1. Constitutional shift in executive rulemaking

Before Lisbon, the Commission’s executive powers were embedded in Article 202, third indent and Article 211, fourth indent of the EC Treaty. Under the former, the Council was obliged to “confer on the Commission, in the acts which the Council adopt[ed], powers for the implementation of the rules which the Council lays down.” In specific cases, it could reserve the right “to exercise directly implementing powers itself.” Article 202 EC also stipulated that the Council could impose certain requirements in respect of the exercise of these powers and provided that the relevant procedures must be consonant with principles and rules to be laid down in advance by the Council, viz. the comitology procedures. This meant that implementation of EU legislation at EU level was entirely carried out through comitology.Footnote ¹⁶ In its White paper on European Governance the Commission, however, called for a revitalisation of the Community method, in particular to lay on the Commission the responsibility to initiate and execute policy and legislation. The Commission saw itself as the only holder of executive powers and emphasised the need to review executive rulemaking. It thus called for a simple mechanism that recognised its responsibility to adopt executive measures under the direct control of Parliament and Council, and for a rethinking of comitology decision-making.Footnote ¹⁷ At the same time, the Parliament, harnessed with co-decision powers, demanded more control over the exercise of the Commission’s executive powers and to be placed on equal footing as the Council in comitology. Lisbon took on these views by introducing in Article 290 TFEU the Commission’s power, put under direct control of both branches of the legislature, to adopt non-legislative acts without comitology, thus recalibrating the institutional balance. This has led authors to describe the ParliamentFootnote ¹⁸ and the CommissionFootnote ¹⁹ coming out as the “winners” from the Lisbon reforms.

2. Limits of executive powers of the Member States and the Commission

A more disputed issue concerns Lisbon’s explicit mention of Member States in Article 291 TFEU. Article 291(1) TFEU states that “Member States shall adopt all measures of national law necessary to implement legally binding Union acts.” This has led some authors to conclude that Article 291(1) TFEU lays down “the basic rule in the EU’s executive federalism”Footnote ²⁰ and that Lisbon consolidated the European legal order’s “own species of executive federalism.”Footnote ²¹ Does Article 291(1) TFEU enshrine a prerogative or a duty for the Member States?Footnote ²² ChamonFootnote ²³ and JacquéFootnote ²⁴ favour the first view. Bradley defends the latter position and convincingly argues that Article 291(1) TFEU affirms Member States’ obligation to implement legally binding Union acts and is a clear manifestation of the more general duty of sincere cooperation laid down in Article 4(3) TEU.Footnote ²⁵ He rightly underlines that the implementation of Union acts by Member States under Article 291(1) TFEU is quite different in character from the implementation by the Commission (or Council) under Article 291(2) and (3) TFEU. Under paragraph (1), Member States are obliged to give effect to EU legal acts in their own national legal and administrative orders. This may be referred to as “national implementation.” Paragraphs (2) and (3) concern instead activities that take place at EU level and may be referred to as “Union implementation.”

Problematic in this respect is, nevertheless, the “palace revolution”Footnote ²⁶ that took place in the wording of Article 291(3) TFEU. The latter assigns the responsibility to control the Commission in the exercise of its implementing powers to the Member States alone, to the exclusion of the Parliament and the Council. Bradley talks in this respect about a “coup de force”Footnote ²⁷ by the Treaty drafters since this infringes the rationale underlying the constitutional and institutional structures of the EU. Following the latter, implementing acts adopted by the Commission should indeed fall under the political supervision of EU institutions. Yet, by conflating two distinct concepts of implementation in Article 291 TFEU, this supervision now falls only to the Member States. What is positive about the explicit mention of Member States in Article 291(3) TFEU is that it is a constitutional recognition of the idea of “executive subsidiarity,” embraced long ago by the Court of Justice of the European Union (hereinafter referred to as “Court”)Footnote ²⁸ and the Commission,Footnote ²⁹ and gives expression to a Member State-oriented understanding of the principle of institutional balance by including its vertical dimension.Footnote ³⁰ It, however, gives the false impression that the EU derives its executive competence only from Article 291(2) TFEU. For it is clear that the EU has two general competences under Articles 114 and 352 TFEU, that include also executive powers.Footnote ³¹ We therefore view that the executive powers of the Commission to implement EU legislative acts are conferred upon the Commission by the EU legislature and should fall under the political supervision of EU institutions, also in view of Article 10 TEU. To some extent this is also recognised by the Comitology Regulation, that gives a right of scrutiny in relation to the Commission’s exercise of implementing powers to both the Parliament and the Council.Footnote ³²

Taking account of the vertical dimension of the institutional balance, it is only logical that comitology evolved as a mechanism of control and participation, allowing Member States to actively take part in decision-making where the Commission was entrusted with the implementation of EU law.Footnote ³³ This kind of deliberative decision-making between the Commission and national representatives in comitology, conceptualised by some as a forum of “deliberative supranationalism,”Footnote ³⁴ has worked and still works effectively in most comitology-based decisions, in the sense that measures are adopted without heated controversies during the decision-making procedures.Footnote ³⁵

3. Constitutional neglect: Executive powers of EU agencies

Another concern raised by Lisbon relates to the neglect of EU agencies as holders of executive power in the EU. Whilst Lisbon made EU agencies prominently visible in various Treaty provisions, relating for example to judicial review,Footnote ³⁶ transparencyFootnote ³⁷ and complaints on instances of maladministration submitted to the Ombudsman,Footnote ³⁸ any sign of agencies is lacking in the Treaty Article where they probably would fit best: Article 291 TFEU. Where the drafters of the Working Group IX on Simplification to the Convention were determined “to make comprehensible”Footnote ³⁹ the EU’s system of instruments and procedures, the disregard of agencies in Article 291 TFEU is quite incomprehensible as they since long, in accordance with the Meroni doctrine,Footnote ⁴⁰ have been allowed to adopt individual executive measures. This constitutional neglect should most likely be explained in terms of the Commission’s own unitary view on the EU executive.Footnote ⁴¹ The view was explicitly stated in the Commission’s White Paper on European Governance, where the Commission presented itself “as the lone hero of European policy-making and implementation.”Footnote ⁴² This was in a time where the Commission had just rejected the proposal by some Member States to insert in the Treaties a separate legal basis for the creation of agencies,Footnote ⁴³ as it feared this would risk creating conflicting centres of power.Footnote ⁴⁴ The Court in ESMA or Short Selling was, nevertheless, ready to save the system by declaring that the conferral of certain decision-making powers on ESMA in “an area which requires the deployment of specific technical and professional expertise”Footnote ⁴⁵ does not “correspond to any of the situations defined in Articles 290 TFEU and 291 TFEU”.Footnote ⁴⁶ Yet, this reasoning does not hold true where we look at the legislative practice that confers binding executive decision-making powers on agencies to adopt, for example, a binding decision of the European Union Intellectual Property Office (EUIPO) on the approval or rejection of a European trademark which is comparable to a Commission decision on the EU-wide approval or refusal of medicinal products. However, while the latter act is a Commission implementing decision under Article 291 TFEU, the act by the agency would not fall under this category. This highlights the uncomfortable position of agencies as actors operating in the shadow of hierarchy which can adopt binding executive acts, and calls for Treaty change.

1. Demarcation between delegated and implementing acts: Analytical and constitutional concerns

To this ambiguity in distinguishing between essential and non-essential elements, the Lisbon Treaty added yet another unclarity by abandoning the general umbrella definition of implementation in favour of the bifurcation between delegated and implementing acts. Although welcomed by some authors as “theoretically sound,”Footnote ⁵¹ such a distinction is in fact confusing.Footnote ⁵² Whilst Advocate General Jääskinen had acknowledged in his opinion to the Short Selling case that the borderline between amending or supplementing and implementing a legislative act is not always easy to draw, he still insisted in that same opinion that the Lisbon Treaty had introduced “a sharp conceptual distinction”Footnote ⁵³ between the two types of acts. In the same vein, the Commission held that it had been the clear intention of the drafters of the Treaty to design Articles 290 and 291 TFEU as “mutually exclusive.”Footnote ⁵⁴ Yet, these allegedly sharp conceptual distinction and mutual exclusivity had to confront the reality of the overlap between Articles 290 and 291 TFEU,Footnote ⁵⁵ as both types of acts permeate the normative content of the legislative act with greater specificity.Footnote ⁵⁶

The Court settled the question of demarcation in the Biocides case.Footnote ⁵⁷ However, rather than providing clear guidance on the dichotomy between the two types of acts, the judges “preferred to resort to elusive formulas so as to demarcate each of them”,Footnote ⁵⁸ placing in the hands of the EU legislature the responsibility for the choice between delegated and implementing acts.Footnote ⁵⁹ It is therefore today clear that the EU legislature has broad discretion in its decision to confer a delegated or implementing power on the Commission. This results in a grey zone instead of a neat distinction and confirms the overlap between the two types of acts.Footnote ⁶⁰

Not only is the analytical divide between delegated and implementing acts rendered “fragile and difficult”Footnote ⁶¹ by the convoluted juxtaposition of “amending and supplementing” and “implementing,”Footnote ⁶² but its constitutional logic has been even further weakened by the reintroduction of a sort of light version of comitology also for the adoption of delegated acts.Footnote ⁶³ With the 2016 Interinstitutional Agreement on Better Law-Making, the Commission formally agreed to consult experts designated by each Member State in the preparation of draft delegated acts.Footnote ⁶⁴ This has so restored the ex ante control on delegated acts through the backdoor and herewith has informally modified the constitutional architecture of the Treaty,Footnote ⁶⁵ leading the Commission back to the future with the ex ante consultation of comitology committees fulfilling the role of Member States’ experts. Such an arrangement therefore openly contradicts the idea of a material and/or functional separation between Articles 290 and 291 TFEU.Footnote ⁶⁶

Finally, to supplement the Interinstitutional Agreement on Better Law-Making, the Parliament, the Council and the Commission adopted non-binding criteria concerning the application of Articles 290 and 291 TFEU.Footnote ⁶⁷ These non-binding criteria reflect the Court’s (limited) case-law and largely confirm the legislature’s broad discretion. They also attempt at defining some, albeit broad and non-exhaustive, guidelines on the type of instrument to choose for the adoption of acts relating to procedures, methods, methodologies, obligations to provide information and authorisations.Footnote ⁶⁸

2. Blurring dividing lines between delegated and implementing acts in practice

Precisely due to the inherently problematic division between the two types of acts, it is often difficult to establish in how far measures have been correctly adopted as delegated or implementing acts. It is, nevertheless, possible to identify at least three problematic practices.

The first emblematic example of the absence of a principled approach in the choice between delegated and implementing acts is offered by the strikingly diverse use of measures for the adoption of lists of authorised products or substances. In the food sector, for instance, we can distinguish between, on the one hand, the common framework for authorisation of food additives, food enzymes and food flavouringsFootnote ⁶⁹ and, on the other hand, other sectoral food legislation, such as the Novel Food RegulationFootnote ⁷⁰ and the Regulation on smoke flavourings.Footnote ⁷¹ Even within the common framework, some inconsistencies exist. So the Union list of food additives was inserted in the annex of the original basic act.Footnote ⁷² The Union list of enzymes has not yet been established,Footnote ⁷³ whilst the Union list of flavourings was included as an annex to Regulation 1334/2008 by an implementing regulation of the Commission.Footnote ⁷⁴ The latter practice seems at odds with the subsequent case-law of the Court in EURES Footnote ⁷⁵ and Visa Reciprocity,Footnote ⁷⁶ where the judges clarified that legislative acts can be amended or supplemented only by delegated acts and not by implementing acts.Footnote ⁷⁷

All three lists for additives, enzymes and flavourings can be amended by means of an executive act adopted under the regulatory procedure with scrutiny (PRAC).Footnote ⁷⁸ As we know the latter procedure will in all likelihood be replaced by a delegated act.Footnote ⁷⁹ In contrast, the Union lists of novel foods and smoke flavourings are established separately from the relevant legislative act and adopted by a Commission implementing regulationFootnote ⁸⁰ and can be amended by means of implementing acts.Footnote ⁸¹ Where it has been suggested in the literature that acts of general scope should be adopted as delegated acts rather than implementing acts,Footnote ⁸² one could try to understand the different approaches underlying the Union lists in relation to the different nature of the authorisations granted therein. Yet, this would not explain why the EU lists on both novel foods and smoke flavourings are adopted as implementing acts. The list of authorised smoke flavourings is for example updated through implementing acts, which, unlike delegated acts, can also be of individual nature. Smoke flavourings are indeed always authorised in connection with a specific authorisation holder. However, authorisations of novel foods are acts of general scope, whereby only upon specific and duly motivated request of the applicant proprietary rights relating to novel foods may be recognised for five years. It is therefore difficult to see why authorisations and subsequent amendments of the EU list of novel foods are both adopted through implementing acts.

An attempt to clarify the rationale behind the choice between delegated and implementing acts comes from the above-mentioned non-binding criteria. Accordingly, acts relating to authorisations should be adopted by means of implementing acts when they concern authorisations of individual application or authorisation of general application “for which the Commission decision is based on criteria defined in the basic act in a sufficiently precise manner.” Conversely, delegated acts should be chosen when the authorisation supplements, within the limits of the delegation, the basic act, in that it does not merely apply the criteria laid down in the basic act but also builds on its content.Footnote ⁸³ Arguably, however, this clarification may only serve, if ever, pro futuro, as it is difficult to maintain that, for instance, the authorisations of food additives supplement the basic act whereas the general authorisations of novel foods merely implement it.Footnote ⁸⁴

While in 2014 the Parliament called for Union lists to be established, if appropriate, in the annexes of legislative acts,Footnote ⁸⁵ the Parliament has in fact been willing, as Xhaferri puts it, “to compromise its position in confidential trialogues, resulting in both the Commission and Parliament including the Union lists in the enacting terms of a legislative act or adopting it using an implementing act”.Footnote ⁸⁶ As exemplified by the case of Union lists of authorised products and substances, this has resulted in an inconsistent practice “flawed in terms of transparency, legal clarity, and political accountability.”Footnote ⁸⁷

The second example of the lack of a principled approach by EU institutions in the choice between delegated and implementing acts is offered by Craig.Footnote ⁸⁸ While only delegated acts, but not implementing acts, can supplement legislative acts, that author shows at least one example of an implementing regulation which supplemented a legislative act in the field of aviation safety.Footnote ⁸⁹ This appears to contradict the wording of the TFEU and the abovementioned case-law.

The third example of a complexity arising from institutional practice lies within the Commission’s rather surprising preference for implementing acts over delegated acts “for reasons of efficiency.”Footnote ⁹⁰ This is highly remarkable as the Commission has claimed since its White paper on European Governance that a direct mechanism of control over the Commission’s acts, as we now find in relation to delegated acts, instead of comitology, would “make decision-making simpler, faster and easier to understand.”Footnote ⁹¹ This practice confirms that, in most fields, the collaboration between the Commission and the committees within the comitology framework has proved overall efficient. At the same time, as we argued above, the Council has imposed on the Commission the obligation to consult national experts in the procedure for the adoption of delegated acts, which in practice are the comitology committees.Footnote ⁹² Hence, the rationale behind the constitutional design of Article 290 TFEU has been practically neglected by the evolving institutional dynamics.

In conclusion, the inconsistent practice exemplified above allows us to draw some general observations. First, delegated and implementing acts can serve the same purpose. In the case of Union lists, the same result can arguably be achieved by including the list either in the annex of a legislative act and then amend it through delegated acts or in an implementing act and then amend it through further implementing acts. This functional overlap blurs the dividing line between the two types of act, and in light of the different forms of democratic control attached to them, it problematises the legislature’s arbitrariness recognised in Biocides. It is simply impossible to ignore the stark contrast between splitting an umbrella definition such as “implementation” into two supposedly different constitutional categories and recognising, afterwards, the overlapping nature of such categories, coupled with the absence of intelligible criteria to support the choice for one rather than the other. Second, the lack of a principled approach may result in institutional practices of dubious legality. The somewhat artificial boundaries between Articles 290 and 291 TFEU have, at times, arguably contributed to the improper use of implementing acts for the purpose of amending or supplementing legislation. Finally, the diffuse use of the PRAC shows that Member States in the Council have been reluctant to complete the transition from the PRAC, where they hold a more prominent role,Footnote ⁹³ to delegated acts. In this way, the PRAC, a regime that was originally meant to be provisional, remains today, fifteen years after the entry into force of the Lisbon Treaty, an “anomalous absurdity”Footnote ⁹⁴ within the legal framework of EU executive rulemaking.

1. Problematic legitimacy of EU executive rulemaking

Whilst the first reactions to the novelties introduced by Lisbon still hailed the Parliament as a winner in view of its enhanced supervision over the Commission after the adoption of delegated acts, this picture was probably too optimistic. Indeed, the role of the Parliament is now marginalised in relation to implementing acts, and at the same time shortcomings of the role of the Parliament in delegated acts may appear. In view of the problematic demarcation between delegated and implementing acts and the fact that comitology is still the prevailing mode of decision-making, the lack of a substantial role of the Parliament may be problematic. This is particularly true when considering that, as Mendes rightly observes,Footnote ⁹⁵ the constitutional framing of delegated and implementing acts should be read in light of the principle of democracy as set forth in Articles 9 to 12 TEU.Footnote ⁹⁶ Recognising that the functioning of the Union is founded on both representative and participatory democracy, these horizontal Treaty provisions design the normative framework that should shape the relationship between, on the one hand, EU institutions and bodies, and, on the other, EU citizens, representatives associations and civil society.Footnote ⁹⁷ This horizontal normative framework also applies to executive rulemaking, highlighting that democratic legitimacy of EU executive rulemaking “extends beyond representation”Footnote ⁹⁸ and “goes beyond mere voting.”Footnote ⁹⁹ Therefore, where Articles 290 and 291 TFEU are arguably not only about institutional (re-)balancing, the making of delegated and implementing acts needs to respect this normative framework, taking into account in particular transparency and participation as founding principles of the EU.Footnote ¹⁰⁰ Hence, participation in decision making beyond representative institutions, as enshrined in Article 11 TEU, can act as a complementary source of democratic legitimacyFootnote ¹⁰¹ also for delegated and implementing acts. Where well-known hurdles to participation relate for example to the articulation, representation and organisation of interests,Footnote ¹⁰² procedures can help overcoming such problems by conveying participation in a way that supports democratic legitimacy, provided that voice is given to the interested parties and that the latter have equal opportunities of influencing the outcomes.Footnote ¹⁰³ Hereby it is important to distinguish this, normative democratic, rationale for participatory engagement from the substantive and instrumental rationales.Footnote ¹⁰⁴

2. The role of the Parliament, Council and Member States in the executive rulemaking practice

The oversight powers of the Parliament over delegated acts have re-adjusted the balance of powers in favour of the Parliament, setting it at equal footing with its co-legislator, the Council. Yet, according to the wording of Article 290 TFEU, the Parliament is not put completely on equal footing with the Council in view of the requirement that the Parliament must act by a majority of its component members instead of the habitual simple majority of votes.Footnote ¹⁰⁵ In practice, this has appeared to be a hurdle for the Parliament.Footnote ¹⁰⁶ In addition, delayed access to information, lack of resources and short timeframes to exercise oversight were problematic issues experienced by 2014 that made the Parliament call upon the Commission to improve its involvement in the preparation of delegated acts.Footnote ¹⁰⁷ In 2016, twenty-eight years after the Plumb-Delors agreement,Footnote ¹⁰⁸ the institutions agreed again, but this time in relation to delegated acts, that the Parliament (as well as the Council) receives all documents at the same time as Member States’ experts. Moreover, experts from the Parliament and from the Council systematically have access to the meetings of Commission expert groups to which Member States’ experts are invited and which concern the preparation of delegated acts.Footnote ¹⁰⁹ In practice, the Parliament seems to rarely make use of its right to participate in these meetings.Footnote ¹¹⁰ Moreover, where the Parliament does attend, it does so through staff members of the secretariat of the relevant committee rather than directly through its Members.Footnote ¹¹¹

Both the Council and the Parliament have used their right to object. The number of objections is however extremely modestFootnote ¹¹² and, as shown by Chamon, the proportion between delegated acts adopted and objected is in line with the figures concerning the objections raised in the PRAC.Footnote ¹¹³ While the low number of objections by the Council is not surprising in light of the involvement of Member States’ experts in the preparation of delegated acts, the relatively low number of objections by the Parliament has been explained by reference to the technical nature of the acts, the institution’s workload and the high majority threshold for the adoption of a veto motion.Footnote ¹¹⁴

Above we already discussed the Council’s imposition on the Commission to consult national experts before the adoption of delegated acts, formalised in the Interinstitutional Agreement of 2016.Footnote ¹¹⁵ Research reveals that often the same individuals are involved in both expert groups and comitology committees.Footnote ¹¹⁶ These expert groups, however, have a broader mandate and may be consulted, in addition to the drafting of delegated acts, also for the drawing up of legislative proposals, policy initiatives and even in the early preparation of an implementing act before sending it to comitology.Footnote ¹¹⁷

For implementing acts, the situation is completely different due to the “palace revolution”Footnote ¹¹⁸ by the drafters of the Lisbon Treaty. The 2011 Comitology Regulation, adopted by both the Council and the Parliament, is based on the recalibrated institutional balance, taking into account the vertical dimension, and accordingly limits the involvement of the Council and the Parliament by solely recognising to those institutions a right of scrutiny. ^{Footnote 119} The right of scrutiny allows both the Council and the Parliament to indicate to the Commission that, in their view, “a draft implementing act exceeds the implementing powers provided for in the basic act”. ^{Footnote 120} In that case, the Commission will have to review the act and inform the co-legislators of its intention to maintain, amend or withdraw the draft implementing act. The Council has made use of its right for the first time only in 2021.Footnote ¹²¹ The rarity of recourse to its right by the Council is not surprising, given the participation of Member States’ representatives in committee meetings.

The Parliament has relied on its right of scrutiny, especially in the fields of GMOsFootnote ¹²² and pesticides. As a matter of fact, whilst under the 1999 Comitology decision the Parliament rarely used its scrutiny powers,Footnote ¹²³ under the current Comitology Regulation the Parliament has made frequent use of it and objected more than eighty times.Footnote ¹²⁴ Interestingly, there is a discrepancy between the wording of Article 11 of the Comitology Regulation, that allows the exercise of the right of scrutiny when “a draft implementing act exceeds the implementing powers provided for in the basic act,” and the Parliament’s Rules of Procedure, that embrace a broader interpretation allowing the Parliament to check whether the implementing act “goes beyond the implementing powers conferred in the basic legislative act or is not consistent with Union law in other respects.”Footnote ¹²⁵ This difference in wording is also reflected into practice. In the case of glyphosate, the Parliament exercised its right of scrutiny in 2017 to observe that the Commission’s draft implementing regulation not only “exceed[ed] the implementing powers” but also “fail[ed] to ensure a high level of protection of both human and animal health and the environment” and “fail[ed] to apply the precautionary principle”.Footnote ¹²⁶ The Parliament reacted there to the heavy reliance on science by the Commission and explicitly called for a new decision in line with the legislative framework, that is, a decision “including not only EFSA’s opinion, but also other legitimate factors and the precautionary principle.”Footnote ¹²⁷

Hence, we may observe that, in practice, the Parliament has been ready to use its powers, although these appear not to be very effective. On the one hand, often the Parliament objects when the implementing regulation has already been adopted. This is partly due to the fact that the Comitology Regulation does not foresee any standstill period for the exercise of the right of scrutiny.Footnote ¹²⁸ Such a standstill period could arguably be introduced by changing the rules of procedures of the comitology committees. On the other hand, the Commission seems reluctant to take into account the Parliament’s objections. For instance, in an important controversial dossier such as glyphosate, in 2017 the Parliament’s objection did not prevent the Commission from authorising the controversial substance for five more years.Footnote ¹²⁹ By way of comparison, the only time that the Council exercised its right of scrutiny, the Commission listened carefully to the Council’s objections and adopted its implementing regulation without the provisions that were criticised by the Council.Footnote ¹³⁰ In order to enhance democratic legitimacy and in view of the fact that the Parliament cannot on its own introduce new legislation when it is not content with the way the Commission exercises its powers, the Parliament should be able to obtain a veto right in comitology.Footnote ¹³¹ We will come back to this below.

3. Participatory engagement in the executive rulemaking practice

In practice, the Commission is opening up the making of delegated and implementing acts to experts, stakeholders and the public. It so promises, in the preparation of delegated acts, “with a view to enhancing transparency and consultation,” to gather, prior to the adoption of delegated acts, all necessary expertise, including through the consultation of Member States’ experts and through public consultations.Footnote ¹³² Moreover, the Commission commits, whenever broader expertise is needed in the early preparation of draft implementing acts, to use expert groups, consult targeted stakeholders and carry out public consultations, as appropriate.Footnote ¹³³ It appears that the Commission views the consultation of stakeholders as an important instrument to collect information for evidence-based policymaking, as “their views, practical experience and data will help deliver higher quality and more credible policy initiatives and evaluations.”Footnote ¹³⁴ The Commission thus collects, in the context of the preparation of delegated and implementing acts, the feedback of stakeholders, who can express general views on a specific document not based on specific questions or consultation background documents.Footnote ¹³⁵ Although the collection of feedback is the rule, this is not done when one of the eight grounds for exception applies.Footnote ¹³⁶ Whilst it goes beyond the scope of this contribution to examine those grounds in detail, we confine ourself to signalling two important issues. First, the Commission exempts authorisation decisions from the feedback mechanisms, where extensive consultation has already occurred during the risk assessment phase. Interestingly, this is presumed to be the case for all individual authorisation decisions but not for measures of general application.Footnote ¹³⁷ Second, the application of exceptions seems to remain entirely within the Commission’s discretion, without any review mechanism or duty to state reasons.Footnote ¹³⁸ Hence, currently the Commission aims to commit to participatory engagement in a limited manner and rather for the substantive rationale, viz. to enhance the quality of the decision to be adopted, rather than the normative democratic rationale.

4. Problematic comitology-based decision-making

Whilst the lack of substantive control by the Parliament over implementing acts may appear problematic, the disappearance of the specific role of the Council in comitology is somewhat less challenging. For the Council has remained indirectly involved in the making of implementing acts through the committees, as they are composed of Member States’ representatives. The practice confirms that Member States’ participation in comitology has revealed sensitivities and different perspectives concerning the areas to be administrated through executive acts. For instance, Member States’ behaviour in the case of GMOs has shown that certain internal market choices are inextricably linked with socioeconomic, cultural, ethical and ideological concerns, ^{Footnote 139} which cannot be addressed by means of purely technical-scientific decision-making. ^{Footnote 140} The case of GMOs is exemplary in underlining that, in the absence of absolute scientific certainty, decision-making requires complex assessments based on the balancing of multiple interests of different nature. With respect to the authorisation procedures for GMOs, between 2004 and 2015 Member States were never able to agree on the Commission’s draft decisions in comitology meetings.Footnote ¹⁴¹ This deadlock revealed the high politicisation of the GMO issue, ^{Footnote 142} with the frequent involvement of the Council to which the matter was ultimately referred in accordance with the pre-2011 comitology framework.

Similarly, a high degree of politicisation has permeated the process for the renewal of glyphosate’s authorisation. The latter has constituted one of the most contentious EU regulatory sagas in recent years,Footnote ¹⁴³ involving several institutional and non-institutional actors and triggering an extraordinary amount of “societal, political, scientific and legal contestation.”Footnote ¹⁴⁴ First, following the divergent assessments made by the International Agency for Research on Cancer (IARC), which in 2015 qualified glyphosate as “probably carcinogenic to humans,” ^{Footnote 145} and the evaluation of the European Food Safety Authority (EFSA) ^{Footnote 146} and the European Chemicals Agency (ECHA), ^{Footnote 147} in 2017 no agreement was found in comitology and the Commission decided for a limited re-authorisation of the substance on EU markets. ^{Footnote 148} In 2019, therefore, the Parliament called for more accountability and transparency in comitology procedures and in particular in the Standing Committee on Plants, Animals, Food and Feed (PAFF). ^{Footnote 149} Second, in 2022, faced with EFSA’s need for more time to complete glyphosate’s risk assessment,Footnote ¹⁵⁰ the PAFF did not deliver an opinion on the Commission’s proposal for a temporary renewal of glyphosate’s authorisation for one year, after which the Commission adopted this renewal. Finally, in 2023, notwithstanding EFSA’s positive opinion, that glyphosate was not to be classified as carcinogen, mutagen or toxic, ^{Footnote 151} again a no opinion scenario in both the PAFF committee and the appeal committee led the Commission to renew glyphosate authorisations for ten years, subject to certain conditions and restrictions.Footnote ¹⁵² These cases underline the problematic legitimacy of comitology-based decision-making and call for change.

5. Ignoring the constitutional requirements of the principle of democracy

Faced with the problematic dossiers of GMOs and glyphosate, the Commission acknowledged the need for change and proposed in 2017 to revise the Comitology Regulation.Footnote ¹⁵³ Yet, this arguably had much more to do with the Commission’s desire to shift the political blame for controversial decisions it would adopt, rather than with a genuine interest in enhancing the transparency and legitimacy of comitology-based decision-making. Accordingly, the Commission’s proposal is centred on an interinstitutional perspective and the sharing of responsibility by introducing a second appeal and the possibility to ask the Council for an advisory opinion, shedding light on Member States’ voting behaviour in comitology and sharpening the rules on how qualified majority is calculated.Footnote ¹⁵⁴ The proposal to bring the Council back in the realm of comitology encountered fierce opposition by the Council Legal Service that strongly rejected it as “this would go beyond the role envisaged by the Treaties for the Council and would be in breach of the principle of institutional balance,” and “would encroach on the competence of the Member States as foreseen by the Treaties.”Footnote ¹⁵⁵ Member States have supported this view.Footnote ¹⁵⁶ Significantly, were one to follow the Council Legal Service’s strict reading of Article 291(3) TFEU, this would be at odds even with the current Comitology Regulation, in that the latter provides for the right of scrutiny of the Council and the Parliament. As we argued above, however, such a reading is not in line with the underlying rationale of the EU’s constitutional and institutional structures and the democratic principle of Articles 9 to 12 TEU. The Parliament has expressed less constitutional concern ^{Footnote 157} and suggested to be accorded an advisory role like the Council ^{Footnote 158} and to broaden the right of scrutiny also to cases in which the draft implementing act is in conflict with the objectives of the basic act. ^{Footnote 159}

Notwithstanding this deadlock, the newly appointed Von der Leyen Commission decided in 2020 not to withdraw the proposal but instead announced that it wanted to go ahead with it within its pending legislative initiatives, in the pursuit of “a new push for European Democracy.” ^{Footnote 160} Unsurprisingly, the proposal has not moved forward. As a matter of fact, we argue that the blame-shifting suggested in the proposal as it stands will not give any substantive “push for democracy” as it completely ignores the constitutional requirements of the principle of democracy enshrined in the TEU. A genuine push for democracy necessitates more fundamental changes, including the introduction of a veto right for both the Council and the Parliament, and the setting of suitable procedural rules detailing participatory engagement in executive rulemaking and requiring increased transparency.Footnote ¹⁶¹ Such procedural rules will diversify participation in the adoption of delegated and implementing acts according to the powers the Parliament has to control these acts.Footnote ¹⁶² These reforms would allow executive rulemaking to go beyond being merely “science-based” to enhance the knowledge and collect more information in the specific dossiers, and respond instead to the normative democratic imperative for participatory engagement, thus allowing participation to serve as a complementary source of democratic legitimacy for delegated and implementing acts.Footnote ¹⁶³