SCCS Opinion on new coating for Titanium Dioxide (nano form)

SCCS members: U. Bernauer (Chairperson and co-rapporteur), L. Bodin, Q. Chaudhry (co-rapporteur), P.J. Coenraads, E. Gaffet, E. Panteri, M. Stepnik, S. Wijnhoven
SCHEER member: W.H. de Jong
SCCS external experts: N. von Goetz, H. Louro 
Contact: SANTE-SCCSec [dot] europa [dot] eu (SANTE-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1667/24
Adopted on: 25 October 2024

Conclusion of the opinion:

(1) In light of the data provided, does the SCCS consider safe the use of Titanium Dioxide (nano) coated with a combination of w/w 6% Aluminium Hydroxide, 14% Sodium Myristoyl Sarcosinate and 10% Dimethicone, for use as UV filter in dermally applied cosmetic products?

Considering all the provided information, the SCCS is of the view that there are a number of uncertainties and data gaps that do not allow a conclusion on the safety of titanium dioxide (nano) coated with a combination of w/w 6% Aluminium Hydroxide, 14% Sodium Myristoyl Sarcosinate and 10% Dimethicone (Eclipse 70) - either on the basis of a similarity to the TiO2 nanomaterials previously assessed by the SCCS, or on the basis of the additional information provided in the current submission and during the commenting period.

(2) Does the SCCS have any further scientific concerns regarding the use of Titanium Dioxide (nano) coated with the above-mentioned materials when used as UV-filter in dermally applied cosmetic products?

The provided information has not demonstrated a similarity of the titanium dioxide with the above-mentioned composite coating (Eclipse 70) to other TiO2 nanomaterials assessed in the previous SCCS Opinion (SCCS/1516/13 - Revision of 22 April 2014) in terms of physicochemical characteristics, stability of the coating, and the lack of dermal absorption of the nanoparticles. If these aspects cannot be addressed, additional data on physicochemical, toxicological and exposure aspects specifically relating to the nanomaterial under evaluation (Eclipse 70) will be needed to conclude on the safety of its use in cosmetic products.

Keywords:

SCCS, scientific opinion, TiO2, coatings, nano, CAS/EC numbers 13463-67-7/236-675-5, 1317-70-0/215-280-1, 1317-80-2/215-282-2, Regulation 1223/2009

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Final Opinion on new coating for Titanium Dioxide (nano form), 25 October 2024, SCCS/1667/24.