Key Changes in Cosmetic Legislation (EU, UK & US)
April saw further regulatory activity affecting cosmetic ingredients and formulations, particularly within the EU. The SCCS published several safety opinions and accepted new safety assessment mandates, which may lead to future restrictions or reformulation requirements.
1. Proposed Updates to the Glossary of Cosmetic Ingredients
What it is: Ongoing review of the EU’s official glossary of INCI names.
Why it matters: Supports harmonised labelling and helps with compliance and inspections.
- April 2025: Public consultation opened on draft updates. Though non-binding, the glossary is widely adopted as best practice.
2. REACH Reform – Final Proposal and Digital Product Passports (DPPs)
What it is: Proposal to revise REACH, including a shift towards digital traceability.
Why it matters: Could change how raw material data is shared, classified and tracked.
- April 2025: DPPs proposed as digital records for storing structured ingredient data (composition, safety, sustainability). Not mandatory for cosmetics yet, but likely to impact materials containing hazardous substances.
3. Reclassification of Cosmetic Ingredients – 21st ATP to CLP
What it is: Update to the EU’s CLP Regulation introducing new CMR classifications.
Why it matters: Some ingredients used in cosmetics are newly classified as CMR, affecting their legal use.
- April 2025: Includes new classifications for substances like Dimethyltolylamine (Carc. 1B) and Trimethylbenzoyl diphenylphosphine oxide (Repr. 1B). May trigger listing in Annex II/III of the Cosmetics Regulation.
4. Preliminary SCCS Opinion – Benzophenone-2 (BP-2) and Benzophenone-5 (BP-5)
What it is: Risk assessment of suspected endocrine-disrupting UV filters following an EC mandate.
Why it matters: May lead to restrictions or bans depending on final conclusions.
BP-2:
- Not currently regulated.
- SCCS cannot confirm safety.
- Shows potential endocrine activity and genotoxicity.
- May pose a risk to consumers.
BP-5:
- Currently allowed up to 5%.
- Considered safe at up to 5% in sunscreen, face/hand creams, lipsticks, and sprays.
- Based on read-across data from BP-4.
- Environmental safety not assessed.
Next step: Public comments open until 17 June 2025. Final opinion may affect regulatory status and labelling requirements.
5. New SCCS Mandates – Hair Dye Ingredients Reassessment
What it is: New safety assessments commissioned by the European Commission for two colourants used in hair dye.
Why it matters: May lead to reformulation or further restriction depending on safety outcomes.
Basic Blue 99 (C059):
- Used in non-oxidative dyes.
- Past safety evaluations were inconclusive.
- New data submitted Feb 2025 on composition and genotoxicity.
- SCCS to assess safety at 1% use level.
Basic Brown 16:
- Also under reassessment.
- Safety review to be completed within 9 months of 27 March 2025.
1. BHT (Butylated Hydroxytoluene) – New Use Limits in Cosmetic Products
What it is: A UK-specific regulation restricting the concentration of BHT across various cosmetic categories, based on safety assessments.
Why it matters: Brands placing products on the UK market must ensure BHT levels comply, especially in oral care products, where the UK diverges from EU limits.
Effective from 22 April 2024, with a sell-through period until 24 June 2025.
BHT is now permitted at the following maximum concentrations:
- 0.1% in toothpaste
- 0.001% in mouthwash
- 0.001% leave-on oral care products
- 0.8% Other leave-on and rinse-off cosmetics
🔍 Key point:
The UK’s restriction on leave-on oral care products (0.001%) is stricter than the EU limit (0.8%), meaning EU-compliant products may not be compliant in the UK.
1. MoCRA Implementation – Ongoing Enforcement Focus
What it is: Continued rollout of MoCRA with increased FDA oversight.
Why it matters: US cosmetic companies must now comply with mandatory registration, safety substantiation, and adverse event reporting.
April 2025:
- FDA releasing technical guidance to support compliance.
- Enforcement expected to increase in Q2 2025.
- Brands should ensure all documentation is in place and accessible.
What This Means for You
At ADSL, we continue to track evolving cosmetic regulations and ingredient safety updates to help you stay compliant. We can assist with:
- Ingredient and INCI compliance checks
- Safety assessments and SCCS position monitoring
- MoCRA documentation and product listings
- Label updates and regulatory forecasting
Need support interpreting these changes? Contact ADSL.
ADSL – Advanced Development & Safety Laboratories
Technical Team | Paignton, UK
