TAGS: Hair Care Sun Care Decorative Cosmetic Toiletries
The European Commission requests SCCS (Scientific Committee on Consumer Safety) for a scientific opinion on the safety of TiO2 in cosmetic products.
TiO2 Used as Opacifying Agent
Titanium dioxide (TiO
2) (CAS/EC No. 13463-67-7/236-675-5, 1317-70-0/215-280-1, 1317-80- 2/215-282-2) is a white, insoluble, inert substance with a high refractive index. In its microcrystalline form, it is used as a white pigment or opacifying agent in make-up, skin care, hair, and oral products.
In addition, since TiO
2 absorbs and scatters both UVA and UVB rays is it also used as an inorganic UV filter primarily in sunscreens, but also in day creams, foundations, and lip balms, to provide protection against UV radiation. The introduction of colorless, ultrafine nanoparticles of TiO
2 improved its application on the skin while maintaining and enhancing its UV-filter properties.
TiO
2 is authorized both as colorant under entry 143 of Annex IV and as UV filter under entries 27 and 27a (nano form) of Annex VI to Regulation (EC) No. 1223/2009 (Cosmetics Regulation). In light of its classification as a Carcinogen, Category 2 (i.e., suspected human carcinogen) by inhalation route only and its inclusion in Annex VI to Regulation (EC) No. 1272/2008 (CLP Regulation) TiO
2 was re-assessed by the SCCS.
Subsequently, entry 321in Annex III was introduced and additional provisions in the existing entries of 143 of Annexes IV and 27 and 27a of Annex VI were added that further restricted the use of TiO
2 in cosmetic products.
Concern for Genotoxicity
In March 2021, the Panel on Food Additives and Flavorings (FAF Panel) of the European Food Safety Authority (EFSA) issued an opinion on the safety of TiO
2 (E171) as a food additive. In particular, based on new relevant scientific evidence considered by the panel to be reliable.
Including data obtained with TiO
2 nanoparticles and data from an extended one-generation reproductive toxicity (EOGRT) study, the panel indicated that a concern for genotoxicity could not be ruled out. In light of this and given the many uncertainties, the panel concluded that E171 should no longer be considered safe when used as a food additive.
In May 2022, the Commission services received a dossier submitted by the industry accompanied by a comprehensive and up-to-date review of the genetic toxicity database for TiO
2 providing scientific evidence to demonstrate the safety of non-nano (pigmentary) and nano form of TiO
2 in cosmetic products.
The Commission requests the SCCS to re-assess the safety of TiO
2 with a focus on genotoxicity and exposure via the inhalation and oral route (lip care, lipstick, toothpaste, loose powder, hair spray) since the currently available scientific evidence supports the overall lack of dermal absorption of TiO
2 particles.
Source: European Commission
