Titanium Dioxide Classification: EU Court Ruling Ends Carcinogen Label

The Background of Titanium Dioxide Classification

Early Proposals and ANSES Involvement (2016)

The classification of certain forms of powdered titanium dioxide (TiO₂) has been the subject of debate for over a decade. Specifically, the discussion concerns powdered forms containing 1% or more of particles with an aerodynamic diameter equal to or less than 10 μm.

In 2016, the French Competent Authority, the Agency for Food, Environmental and Occupational Health & Safety (ANSES), submitted a proposal to the European Chemicals Agency (ECHA) to classify powdered TiO₂ as a carcinogen by inhalation (Category 1B).

 

ECHA’s Risk Assessment and Category 2 Recommendation (2017)

In 2017, ECHA’s Risk Assessment Committee (RAC) recommended a less severe classification — Category 2: “Suspected carcinogen based on limited evidence from animal or human studies.”

 

The European Commission’s 2019 Decision

Carcinogen by Inhalation Label (H351)

By 2019, the European Commission (EC) adopted this Category 2 classification for powdered titanium dioxide. This meant applying the warning H351 (Suspected of causing cancer by inhalation) and two supplemental statements (EUH211 and EUH212) to product labels. From 1 October 2021, all affected products required these labels.

Impact on Industry and Consumer Products

Carrying the “Carc. 2 (H351: inhalation)” label restricted certain consumer goods, such as cosmetics and sunscreens. This caused significant concern in the titanium dioxide industry, leading to strong opposition.

 

Legal Challenges and Annulment

Industry Pushback and the 2022 General Court Judgment

In 2022, manufacturers, importers, and downstream users challenged the classification in the EU General Court. The court annulled the EC’s decision, ruling that the classification was based on scientific studies adopted in error. The Commission had not adequately assessed the reliability of the key study, and thus had not shown that titanium dioxide had inherent carcinogenic properties.

Why the Original Classification Was Overturned

The court concluded that extrapolating results from animal studies to human carcinogenicity was not scientifically justified. This annulment removed the basis for the Category 2 label.

 

The 2025 European Court of Justice Ruling

Final Decision: No Carcinogen Classification

On 1 August 2025, the European Court of Justice (ECJ) issued its final judgment, dismissing appeals from both France (ANSES) and the European Commission. This ruling upheld the 2022 annulment, confirming that titanium dioxide should not be classified as a Category 2 carcinogen.

Scientific Rationale Behind the Judgment

The ECJ reaffirmed that available studies did not demonstrate intrinsic carcinogenic properties in titanium dioxide. The animal data could not be reliably extrapolated to humans, and thus the legal basis for classification failed.

 

What This Means for Industry and Regulation

Relief for Manufacturers and Consistency with UK HSE

The final ruling eliminates the requirement for H351 warnings, easing labelling obligations across the industry. Notably, the UK’s Health and Safety Executive (HSE) had already removed titanium dioxide from its mandatory classification list in 2024, creating inconsistencies with EU rules. This ruling aligns EU and UK approaches, resolving previous labelling conflicts.

Future Possibilities for Reassessment

While the European Commission may reassess titanium dioxide in the future, the ECJ made clear that any new classification must rely on “sufficient, reliable and comprehensive scientific data.” Currently, no reassessment is scheduled.

 

Key Takeaways on Titanium Dioxide Classification

  • The EU Court of Justice has confirmed that titanium dioxide should not be classified as a carcinogen.
  • The 2019 EU classification (Category 2, H351 inhalation) was annulled due to flawed reliance on animal data.
  • The final 2025 ruling brings EU and UK regulations into alignment, ending years of labelling inconsistencies.
  • Industry stakeholders welcomed the decision, which removes restrictions and obligations tied to carcinogen labelling.
  • Any future reclassification will require stronger, more reliable scientific evidence.

 

Frequently Asked Questions (FAQ)

Is titanium dioxide classified as a carcinogen?
No. As of August 2025, the European Court of Justice has confirmed that titanium dioxide should not be classified as a carcinogen. The earlier EU Category 2 classification was annulled due to insufficient scientific evidence.

Why was titanium dioxide originally classified as a carcinogen?
In 2019, the European Commission classified certain powdered forms of titanium dioxide as a suspected carcinogen (Category 2) based on limited animal studies. However, courts later ruled that the studies were unreliable and could not be extrapolated to humans.

What does the 2025 EU Court ruling mean for industry?
The ruling removes the requirement to use H351 inhalation warnings on affected products, easing labelling restrictions and aligning EU regulations with those in the UK.

Could titanium dioxide be reclassified in the future?
Yes. The European Commission may reassess titanium dioxide, but the EU Court has made clear that any new classification must be based on sufficient, reliable, and comprehensive scientific data. At present, no reassessment is planned.