On September 11, 2025, the European Chemicals Agency (ECHA) confirmed the removal of titanium dioxide’s carcinogenic classification from the EU’s C&L Inventory. This decision aligns with the June 2025 ruling by the Court of Justice of the European Union (CJEU), which upheld the annulment of titanium dioxide’s Category 2 “suspected carcinogen” status.
Background Recap
· 2016–2019: France’s ANSES proposed the classification, later endorsed by ECHA’s RAC and formalized by the European Commission through Delegated Regulation (EU) 2020/217. This required powdered titanium dioxide (≥1% particles ≤10 μm) to carry the label H351: Suspected of causing cancer when inhaled.
· 2022: The General Court annulled the classification, citing “manifest errors” in scientific assessment and lack of evidence of intrinsic carcinogenic properties.
· 2025: The CJEU dismissed appeals from France and the European Commission, making the annulment final.
ECHA Updates
· The Carc. 2; H351 (inh) entry for titanium dioxide has been deleted from the C&L Inventory.
· The Registry of Intentions now shows no further harmonized classification plans.
· The guidance document on classification and labeling of titanium dioxide has been withdrawn.
Implications for Industry
Titanium dioxide is no longer classified as carcinogenic in the EU. This change eases obligations related to:
· Labeling and packaging (removal of carcinogen warnings)
· Safety Data Sheets (SDS) updates
· Occupational exposure requirements
Stay ahead in sustainability compliance with Global PCCS —where expert insights meet the latest regulations. Unlock a future where compliance fuels sustainability, helping your business thrive in a greener, well-regulated world. For more information, contact us at info@globalpccs.com
