The European Commission has revised Annex V of the Cosmetics Regulation, imposing stricter labeling requirements for substances that release formaldehyde in cosmetic products.
Businesses have until tomorrow to update their inventories with compliant products and until July 31, 2026, to deplete their existing stock. After these deadlines, all products must adhere to the new regulations.
Consultant Critical Catalyst points out that the CLP Regulation (Regulation (EC) No. 1272/2008) classifies formaldehyde as a skin sensitizer (Category 1) and a carcinogen (Category 1B). It is included in Annex II (List of Substances Prohibited in Cosmetic Products, entry 1577) of the European Cosmetics Regulation (Regulation (EC) No. 1223/2009), which prohibits its use in cosmetic items.
However, certain preservatives known as “formaldehyde releasers,” which are permitted in cosmetics and listed in Annex V of the Cosmetics Regulation, can gradually release formaldehyde to help preserve the final product.
New Requirements
The amendment, detailed in Commission Regulation (EU) 2022/1181, requires that any finished product containing formaldehyde releasers must carry the warning “releases formaldehyde” if the total concentration of formaldehyde exceeds 0.001% (10 ppm).
This change aligns with the 2021 recommendations from the Scientific Committee on Consumer Safety (SCCS), which determined that the previous threshold of 0.05% (500 ppm) was inadequate to protect consumers sensitive to formaldehyde. To better safeguard these individuals, the SCCS recommended lowering the labeling threshold to 0.001% (10 ppm).
Continued Presence of Formaldehyde
A multi-year study by the European Network of Official Cosmetics Control Laboratories (OCCLs) discovered formaldehyde in cosmetic products, despite it being a banned skin sensitizer and presumed carcinogen. The study analyzed over 1,000 products from nine different countries.
OCCLs expressed concern over consumer safety and labeling practices in the cosmetics sector, stating, “When traces of formaldehyde cannot be ruled out, market surveillance authorities will need to scrutinize the labeling requirements for the products in question.”
The study found an overall compliance level regarding formaldehyde presence was “good.” However, 16% of the tested cosmetics that contained formaldehyde at levels exceeding 10 ppm failed to disclose this ingredient on their labels.
In the United States, Washington State has enacted the 2023 Toxic-Free Cosmetics Act (HB 1047), which will ban hazardous substances, including PFAS, phthalates, formaldehyde, and lead, in cosmetics by 2025.
Last October, the FDA suggested it might prohibit formaldehyde and other formaldehyde-releasing chemicals in hair relaxers, as noted in a proposal in the Unified Agenda, a government registry outlining actions that administrative agencies plan to take. However, Good Morning America recently reported that the agency has postponed its consideration, leaving the timeline for addressing the proposal unclear.
Uterine Cancer Controversies
In 2022, the National Institutes of Health ignited a debate within the industry by stating that women who use chemical hair straightening products containing formaldehyde may have a heightened risk of developing uterine cancer.
The Cosmetic, Toiletry and Perfumery Association contested these findings, claiming that “hair straightening products are safe and do not cause cancer.”
In a similar vein, the Personal Care Products Council — which represents approximately 90% of the beauty industry in the U.S. — responded to the warning by asserting that “the fundamental principle of epidemiology is that association does not imply causation; one does not necessarily lead to the other.”
