GHS Harmonized Classification of Titanium Dioxide: CJEU Court Ruling and Compliance Impacts
Regulatory update (July 2026): This article incorporates the latest developments from the Court of Justice of the EU and their impact on the harmonization of your SDS under CLP, WHMIS and OSHA.
Titanium dioxide (TiO2) is a white pigment omnipresent in industry: paints, plastics, cosmetics, coatings, and pharmaceuticals. However, its classification under the Globally Harmonized System (GHS) and the European CLP Regulation sparks intense regulatory and legal debate on an international scale.
Between occupational health imperatives, inhalation risk assessment, and legal challenges from manufacturers, where do regulations stand on titanium dioxide, and what is its impact on your Safety Data Sheets (SDS)?
What is the harmonized classification of titanium dioxide?
Since 2020, the European Commission adopted a harmonized classification designating certain powder forms of titanium dioxide as a suspected human carcinogen (Category 2) by inhalation.
This decision aims to strengthen health protection for workers and consumers handling the material in powder form.
⚠️ Technical Note: The carcinogenic risk does not stem from the intrinsic chemical toxicity of the molecule, but rather from a physical effect related to the inhalation of respirable particles (a so-called "lung overload" effect).
Chronology of an international regulatory and legal battle
To fully understand the scope of this classification and its legal twists, here are the major milestones of the case:
Key Milestones in the Case
2016 – Initial evaluation by ANSES
The French Agency for Food, Environmental and Occupational Health & Safety (ANSES) submits a harmonized classification proposal to the European Chemicals Agency (ECHA).
2017 – Opinion of ECHA's RAC
ECHA's Risk Assessment Committee (RAC) concludes that should be classified as a Category 2 carcinogen by inhalation.
February 2020 – Official integration into the CLP Regulation
The European Commission formalizes the classification via the 14th Adaptation to Technical Progress (ATP) of the CLP Regulation.
October 2021 – Entry into force of obligations
Specific labeling and hazard statements become mandatory on SDSs and packaging in Europe.
November 2022 – Annulment by the General Court of the EU
Appealed by pigment producers, the General Court of the European Union annuls the harmonized classification, ruling that an assessment error was made regarding the consideration of toxicity studies.
August 1, 2025 – Final judgment of the Court of Justice (Joined Cases C-71/23 P and C-82/23 P)
The court dismissed the appeals brought by the European Commission and France. This means the court refused to side with the European Commission and France, confirming the previous decision regarding its classification as a suspected human carcinogen (Category 2) by inhalation.
Impacts on Your Safety Data Sheets (SDS) and WHMIS?
Whether you manufacture, import, or distribute products containing titanium dioxide in Canada or internationally, vigilance is required:
Status and labeling obligations in Europe (CLP Regulation)
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H351i Hazard Statement and EUH211 / EUH212 Supplemental Warnings
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Section 2 & Section 11 Harmonization under CLP Regulations and WHMIS
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EUH211 and EUH212 hazard statements for TiO2 mixtures
Impact and harmonization with WHMIS in Canada
In Canada, the Hazardous Products Regulations (HPR) follow GHS principles. If the ECHA or IARC (CIRC) classification is retained in your hazard evaluations, Section 2 (Hazard Identification) and Section 11 (Toxicological Information) of your SDSs must rigorously reflect these data.
How to ensure the compliance of your chemical products?
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Audit your formulas and particle size distribution
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Identify the percentage and particle size of the titanium dioxide present in your mixtures.
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Update your SDSs and labels
Ensure your safety data sheets comply with the latest versions of the CLP and WHMIS 2015 / revised WHMIS regulations.
Need help classifying your mixtures or authoring your SDSs?
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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