EU Notifies WTO of Cosmetic Regulation Changes
On 21st May 2025, the EU submitted a notification to the WTO (World Trade Organisation) regarding the Draft Ombnibus Act VIII, amending (EC) No 1223/2009 (the "Cosmetic Regulation"). The Act implements Commission Delegated Regulation (EU) 2024/2564 which newly classified certain CMR substances (carcinogenic, mutagenic or toxic for reproduction). Annexes II, III, IV and V are proposed to be amended. The Act will take effect on 1st May 2026.
You can read the notification here.
GB SAG-CS Opinions on Formaldehyde Releasing Substances, Homosalate and 4-MBC
On 21st May 2025, GB's SAG-CS (Scientific Advisory Group on Chemical Safety of Consumer Products) published three Opinions on the safety of Formaldehyde Releasing Substances, Homosalate and 4-Methylbenzylidene Camphor respectively.
For Formaldehyde-Releasing Substances (e.g. DMDM hydantoin, imidazolidinyl urea, diazolidinyl urea), the SAG-CS discussed the current 0.05% formaldehyde labelling threshold and found it to be insufficient to protect consumers due to potential contact dermatitis in allergic persons. Members agreed that a threshold for labelling formaldehyde releasing preservatives up to 10 ppm, or 0.001%, would be adequate to protect consumers.
For Homosalate, the SAG-CS discussed its risks posed to health when used as a UV filter in cosmetic products, reviewing studies on potential endocrine disrupting effects, metabolism and dermal absorption. It was concluded that homosalate is safe at a maximum concentration of 10% in sunscreen products.
4-Methylbenzylidene Camphor, also used as a UV filter in cosmetics, was assessed. Due to insufficient data the Committee was unable to derive a safe level for 4-MBC, however members agreed it exhibits endocrine disrupting properties in in vivo studies. Given limited data and concerns for potential genotoxicity and endocrine disruption, SAG-CS could not conclude that 4-MBC was safe for use in sunscreen or other cosmetic products.
Brazil's Anvisa Defines New Criteria for Amendments to Cosmetic Registrations
On 29th May 2025, Brazil's National Health Surveillance Agency - Anvisa - announced new criteria for accepting amendments to cosmetic registrations. From 9th June, amendments filed before the start of the technical analysis stage of the registration period will be accepted. Amendments may consist of complementary data or replace documents submitted at the time of filing.
Click here for more details.
