The European Commission amended the Regulation on Cosmetic Products (1223/2009) which sets safety and marketing rules for cosmetics in the European Union to add nano titanium dioxide to the list of authorised UV filters (Annex VI).
Nanoparticles of titanium dioxide are known for their increased effectiveness in filtering ultraviolet irradiation and their transparent aspect, for this reason they are an ideal candidate for skin protection products.
On the basis of a revised opinion of the Scientific Committee on Consumer Safety (SCCS) where the experts acknowledged the fact that ‘the use of titanium dioxide (nano) in dermally applied cosmetic products should not pose any significant risk to the consumer’, the EC added the substance to the list.
The entry however specifies that spray applications should be avoided and forbids the use of this substance ‘in applications that may lead to exposure of the end-user's lungs by inhalation’.
The regulation requires that nanoscale titanium dioxide used as UV filters have the following characteristics:
- ‘purity ≥ 99 %,
- rutile form, or rutile with up to 5 % anatase, with crystalline structure and physical appearance as clusters of spherical, needle, or lanceolate shapes,
- median particle size based on number size distribution ≥ 30 nm,
- aspect ratio from 1 to 4,5, and volume specific surface area ≤ 460 m2/cm3,
- coated with Silica, Hydrated Silica, Alumina, Aluminium Hydroxide, Aluminium Stearate, Stearic Acid, Trimethoxycaprylylsilane, Glycerin, Dimethicone, Hydrogen Dimethicone, Simethicone;
- photocatalytic activity ≤ 10 % compared to corresponding non-coated or non-doped reference,
- nanoparticles are photostable in the final formulation.’
Since July 2013, the Regulation requires pre-market notification for nanomaterials used in cosmetic products and the labelling thereof with the word of ‘nano’ in brackets.
Follow this link for the Regulation of 13 July 2016 amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products, and this link for the Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.