The Regulation 2016/1143 of 13 July 2016, published in Official Journal of the European Union on 14 July, amends Annex VI to Cosmetics Regulation 1223/2009, to introduce Titanium Dioxide in its nano-form, and make it an authorised UV-filter, except in spray products.
The whereas of Regulation 2016/1143
(1) Titanium dioxide is authorised both as a colorant under entry 143 of Annex IV to Regulation (EC) No1223/2009 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) No1223/2009, the substances listed in Annexes III to VI to that Regulation do not cover nanomaterials, 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% w/w, 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 products should not pose any significant risk to the consumer.
(3) The characteristics indicated by the SCCS in its opinion concern the physico-chemical …
