Follow-up of the re-evaluation of indigo carmine (E 132) as a food additive.
E 132
EINECS 212‐728‐8
FD&C Blue No. 2
Indigo Carmine
Indigotine
aniline
disodium 3,3‐dioxo‐2,2‐bi‐indolylidene‐5,5‐disulfonate
food additive
Journal
EFSA journal. European Food Safety Authority
ISSN: 1831-4732
Titre abrégé: EFSA J
Pays: United States
ID NLM: 101642076
Informations de publication
Date de publication:
Jul 2023
Jul 2023
Historique:
medline:
28
7
2023
pubmed:
28
7
2023
entrez:
28
7
2023
Statut:
epublish
Résumé
Indigo carmine (E 312) was re-evaluated in 2014 by the EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). The ANS Panel confirmed the acceptable daily intake (ADI) of 5 mg/kg body weight (bw) per day for indigo carmine allocated by JECFA (1975). The ANS Panel indicated that the ADI was applicable to a material with a purity of 93% pure colouring and manufactured using processes resulting in comparable residuals as material used in the Borzelleca et al. studies (1985, 1986) and Borzelleca and Hogan (1985) which were the basis for deriving the ADI. The ANS Panel considered that any extension of the ADI to indigo carmine of lower purity and/or manufactured using a different process would require new data to address the adverse effects on the testes observed in the Dixit and Goyal (2013) study. Following a European Commission call for data to submit data to fill the data gaps, an IBO submitted technical and toxicological data. Considering the technical data, the EFSA Panel on Food Additives and Flavourings (FAF Panel) recommended some modifications of the existing EU specifications for E 132, mainly to lower the limits for toxic elements. Considering the toxicological data, an IBO has submitted a 56-day dietary study to address the adverse effects on testes using a material with 88% purity. The results of this study submitted did not confirm the severe adverse effects observed in the Dixit and Goyal study. Considering all the available information, the Panel confirmed the ADI of 5 mg/kg bw per day for indigo carmine (E 132) disodium salts, meeting the proposed revisions of the specifications (85% minimum for the colouring matter). The Panel concluded that there is no safety concern for the use of indigo carmine (E 132) disodium salts at the reported use levels and submitted analytical data.
Identifiants
pubmed: 37502014
doi: 10.2903/j.efsa.2023.8103
pii: EFS28103
pmc: PMC10369292
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e08103Informations de copyright
© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.
Références
Food Chem Toxicol. 1985 Jun;23(6):551-8
pubmed: 4040101
FAO Nutr Meet Rep Ser. 1975;(55):1-204
pubmed: 819295
Toxicol Appl Pharmacol. 1966 Jan;8(1):29-36
pubmed: 5950860
Mutat Res. 1991 Dec;264(4):155-62
pubmed: 1723492
EFSA J. 2017 Oct 17;15(10):e05042
pubmed: 32625325
Food Chem Toxicol. 1985 Aug;23(8):719-22
pubmed: 4043877
Food Chem Toxicol. 1986 Feb;24(2):159-63
pubmed: 3957164
Arch Toxikol. 1965 Jun 10;21(1):9-29
pubmed: 5836490
FAO Nutr Meet Rep Ser. 1970;(46A):1-161
pubmed: 5525818
EFSA J. 2021 Aug 03;19(8):e06769
pubmed: 34377191