The General Court annulled Titanium Dioxide’s designation as a CMR substance

The EU General Court has annulled the classification of certain forms of titanium dioxide powder as a carcinogenic substance (CMR substance).

In 2020, the European Union (EU) released Commission Delegated Regulation (EU) 2020/217 of 4 October 2019 amending and correcting Regulation (EC) 1272/2008 on Classification, Labeling, and Packaging of Substances and Mixtures (CLP Regulation). That amendment classified titanium dioxide in powder form containing 1% or more of particles with aerodynamic diameter ≤ 10µm as a carcinogenic category 2 substance by inhalation. 

On November 23, 2022, the Court of Justice of the European Union (CJEU) annulled the Commission Delegation Regulation of 2019 on the classification and labeling of titanium dioxide under the CLP Regulation.

In its verdict, the General Court concluded that the Commission made an obvious mistake in its evaluation of the reliability and acceptability of the study on which the classification was based, and improperly applied the classification criteria as provided out by the CLP Regulation to a chemical that possesses the inherent feature of causing cancer.

Titanium dioxide usually serves as a colorant and an ultraviolet (UV) filter in cosmetic formulations. Following its classification as CMR in May 2021, the European Commission restricted its use in cosmetics.

According to the current decision of the General Court, it is foreseeable to tell that the European Commission would revoke the classification and any related restrictions on the use of titanium dioxide in cosmetics.

Resource: https://curia.europa.eu/jcms/upload/docs/application/pdf/2022-11/cp220190en.pdf