This is a rare occasion: the Court of Justice of the European Union annuls the part of the Commission delegated regulation 2020/217, which classifies titanium dioxide as a carcinogenic substance by inhalation in certain powder forms.
Why was Titanium Dioxide classified as carcinogenic?
In the Whereas of Commission delegated regulation 2020/217, section (5), it reads “In its scientific opinion of 14 September 2017 on the substance titanium dioxide, RAC [Committee for Risk Assessment, ed] proposed to classify that substance as carcinogen category 2 by inhalation. As titanium dioxide-induced lung carcinogenicity is associated with inhalation of respirable titanium dioxide particles, retention and poor solubility of the particles in the lung, it is appropriate to define respirable titanium dioxide particles in the titanium dioxide entry. The deposited particles, but not solutes of titanium dioxide, are assumed to be responsible for the observed toxicity in the lung and subsequent tumour development. In order to avoid unjustified classification of non-hazardous forms of the substance, specific notes should be laid down for the classification and labelling of the substance and mixtures containing it. In addition, as some hazardous dust or droplets could be formed during the use of mixtures containing titanium dioxide, it is necessary to inform the users of the precautionary measures that need to be taken to minimise the hazard for human health.”
So what had happened?
Back in 2017, the Committee for Risk Assessment of the European Chemical Agency (ECHA) proposed to classify titanium dioxide as suspected of causing cancer (via inhalation). This was predominantly driven by the French Agency ANSES, and then later adopted by RAC. The RAC recommendation was adopted by the European Commission and turned into law by the Commission delegated regulation 2020/217.
What were the consequences for the industry?
When the regulation came into force, it meant a costly reformulation for the industry. And since other competent authorities, which also assessed the risk of titanium dioxide, did not come to the same conclusion, it meant that only products sold in the European Union needed the reformulation.
What did the industry actors do?
CWS Powder Coatings and other paint manufacturers suspected that the data, on which the recommendation is based, were not scientifically sound, and asked the Court of Justice of the European Commission to evaluate the decision and consequently, the validity of the regulation.
What was the outcome?
Having evaluated the quality of the data, the court stated that “the Commission made a manifest error in its assessment of the reliability and acceptability of the study on which the classification was based and, second, it infringed the criterion according to which that classification can relate only to a substance that has the intrinsic property to cause cancer”.
It further stated “the requirement to base the classification of a carcinogenic substance on reliable and acceptable studies was not satisfied.” And consequently annulled the Commission Delegated Regulation of 2019 in so far as it concerns the harmonised classification and labelling of titanium dioxide as a carcinogenic substance by inhalation in certain powder forms.
What does it mean for titanium dioxide in food?
The annulation only concerns the classification and labelling of titanium dioxide as a carcinogenic substance by inhalation, not by ingestion. It remains to be seen if there will be a reassessment for this route as well.
And the learnings?
The most important learning is that weight of evidence is key when looking at studies. There are many – dare I say: too many – studies published in literature that would not pass the litmus test due to low quality. Especially in risk assessment, it is of utmost importance to evaluate the data quality of studies to be able to make a sound judgement. Hopefully, there won’t be too many of such cases but it shows that even high-level committees can err in their assessments.
