Re-evaluation of titanium dioxide (E 171) as a food additive

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Article
titanium dioxide, E 171, anatase, rutile, food colour
First published in the EFSA Journal
14 settembre 2016
Adopted
28 giugno 2016
Type
Scientific Opinion
Abstract

The present Opinion deals with the re-evaluation of the safety of titanium dioxide (TiO2, E 171) when used as a food additive. From the available data on absorption, distribution and excretion, the EFSA Panel on Food Additives and Nutrient Sources added to Food concluded that the absorption of orally administered TiO2 is extremely low and the low bioavailability of TiO2 appears to be independent of particle size. The Panel concluded that the use of TiO2 as a food additive does not raise a genotoxic concern. From a carcinogenicity study with TiO2 in mice and in rats, the Panel chose the lowest no observed adverse effects levels (NOAEL) which was 2,250 mg TiO2/kg body weight (bw) per day for males from the rat study, the highest dose tested in this species and sex. The Panel noted that possible adverse effects in the reproductive system were identified in some studies conducted with material which was either non-food-grade or inadequately characterised nanomaterial (i.e. not E 171). There were no such indications in the available, albeit limited, database on reproductive endpoints for the food additive (E 171). The Panel was unable to reach a definitive conclusion on this endpoint due to the lack of an extended 90-day study or a multigeneration or extended-one generation reproduction toxicity study with the food additive (E 171). Therefore, the Panel did not establish an acceptable daily intake (ADI). The Panel considered that, on the database currently available and the considerations on the absorption of TiO2, the margins of safety (MoS) calculated from the NOAEL of 2,250 mg TiO2/kg bw per day identified in the toxicological data available and exposure data obtained from the reported use/analytical levels of TiO2 (E 171) would not be of concern. The Panel concluded that once definitive and reliable data on the reproductive toxicity of E 171 were available, the full dataset would enable the Panel to establish a health-based guidance value (ADI).

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
Panel on Food Additives and Nutrient Sources Added to Food
Contact
fip [at] efsa.europa.eu
doi
10.2903/j.efsa.2016.4545
EFSA Journal 2016;14(9):4545 [83 pp.].
Question Number
On request from
European Commission
Print on demand
Number of Pages
83