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Court Upholds Restrictions on Neonicotinoids – A Precautionary Approach to Evidence

Published online by Cambridge University Press:  19 November 2018

Emanuela BOZZINI  and
Elen STOKES
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Type
Case Commentaries
Information
European Journal of Risk Regulation , Volume 9 , Issue 3: Symposium on Effective Law and Regulation , September 2018 , pp. 585 - 593
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© Cambridge University Press 

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Footnotes

*

Department of Sociology and Social Research, University of Trento.

**

School of Law and Politics, Cardiff University.

Our research in this field has been supported by an ERC Starting Grant “Law, science and interests in European policy-making” (LASI) funded under FP7-IDEAS-ERC (project ID 313642), and we gratefully acknowledge that support.

References

1 Joined Cases T-429/13 and T-451/13, Bayer CropScience AG and Others v European Commission ECLI:EU:T:2018:280.

2 Implementing Regulation (EU) 485/2013 amending Implementing Regulation (EU) No 540/2011, as regards the conditions of approval of the active substances clothianidin, thiamethoxam and imidacloprid, and prohibiting the use and sale of seeds treated with plant protection products containing those active substances, OJ L 139, 25.5.2013, pp 12–26.

3 Bayer markets clothianidin and imidacloprid; Syngenta markets thiamethoxam.

4 Directive 2006/41/EC amending Directive 91/414 to include clothianidin and pethoxamid as active substances; Commission Directive 2007/6/EC of 14 February 2007 amending Directive 91/414 to include metrafenone, Bacillus subtilis, spinosad and thiamethoxam as active substances; Commission Directive 2008/116/EC of 15 December 2008 amending Directive 91/414 to include aclonifen, imidacloprid and metazachlor as active substances, OJ L 187, 8.7.2006, pp 24–27.

5 More precisely, in the Implementing Regulation the Commission prohibited the use of neonics in bee-attractive crops (including maize, oilseed rape and sunflower), allowing some exceptions. The process of restriction is governed by Art 49(2) Regulation (EC) No 1107/2009.

6 Bayer CropScience AG and Others v European Commission, supra, note 1, para 110.

7 Treaty on the Functioning of the European Union, OJ C 326, 26.10.2012, Art 191(2).

8 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 L 309, 24.11.2009, Art 1(4), see also recital 8.

9 ibid, para 111.

10 ibid, para 112.

11 ibid, paras 115 and 117.

12 ibid, para 116.

13 ibid, para 120.

14 ibid, paras 334–335.

15 See, for example, European Commission, Communication on the Precautionary Principle COM(2000) 1 final, para 4.

16 For general discussion, see, for example, E Fisher, “Framing Risk Regulation: A Critical Reflection” (2013) 4(2) EJRR 125; S Jasanoff, “The Songlines of Risk” (1999) 8(2) Environmental Values 135.

17 Bayer CropScience AG and Others v European Commission, supra, note 1, paras 580–582.

18 ibid, paras 355–382.

19 ibid, paras 383–415.

20 ibid, para 390.

21 ibid, para 390.

22 ibid, para 142.

23 ibid, para 147.

24 See J Mendes, “Bounded Discretion in EU Law: A Limited Judicial Review Paradigm in a Changing EU” (2017) 80(3) Modern Law Review 443.

25 Bayer CropScience AG and Others v European Commission, supra, note 1, paras 343–347.

26 ibid, paras 349–353.

27 ibid, para 351.

28 ibid, para 314.

29 ibid, see, for example, paras 365 and 393.

30 ibid, paras 306–310.

31 ibid, para 309.

32 ibid, para 456.

33 ibid, para 458.

34 Communication on the Precautionary Principle, supra, note 15, para 6.3.4.

35 European Commission, Better Regulation Toolbox (European Commission 2017) 93.

36 Bayer CropScience AG and Others v European Commission, supra, note 1, para 459.

37 ibid, para 460.

38 ibid, para 460.

39 Better Regulation Toolbox, above, note 35, 93 footnote 101.

40 Bayer CropScience AG and Others v European Commission, supra, note 1, para 463.

41 ibid, para 465.

42 ibid, para 465.

43 Commission Regulation (EU) No 283/2013 setting out the data requirements for active substances, 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, OJ L 93, 3.4.2013; Commission Implementing Regulation (EU) No 844/2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, OJ L 252, 19.9.2012, pp 26–31.

44 It might be useful to recall that the preliminary completeness check of a dossier is often controversial, even in the case of procedures of approval carried out according to detailed rules as set by Regulation 283/2013. See E Bozzini, Assessing Criteria and Capacity for Reliable and Harmonised “Hazard Identification” of Active Substances (European Parliament Research Service 2018).

45 In a first study, Henry and colleagues found that exposure to a non-lethal dose of thiamethoxam can impair the capacity of honey bees to safely return to their hive, thus increasing mortality rate and possibly leading to colony collapse. In a second study, Whitehorn and colleagues calculated that the growth rate of colonies of bumble bees treated with imidacloprid was significantly reduced compared to control colonies. Imidacloprid also had an impact on the production of new queens that was 85% lower in treated colonies compared to control ones. A third study published by Schneider et al found a decrease in foraging activities in bees exposed to sub-lethal doses of imidacloprid and clothianidin.

46 See for example APENET, “Effects of coated maize seed on honeybees” (2011), Report based on results obtained from the third year (2011) activity of the APENET project.

47 Bayer CropScience AG and Others v European Commission, supra, note 1, para 177.

48 ibid, paras 178 and 179.

49 ibid, para 172.

50 A subsequent review on neonicotinoids carried out between 2015 and 2018 included hundreds of papers published since the mid-2000s: S Fryday, K Tiede and J Stein, “Scientific services to support EFSA systematic reviews: Lot 5 Systematic literature review on the neonicotinoids (namely active substances clothianidin, thiamethoxam and imidacloprid) and the risks to bees” (2015) 12(2) EFSA Supporting Publications 2015:EN-756; EFSA, “Evaluation of the data on clothianidin, imidacloprid and thiamethoxam for the updated risk assessment to bees for seed treatments and granules in the EU” (2018) EFSA Supporting Publications 2018:EN-1378.

51 See point 3.8.3 in Annex II Regulation (EC) 1107/2009.

52 EFSA, “Scientific Opinion on the science behind the development of a risk assessment of Plant Protection Products on bees (Apis mellifera, Bombus spp. and solitary bees)” (2012) 10(5) EFSA Journal 2668.

53 Bayer CropScience AG and Others v European Commission, supra, note 1, para 354.

54 EFSA, “Conclusion on the peer review of the pesticide risk assessment for bees for the active substance clothianidin” (2013) 11(1) EFSA Journal (1:3066); EFSA, “Conclusion on the peer review of the pesticide risk assessment for bees for the active substance thiamethoxam” (2013) 11(1) EFSA Journal (1:3067); EFSA, “Conclusion on the peer review of the pesticide risk assessment for bees for the active substance imidacloprid” (2013) 11(1) EFSA Journal (1:3068).

55 EFSA, “Submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009” (2011) 9(2) EFSA Journal 2092. The guidelines establish rules for searching in scientific databases (like PubMed, Web of Science), for the evaluation of the relevance of each paper retrieved, for the reporting on the search strategy, etc.

56 Bayer CropScience AG and Others v European Commission, supra, note 1, para 358.

57 ibid, paras 117, 289 and 354.

58 It could be noted that, since the four chemicals were first assessed under Directive 414/1991/EEC, which did not require any analysis of open peer review literature, any paper published on the substances under review could be considered new and therefore be potentially of relevance for the re-assessment.

59 See Annex to Commission Regulation (EU) 2018/605 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties, OJ L 101, 20.4.2018, pp 33–36.

60 For details of each substance, see the EU pesticide database at <ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN>, accessed 6 September 2018.

61 See the evaluation reports published in Spring 2018: European Parliament Research Service. (2018). “Regulation (EC) 1107/2009 on the Placing of Plant Protection Products on the Market. European Implementation Assessment.” EPRS, Bruxelles; Scientific Advice Mechanism. (2018). “EU Authorisation processes of Plant Protection Products.” Group of Scientific Advisors, Bruxelles.

62 It is of note that in a parallel case on the substance fipronil, the applicant, BASF Agro BV, had its request for annulment of the restrictive Implementing Regulation accepted on the basis of the lack of impact assessment in the risk management stage. See Case T-584/13, BASF Agro BV and Others v European Commission ECLI:EU:T:2018:279.