On November 23, the General Court of the European Court of Justice (ECJ) struck down the Commission classification of titanium dioxide as a category 2 carcinogen under the CLP Regulation.
The Court found that the opinion of the ECHA Risk Assessment Committee (RAC), on which the Commission classification is based, contained two manifest errors of assessment: first of all in mainly relying on the results of a study whose reliability was questioned, and secondly by failing to demonstrate that the criterion of “intrinsic (hazardous) properties” had been met.
The Court decision underlines two key issues for NIA and its members. A stable and predictable regulatory framework is key for companies to be able to meet their obligations in an efficient way: the Court reminder that concepts like intrinsic hazard should not be given new interpretations as the basis for regulatory restrictions, at least not without adequate discussion, is therefore welcome.
The Court decision also supports the point that the nano size of a particle under testing must be taken into account for the results to be reliable. In the case of the titanium dioxide, it appears that the main study guiding the RAC opinion failed to do this, ending up with an excessive exposure which vitiated the validity of its findings. This is why, as NIA has long been advocating for, further test funding is needed: nano-adapted Testing Guidelines (TGs) are a fundamental part of ensuring regulatory compliance (to learn more on this topic, you can check the website of the NanoHarmony project that NIA is a part of).
The Court decision also supports the importance of correct dosimetry, as the starting point of every test; indeed, this topic is the subject of an upcoming Joint Research Centre (JRC) guideline document, and we look forward to its release.
The full Court decision is available at this link. The NIA summary can be seen here.
