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Monday, May 27, 2024Regulation

SCCS' Scientific Advice on Titanium Dioxide : final version

Avis scientifique du CSSC sur le Titanium dioxide : version finale

Following the EFSA (European Food Safety Agency) opinion concluding that titanium dioxide was not considered safe as a food additive, the European Commission asked the SCCS to re-evaluate its safety for use in certain cosmetic products. The Scientific Committee on Consumer Safety has just published the preliminary version of its Scientific Advice.

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Background

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 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 European Cosmetics Regulation (EC) No.1223/2009.
In light of its classification as a Carcinogen Category 2 (i.e. suspected human carcinogen) by inhalation route only, 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 were added that further restricted the use of TiO2 in cosmetic products.
In March 2021, the Panel on Food Additives and Flavourings (FAF Panel) of the European Food Safety Authority (EFSA) issued an opinion on the safety of TiO2 (E171) as a food additive and indicated that a concern for genotoxicity could not be ruled out.
In June 2022, the European Commission européenne requested the SCCS to re-asses the safety of TiO2 ewith focus on genotoxicity and exposure via the inhalation and oral route (lip care, lipstick, toothpaste, loose powder, hair spray).
The SCCS published the preliminary version of its Scientific Advice in December 2023.

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