Joined Cases T-337/18 and T-347/18: Judgment of the General Court of 15 September 2021 — Laboratoire Pareva and Biotech3D v Commission (Biocidal products — Active substance PHMB (1415; 4.7) — Refusal of approval for product-types 1, 5 and 6 — Conditional approval for product-types 2 and 4 — Risks to human health and the environment — Regulation (EU) No 528/2012 — Article 6(7)(a) and (b) of Delegated Regulation (EU) No 1062/2014 — Harmonised classification of the active substance under Regulation (EC) No 1272/2008 — Prior consultation of the ECHA — Manifest error of assessment — Read-across — Right to be heard)
Date: 2021-09-15
Institutions: General Court
Subjects: European Chemicals Agency, biocide, chemical product, health risk, market approval, rights of the defence








C_2021452EN.01001802.xml










8.11.2021   


EN


Official Journal of the European Union


C 452/18






Judgment of the General Court of 15 September 2021 — Laboratoire Pareva and Biotech3D v Commission
(Joined Cases T-337/18 and T-347/18) (1)

(Biocidal products - Active substance PHMB (1415; 4.7) - Refusal of approval for product-types 1, 5 and 6 - Conditional approval for product-types 2 and 4 - Risks to human health and the environment - Regulation (EU) No 528/2012 - Article 6(7)(a) and (b) of Delegated Regulation (EU) No 1062/2014 - Harmonised classification of the active substance under Regulation (EC) No 1272/2008 - Prior consultation of the ECHA - Manifest error of assessment - Read-across - Right to be heard)
(2021/C 452/17)
Language of the case: English

Parties


Applicant in cases T-337/18 and T-347/18: Laboratoire Pareva (Saint-Martin-de-Crau, France) (represented by: K. Van Maldegem, S. Englebert, P. Sellar and M. Grunchard, lawyers)

Applicant in case T-347/18: Biotech3D Ltd & Co. KG (Gampern, Austria) (represented by: K. Van Maldegem, S. Englebert, P. Sellar and M. Grunchard, lawyers)

Defendant: European Commission (represented by: R. Lindenthal and K. Mifsud-Bonnici, acting as Agents)

Interveners in support of the defendant: French Republic (represented by: A.-L. Desjonquères, J. Traband, E. Leclerc and W. Zemamta, acting as Agents), European Chemicals Agency (ECHA) (represented by: M. Heikkilä, C. Buchanan and T. Zbihlej, acting as Agents)

Re:

Applications pursuant to Article 263 TFEU seeking annulment of, in Case T 337/18, Commission Implementing Decision (EU) 2018/619 of 20 April 2018 not approving PHMB (1415; 4.7) as an existing active substance for use in biocidal products of product-types 1, 5 and 6 (OJ 2018 L 102, p. 21), and, in Case T 347/18, Commission Implementing Regulation (EU) 2018/613 of 20 April 2018 approving PHMB (1415; 4.7) as an existing active substance for use in biocidal products of product-types 2 and 4 (OJ 2018 L 102, p. 1).

Operative part of the judgment

The Court:






1.


Joins Cases T-337/18 and T-347/18 for the purposes of the present judgment;










2.


Dismisses the actions;










3.


In Case T-337/18, orders Laboratoire Pareva to bear its own costs and to pay those incurred by the European Commission, including those incurred in the proceedings for interim measures registered under number T-337/18 R and T-337/18 R II;










4.


In Case T-347/18, orders Laboratoire Pareva and Biotech3D Ltd & Co. KG to bear their own costs and to pay those incurred by the Commission, including those incurred in the proceedings for interim measures registered under number T-347/18 R, and orders Laboratoire Pareva also to pay the costs incurred in the proceedings for interim measures registered under number T-347/18 R II;










5.


Orders the French Republic and the European Chemicals Agency (ECHA) to each bear their own costs.






(1)  OJ C 285, 13.8.2018.