Thursday, December 17, 2015News

Titanium dioxide [nano] in Annex VI in 2016

© CosmeticOBS-L'Observatoire des Cosmétiques

The European Commission transmitted to WTO a draft regulation aimed to amend Annex VI to the Cosmetics Regulation 1223/2009. On the agenda: the entry of Titanium dioxide in its nano form in the list on authorized UV-filters. This text is planned to be adopted on second quarter 2016.

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Notification date

December 9, 2015


This draft Commission Regulation aims at authorizing titanium dioxide (nano) as a UV-filter in cosmetic products.

Text of the draft regulation

(1) Titanium dioxide is authorized both as a colorant under entry 143 of Annex IV to Regulation (EC) No 1223/2009 and as a UV-filter under entry 27 of Annex VI to that Regulation. In accordance with point (3) of the Preamble to Annexes II to VI to Regulation (EC) No 1223/2009, the substances listed in Annexes III to VI to that Regulation do not cover nano materials, except where specifically mentioned. Titanium dioxide (nano) is currently not regulated.

(2) According to the Opinion of the Scientific Committee on Consumer Safety (SCCS) of 22 July 2013, which was revised on 22 April 2014, the use of titanium dioxide (nano) as a UV-filter in sunscreens, with the characteristics as indicated in the opinion, and at a concentration up to 25%, can be considered to not pose any risk of adverse effects in humans after application on healthy, intact or sunburnt skin. In addition, considering the absence of a systemic exposure, the SCCS considers that the use of titanium dioxide (nano) in dermally applied cosmetic …

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