At what concentration in the finished product must the warning “Contains formaldehyde” appear on the label of a cosmetic? The regulation currently sets it at 0.05%, but this threshold could be reviewed: the European Commission has just asked the SCCS to re-evaluate it. The Scientific Committee accepted this mandate by written procedure on 12 February 2021.
Background
Formaldehyde (CAS No.50-00-0, EC No.200-001-8) was classified as a carcinogen substance of category 1B by Commission Regulation (EU) No.605/2014; in addition, the substance is also classified as skin sensitizer Cat. 1 (H317 - May cause an allergic skin reaction).
In November 2014, the SCCS concluded in its Opinion SCCS/1538/141Opinion SCCS/1538/141 that nail hardeners with a maximum concentration of about 2.2% of free formaldehyde can be used safely to harden or strengthen nails.
However, the discussions in the Working Group on Cosmetic Products concluded that suitable alternative substances were available and hence a derogation request under Art. 15(2) was rejected. Consequently, the Commission Regulation (EU) No.831/2019 delisted formaldehyde from Annex V (preservatives) and added to the list of substances prohibited in cosmetic products in Annex II (entry 1577).
Annex V contains a number of substances that are releasing formaldehyde in order to achieve a preserving function on the final cosmetic product (so called formaldehyde releasers). In addition, point 2 of the preamble of Annex V requires that:
“All finished products containing substances in this Annex and which release formaldehyde must be labelled with the warning ‘contains formaldehyde’ where the concentration of formaldehyde in the …
