EU
Titanium Dioxide: EU Formally Confirms End of Carcinogenic Classification
On 10 December 2025, the European Commission confirmed in the Official Journal the annulment of the harmonised Carcinogen Category 2 classification for titanium dioxide (TiO₂) under the CLP Regulation.
This follows the Court of Justice of the European Union (CJEU) decision of 1 August 2025, which upheld the annulment of part of Delegated Regulation (EU) 2020/217. As a result, TiO₂ in powder form containing ≥1% of particles ≤10 μm is no longer classified as carcinogenic by inhalation.
The decision concerns chemical hazard classification only and does not amend the EU Cosmetics Regulation. Titanium dioxide remains permitted in cosmetics under existing conditions, particularly for UV filters and colourants.
Reminder: EU fragrance allergen labelling expansion starts in 2026
Under Commission Regulation (EU) 2023/1545, fragrance allergen labelling expands (from the legacy set to a much larger list with defined thresholds). Key deadlines:
- 31 July 2026: compliance for new products placed on the EU market
- 31 July 2028: compliance for products already on the market
Acrylic Acid Under Regulatory Scrutiny
On 17 December 2025, the European Chemicals Agency (ECHA) announced Sweden’s intention to submit a proposal to modify the harmonised classification and labelling (CLH) of acrylic acid (CAS No. 79-10-7), an ingredient relevant to nail cosmetic products.
The proposal intends to add Skin Sensitisation Category 1 (H317) to the existing CLP hazard profile. Acrylic acid is currently not regulated under the EU Cosmetics Regulation.
If adopted, this classification could influence future cosmetic risk assessments, particularly for professional nail products, and may lead to regulatory follow-up at EU level.
SCCS Issues Preliminary Opinion on Micron-Sized Silver in Cosmetics
The Scientific Committee on Consumer Safety (SCCS) has published a preliminary opinion on the safety of micron-sized silver particles in cosmetic products. The consultation is open until 23 February 2026.
Based on new dermal penetration data, the SCCS considers micron-sized silver safe up to:
- 0.2% in rinse-off products
- 0.3% in leave-on products
The opinion excludes propellant-based spray products, as inhalation exposure was not assessed.
Brands using silver in cosmetics should monitor the final opinion and assess product formats carefully ahead of potential regulatory updates.
UK
Draft CMR Bans and New Hexyl Salicylate Limits Notified
On 27 November 2025, United Kingdom notified a draft regulatory update proposing changes to its cosmetics legislation, applicable in Great Britain (England, Wales and Scotland). The proposal is open for consultation until 26 January 2026.
New CMR prohibitions
The draft text would add 13 substances newly classified as carcinogenic, mutagenic or toxic to reproduction (CMR) to Annex II (prohibited substances) of the GB Cosmetics Regulation. Several of these entries mirror recent EU CMR updates, while others reflect classifications introduced through recent ATPs to the CLP Regulation.
If adopted, the bans would apply:
- From 23 March 2027 for products placed on the market
- From 22 September 2027 for products already made available
Hexyl Salicylate: new restrictions proposed
The proposal also introduces Hexyl Salicylate into Annex III (restricted substances), with detailed limits by product type and target population, including significantly lower thresholds for products intended for children under 3 years of age.
These restrictions would apply:
- From 15 August 2026 for products placed on the market
- From 14 February 2027 for products already available on the market
What this means for industry
This notification highlights the UK’s continued alignment with EU chemical classifications, while also confirming regulatory divergence in structure and timelines. Brands marketing in both the EU and Great Britain should plan separate compliance strategies, particularly for fragrance-containing products.
FDA Clarifies Mandatory Cosmetic Recall Powers
USA: FDA consults on draft guidance for mandatory cosmetic recalls (MoCRA)
On 16 December 2025, the U.S. Food and Drug Administration (FDA) opened a 60-day consultation on a draft guidance explaining how it intends to apply its mandatory cosmetic recall powers under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
The draft guidance, presented in a Q&A format, outlines:
- The types of cosmetic products that may be subject to mandatory recall,
- Situations triggering FDA action (e.g. adulteration or products likely to cause serious adverse health consequences),
- The procedural steps, starting with a request for a voluntary recall before ordering a mandatory one,
- The responsibilities of the Responsible Person,
- Possible consequences in cases of non-compliance.
Once finalised, the guidance will be non-binding, but it provides a clear indication of FDA’s enforcement expectations. Comments are encouraged by 17 February 2026.
