Key Changes in Cosmetic Legislation (EU, UK & US)
May brought several notable changes to cosmetic regulations across the EU, UK, and US. From newly banned substances and UV filter limits to MoCRA enforcement data, the updates highlight a clear shift toward stricter safety and compliance expectations—particularly for products targeting children or using UV filters. Below is a breakdown of the key developments, what they mean for your business, and the product categories most likely to be affected.
1. Omnibus Act VII – New CMR Bans in Cosmetics
What is it?
The European Commission adopted Regulation (EU) 2025/877 as part of the 7th Omnibus Act, banning 21 substances newly classified as Carcinogenic, Mutagenic, or Reprotoxic (CMR) under CLP. These substances are now added to Annex II of the Cosmetics Regulation.
Why does it matter?
CMR substances are prohibited in cosmetics unless certain strict conditions are met. This regulation imposes a blanket ban, affecting ingredients that may previously have been permitted for professional or limited use (e.g. in nail products). No sell-through period means existing stock must be reformulated or withdrawn by 1 September 2025.
Applications / Impacted Products:
- Professional nail products (e.g. those using Trimethylbenzoyl Diphenylphosphine Oxide)
- Colour cosmetics and preservative-heavy formulations
- Products exported into the EU must meet these new prohibitions.
2. SCCS Final Opinion – Salicylic Acid Use in Children
What is it?
SCCS confirmed the safe use of salicylic acid (as a preservative) at up to 0.5% in products intended for children over 3 years old — except in oral care.
Why does it matter?
Salicylic acid is widely used in acne and exfoliating products, but its use in children’s products has been scrutinised due to safety concerns. This clarification supports its continued use with defined age and product restrictions.
Applications / Impacted Products:
- Children’s skincare (lotions, cleansers, wipes)
- Products targeting sensitive or young skin
- Reformulation may be needed for products marketed for <3 years or in oral care ranges.
1. UK Restriction Update – Benzophenone-3 (BP-3)
What is it?
UK authorities notified WTO of new use limits for Benzophenone-3, a common UV filter. Limits vary by product type (e.g. 6% in facial care, 2.2% in body sprays, 0.5% elsewhere). Implementation deadlines are set for Jan–July 2026.
Why does it matter?
The UK is diverging from the EU on some UV filter limits, and products using BP-3 must align with specific category caps. Existing formulations may not comply.
Applications / Impacted Products:
- Sunscreens (especially face vs body formats)
- SPF moisturisers, lip balms, and sprays
- Reassess BP-3 levels across multi-category sun care lines
2. UK SAG-CS Opinions – Homosalate, 4-MBC, Formaldehyde Donors
What is it?
The UK Scientific Advisory Group published safety opinions on multiple substances:
- Homosalate (UV filter)
- 4-Methylbenzylidene Camphor (4-MBC)
- Formaldehyde-releasing preservatives
Why does it matter?
These opinions signal a move towards UK-specific safety thresholds, independent of EU SCCS conclusions. Reformulation may be required if formal bans or restrictions follow.
Applications / Impacted Products:
- Sun care and daily wear SPF products (Homosalate, 4-MBC)
- Preservative-heavy leave-on skincare and haircare
- Watchlist for UK-only compliance adjustments
1. MoCRA Enforcement – Facility & Product Listing Data
What is it?
The FDA reported receiving 9,500+ facility registrations and nearly 590,000 product listings under MoCRA as of May 2025, marking a significant compliance milestone.
Why does it matter?
This underscores MoCRA’s regulatory scope and signals FDA’s readiness to enforce — particularly against non-registered products or facilities. Firms operating in or exporting to the US must ensure all documentation is active and traceable.
Applications / Impacted Products:
- Any product sold in the US (domestic or imported)
- Focus on registration completeness, safety substantiation, and adverse event tracking
- Delays or gaps could trigger warnings or enforcement actions.
How ADSL Can Help
We support brands and manufacturers in navigating changing global regulations through:
- ✅ Ingredient & INCI reviews
- ✅ Reformulation support for banned/restricted substances
- ✅ MoCRA listing and documentation
- ✅ UK/EU compliance divergence checks
📩 Need help interpreting or applying these changes? Contact your project lead or email us at [email protected].
ADSL – Advanced Development & Safety Laboratories
Technical Team | Paignton, UK
