EU tightens formaldehyde in cosmetics labeling requirements for consumer transparency

30 Jul 2024 --- The European Commission amends Annex V to the Cosmetics Regulation, introducing stricter labeling requirements for formaldehyde-releasing substances in cosmetic products.

Businesses have until tomorrow to update their inventory with compliant products and until July 31, 2026, to sell through their existing stock. After these dates, all products must comply with the new regulation.

Consultant Critical Catalyst notes that the CLP Regulation (Regulation (EC) No. 1272/2008) classifies formaldehyde as a skin sensitizer (Category 1) and a carcinogen (Category 1B). Formaldehyde is listed in Annex II (List of Substances Prohibited in Cosmetic Products, entry 1577) of the European Cosmetics Regulation (Regulation (EC) No 1223/2009), which forbids its use in cosmetic products.

However, certain preservatives, referred to as “formaldehyde releasers,” which are permitted in cosmetics and included in Annex V of the Cosmetics Regulation, can progressively release formaldehyde to preserve the finished cosmetic product.

New requirements
The amendment, outlined in Commission Regulation (EU) 2022/1181, mandates that any finished product containing formaldehyde releasers must be labeled with the warning “releases formaldehyde” if the total concentration of formaldehyde exceeds 0.001% (10 ppm).

The regulation notes the modification is in accordance with the 2021 advice of the Scientific Committee on Consumer Safety (SCCS), which concluded that the previous threshold of 0.05% (500 ppm) did not sufficiently protect consumers who were sensitized to formaldehyde. To protect these customers, the SCCS suggested lowering the labeling threshold to 0.001% (10 ppm).

The industry is given until 2026 to comply with updated formaldehyde labeling requirements.Formaldehyde still prevails
In a study spanning several years, the European Network of Official Cosmetics Control Laboratories (OCCLs) found formaldehyde in cosmetic products despite being a prohibited skin sensitizer and presumed carcinogen. The study involved over 1,000 products from nine countries.

OCCLs is concerned about consumer safety and labeling practices within the cosmetics industry. “When traces of formaldehyde cannot be ruled out, market surveillance authorities will need to look more closely into labeling requirements for the products concerned,” said the organization.

The study revealed a “good” overall compliance level regarding formaldehyde presence. However, 16% of the tested cosmetics containing formaldehyde at levels higher than 10 ppm did not declare the ingredient on their labels.

In the US, Washington State passed the 2023 Toxic-Free Cosmetics Act (HB 1047), which will ban hazardous chemicals, including PFAS, phthalates, formaldehyde and lead, in cosmetics by 2025.

The FDA suggested it may ban formaldehyde and other formaldehyde-releasing chemicals in hair relaxers last October with a proposal in the Unified Agenda, a government registry of actions that administrative agencies plan to issue. However, Good Morning America recently said the agency has delayed its consideration as it is not clear when the FDA will consider the proposal.

Uterine cancer controversies
In 2022, the National Institutes of Health sparked an industry debate after claiming that women who use chemical hair straightening products with formaldehyde have a higher chance of developing uterine cancer.

The Cosmetic, Toiletry and Perfumery Association challenged the findings, asserting that “hair straightening products are safe and do not cause cancer.”

Similarly, responding to the warning, the Personal Care Products Council — whose members account for roughly 90% of the beauty industry in the US — argued that “the fundamental principle of epidemiology is that association is not the same as causation; one does not necessarily lead to the other.”

By Venya Patel

To contact our editorial team please email us at editorial@cnsmedia.com