SCCS Preliminary Opinion on Benzophenone-2 and Benzophenone-5
The SCCS has published its preliminary Opinion on Benzophenone-2 (BP-2) and Benzophenone-5 (BP-5), following the European Commission’s call to assess suspected endocrine disruptors. Public comments are open until 17 June 2025.
Key Points:
- Benzophenone-2 (BP-2)(not currently regulated):
- SCCS cannot conclude on its safety.
- Evidence of endocrine activity and potential genotoxicity.
- Limited data on repeated dose and reproductive toxicity.
- Conclusion: BP-2 may pose a risk to consumers.
- Benzophenone-5 (BP-5)(regulated up to 5%):
- Evaluated using read-across from Benzophenone-4.
- Considered safe at up to 5% in sunscreen, face/hand creams, lipsticks, and sprays.
Note: Environmental risks were not assessed.
Next Steps:
The SCCS is collecting comments until 17 June 2025. A final Opinion could impact the regulatory status of these substances.
SCCS Accepts New Mandates to Assess Basic Blue 99 and Basic Brown 16
On 27 March 2025, the SCCS accepted new mandates from the European Commission to reassess the safety of two hair dye ingredients: Basic Blue 99 and Basic Brown 16. Both assessments must be completed within 9 months.
Key Points:
Basic Blue 99 (C059):
- Used in non-oxidative hair dye formulations.
- Previous evaluations (2011, 2014) could not conclude on safety due to the highly variable composition across batches.
- A new submission (February 2025) includes updated data on composition and genotoxicity.
- The SCCS will assess whether Basic Blue 99 is safe at 1% in non-oxidative hair dyes and identify any further concerns.
Basic Brown 16 (C009):
- Also used in non-oxidative hair dye formulations.
- Earlier assessments (2008, 2012) raised concerns about genotoxicity and impurities.
- A new dossier (September 2024) provides additional genotoxicity and mutagenicity data.
- The SCCS will determine if Basic Brown 16 is safe at 2% and if any new risks exist.
SCCS Preliminary Opinion on Hydroxyapatite (Nano) in Oral Care Products
The SCCS has published its preliminary Opinion on using Hydroxyapatite (nano) in toothpaste and mouthwash following new data submitted by the cosmetics industry. Comments are open until 30 May 2025.
Key Points:
- Hydroxyapatite (nano) is considered safe when used:
- Up to 29.5% in toothpaste
- Up to 10% in mouthwash
- The evaluation applies only to rod-shaped particles with specific aspect ratios and uncoated hydroxyapatite.
- No mutagenic, cytotoxic, or inflammatory effects were observed at high concentrations.
- Ingested nanoparticles dissolve rapidly in gastric fluids, posing no nano-specific safety concerns.
- Note: Products with needle-shaped particles are excluded from this Opinion.
Reminder: Key Regulatory Changes Effective May 1, 2025 – CLP and Cosmetics Regulations
Two critical regulatory updates take effect on May 1, 2025, impacting cosmetic substances and formulations in the EU:
Key Points:
Delegated Regulation (EU) 2023/707 – CLP Update:
- New hazard classes introduced under the CLP Regulation:
- Endocrine Disruptors (for health and environment) – Categories 1 and 2
- PBT and vPvB substances
- PMT and vPvM substances
- Applies to substances from May 1, 2025, and mixtures from May 1, 2026.
Regulation (EU) 2024/996 – Cosmetics Regulation Amendment:
- 4-Methylbenzylidene Camphor has been banned in cosmetic products placed on the market since May 1, 2025.
- The ban extends to products already on the market from May 1, 2026.
Great Britain Updates GB CLP: New Classifications for Cosmetic Ingredients
On April 7, 2025, Great Britain notified an update to its GB Mandatory Classification and Labelling (MCL) list, aligning some changes with the European Union’s Delegated Regulation (EU) 2024/2564.
Key Points:
- 30 substances impacted, including 9 ingredients relevant to cosmetics.
- Notable substances include:
- Benzotriazole: Aquatic toxicity classification (H411).
- N,N’-Methylenebisacrylamide: Classified as mutagenic (H340).
- Benzoyl Peroxide: Multiple hazards including serious eye irritation and aquatic toxicity.
- Copper: Aquatic toxicity (H400, H410).
- Carbaldehyde compounds: Skin sensitization (H317).
- O-Phenylphenol: Carcinogenicity and skin corrosion risks.
- Ozone: Severe respiratory and aquatic hazards.
- Silver (massive, powder, nano): Reproductive toxicity and aquatic hazards.
- Nitrous Oxide: Reproductive and nervous system toxicity.
Deadlines:
- Voluntary implementation: End of Q3 2025.
- Mandatory compliance: Q1 2028.
Great Britain’s classifications closely mirror those in the EU, but there are some differences, particularly for ozone and nitrous oxide.
Reminder: SI 2024 No.1334 Now Partially in Force in Great Britain
Statutory Instrument 2024 No.1334, published on 17 December 2024, sees its first measures enter into force on April 20, 2025 across England, Wales, and Scotland.
Key Points:
- 64 CMR substances banned, including 8 ingredients with INCI names.
- Now banned for products placed on the market:
- Methylene Di-T-Butylcresol
- MIBK
- Benzophenone
- Theophylline
- Trimethylolpropane Triacrylate
- Azadirachta Indica Seed Extract
- Melamine
- Most of these bans align with European measures already in force since 2022–2023.
Important:
- Products already placed on the market must comply by October 20, 2025.
Manufacturers and Responsible Persons must ensure compliance to continue sales in Great Britain.
