On August 1, 2025, the Court of Justice of the European Union issued a final ruling: upholding its 2022 ruling.

This means removing the carcinogenic classification of titanium dioxide (TiO₂) powder. This decision marks the end of a nearly decade-long scientific and regulatory debate that has impacted numerous industries worldwide.

Titanium dioxide TiO2 powder is widely used in coatings, pharmaceuticals, and food due to its excellent hiding power and whiteness. In 2016, the French Agency for Food Safety, Environmental and Occupational Health (ANSES) submitted a proposal to the European Chemicals Agency (ECHA) requesting that powdered titanium dioxide be classified as a "carcinogen by inhalation." In 2017, ECHA's Risk Assessment Committee (RAC) adopted an opinion supporting its classification as a "Suspected Carcinogen Category 2." In October 2019, the European Commission adopted Delegated Regulation (DE) 2020/217, officially classifying titanium dioxide in powder form (1% or more particles ≤10 microns) as a suspected category 2 carcinogen and requiring the use of a warning label: "H351: May cause cancer by inhalation."

The current classification and labeling are as follows:

Titanium dioxide classification timeline

Scientific Basis of the Decision

The CJEU's ruling was based on three key scientific considerations:

1. Mechanism of Action: The Court agreed that the lung tumors observed in the rat studies were caused by particle overload, rather than the intrinsic carcinogenicity of TiO₂ itself.

2. Extrapolation to Humans: The Court concluded that there was insufficient evidence to demonstrate that rat inhalation studies can reliably predict human cancer risk, especially at typical exposure levels.

3. Other Explanations: The ruling stated that the observed effects may be due to inflammation caused by particle accumulation, rather than chemical toxicity.

Direct Industry Impact

This decision will provide significant relief to several industries:

Paints and Coatings: Eliminate warning labels on most architectural and industrial coatings

Plastics: Reduce the classification burden on food packaging and consumer products

Cosmetics: Sunscreens and color cosmetics can now be marketed without carcinogen warnings

Food Industry: Restore confidence in the use of TiO₂ (E171) in food applications

Global Regulatory Impact

While the EU's decision is binding on member states, other regions may react differently:

US: Occupational Safety and Health Administration (OSHA) maintains the current non-carcinogenic classification

Canada: Health Canada continues to monitor emerging evidence

Asia: Most markets have never adopted the EU's precautionary classification

Products Containing Titanium Dioxide

TiO₂ remains essential in many common products:

The EU Court of Justice's final ruling provides much-needed clarity on the safety of titanium dioxide, confirming the position held by many scientists and manufacturers. While regulatory vigilance remains important, this ruling enables industry to capitalize on titanium dioxide's valuable properties without unnecessary carcinogenicity warnings.

FAQ

Q1: What is titanium dioxide TiO2 powder?

A: Titanium dioxide is a naturally occurring titanium oxide used as a white pigment and functional additive in many industrial and consumer applications.

Q2: What common pigments contain titanium dioxide?

A: Several important pigments contain titanium dioxide:

Titanium dioxide (TiO₂): Pure titanium dioxide pigments

Pearlescent pigments: Often titanium dioxide-coated mica is used to achieve iridescent effects

Compound pigments: Many pigments combine titanium dioxide with other colorants

Q3: Is titanium dioxide safe for use in cosmetics?

A: It is safe for its intended use. An EU ruling clearly confirms that there is no evidence that it causes cancer through skin contact.

Q4: Will food-grade titanium dioxide (E171) be reapproved in the EU?

A: While the court ruling does not automatically reinstate E171, it removes the scientific basis for its 2022 ban, which may pave the way for reconsideration.

Q5: How should manufacturers update their product labels?

A: 1. Companies should: Immediately remove the H351 warning from products containing titanium dioxide.

2. Review safety data sheets for compliance updates.

3. Consult with your legal team regarding transitional labeling requirements.

By Lisa Chen, PhD, a materials safety expert with 15 years of experience in chemical risk assessment. Last updated: August 2025