Published this month on August 7, the preliminary opinion assessed whether use of titanium dioxide (TiO2) was safe to use in cosmetics as a UV filter, colourant or ingredient, considering current data and the European Commission's recent classification of nano form TiO2 as a category-2 carcinogen by inhalation.
Titanium dioxide (TiO2) safety in cosmetics
It was earlier this year that the European Commission (EC) classified TiO2 as a category-2 carcinogen by inhalation under Annex VI of EC Regulation 1272/2008 when used in powder form containing 1% or more of particles with an aerodynamic diameter of ≤ 10 µm. The EC ruled that from September 2021, products containing nano form TiO2 at such levels would have to carry cancer warnings on the label or specific notes to inform users of precautionary measures that needed to be taken to minimise hazard.
The SCCS conducted its safety evaluation on use of TiO2 in cosmetics and published its preliminary opinion following a dossier submission with additional data from Cosmetics Europe in January 2020 supporting the safety of non-nano form TiO2 according to Article 15(1) in EC Cosmetics Regulation No. 1223/2009.
So, is non-nano form TiO2 safe in cosmetics as a colourant, ingredient and UV filter?
Inhalation risk still considered, even for pigmentary TiO2
The SCCS’s preliminary opinion concluded that use of pigmentary TiO2 up to a maximum concentration of 25% was safe in make-up applications as a loose powder. However, it concluded that use at these concentrations in aerosol sprays for general consumers or hairdressers was not safe.
“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).”
The SCCS said use of TiO2 in typical hair styling aerosol spray products was therefore only safe at maximum concentrations of 1.64% for general consumers and 1% for hairdressers.
It added that despite the suggestion from Cosmetics Europe that nano form TiO2 was “not relevant for this submission”, the current safety assessment had taken nano form TiO2 into consideration because pigmentary materials – manufactured with average particle sizes of > 100 nm – “also contain a significant fraction of nano-scale particles”.
“In the SCCS’s view, safety assessment of such a fraction is crucially important for the estimation of inhalation exposure of the alveolar region of the lungs,” it wrote.
The SCCS said its opinion was not applicable to any pearlescent pigment because of the composite nature of such materials where TiO2 was “only a minor constituent”.
Use of TiO2 in other cosmetic applications?
The SCCS said it was important to note that conclusions had 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.”
The SCCS said other applications of pigmentary TiO2 could be considered safe only if the Margin of Safety (MoS) calculation was performed with results of above 25 for general consumers and hairdressers.
The comment period on the SCCS preliminary opinion will remain open until September 7, 2020.