Last Updated on October 25, 2022 by Ithos Global Regulatory Team
EU Lowers Threshold for Labeling Formaldehyde Releasers in Cosmetics
The EU is lowering the threshold for labeling when formaldehyde releasers are present in cosmetics. The October 6, 2022 amendment of the European Cosmetics Regulation 1223/2009 drops the previous level of 0.05% (500 ppm) to 0.001% (10 ppm). This applies to the total formaldehyde released, regardless of whether a product contains one or more formaldehyde releasers.
While formaldehyde is rarely used in today’s cosmetic formulas, preservatives that release the chemical as an impurity in the presence of water are still common in many cosmetic products such as shampoos and creams, as well as topical medications and household cleaners.
All finished products containing substances which are listed in the Annex and which release formaldehyde must now be labeled with the warning “releases formaldehyde,” where the total concentration of formaldehyde released in the finished product exceeds 0,001 % (10 ppm).
Updated to reflect this change, the Ithos Information Network allows brands to quickly evaluate ingredient lists across their portfolio to determine which products are impacted by the new EU policy.
Whether leave-on or rinse-off, any product with releasers must include the specific label “contains formaldehyde.” According to the amendment, products not meeting the new limits may not be placed on the market after July 31, 2024. Further, non-compliant products must not be available for sale after July 31, 2026.
Common ingredients that may be affected by the change include:
In addition, Quaternium-15 is a formaldehyde releaser, now prohibited.
FDA Publishes Information on Formaldehyde Risks in Hair Smoothing Products
Concerned about how this change will affect your products? Contact us for a demo that shows how the Ithos Information Network can keep you up to date on changing regulations.
