Industrials win (temporary) reversal of the classification of TiO₂ as a carcinogen

The European Union General Court invalidates the classification of titanium dioxide

A new twist in the tug-of-war that has pitted industry and health authorities against each other for years over the risks of titanium dioxide (TiO₂): the European Union General Court has just handed down a ruling overturning the classification of TiO₂ as a category 2 carcinogen by inhalation. This classification, which came into effect in October 2019 and was formalized via European Commission Regulation 2020/217, had since been challenged by TiO₂ manufacturers and users who had filed appeals with the European Union General Court.

On what grounds did the Court make its decision?

In the press release issued today, the Court summarizes the reasons that led to this judgment with two main arguments:

• A lack of “reliability” of the file on which the classification is based (the density of non-agglomerated primary TiO₂ nanoparticles was considered, yet it is higher than the density of agglomerates, since agglomeration creates empty spaces, less dense than TiO₂)
• and the fact that the substance would not be “intrinsically” capable of causing cancer, the carcinogenic hazard being related not to TiO₂ per se, but more particularly to respirable titanium dioxide powders containing 1% or more of particles with an aerodynamic diameter of 10 μm or less (i.e., 10,000 nm).

The General Court has thus ruled in favor of the defenders of _TiO2. A possible appeal against the decision of the Court could be filed within two months and ten days.

The irony of it all

This cancellation is particularly problematic insofar as it allows industrialists to no longer alert workers when powders contain nanometric TiO₂, whose danger has not been ruled out. Furthermore, for years manufacturers have been reluctant to provide information on their _TiO2 nanoparticles to health authorities.

AVICENN’s immediate reaction

AVICENN has been contacted by the French radio FranceInfo to comment on this decision:

→ Find the full FranceInfo _TiO2 podcast here.

No implication for consumers but the end of information for workers?

This decision therefore challenges the harmonized classification and labeling of titanium dioxide in all its forms, including _TiO2 nanomaterials. While it does not undermine the ban on E171 in food (which is covered by another regulation), it does compromises workers’ access to information: if they are deprived of information on the potential danger of the product, they will be less able to protect themselves.

That these industrialists openly refuse to inform their employees, despite the risks involved, is revealing.

What data does the EU Court have to consider that workers who breathe unprotected TiO₂ nanoparticles from now on will not develop cancer in the long term?

How can the precautionary principle be applied?

The judgment refers to the lack of reliable and acceptable studies.

However, is it not the manufacturers that have a large share of responsibility in this state of affairs?

Given the health uncertainties, the precautionary principle must prevail: how can it be applied in practice from now on, if an appeal is not filed or if it is rejected?