Formaldehyde (CAS: 50-00-0) is classified as carcinogenic (Category 1B) and skin sensitising (CLP Reg 1272/2008, Annex VI) and is therefore prohibited in cosmetic products (Annex II/1577).
Annex V of the Cosmetics Regulation contains a list of substances permitted as preservatives, some of which (Imidazolidinyl urea, Diazolidinyl urea, DMDM Hydantoin…) may gradually release formaldehyde for the purpose of preserving the finished product.
In order to inform the consumer of the presence of this substance, the preamble to Annex V contains the obligation for these products to indicate the specific warning “contains formaldehyde”. when the concentration of formaldehyde in the finished product exceeds 0.05%.
In light of the latest SCCS evaluations, the Commission (Regulation 2022/1181) has determined that the limit for triggering the labelling obligation must be lowered to 0.001% (10 ppm).
The Regulation enters into force on 31 July 2022, however all products complying with Regulation 1223/2009 in force on 30 July 2022 can be placed on the Union market until 31 July 2024 and be made available on the Union market until 31 July 2026.
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