REGULATION (EC) NO 1223/2009 AND CMR SUBSTANCES
Regulation (EC) No 1272/2008, commonly called CLP Regulation, provides for a harmonized classification of substances as carcinogenic, mutagenic or toxic for reproduction (CMR) based on an opinion prepared by the Committee for Risk Assessment of the European Chemicals Agency (ECHA). Depending on the level of evidence of their CMR properties, substances are classified as CMR substances of category 1A, 1B or category 2.
By default, the use of substances classified as CMR (under the CLP Regulation) is banned according to Article 15 of the European Cosmetics Regulation (Regulation (EC) No 1223/2009). Nevertheless, a CMR substance may be used in cosmetic products, by way of exception, if specific conditions are fulfilled.
With the aim of implementing the prohibition of CMR substances, ensure legal compliance (particularly for economic operators and national competent authorities) and to ensure a high level of protection of human health, these compounds are included in Annex II (list of substances prohibited in cosmetics products) or Annex III (list of substances which cosmetic products must not contain except subject to the restrictions laid down) of the EU Cosmetics Regulation. A CMR substance may also be deleted from Annexes III to VI of the Regulation for these purposes.
COMMISSION DELEGATED REGULATION (EU) 2022/692
On May 3rd 2022, the Commission Delegated Regulation (EU) 2022/692 was published in the Official Journal of the European Union. It amends the CLP Regulation for the purposes of its adaptation to technical and scientific progress.
ECHA has received proposals to introduce harmonized classification and labelling of certain substances and to update or delete harmonized classification and labelling of other substances. Taking into those proposals and comments received from the parties concerned, RAC adopted several opinions on those proposals.
The Commission Delegated Regulation (EU) 2022/692 includes new or updated classification for 12 chemicals that may be used as cosmetic ingredients. Seven out of these 12 are now classified as carcinogenic, mutagenic or toxic to reproduction (CMR). This means that these 7 ingredients may be prohibited or restricted in cosmetic products marketed in the EU in the future.
The ingredients used in cosmetics which are now classified as CMR are the following:
- Benzophenone (CAS number: 119-61-9)
- Teophylline (CAS number: 58-55-9)
- Melamine (CAS number: 108-78-1)
- Azadirachta Extracts (CAS number: 84696-25-3)
- Trimethylolpropane Triacrylate (CAS number: 15625-89-5)
- Pentetic Acid (CAS number: 67-43-6)
- Pentasodium pentetate (CAS number: 140-01-2)
The Commission Delegated Regulation shall enter into force on the twentieth day following that of its publication and shall apply from 1 December 2023.
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- Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
- Commission Delegated Regulation (EU) 2022/692 of 16 February 2022 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures