Opinion of the Advocate General — ECLI:EU:C:2013:871
Date: 2013-12-19
Language of the case: French
Subject matter: Provisions governing the Institutions;Acts of the institutions
Procedure: Action for annulment - unfounded

summary of this provision, that a ‘delegated’ act, as it is called, is a ‘non-legislative act’ of general application of the Commission, and only the Commission, whereby the Commission fulfils the requirements contained in a ‘legislative act’ which has delegated to it the ‘power’ to regulate ‘non‑essential elements’ of the act by supplementing or amending them, with the ‘essential elements of [the relevant] area’ being ‘reserved’ for the legislative act, the objectives, content, scope and duration of the ‘delegation of power’ having first been explicitly defined. I am deliberately leaving aside any aspects relating to the ‘conditions’ referred to in paragraph 2 of the article since these are not required for resolution of this case. At this stage, I would simply like to make the following points, in no particular order. 24. First, this is a type of Union act that is different in form from the other acts that make up the normative system of the European Union. It is called a ‘delegated’ act. (7) In this regard, it seems to me that that description alone of the Union act concerned, inasmuch as it denotes a set of characteristics specific to that act, is sufficient to justify referring to it as a Union act that is different in form from other acts. As the Parliament states in the defence, (8) Articles 290 TFEU and 291 TFEU ‘are among the main innovations introduced by the Lisbon Treaty into the normative architecture of the European Union’. 25. Second, it is solely and exclusively an act ‘of’ the Commission, irrespective of the ‘conditions’ and safeguards laid down in paragraph 2 of Article 290 TFEU. It is in short the Commission, and the Commission alone, that assumes this task and this responsibility. 26. Third, it is an act with normative content (‘of general application’), intended to regulate a particular ‘area’. Article 290 TFEU is therefore, irrespective of who applies it, within a sphere of activity that is essentially normative, relating thus to regulation, which remains unconnected to the later implementation stage. 27. Four, it is a ‘non-legislative’ act, which could simply be a statement of the obvious, namely that it is not an act adopted by means of the ordinary legislative procedure, but could also mean that what is in issue is an act of general application which, in terms of hierarchy, is inferior to a legislative act. 28. Five, if the act is described as ‘delegated’ it is because it must be the result of an essentially discretionary ‘delegation (of power)’, contained in a legislative act, constituting the delegating instrument, which perhaps raises the question, once again, of the nature of that ‘power’. ‘Delegation’ occurs when the decision is taken not to ‘legislate’, but it is much more questionable whether the task delegated can be that of ‘legislating’. It is safer to refer in a more general way to ‘regulating’. 29. Six, the delegation may both ‘supplement’ and ‘amend’ ‘certain’ elements of the legislative act. Supplementing and amending are two presumably different ways of having an effect on a particular legislative act; (9) it is the first which will almost exclusively be of interest to us. In any event the delegation is not general: on the contrary, the aspects capable of expansion by means of the delegated act as well as those capable of amendment must be determined (or made ‘certain’) in the legislative act. The legislative act must therefore specify the elements that, in relation to itself, require ‘supplementing’ as well as those, if any, that the Commission will be authorised to amend. 30. Seven, the ‘essential elements of an area’ are ‘reserved’ for the legislative act, from which it necessarily follows that only ‘non‑essential elements’ of the legislative act (10) can be regulated – whether by supplementing or amending them – by the delegated act. The ‘essential’ elements comprise, therefore, an area that is absolutely reserved. That does not mean, however, that what is reserved for the legislative act is limited to matters that are referred to in Article 290 TFEU, a point to which we will be returning. The article merely identifies what is reserved for a legislative act and is ‘not capable of delegation’ (‘the essential elements’), as opposed to a different form of reservation which is capable of being lifted by the legislature itself (‘the non-essential elements’). Another question, which is not raised on this occasion, is whether this interpretation of ‘what is not capable of delegation’, restricted to ‘the essential elements’, is valid for every sphere of regulation, looking beyond the actual wording of the provision. 31. Finally, ‘the objectives, content, scope and duration of the delegation of power’ are to be explicitly defined in the delegating legislative act. The effect of that stipulation is that the Commission’s normative activity is highly regulated, which enables the legislative act, not to say its authors, to reduce the Commission’s discretion significantly. All the legislature’s ‘essential’ concerns for the regulation of an area can be conveyed by explicitly stating the objectives, content and scope to which the delegated act must be directed. 32. Having outlined those points, we must now turn to history in order, essentially, to assess to what extent the Lisbon Treaty broke new ground in this area. (11) It is widely acknowledged that the precedent for Article 290 TFEU is Article I‑36 of the ill-fated Constitutional Treaty, the fundamental difference being that what were then called ‘delegated regulations’ derived from delegating ‘laws’. (12) The difficulty is that because the precedent never came to fruition, no great weight can be given to it. 33. When considering the status quo prior to ‘Lisbon’, it is important to look carefully at the argument put forward by the Council, (13) to the effect that ‘the power created by Article 290 TFEU is not new in the EU legal order’, so that ‘the novelty of Article 290 TFEU does not lie in its nature, but in the mechanisms for exercising the power that it lays down’, it then immediately being stated that ‘Articles 290 TFEU and 291 TFEU, taken together, merely cover what was previously covered by Article 202 of the EC Treaty’. 34. To my mind, an approach of this kind, which leads us to look at a provision of the Lisbon Treaty that, as such, has no equivalent in the primary law of the European Union through the prism of certain former practices that were, to some extent, based on Article 202 EC, will inevitably result in incorrect inferences being drawn. The same can be said of the transitional ‘regulatory procedure with scrutiny’ as a potential key to interpreting ‘delegated’ acts. (14) In this regard I would simply draw attention to the fact that the content of Article 290 TFEU – and this will be better understood once we have examined ‘implementing’ acts – has not been treated as deriving from a need to create uniform conditions for implementation and, as such, placed in Article 291 TFEU, but is instead treated as a continuation of legislative activity in substantive terms. ii) A suggested approach to delegated acts 35. I will now suggest, first of all, a way of clarifying the meaning of ‘delegated’ acts and then a way of classifying them, inspired by the public law of the Member States. 36. ‘Delegated’ acts represent an opportunity for the EU legislature and the Commission to collaborate in the work of legislating, in substantive terms, whereby the legislature can in principle limit itself to regulating the essential elements of an area and entrust the Commission with the remainder of the normative function, narrowly defining the limits of its discretion in the ways that I have already mentioned. 37. This, in my view, is the fundamental meaning of ‘delegated’ acts, and it is a meaning or raison d’être that is sufficiently well delineated to avoid those acts being easily confused with the Commission’s other normative activities, particularly the activity provided for in the following article, Article 291(2) TFEU, to which I shall shortly be directing my attention. 38. Turning now to attempting to classify ‘delegated’ acts, which, while not being ‘legislative acts’, are not ‘implementing’ acts either, and which can be used both to supplement and to amend a ‘legislative act’, I think it is helpful to look to comparative law, and specifically to the public law of the Member States, particularly as the concept in question is one whose role has an undeniable counterpart and well‑established tradition in the constitutional systems of the Member States. However sui generis the system of Union acts may ultimately have become, as a result of its very nature and its history, (15) in cases where the European Union has sought inspiration from the normative categories of the Member States, (16) as was no doubt the case here, it is almost natural that they should be looked into, even though there is no guarantee as to the result. 39. It is in any event clear that it will not be of any great assistance to classify them as ‘quasi-legislative powers’, (17) or even as some kind of ‘tertium genus’ falling between legislative acts and implementing acts of general application, which are also entrusted to the Commission and which I will be looking at in due course. 40. Furthermore, given that we are dealing with ‘non-legislative acts’, if the delegation were legislative only in substantive terms, that is to say, there were no transfer of any legislative power in the full sense, it would be quite legitimate to wonder whether this so-called ‘delegation’ is in essence another instance of ‘enabling’. If we must refer to it as ‘delegation’ because Article 290 TFEU requires it, perhaps we should agree that it is an ‘incorrect’ delegation. 41. It is in this vein that we should start to think of the delegation of powers provided for in Article 290 TFEU as a case of ‘delegalisation’ (deslegalización). There is no shortage of Member States that have a concept of ‘delegalisation’ for cases where the legislature decides to make use of one or other procedure to ‘transfer’ to the executive – on certain conditions and reserving specific areas – part of the regulation of an area. The area that is thus temporarily ‘removed’ from the scope of the law ceases to be law, although, in substantive terms, it may have to function as such. (18) 42. It is of course true that this concept originates in legal orders in which the hierarchy principle reigns supreme. In this case, however, as I have already mentioned, it could be argued that the term ‘non‑legislative act’ is merely an expression of the obvious, namely that in these circumstances the ordinary legislative procedure has not been, and will not be, followed. Even when thus reduced in scope, I think that the concept has sufficient force as an explanation for it to be applied, mutatis mutandis, to the situation where Article 290 TFEU is activated. 43. In particular, in those cases in which a legislative act provides for its own amendment by a ‘delegated act’, this must relate to elements that, first of all, are not essential and, second, are contained in provisions that can be identified with precision. In these circumstances, those provisions will, by way of exception, not enjoy the ‘passive force’ inherent in an act ranking as a legislative act; in other words, they will be subject to amendment by a provision contained in a ‘non-legislative act’, as Article 290 TFEU describes ‘delegated acts’. 2. Implementing acts 44. In relation to implementing acts of general application under Article 291(2) TFEU, we must, once again, start by reading the text in the most objective way possible. i) The wording of Article 291(2) TFEU 45. Article 291 TFEU reads as follows: ‘1. Member States shall adopt all measures of national law necessary to implement legally binding Union acts. 2. Where uniform conditions for implementing legally binding Union acts are needed, those acts shall confer implementing powers on the Commission or, in duly justified specific cases and in the cases provided for in Articles 24 and 26 of the Treaty on European Union, on the Council. 3. For the purposes of paragraph 2, the European Parliament and the Council, acting by means of regulations in accordance with the ordinary legislative procedure, shall lay down in advance the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers. 4. The word “implementing” shall be inserted in the title of implementing acts.’ 46. First of all, and starting at the end, the description ‘implementing’ means that the acts of the Commission that are issued on the basis of this article can be formally differentiated from delegated acts, which are also acts of the Commission and are issued on the basis of the delegation of powers provided for in Article 290 TFEU. 47. Second, with Article 291 we leave behind the stage of ‘regulation’, as provided for in Article 290, and are now in a different functional realm, namely that of implementation and, more specifically, the realm of implementation of legally binding Union acts. In other words, in the scheme of the Treaty, implementation starts at this point, with Article 291 TFEU. 48. Third, in a similar way to the delegation to the Commission under Article 290 TFEU of regulatory powers that prima facie belong to the domain of legislative acts, in this case the ability to adopt implementing acts is given to the Commission as a result of the need to lay down ‘uniform conditions for [implementation]’ across the whole extent of the European Union. In fact, in the normal course of events, implementing powers belong mainly to the Member States. They may be used by the European Union, and within the Union by the Commission as the institution which has ‘coordinating, executive and management functions, as laid down in the Treaties’ (Article 17(1) TEU), (19) only in a subsidiary capacity (under Article 5(1) TEU). 49. Article 291(2) TFEU is therefore primarily a rule that empowers the European Union, through the Commission, to use, in a subsidiary manner, a competence that belongs to the Member States. 50. Unlike the case of Article 290 TFEU, this empowering is not triggered merely by a decision of the legislature but by an objective cause: the need for uniform conditions for implementing legally binding EU acts. This need makes it possible, in terms of subsidiarity, for the institutions to adopt implementing measures that, in principle, fall within the remit of the Member States. 51. Implementing acts under Article 291(2) TFEU are made subject to the control of the Member States by means of the procedure laid down in Regulation No 182/2011, (20) which simplifies the traditional system known as ‘comitology’. By contrast with the system of control under Article 290 TFEU, the controls laid down in Article 291 TFEU are not freely determined in the ‘legally binding act’ (basic instrument) that confers the implementing power, but rather Article 291(3) TFEU requires the European Parliament and the Council to lay down ‘the rules and general principles concerning mechanisms for control by Member States’. (21) Each individual basic instrument must, in turn, specify which of the control procedures laid down in advance by the European Parliament and the Council is to apply in that case. (22) ii) Meaning and scope of implementing acts 52. ‘Implementing’ acts, within the meaning of Article 291 TFEU, enable the Commission, by way of exception to the principle that implementation falls to the Member States, to implement EU law itself where uniform conditions for implementation are needed. 53. Viewed in these terms, it would be difficult to confuse the meaning of these ‘implementing’ acts with that of ‘delegated’ acts, which are also acts of the Commission (see my earlier comments) and which revolve around the idea that the EU legislature and the Commission collaborate in the legislative task in the substantive sense. 54. The classification of implementing acts is less problematic. By the nature of things there has always been a residuum of normative activity immediately prior to implementation in the narrow sense which, depending on the constitutional traditions of the Member States, is in some cases viewed as belonging to the executive itself, sometimes classified as an inherent regulatory power, and in other cases must be the subject of a specific enabling measure on the part of the legislature. In the EU context, as the principle of conferral applies, the latter is the case. 3. Delegated acts and implementing acts 55. Having considered the import of each of the normative categories referred to in Articles 290 TFEU and 291 TFEU, it is time to look at their interaction. In this respect I shall first of all address certain aspects of the relationship between ‘delegated’ acts and ‘implementing’ acts and then go on to look at how the two might be demarcated. i) The relationship between delegated acts and implementing acts 56. I think a preliminary observation is necessary before entering into the subject. The parties to these proceedings have placed the hierarchy principle centre-stage in the dispute, (23) debating, essentially, whether there is a hierarchical relationship between legislative acts and delegated acts or between delegated acts and implementing acts. There is, of course, much to be said on the subject, yet it is by no means clear that it is essential to enter into this debate in order to rule, even in the abstract, on the Commission’s application. Whether or not it is possible to draw from my understanding of each of these acts conclusions militating in favour of any particular argument is a different matter. In short, I share the view of Finland that, for the purposes of these proceedings, it is not necessary to enter into this debate. 57. On the other hand, we should not lose sight of the fact that, ultimately, the distinction between delegated acts and implementing acts does not depend only on the difference between legislation (even if it is delegated) and implementation, but also on the fact that delegated acts are the product of the exercise of a normative competence belonging to the European Union itself, whereas implementing acts are the result of the (subsidiary) exercise by the Commission (or the Council) of a competence that belongs predominantly to the Member States. (24) 58. In other words, the underlying reason for the dividing line between Articles 290 TFEU and 291 TFEU is not so much (or not only) the need to draw a line between legislation and implementation as successive stages in the EU rule-making procedure, but, more importantly, the desire to make clear the parameters of the respective competences of the European Union and the Member States. 59. In the EU context, the question of normative force clearly arises in the case of Article 290 TFEU, which is concerned with the delegation to one institution of the powers that belong to other institutions of the European Union itself. In the case of Article 291 TFEU it is also necessary to use the criterion of normative force in order to establish whether the Commission (or the Council) has limited itself to ‘implementing’ legally binding Union acts, but a preliminary question always arises, namely whether implementation falls to the European Union or to the Member States, and this will always depend on an objective factor over which the EU institutions have no control: the need for uniform conditions for implementation. In addition to the issue of the demarcation between the general and the specific, which is typical of legislative delegation and enabling, there is the issue of delimiting the competences of the European Union and the Member States. 60. The effects of a delegation under Article 290 TFEU are exhausted once the Commission has been given the power to adopt non‑legislative acts in an area that originally could be governed only by legislative acts; but this has no effect at all on the competence of the European Union vis‑à‑vis the Member States. By this I mean that the delegation does not open the way to any regulatory power other than ‘that of the Commission’. In other words, delegation always occurs within the realm of EU competences and does not affect the distribution of competences between the European Union and the Member States. 61. Furthermore, Article 290 TFEU does not give rise to a measure permitting implementation of a mandate, but to a measure whereby the legislative procedure is supplemented and completed, even though some aspects of the area to which this procedure applies have been the object of ‘delegalisation’. Article 290 TFEU does not authorise implementation, but rather the completion of legislation through the use of regulatory power. There is therefore as yet no place for Article 291 TFEU implementation, which is possible only once ‘legislating’ in the widest sense has taken place. 62. The Commission’s action must relate to matters that, in the absence of a delegation, would be subject to the legislative procedure and would therefore be given a regulatory treatment that is general and abstract, as befits legislative powers. The delegation empowers the Commission to adopt provisions of that kind and therefore to act within certain margins of discretion which it does not have when acting in an implementing capacity. Accordingly, the difference of principle between the powers exercised by the Commission in the case of a delegation by legislative act (Article 290 TFEU) and the powers conferred on it in the case of implementation under Article 291(2) TFEU ultimately lies in the fact that delegation allows a measure of discretion which is not mirrored in the case of implementation. Essentially, the legislature delegates to the Commission the ability to decide issues that, in principle, it should itself have decided, whereas implementation under Article 291 TFEU operates in relation to provisions the content of which has, as regards the substance, been defined by the legislature. 63. Lastly, on account of that difference, Article 291(2) TFEU relates only to the exercise of implementing powers, it being common ground that these include only what is necessary for the specific application of a fully formed and defined measure. For its part, Article 290 TFEU provides that the objectives to be pursued by the delegation must be defined, as must its content and scope, which clearly indicates that the Commission is expected to do something more than merely implement a provision in which all these elements are given. In my view, this ‘something more’ entails some room for ‘creativity’ or ‘trenchancy’ in the rule-making domain that is not possible in the case of mere implementation. ii) Demarcation of the respective areas of normative activity under Articles 290 TFEU and 291 TFEU 64. On the basis of the foregoing, it is possible to put forward an interpretation that might provide guidance when determining whether a particular normative activity can be carried out only pursuant to a delegation or whether the reverse is true and it is more readily accommodated under the heading of implementation. 65. The Commission attributes particular importance to ‘the nature of the power that the legislature wishes to confer’ and deems ‘the level of detail’, the creation of rights and duties and the ‘measure of discretion’ (25) to be inadequate as criteria, referring to the respective areas of the two articles as ‘mutually exclusive’. (26) 66. The Council, on the other hand, focusses on the existence of new substantive rules or new rights and obligations, stating that it is necessary to examine the ‘normative content’. It takes the view that there is a grey area that is difficult to define. Finally, the European Parliament makes reference to the level of detail, the rights and obligations and the measure of discretion. (27) 67. I should like to clarify one point at the outset. There has also been much discussion during these proceedings about whether there is a ‘grey area’ on the dividing line between the content of delegated acts and that of implementing acts, or whether, on the contrary, a clear separation operates to keep each in its distinct area, the contents of which are mutually exclusive. The Commission argues that, conceptually, matters that may be dealt with by delegated act cannot be the subject of an implementing act and vice versa, in a mutually exclusive way. According to the contrary argument, the Commission can be empowered both to relieve the legislature of non-essential rule-making and to entrust it with acts of general application that are essential for implementation in the narrow sense. 68. Once again I am of the view that it is not essential to take sides on this point, particularly as both positions may have some foundation in terms of principle. Ultimately, much depends on the preconceptions that both sides may have of the two types of instrument. 69. On the other hand, the subject of the ‘grey area’ has sometimes been mentioned in association with considerations relating to the ‘level of scrutiny’ that the Court of Justice can legitimately exercise in this area. (28) I believe that this is actually the right way to look at the issue. The question should not be whether ‘ontologically’ a particular measure can be categorically placed within the ambit of either Article 290 TFEU or Article 291 TFEU, but whether or not the Court of Justice can review each and every one of the choices made by the legislature, down to the last detail. (29) 70. In any event, before going any further, I think it is important to note that the Commission is right to expect that the choices made by the legislature when faced with the alternatives under consideration here will be subject to a certain degree of review by the Court of Justice. That is especially true in circumstances like the present, where there has been a change in the primary law and the chances that the parties involved, in this case the legislature, will continue ‘as before’ are not to be dismissed. It is one thing, however, to state the principle and another to define its scope. 71. It can be readily accepted that the ‘role’ of the Court of Justice in policing the frontier between ‘the essential’ (legislation that is not capable of delegation) and the ‘non-essential’ (legislation that is capable of delegation) is, by the nature of things, limited: the opinion of the Court of Justice cannot be substituted for that of the legislature under any hypothesis. The ‘role’ of the Court of Justice must therefore be similarly limited when it comes to policing that other frontier between what, in the terminology used by the representative of the French Government, we might call ‘substantive’ (in any event, not essential), in other words, that which would specifically belong to Article 290 TFEU, and what on the other hand, and conscious of the fact that it is scarcely appropriate, I venture to call ‘the incidental’, in other words, that which would belong to Article 291(2) TFEU. Certainly, this other frontier is not situated on a continuum in the same way as the one we first mentioned, since different functionalities are involved. However, in this case too, the possibilities for review of any choice made by the legislature when faced with these alternatives are limited. 72. Much as Advocate General Jääskinen (30) has pointed out, the existence of an area that is in some way forbidden to the EU judicature does not mean that the Court of Justice is prevented from reviewing, in an effective and appropriate manner, the way in which the legislature has ‘administered’ the choice between delegated acts and implementing acts. 73. Against that background, I should first of all state that the import of each of the articles is, as we have seen, sufficiently different to justify reliance on a teleological interpretation when it comes to drawing the boundary between their respective domains. It seems to me that a boundary based on the raison d’être and purpose of each of these institutional approaches is by far the most appropriate, making possible solutions that are consonant with the spirit of the system created by Articles 290 TFEU and 291 TFEU. 74. To this I would add that, rather than restricting the analysis to a single article of the delegating legislative act, it is also important to analyse the legislative act as a whole in order to ascertain the relative position, in the scheme of the legislative act, of any given choice in favour of the ‘implementing act’ in that whole, particularly by comparison with any potential recourse to delegated acts. 75. Much has also been made of the ‘political aspect’ as a general category that might provide guidance in reaching a view in relation to the choices of the legislature in this area. It is true that the Court of Justice has used the idea of ‘the fundamental guidelines of Community policy’ as a point of reference for defining the boundaries of executive competences. (31) However, I think that comparisons between the ‘political aspect’ and what we might call the ‘technical aspect’ when demarcating the two types of act are not very helpful. I say this because, in the case of Article 290 TFEU, the overall effect of the requirement to define the ‘objectives’, the ‘scope’ and the ‘content’ of the delegated act in the legislative act, means that the ‘political aspect’ is contained, almost exclusively, in the legislative act. In other words, Article 290 TFEU gives the delegation so rigid a framework that there remains virtually no scope for assuming any real accountability. The ‘non‑essential elements’ to which the delegated act is restricted will be those elements in relation to which there is no possibility of going back on the fundamental choices made by the legislature and for which it is accountable. To sum up, in relation to ‘non-essential’ aspects, the scope for adopting measures that entail true legislative accountability may be appreciably reduced owing to the conditions on which the delegation is authorised. 76. That said, it is undeniably the case that the Commission retains a broad ‘margin of discretion’ when supplementing regulation in the area concerned on the basis of Article 290 TFEU. However, to demand that every normative decision taken by means of a delegated act should involve a ‘political element’ of some kind would, it seems to me, be to upset the balance of the relationship between delegated acts and implementing acts to the detriment of the former. 77. In this regard, I should make the point that, in the current post-Lisbon setting, it is necessary to move away from the idea that a ‘law’ is restricted to what is ‘essential’, as has previously been the interpretation of the case-law of the Court of Justice. (32) The existence of Article 290 TFEU means that it is inconceivable that, once the legislature concludes its regulation of the essential elements, it is completely free to choose a delegated act or an implementing act. Such an approach would jeopardise the effectiveness of including delegated acts within primary law, since, as the Commission points out, (33) there is a danger that ‘delegated acts’ end up in a category that is pointless or obsolete from the outset. 78. Finally, and in view of the fact that there is inevitably an element of subjectivity where objectives are concerned, the language used in the recitals to the delegating legislative act can and should be particularly useful. They are ultimately the best means of conveying the legislature’s purpose, whether that be the intention that regulatory activity should cease once the limits of ‘the essential’ have been reached or covered, or that the Commission, or, as the case may be, the Council, should have the power to adopt measures of general application directly linked to the requirements of the implementation stage. 79. Having made all of these admittedly general and largely abstract observations, I think we are in a position to address the particular provision that has given rise to these proceedings, Article 80(1) of Regulation No 528/2012, in that, specifically, it confers on the Commission the power to adopt an ‘implementing regulation’ dealing with certain specific aspects of Regulation No 528/2012. 4. Whether the contested provision was correct in conferring on the Commission the power to adopt an implementing regulation 80. We must, once again, start with the text of the article in question. Article 80(1) of Regulation No 528/2012 calls on the Commission to adopt an implementing regulation specifying the following: ‘(a) the fees payable to the Agency, including an annual fee for products granted a Union authorisation in accordance with Chapter VIII and a fee for applications for mutual recognition in accordance with Chapter VII; (b) the rules defining conditions for reduced fees, fee waivers and the reimbursement of the member of the Biocidal Products Committee who acts as a rapporteur; and (c) conditions of payment.’ 81. The same paragraph provides that the implementing regulation is to apply only with respect to fees paid to the Agency and that those fees ‘shall be set at such a level as to ensure that the revenue derived from the fees, when combined with other sources of the Agency’s revenue pursuant to this Regulation, is sufficient to cover the cost of the services delivered. The fees payable shall be published by the Agency’. 82. In addition, Article 80(3) gives further directions, in the form of principles, namely: ‘(a) fees shall be set at such a level as to ensure that the revenue derived from the fees is, in principle, sufficient to cover the cost of the services delivered and shall not exceed what is necessary to cover those costs; (b) partial reimbursement of the fee if the applicant fails to submit the information requested within the specified time-limit; (c) the specific needs of SMEs shall be taken into account, as appropriate, including the possibility of splitting payments into several instalments and phases; (d) the structure and amount of fees shall take into account whether information has been submitted jointly or separately; (e) in duly justified circumstances, and where it is accepted by the Agency or the competent authority, the whole fee or a part of it may be waived; and (f) the deadlines for the payment of fees shall be fixed taking due account of the deadlines of the procedures provided for in this Regulation’. 83. The Commission argues (34) that the task that is being entrusted to the implementing regulation is the creation of a complete and coherent system of charges payable to the Agency, a coherent set of rules and criteria, a comprehensive and coherent system, which entails supplementing ‘non-essential elements’ of Regulation No 528/2012 on the basis of the principles laid down by the legislature and that, as such, this should be the subject of a delegation under Article 290 TFEU. 84. The Parliament and the Council attribute less importance to the principles relied on by the Commission, arguing that the system laid down in Article 80 of Regulation No 528/2012 is sufficiently detailed to make a delegating act unnecessary, a purely implementing act under Article 291 TFEU being all that is needed. 85. Before continuing, it is worth drawing attention to a point to which I have already given a certain amount of emphasis, which is the advisability of not focussing narrowly on the issues attaching to a single provision of the legislative act in question in isolation, but of attributing importance also to the provision as part of a whole, in particular as far as the choices made therein in relation to the use of delegated acts and implementing acts of general application are concerned. In this respect it should be noted that Article 83(5) of the regulation makes sufficiently extensive use of delegated acts to avoid the danger to which I have already referred of the legislature disregarding the existence of this new instrument for regulating a particular area. (35) Such an appreciation will, of course, not excuse us from continuing with our analysis of the specific provision with which we are here concerned, but I think that the fact that delegated acts are mentioned in the regulation in this way is nevertheless worthy of comment. 86. The question now to be addressed is whether Article 80(1) of Regulation No 528/2012 can reasonably be seen as expressing the legislature’s intention to lay down rules that require further development or whether, instead, it is reasonable to assume that the implementation stage has already been reached, with the inevitable need to adopt acts of general application in advance of implementation in the strict sense. In connection with this point, it is relevant to observe that an area, such as that of fees, where revision is frequently required, quite apart from any clarification that may subsequently be made, tends to be dealt with in the implementation stage. 87. On that basis, it is sufficient to examine whether it can legitimately be argued that, in the present case, we are already in the area of implementation, which inevitably entails finalising certain aspects by clarifying or specifying them, or whether, by contrast, we are still at the stage at which the ongoing normative activity involves a certain measure of discretion which the Commission is unable to provide simply by exercising its implementing powers. 88. It is in the light of the principles laid down by the legislature in Article 80(3) of Regulation No 528/2012 that the extent of the normative power conferred on the Commission must be measured, since their greater or lesser ability to reduce the Commission’s measure of discretion when it comes to defining the content of any provision produced as a result of that power will determine whether it is a question simply of an implementing power or whether it continues to be a ‘legislative’ power that is being exercised. 89. To my mind, the conditions imposed by Regulation No 528/2012 under Article 80(1) and (3) give no scope for the exercise of a normative function going beyond what might reasonably be left to the implementation stage and to either the Member States or the Commission. 90. Twice the article mentions the need to ensure that the costs of the services delivered by the Agency are covered; and on one occasion (Article 80(3)(a)) it specifies that the level of fees ‘shall not exceed what is necessary to cover those costs’. In these circumstances, I think it is clear that setting the level of the fees is not being left to its fate as a political decision but comes down to a question of technicalities. This is because the political aspects of introducing a system of fees have already been exhausted by the legislature itself in taking the decisions, first, that fees will be introduced and, second, that they will be used only to cover the cost of the service and not for any other purpose, and nor will they be set at a level that is excessive in relation to the cost of the services delivered by the Agency. 91. That stated, it is important to pause for a moment to examine the ‘principle’ laid down in Article 80(3)(e), which the Commission argues implies a decision of a political nature, which is equivalent to saying that the Commission is being granted too great a measure of discretion. Admittedly, to allow the Commission to decide the circumstances in which it will be possible to waive the whole or part of the fee would suggest that it is being entrusted with determining what is a particularly delicate issue in any funding arrangement. Indeed, the determination of who is to be obliged to pay a fee is something that has historically been considered to belong to the realm of ‘the political’, there being a close link between taxation and representation, which would mean that, as a matter of principle, it should be reserved to the legislature. 92. However, in the context of the provision at issue it is not a case of the Commission being given complete freedom to determine the group of potential beneficiaries of a waiver. Article 80(3)(e) allows the whole fee or a part of it to be waived only ‘in duly justified circumstances’ and, moreover, requires that the waiver be accepted ‘by the Agency or the competent authority’. In these circumstances, once again, the underlying political dimension of the decision relating to possible waivers has been taken by the legislature itself. The Commission cannot decide whether or not fees will be waived or whether any waiver will be of the whole or part of the fee. Once the legislature has decided that fees may be waived, it only remains for the Commission to provide in the implementing regulation that those wishing to apply for a waiver must provide justification and that the Agency or the competent authority will decide whether it will be granted or not. The work of the Commission is therefore simply to set down in the future implementing regulation certain conditions for waiving the fee which, in reality, the legislature has already laid down in Regulation No 528/2012 itself: justification of the application and acceptance by the Agency or competent authority. This being the case, I do not think that Article 80 applies the provisions of Article 291(2) TFEU in a way that might be found to be unlawful. 93. As far as the remaining principles set out in Article 80(3) are concerned, it seems to me that they circumscribe the Commission’s discretion to a sufficient degree, since they go so far as to require: ‘partial reimbursement of the fee if the applicant fails to submit the information requested within the specified time-limit’ (point (b)); that ‘the specific needs of SMEs’ must be ‘taken into account, as appropriate, including the possibility of splitting payments into several instalments and phases’ (point (c)); and that ‘the deadlines for the payment of fees shall be fixed taking due account of the deadlines of the procedures provided for in this Regulation’ (point (f)). In short, there is, in my view, absolutely no scope for exercising a decision-making power involving a level of discretion that would prevent it from falling within Article 291(2) TFEU. 94. On the other hand, Article 80(2) of Regulation No 528/2012 requires Member States to charge fees for services that they ‘provide with respect to the procedures under this Regulation’. To that end, the second subparagraph of Article 80(2) provides that, ‘[b]ased on the principles set out in paragraph 3, the Commission shall issue guidance concerning a harmonised structure of fees’. It might be inferred from this that the Commission is expected to outline and specify on behalf of the Member States the conditions contemplated, as far as the European Union is concerned, in paragraph 3. If that were the case, it would be an acknowledgement that there remains scope within paragraph 3 for taking decisions involving a certain measure of discretion. I do not think that is the case. 95. In my view, the second subparagraph of Article 80(2) does not enable the Commission to give greater precision to principles that are, in my opinion, already specific enough to exclude any possibility of a political decision on the part of the Commission. This second subparagraph is about the Commission, ‘[on the basis of] the principles set out in paragraph 3’, guiding the actions of the Member States so that the fees introduced by them might have a ‘harmonised structure’. Its purpose is not, therefore, to define the scope for decision making, because this, as I have said, has been determined by the legislature when it laid down the principles contained in paragraph 3, but to ensure that the fees imposed by the Member States reflect a harmonised structure which is based around observance of those principles. 96. Finally, the fact that the Article 80(3) principles are binding on both the Commission and the Member States is confirmation that the legislature regarded the regulatory ‘stage’ as being complete in every respect. I am not convinced by the Commission’s argument (36) to the effect that the Member States can, in turn, so to speak, ‘go back’ to the legislative stage in the formal sense under their own national legal systems when they put in place the relevant regulations. The key issue, as the Parliament notes, (37) is that, as far as the European Union is concerned, the normative stage is over. 97. In view of all the foregoing, I take the view that it was lawful for Article 80(1) of Regulation No 528/2012 to make the Commission responsible for adopting an implementing regulation with the content and conditions contained therein, on the basis of Article 291(2) TFEU; the Commission’s action for annulment must therefore be dismissed. V – Conclusion 98. In the light of the foregoing considerations, I propose that the Court should: (1) dismiss the Commission’s action; (2) order the Commission to pay the costs. 1 – Original language: Spanish. 2 – Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ 2012 L 167, p. 1). 3 – Although, see the recent Opinion of Advocate General Jääskinen in Case C‑270/12 United Kingdom v Council and Parliament, points 60 to 88. 4 – Paragraph 1 of the defence. 5 – Case C‑504/09 P Commission v Poland [2012] ECR, paragraph 98 and the case-law cited. 6 – Loc. cit., citing further case-law. 7 – The act by which the power conferred by the delegation is exercised should take the same form as the delegating legislative act which it supplements or amends; that is a regulation, directive or decision (of general application), with the word ‘delegated’ added to it (Article 290(3) TFEU). 8 – Paragraph 1. 9 – See Craig, P., The Lisbon Treaty, OUP, New York, 2010, p. 276. 10 – References to essential elements were made as far back as Case 25/70 Einfuhr- und Vorratsstelle für Getreide und Futtermittel v Köster and Berodt & Co. [1970] ECR 1161 and further reference thereto is made in Case C‑240/90 Germany v Commission [1992] ECR I‑5383. 11 – On the origins of ‘delegated regulations’ in the European Convention, see Garzón Clariana, G., ‘Les actes délégués dans le système du droit de l’Union Européenne’, ERA-Forum, vol. 12 (2011), supplement 1, pp. 105-34 (106-12). 12 – On the course of events after the failure of the Constitutional Treaty and up until the Lisbon Treaty, see the Opinion of Advocate General Jääskinen in United Kingdom v Council and European Parliament, point 75 and references. 13 – Paragraph 28 of the defence. 14 – A procedure introduced as Article 5a by Council Decision 2006/512/EC of 17 July 2006 (OJ 2006 L 200, p. 11) amending Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission (OJ 1999 L 184, p. 23) (‘Comitology Decision’). 15 – In this regard see Bast, J., ‘Legal Instruments and Judicial Protection’, in A. von Bogdandy and J. Bast (eds.), Principles of European Constitutional Law, second edition, Hart-CH Beck‑Nomos, Munich-Portland, 2010, pp. 345-97. 16 – See the Final report of Working Group IX on Simplification of 29 November 2002, CONV 424/02, WG IX 13. 17 – An expression used by the Commission in paragraph 63 of its application, to which the Council replies in paragraph 42 of its defence. 18 – On ‘delegalisation’ in a national constitutional system, see, for example, De Otto, I., Derecho Constitucional. Sistema de fuentes, Ariel, Barcelona, 1987, pp. 226-28. 19 – On the problems of identifying the executive function of the European Union, see [Ritleng], D., ‘L’identification de la fonction exécutive dans l’Union’, in Duthiel de la Rochère, J. (ed.), L’exécution du Droit de l’Union, entre mécanismes communitaires et Droits nationaux, Bruylant, Brussels, 2009, pp. 27-51. On the distribution of executive competences in the Union, see Fuentetaja Pastor, J.Á., ‘Actos delegados, actos de ejecución y distribución de competencias ejecutivas en la Unión Europea’, in Revista Española de Derecho Administrativo, No 149, 2011, pp. 55-89 (57-63). 20 – Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ 2011 L 55, p. 13). This regulation was adopted pursuant to the mandate in Article 291(3) TFEU, which provides that, for the purposes of the conferral of implementing powers pursuant to Article 291(2), ‘the European Parliament and the Council, acting by means of regulations in accordance with the ordinary legislative procedure, shall lay down in advance the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers’. 21 – These rules and principles have been laid down in Regulation No 182/2011. 22 – Regulation No 182/2011 provides for two control procedures: the advisory procedure (Article 4) and the examination procedure (Article 5), which is much more thorough. In the case of the contested regulation, the examination procedure is applicable, pursuant to the second subparagraph of Article 80(1) of Regulation No 528/2012. 23 – Paragraphs 4, 57, 63, 64, 71, 75 and 91 of the Commission’s application, paragraph 41 of the Council’s defence, paragraphs 27 and 28 of the statement in intervention of the Netherlands and paragraphs 20 to 22 of the statement in intervention of France. 24 – It is an undisputed principle that, in the normal course of events, the implementation of EU rules falls to the Member States (see, for example, Jacqué, J. P., Droit institutionnel de l’Union européenne, sixth edition., Dalloz, Paris, 2010, marginal notes 581-84). That the power to implement is one that belongs to the Member States has its legal basis in Article 4(3) TEU, which provides that ‘[t]he Member States shall take any appropriate measure, general or particular, to ensure fulfilment of the obligations arising out of the Treaties or resulting from the acts of the institutions of the Union’. 25 – Paragraph 15 of its statement in reply. 26 – Paragraph 65 et seq. of the application. 27 – Paragraph 26 of its rejoinder. 28 – The United Kingdom refers in paragraphs 41 to 45 of its statement in intervention to the need to take multi-factorial assessments into consideration, while Denmark alludes (in paragraphs 15 and 28 of its intervention) to objective criteria capable of review by the courts but with a measure of discretion. The Commission argues against this approach in paragraph 36 of its observations on the interventions. 29 On this point, see Ritleng, D., Le contrôle de la légalité des actes communautaires par la Cour de Justice et le Tribunal de Première Instance des Communautés Européennes, unpublished doctoral thesis, Strasbourg, 1998, pp. 376-82. 30 – Point 78 of the Opinion in United Kingdom v Council and European Parliament. 31 – Very early on the Court of Justice emphasised the importance of using accountability as a guide when assessing whether a delegation of powers is lawful in terms of the nature and scope of the power delegated. Thus, in Case 9/56 Meroni [1958] ECR 133, we read that ‘the consequences resulting from a delegation of powers are very different depending on whether it involves clearly defined executive powers’. Points 26 to 29 of the Opinion of Advocate General Mengozzi in Case C‑355/10 Parliament v Council [2012] ECR give a summary of the relevant case-law. 32 – See the previous footnote. 33 – Paragraph 12 of the reply. 34 – Paragraphs 46, 83 and 85 of the application. 35 – Article 83(5) lists the provisions of Regulation No 528/2012 in which a delegation is authorised, namely: Articles 3(4), 5(3), 6(4), 21(3), 23(5), 28(1), 28(3), 40, 56(4), 71(9), 85 and 89(1). 36 – Paragraph 39 of the reply. 37 – Paragraphs 22 and 23 of the Parliament’s rejoinder.