In Case C‑471/18 P in which Tanchev AG Opined last month, Germany is asking the CJEU to set aside judgment in T‑283/15 Esso Raffinage v ECHA by which the General Court annulled entitled a European Chemical Agency (‘ECHA’) letter entitled ‘Statement of Non-Compliance following a Dossier Evaluation Decision under [REACH]’. The letter concerned the outcome of ECHA’s compliance check of Esso Raffinage’s registration dossier for a particular chemical substance. The main thrust of its appeal is that the REACH Regulation does not provide for further examination by ECHA of the conformity of the information submitted with the first compliance check decision, and that this matter falls within the competences of the Member States pursuant to the REACH enforcement provisions. In support of its position, it argues that a registrant must conduct animal testing specified in the Evaluation Decision, and cannot submit adaptations at that stage.
Esso and ECHA find themselves in an unusual alliance with animal rights activists who argue that a registrant must be able to submit adaptations in lieu of performing animal testing specified in a first compliance check decision.
The case mostly concerns the respective competences of Member States and ECHA under Reach, I highlight it here for the AG’s emphasis on the relevance of animal welfare in the Regulation: consideration of animal welfare through the reduction of animal testing is one of the objectives pursued by the REACH Regulation. At 158: ‘Viewed more broadly, as indicated by Esso Raffinage and [NGO], the promotion of animal welfare and alternative methods to animal testing in the REACH Regulation reflects Article 13 TFEU, pursuant to which, in formulating and implementing the European Union’s policies, the European Union and the Member States are to pay full regard to the welfare requirements of animals.’
Animal welfare has come a long way since Michael Rose and I submitted it in CJEU C-1/96 Compassion in World Farming.
A short post on manufactured nanomaterials and data. (Readers will be aware that although the blog focuses mostly on litigation, I dabble in regulatory research and practice, too. And that nanotechnology regulation has been a consistent interest of mine).
Thank you Lynn Bergeson and Carla Hutton for flagging the study by EUON on data collection and reporting methodology for manufactured nanomaterials. EUON, the European Union’s Observatory for Nanomaterials, is hosted by ECHA – the EU’s Chemicals Agency. The study’s purpose is made clear on p.15 (only) of the report: the overall context is for the regulators to have an overview of the heterogeneous market for nanomaterials. In order to do so, the study measures the reliability etc of existing reports and studies on the nanomaterials market. It concludes that a Delphi study of the existing research would be required.
For those of you with an interest in information flows and the transparency of data, the implications are clear: part of the exercise of regulating new technologies is to know what is out there; and manufacturers’ data clearly are not making it into the public domain in a transparent and coherent manner. Consider alongside this report, for instance the proposed US EPA rule on transparency in regulator science.
In Bilbaína de Alquitranes, the ECJ (General Court) has held that producers of chemical substances may challenge the legality of the decision by ECHA to put a substance on the candidate list of ‘substances of very high concern’ under the REACH Regulation. The judgment is a useful addition to the strict conditions under the Treaty on European Union to seek judicial review of decisions made by the EU Institutions.
The appeal was rejected on substance, however both with respect to the issue of what are ‘final’ decisions that may be challenged, and on ‘individual’ and ‘direct’ concern, the judgment is worth a read. I have a summary of the issues pre-Lisbon over at SSRN. Especially in environmental matters, the Court’s case-law on locus standi has for a long time been very limiting.
Under the European Union’s regime on chemicals (REACH), companies manufacturing or importing chemical substances have to notify considerable amounts of data to the European Chemicals Agency (ECHA). Under the general ‘no data, no market’ rule, those chemicals for which no appropriate risk assessment and risk management has been carried out, cannot be put on the market. What may seem a futile part of compliance – paying the correct registration fee – has now come back to haunt several companies.
ECHA’s machinery needs to be financed. Companies registering substances under REACH to that end pay a registration fee. Micro or small and medium sized enterprises (SMEs) receive a discount. Those incorrectly classifying themselves as small, have now had their comeuppance: ECHA has rejected their registrations, effectively meaning that the companies involved can no longer manufacture or import the substance above one ton per annum.
Lessons are clear. Firstly, one should always be careful with statements of size. Secondly, ECHA bites. It is one of only a few of the European Union’s Agencies which is truly ‘regulatory’ (also on issues of chemicals policy much more relevant than size).