Amendments to the classification of Titanium Dioxide in the EU

Titanium Dioxide in the European Union (EU)

In February 2020, the European Union (EU) Commission published Commission Delegated Regulation (EU) 2020/217 which introduced new requirements for products containing titanium dioxide (TiO2). The delegated regulation meant that as of October 1, 2021:

• Titanium dioxide must be classified as a category 2 carcinogen via inhalation if titanium dioxide particles with an aerodynamic diameter of ≤10 µm are present in a substance or mixture at ≥1%, and the product must be labelled with EUH212;
• Non-classified solid mixtures containing at least 1% titanium dioxide must be labelled with EUH212, regardless of the form or particle size of the titanium dioxide; and
• Liquid mixtures containing titanium dioxide need not be classified as carcinogenic but must be labelled with EUH211.

However, in November 2022, the Court of Justice of the European Union announced that it annuls the Commission Delegated Regulation as it pertains to the harmonized classification of titanium dioxide as a carcinogen in certain powder forms. The Court determined that “the requirement to base the classification of a carcinogenic substance on reliable and acceptable studies was not satisfied” and that the classification and labelling of titanium dioxide under Commission Delegated Regulation (EU) 2020/217 “infringed the 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.” The full ruling can be read here.

For questions regarding how this affects your product labels and SDSs, please contact us.