In a landmark ruling, the Court of Justice of the European Union dismissed appeals from the European Commission and France in joined cases C-71/23 P & C-82/23 P, effectively upholding the 2022 General Court decision. This historic judgment removes titanium dioxide (TiO2) from the EU’s carcinogenic classification.
Impact on the Chemical Industry
The decision has immediate, substantial effects on chemical manufacturers, formulators, and distributors across Europe:
- Removal of Carcinogenic Classification (H351/H350): Titanium dioxide no longer requires labeling as a potential carcinogen.
- EUH211/EUH212 Label Phrases Eliminated: All related warning phrases associated with TiO2 dust are now officially obsolete.
- Cosmetics Ban Lifted: The restrictive ban on titanium dioxide usage in cosmetic products is now nullified.
- Intrinsic Property Clarification: The Court emphasized that hazards must originate from intrinsic chemical properties, explicitly rejecting “lung-overload” dust as sufficient evidence for classification.
Actions Required – What Should Companies Do Now?
To remain compliant and communicate effectively with customers, chemical businesses must immediately:
1. Update Your Safety Data Sheets (SDS)
- Revise SDS documents to reflect the removal of carcinogenic classification.
- Clearly communicate these changes internally and externally.
2. Print New Product Labels
- Ensure labels no longer carry H351/H350 or EUH211/EUH212 phrases.
- Provide updated labels swiftly to maintain compliance and market trust.
3. Update PCN and REACH Dossiers
- Submit necessary updates to Poison Centre Notifications (PCN) and REACH dossiers.
- Proactively manage regulatory documentation to avoid compliance delays.
4. Communicate Clearly to Your Customers
- Proactively inform customers of these regulatory changes.
- Explain clearly why the classification and labelling have changed to maintain transparency and trust.
5. Stay Vigilant with ECHA and Future Developments
- Remain attentive to any new actions by the European Chemicals Agency (ECHA).
- Prepare for possible renewed classification processes based on fresh data or alternative scientific approaches.
Why Choose Chemius as Your SDS Authoring Software?
Chemius is specifically designed to simplify the complex process of updating and managing Safety Data Sheets:
- Efficient Updates: Quickly revise SDS documents to align with regulatory changes.
- Compliance Confidence: Ensure documents consistently meet evolving regulatory standards.
- Streamlined Communication: Improve transparency and accuracy in communications with customers and regulatory bodies.
Ready to streamline your SDS processes?
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