Why the changes?
Under Regulation (EC) No 1272/2008 (CLP), the EU harmonises the classification of chemicals after scientific review by the European Chemicals Agency. When substances are classified as CMR (Categories 1A, 1B, or 2), they are generally banned from cosmetics unless strict conditions for an exception are met. The 2025 amendment aligns the Cosmetics Regulation with the latest CMR classifications, increasing legal certainty for businesses and protection for consumers.
Key changes in Regulation (EU) 2025/877
1) New substances added to Annex II (Prohibited List)
Examples include:
- Trimethylbenzoyl Diphenylphosphine Oxide (photoinitiator in nail gels) — now prohibited due to reproductive toxicity.
- Tetrabromobisphenol-A and Bisphenol AF (bisphenol derivatives) — linked to endocrine disruption.
- Clothianidin (neonicotinoid pesticide) — reproductive risks.
- 4-Methylimidazole — carcinogenic concerns.
- 4-Nitrosomorpholine — strong carcinogenic classification.
- Organotin compounds such as Dibutyltin maleate and Dibutyltin oxide — toxic for reproduction.
Tip: Review the full Annex II list in the official regulation to check every newly prohibited entry.
2) Clarification of existing entries
The entry for cymoxanil is updated with additional chemical names and CAS numbers to match CLP terminology.
3) Deletion from Annex III (Restricted List)
Entry 311 (Trimethylbenzoyl Diphenylphosphine Oxide) is deleted from Annex III and fully prohibited under Annex II.
Purpose and impact
- Consumer protection: Removes high-risk ingredients from cosmetics sold in the EU/EEA.
- Harmonisation: Ensures consistent safety rules across Member States.
- Transparency: Aligns ingredient identifiers with chemical safety law for clear compliance checks.
Examples: what these ingredients do & why they’re restricted
- Photoinitiators (e.g., Trimethylbenzoyl Diphenylphosphine Oxide) — initiate curing in gel systems; restricted due to reproductive toxicity.
- Bisphenols (e.g., Tetrabromobisphenol-A, Bisphenol AF) — used as monomers/additives or can migrate from packaging; concerns around endocrine activity.
- Organotin compounds — stabilisers/catalysts in materials; associated with developmental and fertility effects.
- N-nitroso compounds (e.g., 4-Nitrosomorpholine) — potent carcinogens; may occur as impurities if not tightly controlled.
Compliance deadline
The regulation applies from 1 September 2025. From this date, products containing the listed substances cannot be placed on the EU/EEA market.
What businesses should do now
- Audit formulas against the updated Annex II list (including raw materials and potential impurities).
- Engage suppliers for written confirmations and updated specifications.
- Update CPNP and PIF documentation to reflect compliant formulas.
- Review packaging for components that could introduce restricted substances.
Official source
Read the full text in the EU Official Journal:
Regulation (EU) 2025/877.
To read about more ingredients, check our other posts.
