Weekend Edition Nº69 by eulawlive

Nº69

SEPTEMBER 4

2021

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TRAJAN SHIPLEY

SLOVENIAN PRESIDENCY FOCUSES ON AN AUTONOMOUS, POST-PANDEMIC EU ANJUM SHABBIR

GLYPHOSATE IN PESTICIDES: SHORTCOMINGS IN THE EU’S AUTHORISATION PROCESS

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Slovenian Presidency focuses on an autonomous, post-pandemic EU Trajan Shipley

at is precisely the focus of the Slovenian Presidency. Under the mo o ‘Together. Resilient. Europe’, it seeks to advance policies and discussions on how to overcome some of the aws of the EU’s response On 1 July 2021, Slovenia took over from Portugal to the pandemic, ranging from the roles of relevant the Presidency of the Council of the EU, only the seEU agencies to extending the EU’s strategic autocond time it has done so since its accession to the nomy to the eld of critical supply chains. e focus EU in 2004. is Presidency puts an end to a trio on resilience and autonomy is also heavily present that was initiated by Germany shortly a er the end with regard to the EU’s digital and of the rst wave of the COVIDgreen transitions (in transport 19 pandemic, and precedes Franand cyber legislation, for examce which will hold the Presi- Slovenia will be pu ing ple). Speci cally, Slovenia will be dency in the rst half of 2022. pu ing all things digital at the top all things digital at of the agenda, whether it relates to In general terms, while the Porthe top of the agenda competition law or to much more tuguese Presidency was labelled in-depth issues such as regulating a ‘mid-crisis Presidency’, SloveArti cial Intelligence. nia’s leadership can be categorised as one that prioritises a recoOther equally important issues will also inevitably very agenda and deals with relevant issues for the be on the agenda throughout the Presidency. at is post-pandemic world. With the vaccine rollout hathe case of EU values, as the rule of law backlash in ving already made signi cant progress, only the DelPoland and Hungary is increasingly gaining more ta variant and the possible emergence of more troupolitical a ention from EU leaders, and the Confeblesome variants that may escape vaccine protecrence on the Future of Europe reaches its mid-level tion seem to sit in the way of an end to the COVIDstage. According to its programme, the Slovenian 19 pandemic in Europe. Against that background, Presidency will try to broker an honest conversaEU institutions and Member States are now focution on issues concerning EU values. sing on the implementation of the much-awaited recovery fund and on advancing policies that aim to is Presidency does not come without controempower the bloc to address post-pandemic chaversy, speci cally when it comes to the respect of sollenges.

I. Introduction: a two-track, postpandemic Presidency

1. LL.M. candidate at the College of Europe / Legal Reporter at EU Law Live.

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on external players’ and enhance the EU’s preparedness for future 21st century-threats, which in practice will have a horizontal eﬀect on numerous policies and legislative proposals.

me of these values. By the time of publication of this Long Read, Slovenia remains the single participating Member State in the newly-created European Public Prosecutor’s Oﬃce (EPPO) that is yet to appoint a European Delegated Prosecutor, which de facto prevents the EPPO from carrying out its mandate in said country, a particularly important task as the Commission has already endorsed Slovenia’s recovery and resilience plan. Slovenia’s Prime Minister, Janez Janša, is also a very controversial gure on the EU stage, who has been accused of a acking the freedom of the press and siding with Poland and Hungary in their respective actions undermining the rule of law and the rights of minorities.

Digital autonomy e highlight of the Slovenian Presidency is its strong focus on all things digital with a strategic autonomy twist in order to ‘close the gap’ between China and the US, as the EU o en nds itself in the middle of the two superpowers’ competition in the digital race. Slovenia’s agenda in this area is quite exhaustive and stands in contrast with the fairly limited a ention given to it by the Portuguese Presidency. e highlights of this agenda include regulating Articial Intelligence (AI), advancing digital autonomy and nding solutions for the digital single market.

Mr Janša was also the only EU leader to congratulate former President Trump on his alleged ‘victory’ in the 2020 US Presidential Elections. Like the Trump Administration, the Slovenian Presidency might end up being a ‘two-track’ endeavour: highly politicised in the public arena, and perhaps at a leaders’ level, while actually producing substantial policy discussions and results at a lower institutional level. e Presidency’s programme, which will be analysed below, includes an ambitious agenda of priorities that should be on the radar of those following EU legal aﬀairs over the next few months.

With regard to AI, it will seek to broker an agreement on the Commission’s proposal for an Arti cial Intelligence Act, the rst major piece of legislation in this eld. While Slovenia is a true AI maverick in its own right, in order to achieve something at the EU level, it will need to convince other Council members that it can act as a ‘neutral arbiter’, particularly when it comes to issues like content moderation. In that sense, it has already set the stage with a high-level conference on AI taking place on 14-15 September.

II. Advancing the EU’s resilience and strategic autonomy

Besides AI, Slovenia also a empts to bridge diﬀerences between Member States with regard to the Digital Markets Act and Digital Services Act (DMA and DSA, respectively), and ‘speed them up’ along with the proposed Data Governance Act. ese three pieces of legislation constitute the single largest a empt to modernise the digital single market and will provide clear rules for issues ranging from competition, data use, and on the functioning of on-

While resilience has been a common feature in the EU’s approach to the recovery from the COVID-19 pandemic, discussions on strategic autonomy, initially linked to the Common Foreign and Security Policy (CFSP) have increasingly expanded to cover issues ranging from digital sovereignty to health issues. Overall, the common thread of the new Presidency’s approach is a desire to reduce ‘dependence

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e EU has to be be er equipped and less dependent on ‘external players’ to face crises

line platforms. is task might prove to be even more diﬃcult, as the proposals have been widely criticised for multiple reasons (read EU Law Live’s Editorial Comment on the DMA here), and some Member States have taken divergent positions on the proposal. However, Slovenian oﬃcials have reiterated that the Digital Services Package will be the main focus of the Presidency from a regulatory perspective.

Recovery and resilience Again, Slovenia considers that the COVID-19 pandemic has revealed a ‘lack of preparedness’ of the EU to deal with its challenges (presumably including Member States as well). In this sense, its eﬀorts to strengthen the EU’s resilience are the ip side to its focus on digital autonomy. Overall, Slovenia’s policy diagnosis is that the EU has to be be er equipped and less dependent on ‘external players’ to face crises such as cyber a acks or pandemics.

In addition, other priorities of the Slovenian Presidency in this eld include the safety, eﬀectiveness and independence of the EU’s digital infrastructure, with a particular focus on 5G, building up on the recently agreed Connectivity Toolbox or advancing discussions on the Roaming Regulation. is will come hand in hand with the new EU Cybersecurity Strategy and with its desire to advance discussions on the EU’s cyber capabilities, particularly with regard to cybersecurity certi cation schemes and ensuring the security of internet-connected devices (a review of the eIDAS Regulation is currently taking place, in addition to Directive proposals on measures for a high common level of cybersecurity across the EU and on the resilience of critical entities), as well as promoting the digitalisation of certain sectors, such as the justice system.

In this sense, a major focus is placed on its programme to advance EU-wide health policy, in order to work towards a European Health Union as already envisioned by the Commission. Two particular policies stand out: (i) increasing the EU’s preparedness and coordination mechanisms, and (ii) reinforcing its independence with regard to critical supply chains. With regard to the former, key topics on the agenda will include reviewing the roles of EU agencies such as the European Centre for Disease Prevention and Control (ECDC) or the European Medicines Agency (EMA), as well as on the proposal for the creation of a European Health Emergency Preparedness and Response Authority (HE ).

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Concerning the la er, Slovenia will mirror it with discussions on the supply of critical medicines, vaccines and medical equipment with those concerning industrial policy, energy or food supply.

tion will be given to the travel and tourism sectors, for which it intends to cra synergies with other relevant policies such as regarding transport, agriculture or the European Green Deal.

From the wider dimension, the policy focus on resilience will also see discussions on recent Commission proposals such as the proposal for a Directive on the resilience of critical entities, which obliges Member States to identify and protect critical entities, or on the security of supply of the TransEuropean Energy Networks Regulation, which the Council has already agreed to revise. Slovenia also aims to ‘make a shi ’ in order to treat agriculture as a critical and strategic sector and fully integrate it into natural resource management systems, in line with the guidelines set by the Farm to Fork Strategy and wider considerations on climate change.

III. EU values and the future of Europe is Presidency will inevitably have to deal with relevant discussions concerning the values that underpin the EU in areas such as the rule of law, immigration, and the future of European integration. Slovenia, and more speci cally its prime minister, have drawn considerable media a ention and concerns over their suitability to act as an honest broker in these discussions. Although not part of the Visegrád Group, Slovenia nds itself politically aligned with Poland and Hungary in issues concerning EU values, including their current eﬀorts to undermine the rule of law. While the latest Rule of Law Report by the Commission highlighted improvements in judicial independence and the ght against corruption in Slovenia, it drew a ention towards the ‘deteriorating’ situation as regards media pluralism.

is Presidency will inevitably have to deal with relevant discussions concerning the values that underpin the EU in areas such as the rule of law, immigration, and the future of European integration

EU values In all fairness, the Presidency programme certainly does not overlook these issues. However, the likelihood that they will result in disagreements and lack of compromise is still high, as it seems that the precise scope and meaning of some of the values at issue will continue to be up for debate. For instance, Slovenia reckons that while media pluralism is important, it is quick to add that the media’s responsibility towards a democratic society is always subordinated to that of elected representatives. Similarly, it stresses that the novel rule of law mechanism – and by extension, perhaps the conditionality mechanism too – should be applied ‘respecting the

Slovenia will also prioritise the recovery of speci c sectors that were hit hard by the COVID-19 pandemic. As recently con rmed to MEPs, speci c a en-

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plete takeover by the Taliban and the end of US military presence there. Early signs of this have already taken place amidst the collapse of the Afghan Government. While Prime Minister Janez Janša issued a statement stressing that the EU ‘would not be opening European ‘humanitarian’ or migration corridors for Afghanistan nor ‘repeating the strategic mistake from 2015’, European Parliament President Sassoli refuted this saying that ‘[i]t is not for the current presidency of the Council to say what the European Union will do’ and urging the ‘need to show solidarity’. With discussions on the Commission’s New Pact on Migration and Asylum still undergoing, Slovenia will be pushing for a more hawkish approach to tackle illegal migration, protect EU external borders and returning persons, as well as for further harmonisation of Member States’ asylum systems and the Schengen area.

equality of Member States, as well as their national identities’. is stance, while legitimate, amounts to a relativist understanding that in practice favours diverging interpretations of the principles and values that other Member States see as applying universally to the EU. While this is certainly a topic that far exceeds the remit of the Slovenian Presidency, it is likely that debates on the rule of law will be considerably less reluctant of the diverging national views of Member States such as Poland and Hungary. Slovenia speci cally stresses in its programme that it ‘will endeavour to ensure a be er understanding of diﬀerent constitutional solutions adopted by the Member States in response to similar challenges’. In this sense, with regard to the rule of law, it believes that the source for misunderstandings between Member States is the absence of a full change of institutional mentality in the transition to democracy of Eastern European countries, resulting in newly established safeguards and ‘rule of law institutions’ not protecting or upholding EU values, but rather ‘protect[ing] unjusti ed privileges and preserve the culture of operation’ of prior undemocratic regimes.

Future of Europe

e EU’s approach to the inevitable future migration waves will certainly be on the agenda of the Conference on the Future of Europe, the Plenary Session of which will be held during the Slovenian Presidency and will overall reach its mid-level stage. Among Slovenia’s priorities with regard to the Conference, its quest for an inclusive debate when it comes to ‘diﬀering legitimate opinions’ may suit it well in order to balance its pro-EU bias and enhance its representativeness. Slovenia plans to include key policy considerations of its Presidency for citizens to discuss at the Conference, while at the same time to tone it down and make it clear that not all the relevant issues for the future of Europe are to be managed by EU institutions and may remain ‘easier for countries to tackle on their own’.

A likely stress-test on the EU’s common understanding of certain values may emerge from the looming humanitarian and migration crisis currently unfolding in Afghanistan as a result of the country’s com-

Finally, it is necessary to highlight the strong a ention this Presidency will be giving to the Western Balkans, both with regard to their EU accession status, cooperation with the EU in certain policy areas

Other relevant topics with EU values-implications on the agenda of the Slovenian Presidency include the accession of the EU to the European Convention on Human Rights or the speci c a ention it will convey to forging and strengthening strategic alliances with countries such as the US, Israel or ‘democratic Indo-Paci c countries’.

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such as Common Security and Defence Policy, as well as wider Neighbourhood Policy considerations.

IV. Conclusion e Slovenian Presidency takes up its position as the COVID-19 pandemic as an agenda item seems to be fading away, and as Member States have large amounts of money to spend thanks to the Next Generation EU funds. While it is likely to be a more politically contentious Presidency when it comes to ma ers aﬀecting values and non-regulatory aﬀairs, it is likely to produce a signi cant policy output with sizable legal, regulatory and institutional implications. AI and the digital single market will be the hot topics in the next month where signi cant outcomes are likely to take place under the current Presidency. Institutional changes to the EU’s health capabilities are also likely to materialise. However, it is the horizontal approach to boosting the EU’s strategic autonomy and resilience in the context of a major economic recovery that may produce some of the more interesting results, as the areas of policy and economic sectors that will fall under the scope of such an approach are incredibly wide. Along with them, the rule of law conditionality to EU funds, the Conference on the Future of Europe and the fear of a new migration crisis will be recurring political debates that will probably come along with speci c institutional developments. While the fact that it is Slovenia who holds the Presidency may further politicise some of these discussions, it would be unwise to believe that no compromise nor relevant outputs can be reached.

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Glyphosate in Pesticides: Shortcomings in the EU’s authorisation process Anjum Shabbir

is Long Read however examines legal issues in the EU’s decision-making process from a more critical stance, in particular: (1) ambiguous rules on the ‘scienti c and technical knowledge’ that is relied upon in the process, (2) limits to the capacity and independence of the decision-makers, (3) limits to public participation in the EU’s decision-making, and (4) the limits of judicial review through the ongoing failure to address key legal issues, in particular through glyphosate-related litigation before the EU Courts - issues that the present renewal process is still mired by.

Introduction is Long Read considers the EU’s decisionmaking process in the context of renewing marketing authorisations for plant protection products: in this case, for the world’s most used herbicide, glyphosate. e reader is rst directed, for an overview and update of the current renewal process for glyphosate to this Insight published on EU Law Live in July 2021. It serves as an introduction, providing the details of the nature and status of the process that was formally initiated by the request made on 12 December 2019 by the Glyphosate Renewal Group; an optimistic view of the authorisation process this time around if the EU’s newly shaped and strengthened environmental protection policy is taken into account; and legal shi s to a broader approach to transparency and access to (scienti c) documents versus the need to protect con dential information in this eld, re ecting the balancing of market and environmental interests (as reinforced by the EU Courts). is re ects a positively changing legal landscape since the previous ve-year renewal of authorisation that was granted in December 2017 under Commission Implementing Regulation 2017/2324.

1. Ambiguous rules relied on to inform the EU’s decision-making e criteria that must be ful lled for EU authorisation to be granted for plant protection products, as set out in Article 4 of the PPP Marketing Authorisation Regulation 1107/2009 (‘PPP Regulation’), are re ective of the high (and now higher) level of environmental protection that must be shown in the process. Speci cally, there must be ‘scienti c and technical knowledge’ submi ed to show that at least one use of the substance in question does not harm human health (including with respect to residues in food) or animal health or the environment (for the la er, no ‘unacceptable eﬀect’ is allowed): and such

1. Assistant Editor and Legal Reporter at EU Law Live.

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What constitutes that scienti c and technical knowledge?

protection should take priority over the PPP Regulation’s twin objective of improving plant production (see Article 1(3) of the PPP Regulation).

the Commission - which has a risk management role and takes the nal decision on an active substance - took note of these ndings.

What constitutes that scienti c and technical knowledge? at concept is referred to several times in the PPP Regulation, but its scope and de nition is not clear.

In fact, it was prompted to ask the European Food Safety Authority (EFSA) - which is required under the PPP Regulation to provide ‘independent scienti c review’ - to examine them and come to its own conclusions (5). e peer review results were adopted just over six months later on 30 October 2015 and published in November 2015. EFSA came to the contrary conclusion to that of the IARC: that glyphosate was unlikely to pose a carcinogenic hazard to humans, and that evidence did not support it being classi ed with regard to its carcinogenic potential. But EFSA is only supposed to provide an advisory opinion, and the General Court has recalled (T-177/13) that EFSA’s guidance documents do not bind the Commission in its assessment or review.

It could include studies on the health eﬀects of glyphosate that have been produced by a number of international and EU actors: the UN’s Food and Agriculture Organisation (FAO); the World Health Organisation (WHO); the European Chemicals Agency (ECHA); the US Environmental Protection Agency; (2) and the Agency for Toxic Substances and Disease Registry (ATSDR) (3). e March 2015 report of the International Agency for Research on Cancer (IARC) is arguably the most important of this list, because it classi ed glyphosate as ‘probably carcinogenic to humans’ (4), and because

2. In an interim decision of 2017 the EPA assessed glyphosate as suﬃciently safe (More here) 3. e Toxicological Pro le for Glyphosate (Dra for Public Comment)’ (Department of Health and Human Services, Public Health Service 2019). On the other hand, this report aligns on many points with IARC’s conclusions of risk. 4. Beyond the EU context, California followed suit and listed glyphosate as carcinogenic, implying that all glyphosate-based herbicides must be labelled as carcinogenic - (More here). 5. European Commission, Health and Food Safety Directorate-General, ‘Request to consider the ndings by IARC as regards the potential carcinogenicity of glyphosate or glyphosate containing plant protection products in the ongoing peer review of the active substance’, 30 April 2015, Brussels, SANTE/ E3/ DVB/ Wv/ np.

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In the last 20 years of litigation before the EU Courts concerning glyphosate (see section 4 below), no cases have delved very far into the nature, source and substantive assessment of the ‘scienti c and technical knowledge’ that is referred to in the Regulation. A case that comes close is the 2001 Queen v Minister for Agriculture, Fisheries and Food case (C-306/98) - and that was in the very speci c circumstance of the referring court seeking clari cation on how transitional rules apply, and on the application of the requirements of scienti c knowledge to an applicant when the active substance is already on the market before the PPP Directive (the relevant legislation at the time) has been noti ed, when glyphosate is not listed as an active substance in the Annex (it was held that it did not and national rules applied).

A short while later, the ECHA’s report in 2016 blew back in the other direction, and classi ed glyphosate as causing serious eye damage and as toxic to aquatic life - although it did not expressly suggest that it is carcinogenic. If all the above is included in the concept ‘scienti c and technical knowledge’, then the con icts between the ndings of the reports and their diﬀerent methodologies (for example, the IARC looking at glyphosate and glyphosate in PPPs, and the EU agency reports looking at glyphosate as an active substance only) could suggest that there is ‘scienti c uncertainty’ which one could expect could justify the engagement of the precautionary principle under Article 191(2) TFEU and Article 1(4) of the PPP Regulation. at has not occurred, and it remains un xed what weight the Commission can a ach to each of the reports referred to above, or what the credibility is considered to be by the Commission of each body producing the report.

ere is also criticism in the literature of the scope of scienti c and technical knowledge that is taken into account: as mentioned earlier, only one use of the active substance for approval can be examined, and it has been pointed out that in a wider context this leaves blended pesticides that are released onto the market unreviewed and unscrutinised (Arcuri). is criticism is certainly worth considering because it has been suggested that pure glyphosate is not as toxic as it can be when combined or released when combined with other ingredients. In fact, this was raised in one of the pleas submi ed to the General Court by German environmental association TestBioTech in TestBioTech v European Commission (T-177/13): namely that the ‘synergistic or combinatorial eﬀects were not taken into consideration or no appropriate toxicity assessment was required’, but that plea was rejected as unfounded.

At least it is clear that the Assessment Group (AGG) (appointed by the Commission on 10 May 2019)’s dra Renewal Assessment Report ( R) and CLH Report proposing harmonised classi cation and labelling assessment of glyphosate will certainly be taken into account in the decision-making process. e AGG’s dra R, submi ed in June 2021 (as required under Article 11(1) of the PPP Regulation), must contain ‘an independent, objective and transparent assessment in the light of current scienti c and technical knowledge’ - but it is diﬃcult to accept that there can be such objectivity, given that such reports are based on the information that is submi ed in the dossier by an actor that cannot be impartial - the applicant - in this case the Glyphosate Renewal Group.

To conclude this rst section, the EU’s decisionmaking in this eld is characterised by the ambiguous and unexplained nature and scope of the

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santo had improperly in uenced federal agencies with respect to the agencies’ classi cation of glyphosate as a carcinogen (6).

‘scienti c and technical knowledge’ that is ultimately relied upon by the Commission as the decisionmaker granting or refusing to grant marketing authorisation to an active substance used in a plant protection product. is is a problem in the particular case where it can be seen that scienti c studies and reports - taking the example of those produced by the IARC, EFSA and ECHA - con ict with each other on the eﬀects of glyphosate on human health, animal health, and the environment. Such rules could be made clearer, or alternatively emphasise the triggering of the precautionary principle where there is scienti c uncertainty.

In this respect it should at least be borne in mind that in September 2017, e Guardian reported that (for the authorisation process for glyphosate that commenced in 2012) sections of the Renewal Assessment Report prepared by the German Risk Assessment Institute in 2013, and used by EFSA were copy-pasted from a study carried out by Monsanto. One wonders if EFSA is truly independent, and how much in uence it has over the Commission in this process? As noted above in section 1, EFSA is supposed to provide an advisory opinion and its guidance documents do not bind the Commission in its assessment or review.

2. Limits to the capacity and independence of the EU’s decision-maker(s) e role and independence of actors in the authorisation process - in particular EFSA - should also be considered.

e competence of the Commission, however, to make a decision based on scienti c knowledge without having the requisite expertise, tools and knowledge itself is up for debate, and in practice it is rare that the Commission would not - as a result of that own lack of expertise and in recognition of EFSA’s - very closely follow EFSA’s opinion. In any event, the previous 2017 ‘copy-pasting’ scenario suggests that there should be more scrutiny of EFSA - but also of the Commission as the decision-maker.

Mainstream media has paid a ention to what are seen as questionable relations between industry and regulatory agencies

Looking over the pond, it is worth comparing the situation with litigation concerning glyphosate in the US: the disclosure of a considerable amount of internal Monsanto emails and non-published scienti c studies raised the credibility of some of the scienti c evidence used to come to the conclusions that glyphosate is a safe substance, and mainstream media has paid a ention to what are seen as questionable relations between industry and regulatory agencies, revealing possible con icts of interests and the compromised nature of existing risk assessments at the US Environmental Protection Agency. Some claimants accumulated evidence and alleged that Mon6. Sergio J. Campos,

e circumstances described in this section 2 reveal that the capacity and independence of the decisionmaker is potentially awed and in need of strengthening through revision, which also clari es EFSA’s role and independence in the process.

e Commonality of Causation, vol. 46, Ohio Northern University Law Review, 6 May 2020.

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shows a trend of the one million signatures not being formally taken into account, there being ‘no explicit link’ between the ECI and any future EU decision. Even stronger criticism comes from Giulia Leonelli on the accid result, nding that the European Commission had ‘scienti c and legal grounds, as well as compelling political reasons’, to accept the requests put forward by the ‘Ban Glyphosate’ European Citizens’ Initiative and the European Parliament, but that it relied on a ‘narrow evidence-based approach, disregarding the widespread public perception that the uncertain risks posed by glyphosate are socially unacceptable, and ignoring the argument that the existing risk management measures are insuﬃcient to achieve the intended EU level of public health and environmental protection’.

3. Lack of Public Participation in the EU’s decision-making process e need for reform of the process for the issues highlighted in sections 1 and 2 is visible through the voices of the public, private companies, Member States, and the European Parliament, but despite such eﬀorts has not been translated into a speci c course of action at the EU level. Civil society in the EU took notice and action in response to perceived health and environmental concerns of glyphosate. In 2017, a European Citizens’ Initiative (ECI) with over a million signatures called for a ban on glyphosate-based herbicides arguing its links with cancer as a carcinogen, and environmental contamination. It also pushed for reform of the pesticide approval procedure, and for the se ing of EU-wide mandatory reduction targets for pesticide use. However, as noted by Alberto Alemanno on the aws in public participation in EU-decision making in general, the Glyphosate Ban ECI in particular

Some private companies have even followed suit: in June 2019, Deutsche Bahn and Swiss Federal Railways announced that glyphosate (and other commonly used herbicides) for weed eradication along railway tracks will be phased out by 2025, to be replaced with more environmentally sound methods.

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2019. Germany announced in September that it will In support of the civil society concerns referred to, begin phasing out the controversial weedkiller by the European Parliament was very active around the 2023. Other EU countries that have some sort of letime of the 2017 authorisation process: passing a Regislation around glyphosate include: Belgium, solution on 15 November 2017 for an Action Plan Czech Republic, Denmark, France, Italy and the for nature, people and the economy on the role of ciNetherlands. (See here for a vil society in implementation Civil society, the European list.) of EU law and minimum access to judicial review; estaParliament, and even private e above shows a diverse blishing a dedicated PEST companies and Member States trend of pushback against the Commi ee to scrutinise the use and authorisation of regulatory regime for glyphohave pushed back against the glyphosate - from civil society, sate; and producing a report use and authorisation the European Parliament, and opposed to ‘compartmentalieven private companies and sation’ - namely calling for the of glyphosate certain Member States themCommission to conduct a selves - but this has not been translated into the EU’s study that would look at the real-life impact of pestipolitical stance on the authorisation process - apart cides on human health - and not, as discussed earfrom in transparency ma ers, as discussed in the lier, the narrow examination of one use of an active Insight referred to above. substance contained in a pesticide. Opposition from this institutional and democraticallyrepresentative EU actor continues in 2021: certain 4. Legal issues unresolved by litigation Members of the European Parliament have voted before the EU Courts for a ban on glyphosate, also shown by past and ongoing litigation before the EU Courts (see section ere are at least 15 judgments and orders of the 4). Court of Justice of the European Union (CJEU) - delivered either by the Court of Justice or General Emblematic of the seriousness of the issues suCourt, connected in one way or another to the autrrounding glyphosate, action has also been taken by horisation of active substances in plant protection Member States: Austria became the rst EU products/pesticides, over a 20 year period from country to propose a total ban on glyphosate in July 2000 to 2020 (7). is is in stark contrast to the liti7. Queen v Minister for Agriculture, Fisheries and Food (C-306/98) (on how the Directive applies in a transitional period) Eva Glawischnig v Bundesminister für soziale Sicherheit und Generationen (C-316/01) (on access to documents); Ministero della Salute v Coordinamento delle associazioni per la difesa dell’ambiente e dei diri i degli utenti e dei consumatori (Codacons), Federconsumatori (on labelling of infant food) (C-132/03); Monsanto Technology LLC v Cefetra BV, Cefetra Feed Service BV, Cefetra Futures BV, Al ed C. Toepfer International GmbH (C-428/08) (on patent infringement); European Commission v Stichting Greenpeace Nederland and Pesticide Action Network Europe (PAN Europe) (C-673/13 P) (on access to documents): Bayer CropScience and Stichting De Bijenstichting (C-442/14); TestBioTech eV, European Network of Scientists for Social and Environmental Responsibility eV, Sambucus eV v European Commission, supported by UK and Monsanto (T-177/13) (on internal review of an authorisation decision); Mellifera eV, Vereinigung für wesensgemäße Bienenhaltung v European Commission (T-12/17) (on internal review of an authorisation decision); Taminco BVBA v EFSA, supported by Commission (T-621/17 R) (on access to documents v con dential information); Stichting Greenpeace Nederland, PAN Europe v European Commission (supported by various) (T-545/11 RENV) (on access to documents); Anthony C. Tweedale v European Food Safety Authority (T-716/14) (on access to documents and transparency); Blaise and Others (C-616/17) (on the validity of Regulation 1107/2009 and clari cation of it); Heidi Hautala and Others v EFSA (supported by Monsanto and others) (T-329/17) (on access to documents and transparency); Associazione Nazionale GranoSalus – Liberi Cerealicoltori & Consumatori (Associazione GranoSalus) v Commission (C-313/19 P); and Brussels Capital v Commission (C-352/19 P).

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Two cases concerning internal reviews of authorisation of glyphosate show how the General Court maintained a distance from the substantive legal issues. In the rst example, the General Court (though without asserting that this was an incorrect stance) made sure it distinguished between a possible annulment of that internal review decision (for which a new and diﬀerent outcome is not guaranteed) from a challenge to the authorisation itself. It also considered the scope of its judicial review was limited (T-177/13). In the second example, an annulment action was dismissed, the Court holding that Implementing Regulation 2016/1056 (renewing glyphosate authorisation) is of general application and not an administrative act; it does not state to whom it is addressed; approval of an active substance entails legal eﬀects not only for the entity requesting approval but any other operator whose activities require such approval - ultimately constituting a bar for such cases to be covered by its jurisdiction. In that instance, it was pointed out that the fact the EU is a member of the Aarhus Convention did not help: that international convention was simply ruled out as irrelevant in the case because of the declared hierarchy of the EU Courts in the legal order in interpreting EU law (T-12/17).

gation landscape in the US (not ignoring the obvious diﬀerences in the tortious systems and the less strict rules on glyphosate authorisation there), where around 13,000 cases are currently open against Monsanto for glyphosate exposure, and courts have awarded payouts of 80 million, 289 million, and even up to two billion dollars, with many in the process of se lement with Bayer (which took over Monsanto) last summer (8). As well as this quantitatively meek CJEU picture, this small body of case-law re ects an overall failure to tackle the real substantive issues, and generally the strict procedural rules on standing under Plaumann (25/62) exclude environmental NGOs to a large degree (9) (despite the case for greater access to justice considering that “plants cannot go to court” to protect themselves). Only one of that selection of CJEU cases, a recent ruling handed down by the Court of Justice in 2019 Blaise and Others (C-616/17), concerns the PPP Regulation directly, namely its validity. e case is signi cant for its impact on all EU marketing authorisations for pesticides, as it provided essential clarications and interpretation of the PPP Regulation, and is said to reveal that evaluation procedures are not correctly applied by the EU authorities. It looks as if however, it was taken creatively as an opportunity to come to such ndings: Advocate General Bobek has pointed out that the Court’s examination of those issues was actually remote from the speci c substantive issues in the actual case, which concerned criminal proceedings over wilful damage of glyphosate-connected products.

Two more recent appeal cases before the Court of Justice in late 2020 have also been unsuccessful, being found to be inadmissible on procedural grounds. First, in Brussels Capital v Commission (C352/19 P), the Brussels Capital region had banned glyphosate and asked for annulment of the Commission’s Implementing Regulation 2017/2324 renewing its approval. It was held to be inadmissible in December 2020, because the Court of Justice

8. Roundup Lawsuit 2018 Against Monsanto: Can Glyphosate Cause Cancer?’ (Drugwatcher.org, 3 April 2019). More here, accessed 30 April 2019. 9. For a more in-depth assessment of that issue, see M. Pagano, ‘Overcoming Plaumann in EU Environmental Litigation – An Analysis of ENGOs Legal Arguments in Actions for Annulment’, Diri o e Processo, 2019, pp. 311-360.

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agreed with the General Court that the region had a lack of standing to bring the proceedings (see this Op-Ed by Araceli Turmo for an assessment of the decision). Second, in Associazione Nazionale GranoSalus – Liberi Cerealicoltori & Consumatori (Associazione GranoSalus) v Commission (C-313/19 P), an appeal brought by an Italian association of wheat producers and consumers, the Court of Justice threw it out as inadmissible in October 2020 on the procedural ground that the applicant was not individually concerned and did not have standing, again agreeing with the General Court. Revealingly, at least six of the selection of the 15 CJEU cases over the period 2000 to date concern access to documents in the authorisation process (including challenging a refusal by the Commission to provide an assessment report for glyphosate due to the need to protect the con dential information and commercial interests of the companies involved, and a partial refusal of EFSA to provide carcinogenicity studies). is shows that transparency in glyphosate litigation is an issue that the EU Courts are less likely to skip over. Speci cally, a ruling of the General Court in March 2019, Anthony C. Tweedale v European Food Safety Authority (T-716/14) held that EFSA should grant access to safety studies about glyphosate. e Court stated that EFSA cannot use commercial interests as a reason not to disclose information that relates to emissions released into the environment as an EU institution: there is a presumption that such information is an overriding public interest which cannot be outweighed by commercial interests. It held that there should be ‘more eﬀective public participation in the decision-making process’, which would increase ‘the accountability of decision-making and contributing to public awareness and support for the decisions taken’. e above shows the limited judicial review concerning the renewal process for active substances, in particular glyphosate, due to strict procedural rules and limited access to justice in the environmental law domain, an (intentional or unintentional) skirting of the substantive legal issues that characterise the process, and a comparatively small number of cases that land before the EU Courts. is adds up in a manner that is detrimental to the EU’s decision-making process in this eld, meaning ambiguous rules such as the interpretation of the concept of ‘scienti c and technical knowledge’, clari cation of the actors involved and their competences, and general scrutiny of the EU-decision making process, are le unaddressed.

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of a legislative reform or interpretation to clarify the concept of ‘scienti c and technical knowledge’ or the method of scienti c assessment of only one use of an active substance in a PPP; the role and independence of actors in making highly expert decisions; no indication of plans to widen access to justice for environmental NGOs in this respect; and litigation kicked out as inadmissible may be legitimate or may be re ective of judicial avoidance (especially compared to the far greater number of cases ongoing in the US concerning the same active substance). Finally, despite a widespread response from civil society and other actors, ECIs have not been eﬀective (enough) in eﬀecting change, re ecting that public participation is not driving change either.

Conclusion e perceived aws raised above concerning the EU’s decision-making process in the current renewal process for glyphosate (and the renewal process generally) cannot be redressed in time for the upcoming decision: in fact authorisation is occurring under the same procedure as in 2017, because any legislative proposals for reform of the procedure will not be presented until 2022. e bleak view that this Long Read ends on considers that there are no plans for these legal issues to be addressed (with the exception of the shi towards a more transparent process), despite more robust EU environmental policies, strategies, targets and promised commitments. ere is no indication

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News Highlights 30 Aug to 3 Sept 2021

EU’s use of Trade Defence Instruments: Update from the Commission Monday 30 August

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e European Commission published its annual report with an update on the EU’s more assertive Trade Defence Strategy in defending its interests, considering the ‘robust and innovative ways’ devised for using Trade Defence Instruments (TDIs).

Frontex publishes rst Fundamental Rights Oﬃce report Monday 30 August

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Frontex published the rst annual report on the activities carried out by its Fundamental Rights Oﬃce, a body entrusted with the implementation of its Fundamental Rights Strategy and its action plan, as well as with the handling of complaints related to fundamental rights issues.

Credit Assessment and Data Protection Rights: European Data Protection Supervisor’s suggestions to improve proposed Directive Monday 30 August

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e European Data Protection Supervisor (EDPS) recently published Opinion 11/2021 on the impact that the Commission’s legislative proposal for a Consumer Credit Directive will have on data protection and consumer protection rights under EU law.

Ryanair appeals General Court rulings dismissing its challenge against Swedish, Danish and Finnish State aid measures for airlines Monday 30 August

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Member States met their pollutant emission limits in 2019, according to a European Environment Agency brie ng Monday 30 August

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Belgian capacity mechanism to ensure electricity supply approved as compliant with EU State aid rules

Publication of Commission authorisations of certain feed additives for animals

Monday 30 August

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Community Plant Variety Oﬃce recruiting new President

F and CEPOL sign a Working Arrangement

Monday 30 August

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ECtHR clari es freedom of expression and procedural-related safeguards applicable to political programmes broadcasted by domestic State television channels Tuesday 31 August

ECtHR clari es applicability of non bis in idem principle to domestic violence cases Tuesday 31 August

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e European Court of Human Rights ruled in Galović v. Croatia (application no. 45512/11), ruling that domestic violence convictions in several sets of minor-oﬀence proceedings and in criminal proceedings on indictment did not breach the right not to be tried or punished twice (non bis in idem) under Article 4 of Protocol No. 7 to the ECHR.

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e European Court of Human Rights ruled in Associazione Politica Nazionale Lista Marco Pannella v. Italy (application no. 66984/14) and Associazione Politica Nazionale Lista Marco Pannella and Radicali Italiani v. Italy (application no. 20002/13) on the compatibility with the freedom of expression in Article 10 ECHR of certain decisions taken by the Italian State-run television I in respect of the contents of political programmes broadcasted by it.

Preliminary ruling request on categorisation of claims se lements services in EU VAT Directive published Tuesday 31 August

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Publication of preliminary ruling request on the extraordinary circumstances that mean air carriers do not have to pay compensation

Updated list of non-EU territories: Recommendation to li COVID-19 travel restrictions into the EU Tuesday 31 August

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Tuesday 31 August

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Legislation applicable to workers regarding social security schemes: preliminary ruling request published

New measure on the exclusion of incoming ights from the UK from the EU’s emissions trading system

Tuesday 31 August

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European Parliament to take Commission to court over failure to launch the rule of law conditionality procedure against Hungary Wednesday 1 September

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e European Parliament decided to continue with the procedure to take the European Commission to court over its failure to activate the general regime of conditionality for the protection of the Union budget (Regulation 2020/2092) in respect of the recent anti-LGBT legislation in Hungary, a er receiving the Commission’s response to its le er of 23 June.

OLAF cannot refuse access to documents where an investigation has been closed and will no longer be prejudiced by disclosure: General Court’s ruling in Homoki Wednesday 1 September

EU Ministers of Home Aﬀairs issue statement on the situation in Afghanistan Wednesday 1 September

Following an extraordinary Council meeting, the EU Ministers of Home Aﬀairs issued a statement on the potential implications of the situation in Afghanistan in the areas of international protection, migration and security. Ministers reaﬃrmed the EU’s commitment to continue evacuating European citizens and Afghans and provide humanitarian aid.

New system to exchange information on refusals to grant authorisations for rearms: Commission Delegated Regulation Wednesday 1 September

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e General Court in Homoki v Commission ruled in favour of the claim brought to annul OLAF’s decision not to grant partial access to the nal report of its investigation relating to street-lighting projects implemented by the company Elios in Hungary with nancial participation from the EU.

Vacancy position for Senior Research Fellow in the Max Planck Institute for Comparative Public Law and International Law Wednesday 1 September

Guide to implementation of CETA Protocol published Wednesday 1 September

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Certi cation required for animal slaughter at holding of provenance: new rules published Wednesday 1 September

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Court of Justice con rms the entitlement of third-country nationals holding a single permit to receive childbirth and maternity allowances

ECtHR: new resolution on judicial ethics comes into eﬀect ursday 2 September

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e new resolution on judicial ethics of the European Court of Human Rights, adopted by the Plenary of the ECtHR on 21 June 2021, came into eﬀect on 1 September 2021. e resolution articulates the principles that apply to serving members of the ECtHR as well as, where relevant, former and ad hoc judges.

ursday 2 September

EPSU v Commission appeal: No errors of law in General Court ruling and Commission not obliged to submit proposal to Council of EU to implement social partners’ agreement ursday 2 September

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Court of Justice: Citizen’s Directive regime of retention of residence rights for victims of domestic violence is not discriminatory READ MORE ON EU LAW LIVE

e Grand Chamber of the Court of Justice issued its judgment in Belgian State (Right of residence in the event of domestic violence) (C-930/19), a preliminary ruling on the scope of Article 13(2)(c) of the Citizens Directive (2004/38), as well as on its validity in the light of Articles 20 (equality before the law) and 21 (non-discrimination) of the Charter.

Energy Charter Treaty: Court of Justice clari es concept of ‘investment’ and con rms its jurisdiction to issue preliminary rulings raised in respect of nonEU disputes ursday 2 September

e Court of Justice gave its Grand Chamber judgment in INPS (C-350/20) on the scope of the right to social bene ts recognised under Article 34 of the Charter and of the right to equal treatment in the eld of social security granted to third country workers set out in Article 12(1)(e) of Directive 2011/98.

ursday 2 September

e Court of Justice denied the appeal of the European Federation of Public Service Unions in EPSU v Commission (C928/19 P), upholding the General Court’s ruling in T310/18. It found that no errors of law were commi ed on the basis that the Commission has discretion as to whether it submits such proposals.

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AG Bobek: how to apply the ‘non bis in idem’ principle where the same infringement is prosecuted in diﬀerent Member States ursday 2 September

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e Court of Justice ruled in Grand Chamber case Republic of Moldova (C-741/19) on the interpretation of the concept of ‘investment’ under Articles 1(6) and 26(1) of the Energy Charter Treaty, as well as the question of whether the Court has jurisdiction to rule on disputes concerning an international convention and a situation involving a non-EU State and a non-EU established company.

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Advocate General Bobek delivered his Opinion in Nordzucker and Others (C-151/20), a case stemming from a preliminary ruling request made by the Austrian Supreme Court of Justice (Oberster Gerichtshof) concerning the ‘non bis in idem’ principle under the Charter of Fundamental Rights of the European Union.

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Hungarian law precluding annulment of a loan in foreign currency for including an unfair term related to exchange rate is compatible with EU law, says Court of Justice

Council of the EU used incorrect legal basis in Decisions to regulate Partnership Council for EU-Armenia Agreement: Court of Justice annuls the Decisions ursday 2 September

ursday 2 September

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e Grand Chamber of the Court of Justice decided to annul two Decisions of the Council of the EU se ing out the implementation of the Partnership Council for the partnership agreement between the EU and Armenia (CEPA), in an inter-institutional legal dispute between the European Commission and Council of the EU – Commission v Council (C180/20).

Judgments of Court of Justice nd that ‘zero tariﬀ’ options are incompatible with Open Internet Access Regulation ursday 2 September

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ursday 2 September

Commission Implementing Regulation imposing de nitive anti-dumping duty on PSC wires and strands from China ursday 2 September

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Ms Petra Hielkema starts her position as Chairperson of EIOPA ursday 2 September

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ECtHR: politicians can be criminally convicted for failure to prevent hate speech by others on their Facebook accounts – no freedom of expression violation ursday 2 September

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Portuguese rules to calculate registration tax on imported second-hand vehicles infringe free movement of goods: Court of Justice

EFTA-approved State aid announcements in the Oﬃcial Journal today ursday 2 September

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Market Surveillance: Commission Recommendation on authorisation of PPE and medical devices in context of COVID-19 pandemic ursday 2 September

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Changes to data requirements on Member States for heavy-duty vehicles ursday 2 September

Lowering eligibility age for family reuni cation is a valid ‘new restriction’ under EU-Turkey Association Council: Court of Justice

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Friday 3 September

AG Bobek: GDPR allows tax authorities to request personal data from third parties without any time limits if that is provided for under national law Friday 3 September

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Advocate General Bobek in Valsts ieņēmumu dienests (C-175/20) advised the Court of Justice to rule that Article 6(1)(c) and (3) of the GDPR does not preclude national law from laying down an obligation for Internet advertising service providers to communicate certain personal data to a tax authority, as long as there is a clear legal basis in national law to do so.

In Udlændingenævnet (C-379/20), the Court of Justice conrmed that the lowering of the eligibility age for family reunication by national law from 18 to 15 constitutes a ‘new restriction’ under Article 13 of Decision 1/80 of the EU-Turkey Association Council, but that the restriction is valid if it is justi ed by the objective of ensuring the successful integration of the third-country nationals concerned.

EU passenger rights when maritime transport services have been cancelled: Court of Justice’s Irish Ferries ruling Friday 3 September

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Sweden failed to ful l obligations under Urban Wastewater Directive by not providing Commission with information in pre-litigation procedure, Court of Justice rules

According to Court of Justice Commission must investigate whether the sale of the Nürburgring complex constituted State aid Friday 3 September

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In its judgment in the case Irish Ferries Ltd v National Transport Authority (C-570/19), the Court of Justice provided the interpretation of several provisions of Regulation 1177/2010 on the rights of passengers travelling by maritime transport, in particular compensation rights when services are cancelled, and did not consider that the validity of the Regulation has been called into question.

Court of Justice clari es relationship between users and providers and guarantors under Payment Services Directive Friday 3 September

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Friday 3 September

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Commission terminates review of antidumping and countervailing measures on imports of biodiesel from Canada

Alleged unlawful Romanian aid to TAROM: invitation to submit comments oﬃcially published

Friday 3 September

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State Aid approval decisions in the Oﬃcial Journal today

Decomposed, degraded or mixed animal by-products no longer t for human consumption should be reclassied: Court of Justice ruling Friday 3 September

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Friday 3 September

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Appeal against General Court’s ruling that Commission should have initiated formal investigation into UK electricity capacity aid-scheme upheld by Court of Justice, but request to annul Commission’s Decision approving the State aid dismissed Friday 3 September

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Insights, Analyses & Op-Eds Family reuni cation : when the ECtHR navigates within the EU legal order… by Laurence Burgorgue-Larsen

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Op-Ed on the Grand Chamber judgment from the ECtHR, A.M. v Denmark (application no. 6697/18) ‘on a highly sensitive issue’: the regulation of family reuni cation, which delivers a ‘pro persona solution’.

e Role of Asset Management Companies against a possible surge in NonPerforming Loans in the EU by Conce a Brescia Morra and Alberto Pozzolo

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Op-Ed analysing how to anticipate and address the problems caused by a possible surge in non-performing loans in the EU as a crucial step to reduce the likelihood of a future nancial crisis, such as through the creation of publicly funded asset management companies.