# C_2018022EN.01004301.xml

| 22.1.2018 | EN | Official Journal of the European Union | C 22/43 |
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Action brought on 23 October 2017 — DuPont de Nemours and Others v Commission

(Case T-719/17)

(2018/C 022/60)

Language of the case: English

Parties

Applicants: DuPont de Nemours (Deutschland) GmbH (Neu-Isenburg, Germany) and 12 others (represented by: D. Waelbroeck, I. Antypas and A. Accarain, lawyers)

Defendant: European Commission

Form of order sought

The applicants claim that the Court should:

| — | annul Commission Regulation (EU) 2017/1496 of 23 August 2017 concerning the non-renewal of approval of the active substance Flupyrsulfuron-Methyl (‘FPS’), and the withdrawal of marketing authorisations for plant protection products containing that substance( 1 ); |
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| — | order the defendant to pay all costs and expenses. |
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Pleas in law and main arguments

In support of the action, the applicant relies on six pleas in law.

| 1. | First plea in law: violation of the PPP Regulation (1107/ 2009)( 2 ), the Renewal Regulation (1141/ 2010)( 3 ), the CLP Regulation (1272/ 2008)( 4 ) and the Animal Testing Directive (2010/ 63)( 5 ):
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the applicants submit that the Contested Regulation was adopted in violation of the Renewal Regulation (1141/2010) and Renewal Guidance (SANC0/10387/2010 rev. 8) insofar as the EFSA re-evaluated the hazard profile of FPS despite there being no change in the state of scientific knowledge and in the applicable legal framework; —
the applicants submit that the Contested Regulation was adopted in violation of the CLP Regulation (1272/2008) and the Commission Guidance on Groundwater Metabolites (SANC0/221/2000 rev.10) insofar as the EFSA relied on its own hazard classification proposal for FPS to presume the toxicity of three groundwater metabolites; —
the applicants submit that the Contested Regulation was adopted in violation of the EU rules on animal testing contained in the PPP Regulation (1107/2009) and the Animal Testing Directive (2010/63) insofar as the EFSA identified a data gap for additional genotoxicity studies without giving proper consideration to the overall weight of evidence and despite there being no demonstrated necessity to perform any further testing. | — | the applicants submit that the Contested Regulation was adopted in violation of the Renewal Regulation (1141/2010) and Renewal Guidance (SANC0/10387/2010 rev. 8) insofar as the EFSA re-evaluated the hazard profile of FPS despite there being no change in the state of scientific knowledge and in the applicable legal framework; | — | the applicants submit that the Contested Regulation was adopted in violation of the CLP Regulation (1272/2008) and the Commission Guidance on Groundwater Metabolites (SANC0/221/2000 rev.10) insofar as the EFSA relied on its own hazard classification proposal for FPS to presume the toxicity of three groundwater metabolites; | — | the applicants submit that the Contested Regulation was adopted in violation of the EU rules on animal testing contained in the PPP Regulation (1107/2009) and the Animal Testing Directive (2010/63) insofar as the EFSA identified a data gap for additional genotoxicity studies without giving proper consideration to the overall weight of evidence and despite there being no demonstrated necessity to perform any further testing. |
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| — | the applicants submit that the Contested Regulation was adopted in violation of the Renewal Regulation (1141/2010) and Renewal Guidance (SANC0/10387/2010 rev. 8) insofar as the EFSA re-evaluated the hazard profile of FPS despite there being no change in the state of scientific knowledge and in the applicable legal framework; | | | | | | |
| — | the applicants submit that the Contested Regulation was adopted in violation of the CLP Regulation (1272/2008) and the Commission Guidance on Groundwater Metabolites (SANC0/221/2000 rev.10) insofar as the EFSA relied on its own hazard classification proposal for FPS to presume the toxicity of three groundwater metabolites; | | | | | | |
| — | the applicants submit that the Contested Regulation was adopted in violation of the EU rules on animal testing contained in the PPP Regulation (1107/2009) and the Animal Testing Directive (2010/63) insofar as the EFSA identified a data gap for additional genotoxicity studies without giving proper consideration to the overall weight of evidence and despite there being no demonstrated necessity to perform any further testing. | | | | | | |

| 2. | Second plea in law: reliance on new and unestablished guidance in violation of the principle of legal certainty, the rights of the defence and several provisions of EU law:
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The applicants submit that the Contested Regulation was adopted in violation of the principle of legal certainty, the renewal applicant's rights of the defense as well as several provisions of EU law in that the EFSA performed the genotoxicity assessment for two FPS metabolites on the basis of a new and unapproved scientific opinion currently under review, which led the EFSA to identify an artificial data gap in the renewal dossier, which they were subsequently given no opportunity to address. | — | The applicants submit that the Contested Regulation was adopted in violation of the principle of legal certainty, the renewal applicant's rights of the defense as well as several provisions of EU law in that the EFSA performed the genotoxicity assessment for two FPS metabolites on the basis of a new and unapproved scientific opinion currently under review, which led the EFSA to identify an artificial data gap in the renewal dossier, which they were subsequently given no opportunity to address. |
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| — | The applicants submit that the Contested Regulation was adopted in violation of the principle of legal certainty, the renewal applicant's rights of the defense as well as several provisions of EU law in that the EFSA performed the genotoxicity assessment for two FPS metabolites on the basis of a new and unapproved scientific opinion currently under review, which led the EFSA to identify an artificial data gap in the renewal dossier, which they were subsequently given no opportunity to address. | | |

| 3. | Third plea in law: Failure to conduct a complete risk assessment in violation of the rights of the defence and several provisions of EU law:
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The applicants submit that the Contested Regulation was adopted in violation of the renewal applicant's rights of the defence and several provisions of EU law in that the Commission relied exclusively on the conclusions drawn by the EFSA to decide to ban FPS, without taking into account all available scientific information evidencing the safety of FPS, and in particular the additional studies spontaneously performed by the renewal applicant to address the alleged data gap and concerns identified by the EFSA, as well as the assessment of the Rapporteur Member State and the other Member States' comments during the renewal review. | — | The applicants submit that the Contested Regulation was adopted in violation of the renewal applicant's rights of the defence and several provisions of EU law in that the Commission relied exclusively on the conclusions drawn by the EFSA to decide to ban FPS, without taking into account all available scientific information evidencing the safety of FPS, and in particular the additional studies spontaneously performed by the renewal applicant to address the alleged data gap and concerns identified by the EFSA, as well as the assessment of the Rapporteur Member State and the other Member States' comments during the renewal review. |
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| — | The applicants submit that the Contested Regulation was adopted in violation of the renewal applicant's rights of the defence and several provisions of EU law in that the Commission relied exclusively on the conclusions drawn by the EFSA to decide to ban FPS, without taking into account all available scientific information evidencing the safety of FPS, and in particular the additional studies spontaneously performed by the renewal applicant to address the alleged data gap and concerns identified by the EFSA, as well as the assessment of the Rapporteur Member State and the other Member States' comments during the renewal review. | | |

| 4. | Fourth plea in law: violation of the principle of proportionality:
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The applicants submit that the Contested Regulation is plainly disproportionate to the overall safety profile of FPS and that the Commission could have addressed the alleged concerns underlying the Contested Regulation through less restrictive measures not entailing a ban on the use of FPS, e.g. through the use of the Confirmatory Data Procedure provided for in Article 6(f) of the PPP Regulation (1107/2009) or through risk mitigating measures decided at national level by the EU Member States. | — | The applicants submit that the Contested Regulation is plainly disproportionate to the overall safety profile of FPS and that the Commission could have addressed the alleged concerns underlying the Contested Regulation through less restrictive measures not entailing a ban on the use of FPS, e.g. through the use of the Confirmatory Data Procedure provided for in Article 6(f) of the PPP Regulation (1107/2009) or through risk mitigating measures decided at national level by the EU Member States. |
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| — | The applicants submit that the Contested Regulation is plainly disproportionate to the overall safety profile of FPS and that the Commission could have addressed the alleged concerns underlying the Contested Regulation through less restrictive measures not entailing a ban on the use of FPS, e.g. through the use of the Confirmatory Data Procedure provided for in Article 6(f) of the PPP Regulation (1107/2009) or through risk mitigating measures decided at national level by the EU Member States. | | |

| 5. | Fifth plea in law: Violation of the principle of non-discrimination:
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The applicants submit that the Commission infringed the principle of non-discrimination in that the alleged concerns underlying the Contested Regulation have consistently been handled through less restrictive measures in the Commission's past decisional practice. However, the Commission has so far never relied on such concerns to justify an outright ban on the use of a substance. | — | The applicants submit that the Commission infringed the principle of non-discrimination in that the alleged concerns underlying the Contested Regulation have consistently been handled through less restrictive measures in the Commission's past decisional practice. However, the Commission has so far never relied on such concerns to justify an outright ban on the use of a substance. |
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| — | The applicants submit that the Commission infringed the principle of non-discrimination in that the alleged concerns underlying the Contested Regulation have consistently been handled through less restrictive measures in the Commission's past decisional practice. However, the Commission has so far never relied on such concerns to justify an outright ban on the use of a substance. | | |

| 6. | Sixth plea in law: Violation of good administration principles and DuPont's legitimate expectations:
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The applicants submit that the Commission failed to properly handle the review process for FPS, which caused DuPont to invest considerable resources into the preparation of scientific dossiers that eventually proved entirely useless as the Commission unexpectedly revised its stance in relation to certain concerns. In addition, the applicants submit that the Contested Regulation undermines the competition policy objectives underlying the divestment of FPS, which the Commission itself imposed on Dow/DuPont to avoid the creation of a dominant position in the EEA market for cereal herbicides. This mishandling of the review process for FPS amounts to a violation of the Commission's duty of care, good administration principles and DuPont's legitimate expectations. | — | The applicants submit that the Commission failed to properly handle the review process for FPS, which caused DuPont to invest considerable resources into the preparation of scientific dossiers that eventually proved entirely useless as the Commission unexpectedly revised its stance in relation to certain concerns. In addition, the applicants submit that the Contested Regulation undermines the competition policy objectives underlying the divestment of FPS, which the Commission itself imposed on Dow/DuPont to avoid the creation of a dominant position in the EEA market for cereal herbicides. This mishandling of the review process for FPS amounts to a violation of the Commission's duty of care, good administration principles and DuPont's legitimate expectations. |
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| — | The applicants submit that the Commission failed to properly handle the review process for FPS, which caused DuPont to invest considerable resources into the preparation of scientific dossiers that eventually proved entirely useless as the Commission unexpectedly revised its stance in relation to certain concerns. In addition, the applicants submit that the Contested Regulation undermines the competition policy objectives underlying the divestment of FPS, which the Commission itself imposed on Dow/DuPont to avoid the creation of a dominant position in the EEA market for cereal herbicides. This mishandling of the review process for FPS amounts to a violation of the Commission's duty of care, good administration principles and DuPont's legitimate expectations. | | |

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( 1 )  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)

( 2 )  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/EEC (OJ 2009 L 309, p. 1)

( 3 )  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/EEC and establishing the list of those substances (OJ 2010 L 322, p. 10)

( 4 )  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)

( 5 )  Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ 2010 L 276, p. 33)

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