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GHS - Disputed Harmonized Classification: The Titanium Dioxide Dilemma

30 march 2023

Titanium Dioxide challenge

Since 2020, the European Commission has adopted a harmonized classification for titanium dioxide: suspected carcinogen (category 2) by inhalation for certain powder forms. This classification has since been contested by industrialists.

This classification aims to protect the health of European citizens and workers who handle this substance.

Chronology to understand the debate:

  • 2016: Submission to the European Chemicals Agency (ECHA) for evaluation of the draft classification of titanium dioxide as a suspected carcinogen by the French authority Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES).
  • October 4 2019: Adoption of Regulation 2020/217 by the European Commission including the harmonization of the classification of titanium dioxide as a suspected carcinogen category 2.
  • May 12 2020: Action for annulment brought by the industrialists.
  • November 23 2022: Annulment of the part concerning titanium dioxide in the European Commission Regulation by the General Court of the European Union (TEU).
  • February 8 2023: Challenge by France of the TEU decision. France appealed the annulment.

Based on studies provided by ANSES, ECHA’s Committee for Risk Assessment (RAC) ruled that titanium dioxide was suspected of being carcinogenic to humans, by inhalation, in the form of a powder containing 1% or more particles with a diameter of 10 μm or less.

According to expert opinion: “The carcinogenicity of titanium dioxide to the lungs is associated with inhalation of respirable titanium dioxide particles, retention and low solubility of particles in the lungs. In order to avoid an unjustified classification of non-hazardous forms of that substance, specific notes should be added concerning the classification and labelling of the substance and mixtures containing it. (Regulation 2020/217) Consequently, the classification of titanium dioxide may vary depending on its bioaccessibility.

The Tribunal relied on these same studies to have the regulation annulled by carrying their own assessments and interpretations of the scientific data. In so doing, France considers that the General Court has exceeded the limits of its judicial review and is appealing the case.

This appeal suspends the judgment of the General Court and the harmonized classification of Regulation 2020/217 will therefore continue to apply until the outcome of this new procedure.

To read the article on the challenge by France of the annulment.

To read the press release (in French only) on the TEU Judgment.

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