Introduction

Titanium Dioxide (TiO₂) is one of the world’s most essential white pigments, valued for its exceptional whiteness, brightness, and UV protection. It is a key ingredient in paints, plastics, coatings, food, pharmaceuticals, and even cosmetics. Because of its widespread use, any regulatory change involving TiO₂ has global implications for manufacturers and suppliers.

In August 2025, the Court of Justice of the European Union (CJEU) delivered a landmark judgment overturning earlier restrictions that classified certain forms of Titanium Dioxide distributor as a potential carcinogen by inhalation. This ruling reshaped the legal framework for TiO₂ within the EU and influenced global trade and compliance practices.

This blog explains the current legal status of Titanium Dioxide following the CJEU ruling, why it matters, and what businesses—especially Indian exporters—should know.

Background: How TiO₂ Became a Regulatory Debate

The Titanium Dioxide classification debate began in Europe in 2017, when the European Chemicals Agency (ECHA) proposed labelling TiO₂ powder as a Category 2 Carcinogen by Inhalation under the CLP Regulation (Classification, Labelling and Packaging).

The reasoning was that when fine TiO₂ particles are inhaled in large amounts, they might cause lung inflammation and tumours in rats—although these effects were linked to particle overload, not to TiO₂’s chemical toxicity.

Despite industry opposition, the European Commission adopted Delegated Regulation 2020/217, which required TiO₂ powders containing ≥ 1 % particles ≤ 10 µm to carry the hazard label:

H351: Suspected of causing cancer by inhalation.

The regulation came into force in October 2021 and affected numerous products—paints, coatings, adhesives, and plastics—forcing manufacturers to re-label and re-evaluate their formulations.

The Legal Challenge

Many producers, industry associations, and downstream users filed appeals, arguing that:

• The classification was based on mechanical dust effects, not intrinsic carcinogenic properties.
• The Commission had made a manifest error of assessment in interpreting the data.
• The labelling would create confusion and trade barriers without improving safety.

In 2022, the General Court of the European Union sided with the industry, annulling the Commission’s decision and finding that the scientific evidence did not prove TiO₂ itself to be carcinogenic.

However, the European Commission and France appealed the judgment, taking the case to the CJEU.

The CJEU Ruling (1 August 2025)

The CJEU dismissed the Commission’s appeal and upheld the General Court’s annulment of the TiO₂ classification.
In plain terms, the EU’s official labelling of Titanium Dioxide as a “suspected carcinogen by inhalation” is no longer valid.

Key points from the ruling

1. No intrinsic carcinogenic property demonstrated
   The Court confirmed that the risk identified in rats was due to particle overload and lung irritation, not chemical toxicity. Thus, TiO₂ does not meet the criteria for a carcinogen under CLP Regulation.
2. Scientific assessment must be robust
   The CJEU emphasised that classification must rely on clear evidence of intrinsic hazard, not on uncertain or context-dependent data.
3. The regulatory procedure was flawed
   The Commission was found to have overstepped scientific bounds and failed to evaluate alternative interpretations properly.

Current Legal Status of Titanium Dioxide in the EU (2025 onward)

• The harmonised classification of TiO₂ under CLP is annulled.
• The entry as a Category 2 Carcinogen by Inhalation has been removed from Annex VI of the CLP Regulation.
• Manufacturers and importers are no longer obliged to use the H351 hazard statement for TiO₂ powders under that classification.
• Products can be marketed without the specific carcinogen labelling—provided they meet current safety and exposure standards.
• Other regulations remain in place: the EU ban on TiO₂ as a food additive (E171) continues, and cosmetic and industrial uses still require risk assessment and safety data.

Implications for Industry

1. For Manufacturers and Distributors

This ruling is a significant relief for the TiO₂ industry. Companies no longer face the stigma and additional costs of carcinogen labelling within the EU.
However, manufacturers must continue to:

• Maintain occupational safety measures for dust handling.
• Update Safety Data Sheets (SDS) to reflect the current legal status.
• Stay alert for any new classification proposals from ECHA or the Commission.

For Indian suppliers like Aanya Enterprise, this decision simplifies exports to EU markets and reduces documentation burdens, but continued compliance with EU REACH and national rules is essential.

2. For Downstream Users in Coatings, Plastics & Textiles

• Paints and plastics manufacturers can resume using TiO₂ without the “H351” warning.
• The ruling restores consumer confidence and helps stabilise supply chains that had been disrupted by the earlier classification.
• Nonetheless, companies must still monitor dust levels and worker exposure under occupational safety laws.

3. For Cosmetic and Medical Applications

The CJEU decision concerns only classification under CLP, not other sectoral regulations.

• Cosmetics Regulation (EC 1223/2009): TiO₂ remains approved as a colorant and UV filter in specified forms (non-nano grades) and concentrations.
• Pharmaceuticals and Medical Devices: Permitted under relevant safety standards with purity requirements.
• Food Additive Ban: TiO₂ (E171) remains prohibited in EU food products.

Thus, each application area still has its own rules, and the 2025 ruling does not override those.

4. For Global Markets and India

While the CJEU ruling applies only to the EU, its influence extends worldwide.

• Regulators in Asia, the U.S., and Canada are likely to review their positions to ensure alignment with the latest science.
• India’s chemical sector benefits from regulatory clarity for exports to the EU and greater market confidence in TiO₂-based products.

Aanya Enterprise continues to supply high-purity TiO₂ grades compliant with international standards, supporting our clients through documentation, safety data, and regulatory updates.

Scientific Perspective: Why TiO₂ Remains Safe in Most Uses

Titanium Dioxide has been used for decades and is one of the most studied materials in industrial history. Extensive toxicological data show that:

• Oral and dermal exposure present minimal risk.
• Inhalation hazards are associated only with prolonged exposure to uncontrolled fine dust.
• TiO₂ is chemically inert, non-reactive, and non-soluble under normal conditions.
• Its use in solid matrices (plastics, paints, papers) poses negligible exposure risk.

This scientific consensus informed the CJEU’s reasoning that the previous classification was not justified.

What Companies Should Do Now

1. Update Safety Data Sheets
   Reflect the annulment of the harmonised classification and revise Section 2 (Hazard Identification) accordingly.
2. Review Product Labels
   Remove the H351 statement where applicable and ensure transitional compliance as national authorities adapt to the CJEU ruling.
3. Maintain Worker Safety
   Continue best practices for handling powders—dust extraction, PPE, and training.
4. Monitor Regulatory Updates
   The Commission may propose new scientific reviews or classifications; stay informed via ECHA and industry associations.
5. Document Material Form
   Keep technical data on particle size, surface treatment, and dispersion to demonstrate compliance during audits.

The Broader Significance

The CJEU ruling marks an important moment in EU chemical policy. It underscores that hazard classification must rest on sound science and clear criteria, not precaution alone. For businesses, it restores confidence in evidence-based regulation and predictable legal processes.

It also signals the need for regulators and industry to collaborate in developing accurate exposure assessments and risk communication, ensuring both safety and economic growth.

Aanya Enterprise’s Commitment

As a leading Titanium Dioxide distributor in India, Aanya Enterprise is dedicated to providing our clients with both premium-quality TiO₂ and up-to-date regulatory support.

We supply Rutile and Anatase grades that meet global standards for opacity, brightness and safety. Our team closely monitors EU and international regulatory developments to help customers navigate compliance with ease.

By staying informed and transparent, Aanya Enterprise ensures our partners can continue to use Titanium Dioxide with confidence—across coatings, plastics, textiles, and cosmetics industries.

Conclusion

The 2025 CJEU ruling has clarified Titanium Dioxide’s legal standing within the European Union, lifting the previous carcinogenic label and restoring regulatory certainty for industry. While the decision is welcome news, companies must remain vigilant about workplace safety and monitor future policy developments.

Titanium Dioxide remains a safe, effective, and indispensable material for modern manufacturing—and Aanya Enterprise continues to lead as your trusted partner for high-performance TiO₂ solutions worldwide.