June 8, 2021
by Percefoni Doufou-Shafiq, Ph.D.
On May 26, 2021, the EC published amendment (EU) No 2021/850 to Cosmetics Regulation (EC) No 1223/2009, updating Annexes II, III, IV and VI to the Regulation.
Article 15 provision of the Cosmetics Regulation stated that substances classified as CMR categories 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 (CLP) are prohibited from use in cosmetic products. An exception to this provision is laid out in Article 15(1) or Article 15(2) of the Cosmetics Regulation. If certain requirements are met, a CMR substance can still be used in cosmetic products under restrictions. The provision of Article 15 of the Cosmetics Regulation ensures uniformity on implementation of legislation regarding CMR substances, provides legal certainty to competent authorities and economic operators, and protects human health.
Amendment (EU) No 2021/850 follows the (EU) 2020/217 CLP amendment with new CMR classifications for substances. For titanium dioxide, classified as a CMR substance in (EU) 2020/217, a request for an exception pursuant to Article 15(1) of the Cosmetics Regulation was made for its use in cosmetics.
Some of the changes due to Amendment (EU) No 2021/850 include:
- Prohibition of 13 substances including diisohexyl phthalate, 2-methylimidazole and others
- Addition in Annex III of Titanium dioxide in powder form containing 1% or more of particles with aerodynamic diameter ≤ 10 μm, following its classification as Carcinogen Category 2 (inhalation) with the following restriction:
- Face products in loose powder at 25% maximum concentration, only in pigmentary form
- Maximum concentration for hair aerosol sprays: general consumers 1.4% and professional use 1.1%
- Prohibited from use in other products that may lead to exposure of the end user’s lungs by inhalation
- Titanium dioxide is still authorized as a colorant in Annex IV entry 143 and as a UV filter in Annex VI entry 27 of the Cosmetics Regulation, but a reference to the restriction under Annex III is added.
- Update of entry 98 of Annex III — Salicylic acid, by allowing a 0.5% maximum concentration in body lotion, eye shadow, mascara, eyeliner, lipstick and roll-on deodorant.
The changes mentioned above take effect from Oct. 1, 2021.