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July 18, 2022

EC Requests Scientific Opinion on Titanium Dioxide in Cosmetic Products

Lynn L. Bergeson Carla N. Hutton

The Scientific Committee on Consumer Safety (SCCS) announced on June 22, 2022, that the European Commission (EC) asked that it reassess the safety of titanium dioxide with a focus on genotoxicity and exposure via the inhalation and oral route (lip care, lipstick, toothpaste, loose powder, hair spray) “since the currently available scientific evidence supports an overall lack of dermal absorption” of titanium dioxide particles.

The request notes that titanium dioxide is authorized both as a colorant under entry 143 of Annex IV and as an ultraviolet (UV) filter under entries 27 and 27a (nano form) of Annex VI to Regulation (EC) No. 1223/2009 (Cosmetics Regulation). The request states that in light of titanium dioxide’s classification as a Carcinogen Category 2 (i.e., suspected human carcinogen) by inhalation route only and its inclusion in Annex VI to Regulation (EC) No. 1272/2008 (Classification, Labeling, and Packaging (CLP) Regulation), SCCS has reassessed titanium dioxide. Subsequently, entry 321in Annex III was introduced and additional provisions in existing entries 143 of Annex IV and 27 and 27a of Annex VI were added that further restricted the use of titanium dioxide in cosmetic products.

As reported in our May 10, 2021, blog item, on May 6, 2021, the European Food Safety Association (EFSA) announced that E171 is no longer considered safe when used as a food additive. According to EFSA, “[a] critical element in reaching this conclusion is that we could not exclude genotoxicity concerns after consumption of titanium dioxide particles.”

According to the request, in May 2022, the EC received a dossier submission by industry accompanied by a comprehensive, up-to-date review of the genetic toxicity database for titanium dioxide “providing scientific evidence to demonstrate the safety of non-nano (pigmentary) and nano form” of titanium dioxide in cosmetic products.