European Commission reduces the threshold of specific warning ‘contains formaldehyde’ in cosmetic products.
European Commission published Regulation (EC) 2022/1181 to amend the threshold for the warning of ‘contains formaldehyde’ for formaldehyde-releasing substances in cosmetic products.
Currently, a specific warning ‘contains formaldehyde’ is required when the concentration of formaldehyde released exceeds 0.05% due to the presence of formaldehyde-releasing substances in the finished product. Considering the advice from SCCS opinion SCCS/1632/21 that the present threshold of 0.05% does not sufficiently protect consumers sensitized to formaldehyde, the European Commission decided to follow opinion from SCCS and reduces the threshold to 0.001%.
The regulation will come into force from 31 July 2022, while a transition period is given for industry to adopt the new requirement.
- From 31 July 2024, only finished product complying with new requirement shall be placed onto the Union Market.
- From 31 July 2026, only finished product complying with new requirement shall be made available in the Union Market.
|Point 2 to the Preamble of Annex V to Regulation (EC) 1223/2009|
|Current||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 %|
|Amendment||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.|
Formaldehyde (CAS No. 50-00-0) has been classified as a carcinogen (category 1B) and a skin sensitizer (category 1), and therefore, the use of formaldehyde as an intentionally added ingredient has been prohibited in cosmetic products under Annex II to Regulation (EC) No. 1223/2009
The new requirement has a lower threshold value for making this specific warning. Cosmetic players shall examine the cosmetic products containing formaldehyde releasers to determine the level of formaldehyde released in the products. In necessary, changes on product label by including specific warning before the end of transition period is needed.
Cosmetics & Hygiene - Technical Services Manager