The harmonization of titanium dioxide
On February 18th 2020 Regulation (EU) n. 2020/217, corresponding to the 14th ATP, has been published on the official EU Journal. This regulation amends Annex VI to Regulation 1272/2008 (CLP) by adding, removing or modifying the harmonized classification of certain substances.
Of the updated substances, the most controversial classification update regarded the titanium dioxide (CAS: 13463–67–7), a substance widely used in paint products which has now a classification as cancerogenous via inhalation of category 2 due to the toxicity of respirable particles. In order to avoid unjustified classification of non-hazardous forms of the substance, ATP 14th also introduced specific notes for the classification and labelling of the substance and mixtures containing it.
However, last November 23rd 2022 the EU General Court ruled on the matter by issuing a sentence that annulled the part relating to titanium dioxide.
Based on the three joined cases ‑279/20, T‑288/20 and T‑283/20, the judgment annuls the harmonized classification and labelling of titanium dioxide in powder form containing 1% or more of particles of a diameter equal to or below 10 μm.
In its judgment, the General Court ruled that the Commission made an error in the assessment of the reliability and acceptability of the study upon which the classification was based, and incorrectly applied the classification criterion according to which the classification of a substance as carcinogenic can apply only to a substance that has the intrinsic property to cause cancer. Since the carcinogenic potential has been recognized as a property of only a specific form of titanium dioxide, the carcinogenic classification has then been contested.
The European Commission is therefore called to legislate on the matter within a period of two months and ten days from the date of the sentence. However, we remind you that until the eventual publication of a regulation on the subject, the harmonized classification relating to titanium dioxide as a carcinogen of category 2 prescribed according to the 14th ATP will continue to apply.
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