NEW EC Request on the safety of Titanium Dioxide (nano) in sunscreens and personal care sprays

On 14th September 2015, the European Commission requested a scientific opinion on the safety of the nano form of Titanium Dioxide (TiO2) when used as UV-Filter in sunscreens and personal care spray products.

Scientific background

Titanium Dioxide (CAS/EC numbers 13463-67-7/236-675-5, 1317-70-0/205-280-2, 1317-80-2/215-282-2) is an ingredient  allowed in beauty care products on the European beauty products market as a colorant according to the Annex IV/143 of the Cosmetic Regulation EC  1223/2009 and as a UV-Filter according to the Annex VI/27. The European cosmetic regulation restricts the use of TiO2 as UV-Filter to a maximum concentration in ready-for-use preparation of 25%.

In July 2013, with the Opinion SCCS/1516/13, the Scientific Committee on Consumer Safety has concluded that the use of TiO2 nanomaterial, with the characteristics as indicated in the opinion, at a concentration up to 25% as a UV-filter in sunscreens, can be considered to not pose any risk of adverse effects in humans after application on healthy, intact or sunburnt skin. This, however, does not apply to applications that might lead to inhalation exposure to TiO2 nanoparticles (such as powders or sprayable products).

In September 2014, with the Opinion SCCS/1539/14, the SCCS clarified that the concern expressed in the previous Opinion shall apply to spray applications that might lead to exposure of the consumer’s lungs to TiO2 nanoparticles by inhalation.

New data provided by the beauty products industry in July 2015 lead the European Commission to make the following requests.

Terms of reference

  • In light of the data provided, does the SCCS consider Titanium Dioxide (nano) safe when used as UV-Filter in sunscreens and personal care spray products at a concentration up to 5.5%?
  • Does the SCCS have any further scientific concerns regarding the use of Titanium Dioxide (nano) when used as UV-Filter in sunscreens and personal care spray products?

Future developments

Cosmetics manufacturers and their designated EU Responsible Person shall closely follow the developments of the SCCS safety evaluation on the mentioned ingredient in order to ensure the beauty product safety and its regulatory compliance.

If you want to know more about product safety regulations and product regulatory compliance contact us.

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