Action brought on 27 March 2024 – PMC Vlissingen Netherlands v Commission
(Case T-169/24)
Language of the case: English
Parties
Applicant: PMC Vlissingen Netherlands BV (Leiden, Netherlands) (represented by: J.-P. Montfort, P. Chopova-Leprêtre and N. Kyriazopoulou, lawyers)
Defendant: European Commission
Form of order sought
The applicant claims that the Court should:
Annul Commission Delegated Regulation (EU) 2024/197 of 19 October 2023 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008, 1 insofar as it introduces a harmonised classification and labelling for dibutyltin oxide (‘DBTO’) as reproductive toxicant in Category 1B (the ‘contested Regulation’); 2
Order the defendant to pay the costs of these proceedings.
Pleas in law and main arguments
In support of the action, the applicant relies on four pleas in law.
First plea in law, alleging that the Commission breached Articles 36(1)(d) and 37(5), Section 3.7.2.3.1 of Annex I to Regulation (EC) No 1272/2008 and the principle of sound administration, because it did not consider ‘all’ the available information on DBTO in a comprehensive weight of evidence (‘WoE’) determination, including a new and decisive study, which became available after the adoption of the opinion of the Committee for Risk Assessment but well before the adoption of the contested Regulation.
Second plea in law, alleging that the Commission breached Articles 36(1)(d) and 37(5), Sections 1.1.1.3 and 3.7.2.3.1 of Annex I to Regulation (EC) No 1272/2008 and Annex XI of Regulation (EC) No 1907/2006 (‘REACH’) 1 and committed a manifest error of assessment, because it adopted the contested Regulation based on a read-across approach that was not necessary, nor justified based on the available evidence, in accordance with Annex XI of REACH, the related ECHA guidelines and, in particular, the ECHA’s comprehensive Read-Across Assessment Framework.
Third plea in law, alleging that the Commission breached Articles 36(1)(d) and 37(5), Section 3.7.2.1.1 and Table 3.7.1(a) of Annex I to Regulation (EC) No 1272/2008 and committed a manifest error of assessment, because it did not base the contested Regulation on ‘clear evidence’ that DBTO has the intrinsic, specific property to produce an adverse effect on reproduction, which is the required legal threshold for classification in Category 1B. The Commission also failed to consider the influence of severe maternal toxicity on the findings in the studies supporting the contested Regulation.
Fourth plea in law, alleging that the Commission adopted the contested Regulation in breach of the procedural requirement of Article 37(4) of Regulation (EC) No 1272/2008 to consult on the opinion of the Committee for Risk Assessment prior to adopting a harmonised classification and labelling.
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1 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1).
1 The contested Regulation is published in OJ L 2024/197.
1 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1).