Warning threshold on the label for formaldehyde content in cosmetic products

Proposal to lower the level from 0,05% to 0,001%

Formaldehyde is a substance classified as Carcinogen 1B and Skin sensitizer 1. It is listed in Annex II/1577 of Reg. (EC) 1223/2009, so it is forbidden in cosmetic products. However, a number of substances listed in Annex V release formaldehyde in order to achieve a preservative function. For this reason, products containing formaldehyde releaser (FR) preservatives must be labelled with the warning “contains formaldehyde” where the concentration of free formaldehyde in the final product exceeds 0,05%. FR substances are, for example, DMDM Hydantoin, Imidazolidinyl Urea, Diazolidinyl Urea, Polyoxymethylene Urea, Sodium Hydroxymethylglycinate and Glyoxal. Those substances are quite commonly used in nail and hair products.

In 2020 the Commission received additional information suggesting that formaldehyde exposure to levels below 0,05% could cause contact dermatitis in persons with formaldehyde allergy. In the light of data provided, the commission asked in February 2021 the SCCS if the 0,05% threshold for labelling FR substances adequate to protect consumers and if considered necessary to change it.

In May 2021 SCCS published an opinion in response to the Commission request. SCCS stated that the 0,05% threshold is insufficient to protect the formaldehyde-sensitive subjects and proposed to reduce the threshold from 0,05% to 0,001%. This new threshold applies to the total free formaldehyde irrespective of whether a product contains one or more formaldehyde releasers, both for leave-on and rinse-off products.

This new restriction is likely to be adopted soon questioning product formulations containing FRs and new analyses on free formaldehyde will be needed.