Background

Titanium Dioxide, TiO₂, (CAS/EC numbers 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, as UV filter under entry 27 of Annex VI, and in powder form in entry 321 of Annex III to Regulation (EC) No 1223/2009.

In July 2013, the SCCS issued the safety evaluation on Titanium Dioxide (nano) concluding that the use of Titanium Dioxide (nano) as UV-filter, at concentrations up to 25% and with the characteristics indicated in the opinion, can be considered not to pose any risk of adverse effects in humans after application on
healthy, intact or sunburnt skin. Among the characteristics reported in that opinion, the SCCS indicated the substances considered safe for use as coating for TiO₂ (nano).

Regarding the use of other coatings, not covered in the opinion, the SCCS concluded that for the use of a substance as coating on TiO₂ nanomaterials, the applicant has to demonstrate that properties/behaviour of the particles with the new coating are not significantly different compared to those already covered in the SCCS opinion. This would need provision of data on physico-chemical properties and data on dermal penetration.

In August 2023, the Commission’ services received a dossier related to a new nano-form of TiO₂ material (i.e., Eclipse 70) coated with ‘Aluminium Hydroxide’, ‘Sodium Myristoyl Sarcosinate’ and ‘Dimethicone’. ‘Aluminium Hydroxide’ and ‘Dimethicone’ coatings were already assessed by SCCS in 2014, while ‘Sodium Myristoyl Sarcosinate’ coating has not yet been assessed.

The Commission requested the SCCS to carry out a safety assessment on ‘Sodium Myristoyl Sarcosinate’ (CAS No. 30364-51-3/ EC No. 250-151-3) as a coating of Titanium Dioxide (nano) in light of the information provided.

What’s new?

In light of the information provided, the SCCS considers that the data is insufficient to conclude on safety of Titanium Dioxide (nano) coated with a combination of w/w of 6% aluminium hydroxide, 14% sodium myristoyl sarcosinate and 10% dimethicone (Eclipse 70).

The data provided do not demonstrate a similarity of the Titanium Dioxide with the above-mentioned composite coating (Eclipse 70) to other TiO₂ nanomaterials assessed in the previous SCCS Opinion (SCCS/1516/13 – Revision of 22 April 2014) in terms of physicochemical characteristics, stability of the coating, and the lack of dermal absorption of the nanoparticles.

If these aspects cannot be addressed, additional data on physicochemical, toxicological and exposure aspects specifically relating to the nanomaterial under evaluation (Eclipse 70) will be needed to conclude
on the safety of its use in cosmetic products.

References

Scientific Committee on Consumer Safety (SCCS) – Opinion on new coating for Titanium Dioxide (nano form), 20 May 2024, SCCS/1667/24