Case T-169/24: Judgment of the General Court of 8 October 2025 – PMC Vlissingen Netherlands v Commission (Environment and protection of human health – Regulation (EC) No 1272/2008 – Classification, labelling and packaging of certain substances and mixtures – Delegated Regulation (EU) 2024/197 – Classification and labelling of dibutyltin oxide – Criteria for classification of a substance in the hazard class reproductive toxicity, Category 1B – Absence of public consultation on the opinion of ECHA’s Committee for Risk Assessment – No obligation to review – Regulation (EC) No 1907/2006 – Read-across – Maternal toxicity – Manifest error of assessment)
Date: 2025-10-08
Institutions: General Court
Subjects: classification, environmental protection, labelling, packaging, reproductive health, toxic substance








C_202506173EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2025/6173


24.11.2025






Judgment of the General Court of 8 October 2025 – PMC Vlissingen Netherlands v Commission


(Case T-169/24)
                (1)

(Environment and protection of human health - Regulation (EC) No 1272/2008 - Classification, labelling and packaging of certain substances and mixtures - Delegated Regulation (EU) 2024/197 - Classification and labelling of dibutyltin oxide - Criteria for classification of a substance in the hazard class reproductive toxicity, Category 1B - Absence of public consultation on the opinion of ECHA’s Committee for Risk Assessment - No obligation to review - Regulation (EC) No 1907/2006 - Read-across - Maternal toxicity - Manifest error of assessment)
(C/2025/6173)
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 (represented by: J. Jokubauskaitė and B. Cullen, acting as Agents)

Interveners in support of the defendant: Kingdom of the Netherlands (represented by: M. Bulterman and J. Langer, acting as Agents), Republic of Austria (represented by: J. Schmoll, acting as Agent), Kingdom of Sweden (represented by J. Olsson, F.-L. Göransson, C. Meyer-Seitz and H. Eklinder, acting as Agents), European Chemicals Agency (represented by: A. Hautamäki, A. Deloff Bialek, W. Broere and M. Heikkilä, acting as Agents)

Re:

By its action under Article 263 TFEU, the applicant seeks the annulment of Commission Delegated Regulation (EU) 2024/197 of 19 October 2023 amending Regulation (EC) No 1272/2008 as regards the harmonised classification and labelling of certain substances (OJ L, 2024/197; ‘the contested regulation’), in so far as it introduces the harmonised classification and labelling of the substance dibutyltin oxide in the hazard class reproductive toxicity, Category 1B.

Operative part of the judgment

The Court:






1.


Dismisses the action;










2.


Orders PMC Vlissingen Netherlands BV to bear its own costs and to pay the costs incurred by the European Commission;










3.


Orders the Kingdom of the Netherlands, the Republic of Austria, the Kingdom of Sweden and the European Chemicals Agency (ECHA) each to bear their own costs.






(1)  
            OJ C, C/2024/3341, 3.6.2024.


ELI: http://data.europa.eu/eli/C/2025/6173/oj
ISSN 1977-091X (electronic edition)