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Cosmetic Days - Sun protection
Monday, September 19, 2022European Commission

Publication of the 5th Regulation on CMRs

Publication du 5e Règlement CMR

The European Union has just published Regulation 2022/1531, the 5th annual text aiming to ban or regulate substances recently classified as CMR. It confirms the entry of 14 new substances in Annex II (banned substances) to the Cosmetics Regulation 1223/2009, provides for new use restrictions for Methyl Salicylate (fragrance ingredient) and corrects Annexes II and V for the entries concerning Sodium hydroxymethylglycinate (preservative).

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This Regulation deals with substances classified as CMR by Regulation 2021/849 (17th ATP to CLP), which will apply from 17 December 2022.

Key points of Regulation 2022/1531

• 14 new entries are added to Annex II (prohibited substances) to Cosmetics Regulation 1223/2009. Of these, only two have INCI names, Methylene Di-t-Butylcresol and MIBK.
• Methyl Salicylate (fragrance ingredient) is added to Annex III (restricted substances) to limit its maximum permitted concentrations in the different product categories.
• The entries for Sodium Hydroxymethylglycinate in Annexes II and V are amended to clarify the rules for this preservative.
• This Regulation enters into force on the same date as the ATP it transposes, 17 December 2022.

The “Whereas” of Regulation 2022/1531

1) Regulation (EC) No.1272/2008 of the European Parliament and of the Council provides for a harmonised classification of substances as carcinogenic, mutagenic or toxic for reproduction (CMR) based on a scientific assessment by the Risk Assessment Committee of the European Chemicals Agency. The substances are classified as CMR substances of category 1A, CMR substances of category 1B or CMR substances of category 2 depending on the level of evidence of their CMR properties.

2) Article 15 of Regulation (EC) No.1223/2009 provides …

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