Actions against ECHA decisions identifying substances of very high concern under REACH found admissible but dismissed on substance

In a series of cases (Cases T-93 to 96/10, Rutgers a.o. -v- ECHA), the European General Court has considered challenges to the classification of various UVCBs (substances of Unknown or Variable composition, Complex reaction products or Biological materials) as substances of very high concern (SVHCs) within the meaning of Article 57 of Regulation 1907/2006 (REACH). The cases are of interest as regards admissibility and substance.

On admissibility, in analysing whether the applicants were "legally affected" by and could therefore challenge these decisions, the court found that the decisions constituted new information which triggered their obligation to update their safety data sheets. The court therefore concluded that the decisions affected the legal situation of the applicants which were, as a result, directly concerned. This contrasts with the conclusion in the Etimine case (T-343/10, Etimine SA and AB Etiproducts Oy -v- ECHA) where no obligations flowed from the classification of borates as SVHCs and the action was accordingly dismissed as inadmissible.

Moreover, the mere fact that Commission decisions were to be adopted in the subsequent stage of the authorisation procedure - namely the inclusion of the substances in the list of substances subject to authorisation - was not sufficient to regard these as "implementing measures" preventing the companies concerned from challenging directly before the General Court the basic acts. Indeed, the decisions caused their own autonomous effects and triggered, for instance, information obligations. As a result, the General Court found that the conditions set out in Article 263(4) TFEU were met and that the actions were admissible.

The actions were, however, all dismissed on the substance. Notably, in all cases, the court rejected the argument that UVCB substances could not be identified as having "PBT" (persistent, bioaccumulative and toxic) or "vPvB" (very persistent and very bioaccumulative) properties on the basis that their constituents had such properties.

In upholding the ECHA's approach, the court referred among others to the underlying purpose of REACH and the "comparable" approach to classification of mixtures under CLP Regulation 1272/2008.

The court also considered that there was no breach of the principle of equality, since the ECHA does not have any power as regards the choice of the substance to be identified as an SVHC. In some of the cases, procedural points were also raised. In rejecting these, the court confirmed, among others, the ECHA's ability to add to the headings under which a substance should be considered for classification as an SVHC.

While the four cases contain their specificities, all the judgments once again confirm the broad discretion left to EU bodies in scientific matters and the marginal nature of the court's review.

Please click on the links below for the other articles in the March 2013 Life sciences and regulatory newsletter

• Italian antitrust court ruling on access to data
• European Court of Justice rules on application of waste and chemicals law to duckboards in Lapland
• European General Court upholds Commission decision for product recall and sales ban as a result of serious GMP shortcomings
• AG confirms that the sale of medicines drawn off in different containers should be authorised
• New actions before the European courts