Publication of the Amendments to the EU Cosmetics Regulation on Zinc Oxide and Potassium Hydroxide

BIORIUS is pleased to inform you that the amendments to the EU Cosmetics Regulation on Zinc Oxide and Potassium Hydroxide finally got published.

The publication of new amendments is not always the synonym of bad news and these two modifications of the EU Cosmetics Regulation annexes have been eagerly awaited for years.

The first one (EU No 621/2016) officially recognizes the use of Zinc Oxide as a UV filter and Annex VI of the EU Cosmetics Regulation has been updated accordingly. Both the normal and the nano forms can now be used as a UV filter at up to 25% (except in applications that may lead to exposure of the end-user’s lungs by inhalation where the use of Zinc Oxide is not allowed).

In addition, the use of the nano form is conditioned by several strict purity criteria:

  • purity ≥ 96 %, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or isometric shapes, with impurities consisting only of carbon dioxide and water, whilst any other impurities are less than 1 % in total
  • median diameter of the particle number size distribution D50 (50 % of the number below this diameter) > 30 nm and D1 (1 % below this size) > 20 nm  water solubility < 50 mg/L
  • uncoated, or coated with triethoxycaprylylsilane, dimethicone, dimethoxydiphenylsilanetriethoxycaprylylsilane crosspolymer, or octyl triethoxy silane.

In case both forms are used in the same products, the maximum use level of 25% applies to the combination of normal and nano Zinc Oxide.

Please, note that Annex IV of the legislation has not been amended yet, which means that (at least in theory) the use of nano Zinc Oxide as a colorant is still regulated by the provisions of Article 16 on the notification of nanomaterials to the EU Commission.

The second amendment (EU No 622/2016) officially recognizes the use of Potassium Hydroxide as a callosity softener/remover and Annex III was updated to highlight this change. The maximum use level of Potassium Hydroxide in this product category is 1.5% and the following precautionary use statements must be labeled: Contains alkali, Avoid contact with eyes, Keep out of reach of children Read directions for use carefully.

Any questions?