Titanium Dioxide (TiO2) in Cosmetics: Regulatory Updates and Restrictions
Titanium dioxide (TiO2) is a chemical compound appearing as a colourless to white crystalline powder. Thanks to its high refractive index, it is used in many sectors, ranging from food to pharmaceuticals, construction materials and paints.
In cosmetics
Titanium dioxide (TiO2) is allowed in cosmetic products under Regulation EC 1223/2009 both as a colourant, under entry 143 of Annex IV, and as a UV filter, under entries 27 and 27a of Annex VI for the nanomaterial form. Ingredients classified as nanomaterials are subject to dedicated procedures both for notification and labelling, and the SCCS pays particular attention to their safety profile and consumer risk.
In July 2013, the SCCS issued an opinion on TiO2 (nano) and concluded that its use as a UV filter in sunscreens up to 25% does not pose a risk to human health. In the same opinion, however, the SCCS considered the use of TiO2 (nano) in products that may lead to inhalation exposure, such as powders and sprays, as not safe.
Carcinogenic?
The European Chemicals Agency’s Risk Assessment Committee (RAC) published an opinion in September 2017 recommending classification of TiO2 as a category 2 carcinogen, that is, a suspected carcinogen for humans, only by inhalation. Following this recommendation, on 4 October 2019 the European Commission adopted this classification for TiO2 for the purposes of the CLP Regulation.
The European Commission therefore requested the SCCS to carry out a safety assessment on TiO2 in order to adopt any necessary measures. The SCCS issued an opinion based on three inhalation carcinogenicity studies in rats identified after a broad literature review.
The SCCS considers that the CMR2 classification of TiO2 cannot be disregarded once an official body has reached a classification conclusion and the Commission has included it in the CLP Regulation. In the absence of conclusive evidence to the contrary, the carcinogenic effects observed in animals must therefore be considered potentially relevant to humans. Although the exact mode of action is not fully clarified, an inflammatory process and an indirect genotoxic effect related to ROS generation appear to be the main mechanisms explaining TiO2-induced effects.
Conclusions
The SCCS assessed the use of titanium dioxide in hair styling spray products as safe up to a maximum concentration of 1.4% for the general consumer and 1.1% for hairdressers. The safety assessment also showed that the use of pigmentary TiO2 in loose powder products up to a maximum concentration of 25% is safe for the general consumer.
These conclusions are specifically linked to the safety assessment of TiO2 in the context of its possible classification as a category 2 carcinogen by inhalation. This means the conclusions apply to uses of TiO2 in cosmetic products that may lead to inhalation exposure, such as aerosols, sprays and powder products.