Titanium dioxide – new SCCS opinion

Here is it! The new opinion of the Scientific Committee on Consumer Safety – SCCS No. SCCS/1617/20 concerning the safety of titanium dioxide was released on October 8^th. The current opinions of the SCCS concerned mainly titanium dioxide as a UV filter in its nano-form (opinion no. SCCS/1516/13 of 2013 and opinion no. SCCS/1583/17 of 2018). Earlier, in 2000, there appeared an opinion of the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) with the number SCCNFP/0005/98. It confirmed the safety of using titanium dioxide as a UV filter at a maximum concentration of 25%. In contrast, the latest SCCS publication for the first time focuses on pigmented TiO₂ materials. The current classification of titanium dioxide as Carc. 2 (suspected of causing cancer by inhalation) has caused quite a confusion in the cosmetics industry. Does the latest SCCS opinion dispel these concerns?

Let’s start with the versatile use of titanium dioxide in cosmetics. This raw material is a naturally occurring inorganic compound obtained from ilmenite, rutile and anatase. It is commonly used in cosmetics as a white pigment (so-called titanium white), an opacifier and a physical UV filter. For decades, TiO₂ has been mainly used in makeup, sunbathing, hair, skin and oral care cosmetics. Taking into account the current legal status, titanium dioxide is included in:

• Annex IV (list of colorants allowed in cosmetic products) of the Regulation 1223/2009 – Titanium dioxide (entry 143, CI marking: 77891). Conditions of use: purity criteria must be as set out in Commission Directive 95/45/EC (E 171),
• Annex VI (list of UV filters allowed for use in cosmetic products) of the Regulation 1223/2009:
  • Position 27: Titanium dioxide; the maximum concentration in ready for use preparation is 25.0%;
  • Position 27a: Titanium dioxide (nano); the maximum concentration in ready for use preparation is also 25.0%. In addition, there are numerous other conditions for the use of nano-titanium dioxide, which can be read here: https://www.cosmeticscare.eu/en/titanium-dioxide-climbazole-and-a-new-preservative-changes-in-the-regulation-1223-2009/

Except from cosmetic applications, this substance is also widely used in pharmacy and as a food colourant.

As various scientific and regulatory bodies have considered titanium dioxide as a potential human carcinogen after inhalation exposure, this has led to many challenges and discussions in the cosmetics industry. Following the recommendation of the RAC (The European Risk Assessment Committee), on October 4^th, 2019, the European Commission adopted the classification of titanium dioxide as Carc. 2 (suspected of causing cancer, by inhalation; in powder form containing 1% or more of particles with aerodynamic diameter ≤ 10 μm). It should be remembered that this classification is based only on the inhalation route of exposure, and that no carcinogenic effects were found for oral and dermal exposure. In addition, carcinogenicity has been shown in animals (rats) but has not been confirmed by epidemiological studies in humans.

Therefore, the SCCS Committee took a closer look at the safety of using titanium dioxide in cosmetic products with inhalation exposure. So, what are the conclusions of the latest SCCS/1617/20 opinion?

• The SCCS concluded that the use of pigmentary TiO₂ in a conventional hair styling aerosol spray is safe up to a maximum concentration of 1.4% for general consumers and up to 1.1% for professional users – in this case: hairdressers;
• The safety assessment showed that the use of titanium white in loose powders (in a typical face makeup application) is safe for the general consumer up to a maximum concentration of 25%.

These conclusions only apply to pigmentary TiO₂ in products that may give rise to consumer exposure by the inhalation route (i.e. aerosol, spray and powder cosmetics). Moreover, the conclusions of the SCCS were drawn from a very selected group of cosmetic products based on only one type of TiO₂ material (pigmentary, anatase, surface-treated). So what about the other uses of TiO₂ pigmentary materials in other similar cosmetics? The SCCS is of the opinion that pigmentary titanium dioxide can also be considered safe in similar products. A prerequisite, of course, is that margins of safety are properly calculated as described in this SCCS Opinion. This margin of safety should be > 25 for both general and professional users (hairdressers) for cumulative use of different products.

In summary, the latest SCCS opinion provides information on the maximum and safe limit of titanium white concentrations in such products as: hair styling sprays and face powders. The focus was on this type of cosmetics due to inhalation exposure, which may lead to a potential carcinogenic risk of titanium dioxide. It seems that at the moment we can be calm about the use of titanium white in products that do not cause exposure to this substance by inhalation, e.g. nail polishes or eye shadows. Nevertheless, the cosmetics industry is likely to grapple with the bad reputation of titanium dioxide and the attribution of carcinogenic properties to, for example, solid products that do not pose such a risk. Will the cosmetics industry be forced to look for alternative “substitutes” for titanium dioxide? Time will tell…

I encourage you to read the full SCCS opinion at the link: https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_238.pdf