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 finished product exceeds 0.05%.”
This …
