European Union Court of Justice Annuls Titanium Dioxide Regulation

November 28, 2022 | The European Union Court of Justice (ECJ) recently annulled the sections of the European Commission’s Regulation 2020/217 that classified titanium dioxide (TiO2), a substance frequently found in toys and many other consumer products, as a carcinogen.

The judgement states that “the Commission made a manifest error in its assessment of the reliability and acceptability of the scientific study on which the classification was based.” It also determined that the Commission infringed on the criterion for a substance to be classified as a carcinogen; since titanium dioxide does not have an intrinsic property to cause cancer, it cannot be defined as such.

Although unlikely, the Commission has approximately two and a half months to file an appeal.

“An appeal notwithstanding, the annulment is a welcome development because it reiterates the regulatory obligation that reliable science and the requirements for classification are followed,” said Jos Huxley, senior vice president of technical affairs at The Toy Association. “Importantly, the court has clarified that while a substance may present a hazard in limited circumstances, this does not automatically result in the classification that the substance itself is intrinsically hazardous.”

Titanium dioxide is an inorganic substance that is mainly used for its coloring and covering properties in various products, including toys, ceramics, over-the-counter drugs, and cosmetics. The chemical may be used as a pigment in plastics, modeling clays, paint, inks, and more.

The full ECJ notice is available here. Questions from members may be directed to The Toy Association’s Jos Huxley, senior vice president of technical affairs.