FMC Corporation v European Commission.

• Jurisdiction: European Union
• ECLI: ECLI:EU:T:2021:143
• Docket Number: T-719/17
• Date: 17 March 2021
• Celex Number: 62017TJ0719
• Court: General Court (European Union)

JUDGMENT OF THE GENERAL COURT (Fifth Chamber)

17 March 2021 (*)

(Plant-protection products – Active substance flupyrsulfuron-methyl – Non-renewal of inclusion in the Annex to Implementing Regulation (EU) No 540/2011 – Assessment procedure – Proposed classification of an active substance – Precautionary principle – Rights of defence – Legal certainty – Manifest error of assessment – Proportionality – Principle of non-discrimination – Principle of sound administration – Legitimate expectations)

In Case T‑719/17,

FMC Corporation, established in Philadelphia, Pennsylvania (United States), represented by D. Waelbroeck, I. Antypas and A. Accarain, lawyers,

applicant,

v

European Commission, represented by X. Lewis, G. Koleva and I. Naglis, acting as Agents,

defendant,

APPLICATION under Article 263 TFEU for the annulment of Commission Implementing Regulation (EU) 2017/1496 of 23 August 2017 concerning the non-renewal of approval of the active substance DPX KE 459 (flupyrsulfuron‑methyl), in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (OJ 2017 L 218, p. 7).

THE GENERAL COURT (Fifth Chamber),

composed of D. Spielmann, President, O. Spineanu‑Matei and R. Mastroianni (Rapporteur), Judges,

Registrar: J. Palacio González, Principal Administrator,

having regard to the written part of the procedure and further to the hearing on 30 June 2020,

gives the following

Judgment

I. Background to the dispute

1 The active substance DPX KE 459 (flupyrsulfuron-methyl) (‘FPS’) is used as a selective broad-spectrum herbicide, registered for use on various cereal crops.

2 FPS was included in Annex I to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1) by Commission Directive 2001/49/EC of 28 June 2001 amending Annex I to Directive 91/414 to include DPX KE 459 (flupyrsulfuron-methyl) as an active substance (OJ 2001 L 176, p. 61).

3 The active substances listed in Annex I to Directive 91/414 are deemed to be approved under Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414 (OJ 2009 L 309, p. 1) and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation No 1107/2009 as regards the list of approved active substances (OJ 2011 L 153, p. 1). Approval of FPS, as resulting from its inclusion in that annex, expired on 30 June 2018.

4 On 25 March 2011, DuPont de Nemours (Deutschland) GmbH, the German subsidiary of the DuPont de Nemours group (‘DuPont’), applied, in accordance with Article 14 of Regulation No 1107/2009, for the renewal of approval for FPS. That renewal application was made pursuant to Article 4 of Commission Regulation (EU) No 1141/2010 of 7 December 2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414 and establishing the list of those substances (OJ 2010 L 322, p. 10), within the period prescribed by that article.

5 The French Republic and the Kingdom of Denmark were designated as Rapporteur Member State (‘RMS’) and co-Rapporteur Member State respectively to carry out the renewal risk assessment for FPS on behalf of the European Union, in the context of the procedure for renewing the approval for FPS.

6 In September 2013, the RMS completed its review of the renewal dossier submitted by DuPont in March 2011, complemented by a supplementary dossier in May 2012, and issued a draft renewal assessment report for FPS (‘the renewal assessment report’). The RMS noted that the renewal file was complete. It recommended renewing the approval of FPS.

7 On 27 September 2013, a copy of the renewal assessment report was sent to DuPont and to the European Food Safety Authority (EFSA). On 2 October 2013, EFSA initiated the peer review process by sending the renewal assessment report to DuPont and to the Member States for consultation. DuPont and the Member States were requested to provide comments on that report within a period of two months.

8 On 3 December 2013, within the period prescribed, DuPont submitted its comments on the renewal assessment report to EFSA.

9 After considering the comments received on the renewal assessment report, the European Commission decided to mandate EFSA to conduct an expert consultation in the areas of mammalian toxicology, environmental fate and behaviour, and ecotoxicology.

10 At the peer review meeting held on 16 May 2014, EFSA and Member States’ experts reviewed the available mammalian toxicity studies on FPS. On the basis of ambiguous hepatic effects observed in a long-term mouse study, the majority of the peer review experts decided to propose, as regards the hazards of FPS, that it be classified as a category 2 carcinogen.

11 Subsequently, when finalising its scientific conclusion on the risk assessment of FPS (‘the EFSA conclusion’), EFSA proposed to classify FPS also as a category 2 reproductive toxicant (R2). That proposal was based on ambiguous results in a rat developmental study (delayed hyoid bone ossification).

12 While recognising that hazard classification is formally decided by the European Chemicals Agency (ECHA) under 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’), EFSA went on to identify two ‘critical areas of concern’ on the basis of its own classification proposal for FPS:

– In the first place, EFSA concluded that FPS fulfilled the interim endocrine disrupting criteria laid down in Regulation No 1107/2009 on the basis that it was proposed that FPS should be classified as a category 2 carcinogen and as a reproductive toxicant category 2. Nevertheless, EFSA also acknowledged that no endocrine disrupting effects had been observed in vivo and that ‘therefore flupyrsulfuron-methyl [was] unlikely to be an endocrine disruptor in mammals according to the current state-of-play’.

– In the second place, EFSA concluded that ‘consequent to the classification of the parent compound’, the three main soil metabolites of FPS (IN‑JV460, IN‑KC576 and IN‑KY374) that were expected to exceed the concentration limit of 0.1 μg/L in groundwater had to be regarded as toxicologically relevant in accordance with the presumption set out in the Commission guidance document of 25 February 2003 on the assessment of the relevance of groundwater metabolites in the context of Directive 91/414 (Sanco/221/2000 – rev.10 – final) (‘Commission guidance document on groundwater metabolites’).

13 EFSA invited the Member States to comment on the proposed classification of FPS as toxic for reproduction category 2 and on the two ‘critical areas of concern’ identified on that basis.

14 In their comments, a number of Member States expressed concerns regarding EFSA’s proposal to classify FPS as toxic for reproduction category 2 as well as the consequences ensuing from the EFSA classification proposal.

15 EFSA issued its scientific conclusion on FPS on 6 November 2014. EFSA maintained its classification proposal and concluded that FPS was not expected to meet the approval criteria of Article 4 of Regulation No 1107/2009. In support of that conclusion, EFSA identified four ‘critical areas of concern’:

– in the first place, it could not be concluded that the batches used in the toxicity studies were representative of the proposed technical specifications;

– in the second place, FPS was considered to meet the interim endocrine disrupting criteria since there was a proposal to classify it as a category 2 carcinogen and as a reproductive toxicant category 2;

– In the third place, the potential for groundwater exposure above the concentration limit of 0.1 μg/L to the three main soil metabolites of FPS (IN‑JV460, IN‑KC576 and IN‑KY374) was deemed unacceptable as those three metabolites were presumed toxicologically relevant on the basis of the EFSA classification proposal for FPS;

– In the fourth place, a risk was identified for aquatic plants.

16 In addition, EFSA identified a ‘data gap’ as no groundwater exposure assessment was available for two other FPS metabolites (IN‑JE127 and IN‑KF311).

17 On 2 December 2014, DuPont sent a letter to the Commission setting out its comments on the EFSA conclusion and, in particular, opposing EFSA’s classification proposal for FPS. In addition, DuPont expressed surprise that, despite expressly ruling out endocrine activity, EFSA nonetheless went on to identify FPS as a potential endocrine disruptor on the basis of the interim endocrine disrupting criteria under Regulation No 1107/2009.

18 On the basis of the EFSA conclusion, the Commission issued a draft review report on FPS on 18 March 2015, in which it proposed to withdraw the approval of FPS. The Commission proposal was based on three key concerns, namely:

– the interim endocrine disrupting criteria, which were considered to be fulfilled on the basis of the EFSA classification proposal for FPS as a category 2 carcinogen and as a reproductive toxicant category 2;

– the available information that was not sufficient to assess the risk of groundwater exposure to the relevant metabolites;

– a risk to aquatic organisms.

19 On the same day, the Commission informed DuPont that internal discussions were still ongoing within the Commission regarding the EFSA classification proposal and, therefore, regarding the interim endocrine disrupting criteria.

20 On 8 April 2015, DuPont sent a letter to...