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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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Type
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

I. Introduction

Transparency, accountability and integrity are the unequivocal building blocks of a democracy based on the rule of law. Adherence to these principles can help to ensure good governance and instill trust in the decision-making process, exalting both the credibility and the legitimacy of public institutions. Footnote 1 Indeed, they are the foundational values of the European Union. Footnote 2 Notwithstanding the fundamental importance of these values, the adequacy of existing EU standards of transparency has been called into question within the context of decisions made by European agencies; specifically, the European Food Safety Authority (EFSA). It was clear from the 2018 public consultation on transparency in relation to risk assessments conducted by EFSA that there was overwhelming support for increased and improved public access to EFSA evaluations and documents. Footnote 3 Namely, clear indications of which studies were being used in EFSA’s decisions were called for, particularly that this information should be presented in a more accessible and transparent format. Efforts have been made to reflect such changes by Regulation (EU) No. 2019/1381. Footnote 4

Taking stock of the existing literature on the understanding of transparency in EU administrative processes, this author will examine the efficacy of several key changes introduced by the 2019 Regulation. To discern the potential to enhance transparent assessments and to increase trust among European citizens, the key changes will be measured against existing notions of transparency in the annals of the EU. While heralded as “the new gold standard”, Footnote 5 this author will submit that although it is not without its deficiencies, it can be viewed as a stepping stone towards mitigating the opacity of EU risk assessment processes.

II. Conceptualising transparency in EU risk assessment

Discourse surrounding transparency in Europe has developed manyfold. Throughout the history of EU integration, transparency has been a normative concern. While the Treaty of Maastricht and the political union are generally credited with the inception of transparency, visibility of the actions of the institutions as a determination of success pre-existed in the formation of the European Coal and Steel Community during the 1950s. Footnote 6 Indeed, the concept of transparency played an important role in ensuring that Member States, subject to the power exercised by the Community institutions, understood and accepted its ethos. As Mendes writes, “this was essential to the ability of the new Community to affirm itself as a legitimate authority”. Footnote 7 It remained instrumental to the building of the internal market and a feature of a democratic polity in EU law and institutional practice.

Yet in the decades that followed, it became clear that the importance of transparency had shifted from Member States to Community citizens when it came to the effective application of Community law. Indeed, the removal of trade barriers that ensued following the launch of the internal market in the 1980s meant that Member States were required not only to understand their obligations, but also to ensure that Community citizens were aware of their own rights. Footnote 8 This was later strengthened by the 1992 Sutherland Report, which affirmed transparency as a quality of the Community rule-making procedures, concurrent with the participation “of those concerned by [law]”. Footnote 9 In essence, the Commission appreciated that to ensure the visualisation of the ideal of the internal market, transparency meant legislative consolidation Footnote 10 to bring the “Community close to its citizens”. Footnote 11 In unpacking its potential, the White Paper on Governance of 2001 proclaimed that transparency through active communication surrounding the roles and functions of the EU in a language that is “accessible and understandable for the general public” leads to good governance under the concept of “openness”. Footnote 12 Openness, as a matter of Treaty codification, is now at the core of the democratic foundations of the Union, ancillary to both representative and participatory democracy. Footnote 13 When taken together, transparency and openness should instill public confidence in the institutions of the EU and their agencies “to promote good governance and ensure the participation of civil society”. Footnote 14

While the normative strength of openness as a standalone principle has been questioned, Footnote 15 the normative content of transparency helps to situate this discussion surrounding EU risk assessment processes and the capacity to achieve transparency. Correspondingly, the fundamental right of access to documents is governed by Article 15 TFEU, which not only ensures the publication of the documents related to the legislative procedures of the institutions, but also requires the institutions to convene publicly. As Alemanno observes, this engages the concept of “passive transparency” in the form of access to information upon request, as well as “active transparency” in requiring the EU institutions to proactively safeguard the transparency of their procedures and regional output. Footnote 16 To this end, measuring EU risk assessment and risk analysis processes against these underpinnings of transparency is fundamental to ensuring the integrity of decision-making for the purpose of this discussion. The reason for this is that regulatory systems do not only respond to public concerns, but they also contribute to informing public attitudes in a demonstrable way. Footnote 17 In the 1990s, a series of food crises and scandals raised concerns about the lack of transparency, openness, functioning and independence of the responsible scientific agencies involved in EU food governance. Footnote 18 Food represents a crucial EU socio-economic policy area, one that directly affects individuals and their health. Footnote 19 Instances where such systems fail to inform the public and neglect the right to transparency, particularly where public health is at stake, are a cause for immediate concern and scrutiny. Accordingly, commitments to ensure transparency in prospective statutory instruments, as in the 2019 Regulation, must be considered from this perspective: does the framework have the capacity to ensure both passive and active transparency?

III. Impetus for the regulation

In 2002, the General Food Law Regulation Footnote 20 established risk analysis as a general principle in EU food law. It forged a European food safety regime, engaging both science and policy, but one where responsibility for risk assessment and risk management are kept separate. Within the same framework, EFSA was conceived as an independent EU agency to oversee scientific advice on risks related to the agri-food chain. Footnote 21 The results of a long overdue Fitness Check of the 2002 Regulation published earlier in 2018 demonstrated that while it met its aims of ensuring the smooth functioning of the internal market and a high level of protection for human health, concerns prevailed over the transparency of scientific studies and the risk assessment process in the agri-food chain. Footnote 22 Simultaneously, a European Citizens’ Initiative (ECI) on glyphosate was submitted to the European Commission in October 2017 fronted by burgeoning tensions in EU good governance and risk regulation. Concerns surrounding the accountability lacunae affecting expert-based decisions as a result of their complexity and “value-neutrality”, Footnote 23 coupled with the struggle of EFSA and the Commission to gain citizens’ trust, Footnote 24 formed the undercurrent of the glyphosate dispute. Morvillo proposes that for these reasons, the very meaning of the glyphosate saga transcended the individual case as it spoke to broader issues of the accountability of EU risk regulation. Footnote 25 To this end, the ECI submission levied criticisms against EFSA as being too reliant upon business- and industry-led studies. Footnote 26

Following investigations conducted by the Commission, Footnote 27 EFSA embarked upon a public consultation to get a sense of what Community citizens would like to see done to ensure that post-glyphosate problems were not repeated: Footnote 28 specifically, how confidence could be improved, how transparency could be increased and, ultimately, how the sustainability of EFSA processes could be ensured. This public consultation took place in the first quarter of 2018, receiving a very positive response. Footnote 29 Consequently, the public consultation led to a proposal in the same year that clearly set out the aim of the new Regulation, which would be to strengthen the transparency of the risk assessment process. In their view, this would give EFSA greater legitimacy in the eyes of the consumer and the general public, thereby increasing public confidence in its work.

It is important to note that this was not necessarily about changing EFSA’s risk assessments, but rather improving the transparency and processes used to make such decisions in order to maximise consumer confidence. Footnote 30 And yet Arcuri and Hendlin have submitted that while the 2019 Regulation is “a first step in changing the current system towards more stringent accountability and transparency”, it “fails to meet the requests of the European citizens”. Footnote 31 Accordingly, the following discussion will appraise several key changes in relation to access to documents, confidentiality, risk communication and changes to the management board on the basis of this criticism and considerations of transparency.

IV. The key changes

1. Access to documents

The first change introduced is seen through Article 38 of the 2002 Regulation, which amends some of the existing provisions of the 2002 Regulation concerning transparency. It provides that any studies that have been produced in support of applications for authorisations, renewals or related documents must be made public, Footnote 32 a patent feature of passive transparency. Clarified in Article 32d, the amending provision requires specific documentation to be commissioned for public access. In widening the scope of Article 38 of the 2002 Regulation, the Authority shall now make public documentation including inter alia agendas, participant lists and minutes of the Management Board, all scientific outputs and the annual reports of its activities.

This is also supplemented by Article 32b(1), which provides for the establishment of a database by EFSA that advances the accessibility of documents. It requires the mandatory registration of all the studies commissioned to private laboratories with a view to applying for authorisation under EU food law, stating that “the Authority shall establish and manage a database of studies commissioned or carried out by business operators to support an application or notification in relation to which Union law contains provisions for the Authority to provide a scientific output, including a scientific opinion”. Consequently, the obligation falls both on EU-based laboratories and on commissioning business operators to proactively notify the Authority of the title and scope of commissioning studies to ensure information accuracy for wider public consumption; a proactivity characteristic of active transparency.

In addition, documents must be made publicly available at the earliest possible stage in the risk assessment process, as stipulated in the Preamble. Footnote 33 To this end, the documents that are made available must be “easily accessible”, but what is meant by accessible in this context and how does this differ from what previously existed? To answer, the amendment of Article 38(1) now requires that documents should be made available in an electronic format and that format need be searchable, printable and downloadable, allowing anyone with the internet to gain access. It should be presented in a format that is easy to understand, addressing another glaring concern exposed by the consultation exercise. Footnote 34 This is particularly important as modern standards of transparency, as iterated throughout the Treaties, require proactive online publication of relevant documents by the EU institutions. Indeed, the use and advancement of modern technology to ensure the timely and accessible publication of documents is in accordance with the right of citizens to access such information as it arises. Footnote 35

This new gold standard found in the 2019 Regulation requires information to be made available during risk assessment procedures rather than after relevant decisions have been taken, thereby vindicating modern citizens’ rights in this respect. Footnote 36 Without question, this reformulation should encourage public scrutiny of EFSA decisions and, by the same token, EU risk assessment. Consequently, the Regulation’s capacity to ensure transparency both passively and actively as it relates to access to documents seems, at least at this stage, convincingly robust in this author’s opinion.

2. Confidentiality

Concerns were also raised in the consultation exercise surrounding confidentiality as it relates to intellectual property rights holders. Specifically, the public consultation alerted the potential for exploitation of intellectual property rights without a controlled mechanism to ensure that disclosed information did not compromise innovation and competitiveness in the EU. Footnote 37 In response to this, a requirement has been introduced whereby two dossiers, one confidential and the other non-confidential, must be submitted as part of an application where confidentiality is required for intellectual property collection purposes. Footnote 38 This is a welcome change and one that ensures active transparency in prioritising consumer protection and public health considerations above commercial interests. Footnote 39 However, it has not gone without its criticisms, particularly from parties within the industry who argue that securing transparency should not be at the cost of disclosing legitimate business information. Footnote 40 How the Regulation will reconcile these competing aims remains to be seen following full implementation in 2021. Footnote 41

Furthermore, the desire to increase transparency and confidence in EFSA processes corresponds to two different types of applications, and both are addressed separately in the 2019 Regulation. The first relates to applications for the authorisation of new products as dealt with by Article 32c inserted by the 2019 Regulation. Footnote 42 In relation to new authorisations, the second paragraph states that “[EFSA] shall consult stakeholders and the public on the basis of the non-confidential version of the application, in order to identify whether relevant scientific data or studies are available on the subject matter concerned by the application”. In this way, increasing public engagement in processes that directly affect EU citizens not only instills a degree of confidence in giving them a stake in decision-making processes, but actively enhances the transparency of these processes beyond passivity. Footnote 43 Indeed, a cursory analysis demonstrates how this is a significant departure from what existed previously and is therefore a positive step in addressing previous criticisms that EFSA is overly reliant on studies generated by the business sector in particular. As a result, there exists the potential for anyone to alert the Authority to the extant of other studies that may show a negative impact on prospective applications for authorisation to EFSA. The hope is that by casting this net much wider, EFSA will be in a position to take all relevant scientific studies into consideration. This author submits that this overhaul generates significant practical advantages that have the potential to improve EFSA transparency standards in a proactive manner, leaving EFSA far less open to the criticism that it is taking only select studies into consideration. Footnote 44

Renewals are dealt with in the first paragraph inserted by Article 32c of the 2019 Regulation, which provides for stakeholder engagement for risk assessment of renewal applications. Footnote 45 As a consequence, full disclosure in relation to these applications now exists, but the applications must be made public and before any decision is made in order to give citizens a fair chance to object or to support an application for authorisation or renewal. However, this begs the question of what happens as a result of Article 32c(1) or (2) where a problem is identified? For example, if a member of the public comes forward in relation to an application for a new authorisation, which may include the scientist who has conducted the study or some other business that has conducted its own study. Ergo, what happens if their studies now conflict with those that show that the product is perfectly safe? In those circumstances, Article 32d is ignited. This provides that the European Commission, in circumstances where there is any controversy or conflicting results between supporting studies, can ask EFSA to conduct wholly new studies in order to address this conflict or controversy. Footnote 46 As a result, we should avoid situations where we have conflicting scientific evidence, and where EFSA has not carried out further investigations into the basis of these competing evidentiary claims.

Indeed, the 2019 Regulation should inhibit the authorisation or renewal of any application by EFSA without first resolving any points of scientific contestation. The value and consequences of public engagement translate into public empowerment and democratic accountability. The importance of civic engagement in the monitoring and examination of technoscientific research and related policies furnishes citizens with not only clear data and information, but also the tools, knowledge and opportunities to ask questions and make sense of such data and information. Footnote 47 Undoubtedly, this is a reassuring development in terms of ensuring transparency through active commitments to engage the public. Yet absent are substantive mechanisms for which valuable public scrutiny and engagement may be achieved, eclipsed by transparent assurances in the framework’s language. Its capability to deliver both passive and active transparency, as a result, is uncertain in the absence of resolute measures, although its practical effect remains to be seen.

3. Risk communication

Further, the insertion of Article 8c, which deals with risk communication, is an additional change introduced within the 2019 Regulation and is perhaps the most welcome and effective addition. It calls on the Commission, EFSA and the public to be consulted on the development of a new general plan for risk communication. Specifically, where any risk is identified, full and proper communication will be publicly issued pending this development. In effect, Article 8c calls for prospective action in the form of a further consultation exercise in conjunction with the Commission and EFSA to develop a general risk communication plan. However, this plan must be based on a set of principles, which are set out in Article 8a of the 2019 Regulation. They include the need for clear and proper public understanding of the risk that is being communicated to them; for consistency in risk communication; for consumers and consumer groups, where possible, to be involved in the risk communication; Footnote 48 and for this general plan for risk communication to prevent the spread of false or misleading information. Footnote 49 While these specifications may well be obvious, their codification is indicative of a lack of application in the past, hence the need for their clear and concise provision in statute. This is perhaps one of the most crucial reforms that the 2019 Regulation will implement to ensure the practical efficacy of the legislation. Against the backdrop of normative understandings of transparency, the obligation placed on EFSA to proactively safeguard the transparency of their risk communication procedures through consumer engagement does go some way to proving its capabilities.

4. EFSA management board

Finally, the 2019 Regulation has also made several changes in relation to the EFSA management board. Initially, the thinking behind this change was to increase stakeholder interests in the management board, which has undoubtedly been achieved from a numerical standpoint. Yet by the same token, the stakeholder voice in the EFSA management board is significantly diluted as a result of the overall increased size of the board. Under the 2002 Regulation, EFSA was considerably smaller with only 14 members on its management board, Footnote 50 and nomination was contingent upon the members’ experience and expertise as opposed to nationality. Footnote 51 However, the 2019 Regulation stipulates for increasing from 14 members to a minimum of one member per Member State, equating to 28 board members.

In addition, it requires that two members from the European Commission, as well as four representatives of civil society and the food chain, must be present. The latter are to be drawn from four distinct areas: consumer interests, environmental NGOs, farmers groups and the industry. Effectively, this leaves one consumer representative on a board where the members already exceed 30. While this reform does pursue certain objectives “to improve governance of and strengthen the scientific cooperation of Member States with and their involvement in the EFSA”, it does not represent concerns of EFSA’s politicisation as identified by Morvillo. Footnote 52 Rather, it stands that Member State representatives on the management board must fulfil strict appointment criteria, Footnote 53 delineating them as risk assessors who must act “independently in the public interest”. Footnote 54

Moreover, as with any committee, the board operates on the basis of one member one vote, and decisions are largely made on the basis of a simple majority. Evidently, the voice of consumer representatives, and even that of civil society and food chain representation, is quite insignificant in relation to the overall decision-making powers of the management board, given that there are seven times as many Member State representatives as there are civil society and food chain representatives. An immediate concern arising from this relates to purposive participation and the practical realities of overcrowded committees; where majority rules, how does one make a difference when outnumbered? The chances of these groups ever holding a balance of power in relation to decision-making on the board are very small, if not unrealistic, rendering any attempt for enhanced participation and meaningful collaboration, arguably, moot.

V. Concluding remarks

At a time of structural challenges to the integrity of scientific data, the 2019 Regulation supports a revolutionary rethinking of risk assessment practices in a participatory sense, democratising the cognitive structure within which policies are designed. In this way, the widest range of knowledge in society may reach the table of decision-makers to uphold the integrity of regulatory processes and for the achievement of a more democratic vision of EU society under prevailing uncertainties. While the 2019 Regulation discusses a great deal transparency in the spirit of the framework and addresses tensions concerning the sources of EU decision-making, considerations of its practical purpose are absent. Indeed, none of the amendments introduces substantive measures to extricate uncertainty between objectives of EU food regulation in proactively guaranteeing transparency. While it does speak to passive and active concepts of transparency, neither is sufficiently improved to amount to tangible change in the absence of resolute scrutiny mechanisms.

What is more, the overhauled reform ignores that many experts with corporate financial links continue to be involved in EFSA’s authorisation processes. Footnote 55 Further, the entire process around market authorisation remains a complete blindspot: the positions and votes of the Member States on the board on whether or not to approve regulated products for the EU market remain entirely opaque.

Yet not all hope is lost. Undoubtedly, the focus on codification of the risk assessment process and its findings having greater clarity creates a new frontier for openness in the EU, Footnote 56 and represents a desire to place transparency at the top of the food chain, as its language demonstrates. Indeed, it has made laudable strides in advancing the parameters of access to documents, robustly enhancing the Regulation’s capacity in this regard. Against these positive developments, perennial concerns of transparency are inherent and systemic, and will continue to haunt EU law as long as statutory instruments build on specific procedural decision-making provisions. Footnote 57 The full effectiveness of the 2019 Regulation will be clearer following implementation in March 2021. Whether or not it will deliver upon its aims and fortify this discussion’s benchmark of transparency within European risk analysis and public health is uncertain, but this author is not wholly satisfied that it will prove to be a bona fide instrument of active change.

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.