AMENDMENT TO THE PREAMBLE OF ANNEX V TO REGULATION (EC) NO 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL REGARDING THE PRESENCE OF FORMALDEHYDE IN COSMETIC PRODUCTS.

Formaldehyde has been classified as a carcinogen and a skin sensitizer in Part 3 of Annex VI to Regulation (EC) No 1272/2008(2).

According to Article 15 of Regulation (EC) No 1223/2009, substances classified as carcinogenic of category 1B in that Annex are to be prohibited from use in cosmetic products. Therefore, the use of formaldehyde as such has been prohibited in cosmetic products and is currently listed in entry 1577 of Annex II to Regulation (EC) No 1223/2009.

Anyway, Annex V to Regulation (EC) No 1223/2009 contains a list of substances allowed for use in cosmetic products as preservatives and some of those preservatives gradually release formaldehyde in order to fulfil a preserving function in the final cosmetic product.

In order to inform consumers about the presence of formaldehyde that may trigger an allergic reaction, it is set out in point 2 of the preamble of Annex V to Regulation (EC) No 1223/2009 that all finished products containing substances which release formaldehyde need to be labelled with the warning “contains formaldehyde”.

This warning is to be used where the concentration of formaldehyde in the finished product exceeded 0,05 %; however the Scientific Committee on Consumer Safety (SCCS) in May 2021 concluded that the present threshold of 0,05 % (500 ppm) does not sufficiently protect consumers sensitized to formaldehyde and that in order to protect the vast majority of those consumers, the threshold for the labelling requirement should be reduced to 0,001 % (10 ppm), considering the total formaldehyde released in a product.

Point 2 to the Preamble of Annex V to Regulation (EC) No 1223/2009 will then be updated accordingly.

Nevertheless, in order to give the industry a reasonable period of time to make the required adjustments, all finished products which comply with Regulation (EC) No 1223/2009 as applicable on 30 July 2022 may 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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