Opinion on titanium dioxide (nano form) coated with cetyl phosphate, manganese dioxide or triethoxycaprylylsilane as UV-filter in dermally applied cosmetic
Titanium Dioxide, TiO2, (CAS/EC numbers 13463-67-7/236-675-5, 1317-70-0/205-280-2, 1317-80-2/215-282-2) is authorized both as colorant under entry 143 of Annex IV and as UV-filter under entry 27 of Annex VI to Regulation (EC) No 1223/2009. In July 2013, the Scientific Committee on Consumer Safety (SCCS) delivered an Opinion on Titanium Dioxide (nano) (SCCS/1516/13) to assess the safety of the nano form of Titanium Dioxide. In the Opinion, the SCCS concluded that the use of Titanium Dioxide (nano) as UV filter in sunscreens, with the characteristics indicated in the Opinion, and at a... concentration of up to 25 %, can be considered not to pose any risk of adverse effects in humans after application on healthy, intact or sunburnt skin. Among the characteristics reported in the SCCS Opinion (SCCS/1516/13), substances considered safe for use as coating for TiO2 (nano) are indicated. Consequently as for the use of other coatings not covered in the Opinion, the SCCS concluded that: ‘Other cosmetic ingredients applied as stable coatings on TiO2 nanomaterials can also be used, provided that they can be demonstrated to the SCCS to be safe and the coatings do not affect the particle properties related to behaviour and/or effects, compared to the nanomaterials covered in this Opinion’. The SCCS conclusion clarifies that for the use of a substance as coating on TiO2 nanomaterials, the applicant has to demonstrate that properties/behaviour of the particles with the new coating are not significantly different compared to those already covered in the SCCS Opinion. This would require provision of data on physico-chemical properties (in line with those provided in Tables 1-3 of the SCCS/1516/13 opinion), and data on dermal penetration. In September 2015, the Commission' services received data from industry in order to assess the safety of the following additional coatings for Titanium Dioxide (nano form) used as UV-filter in dermally-applied cosmetic products: - Cetyl Phosphate (CAS 3539-43-3) - Manganese Dioxide (CAS 1313-13-9) - Triethoxycaprylylsilane (CAS 2943-75-1).