New European Cosmetics Regulation Amendment: Formaldehyde Releasers

Cosmetic products in the EU must be labelled "contains formaldehyde" where formaldehyde is present at levels greater than 0.001%

The World Trade Organization has been notified about draft amendments to Annex V of the European Cosmetics Regulation (EC) 1223/2009 on labelling cosmetic products containing formaldehyde-releasing preservatives. The proposed updates would require warnings on finished products with formaldehyde concentrations over 0.001%, down from 0.05%. Manufacturers will need to add this warning to existing products, where applicable, or reformulate to ensure formaldehyde release is below this threshold, yet still ensuring products are adequately preserved. Publication of the new EU regulation will likely follow in the first half of 2022. Manufacturers of cosmetic products and brand owners must ensure their products are compliant with this new labelling requirement expected to take effect from 2024.

Preservatives such as DMDM hydantoin, Imidazolidinyl urea, and Diazolidinyl urea, which are commonly used in cosmetic products, are known to release formaldehyde to fulfill a preserving function in the finished product.

While formaldehyde is prohibited in cosmetic products and cannot be added intentionally, formaldehyde-releasing preservatives are permitted provided they are listed on Annex V of the Cosmetics Regulation and used within the restrictions noted there.

Currently, products known to contain or release formaldehyde require the warning "contains formaldehyde" where the concentration of formaldehyde in the finished product exceeds 0.05%. In 2020, the European Commission received additional information suggesting formaldehyde exposure below 0.05% could induce contact dermatitis in sensitized individuals. Considering these new data, the EU Scientific Committee on Consumer Safety (SCCS) issued an opinion concluding that the current threshold does not sufficiently protect consumers and should be reduced from 0.05% to 0.001%.

The EU Commission has proposed a transition period of 24 months for products to be placed on the market and then a further 24 months to sell through existing stock. The responsible person for any affected products must ensure that products are tested to confirm levels of free formaldehyde and labelled where required according to the timescales provided in the amendment. Therefore, if the new regulation were to be published in June 2022, products containing greater than 0.001% formaldehyde can still continue to be sold but must be labelled "contains formaldehyde" by June 2024. Since this is only a transitional arrangement, any non-compliant products must be sold or removed from sale by June 2026.

There is currently no equivalent change planned to the UK Cosmetics Regulation. However, this regulation will be implemented in Northern Ireland.

How Exponent Can Help

Exponent's experts in chemical and cosmetic regulations are ready to help manufacturers and brands selling products in the EU keep their products legal and compliant by carrying out thorough formulation reviews. We continuously monitor changes to regulations, actively scanning the horizon for future trends in ingredient restrictions and providing our clients with timely updates and advice.