Commission Regulation (EU) 2022/1181: warning for products containing Formaldehyde releasers modified.
On the 8th of July 2022, the European Commission published the Commission Regulation (EU) 2022/1181. This publication amends the preamble of Annex V to Regulation (EC) No 1223/2009. The modification lowers the current threshold for labelling formaldehyde from 500 to 10 ppm.
Formaldehyde is forbidden by the Cosmetics Regulation (EC) No 1223/2009, is included in Annex II (List of Substances Prohibited in Cosmetic Products), and is classified as a carcinogen (category 1B) and a skin sensitiser (Category 1), according to CLP Regulation (Regulation (EC) No. 1272/2008).
Some preservatives allowed in cosmetic products fulfil their function since they are Formaldehyde releasers, preserving the final cosmetic product. Substances such as DMDM hydantoin, Imidazolidinyl Urea, and Diazolidinyl Urea, commonly used in cosmetic products, are known to release formaldehyde to fulfil a preserving function in the finished product.
Formaldehyde is prohibited in cosmetic products (entry 1577 of Annex II of the Cosmetic Regulation) and cannot be intentionally added, but formaldehyde-releasing substances are permitted, they are listed on Annex V of the Cosmetics Regulation and have to be used within the restrictions given.
According to the previous regulation, these products must be labelled with the warning ‘contains formaldehyde’ when the amount of released formaldehyde was more than 0.05% in the final product, to communicate the presence of the substance and avoid allergic reactions to sensitised customers.
Recently, the SCCS concluded that the present threshold of 0.05% (500 ppm) does not sufficiently protect consumers sensitised to formaldehyde from exposure to free formaldehyde at cosmetic products, and concluded that the threshold should be reduced to 0.001% in order to protect the consumers. This threshold should apply to the final product. This SCCS opinion was adopted by the European Commission with the published Regulation to amend the preamble of Annex V (List of Preservatives Allowed in Cosmetic Products).
On July 8th, the European Commission published the Regulation (EU) 2022/1181 amending the preamble of Annex V to Regulation (EC) No 1223/2009. This amendment of the Cosmetics Regulation states the following:
“All finished products containing substances which are listed in this Annex and which release formaldehyde shall be labelled with the warning “releases formaldehyde” where the total concentration of formaldehyde released in the finished product exceeds 0,001 % (10 ppm), irrespective of whether the finished product contains one or more substances releasing formaldehyde.”
So, the formaldehyde threshold to be labelled at cosmetic products was lowered as proposed by the SCCS.
The EU Commission proposed a transition period of 24 months for the products to be placed on the market and an extension of 24 months to sell the existing stock.
“However, all finished products containing substances referred to in the first subparagraph which comply with Regulation (EC) No 1223/2009 as applicable on 30th July 2022 may be placed on the Union market until 31st July 2024 and be made available on the Union market until 31 July 2026.”
Any affected product must be revised and the brands must ensure that products comply with this amendment. Products in compliance with the old regulation can be placed on the market until July 2024, and these products can remain on the shelves since July 2026.
At this moment, there is currently no equivalent change planned to the UK Cosmetics Regulation, however, this regulation will be implemented in Northern Ireland, as being part of the EU.
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