EU Court Reignites the Debate on Titanium Dioxide's Carcinogenic Classification

On February 6, 2025, Advocate General Ćapeta of the EU Court delivered an opinion on the appeal regarding the carcinogenic classification of titanium dioxide, supporting the positions of the European Commission and the French government and arguing that the previous ruling should be overturned.

Previously, the European Commission's decision to classify titanium dioxide as a "suspected human carcinogen (Category 2 carcinogen) that may cause cancer through inhalation" was annulled by the General Court.

Case Background

• In 2016, a French institution submitted a proposal to the European Chemicals Agency (ECHA), suggesting that titanium dioxide be classified as a carcinogenic substance.
• In 2017, the ECHA's Risk Assessment and Classification Committee (RAC) adopted the opinion and classified titanium dioxide as a Category 2 carcinogen.
• In 2020, based on the RAC's recommendation, the European Commission adopted Delegated Regulation (EU) 2020/217, officially confirming the classification of titanium dioxide as a Category 2 carcinogen.
• On November 23, 2022, the decision was annulled again by the EU General Court, triggering widespread legal and scientific debates.

Reasons for the Previous General Court's Annulment

• Particle Density Issue: The General Court held that the RAC failed to adequately consider the aggregation of nano-sized titanium dioxide particles and its impact on density when assessing the toxicity of inhaled titanium dioxide, leading to an incorrect evaluation of the reliability of experimental data.
• Interpretation of the "Inherent Property" Concept: The General Court considered that the RAC incorrectly attributed the carcinogenicity of titanium dioxide to its "inherent properties," while in fact, the carcinogenicity was due to the inflammatory response caused by the accumulation of particles in the lungs, not the chemical properties of titanium dioxide itself.

Opinion of the Advocate General

• Scope of Judicial Review: The Advocate General opined that the General Court had exceeded its judicial review authority when assessing the scientific evidence. The court should not replace the European Commission in interpreting scientific data, and the relevant scientific facts should only be considered by the review committee.
• Interpretation of "Inherent Property": The Advocate General proposed that the General Court's interpretation of "inherent property" was too narrow, arguing that the concept should be broadly understood to include the physical state, characteristics of the substance, and its impact on health, rather than just its chemical composition.
• Evidence Assessment: The Advocate General believed that the General Court incorrectly introduced the concept of "decisive" evidence, which contradicted the "comprehensive assessment" principle required by the CLP Regulation.

Next Steps

The Advocate General recommended that the case be referred back to the General Court for further consideration of the remaining legal requests. Although this opinion is not binding, it provides an important legal basis for future rulings.

Industry Response

The Titanium Dioxide Manufacturers Association (TDMA) and related industry representatives expressed disappointment at this outcome and plan to discuss with relevant parties how to further influence this unfavorable result. Experts within the industry believe that the safety and usage standards of titanium dioxide will continue to be subject to strict scrutiny, and companies need to be prepared to respond.

About CIRS

CIRS Group is a leading provider of comprehensive regulatory compliance services and solutions for chemicals, cosmetics, food and food-related products, agrochemicals, and medical devices. Its chemical team consists of experts with extensive knowledge in chemistry, toxicology, environmental science, and related fields. They are well-versed in various international regulations, including but not limited to EU REACH, CLP, GHS, TSCA, and K-REACH. Our chemical compliance services in the EU cover:

• EU REACH Registration (including OR services);
• EU REACH Evaluation Compliance Services;
• SVHC Testing;
• EU CLP Compliance;
• EU Poison Center Notification; and 
• EU BPR Compliance.

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