Non-compliance with REACH requirements
Germany decided to appeal the EU General Court judgment of 8 May 2018 in T-283/15, Esso Raffinage -v- European Chemicals Agency (ECHA), annulling a 'Statement of Non-Compliance with the REACH Regulation' sent by ECHA to the French authorities in the form of a mere letter. In particular, Germany criticizes the GC's view that ECHA alone is competent (and not Member States) to decide whether registration information complies with the REACH requirements (C-471/18, Germany -v- Esso Raffinage, OJ of 5 November 2018).
REACH – Classification of siloxanes D4, D5, and D6 as substances of very high concern
A new action has been brought before the EU General Court against the inclusion by the European Chemicals Agency (ECHA) of siloxanes D4, D5, and D6 in the candidate list of substances of very high concern (T-519/18, Global Silicones Council and Others -v- ECHA, OJ of 5 November 2018).
Plant Protection Products – Non renewal of oxasulfuron
A new action has been brought before the EU General Court against the EU Commission's regulation not to renewal the approval of the active substance oxasulfuron (T-574/18, Agrochem-Maks -v- Commission, OJ of 26 November 2018). The applicant claims in particular that the EU Commission erroneously applied the precautionary principle.
Non-authorisation of generic medicine
A new action has been brought before the EU General Court against the European Medicines Agency (EMA) for refusing to authorise the generic version of the medicinal product Aubagio®. The applicant incidentally also challenges the EU Commission's 2013 conclusion that Teriflunomide was a new active substance (T-549/18, Hexal -v- EMA, OJ of 3 December 2018).
Scope of notion of biocidal products
The College van Beroep voor het Bedrijfsleven (Administrative Court of Appeal for Trade and Industry, Netherlands) has asked the EU Court of Justice to clarify whether substances consisting of one or more types of bacteria, enzymes or other constituents should be considered as 'biocidal products' within the meaning of Regulation 528/2012 (C-592/18, Darie B.V. -v- Staatssecretaris van Infrastructuur en Milieu, OJ of 3 December 2018).