¹ The active substance glyphosate is approved for use in the EU until 15 Dec. 2022 (Commission Implementing Regulation (EU) 2017/2324 Renewing the Approval of the Active Substance Glyphosate in Accordance with Regulation 1107/2009 concerning the Placing of Plant Protection Products on the Market, and Amending the Annex to Implementing Regulation (EU) 540/2011 [2017] OJ L 333/1). In May 2022, the European Food Safety Authority (EFSA) informed the institutions that there will be a delay in the delivery of its Conclusion on the risk assessment of glyphosate. Commissioner Kyriakides has thus announced that an extension to the current approval period will be necessary. For more information, see European Commission, ‘Status of Glyphosate in the EU’, available at: https://ec.europa.eu/food/plants/pesticides/approval-active-substances/renewal-approval/glyphosate_en.

² Case T-178/18, Région de Bruxelles-Capital v. Commission, EU:T:2019:130; Case C-352/19 P, Région de Bruxelles-Capital v. Commission, EU:C:2020:978 (Brussels-Capital Region).

³ Case T-366/03, Land Oberösterreich and Austria v. Commission, EU:T:2005:347; and Joined Cases C-439/05 and C-454/05, Land Oberösterreich and Austria v. Commission, EU:C:2007:510 (Upper Austria).

⁴ European Commission, Communication on the European Green Deal, COM(2019) 640 final, 11 Dec. 2019; European Commission, Communication on a Farm to Fork Strategy for a Fair, Healthy and Environmentally-friendly Foods System, COM(2020) 381 final, 20 May 2020.

⁵ IARC, Some Organophosphate Insecticides and Herbicides (IARC, 2015), available at: http://monographs.iarc.fr/ENG/Monographs/vol112/mono112.pdf.

⁶ For a detailed account of the glyphosate controversy, see Leonelli, G.C., ‘The Glyphosate Saga and the Fading Democratic Legitimacy of European Union Risk Regulation’ (2018) 25(5) Maastricht Journal of European and Comparative Law, pp. 582–606CrossRefGoogle Scholar.

⁷ In May 2019, the Commission appointed 4 Member States (France, Hungary, the Netherlands, and Sweden) as co-Rapporteurs for the first stage of the glyphosate risk assessment. In Dec. 2019, the Glyphosate Renewal Group submitted an application for renewal of approval after Dec. 2022. In June 2021, the co-Rapporteurs finalized their Draft Assessment Report and a further Report on the (proposed) harmonized classification and labelling of this active substance; these will be reviewed by the European Food Safety Authority (EFSA) and the European Chemicals Agency; see European Commission, ‘Status of Glyphosate in the EU’, n. 1 above.

⁸ For access to the key documents produced before the US federal and state courts, see US Right to Know, ‘Roundup (Glyphosate) Cancer Cases: Key Documents & Analysis’, available at: https://usrtk.org/monsanto-papers.

⁹ Bayer AG has set aside more than USD 15 billion for glyphosate-related settlements and litigation: L. Burger, ‘Bayer Loses Third Appeals Case over Glyphosate Weedkiller’, Reuters, 10 Aug. 2021, available at: https://www.reuters.com/business/healthcare-pharmaceuticals/bayer-loses-third-appeals-case-over-glyphosate-weedkiller-2021-08-10.

¹⁰ G.C. Leonelli, Transnational Narratives and Regulation of GMO Risks (Hart, 2021). For an examination of the point that the determination that a risk exists ‘cannot be a matter of pure science’, see Walker, V.R., ‘The Myth of Science as a “Neutral Arbiter” for Triggering Precautions’ (2003) 26(2) Boston College International and Comparative Law Review, pp. 197–228Google Scholar.

¹¹ National Research Council, Risk Assessment in the Federal Government: Managing the Process (National Academies Press, 1983) (the ‘Red Book’), pp. 28 ff. See also S. Jasanoff, The Fifth Branch: Science Advisers as Policy-makers (Harvard University Press, 1990); S. Jasanoff (ed.), States of Knowledge: The Co-production of Science and Social Order (Routledge, 2004).

¹² For an analysis of ‘sound scientific’ and ‘prudential’ approaches through the lens of ideal ‘evidence-based’ and ‘socially acceptable risk’ paradigms, see Leonelli, n. 10 above. In a similar vein, albeit from the different (procedural) perspective of Rational-Instrumental and Deliberative-Constitutive paradigms, see E. Fisher, Risk Regulation and Administrative Constitutionalism (Hart, 2007). The terminology of ‘sound scientific’ risk assessments (and ‘sound science’) has been traditionally employed by the denigrators of the precautionary principle. For an analysis see, e.g., Wagner, W.E., ‘The Bad Science Fiction: Reclaiming the Debate over the Role of Science in Public Health and Environmental Regulation’ (2003) 66(4) Law and Contemporary Problems, pp. 63–134Google Scholar.

¹³ For an analysis of methodological questions in the context of the glyphosate debate see, e.g., Hendlin, Y. et al. , ‘Like Oil and Water: the Politics of (Not) Assessing Glyphosate Concentrations in Aquatic Ecosystems’ (2020) 11(3) European Journal of Risk Regulation, pp. 539–64CrossRefGoogle Scholar. For a procedural analysis and a focus on the EU regulatory epistemology see Morvillo, M., ‘Glyphosate Effect: Has the Glyphosate Controversy Affected the EU's Regulatory Epistemology?’ (2020) 11(3) European Journal of Risk Regulation, pp. 422–35CrossRefGoogle Scholar.

¹⁴ A ‘hazard’ is defined as a biological, chemical or physical agent with the potential to cause adverse effects. A ‘risk’, on the other hand, is a function of the probability of occurrence of adverse effects and the severity of these effects, consequential on exposure to a hazard: Codex Alimentarius Commission, Procedural Manual, 27^th edn (Joint FAO/WHO Food Standards Programme, 2019), p. 128.

¹⁵ Leonelli, n. 10 above.

¹⁶ This second dimension is distinct from that of recourse to ‘sound scientific’ or ‘prudential’ approaches to risk assessment. Firstly, the ‘sound science’ versus ‘uncertainty’ dichotomy does not centre on scientific methodological questions pertaining to the risk assessment stage, but on the interpretation of the available data by regulators. Secondly, it encompasses a focus on the different ways in which the ‘same’ evidence base may be interpreted by various regulators. Thirdly, in cases where hazards and risks have been conclusively established, the former dimension (recourse to ‘sound scientific’ or ‘prudential’ approaches) may result in regulatory divergencies; the latter dimension (‘sound science’ versus ‘uncertainty’), by contrast, will not come into play.

¹⁷ For an in-depth analysis of this and the following points, including the linkage between ‘sound scientific’ approaches to risk assessment, adherence to ‘sound science’ and the pursuit of cost-benefit effective levels of protection, see Leonelli, n. 10 above.

¹⁸ On the notion of co-production, see Jasanoff (2004), n. 11 above.

¹⁹ Regulation (EC) No. 1107/2009 concerning the Placing of Plant Protection Products on the Market and Repealing Directives 79/117/EEC and 91/414/EEC [2009] OJ L 309/1 (PPP Regulation).

²⁰ Ibid., Recital 8 and Art. 13(2).

²¹ Annex I of the PPP Regulation identifies three zones for the assessment of PPPs: these are Zone A (North), Zone B (Centre), and Zone C (South). The three zones are characterized by specific agricultural, plant health, environmental and climatic conditions.

²² PPP Regulation, n. 19 above, Recital 8 and Art. 1(4).

²³ Ibid., Art. 43(1), (2).

²⁴ Ibid., Arts 43(3)–(6), 35, 36.

²⁵ European Commission, ‘Guidance Document on the Renewal of Authorisations According to Article 43 of Regulation (EC) No. 1107/2009’, SANCO/2010/13170 rev. 14, 7 Oct. 2016, p. 6.

²⁶ Ibid.

²⁷ Ibid., p. 13.

²⁸ PPP Regulation, n. 19 above, Art. 35.

²⁹ Ibid., Arts 36(2), (3).

³⁰ Ibid., Art. 36(3).

³¹ Ibid.

³² A refusal to authorize a PPP must also be notified to the Commission with a specific technical-scientific justification: ibid., Art. 36(2).

³³ PPP Regulation, n. 19 above, Arts 40(1), 41(1).

³⁴ See the express references in Case T-178/18, Brussels-Capital Region, n. 2 above, paras 45–6; and in the Opinion of AG Bobek in Case C-352/19 P, Brussels-Capital Region, EU:C:2020:588, paras 88–98 and 99–104.

³⁵ N. 1 above.

³⁶ Opinion in Case C-352/19 P, Brussels-Capital Region, n. 34 above, paras 25–6.

³⁷ Lisbon (Portugal), 13 Dec. 2007, in force 1 Dec. 2009 [2012] OJ C 326/47, available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2012:326:FULL:EN:PDF.

³⁸ Case T-178/18, Brussels-Capital Region, n. 2 above, para. 44.

³⁹ N. 1 above.

⁴⁰ See, e.g., Case C-622/16 P, Scuola Elementare Maria Montessori v. Commission, EU:C:2018:873, para. 42; and Case C-663/17 P, ECB v. Trasta Komercbanka and Others, EU:C:2019:923, para. 103.

⁴¹ Case T-178/18, Brussels-Capital Region, n. 2 above, para. 53.

⁴² Ibid., para. 54.

⁴³ Opinion in Case C-352/19 P, Brussels-Capital Region, n. 34 above, paras 49–55.

⁴⁴ Ibid., paras 83–6, and all the case law cited therein.

⁴⁵ Ibid., paras 97, 141.

⁴⁶ For an express reference to this principle, see the applicants’ arguments in Case T-236/04, EEB and Stichting Natuur en Milieu v. Commission, EU:T:2005:426, para. 47.

⁴⁷ With the only exception of challenges against a decision to have recourse to the comparative assessment procedure: Case C-244/16 P, IQV v. Commission, EU:C:2018:177; Case C-384/16 P, Copper v. Commission, EU:C:2018:176.

⁴⁸ Case T-429/13, Bayer CropScience v. Commission; Case T-584/13, BASF Agro and Others v. Commission, EU:T:2018:279.

⁴⁹ Opinion in Case C-352/19 P, Brussels-Capital Region, n. 34 above, para. 77 (emphasis added).

⁵⁰ Ibid.

⁵¹ Ibid., paras 172–3 (citing, inter alia, the Opinion of AG Cruz Villalón in Case C-456/13 P, T&L Sugars and Sidul Açucares v. Commission, EU:C:2014:2283, para. 32).

⁵² Ibid., para. 163 (emphasis added).

⁵³ Leonelli, G.C., ‘A Threefold Blow to Environmental Public Interest Litigation: The Urgent Need to Reform the Aarhus Regulation’ (2020) 45(3) European Law Review, pp. 324–47Google Scholar, at 331–3.

⁵⁴ The 2021 reform of the Aarhus Regulation, however, has now enabled NGOs and specific categories of stakeholders to request an internal review of provisions of non-legislative acts which entail implementation, and challenge the refusal to grant review before the CJEU. This finally resolves the problems associated with the third limb of Art. 263(4) TFEU. For an in-depth analysis, see Leonelli, G.C., ‘Access to the EU Courts in Environmental and Public Health Cases and the Reform of the Aarhus Regulation: Systemic Vision, Pragmatism, and a Happy Ending’ (2021) 40 Yearbook of European Law, pp. 230–64CrossRefGoogle Scholar.

⁵⁵ For a detailed analysis, see Leonelli, G.C., ‘Acknowledging the Centrality of the Precautionary Principle in Judicial Review of EU Risk Regulation: Why It Matters’ (2020) 57(6) Common Market Law Review, pp. 1773–818CrossRefGoogle Scholar.

⁵⁶ See, e.g., Case T-13/99, Pfizer Animal Health SA v. Council, EU:T:2002:209, para. 166; and Case T-70/99, Alpharma v. Council, EU:T:2002:210, para. 177.

⁵⁷ In a limited number of cases, the CJEU has instead employed a quasi-substantive standard. For an analysis of different strands of procedural review see Leonelli, n. 55 above.

⁵⁸ Reference here is made to actions for annulment or preliminary rulings on the validity of EU non-legislative acts adopted in the field of risk regulation (rather than in the broader field of environmental law) and challenged for being insufficiently protective on the grounds of an infringement of the precautionary principle (stricto sensu). Paraquat, to date, is the only successful action: Case T-229/04, Sweden v. Commission, EU:T:2007:217 (Paraquat). In Case T-257/07, France v. Commission, EU:T:2011:444, unsuccessfully appealed (Case C-601/11 P, France v. Commission, EU:C:2013:465), the EU Courts assessed and rejected France's claims on alleged breaches of the precautionary principle.

⁵⁹ The former applies to France v. Commission, where the GC applied the manifest error of assessment test in a very different way from the ‘traditional’ application in challenges to acts that are deemed too restrictive. The latter applies to Paraquat, in which the application of a procedural standard of review would not have justified the annulment of the challenged act; see Leonelli, G.C., ‘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(2) German Law Journal, pp. 184–215CrossRefGoogle Scholar.

⁶⁰ Case T-229/04, Paraquat, n. 58 above, para. 161 (emphasis added).

⁶¹ Ibid., para. 170 (emphasis added).

⁶² European Commission, Communication on the Precautionary Principle, COM(2000)1 final, 2 Feb. 2000, pp. 7, 12, Section 5.

⁶³ Leonelli, n. 59 above.

⁶⁴ Ibid.

⁶⁵ Whether the severity of the relevant potential adverse effects also plays a role, on the other hand, is less clear-cut.

⁶⁶ France v. Commission, n. 58 above, paras 96, 98, 100, 104, 107–9, 137, 149–51, 155, 159, 163–71, 219, 229, 230, 250, 240, 251, 261, 265.

⁶⁷ N. 5 above.

⁶⁸ Paraquat, n. 58 above, para. 161.

⁶⁹ Ibid., paras 70–1 and 172–92.

⁷⁰ The relevant requirements were enshrined in Art. 5 and Annex VI of Directive 91/414/EC concerning the Placing of Plant Protection Products on the Market [1991] OJ L 230/1 (the predecessor of the PPP Regulation).

⁷¹ PPP Regulation, n. 19 above, Annex II, point 3.6.3, and Art. 4(7).

⁷² [2015] OJ L 241/1. In June 2021, after the failed attempts to enact a total ban, the Austrian pesticide law was amended to prohibit specific uses of glyphosate-based PPPs, including private use.

⁷³ E. Wax, ‘EU Blocks Austria's Planned Glyphosate Ban, Rejecting Claim that Weedkiller Harms Human Health’, Genetic Literacy Project, 20 Aug. 2020, available at: https://geneticliteracyproject.org/2020/08/20/eu-blocks-austrias-planned-glyphosate-ban-rejecting-claim-that-weedkiller-harms-human-health.

⁷⁴ N. 1 above.

⁷⁵ Wax, n. 73 above.

⁷⁶ PPP Regulation, n. 19 above, Recital (10) and Ch. II, Section 1, Arts 4–24.

⁷⁷ Ibid., Recital (23) and Ch. III, Arts 28–57.

⁷⁸ See also the references in ibid., Arts 8(1)(a), 8(1)(c), 14(1), 29(3), and Annex II.

⁷⁹ Ibid., Annex II, para. 2.1.

⁸⁰ See the comments submitted by COCERAL on 6 Aug. 2020. Public comments are available on the Commission's TRIS database, available at: https://ec.europa.eu/growth/tools-databases/tris/en/search.

⁸¹ See the comments submitted by Nufarm Europe GmbH on 5 Aug. 2020, available ibid.

⁸² Ultimately, national discretion must be exercised within the specific boundaries of the PPP Regulation; if a Member State wishes to challenge the EU regulatory approach to a specific active substance, it must have recourse to the Regulation's specific procedures (PPP Regulation, Arts 21, 36, 43, 40–41, 44, 69–71).

⁸³ Joined Cases C-439/05 and C-454/05, Upper Austria, n. 3 above, paras 61–4.

⁸⁴ Opinion of AG Sharpston in Joined Cases C-439/05 and C-454/05, Upper Austria, EU:C:2007:285, para. 109; and judgment, para. 64.

⁸⁵ Commission Decision 2003/653/EC relating to National Provisions on Banning the Use of Genetically Modified Organisms in the Region of Upper Austria Notified by the Republic of Austria pursuant to Article 95(5) of the EC Treaty [2003] OJ L 230/34.

⁸⁶ [2001] OJ L 106/1.

⁸⁷ Opinion, n. 84 above, para. 122.

⁸⁸ Ibid., paras 114–23.

⁸⁹ Ibid., paras 127–34.

⁹⁰ See the press release ‘Luxembourg, the First EU Country to Ban Glyphosate’, 16 Jan. 2020, available at: https://gouvernement.lu/en/actualites/toutes_actualites/communiques/2020/01-janvier/16-interdiction-glyphosate.html.

⁹¹ Question parlementaire n. 2742 de l'honorable Députée Madame Martine Hansen, 6 Oct. 2020, Ref: 436/2020. See also the database of Administration of Technical Agricultural Services (ASTA), Luxembourg's national regulator, available at: https://ma.gouvernement.lu/en/administrations/asta.html.

⁹² Unlike the emergency procedure of the PPP Regulation: cf. Art. 44(4) and Art. 71(1), (2) and (3).

⁹³ G. Trompiz & S. de la Hamaide, ‘France to Ban Dozens of Glyphosate Weedkillers amid Health Risk Debate’, Reuters, 9 Dec. 2019, available at: https://www.reuters.com/article/us-france-glyphosate-idUSKBN1YD1BG.

⁹⁴ France is part of Zone C (South).

⁹⁵ PPP Regulation, n. 19 above, Recitals (8), (23), (24) and Arts 1(4), 29.

⁹⁶ Avis de l'agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail relatif à la saisine glyphosate n. 2015-SA-0093, available at: https://www.anses.fr. See Regulation (EC) No. 1272/2008 on the 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 [2008] OJ L 353 (CLP Regulation).

⁹⁷ Trompiz & de la Hamaide, n. 93 above.

⁹⁸ Case C-616/17, Blaise and Others, EU:C:2019:800; Case C-616/17, Blaise and Others, EU:C:2019:190, Opinion of AG Sharpston. For a detailed analysis of Blaise, see Leonelli, n. 59 above.

⁹⁹ As mandated by Art. 4(1) and Annex II of the PPP Regulation, n. 19 above..

¹⁰⁰ See ibid., point 3.6.1 of Annex II.

¹⁰¹ The ‘cumulative and synergistic effects’ of the interaction between active substance and co-constituents in the representative pesticides must also be taken into account.

¹⁰² PPP Regulation, n. 19 above, Art. 4(1) and (5).

¹⁰³ Leonelli, n. 59 above, pp. 202–14. Despite their odd framing and imprecise formulation, the first and the third questions of the referring court pointed to this specific aspect and to the missing gap in the multi-level dynamics of the PPP Regulation.

¹⁰⁴ European Parliament, ‘Report on the Union's Authorization Procedure for Pesticides’, 2018/2135 (INI), pp. 7, 14, 15, 22, 26; available at: https://www.europarl.europa.eu/doceo/document/A-8-2018-0475_EN.html. See also European Parliament, Resolution of 13 Sept. 2018 on the Implementation of the Plant Protection Products Regulation (EC) No. 1107/2009, 2017/2128 (INI), point 38, available at: https://www.europarl.europa.eu/doceo/document/TA-8-2018-0356_EN.html.

¹⁰⁵ In Oct. 2020, the ANSES finalized its research on the existence of available alternatives to glyphosate-based PPPs. All relevant data is available at: https://www.anses.fr. Taking this data into consideration, it relied on the procedure of Art. 50(2) of the PPP Regulation to further restrict the use of the glyphosate-based PPPs that it had re-authorized.

¹⁰⁶ Regrettably, at the current stage of technical-scientific knowledge, the preconditions to classify glyphosate as a candidate for substitution and to activate the comparative assessment procedure are not likely to be met (Recital (19), Art. 50, point 4 of Annex II, and Annex IV to the PPP Regulation).

¹⁰⁷ Leonelli, n. 6 above.