifications prepared
F. Aliphatic secondary alcohols, ketones and related esters
Flavouring agent |
No. |
Specificationsa |
Conclusions based on current intake |
3-Decanone |
1118 |
N |
No safety concern |
5-Methyl-5-hexen-2-one |
1119 |
N |
No safety concern |
6-Methyl-5-hepten-2-one |
1120 |
N |
No safety concern |
3,4,5,6-Tetrahydropseudoionone |
1121 |
N |
No safety concern |
6,10-Dimethyl-5,9-undecadien-2-one |
1122 |
N |
No safety concern |
2,6,10-Trimethyl-2,6,10-pentadecatrien-14-one |
1123 |
N |
No safety concern |
3-Penten-2-one |
1124 |
N |
No safety concern |
4-Hexen-3-one |
1125 |
N |
No safety concern |
2-Hepten-4-one |
1126 |
N |
No safety concern |
3-Hepten-2-one |
1127 |
N |
No safety concern |
3-Octen-2-one |
1128 |
N |
No safety concern |
2-Octen-4-one |
1129 |
N |
No safety concern |
3-Decen-2-one |
1130 |
N |
No safety concern |
4-Methyl-3-penten-2-one |
1131 |
N |
No safety concern |
5-Methyl-3-hexen-2-one |
1132 |
N |
No safety concern |
5-Methyl-2-hepten-4-one |
1133 |
N |
No safety concern |
6-Methyl-3,5-heptadien-2-one |
1134 |
N |
No safety concern |
(E)-7-Methyl-3-octen-2-one |
1135 |
N |
No safety concern |
3-Nonen-2-one |
1136 |
N |
No safety concern |
(E) and (Z)-4,8-Dimethyl-3,7-nonadien-2-one |
1137 |
N |
No safety concern |
(E)-6-Methyl-3-hepten-2-one |
1138 |
N |
No safety concern |
(E,E)-3,5-Octadien-2-one |
1139 |
N |
No safety concern |
3-Octen-2-ol |
1140 |
N |
No safety concern |
(E)-2-Octen-4-ol |
1141 |
N |
No safety concern |
2-Pentyl butyrate |
1142 |
N |
No safety concern |
(+/–)Heptan-3-yl acetate |
1143 |
N |
No safety concern |
(+/–)Heptan-2-yl butyrate |
1144 |
N |
No safety concern |
(+/–)Nonan-3-yl acetate |
1145 |
N |
No safety concern |
2-Pentyl acetate |
1146 |
N |
No safety concern |
1-Penten-3-one |
1147 |
N |
No safety concern |
1-Octen-3-one |
1148 |
N |
No safety concern |
2-Pentyl-1-buten-3-one |
1149 |
N |
No safety concern |
1-Penten-3-ol |
1150 |
N |
No safety concern |
1-Hexen-3-ol |
1151 |
N |
No safety concern |
1-Octen-3-ol |
1152 |
N |
No safety concern |
1-Decen-3-ol |
1153 |
N |
No safety concern |
(E,R)-3,7-Dimethyl-1,5,7-octatrien-3-ol |
1154 |
N |
No safety concern |
6-Undecanone |
1155 |
N |
No safety concern |
2-Methylheptan-3-one |
1156 |
N |
No safety concern |
a N, new specifications prepared
Flavouring agents considered for specifications only
No. |
Flavouring agent |
Specificationsa |
111 |
Lauric acid |
R |
113 |
Myristic acid |
R |
115 |
Palmitic acid |
R |
116 |
Stearic acid |
R |
182 |
Isoamyl laurate |
R |
310 |
Isopropyl isovalerate |
R |
390 |
gamma -Ionone |
R |
455 |
Butyl sulfide |
R |
476 |
Ethyl 3-methylthiopropionate |
R |
483 |
Ethyl thioacetate |
R |
490 |
Allyl thiopropionate |
R |
492 |
Methylthio 2-(acetyloxy)propionate |
R |
493 |
Methylthio 2-(propionyloxy) propionate |
R |
540 |
1,6-Hexanedithiol |
R |
542 |
1,9-Nonanedithiol |
R |
551 |
2-Mercaptopropionic acid |
R |
553 |
Ethyl 3-mercaptopropionate |
R |
564 |
Dimethyl disulfide |
R |
566 |
Propyl disulfide |
R |
601 |
Ethyl 3-hydroxyhexanoate |
R |
602 |
Ethyl 3-oxohexanoate |
R |
606 |
Laevulinic acid |
R |
608 |
Butyl levulinate |
R |
609 |
1,4-Nonanediol diacetate |
R |
614 |
Diethyl malonate |
R |
616 |
Dimethyl succinate |
R |
617 |
Diethyl succinate |
R |
622 |
Diethyl tartrate |
R |
624 |
Diethyl sebacate |
R |
625 |
Dibutyl sebacate |
R |
626 |
Ethylene brassylate |
R |
627 |
Aconitic acid |
R |
642 |
3-Phenylpropyl hexanoate |
R |
678 |
alpha -Amylcinnamyl isovalerate |
R |
729 |
Dihydroxyacetophenone |
R |
745 |
5-Methylfurfural |
R |
752 |
2-Phenyl-3-carbethoxyfuran |
R |
814 |
alpha-Methylphenethyl butyrate |
R |
817 |
4-(para-Tolyl)-2-butanone |
R |
847 |
Benzyl 2,3-dimethylcrotonate |
R |
861 |
Glyceryl tribenzoate |
R |
862 |
Propylene glycol dibenzoate |
S |
866 |
Tolualdehydes (mixed ortho, meta and para) |
R |
870 |
Butyl para-hydroxybenzoate |
S |
872 |
Anisyl formate |
R |
910 |
3-Oxohexanoic acid diglyceride |
R |
911 |
3-Oxooctanoic acid glyceride |
R |
914 |
3-Oxodecanoic acid glyceride |
R |
915 |
3-Oxododecanoic acid glyceride |
R |
916 |
3-Oxotetradecanoic acid glyceride |
R |
917 |
3-Oxohexadecanoic acid glyceride |
R |
918 |
Glyceryl monostearate |
R,T |
919 |
Glyceryl monooleate |
R,T |
921 |
Glyceryl tripropanoate |
S |
922 |
Tributyrin |
S |
923 |
Glycerol 5-hydroxydecanoate |
S,T |
924 |
Glycerol 5-hydroxydodecanoate |
S,T |
926 |
Propylene glycol stearate |
R |
937 |
Pyruvaldehyde |
S,T |
943 |
Acetaldehyde ethyl cis-3-hexenyl acetal |
R |
954 |
Ethyl vanillin propylene glycol acetal |
R |
955 |
4-Hydroxybenzyl alcohol |
N |
956 |
4-Hydroxybenzaldehyde |
N |
957 |
4-Hydroxybenzoic acid |
N |
958 |
2-Hydroxybenzoic acid |
N |
959 |
4-Hydroxy-3-methoxy benzoic acid |
N |
960 |
Vanillin erythro- and threo-butan-2,3-diol acetal |
N |
a |
R, existing specifications revised; S, existing specifications were maintained; T, the existing, new, or revised specifications are tentative and new information is required. |
Flavouring agents for which confirmation of flavour use was required
The Committee could not complete its evaluation of 18 substances at its fifty-seventh meeting, pending confirmation that they were in current use as flavouring agents. The Committee received information from the flavour industry on these substances, and concluded that flavour uses have been established for 16 of them. The conclusions of the Committee are summarized in the following table.
No. |
Flavouring agent |
Evaluation based on current intake as a flavouring agent |
850 |
Benzoic acida |
No safety concern |
861 |
Glyceryl tribenzoate |
No safety concern |
862 |
Propylene glycol dibenzoate |
No safety concern |
870 |
Butyl-para-hydroxybenzoate |
No safety concern |
909 |
Glycerolb |
Evaluation not finalized, pending definition of ‘flavouring agent’ |
914 |
3-Oxodecanoic acid glyceride |
No safety concern |
915 |
3-Oxododecanoic acid glyceride |
No safety concern |
916 |
3-Oxotetradecanoic acid glyceride |
No safety concern |
917 |
3-Oxohexadecanoic acid glyceride |
No safety concern |
918 |
Glyceryl monostearatec |
No safety concern |
919 |
Glyceryl monooleatec |
No safety concern |
920 |
Triacetind |
No safety concern |
921 |
Glyceryl tripropionate (Tripropionin) |
No safety concern |
922 |
Tributyrin |
No safety concern |
923 |
Glycerol 5-hydroxydecanoate |
No safety concern |
924 |
Glycerol 5-hydroxydodecanoate |
No safety concern |
925 |
Propylene glycole |
Evaluation not finalized, pending definition of ‘flavouring agent’ |
926 |
Propylene glycol stearatef |
No safety concern |
See Also: Toxicological Abbreviations