Published online by Cambridge University Press: 20 January 2017
On 22 April 2015 the European Commission published a review of the current GMO legislation (the GM Review) and tabled a proposal for its amendment (the GM Proposal). The GM Proposal aims to allow to the member states to ban on their territory the use of GMOs authorised under the EU legislation. This is very similar to the possibility for opting out from cultivation of authorised GMOs which was finally adopted earlier this year. While this may look like a new trend, all the more interesting in the context of possible Brexit, Grexit and Danish opt-out from the provisions on Justice and Home Affairs, the present article will focus only on the GM Review, which essentially admits that the existing GMO regime is a failure.
1 Communication from the Commission Reviewing the decisionmaking process on GMOs, COM (2015) 176 final, from 22.4.2015.
2 Proposal for Regulation amending Regulation 1829/2003 (Food and Feed), COM(2015) 177 final, 2015/0093 (COD) from 22.4.2015.
3 Directive (EU) 2015/412 amending Directive 2001/18/EC (Deliberate Release) from 11 March 2015. It is noteworthy that it took full five years for this simple change to be adopted.
4 The GM Proposal itself is discussed in Sara Poli's paper in the present issue.
5 T-240/10 Hungary v. Commission [2013].
6 In his Opening Statement to the European Parliament on 15 July 2014 J-C Juncker stated that on the matter of GMOs “I would not want the Commission to be able to take a decision when a majority of Member States has not encouraged it to do so.”
7 Under the old comitology rules the issue could be raised to the Council, which routinely failed to reach any decision too.
8 The process is governed by Directive 2001/18/EC, hereinafter ‘the Deliberative Release Directive’ and Regulation 1829/2003 of GM Food and Feed, hereinafter ‘the Food and Feed Regulation.’ EFSA is established and governed by Regulation (EC) 178/2002 laying down the general principles and requirements of food law, hereinafter ‘the General Food Law.’ The proceedings of the committees of national experts are governed by Regulation (EU) No 182/2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers, hereinafter ‘the Comitology Regulation.’
9 Sheila Jasanoff, ‘Relating Risk Assessment and Risk Management: Complete Separation of the Two Processes is a Misconception’ [1993] EPA Journal 37. For a more comprehensive study see Elizabeth Fisher, Risk Regulation and Administrative Constitutionalism (Hart 2007)
10 van Asselt, Marjolein B. A. and Vos, Ellen, ‘Wrestling with uncertain risks: EU regulation of GMOs and the uncertainty paradox’ (2010) 11 Journal of Risk Research 281–300 CrossRefGoogle Scholar.
11 For an excellent primer how different agencies draw opposite conclusions from the same data see ‘Weed Killer, Long cleared, Is Doubted’, New York Times 27 March 2015. Notably, in 1999 the US Environmental Protection Agency reversed its own original conclusion from 6 years earlier on the basis of the very same mouse study.
12 Case 9/56 Meroni & Co, Industrie Metallurgiche SpA v High Authority [1958] ECR 152.
13 Operating Framework for the European Regulatory Agencies, COM(2002) 718 final, 5.
14 T-13/99 Pfizer Animal Health SA v. Council [2002] ECR II-03305
15 Although I do not think that this is the correct interpretation of the Pfizer case, this is precisely how the Commission understands its role in the authorization process, as per admitted in the GM Review. I shall discuss the problems with that in section 3.
16 In principle these committees may be constrained by Pfizer as much as EFSA and the Commission, but they are in better position to rely on the “other factors”. I will return to the role of the latter below.
17 See the GM Proposal, recital 4.
18 Jacques Pelkmans and Marta Simoncini, ‘Mellowing Meroni: How ESMA can help build the single market’ CEPS Commentary (2014).
19 UK v. Council, C-270/12. See also Paul P. Craig, ‘Comitology, Rulemaking and the Lisbon Settlement: Tensions and Strains’, 2014, Oxford Legal Studies Research Paper No 75.
20 Niamh Moloney, quoted by Craig, ibid.
21 ibid, 47.
22 Certainly, after the Commission rubber-stamps the authorization, it can be subject to judicial review, but the courts are unlikely to assume responsibility to make judgements where the Commission abdicates. Thus, EFSA will be allowed the same broad discretion accorded to the Union institutions as discussed in the next section.
23 The case in point is the vote in Council on 11 February 2014 where 19 member states were against the proposal for authorization of Pioneer Maize 1507.
24 C-77/09.
25 C-15/83.
26 C-154/04.
27 C-491/01, para 123.
28 C-84/94, para 58.
29 C-157/96, para 61.
30 C-59/11.
31 For the standard interpretation see Damian Chalmers, Davies, Gareth, and Monti, Giorgio, European Union Law (2nd edn, CUP 2010)Google Scholar. However, it can be understood just as a requirement for rigorous reasoning, see Paskalev, Vesco, ‘Courts as Academies: Balancing of Scientific Arguments in Regulation of Uncertainties’ in Santosuosso, A. (ed), Young Scholars Informal Symposium (2012) (Pavia University Press 2013)Google Scholar.
32 See the extensive analysis of Kritikos, Mihail, ‘Traditional risk analysis and releases of GMOs into the European Union: space for non-scientific factors?’ (2009) 34 European Law Review 405–432 Google Scholar.
33 GM Review, 3.
34 Art. 7 (1) Food and Feed Regulation.
35 The other way is to abandon the system of rigid separation of risk assessment and risk management altogether.
36 This is what the current regulation requires even now, but the practice deviates from that so the relevant provisions need to be strengthened.
37 For the falsity of this dichotomy see Fisher, Risk Regulation and Administrative Constitutionalism (n 7).
38 The old comitology Decision provided that is ‘shall’ adopt it, see Decision 1999/468.
