On 3 November 2021 the EU Official Journal published Commission Regulation (EU) 2021/1902, an amendment to the Cosmetics Regulation (EC) No. 1223/2009, which bans several carcinogenic, mutagenic, or toxic for reproduction (CMR) substances from being used in cosmetic products. The modification will enter into force on 23 November 2021 but will start to apply as of 1 March 2022.
In 2020 several substances were given harmonized classifications as carcinogenic, mutagenic, or toxic for reproduction by the 15th Adaptation to Technical Progress to the Classification, Labeling, and Packaging (CLP) Regulation (Commission Delegated Regulation (EU) 2020/1182).
To uniformly ban CMR substances on the EU market and to ensure a high level of protection of human health, Commission Regulation (EU) 2021/1902 prohibits these CMR substances from being used in cosmetic products.
In particular, the regulation adds 23 new entries to Annex II (List of Prohibited Substances), which now contains in total 1,680 entries (compared to 1,657 entries in the previous version).
Because some of the newly banned substances have authorized exceptions for use in cosmetic products, the amending regulation also introduces the following modifications:
Annex III: List of Restricted Substances
- 2-(4-tert-butylbenzyl)propionaldehyde (entry No. 83) and zinc pyrithione (entry 101) are deleted
- Water-soluble zinc salts (entry No. 24), with the exception of zinc 4-hydroxy-benzenesulphonate and zinc pyrithione, is revised in order to make an editorial change for zinc pyrithione
Annex V: List of Allowed Preservatives
- Zinc pyrithione (entry No. 8) is deleted
- Sodium hydroxymethylamino acetate (entry No. 51) is revised in order to take into consideration the new entry No. 1669 of Annex II banning products in which the maximum theoretical concentration of releasable formaldehyde is ≥ 0.1% w/w
Concerning the ban of zinc pyrithione, Regulation (EU) 2021/1902 highlights that despite the opinion of the Committee on Consumer Safety (SCCS) that the substance can be used safely as an anti-dandruff ingredient in rinse-off hair products up to a maximum concentration of 1%, the conditions for exceptional authorization laid down in Article 15(2) of the Cosmetics Regulation (EC) No. 1223/2009 have not been met. In particular, it has not been proven that the use of zinc pyrithione in rinse-off hair products is justified by the non-availability of other alternative substances.
Starting 1 March 2022 economic operators in the cosmetic industry (primarily manufacturers and importers) need to comply with the new regulatory requirements. In addition, they need to assess their products and, if necessary, ensure compliance by changing their product formulations. They also are advised to update their internal databases in order to take into consideration the newly banned ingredients.