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Home > Nanotechnology Columns > Bergeson & Campbell, P.C. > EC Amends Cosmetics Regulation To Allow Use Of Titanium Dioxide (Nano) as UV Filter

Lynn L. Bergeson
Managing Director
Bergeson & Campbell, P.C.

Abstract:
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.

July 21st, 2016

EC Amends Cosmetics Regulation To Allow Use Of Titanium Dioxide (Nano) as UV Filter

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. See http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2016.189.01.0040.01.ENG&toc=OJ:L:2016:189:TOC 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 users 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.

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