Monday, June 27, 2022SCCS

Request to the SCCS to re-evaluate the safety of Titanium Dioxide

Demande de ré-évaluation de la sécurité du Titanium dioxide au CSSC

Following the EFSA (European Food Safety Agency) opinion concluding that titanium dioxide was not considered safe as a food additive, the European Commission has now asked the SCCS to re-evaluate its safety for use in certain cosmetic products. The Scientific Committee on Consumer Safety accepted this mandate at its plenary meeting on 21-22 June 2022 and has nine months to deliver its Opinion.

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Titanium Dioxide (TiO2) (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 TiO2 absorbs and scatters both UVA and UVB rays is it also used as inorganic UV-filter primarily in sunscreens, but also in day creams, foundations and lip balms, to provide protection against UV radiation. The introduction of colourless, ultrafine nanoparticles of TiO2 improved its application on the skin while maintaining and enhancing its UV-filter properties.

TiO2 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) TiO2 was re-assessed by the SCCS. Subsequently, entry 321 in Annex III was introduced and additional provisions in the existing entries of 143 of Annexes IV and 27 and 27a of Annex VI …

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