EC Requests SCCS for Scientific Opinion on Titanium Dioxide (Nano) as UV-filter

European Commission Seeks SCCS Expertise on Titanium Dioxide (Nano) Coating for Dermally Applied Cosmetic UV-Filters

In a recent development, the European Commission has formally requested the Scientific Committee on Consumer Safety (SCCS) to provide a scientific opinion on the novel coating for Titanium Dioxide (nano form) (Sodium Myristoyl Sarcosinate, CAS No. 30364-51-3/EC No. 250-151-3) proposed for use as a UV-filter in dermally applied cosmetic products.

Background Overview

Titanium Dioxide, denoted as TiO2, holds multiple authorizations: as a colorant under entry 143 of Annex IV, a UV-filter under entry 27 of Annex VI, and in powder form under entry 321 of Annex III to Regulation (EC) No 1223/2009.

Back in July 2013, the Scientific Committee on Consumer Safety (SCCS) conducted a safety assessment on Titanium Dioxide (nano), affirming that its use as a UV-filter, at concentrations up to 25%, demonstrated no discernible risk of adverse effects on humans when applied to healthy, intact, or sunburnt skin. This assessment acknowledged specific coatings deemed safe for TiO2 (nano) in the SCCS opinion.

However, the SCCS specified that the use of other coatings not covered in their assessment could be permissible, contingent upon the applicant demonstrating their safety and confirming that these coatings do not alter particle properties relevant to behavior and effects compared to those already assessed.

Recent Development and Request

In August 2023, the Commission received a dossier regarding a new nano-form of TiO2 material, known as Eclipse 70, coated with ‘Aluminum Hydroxide’, ‘Sodium Myristoyl Sarcosinate’, and ‘Dimethicone’. While the coatings of ‘Aluminum Hydroxide’ and ‘Dimethicone’ had undergone SCCS assessment in 2014, the ‘Sodium Myristoyl Sarcosinate’ coating remained unexplored.

As part of the comprehensive safety evaluation, the Commission has urged the SCCS to assess the safety of ‘Sodium Myristoyl Sarcosinate’ (CAS No. 30364-51-3/EC No. 250-151-3) as a coating for Titanium Dioxide (nano). The evaluation will consider the provided information, focusing on physico-chemical properties (aligned with Tables 1-3 of the SCCS/1516/13 opinion) and data on dermal penetration.

Terms of Reference and Deadline

The SCCS will address two key questions:

1. Does the SCCS deem the use of Titanium Dioxide (nano) coated with a combination of 6% Aluminum Hydroxide, 14% Sodium Myristoyl Sarcosinate, and 10% Dimethicone as safe for application as a UV-filter in dermally applied cosmetic products?

2. Are there additional scientific concerns that the SCCS wishes to highlight regarding the use of Titanium Dioxide (nano) coated with the aforementioned materials as a UV-filter in dermally applied cosmetic products?

The SCCS has been given a 9-month timeframe to deliver its scientific opinion.

Supporting Documents

The Commission has provided the SCCS with a submission dossier from Miyoshi Europe SAS dated August 2023, along with a folder containing relevant references.

For those seeking alternative UV-filters, an extensive database comprising 1700+ options is available for exploration. Stay tuned for further updates on this pivotal evaluation impacting the landscape of dermally applied cosmetic products.