Scientific Opinion on the re-evaluation of Indigo Carmine (E 132) as a food additive


Panel on Food Additives and Nutrient Sources Added to Food
EFSA Journal
EFSA Journal 2014;12(7):3768 [51 pp.].
Panel members at the time of adoption
Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Alicja Mortensen, Pasquale Mosesso, Dominique Parent-Massin, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes.

The Panel wishes to thank the members of the Working Group "A" Food Additives and Nutrient Sources (2011-2014): Pierre Galtier, Rainer Gürtler, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Pasquale Mosesso, Dominique Parent-Massin, Ivan Stankovic, Christina Tlustos and Matthew Wright for the preparatory work on this scientific opinion and, EFSA staff: Ana Rincon, Stavroula Tasiopoulou and Alexandra Tard for the support provided to this scientific opinion.

Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
4 July 2014
Published in the EFSA Journal
25 July 2014
European Food Safety Authority (EFSA), Parma, Italy

The ANS Panel provides a scientific opinion re-evaluating the safety of Indigo Carmine (E132). The Panel observed that Indigo Carmine was poorly absorbed and does not raise concern for genotoxicity. No adverse effects in subacute, chronic, reproduction and developmental toxicity studies, and no modifications of haematological and biological parameters in chronic toxicity studies have been identified at doses less than or equal to 500 mg/kg bw/day. The only report of an adverse effect was in testis with a LOAEL of 17 mg/kg bw/day which would give rise to a safety concern if confirmed. The Panel considered that this study has shortcomings since it is not clear to the Panel whether the adverse effects observed were due to the food additive itself or to impurities and/or contaminants present in the material tested and/or to the conduct of the study. The Panel considered that the current ADI of 5 mg/kg bw/day for Indigo Carmine was applicable to a material with the same purity and manufacturing process as material used in studies without adverse effects on testis (93% pure colouring and 7% volatile matter) and concluded that any extension of this ADI to Indigo Carmine of lower purity and/or manufactured using a different process would require new data which would need to address the adverse effects on testis. The Panel noted that at the MPL, exposure estimates of Indigo Carmine would exceed the ADI for toddlers and children at the high level. Exposure estimates using the available usage and analytical data did not show an exceedance of the ADI for any population groups.

Indigo Carmine, Indigotine, E 132, disodium 3,3'dioxo-2,2'-bi-indolylidene-5,5'-disulphonate, food additive, EINECS 212-728-8, FD&C Blue No. 2
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