SCCS OPINION on Titanium dioxide (TiO2) used in cosmetic products that lead to exposure by inhalation - SCCS/1617/20, Final Opinion

SCCS OPINION on TTitanium dioxide (TiO2) used in cosmetic products that lead to exposure by inhalation - SCCS/1617/20, Final Opinion U. Bernauer, L. Bodin, Q. Chaudhry, (SCCS Chair), P.J. Coenraads (SCCS Vice-Chair and Chairperson of the WG), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogier (SCCS Vice-Chair), Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven (Rapporteur), A. Koutsodimou, A. Simonnard, W. Uter, N. von Goetz The SCCS adopted this document by written procedure on 6 October 2020 (67 Pages) Mise en ligne le 8 Octobre 2020 https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_238.pdf Conclusion of the opinion: 1. In light of the data provided and of the possible classification as Carcinogen Cat. 2 (inhalation) in Annex VI to Regulation (EC) n.1272/2008, does the SCCS consider Titanium dioxide safe when used as a UV-filter (entry 27 Annex VI) in cosmetic products up to a maximum concentration of 25 %, as a colorant (entry 143 Annex IV) and as an ingredient in all other cosmetic products? On the basis of safety assessment, the SCCS is of the opinion that the use of pigmentary titanium dioxide (TiO2) up to a maximum concentration of 25% in a typical hair styling aerosol spray product is not safe for either general consumers or hairdressers. The safety assessment has shown that the use of pigmentary TiO2 in loose powder up to a maximum concentration of 25% in a typical face make-up application is safe for the general consumer. It needs to be noted that these conclusions are based on safety assessment of TiO2 in the context of possible classification as category-2 carcinogen (via inhalation). This means that the conclusions drawn in this Opinion are applicable to the use of pigmentary TiO2 in a cosmetic product that may give rise to consumer exposure by the inhalation route (i.e. aerosol, spray and powder form products). As such, the Opinion is not applicable to any pearlescent pigment because of the composite nature of such materials, of which TiO2 is only a minor constituent. 2. Alternatively, if up to 25% use is not considered safe, what is according to the SCCS, the maximum concentration considered safe for use of Titanium dioxide as an ingredient in cosmetic products? In the SCCS’s opinion, the use of pigmentary TiO2 in a typical hair styling aerosol spray product is safe up to a maximum concentration of 1.4 % for general consumers, and 1.1 % for hairdressers. 3. Does the SCCS have any further scientific concerns with regard to the use of Titanium dioxide in cosmetic products? It needs to be emphasised that the SCCS conclusions have been drawn from a very selected group of cosmetic products based on only one type of TiO2 material (pigmentary, anatase, surface-treated). In the absence of more information, it may not be clear whether these conclusions would be applicable to the use of pigmentary TiO2 materials in other similar types of cosmetic applications that may be on the market. In this regard, the SCCS is of the opinion that other applications of pigmentary TiO2 materials can also be considered safe if the MoS calculation is performed as detailed in the current Opinion, and if the resultant MoS for the combined use of different products is above 25 for general consumers and for hairdressers. Keywords: SCCS, scientific opinion, Titanium dioxide (TiO2), Regulation 1223/2009, CAS/EC numbers 13463-67-7/236-675-5, 1317-70-0/215-280-1, 1317-80-2/215-282-2 Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Titanium dioxide (TiO2), preliminary version of 7 August 2020, final version of 6 October 2020, SCCS/1617/20