Updates on Cosmetic Regulations in Europe(May)
EU SCCS Issues Final Opinion on Butylparaben
On May 2, 2025, the EU Scientific Committee on Consumer Safety (SCCS) published its final opinion on butylparaben (SCCS/1674/25).
The SCCS concluded that, for children aged 0.5–1, 1–3, 3–6, and 6–10 years, a maximum concentration of 0.14% (as acid) of butylparaben used as a preservative is unsafe when combined across all cosmetic products included in this exposure assessment, except for body lotion. It is only safe when used in individual product categories for single dermal and oral (for oral products) exposure. Furthermore, based on these reduced concentrations, butylparaben is considered safe for children of all age groups and for the product types covered in this assessment, whether used individually or in combination.
EU SCCS Issues Final Opinion on Salicylic Acid
On May 2, 2025, the EU SCCS published its final opinion on salicylic acid (SCCS/1675/25). The SCC concluded that, for children aged 3–10 years, salicylic acid is safe only when used in individual product categories for single dermal and oral exposure, except for body lotion. It is recommended to maintain salicylic acid concentration at 0.5% in rinse-off products, reduce it to 0.15% in leave-on products, and lower it to 0.1% in oral care products. These concentrations are considered safe for children aged 3–10 years.
EU SCCS Issues Preliminary Opinion on Methyl Salicylate
On May 2, 2025, the EU SCCS published an assessment opinion on methyl salicylate exposure in children (SCCS/1676/25), formally revising SCCS/1654/23. The SCCS concluded that methyl salicylate is considered safe for products intended for children aged 0–3 years only when its concentration does not exceed 0.4% in toothpaste and 0.02% in other products.
EU Revises List of Cosmetic Ingredients Related to CMR Substances
On May 12, 2025, the European Commission published Regulation (EU) 2025/877, formally amending Annex II (prohibited substances) and Annex III (restricted substances) of the EU Cosmetics Regulation (EC) No 1223/2009. The update incorporates carcinogenic, mutagenic, or reprotoxic (CMR) substances recently identified under the CLP Regulation (EC) No 1272/2008, involving over 20 ingredients. The regulation will officially take effect on September 1, 2025.
EU Proposes Revision of Cosmetic Ingredients List
On May 21, 2025, the European Commission submitted notification G/TBT/N/EU/1140 to the World Trade Organization (WTO), proposing amendments to (EC) No 1223/2009 (the EU Cosmetics Regulation). The revision involves Annex II (prohibited substances), Annex III (restricted substances), Annex IV (permitted colorants), and Annex V (permitted preservatives).
The update primarily adds CMR substances identified in the June 2024 revision of Annex VI to (EC) No 1272/2008 (the EU CLP Regulation). The regulation is expected to be adopted and implemented in the first quarter of 2026.
EU Plans to Develop Roadmap for "Animal Testing-Free" by Q1 2026
On May 27, 2025, European Commission Executive Vice-President Séjourné stated that, in response to the European Citizens' Initiative (ECI) "Save Cruelty-Free Cosmetics – Commit to a Europe Without Animal Testing," the European Commission plans to finalize the action roadmap by the first quarter of 2026 at the latest.
Once published, the roadmap will promote the integration of New Approach Methodologies (NAMs) into 15 legislative areas that currently require animal testing, including the REACH Regulation, significantly impacting the broader EU chemicals regulatory framework.
UK Proposes Revision of Use Restrictions for Benzophenone-3 in Cosmetics
On May 8, 2025, the UK submitted notification G/TBT/N/GBR/102 to the WTO, proposing amendments to the use requirements for benzophenone-3 in cosmetics.
If the draft is adopted, it is expected to take effect on January 21, 2026, with transitional arrangements for cosmetics containing benzophenone-3. According to the provisions, such products placed on the market before January 21, 2026, may continue to be sold until July 21, 2026.
UK SAG-CS Issues Final Opinion on Formaldehyde Releasers
In May 2025, the UK Scientific Advisory Group on Chemical Safety in Consumer Products (SAG-CS) published its final opinion on formaldehyde releasers (SAG-CS opinion 16), establishing an assessment opinion on the labeling threshold for formaldehyde releasers.
The SAG-CS concluded that a labeling threshold of 10 mg/kg (10 ppm) or 0.001% for formaldehyde-releasing preservatives in leave-on or rinse-off products is necessary to adequately protect consumers.
UK SAG-CS Issues Assessment Opinion on Homosalate
In May 2025, the UK SAG-CS published an assessment opinion on the use of the UV filter homosalate in cosmetics (SAG-CS opinion 17). The SAG-CS concluded that a maximum concentration of 10% homosalate in sunscreen products is safe.
UK SAG-CS Issues Preliminary Opinion on 4-MBC
In May 2025, the UK SAG-CS published an assessment opinion on the use of the UV filter 4-methylbenzylidene camphor (4-MBC) in cosmetics (SAG-CS opinion 18). Due to limited reviewable data and considering its potential genotoxicity and endocrine-disrupting risks, the SAG-CS determined that the safety of 4-MBC in sunscreen products and other cosmetics cannot be confirmed.