Regulation 2019/1857 of 6 November 2019, published in the Official Journal of the European Union on 7 November 2019, amends Annex VI (UV-Filter) of Cosmetics Regulation 1223/2009 to authorize three new coatings for titanium dioxide in its nano form. The provision is effective immediately (20 days after the publication of the text).
The whereas of Regulation 2019/1857
Titanium dioxide is currently allowed as a UV-filter in cosmetic products, including in the form of nanomaterial. Titanium dioxide (nano) is listed in entry 27a of Annex VI to Regulation (EC) No.1223/2009. It is allowed at a maximum concentration of 25% in ready for use preparation, except in applications that may lead to exposure of the end user’s lungs by inhalation and subject to the characteristics listed in the entry.
The characteristics listed in entry 27a of Annex VI concern the allowed physico-chemical properties of titanium dioxide (nano) and the substances with which it can be coated.
The Scientific Committee on Consumer Safety (SCCS) concluded in an opinion of 7 March 2017, corrected on 22 June 2018, that the use of the three forms of titanium dioxide (nano) under assessment, coated with either silica and cetyl phosphate (up to 16% and 6%, respectively), alumina and manganese dioxide (up to 7% and 0.7%, respectively), or alumina and triethoxycaprylylsilane (up to 3% and 9%, respectively), can be considered safe for use in cosmetic products intended for application on healthy, intact or sunburnt skin. The SCCS added that this conclusion, however, does not apply to applications that might …