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Piecemeal Transparency: An Appraisal of Regulation (EU) No. 2019/1381 on the Transparency and Sustainability of the EU Risk Assessment in the Food Chain

Published online by Cambridge University Press:  18 January 2021

Blánaid NÍ CHEARNAIGH Open the ORCID record for Blánaid NÍ CHEARNAIGH [Opens in a new window]
Blánaid NÍ CHEARNAIGH*
Affiliation:
LLB Graduand, Trinity College Dublin, Ireland; email: kearnebl@tcd.ie.
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Abstract

For some time, pressure was placed on the European Food Safety Authority concerning the manner in which it conducted risk assessments in relation to food safety. This pressure culminated in the introduction of Regulation (EU) No. 2019/1381 as the upshot to the European Citizens’ Initiative on glyphosate. Concerns were expressed in the initiative regarding the transparency of the scientific studies used to evaluate pesticides, and following a Fitness Check conducted by the European Commission. Effectively, the new Regulation seeks to impose an obligation on EFSA to publish industry studies at the beginning of the risk assessment process. However, the mandatory nature of this obligation raises a number of concerns as to whether the urge to increase the transparency of the work of the EU authorities is more important than keeping the research confidential, two converse ideals in the realm of European law and effective processes. The present article submits that this codified focus on the risk assessment process and its accessibility for European citizens is a new frontier for transparency within the EU risk assessment processes. Yet while the changes pioneered by this framework are laudable, the Regulation is not without its qualifications.

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Articles
Information
European Journal of Risk Regulation , Volume 12 , Issue 3: Special Issue on Biotechnology in International Economic Law and Human Rights , September 2021 , pp. 699 - 710
Copyright
© The Author(s), 2021. Published by Cambridge University Press

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Footnotes

The author would like to extend her deepest gratitude to Dr Caoimhín MacMaoláin, Fellow of Trinity College Dublin, for his tutelage, expertise, and earlier feedback on this article, and Eolann Davis for his unwavering support and insight throughout the process. This author would also like to thank the anonymous referee for their comments and appreciation. Any errors and omissions remain my own.

References

1 European Parliament, “Briefing for the PETI Committee: Transparency, Integrity and Accountability in the EU Institutions” (Policy Department for Citizens’ Rights and Constitutional Affairs, March 2019) <www.europarl.europa.eu/RegData/etudes/BRIE/2019/608873/IPOL_BRI(2019)608873_EN.pdf> (last accessed 10 December 2019).

2 This is evidenced through several European legislative instruments. See, for example, Art 10(3) TEU: “Every citizen shall have the right to participate in the democratic life of the Union. Decisions shall be taken as openly and as closely as possible to the citizen”; Art 11(2) TEU: “The institutions shall maintain an open, transparent and regular dialogue with representative associations and civil society”; Art 15 TFEU: “In order to promote good governance and ensure the participation of civil society, the Union’s institutions, bodies, offices and agencies shall conduct their work as openly as possible.” This Art also generally deals with access to documents as well as the general transparency of the institutions. For a general reading of European administration obligations to encourage transparency, see Art 297 and Art 298 TFEU. Finally, on this point, see Art 42 of the Charter of Fundamental Rights of the European Union (2000/C 364/01) concerning the right of access to documents. Clearly, access to documentation is very much enshrined in EU Law.

3 European Commission, “Public Consultation on the transparency and sustainability of the EU risk assessment in the food chain” <ec.europa.eu/info/consultations/public-consultation-transparency-and-sustainability-eu-risk-assessment-food-chain_en> (last accessed 13 November 2019). Hereinafter referred to as “the Public Consultation”.

4 Regulation (EU) No 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain, and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC [2019] OJ L 231/1. Hereinafter referred to as “the 2019 Regulation”.

5 H Hofmann and P Leino-Sandberg, “An Agenda for Transparency” (European Law Blog, 12 September 2019) <europeanlawblog.eu/2019/10/23/an-agenda-for-transparency-in-the-eu/> (last accessed 10 December 2019).

6 For an overview of evolution of the principle of transparency in EU law, see further S Peers, “From Maastricht to Laeken: The Political Agenda of Openness and Transparency in the European Union”, in V Deckmyn (ed) Increasing Transparency in the European Union? (EIPA 2002) pp 7–32.

7 J Mendes, “The Principle of Transparency and Access to Documents in the EU: For What, For Whom, and Of What?” (University of Luxembourg Law Working Paper, 2020) <orbilu.uni.lu/bitstream/10993/42495/1/Mendes_chapter_Jan2020.pdf> (last accessed 10 September 2020).

8 White Paper from the Commission to the European Council, “Completing the Internal Market” COM (85) 310 final, 14 June 1985, para 155.

9 “The Internal Market after 1992: Meeting the Challenge”, Report to the EEC Commission by the High Level Group on the Operation of the Internal Market, pp 5–6, SEC (92) 2044. See also Recommendations 8 and 9, the latter outlining that: “[T]he Commission should, in collaboration with the Council and Parliament, initiate a wide-ranging discussion on the rules and procedures for formally ensuring the transparency of the entire Community legislative process. This discussion is urgently needed and its follow-up must include specific action to ensure the free flow of information to the citizen.”

10 ibid.

11 European Council, Conclusions of the Presidency, Birmingham, 16 October 1992, SN 343/1/92. On 16 October 1992, the European Council adopted the “Birmingham Declaration” with a view to bringing the European Community closer to its citizens (see Annex I). In articulating a roadmap, it allows for heads of state or government to call on foreign ministers to suggest ways of opening up the work of the Community’s institutions, including the possibility of some open Council discussion. Following the difficulties that certain countries encountered in referenda on the ratification of the Maastricht Treaty, it was imperative to bring the European Community closer to its citizens.

12 Communication from the Commission, “European Governance – A White Paper” COM (2001) 428 final, Brussels, 25 July 2001, pp 10–11.

13 Arts 10(3) and 11(2) TEU.

14 Art 15(1) TFEU.

15 A Alemanno, “Unpacking the Principle of Openness: Transparency, Participation and Democracy” (2014) 8 European Law Review <ssrn.com/abstract=2303644> (last accessed 10 September 2020).

16 ibid.

17 S Chatzopoulou, N Leiva Eriksson and D Eriksson, “Improving Risk Assessment in the European Food Safety Authority: Lessons from the European Medicines Agency” (2020) 11 Frontiers in Plant Science 3.

18 European Parliament, “Report on alleged contraventions or maladministration in the implementation of Community law in relation to BSE, without prejudice to the jurisdiction of the community and national courts”. Report of the inquiry from a temporary committee into BSE; rapporteur: Manuel Medina Ortega, 7 February, DOC EN\RR\319\319544 (Strasbourg 1997).

19 S Chatzopoulou, “Unpacking the Mechanisms of the EU “Throughput” Governance Legitimacy: The Case of EFSA” (2015) 16(2) European Politics and Society 160.

20 Regulation (EC) No 178/2002 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 L 31. Hereinafter referred to as “the 2002 Regulation”.

21 ibid.

22 As part of its “Smart Regulation” policy, the European Commission initiated a Regulatory Fitness and Performance Programme (REFIT). It involves a continuous process, which affects the entire policy cycle from the design of legislation to implementation, enforcement, appraisal and, where necessary, revision. Under the first stages of this programme, the Commission reviewed the entire stock of EU legislation and decided upon follow-up actions, including Fitness Checks, which involve comprehensive policy evaluations aimed at assessing whether the regulatory framework for a specific policy sector is indeed “fit for purpose”. In this instance, one such evaluation was conducted on the General Food Regulation. See European Commission, Commission Staff Working Document Executive Summary of the Refit Evaluation of the General Food Law, Regulation (EC) No 178/2002 SWD (2018) 38 final <ec.europa.eu/food/sites/food/files/gfl_fitc_executive_summary_2018_en.pdf> (last accessed 12 December 2019).

23 M Weimer and A de Ruijter (eds) Regulating Risks in the European Union: The Co-production of Expert and Executive Power (Hart 2017) p 8.

24 E Vos and M Everson (eds) Uncertain Risks Regulated (Routledge 2009) p 251.

25 M Morvillo, “Glyphosate Effect: Has the Glyphosate Controversy Affected the EU’s Regulatory Epistemology?” (2020) 11 European Journal of Risk Regulation 423.

26 See the European Citizens’ Initiative, “Ban Glyphosate and Protect People and the Environment from Toxic Pesticides” ECI (2017) 000002 < ec.europa.eu/citizens-initiative/public/initiatives/successful/details/2017/000002> (last accessed 10 December 2019). For further discussion and legal justification, see Case T-329/17, Heidi Hautala and Others v European Food Safety Authority, ECLI:EU:T:2019:142. In this case, the CJEU requested EFSA to disclose details of studies on the toxicity and carcinogenic properties of glyphosate. Interestingly, this judgment is grounded on interpreting “the concept of information which ‘relates to emissions into the environment’ as covering not only information on emissions as such, but also data concerning the medium- to long-term consequences of those emissions on the environment”. As a result, the CJEU de facto reconfirmed the paramount importance of increasing transparency in food and health safety.

27 The ECHA’s Committee for Risk Assessment found that glyphosate itself was not carcinogenic, despite the ban in various states, including some US states, and in Austria, as they feel that it may still have significant health consequences in cases of intermittent use. See further, European Chemicals Agency, “Glyphosate not classified as a carcinogen by ECHA”, ECHA/PR/17/06 <echa.europa.eu/-/glyphosate-not-classified-as-a-carcinogen-by-echa> (last accessed 10 December 2019).

28 European Citizens’ Initiative, supra, note 26. The ban on glyphosate-based herbicides stemmed from concerns over its exposure, as it had been linked to cancer in humans and led to ecosystem degradation.

29 There were approximately 471 participants in the exercise on how things would need to change in relation to EFSA decision-making processes. Surprisingly, out of these 471 participants, around two-thirds of them (318) were private citizens making their point and the remaining 153 represented a broad group of stakeholders, consumer groups, industry and retail, etc. See further the Public Consultation, supra, note 3.

30 Commission Working Document, Proposal for a Regulation of the European Parliament and of the Council on the transparency and sustainability of the EU risk assessment in the food chain amending Regulation (EC) No 178/2002 (on general food law), Directive 2001/18/EC (on the deliberate release into the environment of GMOs), Regulation (EC) No 1829/2003 (on GM food and feed), Regulation (EC) No 1831/2003 (on feed additives), Regulation (EC) No 2065/2003 (on smoke flavourings), Regulation (EC) No 1935/2004 (on food contact materials), Regulation (EC) No 1331/2008 (on the common authorisation procedure for food additives, food enzymes and food flavourings), Regulation (EC) No 1107/2009 (on plant protection products) and Regulation (EC) No 2015/2283 (on novel foods) COM (2018) 179 final. Specifically, see p 7 of the Commission Working Document concerning Impact Assessment, which outlines that: “[N]o impact assessment was carried out for this initiative, as the measures that are to be introduced by the proposal will mainly concern the transparency and the way the Commission as risk manager and the EFSA as risk assessor will gather and manage the evidence needed to perform their tasks on the basis of unchanged criteria. Such measures are therefore not expected to have significant socio-economic and environmental impacts that are clearly identifiable ex ante.”

31 A Arcuri and Y Hale Hendlin, “The Chemical Anthropocene: Glyphosate as a Case Study of Pesticide Exposures” (2019) 30 King’s Law Journal 248. See also S Paulini, “Fact or Fiction? Case C-616/17 and the Compatibility of the EU Authorisation Procedure for Pesticides with the Precautionary Principle” (2020) 11(3) European Journal of Risk Regulation 481.

32 Specifically, full and proper public access to the studies and documents used in the EFSA decision-making process is called for.

33 See Recital 28 of the 2019 Regulation, supra, note 4.

34 See Public Consultation, supra, note 3.

35 Hofmann and Leino-Sandberg, supra, note 5.

36 ibid.

37 Public Consultation, supra, note 3. Many of these concerns were submitted by organisations emphasising “how a correct balance needs to be struck between ensuring greater transparency and the need to protect confidential business information and intellectual property”.

38 The applicant for the authorisation or renewal can request that the documents be kept confidential where they feel that there is some good reason for this as they may not want to give away their trade secrets or ideas. This requirement to submit two dossiers also arises out of Art 7 of the 2019 Regulation, which amends Regulation (EC) No 1107/2009, where there were much briefer requirements of confidentiality. Specifically, Art 7(2) amends Art 10 of the 2009 Regulation requiring public access to the dossiers: “The Authority shall without delay make the dossiers referred to in Art 8, including any supplementary information supplied by the applicant, available to the public, with the exception of any information to which the rapporteur Member State has granted confidential treatment pursuant to Art 63.”

39 The European Consumer Organisation’s (BEUC) stated that, “[P]ublic health prevails over commercial considerations when examining industry confidentiality requests. No important piece of safety-related information should be hidden away from the public. It must allow independent scientists to quote or re-use the data disclosed by EFSA without having to ask for industry’s permission. It must foresee meaningful sanctions for industry applicants failing to notify EFSA of studies commissioned to support a regulatory dossier.” See further BEUC, the European Consumer Organisation, “Closing the Trust Gap between Consumers and the EU Food Regulatory System: BEUC’s view on the Commission’s proposal on the transparency and sustainability of the EU risk assessment in the food chain” (20 June 2018) <www.beuc.eu/publications/beuc-x-2018-059_beuc_position_paper_general_food_law_revision.pdf> (last accessed 10 December 2019).

40 See M Dræbye Gantzhorn et al., “New EU Food Regulation may influence the disclosing of legitimate business information” (10 September 2019) <www.bechbruun.com/en/news/2019/new-eu-food-regulation-may-influence-the-disclosing-of-legitimate-business-information> (last accessed 10 December 2019). This appears to be a recurring issue within EU law, particularly in relation to organic farming, and this resistance to share their data for public benefit, mostly for reasons of personal data privacy, fiduciary allocation of risk and corporate market competitiveness, is strongly preventing the embedding of more democratic values about knowledge production in business operations. See further A Alemanno, “Big Data for Good: Unlocking Privately-Held Data to the Benefit of the Many” (2018) 9(2) European Journal of Risk Regulation 183–191. See also L Leone, “Lost in Translation: The EU Law Reform of Organic Farming” (2018) 13 European Food & Feed Law Review 421.

41 The key claim of businesses was that their intellectual property rights were being threatened for something that is not even particularly useful because no one can truly understand the information that they have to make public. It was contended that if they were going to make some of this information public, it should at least be obligatory to make it more useful for public consumption and to allow businesses to have some confidentiality requirements in relation to this as well. See further L Strom and A Williams, “Strengthened Transparency in the EU General Food Law Regulation” (Arnold & Porter, BioSlice Blog, 12 September 2019) <www.biosliceblog.com/2019/09/strengthened-transparency-in-the-eu-general-food-law-regulation/> (last accessed 10 December 2019).

42 Art 32 of our original 2002 Regulation deals with scientific studies and there are some amendments made here by Art 32c(2). See further the 2002 Regulation, supra, note 20.

43 The non-confidential version, which in some circumstances may be the only version, always has to exist; EFSA must make this public in order to provide the public and other interested stakeholders with the opportunity of identifying the existence of other possibly conflicting studies.

44 Furthermore, full disclosure and full transparency in relation to renewal applications have also been introduced. These were made public and done before any decision was made to give the public the chance to object or to support an application for authorisation or a renewal.

45 This section provides as follows: “Where the relevant Union law provides that an approval or authorisation, including by means of a notification, may be renewed, the potential applicant or notifier for the renewal shall notify the Authority of the studies it intends to perform for that purpose, including information on how the various studies are to be carried out to ensure compliance with regulatory requirements. Following such notification of studies, the Authority shall launch a consultation of stakeholders and the public on the intended studies for renewal, including on the proposed design of studies. Taking into account the received comments from stakeholders and the public which are relevant for the risk assessment of the intended renewal, the Authority shall provide advice on the content of the intended renewal application or notification, as well as on the design of the studies. The advice provided by the Authority shall be without prejudice and non-committal as to the subsequent assessment of the applications or notifications for renewal by the Scientific Panels.”

46 As per Art 32d of the 2019 Regulation, it states that “[the Commission] may request the Authority to commission scientific studies with the objective of verifying evidence used in its risk assessment process. The studies commissioned may have a wider scope than the evidence subject to verification”, supra, note 4.

47 A Smith et al, “Communicating to and Engaging with the Public in Regulatory Science” (2019) EFSA Journal 17(S1):e170717, p 15 <doi.org/10.2903/j.efsa.2019.e170717> (last accessed 10 January 2020).

48 For example, this could be in the form of seeking advice from stakeholders when developing a risk communication strategy, as alluded to in earlier parts of this discussion and within the Regulation itself, both a recommendation and an aim on which great emphasis has been placed. See further, Commission Working Document, supra, note 30.

49 See Art 8a of the 2019 Regulation for full reading of these principles outlined, supra, note 4.

50 Art 25(1) of the 2002 Regulation provided that, “[T]he Management Board shall be composed of 14 members appointed by the Council in consultation with the European Parliament from a list drawn up by the Commission which includes a number of candidates substantially higher than the number of members to be appointed, plus a representative of the Commission. Four of the members shall have their background in organisations representing consumers and other interests in the food chain[.]” It went on to outline various procedural issues in terms of selection and committee formalities within the same Article. This has now been amended by Art 8c of the 2019 Regulation. See the 2002 Regulation, supra, note 20.

51 European Food Safety Authority, “Benchmarking of EFSA’s Independence – Comparison Between the Tools Ensuring EFSA’s Independent Scientific Advice and the Instruments in Use by Organisations Similar to EFSA” (Milieu Ltd 2011).

52 Morvillo at 433, supra, note 25.

53 In particular, to ensure “high competence in the area of food safety risk assessment as well as competences in the food chain safety legislation and policy”.

54 Art 25 of the 2002 Regulation, supra, note 20.

55 M Pigeon, “Massive Transparency win as MEPs pass EU General Food Law Revision” (Corporate Europe, 16 March 2019) <corporateeurope.org/en/2019/04/massive-transparency-win-meps-pass-eu-general-food-law-revision> (last accessed 10 December 2019).

56 Hofmann and Leino-Sandberg, supra, note 5.

57 ibid.