According to the European Cosmetics Regulation (EC 1223/2009), the use of formaldehyde is prohibited in cosmetic products, and it is included in Annex II (List of Substances Prohibited in Cosmetic Products, entry 1577), as it is classified as a carcinogen (category 1B) and a skin sensitizer (Category 1) – CLP Regulation (Regulation (EC) No. 1272/2008).
Some preservatives that release formaldehyde are still allowed to be used. Formaldehyde-releasers were first put into cosmetics to keep them from spoiling and causing bacterial or fungal infections and to prolong their shelf life; and they are, essentially, substances that release formaldehyde over time, keeping the product fresh. In order to inform consumers sensitized to formaldehyde about its presence that may trigger an allergic reaction, it is set out (point 2, preamble of Annex V – EC 1223/2009) that all finished products containing substances listed and which release formaldehyde are to be labelled with the specific warning ‘contains formaldehyde’.
What’s new?
In May 2021, the SCCS (European Commission’s Scientific Committee on Consumer Safety) published a scientific advice on the threshold for the warning ‘contains formaldehyde’ in Annex V, concluding that the present threshold of 0.05% (500 ppm) does not sufficiently protect consumers sensitized to formaldehyde from exposure to free formaldehyde from formaldehyde releasers. Moreover, the SCCS concluded that this threshold should be reduced by a factor of 50, to 0.001% (10 ppm), in order to protect the vast majority of consumers.
In July 2022 the European Commission published the Commission Regulation (EU) 2022/1181 amending the preamble of Annex V to the Cosmetic Regulation with the aim of lowers the current threshold for labelling formaldehyde from 500 ppm to 10 ppm:
Article 1 – Point 2 to the Preamble of Annex V to Regulation (EC) No 1223/2009 is replaced by the following
“2. 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. However, all finished products containing substances referred to in the first subparagraph which comply with Regulation (EC) No 1223/2009 as applicable on 30 July 2022 may be placed on the Union market until 31 July 2024 and be made available on the Union market until 31 July 2026.”
How Mérieux NutriSciences perform the analysis?
Following the provisions in Article 12 of European Union Regulation (EC) No 1223/2009 for “reliable and reproducible” methods to be used in cosmetics testing, the European Network of Official Cosmetics Control Laboratories (OCCLs) has validated an analytical method for the determination of free formaldehyde in cosmetic products. The Mérieux NutriSciences CosmeticLAB performs the official method (Directive 90/207/CEE) to ensure the accuracy of the result.