On July 19, 2023, the European Commission issued Regulation (EU) No 2023/1490, revising Cosmetic Regulation (EC) 1223/2009 and updating Annex II regarding the use of certain substances classified as carcinogenic, mutagenic or reproductive toxic (CMR).

This amendment is based on Article 15 of the Cosmetic Regulations, which prohibits the use of substances classified as CMR categories 1A, 1B, or 2 in cosmetics according to Part 3 of Annex VI to Regulation (EC) No 1272/2008 (CLP). If certain requirements are met and an exception application for use has been made, CMR substances can still be allowed to be used in cosmetics. The provisions of Article 15 of the Regulations on the Administration of Cosmetics ensure the uniformity of legislation related to CMR substances, provide legal certainty for competent authorities and economic operators, and protect human health.

The latest amendment (EU) 2023/1490 to the Cosmetic Regulations covers substances classified as CMR categories 1A, 1B, or 2 in the revised Commission Regulation (EU) 2022/692 of Annex VI Part 3 of the CLP. There are no exceptional requirements for the use of these substances in cosmetics. This amendment includes an update to Article 1024 of Annex II of the Cosmetic Regulations, which prohibits the use of salts of 2-ethylhexanoic acid (Chemical Abstracts Society number: 149-57-5) as part of this provision. In addition, Annex II of the Cosmetic Regulations has added 29 new substances. These updates will take effect from December 1, 2023.

According to Article 13 of the new EU Cosmetics Regulation (EC) No 1223/2009, information related to cosmetics needs to be reported in the CPNP notification system. Starting from July 11, 2013, cosmetics are required to pass mandatory CPNP notification before they can be marketed and sold in the European Union. However, successful notification does not necessarily mean that the product meets all other requirements of Regulation (EC) No 1223/2009.

The definition of EU cosmetics: Cosmetics are products that are applied, sprayed, or other similar methods to any external part of the human body (skin, hair, nails, lips, and external genitalia), or substances or mixtures of teeth and oral mucosa, in order to achieve cleansing, remove unpleasant odors, skincare, beauty, and decoration, except for products that are solely for treatment or disease prevention. The definition of mucosa: refers to the area near the eyes, lips, mouth, or external reproductive organs, but does not include cosmetics that come into brief contact with the skin. Leave on products: Cosmetics will stay on the skin, hair, or mucous membranes for a period of time. Rinse off products refer to cosmetics that are quickly rinsed off upon contact with the skin, hair, or mucous membranes.