I. Introduction
At the heart of the European Commission’s (“EC” or “Commission”) competitiveness narrative surrounding the Omnibus proposalsFootnote 1 lies a semantic sleight of hand: simplification. Yet closer scrutiny of the Omnibus initiatives exposes them for what they are: deregulatory measures which, beneath the inconspicuous rhetoric of simplification, clearly reduce existing levels of protection.Footnote 2
The Food and Feed Safety Simplification Package (“Omnibus X”)Footnote 3 is a case in point. Beyond eliminating overlaps in administrative requirements and reporting standards, it entails a real downscaling of safety standards. Provisional product authorisations based on incomplete risk assessments,Footnote 4 unlimited market approvals,Footnote 5 or doubled grace periodsFootnote 6 – to name just a few – are not mere bureaucratic, technical fixes; they constitute significant downward adjustments of the European Union’s (“EU”) health and environmental commitments.Footnote 7
In international and EU law alike, a principle has been gaining ground that seeks to contain precisely such rollbacks: the non-regression principle.Footnote 8 In this contribution, we argue that the precautionary principle, operationalised through proportionality, provides the normative backbone for a principle of non-regression in EU risk regulationFootnote 9 .Footnote 10 Much like environmental non-regression in international economic law, our notion of non-regression can serve as bulwark against deregulation of EU environmental and health standards in the face of (geo-)economic pressures.Footnote 11 Recent jurisprudence has made it plain that the precautionary principle is more than “just” a guideline for EU executive action; it is the constitutional benchmark to which EU (deregulatory) legislation governing health and environmental risks must be held.Footnote 12
Yet, to date, only few authors have examined the legislative implications of the precautionary principle in the EU,Footnote 13 and they have done so primarily within the narrow scope of Blaise and Others Footnote 14 – a case in which the Court of Justice of the European Union was called upon to perform a static review of pesticides legislation in light of the precautionary principle. However, with one notable exception,Footnote 15 no study of the precautionary principle has ventured into the dynamic context of deregulatory legislative reform yet. This is hardly surprising, given that, until relatively recently, the trajectory of European integration has offered little reason to develop and advance arguments against legislative backsliding in the EU. Yet, with the Omnibus surge and its underlying deregulation agenda, this premise no longer seems to hold: the EU is on course for the most sweeping episode of regulatory retrenchment in its history, spanning policy fields as diverse and strategically important as defense, climate governance, artificial intelligence, chemical regulation and food safety.Footnote 16
It is against the backdrop of this transformational moment for the EU regulatory state that we turn to the precautionary principle to explore its potential as a constitutional backstop against deregulation in EU risk governance. In doing so, we seek not only to contribute to the scant literature on the legislative dimension of the precautionary principle but also to bring an EU primary law perspective to bear on the emerging academic debate surrounding the EU Omnibus reforms.
We pursue this enquiry in three steps. First, drawing on the evolving concept of non-regression in international and EU law, we derive an EU risk governance-specific version of non-regression which is normatively anchored in the precautionary principle and operationalised through proportionality (Section II). Second, applying the principle of non-regression so conceived to an extreme instance of pesticides deregulation contained in Omnibus X, we sound out its capacity to fend off concrete legislative attempts at deregulation (Section III). Third, we conclude by outlining key findings and offering some broader observations that link our notion of non-regression to debates on democratic legitimacy (Section IV).
II. Analytical framework: non-regression in EU risk regulation
1. Tracing the principle of non-regression in international and EU law
Non-regression as a principle of international law has a relatively long-standing and well-established pedigree in global human rights instruments. Anchored in the idea of progressive realisation of human rights, it generally requires states not to backtrack on rights they have once agreed to of their own volition.Footnote 17 Another variant of the non-regression principle at international level is environmental non-regression. Environmental non-regression – understood as a safeguard against environmental deregulation – has made its appearance on the international plane only relatively recently.Footnote 18 Counterintuitively perhaps, it has seen the “widest uptake and progression” in international economic regimes, notably through non-regression clauses in international trade and investment treaties.Footnote 19 Conversely, it remains the least developed in international environmental law.Footnote 20 Attempts at explaining this anomaly have centred around pressures from domestic interest groups: local concerns about negative environmental externalities arising from economic liberalisation have prompted major trading nations, such as the United States, to embed environmental non-regression provisions in international trade and investment instruments.Footnote 21 On this view, environmental non–regression can serve to legitimate international economic integration by outlawing the use of environmental deregulation as a lever for competitiveness and industrial relocation.
In the EU, non-regression is typically associated with Article 2 of the Treaty on European UnionFootnote 22 (“TEU”) and Union legislation on social policies. Article 52(1) of the Charter of Fundamental Rights of the European UnionFootnote 23 (“EU Charter”), too, has been argued to operate as sort of non-regression clause with regard to rights set out therein.Footnote 24 Yet, beyond the topical rule of law debateFootnote 25 and EU labour law,Footnote 26 legal scholarship has been largely indifferent toward non-regression in the EU so far. Indeed, as observed by Avril, until now regulatory overhauls in the EU have been, on the whole, about building procedures and standards that legitimise the EU regulatory state, rather than dismantling them.Footnote 27 In other words, until very recently there seems to have been relatively little added value in construing and advancing arguments against regulatory backsliding in the EU. Yet with the onslaught of the Omnibus proposals, one might expect EU legal scholarship on non-regression to pick up momentum beyond Article 2 TEU and labour law debates. In this article, we seek to make a start by conceptualising and applying non-regression in the domain of EU risk regulation.
However, before delving into the matter, a word on the methodological challenges raised by non-regression analyses is in order. An endemic difficulty in operationalising non-regression lies in establishing a meaningful threshold of regression, that is, the point beyond which regressions become impermissible. Approaches vary depending on the legal framework in question. Broadly speaking, one may discern two conceptions of the threshold of regression: a maximalist one,Footnote 28 under which no regression, however minimal, is tolerable, and a qualified one,Footnote 29 which allows for a certain degree of regression so long as it is duly justified and proportionate. Non-regression clauses in international trade or investment treaties, which do typically not permit any derogation, are examples of a maximalist conception of the threshold of regression.Footnote 30 Conversely, non-regression provisions in human rights instruments, including the EU Charter, which allow for limited and duly justified deviations, are examples of a qualified conception of the threshold of non-regression.Footnote 31
2. Conceptualising non-regression in the context of EU risk regulation
A first issue in delineating a concept of non-regression in EU risk regulation concerns its normative foundations. A prima facie obvious starting point is the EU Charter, and, more concretely, the commitments to high levels of health and environmental protection reflected in Articles 35 and 37 thereof.Footnote 32 The advantage of linking a principle of non-regression in EU risk regulation to EU Charter rights lies in the fact that, pursuant to Article 52(1) thereof, the CJEU typically engages in vigorous scrutiny of rights restrictions.Footnote 33 In other words, invoking a Charter right would presumably entail a relatively low judicial tolerance for regression.Footnote 34 Yet, as clarified by the Court, provisions such as Article 37 of the EU Charter for which corresponding provisions exist in the Treaties do not constitute rights within the meaning of Article 52(1) of the EU Charter, but must be applied in line with “the conditions and within the limits defined by those Treaties.”Footnote 35 Moreover, unlike the European Court of Human Rights, the CJEU has been reluctant so far to engage in the “greening” of human rights by adopting an expansive interpretation of provisions in the Charter that do undoubtedly constitute rights, such as the right to life,Footnote 36 or by establishing a stand-alone right to a healthy environment.Footnote 37 It follows that, as the law stands, it seems rather unlikely that environmental or health protection could successfully be invoked under or as an EU Charter right to trigger an intensive rights review under Article 52(1) thereof.Footnote 38
So what, then, of the corresponding Treaty commitments to high levels of health and environmental protection set out in, inter alia, Article 114(3) of the Treaty on the Function of the European Union (“TFEU”)?Footnote 39 Provisions such as Article 114(3) TFEU have been argued to give rise to a common principle of a high level of health and environmental protection “to which particular importance must be attached given the number of provisions of EU law in which it is enshrined.”Footnote 40 Yet, significant as they may well be, protection pledges such as those contained in Article 114(3) TFEU fall short on one essential count: they lack a risk governance-specific anchor. Risks posed by modern technological innovations, be it in biotechnology, nanotechnology or synthetic chemistry, are inherently uncertain, i.e., they are neither fully controllable nor measurable.Footnote 41 This is why legislation in the domain of EU risk regulation is designed to enable preventive action, ensuring, in theory at least, that uncertain risks can be tackled before harm comes to pass.Footnote 42 In a context of uncertainty, prevention or anticipation is thus risk governance’s distinct pathway toward high levels of protection. It follows that a principle of non-regression in EU risk regulation can only be fully effective, if it reflects the anticipatory or preventive imprint of the risk regulatory environment it ought to safeguard. Indeed, if it were otherwise, risk legislation might undergo regression without ever being recognised as such.
a. The normative component of non-regression in EU risk regulation: the precautionary principle
It is against this backdrop that we turn to the precautionary principle as the normative anchor for a concept of non-regression in EU risk governance. Much has been written about the precautionary principle,Footnote 43 which is undoubtedly a linchpinFootnote 44 – if not the linchpin – of EU risk regulation. It is conventionally understood as a normative source of empowerment for the executive to take preventive measures in the face of uncertain risks. The precautionary principle’s preventive rationale in connection with scientific uncertainty has been first – and most prominently – articulated in the Pfizer.Footnote 45 While initially confined to environmental policy, it has been elevated to a general principle of EU law by the Court in Artedogan Footnote 46 underpinning and informing executive action regarding health, consumer safety and environmental protection across all spheres of EU activity.Footnote 47 As such, it is regularly invoked to interpret or review the legality of executive acts of the EC or Member State (“MS”) competent authorities before the EU judiciary. Yet despite its fundamental importance for the Union legal order, and EU risk governance in particular, the precise meaning of the precautionary principle remains shrouded in ambiguity.Footnote 48 As a consequence, scholars have criticised the vagueness and consequent limited utility for practical application of the precautionary principle.Footnote 49 Others have pointed at the risk for political instrumentalisation that derives from its open-textured nature.Footnote 50
While this critique is certainly not without merit, we consider that it should be nuanced in two important respects: first, as a general principle, the precautionary principle was never meant to be self-defining but acquires concrete meaning only in the specific (regulatory) context in which it is applied and operationalised.Footnote 51 Second, the flexibility or malleability of the precautionary principle also harbours an opportunity – the potential to build legal strategies and arguments around the precautionary principle as normative safeguard against sweeping legislative deregulation attempts. This possible role for the precautionary principle has received little attention in the literature so far.Footnote 52 As alluded to above, this might be due to the fact that systematic legislative backsliding is a novel phenomenon in the history of European integration. It might have also to do with the circumstance that cases where legislative measures are challenged before the Court on the basis of the precautionary principle are very rare.Footnote 53 Indeed, it is only after the CJEU delivered its judgement in Blaise and Others Footnote 54 that a select number of legal scholars have started to engage with the relevance of the precautionary principle as a normative benchmark for the validity of legislation.Footnote 55
Yet, limited as they may be, existing judicial and scholarly accounts of the precautionary principle’s legislative implications do nevertheless offer a few key insights for our purposes: first, the precautionary principle can be invoked as a “sword” against legislation considered insufficiently precautious.Footnote 56 Until relatively recently, authoritative legal commentary had expressed serious doubts about the possibility to resort to the precautionary principle as a stand-alone ground to challenge EU legislation deemed insufficiently protective.Footnote 57 However, the decision in Blaise and Others has effectively dispelled these reservations – at the very least in the domain of EU risk regulation.Footnote 58
Second, in translating the precautionary principle’s preventive rationale from the executive to the legislative realm, the Court has endowed the principle with a distinctive legislative design dimension.Footnote 59 Accordingly, for risk legislation to live up to the precautionary principle’s preventive rationale, it must conform to a to a specific model of regulatory knowledge-making (“regulatory epistemology”) – namely one that is based on sound science. More concretely, the CJEU held that risk legislation needs to provide for a regulatory epistemology based on a hazard and comprehensive risk assessment grounded in the most reliable and up to date science.Footnote 60 Such a regulatory epistemology, in turn, has been deemed a sine qua non for competent authorities to be able to adequately assess and decide on health and environmental risks in substance and product authorisation procedures,Footnote 61 and thus, ultimately, for the Union to live up to the high health and environmental protection standards enshrined in the Treaties.Footnote 62 Insofar as this regulatory epistemology is not only instrumental in assessing, but also in deciding on risks with a view to preventing harm, it properly qualifies as a prevention-oriented, i.e., preventive, regulatory epistemology. It follows from all the above, that, when it comes to EU risk legislation, the Court has interpreted the precautionary principle as requiring such legislation to embody a preventive regulatory epistemology. Concretely, this implies that authorisation procedures established pursuant to risk legislation must be (i) based on science, which is (ii) sound (i.e., reliable and up to date). Legislative acts – and not “just” administrative measures – ought to be judged against these basic legislative design requirements.
Third, as underlined in the previous paragraph, it is evident that EU courts do not view the legislative design dimension of the precautionary principle as an end in itself; it is seen as instrumental in achieving the Union’s high levels of protection, as set out in, e.g., Article 114(3) TFEU. This is not particularly noteworthy on its own, given that the precautionary principle has traditionally always been construed by the EU judicature as a means to an end, namely that of achieving high levels of protection.Footnote 63 What is noteworthy though, in our view, is the distinctive articulation the protection goals tend to receive in contexts where the precautionary principle is at stake, namely that of a teleological hierarchy: as the Court has repeatedly highlighted, the precautionary principle requires that health- and environment-related concerns be given precedence vis-à-vis economic interests.Footnote 64 This teleological hierarchy between health and environmental protection, on the one hand, and economic considerations, on the other, imbues the precautionary principle with a unique teleological dimension. This teleological dimension takes on particular importance when read against the well-established judicial doctrine of legislative discretion. According to that doctrine, judicial review of legislative acts, including in light of the precautionary principle, must necessarily be limited to whether the Union legislator committed a manifest error of assessment. This serves the purpose of safeguarding the legislator’s leeway in “strik[ing] a balance between several objectives and principles.”Footnote 65 Yet, where the precautionary principle is at stake, its teleological dimension implies that the legislator’s broad discretion in balancing competing objectives is curtailed in one significant way: environmental and health protection must be afforded priority relative to economic interests. In consequence, judicial review of legislation in light of the precautionary principle must be necessarily tilted in favour of health and environmental protection. The implications of this teleological dimension of the precautionary principle have gone largely unnoticed in the legal scholarship so far. Perhaps because they are perceived as pertaining to its “sloganistic” or policy dimension,Footnote 66 which, for the reasons expounded above, is a facet of the precautionary principle that has been typically eyed rather critically in the literature.Footnote 67 Yet while teleological dimension certainly speaks to the principle’s policy foundation, it does give the precautionary principle a normative spin that may prove decisive in the face of attempts at large-scale legislative rollbacks of environmental and health protection standards.
If the precautionary principle – both in its legislative design and teleological dimensions – represents the normative anchor of our notion of non-regression, then proportionality can be construed as its procedural vehicle. As we argue in the next sub-section, it is through the mechanics of a proportionality test that the normative clout of the precautionary principle can best be leveraged in the face of legislative backsliding.
b. The procedural component of non-regression in EU risk regulation: proportionality
When it comes to contesting legislation deemed insufficiently protective under the banner of the precautionary principle, an important prima facie caveat remains, however. So far, each of the legal challenges mounted has, without exception, been dismissed on the merits.Footnote 68 While Paulini (2020) has criticised the EU judges for failing to follow through on the concrete application of the preventive design imperative they had themselves derived from the precautionary principle,Footnote 69 Leonelli (2021) has been more sympathetic to the judiciary’s deferential stance, asserting that questions of basic legislative design would best be dealt with in the policy-making process.Footnote 70 Whichever position one may ultimately take in this debate, these cases offer no grounds for concluding that the precautionary principle can, or should, never “bite” when invoked to challenge the legality of legislation. Indeed, there is a strong case to be made that the specific legal frameworks at stake in those lawsuits, do, in fact, live up to the basic legislative design requirements derived from the precautionary principle.Footnote 71 It therefore seems unsurprising, on the whole, that the Court upheld their legality. In addition, answering the question whether a legislative framework conforms to a certain model of regulatory knowledge-making does indeed seem to require venturing into the ambiguous space between legal and policy considerations. To be clear, by pointing this out, we do not intend to make a case against judicial intervention in this matter; what we seek to highlight, instead, is the crucial importance of framing in precaution-based challenges to legislation. Indeed, as Leonelli has convincingly argued, “the Court will find that a legislative act is in breach of the precautionary principle only where it has robust legal elements to draw this conclusion.”Footnote 72 This reinforces our point above on the importance of leveraging (rather than reproducing) the malleability of the precautionary principle though its strategic deployment, using a “language” that the Court can meaningfully engage with – a legal language which frames the precautionary principle in terms of proportionality. Legal theorists have argued that proportionality, as a balancing test, is especially apt for adjudicating constitutional disputes, exacting to a degree that is akin to mathematic precision.Footnote 73 Now, while the proportionality test applied by the Union judicature does certainly not live up to standards of mathematical accuracy,Footnote 74 testing legislation’s compliance with the precautionary principle through the procedural lens of proportionality is nevertheless strategically advantageous for a number of reasons.
First, by providing a legal methodology that enables disparate interests to be weighed and reconciled with one another, proportionality allows EU judges to inject legal rationality into policy conflicts at the heart of both the precautionary principle and the legislation under review. That legal methodology is firmly entrenched in the constitutional traditions of many EU Member StatesFootnote 75 and, indeed, in the CJEU’s case-law itself.Footnote 76 The classic test established by the Union judicature to assess proportionality rests on three limbs: i) appropriateness, ii) necessity, and iii) proportionality stricto sensu.Footnote 77 Moreover, in its more recent case-law, the EU judiciary has supplemented the substantive check (balancing exercise) underlying the proportionality stricto sensu limb with a process check. The process check requires the Court to ascertain whether the legislature has considered “all the relevant factors and circumstances of the situation the act was intended to regulate.”Footnote 78 Turning to these three limbs of the proportionality test to assess whether legislation may entail a disproportionate interference with the precautionary principle implies applying what we refer to as precaution-inflected proportionality test. Drawing on the relevant case-law of the CJEU,Footnote 79 the contours of this test can be sketched out as follows:
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i. Appropriateness: the measure interfering with the interests served by the precautionary principle must be appropriate for attaining a legitimate aim.
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ii. Necessity: the measure must not go beyond what is necessary to achieve its legitimate aim. This implies that:
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a. there must be no other equally appropriate measure for attaining the legitimate aim concerned,
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b. which is less restrictive in its impact on the interests served by the precautionary principle.
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iii. Proportionality stricto sensu:
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a. Process check: the legislature must have taken account of all the relevant factors and circumstances.
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b. Substantive check (balancing exercise): The disadvantages caused by the measure – in relation to the precautionary principle – must not be disproportionate to the objectives pursued by that measure.
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While operationalisation through proportionality is likely to incentivise more meaningful judicial review of legislation in light of the precautionary principle, it also reproduces a potential obstacle in this regard: the legislature’s broad discretion. Settled case-law has it that the standard of review to be applied by EU judges when reviewing legislation in light of the proportionality principle is that of manifest inappropriateness.Footnote 80 Unlike the label seems to imply, manifest inappropriateness is not just about the first limb of proportionality; it is the shorthand the Court uses to signal low-intensity review under the proportionality test as a whole. It follows that, a principle of non-regression, operationalised through proportionality, must be necessarily a qualified one.Footnote 81 In other words, a version of the principle of non-regression with proportionality as its procedural component must be understood as tolerating legislative rollbacks up to a certain threshold or level of regression. Yet low-intensity review must not be mistaken for superficial scrutiny. Indeed, we have found that, where the claimants’ arguments so require, the Court is prepared to go to considerable lengths when reviewing legal acts, including legislation, under each of the three limbs of the proportionality test. In such cases, the Union judges appear both willing and able to engage with even the most obscure or technically intricate features of legislativeFootnote 82 or administrativeFootnote 83 acts.
Second, and relatedly, with its teleological dimension, i.e., the in-built primacy of health and environmental interests, the precautionary principle quite literally harbours a “trump card” in the context of proportionality. Under the balancing logic of a proportionality test, this “trump card” may be leveraged strategically against legislation seeking to lower environmental and health standards. Throwing the precautionary principle into a contest of competing interests via proportionality means that any legislative measure – a fortiori deregulatory legislative measures – will necessarily have to fight the uphill battle of overcoming the primacy of health and environmental concerns underlying the precautionary principle. As emerges from the case law on the proportionality of legal acts in risk governance, the Court does indeed appear quite keen on drawing this “trump card” to tilt the balance in favour of health and environmental protection.Footnote 84 Thus, where the precautionary principle is at stake, the leeway afforded to the legislature to weigh competing interests might be considerably more limited than would otherwise be the case.
It is through these features inherent to proportionality test – its rationalising and balancing logic – that we conceive the strategic operationalisation of the precautionary principle, which makes up the procedural strand of a principle of non-regression in EU risk regulation. Having derived both the procedural (proportionality) and normative (precautionary principle) components of our principle of non-regression, the next section considers how that principle may play out in concrete terms. To this effect, a precaution-inflected proportionality test is applied to what is, arguably, the most far-reaching instance of deregulation foreseen in Omnibus X: the abolition of the regime for mandatory re-approvals of pesticide active substances.
III. A non-regression analysis of pesticides deregulation
Prior to examining the selected case of deregulation in light of the precaution-inflected proportionality test presented above, a brief methodological detour is warranted to outline (i) the concept of deregulation relied on for the purposes of our analysis and (ii) our case selection.
1. Conceptualising deregulation: a misnomer for simplification
Simplification is commonly defined as “the reduction or elimination of complexity.”Footnote 85 Conversely, deregulation can be taken to denote measures that lower pre-existing levels of protection.Footnote 86 In practice, however, the distinction between simplification and deregulation is not always straightforward. Indeed, as noted by Mazzocchi and Spitzer, “materially reducing complexity […] may effectively come down to deregulation.”Footnote 87 In other words, simplification can amount to deregulation when it has the specific effect of lowering levels of protection. This suggests that the terms simplification and deregulation differ not so much in ontology but rather in their level of semantic abstraction. Accordingly, deregulation may be seen as denoting a specific sub-category within the broader, more abstract, category represented by simplification. However, this difference in abstraction is far from trivial: only the semantically more precise notion of deregulation clearly conveys the idea of reducing safety standards. Using the more generic term simplification in its stead risks obscuring the political and normative stakes of deregulation, thus, impeding effective legal and political accountability.
2. An extreme instance of pesticides deregulation in omnibus X: mandatory re-approvals no more
The semantically most accurate choice between the terms simplification and deregulation may not be self-evident where the deregulatory effects of a measure are merely marginal. To avoid – or, at least, mitigate – such conceptual ambiguities, we concentrate on a measure featured in Omnibus X that entails a severe reduction of protection levels relative to the status quo: the abolition of the regime for mandatory re-approvals of pesticide active substances. This choice is also conditioned by our analytical parameters. Given the threshold of regression – the manifest appropriateness standard – pertaining our notion of non-regression, we are rather sceptical that minor or even moderate instances of deregulation would qualify as impermissible regressions within the meaning of our light version of non-regression. As we venture into the uncharted terrain of non-regression in EU risk regulation, an extreme instance of deregulation thus appears to be particularly well suited to the purposes of this enquiry:Footnote 88 if the selected measure does not qualify as impermissible regression under our conception of non-regression, this would support broader deductions about the de facto ineffectiveness of an EU risk regulation-specific notion of non-regression in the face of legislative backsliding. Conversely, if the measure does amount to an objectionable regression under the concept of non-regression herein developed, this could provide a stepping stone for further research into measures with comparable deregulatory impacts.
Finally, our case selection is also motivated by the high salience of EU pesticides governance.Footnote 89 Anchored in the precautionary principle, the Union regulatory regime governing pesticide authorisations is widely regarded as one of the strictest in the world.Footnote 90 And yet it continues to be haunted by controversy. The “glyphosate saga” in particular has shaken the foundations of EU pesticides governance at their core, setting off what has been described as “one of the most acute crises in EU food governance over – at least – the last decade.”Footnote 91 While Regulation (EU) 2019/1381Footnote 92 seeks to pacify (some of) these concerns,Footnote 93 recent judicial disputes surrounding systematic delays of pesticide re-approval proceduresFootnote 94 and safety concerns associated with the re-approval of the pesticide active substance cypermethrinFootnote 95 seem to suggest that debates surrounding pesticides remain as alive as ever. Indeed, pesticides have evolved into a “symbol of polarisation”Footnote 96 mobilising large factions of the European citizenry on both sides of the debate. In keeping with these developments, the “simplification” measures envisaged for pesticides – undoubtedly the cornerstone of Omnibus XFootnote 97 – are likely to kick off a new phase of protracted contestation. The initial reactions already reveal so much.Footnote 98
It is for these reasons that we turn our attention to what arguably constitutes the most sweeping instance of pesticides deregulation in Omnibus X: the abolition of the regime for mandatory re-approvals of pesticide active substances (“substances” or “a.s.”).Footnote 99 In what follows we, first, briefly describe the measure in question, and, second, lay out the reasons underlying our classification of the measure as extreme instance of deregulation (in the sense of entailing a severe reduction of protection levels relative to those guaranteed by current system for mandatory re-approvals laid out in the Pesticides Regulation).
The EC proposal provides that, save for three categories of pesticide a.s., namely a.s:
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i) which are candidates for substitution,Footnote 100
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ii) were subject to emergency approvals,Footnote 101 or
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iii) for which a limited approval period has been set due to relevant uncertainties,Footnote 102
a pesticide substance’s approval duration shall be unlimited.Footnote 103 It is foreseen that most pesticide a.s. would benefit from the abolition of the regime for mandatory re-approvals.Footnote 104 This includes highly controversial pesticide substances, such as glyphosate or acetamiprid, whose safety cannot be taken for grantedFootnote 105 despite being currently authorised on the market.
In the place of a regime for mandatory re-approvals of pesticide substances, the Commission proposes a new system of targeted full re-approvalFootnote 106 or partial re-approval procedures.Footnote 107 The EC, after consulting the competent EU-level scientific expert body – the European Food Safety Authority (“EFSA”) – would be in charge of selecting pesticide a.s. or groups of pesticide a.s. with unlimited approval periods that ought to undergo a full re-approval or partial re-approval “tak[ing] into account, among others, indications of safety concerns, new scientific or technical knowledge and available monitoring data and […] requests from Member States.”Footnote 108 The terms “take into account” and “among others” signal a wide margin of discretion for the Commission to identify relevant substances for full re-approval or partial re-approval. It is only with regard to “new scientific or technical knowledge” that EC discretion would be somewhat qualified: the EC “shall” select pesticide substances for full re-approval or partial re-approval at the latest 3 years:
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after amendments to approval criteria laid out in Annex II to the Pesticides Regulation “relevant” for these pesticide substances, or
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when new data requirements or guidance documents “relevant” for these pesticide substances
become applicable.Footnote 109 Again, the term “relevant” connotes a certain latitude on part of the EC when identifying pesticide substances for full re-approval or partial re-approval, even where new scientific or technical knowledge is at stake.
As the Union judicature has authoritatively held, the regime for mandatory re-approvals serves to “avoid maintaining active substances on the market which could prove to present unacceptable risks.”Footnote 110 The Court thus seems to conceive mandatory re-approvals as a safety net designed to filter out pesticide substances from the market which, according to the latest scientific and technical knowledge, turn out to be unsafe. On that view, abolishing mandatory re-approvals would be tantamount to abolishing the very safety net they stand for. Now, based on the EC proposal, one might contend that the mandatory re–approval regime is not abolished outright but instead recast as a system of targeted re–approvals managed at the discretion of the EC. Yet, whether re-approvals whose initiation depends on policy discretion are a real match for mandatory re-approvals in terms of safety seems questionable, to say the least. The fact that, under the new system, substances such as glyphosate would presumably remain on the market for an unlimited period of timeFootnote 111 is a case in point: since its last safety evaluation, glyphosate has been the subject of a growing body of scientific evidence that raises serious healthFootnote 112 and environmental concerns.Footnote 113 Through mandatory re-approvals regulators would be forced to engage with such concerns and, by extension, to draw appropriate regulatory consequences from them. Under a system that is based on policy-discretion, no corresponding impetus exists: glyphosate, and other similar substances, may potentially remain on the market indefinitely, even as mounting evidence calls their safety into question.
Overall, considering in particular the safety net function fulfilled by the current system of mandatory re-approvals, there can be little doubt that its abolition would tear open a significant gap in the system of protective safeguards constituted by the Pesticides Regulation – one that cannot, in our view, be adequately filled with targeted re-approvals driven by policy considerations. Doing away with mandatory re-approvals would thus be liable to result in a significant reduction of the level of protection currently afforded by the pesticides regulatory framework. In the sub-section that follows we analyse how this extreme instance of deregulation measures up against the notion of non-regression developed in this article. Our assessment proceeds through the three limbs of the precaution-inflected proportionality test introduced in section II.
3. Analysing the abolition of mandatory re-approvals through the lens of precaution-inflected proportionality
a. Appropriateness: the measure interfering with the interests served by the precautionary principle must be appropriate for attaining a legitimate aim
The overall objective underpinning Omnibus X is twofold: (a) “to reduce […] unnecessary regulatory burdens,” while (b) “maintaining high standards […] for the protection of human and animal health, and environmental protection.”Footnote 114 This twofold aim is also translated to the specific measure laying down the abolition of mandatory re-approvals (“measure”). On the one hand, that measure sets out to reduce the regulatory burden on companies and Member States, which has been identified as “the most significant” among those raised by the Pesticides Regulation.Footnote 115 On the other hand, it seeks to “maintain a high level of protection of human and animal health and the environment.”Footnote 116 However, the EC’s rhetoric regarding levels of protection seems to oscillate between this rather stringent formulation in the proposal, and its subtly less exacting iterations in the accompanying Commission Staff Working Document (“SWD”). According to the SWD, the EC proposal merely commits to maintaining “fundamental protection standards”Footnote 117 or “core safety standards.”Footnote 118 Bearing that in mind, and considering, as alluded to above, that even genuine simplification efforts may lead to some incidental, marginal deregulation, we take the view that the measure’s twofold objective should not be read too literally. For the purposes of our precaution-inflected proportionality test, we do therefore not adopt an overly strict verbatim interpretation of the measure’s aims but, instead, read them as being concerned with the reduction of unnecessary burdens, while maintaining fundamental/core protections.
In assessing whether the measure is appropriate to attain this two-fold aim, it is worth recalling that the manifest inappropriateness standard developed by the CJEU bars any overly rigorous appraisal. Our analysis thus focuses on whether there are any factors which may render the measure blatantly unsuitable for achieving its stated objectives. What seems relatively uncontentious in that regard – at least at first sight – is the measure’s suitability to attain the objective of reducing regulatory burdens: by removing the requirement for most pesticide substances to undergo periodic re-approvals, both businesses and EU authorities would, prima facie, be relieved of considerable administrative red tape and expenses. However, upon closer scrutiny, several factors emerge which cast the measure’s suitability to achieve the goal of administrative streamlining in serious doubt.
First of all, if the second aim of the measure – maintaining core protections – is taken seriously, presumably around 50% of the pesticides substances currently approved would still need to undergo a targeted re-approval procedure.Footnote 119 That, in itself, would already seem to fundamentally contradict the EC’s claim that abolishing mandatory re-approvals may yield unlimited approvals for “most active substances.”Footnote 120 It also significantly qualifies, at the very outset, the extent of the burden reductions that the abolition of mandatory re-approvals could plausibly generate vis-à-vis both competent authorities and industry. Second, owing to their non-automatic nature, targeted re-approvals would require at least three additional steps relative to mandatory re-approvals: (i) an EC pre-selection of pesticide substances that ought to undergo a full or partial re-approval, (ii) an EFSA consultation and, ultimately, (iii) an EC decision to subject relevant pesticide substances to a targeted re-approval process.Footnote 121 These three additional steps would certainly require considerable resources, especially in the kick-off phase. Third, and relatedly, compared with the repetitive, calendar-driven character of mandatory re-approvals, the individual, ad hoc nature of targeted re-approvals may come at the expense of routine and economies of scale leading to a commensurate loss of administrative efficiency for each targeted re-approval procedure triggered. Fourth, the abolition of mandatory re-approvals may cause what has been referred to as the “structural judicialisation of scientific disputes.”Footnote 122 The mandatory re-approval procedure affords stakeholders systematic opportunities to challenge underlying scientific determinations internally, i.e., within the administrative procedure.Footnote 123 Abolishing mandatory re-approvals and, thus, any corresponding avenues for internal scientific dispute settlement, may entail the externalisation of scientific disagreements in the form of litigation. This could manifest in two distinct ways: on the one hand, environmental non-governmental organisations might opt for legally challenging the (non-) inclusion of certain pesticide substances in the work programme for targeted re-approvals, or, where a substance was included in that work-programme, the scope of the envisaged assessment (in case the EC opts for of a partial re-approval for a given pesticide substance). On the other hand, Member States may challenge the mutual recognition of pesticide authorisations before the courts where they consider that, despite the potentially harmful nature of the pesticide substance concerned, the Commission has refused to mandate a targeted re-approval procedure. The actual prevalence of this latter scenario will depend on the EC’s receptiveness to MS requests for targeted re-approvals – one of the criteria the Commission ought to consider when selecting pesticide substances for targeted re-approvals. What seems rather likely, however, is that courts would, overall, be confronted with a greater volume of scientific disputes than they are at present.Footnote 124 As a result, much of what is gained in administrative efficiency could be lost again upstream in the adjudicative machinery of the courts – not least because the judiciary might lack the capacity to adjudicate extensive scientific disputes both qualitatively and quantitatively. Fifth, and finally, in the short term the envisaged measure would cause a considerable workload for the dedicated Commission services. It would be the EC’s responsibility, after all, to flesh out the targeted re-approval scheme by laying out, amongst other things, new procedural arrangements for EFSA consultations and MS requests as well as detailed guidelines to interpret the generic selection criteria, such as “new scientific and technical knowledge.” These administrative adjustments may also spill over onto MS authorities and EFSA respectively, who would need to adapt their own procedures to accommodate a higher volume of non-routine tasks. Thus, in the early implementation phase, administrative efficiency gains associated with the abolition of mandatory re-approvals might be offset in full or in part by the work needed to implement the regime for targeted re-approvals.
The prospect of tangible efficiency gains and cost savings hinges, in large part, on the number of unlimited approvals granted under the new system. However, unlimited approvals for “most active substances,” as envisaged by the Commission, would seem fundamentally incompatible with the objective of maintaining core protections. As alluded to above, and if past statistics are any indication,Footnote 125 such a reading would imply that a substantial share of pesticide substances that currently fail re-approval due to health and environmental concerns – or are withdrawn prior or during the re-approval procedure for the same reasons – would continue to stay on the market. Overall, it would thus seem that neither of the two objectives – reducing regulatory burdens and maintaining core protections – can be pursued without seriously compromising the other: administrative streamlining would yield material effects only insofar as most pesticide substances were granted unlimited approval; granting unlimited approval to most pesticide a.s., however, would effectively entail abandoning the EU’s fundamental protections. These internal contradictions are not minor technicalities – they are far-reaching and readily apparent to anyone seriously engaging with the measure’s potential regulatory implications. There can, therefore, be no other conclusion than that the measure is clearly inappropriate for achieving its underlying twofold objective – at least in its current form.
b. Necessity: the measure must not go beyond what is necessary to achieve its legitimate aim
i. There must be no other equally appropriate measure(s) for attaining the legitimate aim concerned
Even if the measure were to pass the first limb (appropriateness) of the precaution-inflected proportionality test, it would still need to be ascertained whether it does not go beyond what is necessary to achieve its legitimate aim. This entails, in the first instance, an appraisal as to whether there are (or not) other measures that might be equally appropriate for attaining the stated objective. Given the inevitable trade-offs between simplification on the one hand, and the Union’s fundamental protections on the other – both of which are placed on an equal footing in the Commission proposal, it would not seem reasonable to construe effectiveness with too one-sided a focus on reducing regulatory burdens. Indeed, both facets (simplification and core protections) of the measure’s aim are formally on an equal footing.Footnote 126 Viewed from this vantage point, there are, in principle, numerous other ways to strike a fair balance that does not undermine the Union’s fundamental protections, while contributing to the objective of reducing unnecessary burdens. Moreover, it should be recalled, as established above, that the teleological hierarchy inherent to the precautionary principle requires that precedence be given to health and environmental concerns vis-à-vis economic interests. Thus, when it comes to uncertain trade-offs in terms of effectiveness, the precautionary principle would seem to dictate an approach that favours a protection-leaning policy mix – not one that assumes a one-sided bias toward burden reductions.
ii. The equally appropriate measure(s) must be less restrictive in its/their impact on the interests served by the precautionary principle
Before any potentially less restrictive measure(s) can be identified, a brief word on the severity of the measure’s interference with the precautionary principle is in order. We develop this point in greater detail below under the second leg (substantive check) of the third limb (proportionality stricto sensu) of the precaution-inflected proportionality test. For present purposes, suffice it to say that we consider the impact of the abolition of mandatory re-approvals on the interests served by the precautionary principle to be severe. The measure would significantly hollow out the central pillar of the Union’s preventive regulatory epistemology – sound science – and, with it, the Union’s high health and environmental protection standards.
While this is not the place for an in-depth policy analysis, several less restrictive options readily present themselves, including harnessing automation and responsible AI-use more effectively,Footnote 127 leveraging cooperation and integration between EU scientific authorities involved in chemical safety assessments along the lines of the “one substance, one assessment” trajectory,Footnote 128 and/or enforcing existing rules in the renewal procedure more rigorously.Footnote 129 Yet another pathway would be to provide stronger regulatory and/or financial incentives for Europe’s chemical industry to pursue long-term competitiveness strategies based on innovation and sustainability, rather than short-term profits and shareholder payouts.Footnote 130 Such an approach might prompt investments in the development of new bio-/low-risk pesticide substances (requiring first authorisations) and voluntary phase-outs of older, often more harmful pesticide substances (requiring re-approvals). That way the number of re-approval applications could be significantly reduced without resorting to the “nuclear” option of abolishing mandatory re-approvals altogether. Finally, also EFSA has put forward an alternative solution (although not expressly framing it as such): according to its estimates, fifty additional staff members, combined with mechanisms to ensure improved quality of application dossiers for re-approval, would “offer[…] a credible way to both clear the current [re-approval] backlog and prevent future delays.” In addition, EFSA confirmed that rejecting incomplete application dossiers as inadmissible “would reduce workload for Member States and EFSA and could thus contribute to the prevention of future backlogs.”Footnote 131
All the above-mentioned alternatives appear capable of meaningfully contributing to administrative streamlining and economic competitiveness, while being considerably less restrictive in their impact on the interests served by the precautionary principle. In fact, some of the proposed alternatives, such as strengthened cooperation between EU scientific authorities or additional staffing for EFSA, would appear to actually strengthen the robustness of the EU’s prevention-oriented regulatory epistemology through improved scientific capacity and agility.
In light of the foregoing – specifically, the availability of multiple alternatives that are equally appropriate yet markedly less restrictive – we consider it highly unlikely that the abolition of mandatory re-approvals could satisfy the second limb (necessity) of the precaution-inflected proportionality test.
c. Proportionality stricto sensu:
i. Process check: the legislature must take account of all the relevant elements and circumstances
As clarified by the EU judiciary, although the omission of an impact assessment cannot per se lead to an infringement of the principle of proportionality, the EU legislature must nevertheless be able to demonstrate that it had sufficient information enabling it to assess the proportionality of an adopted measure.Footnote 132 This implies that the legislature must take account of all the relevant elements and circumstances when weighing up the different interests at stake.Footnote 133 Alleging the “highly technical” nature of the measures proposed under Omnibus X, the Commission discarded the option of a fully-fledged impact assessment in this case, and opted for an analytical document in the form of a Staff Working Document instead.Footnote 134 As said, in principle, there is nothing objectionable to this from a proportionality point of view. However, that it must be apparent that the available information was adequate to take account of all the relevant factors.
The Commission estimated industry cost savings resulting from the abolition of mandatory re-approvals at EUR 49.6 million per year in the SWD.Footnote 135 Strikingly, however, no comparable estimates of costs (or benefits) for society at large have been provided.Footnote 136 This does not seem to be compatible with the CJEU’s line of case-law requiring consideration of all pertinent elements – not a selective, one-sided focus on industry gains. Indeed, a narrow emphasis on industry benefits risks further compounding the already significant mismatch between economic benefits and societal costs of pesticide use in the EU: according to data produced outside of the Commission services, annual societal costs of pesticide use in the EU tend to be more than twice as high as corresponding economic benefits.Footnote 137 This figure illustrates rather forcefully that focusing on industry benefits alone yields, at best, a very partial image of the financial impact of the measure at stake. As such, it seems unlikely that the assessment carried out in the SWD would meet the judge-made requirement that account be taken of all the relevant elements and circumstances.Footnote 138
ii. Substantive check (balancing exercise): the disadvantages caused by the measure – in relation to the precautionary principle – must not be disproportionate to the objectives pursued by that measure
The manifest inappropriateness standard also informs the intensity of review under the second leg of the third limb of the precaution-inflected proportionality test: the substantive check or balancing exercise. Accordingly, disadvantages in relation to the interests served by the precautionary principle are only objectionable insofar as they are evidently disproportionate to the measure’s objectives, i.e., where they clearly outweigh any benefits the measure may bring about.
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1) Advantages
Besides the purported industry gains mentioned above,Footnote 139 the EC attributes four additional advantages to the abolition of the regime for mandatory re-approvals: first, it argues that the measure would “free resources” of competent authorities (in particular Member State authorities) that could be shifted toward procedures for authorisation of new, potentially more sustainable pesticide substances and products.Footnote 140 Second, the EC posits that the resulting cost savings generated for industry can be re-invested into the development of alternatives and new and/or improved products.Footnote 141 Third, when it comes to pesticide-use, it is maintained that it would “increase the availability of innovative and lower-concern” products to farmers and other professional uses.Footnote 142 Fourth, and finally, it is claimed that this would also contribute to reducing in vivo animal testing.Footnote 143
Although no underlying data or methodology is provided, reduced animal testing seems a plausible benefit of the measure, as many of the pesticide substances that would be granted unlimited approval are synthetic pesticides subject to in vivo animal testing obligations. The same goes for industry cost savings which are, moreover, supported by quantitative estimates and a methodology for cost savings, i.e., the Standard Cost Model.Footnote 144 Yet the magnitude of these measures’ positive effects might be overstated.Footnote 145 What is more, the purported industry cost savings would seem to primarily serve a narrow pool of economic operators: corporate giants of the likes of Bayer, BASF, Syngenta or Corteva, which collectively control about 60–70% of the global pesticide and commercial seed market.Footnote 146 As for all the other benefits associated with the abolition of mandatory re-approvals, not only their magnitude but their very reality is open to serious doubt. In essence, these other advantages revolve around the narrative that the abolition of mandatory re-approvals would allow for an increased uptake of new and more sustainable pesticide substances as well as products. This narrative rests on three assumptions as to the effect of the measure, namely that it would (i) redirect freed resources within competent authorities toward new, potentially more sustainable pesticide substances and products, (ii) lead industry to re-invest cost-savings into developing and marketing alternative as well as new or improved substances and products, and (iii) expand the pesticides toolbox available to farmers and other professional users, including innovative and low-concern products. However, these assumptions lack any empirical foundation or reasoned justifications that would allow for an evidence-based debate. Logically, each of them can be challenged.
As for the first assumption, i.e., the assumption that the measure would encourage redirection of public resources to sustainable products, there are at least two reasons to be sceptical. First, if it holds true that, as alleged in the SWD, competent authorities currently experience persistent delays,Footnote 147 the question arises whether the resource savings resulting from the measure would indeed be sufficient to go beyond closing existing bottlenecks (first assumption). Second, even if resource savings would potentially suffice for these purposes, there is no guarantee whatsoever that competent authorities, in particular Member States, would actually redirect freed resources toward sustainable products. Indeed, the EC proposal does not include any mechanism to ensure that freed capacities would be used accordingly. The same is also true of industry cost savings (second assumption): there is no guarantee that businesses will redirect the accrued cost savings toward more sustainable products. In fact, as a recent report shows, the European chemicals industry has spent three-quarters of its net profit generated between 2010 and 2023 on pay-outs to shareholders rather than on investments in long-term strategies for competitiveness based on innovation and sustainability.Footnote 148 If this is any indication of how the projected cost-savings might be put to use, their prospects for inducing a major industry shift towards sustainable products appear rather bleak. Yet, if there is no major impact on the uptake in sustainable products upstream (i.e., on the part manufacturers, facilitated by public authorities), this will also have corresponding knock-on effects downstream for end-users, such as European farmers. Thus, the third assumption likewise rests on rather shaky foundations: it hinges on anticipated upstream dynamics which might never come to pass.
Overall, our above analysis provides ample support for the view that the purported benefits of abolishing mandatory re-approvals are largely speculative and, to the extent they are real, likely to be overstated as well as heavily concentrated in their scope.Footnote 149
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2) Disadvantages: Serious Interference with the Precautionary Principle
Conversely, the interference with the precautionary principle it implies is very real and potentially devasting in its implications. To recall, the legislative design dimension of the precautionary principles requires that risk legislation provides for a preventive regulatory epistemology based on sound science. In other words, authorisation procedures established pursuant to risk legislation must be (i) based on science, which is (ii) sound (i.e., reliable and up to date). Such a prevention-oriented regulatory epistemology, in turn, is instrumental in securing the Union’s high levels of health and environmental protection.
Abolishing a regime of mandatory re-approvals for a largely discretionary, Commission-managed, targeted re-approval system would amount to a significant interference with the legislative design dimension of the precautionary principle for two principal reasons. First, because re-approvals would not be strictly science-based anymore, but – in the first instance at least – at the mercy of the Commission’s discretionary considerations. Science would be only allowed to play a role, if and to the extent, the EC has deemed new scientific or technical knowledge worthy of being “take[n] into account” and considered such scientific or technical knowledge “relevant” for the substance(s) at stake. Now, it is true that the proposal envisages that the Commission makes these determinations “after consulting the [European Food Safety] Authority.” Yet even so, there is no requirement whatsoever for the EC to follow through on the EFSA scientific recommendations. This represents a fundamental departure from the current approach. Indeed, at present, the re-approval procedure is initiated automatically (provided the industry applicant submits its application dossier by the applicable deadline), and its first underlying stage consists in a science-based risk assessment. Doing away with this system, in the manner envisaged by the EC proposal, would imply that policy gatekeepers (i.e., the EC) would take the place of scientific gatekeepers (EFSA in particular) for re-approval procedures.Footnote 150
Second, and relatedly, the fact that the launch of renewal/reassessment procedures would depend on the Commission’s discretion is not only weakening the science-based nature of this type of procedure but also prevailing standards of sound science, i.e., both its (i) reliability and (ii) up-to-date character. As for the standard of reliability, it is worth highlighting that separation between science and politics is – and has been since longFootnote 151 – an essential prerequisite for ensuring the objectivity and reliability of scientific assessments underpinning pesticides regulation.Footnote 152 Yet, rendering the commencement of re-approval procedures contingent on the will of EC would be tantamount to a considerable weakening of the science–politics divide: when it comes to targeted re-approvals, policy gatekeeping would not only imply conditioning the timing of re-approval procedures, but also the very scope of the underlying scientific assessments.Footnote 153 The Commission would be able to identify the relevant data requirements, guidance documents and scientific opinions that ought to guide the scientific assessment.
As for the up-to-date character of science, it must be underlined from the outset that the current regime of mandatory re-approvals ensures that no pesticide substance can remain on the market without undergoing reassessment in light of up–to–date scientific and technical knowledge. Consider the past 15 years: for many pesticide substances currently on the market, the last full scientific evaluation dates back to 2016 or earlier. Since then, EU regulatory science has undergone several major developments, for example, the adoption of scientific criteria for endocrine disrupting properties in 2018, the publication of the revised bee guidance in 2023, and continuous updates to risk assessment methodologies for aquatic organisms. Mandatory re-approval procedures ensure that pesticide substances that ought to remain on the market are evaluated against these evolving scientific benchmarks.Footnote 154 That does not mean that the mandatory re-approval regime is the most dynamic catalyst for engagement with up-to-date science – far from it. Consideration of new scientific insights is conditioned by statutory timelines (e.g., approval expiry dates and process deadlines) and often delayed by the painstaking process of translating academic scientific insights into EU regulatory science guidelines and criteria. Yet, despite these constraints, and differently than the regime for targeted re-approvals, the system for mandatory re-approvals guarantees that no pesticide substance can remain on the market without being periodically assessed against the evolving body of scientific and technical knowledge. Conversely, a system such as the envisaged targeted re-approval scheme would lack a corresponding legal guarantee for up-to-date science. Instead, the uptake of scientific developments would be driven by policy considerations. Thus, pesticide substances could, in principle, remain on the market without consideration of the latest science for decades or beyond. Indeed, if and when the latest science would be taken up for such substances would be left to the political whim of the Commission.
In light of the foregoing, it seems to us that the abolition of mandatory re–approvals as currently foreseen would leave little of the precautionary principle’s legislative design dimension intact. The core tenet of the Union’s preventive regulatory epistemology – its sound basis – would be undermined in three principal ways:
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i) by substituting policy-gatekeeping for scientific gatekeeping, re-approval procedures would be deprived of their scientific basis,
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ii) by exposing the underlying scientific assessment processes to political interference, the reliability of science would be compromised, and, ultimately,
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iii) by rendering the uptake of the latest science for marketed substances dependent on policy discretion rather than the requirement for mandatory periodic engagement with up-to-date science, re-approval procedures would be likely less responsive to up-to-date scientific and technological developments.
The magnitude of the impact of this interference with the precautionary principle on the Union’s health and environmental commitments cannot be overstated. Up to now, mandatory re-approvals have resulted in the market removal of roughly half of all pesticide substances since 2011 due to their unacceptable health and/or environmental effects.Footnote 155 By that measure, the new regime of unlimited approvals for “most active substances” does inevitably raise the spectre of systemic pesticide risks – and, with it, the risk of exorbitant health and environmental costs. This presumption is not only borne out by the substance-removal record since 2011, but also by cost imbalances underlying pesticide use as such: as mentioned previously, annual societal costs of pesticide use in the EU are already more than twice as high as corresponding economic benefits. Overall, therefore the effects of abolishing mandatory re-approvals on the EU’s health and environmental protection levels are likely drastic in magnitude and diffuse in scope.
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3) Weighing the Benefits of the Abolition of Mandatory Re-Approvals against its Disadvantages
Set against the largely speculative, likely overstated and highly concentrated benefits of the abolition of mandatory re-approvals, we take the view that the measure’s inevitable downside – the severe interference with the legislative design dimensions of the precautionary principle – weighs significantly more heavily. As established above, it would imply a significant erosion of the Union’s preventive regulatory epistemology based on sound science with drastic and diffuse consequences for the Union’s high protection levels. If any doubts remain as to whether that suffices for the purposes of the manifest inappropriateness standard, they might be dispelled by the teleological dimension of the precautionary principle, i.e., its in-built primacy of health and environmental concerns over economic interests. As per the discussion in section II, the teleological facet of the precautionary principle operates as interpretative “trump card”: insofar as the precautionary principle serves health and environmental interests, any interference with that principle must be given special weight relative to the economic advantages such interference may bring about. Thus, given the severe encroachment upon the precautionary principle’s legislative design dimension – and bearing in mind that the principle’s teleological dimension amplifies the weight of this encroachment – there can be little doubt that the disadvantage associated with the measure in question would clearly outweigh any of its potential or actual benefits.
Overall, our analysis therefore shows that the abolition of the regime for mandatory re-approvals satisfies the “manifest inappropriateness” standard under all three limbs of the precaution-inflected proportionality test. The measure is:
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i) evidently unsuitable to simultaneously pursue the two-fold objective of burden reductions and maintaining high levels of protection,
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ii) not necessary to achieve that objective, given existence of multiple alternative policy options that are equally appropriate yet markedly less restrictive, and
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iii) plainly disproportionate in the narrow sense of the word because
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a. the legislature failed to account for all the relevant elements and circumstances necessary to assess proportionality, in particular social costs, and,
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b. the largely speculative, likely overstated and highly concentrated benefits of the measure are clearly outweighed by the inevitable disadvantage it would bring about: a severe interference with the precautionary principle’s legislative design dimension, amplified in weight by the teleological dimension of the principle (which requires that precedence be given to health and environmental protection over economic concerns).
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By the standards of the precaution-inflected proportionality test, which embodies the notion of non-regression for EU risk regulation developed in this article, the abolition of mandatory re-approvals must therefore be deemed to constitute a severe regression. It exceeds the permissible threshold of regression represented by the manifest inappropriateness standard on every count.
IV. Conclusion
The current simplification wave has no precedent in the history of European integration. What is unique is not only the scale, but also the depth of its potential effects on the EU regulatory state. While the official narrative of simplification might sooth the conscience of the relevant Commission services, influential EU parliamentarians,Footnote 156 alongside broad alliances of civil society and academia,Footnote 157 have started to call reality by its name: that name is deregulation – plain to see and hard to deny for anyone willing to venture into the fine print of the underlying legislative proposals. Omnibus X is a telling example: it promises bureaucratic, technical fixes but delivers changes that cut deep into the substance of existing protections.
Scholarship is only beginning to fathom the implications of this deregulatory turn. With this article, we have joined these burgeoning efforts by exploring deregulation from an EU primary law perspective. Drawing on the concept of non-regression articulated in other fields of international and EU law, we have made two main contributions: first, we developed a novel version of the principle of non-regression that is attuned to the regulatory specificities of EU risk regulation, and, second, we illustrated its constraining potential in the face of legislative backsliding by applying it to what is, arguably, the most far-reaching instance of deregulation foreseen in Omnibus X: the abolition of the regime for mandatory re-approvals of pesticide substances.
To delineate EU risk governance’s own distinct version of non-regression, we turned to the precautionary principle as normative anchor and proportionality as procedural vehicle for its operationalisation (through a precaution-inflected proportionality test). The normative components of our notion of non-regression rest in the precautionary principle’s legislative design and teleological dimensions respectively. Whereas the former implies basic legislative design requirements – authorisation procedures established pursuant to risk legislation must be based on science, which is sound (i.e., reliable and up to date) – the latter relates to the precautionary principle’s in-built primacy of health and environmental concerns vis-à-vis economic interests. These normative components can be harnessed through the procedural component of our notion of non-regression, namely proportionality. Proportionality’s balancing logic, in particular, allows for the teleological dimension of the precautionary principle to be mobilised as an interpretative “trump card,” amplifying the weight of the precautionary principle when balanced against economic interests.
To analyse how the selected case of pesticides deregulation measures up against our notion of non-regression, we proceeded through the three limbs of the precaution-inflected proportionality test. The outcome yields a disquieting picture of failure across the board, from suitability and necessity to proportionality stricto sensu. What stands out the most is the troubling imbalance between the deregulatory measure’s tenuous benefits and its substantial interference with the precautionary principle: in its current form, it would entail significant erosion of the Union’s preventive regulatory epistemology based on sound science, along with potentially drastic and diffuse consequences for the Union’s high protection levels.
While our findings suggest that there might indeed be considerable merit in resorting to the kind of non-regression framework developed in this article, it is certainly no miracle cure – far from it. Non-regression in EU risk governance will likely only ever succeed in preventing deregulatory legislative measures in the most extreme of cases, namely where the measure in question exceeds the permissible threshold of regression represented by the manifest inappropriateness standard. Other measures, possibly even most of them, may inevitably slip through the cracks of legislative discretion. It will fall on future research – and the CJEU – to grapple with, and further delineate, the boundaries of legislative discretion in the face of systematic deregulation.
While low intensity judicial review of legislation might be criticised from a health and environmental protection perspective, from the point of view of input legitimacy there seems nothing fundamentally wrong with it. The EU legislature, after all, has been delegated the authority to exercise legislative discretion on behalf of its constituents. The manifest inappropriateness standard suggests that this may include the freedom to deregulate up to a certain point. And if the electorate disapproves, it can express its dissent in the political process.
That said, it cannot be brushed aside that the EU – unlike other democratic polities – derives comparatively less of its legitimacy from direct electoral input. It has traditionally been, and arguably still is, largely dependent on the quality of its output as a surrogate for weak input legitimacy.Footnote 158 The quality of legislation can, of course, be judged from different perspectives – the debate on simplification versus deregulation illustrates this rather vividly. However, as highlighted in this contribution, with the precautionary principle the EU has set itself a constitutional floor. That floor rests on a preventive regulatory epistemology grounded in sound science and geared towards high levels of health and environmental protection. Legislative backsliding that undercuts this constitutional floor would risk eroding some of the most accomplished achievements pertaining to the non-market dimension of the internal marketFootnote 159 – and, with them, key pillars of the Union’s already tenuous democratic legitimacy.Footnote 160 This, ultimately, is the deeper case against unfettered deregulation.
Competing interests
The authors declare none.
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