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2019 | OriginalPaper | Chapter

Managing Novel Food Technologies and Member States’ Interests

Shifting More Powers Towards the Member States?

Author : Ludivine Petetin

Published in: Between Compliance and Particularism

Publisher: Springer International Publishing

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Abstract

The contentiousness surrounding novel food technologies and their risks is reflected in the tensions between the different actors involved in the EU decision-making process. Asymmetric relationships between competing European and national policy choices have led EU Member States to challenge the current governance system and existing regulatory frameworks that do not accommodate consumer concerns and more generally non-scientific factors. This chapter argues that initiatives that aim to challenge and reverse the trend towards centralisation are crucial to the strengthening of the EU system by giving greater leeway to the Member States in the authorisation procedures for novel food technologies. With multilevel governance and subsidiarity, the control and influence of supra-national entities are limited and lower level entities play a growing role in the regulation of novel food technologies. In contrast, fragmentation within the risk analysis for novel food technologies favours the weight of scientific evidence within the decision-making process and encourages centralisation. This problematic fragmentation must be tackled since it prevents non-scientific factors from being considered across the whole approval systems for novel food technologies.

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Footnotes
1
More specifically, there are disputed adverse effects of GMOs. First, in relation to humans because of the unknown long-term effects of consuming biotech foods (including nutritional differences and allergic reactions). Second, there are environmental impacts both in relation to the environment per se (the development of super weeds, out-competition of native plants, biodiversity reduction) and effects to other organisms within the ecosystem. For instance, crops modified to kill certain pests could be toxic to non-target species. See e.g., the following US case: In re StarLink Corn Products Liability Litigation 212 F Supp 2d 828 (ND Ill 2002). See further, inter alia, Coghlan (2005) and Wolfenbarger and Phifer (2000).
 
2
Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, [2003] OJ L106/1. In a 2018 judgment, the EU Court of Justice expanded the application of the directive to include CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) gene editing. This means that CRISPR, like GM crops, must be pre-approved before being placed on the EU market. See Judgment of 25 July 2018, Confédération paysanne and Others v Premier ministre and Ministre de l‘Agriculture, de l‘Agroalimentaire et de la Forêt, C-528/16, EU:C:2018:583.
 
3
Regulation (EC) 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (Food and Feed Regulation), [2003] OJ L268/1; Regulation (EC) 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC, [2003] OJ L268/24; Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods (Novel Foods Regulation), [2015] OJ L 327/1. The 2015 Novel Foods Regulation replaced the 1997 Novel Foods Regulation from 1 January 2018. See Regulation (EC) 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel foods ingredients, [1997] OJ L43/1.
 
4
Article 5 Food and Feed Regulation and Article 10 Novel Foods Regulation.
 
5
Article 12 Food and Feed Regulation and Article 9 Novel Foods Regulation.
 
6
The multiple waves of reports, policy documents, agreements and EU treaties have increased the policy areas covered by the process.
 
7
Directive 2015/412/EU of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of Genetically Modified Organisms (GMOs) in their territory, [2001] OJ L68/1.
 
8
Article 6 Food and Feed Regulation and Article 11 Novel Foods Regulation.
 
9
Article 7(1) Food and Feed Regulation.
 
10
See Article 3 TEU and Article 191 TFEU.
 
11
This is further indicated in the recent news reporting that the EFSA “copied and pasted” chunks of the scientific data provided by Monsanto in its application to place glyphosate (“Roundup Weedkiller”) on the market, Nelsen (2017).
 
12
See Article 5 TEU.
 
13
Article 5(3) TEU states there are three preconditions for intervention by EU institutions in accordance with the principle of subsidiarity: (a) the area concerned does not fall within the Union’s exclusive competence; (b) the objectives of the proposed action cannot be sufficiently achieved by the Member States (the necessity test); (c) the action can therefore, by reason of its scale or effects, be implemented more successfully by the Union (i.e., added value can be provided if the action is carried out at Union level).
 
14
For further discussion, see Wendel (2017). In the former Commission President’s view, “subsidiarity is the translation of a democratic principle”, Barroso (2009), p. 38. In this context, the proximity principle referred to in Article 10(3) TFEU must also be considered.
 
15
See Judgment of 8 June 2010, Vodafone Ltd and others, C-58/08, EU:C:2010:321, paragraph 73.
 
16
Further, when exercising this new competence, Member States remain bound by their international obligations, especially obligations under the WTO Agreements.
 
17
For the general frame of legal interpretation on overriding reasons of public interest (or mandatory requirements), see e.g., Judgment of 20 February 1979, Rewe-Zentral v Bundesmonopolverwaltung für Branntwein (Cassis de Dijon), 120/78, EU:C:1979:42. Any adopted measure must also be in line with the principles of proportionality and non-discrimination.
 
18
The list of grounds includes the following: environmental policy objectives, land use, socioeconomic impacts and public policy. The list of grounds is non-exhaustive. In the post-authorisation stage, claims must be substantiated under Article 36 TFEU and the case-law on overriding reasons of public interest, and must meet the requirement of proportionality. Further, any opt-outs justified under “environmental policy objectives” must not be contrary to the EFSA’s environmental assessment of the specific GMO under authorisation.
 
19
World trade issues are beyond the scope of this chapter.
 
20
For an analysis, see Graham and Hsia (2002).
 
21
Article 7, Regulation (EC) 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, [2002] OJ L31/1.
 
22
For more on the precautionary principle in food law, see Cazala (2004), Macmaolain (2007), de Sadeleer (2006) and Szajkowska (2012).
 
23
A risk analysis is comprised of three steps: a risk assessment followed by risk management and risk communication.
 
24
See also Anker and Grossman (2009).
 
25
See also de Sadeleer arguing for a role for the principle within both risk assessment and risk management, de Sadeleer (2007), p. 18.
 
26
Recital 32 Food and Feed Regulation.
 
27
Article 12(1)(d) Novel Foods Regulation.
 
28
Article 10(6) Novel Foods Regulation.
 
29
Recital 19 and Article 3(12) General Food Law Regulation.
 
30
For more on such a “co-production” approach to governance, see Jasanoff (2004).
 
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Metadata
Title
Managing Novel Food Technologies and Member States’ Interests
Author
Ludivine Petetin
Copyright Year
2019
Publisher
Springer International Publishing
DOI
https://doi.org/10.1007/978-3-030-05782-4_11