How Can New Scientific and Technical Knowledge Affect the Authorisation of Plant Protection Products at Member State Level? Some Clarifications from the Court of Justice - 2025
How Can New Scientific and Technical Knowledge Affect the Authorisation of Plant Protection Products at Member State Level? Some Clarifications from the Court of Justice
Mattioli, Pietro
2025 • In European Journal of Risk Regulation, p. 1-7
Mattioli, Pietro ; Université de Liège - ULiège > Département de droit > Droit matériel européen
Language :
English
Title :
How Can New Scientific and Technical Knowledge Affect the Authorisation of Plant Protection Products at Member State Level? Some Clarifications from the Court of Justice
H2020 - 948473 - EUDAIMONIA - National institutional autonomy within the EU legal order: uncovering and addressing its distinctive appearances, origins and impact on Member States' administrations
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 [2009] OJ L 309/1, Art 75.
Case C-308/22, PAN Europe (Closer) [2024] EU:C:2024:350;
Commission Implementing Regulation (EU) 2015/1295 of 27 July 2015 approving the active substance sulfoxaflor [2015] OJ L 199/8.
Regulation 1107/2009 (n 1), Annex I.
European Commission, “Guidance Document on Terrestrial Ecotoxicology” SANCO/10329/2002 (17 October 2002);
and European Food Safety Authority, “Guidance on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees” (2013) 11 EFSA Journal 3295.
Joined Cases C-309/22 and C-310/22, PAN Europe (Evaluation of Endocrine Perturbation Properties) [2024] EU: C:2024:356. At the time of the application, the validity of the approval of the two active substances was already extended. Commission Implementing Regulation 2021/1449 extended the validity of fludioxonil until 31 October 2022, and Commission Implementing Regulation (EU) 2021/745 extended the validity of folpet until 31 July 2022.
Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties [2018] C/2018/2229/33.
Joined Cases C-309/22 and C-310/22 (n 5). Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances [2011] OJ L 153/1.
Commission Regulation 2018/605 (n 6); and European Chemicals Agency et al., “Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009” (2018) 16 EFSA Journal 5311.
Case C-308/22 (n 2), para 51.
Case C-308/22 (n 2), 70.
The Court follows the Advocate General's reasoning. Case C-308/22, PAN Europe (Closer) [2024] EU: C:2023:716, Opinion of Advocate General Medina, paras 55-57.
Case C-308/22 (n 2), para 84.
Case C-308/22 (n 2), para 76.
Case C-308/22 (n 2), paras 75-76.
Case C-308/22 (n 2), paras 88 and 110.
Case C-308/22 (n 2), paras 103-107.
Joined Cases C-309/22 and C-310/22 (n 5) 82. Also, Case T-600/15, PAN Europe and Others v Commission [2016] EU:T:2016:601, para 33.
Joined Cases C-309/22 and C-310/22 (n 5), para 100. The Court follows the reasoning of AG Medina. Joined Cases C-309/22 and C-310/22, PAN Europe (Evaluation of Endocrine Perturbation Properties) [2024] EU:C:2023:717, Opinion of Advocate General Medina, paras 68-75.
Joined Cases C-309/22 and C-310/22 (n 5), para 88-93.
Case T-229/04, Kingdom of Sweden v Commission of the European Communities [2007] ECR II-02437;
Case C-499/18 P, Bayer CropScience AG and Bayer AG v European Commission [2021] EU:C:2021:367;
Case C-374/20 P, Agrochem-Maks d.o.o. v European Commission [2021] EU:C:2021:990.
Case C-162/21, Pesticide Action Network Europe ASBL and Others v État belge [2023] EU:C:2023:30.
Regulation 1107/2009 (n 1) Art 1(4). The EU has also integrated the precautionary principle into other EU policies. Again, the Court has helped to clarify how the principle operates. K De Smedt, and E Vos, “The Application of the Precautionary Principle in the EU” in HA Mieg (eds) The Responsibility of Science. Studies in History and Philosophy of Science, (Springer, 2022) 175-176.
E Fisher, Risk Regulation and Administrative Constitutionalism (Hart Publishing 2007) 211-212;
M Weimer and G. Pisani, “Expertise as Justification: The Contested Legitimation of the EU 'Risk Administration'” in M Weimer and A de Ruijter (eds) Regulating Risks in the European Union (Hart Publishing 2017).
Most recently, the Court has also confirmed the compatibility of Regulation 1107/2009 with the precautionary principle in Case C-616/17, Criminal Proceedings against Mathieu Blaise and Others [2020] EU: C:2019:800.
Leonelli, “Judicial Review of Compliance with the Precautionary Principle from Paraquat to Blaise: 'Quantitative Thresholds, ' Risk Assessment, and the Gap Between Regulation and Regulatory Implementation” (2021) 22 German Law Journal 184, 195-196.
Case T-229/04 (n 18), paras 161 and 170.
Case C-333/08, European Commission v French Republic [2010] ECR-I-00757, para 91 and case law mentioned.
Case C-616/17 (n 23) para 46 and case law mentioned.
Case C-616/17 Blaise and Others [2019] EU:C:2019:190, Opinion of Advocate General Sharpston, para 48.
Joined Cases C-78/16 and C-79/16, Giovanni Pesce and Others v Presidenza del Consiglio dei Ministri - Dipartimento della Protezione Civile and Others [2016] EU:C:2016:428, para 48.
Case C-308/22 (n 2) 107;
Joined Cases C-309/22 and C-310/22 (n 3), para 97.
Case C-308/22 (n 2) para 110.
Case C-308/22 (n 2) paras 68-70. Case C-308/22 (n 2) 107.
To a certain degree, the Court extends the boundaries beyond what was previously established in Case C-313/19 P, Associazione Nazionale GranoSalus - Liberi Cerealicoltori & Consumatori (Associazione GranoSalus) v European Commission [2020] EU:C:2020:869, para 55.
Regulation 1107/2009 (n 1), Art 40(1).
Regulation 1107/2009 (n 1), Annex I.
Regulation 1107/2009 (n 1), Arts 33(1) and 35.
Regulation 1107/2009 (n 1), Art 36(2).
Regulation 1107/2009 (n 1), Art 36(3).
European Parliamentary Research Service (EPRS), European Implementation Assessment: Regulation (EC) 1107/2009 on the placing of plant protection products on the market' (2018) accessed 20 November 2024, 26;
and W de Braal, “National responses to great uncertainty in EU authorisation of pesticides and industrial chemicals” (2023) 3 Review of European Administrative Law 33, 46-47.
Case C-308/22 (n 2) 108; and Joined Cases C-309/22 and C-310/22 (n 5) para 98.
In this regard, the glyphosate saga has highlighted the limited access to information and the possibility to scrutiny in relation to the procedures to approve active substances. Case T-716/14, Anthony C Tweedale v European Food Safety Authority [2019] EU:T:2019:141;
Case T-329/17, Heidi Hautala and Others v European Food Safety Authority [2019] EU:T:2019:142.
In more detail, M Morvillo, “The General Court Orders Disclosure of Glyphosate-related Scientific Studies: Tweedale, Hautala, and the Concept of Environmental Information in the Context of Plant Protection Products” (2019) 10 European Journal of Risk Regulation 419, 426-427;
M Morvillo, “Glyphosate Effect: Has the Glyphosate Controversy Affected the EU's Regulatory Epistemology?” (2020) 11 European Journal of Risk Regulation 422.
Case C-616/17 (n 23) para 102;
A de Boer, M Morvillo, and S Röttger-Wirtz, “Fragmented Transparency: The Visibility of Agency Science in European Union Risk Regulation” (2023) 14 European Journal of Risk Regulation (2023) 313, 317-319.
EPRS (n 37), 55-56 and Annex III-79 et seq. Case C-442/14, Bayer CropScience SA-NV and Stichting De Bijenstichting v Board for the Authorisation of Plant Protection Products and Biocides [2016] EU:C:2016:890.
EPRS (n 367), Annex III-79 et seq.;
Morvillo, “The General Court Orders Disclosure of Glyphosate-related Scientific Studies” (n 39) 426-427.
