Monday, July 31, 2023European Commission

The European "New Allergens" Regulation has been published!

Le Règlement européen "Nouveaux allergènes" est publié !

The European Union has just published Regulation 2023/1545, which concerns the labelling of fragrance allergens on cosmetic products. It imposes compulsory labelling of a total of 80 substances identified as allergens, and comes into force from July 2026.

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Key points of Regulation 2023/1545

• This Regulation is the consequence of the SCCS Opinion of 26 and 27 June 2012 which confirmed that the labelling requirement for fragrance allergens was still relevant, and identified 56 additional fragrance allergens to be labelled. It was already following this Opinion that Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde (HICC), Atranol and Chloroatranol had been banned by Regulation 2017/1410.
• The text updates certain INCI names, CAS and EC numbers, and groups certain substances under the same INCI name.
• It amends 17 entries in Annex III of Regulation 1223/2009, and adds 45 others.
• All the substances concerned must be labelled in the list of ingredients on the packaging as soon as their concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products.
• In total, the list of labellable allergens now has 80 entries.
• These provisions come into force on 31 July 2026 for products placed on the market, and on 31 July 2028 for products made available on the market.

The “Whereas” of Regulation 2023/1545

(1) Fragrance substances are organic compounds with characteristic, usually pleasant, odours. They are widely used in perfumes and other perfumed cosmetic products, but also in many …

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