The Court of Justice of the European Union recently annulled the labeling of titanium dioxide as a carcinogenic substance by inhalation in certain powder forms.
According to a press announcement, in 2016, the competent French authority submitted a proposal to classify titanium dioxide as a carcinogenic substance to the European Chemicals Agency (ECHA). The following year, the ECHA’s Committee for Risk Assessment (RAC) classified titanium dioxide as a category 2 carcinogen.
The European Commission adopted regulation 2020/217 based on this decision from the ECHA, which also classified titanium dioxide as a carcinogen.
Due to an error in the assessment of the study this classification was based upon, and the infringement of the criterion that the substance must have the intrinsic property to cause cancer, the label was annulled, the Court of Justice reported.
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The General Court interpreted the concept of intrinsic properties in its literal sense as referring to the properties which a substance has in and of itself, concluding that by upholding the opinion of the RAC that the mode of action of carcinogenicity the committee relied on could not be regarded as intrinsic toxicity.
According to the General Court, the carcinogenicity hazard of titanium dioxide is linked solely to certain respirable titanium dioxide particles when they are present in a certain form, physical state, size and quantity, and the hazard occurs only in lung overload conditions and corresponds to particle toxicity.