The European Commission (EC) published on July 14, 2016, a regulation in the Official Journal of the European Union that amends Annex VI, the list of ultraviolet (UV) filters allowed in cosmetic products, of the cosmetics regulation. Under the amendment, the entry for titanium dioxide is revised to state that the combined use of titanium dioxide and titanium dioxide (nano) must not exceed 25 percent maximum concentration in ready-for-use preparation. The amendment also adds an entry for titanium dioxide (nano), stating that it must not exceed 25 percent maximum concentration in ready-for-use preparation. Titanium dioxide (nano) is not to be used in applications that may lead to exposure of the end user’s lungs by inhalation. Only nanomaterials having the following characteristics are allowed:
- Purity ≥ 99 percent;
- Rutile form, or rutile with up to 5 percent anatase, with crystalline structure and physical appearance as clusters of spherical, needle, or lanceolate shapes;
- Median particle size based on number size distribution ≥ 30 nanometers (nm);
- Aspect ratio from 1 to 4.5, and volume specific surface area ≤ 460 square meters per cubic meter (m2/cm3);
- Coated with silica, hydrated silica, alumina, aluminum hydroxide, aluminum stearate, stearic acid, trimethoxycaprylylsilane, glycerin, dimethicone, hydrogen dimethicone, or simethicone;
- Photocatalytic activity ≤ 10 percent compared to corresponding non-coated or non-doped reference, and
- Nanoparticles are photostable in the final formulation.