On 13 May 2025, the European Commission published Commission Regulation (EU) 2025/877, amending Regulation (EC) No 1223/2009 on cosmetic products. This amendment enforces a ban on several substances recently classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) under the CLP Regulation (EC) No 1272/2008.
This regulation marks the seventh Update under the so-called “Omnibus Acts”, ensuring the timely implementation of newly classified CMR substances into EU cosmetic law.
Legal Basis and Background
The Update draws from Article 15 of Regulation (EC) No 1223/2009, which states:
Substances classified as CMR (category 1A, 1B, or 2) must be prohibited in cosmetic products, unless specific conditions for exemption are met (e.g., safe use and authorization for use in food).
These classifications are defined by the European Chemicals Agency’s Risk Assessment Committee and harmonized under the CLP Regulation.
According to Recital (3) of the Regulation:
“To ensure a high level of protection of human health and uniform implementation, all CMR substances should be included in Annex II (prohibited list), and, where relevant, deleted from the lists of restricted or allowed substances in Annexes III to VI.”
Date of Enforcement
Effective Date: 1 September 2025
From this date:
- The banned substances may not be present in any cosmetic product placed or made available on the EU market.
- There is no grace period—products must be removed or reformulated before this deadline.
Major Substances Banned
The regulation adds over 20 substances to Annex II (prohibited list), including:
- Trimethylbenzoyl Diphenylphosphine Oxide (CAS 75980-60-8) – previously allowed in nail systems under Annex III.
- Tetrabromobisphenol-A
- Clothianidin
- Dibutyltin oxide and maleate
- 4-nitrosomorpholine
- Bisphenol AF
- Cymoxanil, with corrected CAS name
- …and various reaction masses and fluorinated derivatives.
Removing Trimethylbenzoyl Diphenylphosphine Oxide from Annex III is particularly significant, as this substance was widely used in UV-cured nail systems. It is now listed in Annex II and completely banned.
Legislative Highlights from Regulation 2025/877
📌 Article 1:
Annexes II and III of Regulation (EC) No 1223/2009 are amended to reflect the substances’ updated CMR status.
📌 Article 2:
This regulation shall enter into force 20 days after its publication and apply from 1 September 2025.
💬 The European Commission clarified that:
- No exemption requests were submitted for any of the newly banned substances.
- Amendments are harmonised with Delegated Regulation (EU) 2024/197.
Entries were also updated to align chemical names and CAS numbers with those listed in the CLP Regulation for clarity and legal consistency.
What You Must Do Now
Companies must take immediate steps to:
✅ Audit product formulations
✅ Identify banned ingredients
✅ Reformulate if needed
✅ Update:
- Product Information File (PIF)
- Cosmetic Product Safety Report (CPSR)
- CPNP Notifications
Distributors and importers must also ensure their entire supply chain is compliant by the enforcement date.
How Ceway Can Support
We’re here to help you stay compliant and avoid last-minute disruptions:
🔍 Ingredient safety assessment
🔄 Reformulation guidance and safer alternatives
📂 PIF, CPSR, and CPNP updates
📢 Strategic consulting for long-term compliance
Contact Ceway today for a comprehensive review of your portfolio and support with compliance under Regulation (EU) 2025/877.
