CELEX: 62016CC0244
Language: en
Date: 2017-09-06 00:00:00
Title: Opinion of Advocate General Wathelet delivered on 6 September 2017.#Industrias Químicas del Vallés, SA v European Commission.#Appeal — Plant protection products — Implementing Regulation (EU) 2015/408 — Placing on the market of plant protection products and establishing a list of candidates for substitution — Inclusion of active substance metalaxyl in that list — Action for annulment — Admissibility — Article 263, fourth paragraph, TFEU — Regulatory act that does not entail implementing measures — Individually concerned person.#Case C-244/16 P.

OPINION OF ADVOCATE GENERAL
      MELCHIOR WATHELET
      delivered on 6 September 2017 (
            1
         )
      
         Case C-244/16 P
      
      Industrias Químicas del Vallés SA
      v
      European Commission
      (Appeal — Action for partial annulment — Fourth paragraph of Article 263 TFEU — Regulatory act which does not entail implementing measures — Individual concern — Plea of partial illegality — Plant protection products — Regulation (EC) No 1107/2009 — Implementing Regulation (EU) No 540/2011 — Implementing Regulation (EU) 2015/408 — Placing of plant protection products on the market and establishing a list of candidates for substitution — Metalaxyl)
      
         I. Introduction
      
      
               1.
            
            
               The present case concerns the appeal brought by Industrias Químicas del Vallés SA (‘IQV’) against the order of the General Court of the European Union of 16 February 2016, Industrias Químicas del Vallés v Commission (T-296/15, not published, ‘the order under appeal’, EU:T:2016:79).
            
         
               2.
            
            
               By the order under appeal, the General Court dismissed as inadmissible IQV’s action for the partial annulment of Commission Implementing Regulation (EU) 2015/408 of 11 March 2015 on implementing Article 80(7) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and establishing a list of candidates for substitution (‘the regulation at issue’). (
                     2
                  ) The General Court essentially held that the regulation at issue was not of individual concern to the appellant and that, moreover, it entailed, as regards the appellant, implementing measures within the meaning of the final limb of the fourth subparagraph of Article 263 TFEU.
            
         
               3.
            
            
               By its appeal, IQV gives the Court the opportunity to clarify the interpretation of the verb ‘entail’ used in that provision. (
                     3
                  ) Although that term is essential to the application of the aforementioned provision, the Court has not yet actually addressed the issue of its interpretation, be it, for example, in the cases which gave rise to the judgments of 19 December 2013, Telefónica v Commission (C-274/12 P, EU:C:2013:852) or of 28 April 2015, T & L Sugars and Sidul Açúcares v Commission (C-456/13 P, EU:C:2015:284).
            
         
         II. Legal context
      
      
         A. 
            Directive 91/414/EEC
         
      
      
               4.
            
            
               Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (
                     4
                  ) set out, in Annex I thereto, a list of active substances authorised for incorporation in plant protection products.
            
         
               5.
            
            
               In accordance with Article 1 and the annex to Commission Directive 2010/28/EU of 23 April 2010 amending Council Directive 91/414/EEC to include metalaxyl as active substance, (
                     5
                  ) the list contained in Annex I to Directive 91/414 was amended to add, inter alia, metalaxyl.
            
         
         B. 
            Regulation (EC) No 1107/2009
         
      
      
               6.
            
            
               Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (
                     6
                  ) provides, in Article 50 thereof, entitled ‘Comparative assessment of plant protection products containing candidates for substitution’:
               ‘1.   A comparative assessment shall be performed by Member States when evaluating an application for authorisation for a plant protection product containing an active substance approved as a candidate for substitution. Member States shall not authorise or shall restrict the use of a plant protection product containing a candidate for substitution for use on a particular crop where the comparative assessment weighing up the risks and benefits, as set out in Annex IV, demonstrates that:
               …
               4.   For plant protection products containing a candidate for substitution Member States shall perform the comparative assessment provided for in paragraph 1 regularly and at the latest at renewal or amendment of the authorisation.
               Based on the results of that comparative assessment, Member States shall maintain, withdraw or amend the authorisation.’
            
         
               7.
            
            
               Chapter XI, entitled ‘Transitional and final provisions’, contains Article 80 of Regulation No 1107/2009, entitled ‘Transitional measures’, paragraph 7 of which provides:
               ‘By 14 December 2013, the Commission shall establish a list of substances included in Annex I to Directive 91/414/EEC which satisfy the criteria set out in point 4 of Annex II to this Regulation and to which the provisions of Article 50 of this Regulation shall apply.’
            
         
               8.
            
            
               Article 83 of Regulation No 1107/2009, entitled ‘Repeal’ states:
               ‘Without prejudice to Article 80, [Council] Directives 79/117/EEC [of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances (OJ 1978 L 33, p. 36)] and 91/414/EEC, as amended by the acts listed in Annex V, are repealed with effect from 14 June 2011, without prejudice to the obligations of the Member States relating to the time limits for transposition into national law and application of the Directives set out in that Annex.
               References to the repealed Directives shall be construed as references to this Regulation. ...’
            
         
         C. 
            Implementing regulations
         
      
      
         1. Implementing Regulation (EU) No 540/2011
      
      
               9.
            
            
               According to recital 1 and Article 1 of Implementing Regulation (EU) No 540/2011 implementing Regulation No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances, (
                     7
                  ) active substances included in Annex I to Council Directive 91/414/EEC are to be deemed to have been approved under Regulation No 1107/2009.
            
         
         2. The regulation at issue
      
      
               10.
            
            
               Entitled ‘Candidates for substitution’, Article 1 of the regulation at issue is worded as follows:
               ‘Active substances included in Annex I to Directive 91/414/EEC which fulfil the criteria set out in point 4 of Annex II to Regulation (EC) No 1107/2009 shall be as set out in the list in the Annex to this Regulation.
               The first paragraph shall also apply to active substances approved under Regulation (EC) No 1107/2009 pursuant to the transitional measures of Article 80(1).’
            
         
               11.
            
            
               The list in the annex to that regulation includes:
               ‘…
               metalaxyl
               …’
            
         
         III. Background to the dispute
      
      
               12.
            
            
               The background to the dispute was briefly set out by the General Court in paragraphs 1 to 9 of the order under appeal. It can be summarised as follows.
            
         
               13.
            
            
               The appellant is a Spanish company whose activities include the production, sale, distribution, representation and marketing of plant protection products, animal feed products and other chemical products. In particular, it imports an active chemical substance, metalaxyl, into Spain and markets plant protection products containing that active substance in a number of Member States.
            
         
               14.
            
            
               In April 1995, the appellant and another company submitted an application to the competent authorities of the Portuguese Republic requesting the inclusion of metalaxyl in Annex I to Directive 91/414/EEC.
            
         
               15.
            
            
               By Decision 2003/308/EC of 2 May 2003 concerning the non-inclusion of metalaxyl in Annex I to Council Directive 91/414 and the withdrawal of authorisations for plant-protection products containing this active substance, (
                     8
                  ) the Commission rejected the application for the inclusion of metalaxyl on the list of active substances set out in that annex and asked the Member States to withdraw the authorisations for plant-protection products containing metalaxyl and not to grant any further authorisations.
            
         
               16.
            
            
               By judgment of 28 June 2005, Industrias Químicas del Vallés v Commission (T-158/03, EU:T:2005:253), the General Court dismissed the action for annulment brought by the appellant against Decision 2003/308. However, that judgment was set aside by the Court of Justice. (
                     9
                  ) In addition, the Court of Justice, considering that the state of the proceedings permitted final judgment to be given, under the second sentence of the first paragraph of Article 61 of the Statute of the Court of Justice of the European Union, ruled on the substance of the case and annulled Decision 2003/308.
            
         
               17.
            
            
               Following that judgment, the Commission, on 23 April 2010, adopted Directive 2010/28 in order to include the active substance metalaxyl. That directive was ultimately repealed by Regulation No 1107/2009. However, according to recital 1 and Article 1 of Implementing Regulation No 540/2011, active substances listed in Annex I to Directive 91/414 are henceforth deemed to have been approved under Regulation No 1107/2009.
            
         
               18.
            
            
               On 11 March 2015, the Commission adopted the regulation at issue for the purposes of implementing Article 80(7) of Regulation No 1107/2009, the latter provision providing that the Commission must establish a list of substances included in Annex I to Directive 91/414 which satisfy the criteria to be fulfilled in order to be deemed candidates for substitution and to which Article 50 of that regulation applies. That list, which is annexed to the regulation at issue, includes metalaxyl.
            
         
         IV. The procedure before the General Court and the order under appeal
      
      
               19.
            
            
               By application lodged at the Court Registry on 5 June 2015, the appellant brought an action for partial annulment of the regulation at issue and for a declaration that Regulation No 1107/2009 is partly inapplicable.
            
         
               20.
            
            
               By the order under appeal, the General Court upheld the plea of inadmissibility raised by the Commission. It held, first, that the regulation at issue was not of individual concern to the appellant within the meaning of the fourth paragraph of Article 263 TFEU and, secondly, that the regulation at issue was a regulatory act that entails implementing measures within the meaning of the final limb of the fourth paragraph of Article 263 TFEU.
            
         
               21.
            
            
               The General Court also rejected the appellant’s line of argument relating to the infringement of its right to effective judicial protection.
            
         
         V. The forms of order sought by the parties and the procedure before the Court of Justice
      
      
               22.
            
            
               By its appeal, the appellant claims that the Court should set aside the order under appeal, declare its action for annulment of the regulation at issue admissible and refer the case back to the General Court for a decision on the substance. It also claims that the Court should order the Commission to pay the costs of the appeal proceedings.
            
         
               23.
            
            
               The Commission contends that the Court should dismiss the appeal and order the appellant to pay the costs.
            
         
         VI. The appeal
      
      
               24.
            
            
               The appellant relies on three grounds in support of its appeal. First, it argues that the General Court committed an error of law in considering that the regulation at issue was a regulatory act that entails, with regard to the appellant, implementing measures within the meaning of the final limb of the fourth paragraph of Article 263 TFEU. Secondly, it submits that the General Court committed an error of law in holding that the inadmissibility of the appellant’s action did not deprive it of effective judicial protection. Finally and thirdly, the General Court committed an error of law in considering that the regulation at issue was not of individual concern to the appellant.
            
         
               25.
            
            
               Furthermore, the appellant submits that it is directly concerned by the regulation at issue.
            
         
         A. 
            The first ground of appeal, concerning the absence of measures implementing the regulation at issue
         
      
      
         1. Arguments of the parties
      
      
               26.
            
            
               By its first ground of appeal, the appellant disputes paragraphs 39 to 41, 43 to 46, 48 to 50, 58 and 59 of the order under appeal. It criticises the General Court for having held that the regulation at issue entails implementing measures within the meaning of the final limb of the fourth paragraph of Article 263 TFEU.
            
         
               27.
            
            
               According to the appellant, the classification of metalaxyl as ‘a candidate for substitution’ and the subsequent application of the regime established by Regulation No 1107/2009 arise without the need for implementing measures.
            
         
               28.
            
            
               First, while any renewal of the authorisation for metalaxyl is to be formally laid down by an act of the Commission following an application to that effect made by IQV, that act cannot be considered a measure implementing the regulation at issue, but rather must be regarded as a measure implementing Regulation No 1107/2009, which governs the procedure for the renewal of approval for active substances.
            
         
               29.
            
            
               Next, the appellant submits that the regulation at issue has the immediate effect of making plant protection products containing metalaxyl registered by IQV and their use subject to the comparative assessment referred to in Article 50 of Regulation No 1107/2009. Article 50(4) of that regulation requires Member States to perform the comparative assessment regularly and, at the latest, at renewal or amendment of the authorisation.
            
         
               30.
            
            
               In finding, in paragraph 43 of the order under appeal, that the performance of that comparative assessment has no bearing on the circumstances in which the marketing authorisations are granted or refused, renewed, withdrawn or amended by Member States, the General Court does not take account of the fact that the effect of the regulation at issue is unconnected with any decision taken by a national authority.
            
         
               31.
            
            
               Since any measures that the national authorities take will have no effect on the legal status of metalaxyl as a candidate for substitution or on the regime introduced by Regulation No 1107/2009, they cannot be regarded as measures implementing the regulation at issue.
            
         
               32.
            
            
               Lastly, the appellant submits that a similar conclusion must be drawn in relation to the principle of mutual recognition of plant protection products between Member States. As a result of the adoption of the regulation at issue, mutual recognition of a product containing a candidate for substitution is no longer automatic, as is the case, by contrast, for all other active substances.
            
         
               33.
            
            
               The Commission contends that that first ground of appeal is unfounded.
            
         
               34.
            
            
               It appears to accept that the legal basis of acts adopted by the Commission or by the Member States as a result of the inclusion of metalaxyl on the list of candidates for substitution will not be the regulation at issue but rather Regulation No 1107/2009. However, the Commission argues that those acts are implementing measures within the meaning of the fourth paragraph of Article 263 TFEU since they give the appellant a means of accessing a court, ‘in accordance with the logic of that provision’. (
                     10
                  )
            
         
               35.
            
            
               Next, the appellant’s argument that the acts of the Commission or of the Member States will have no effect on the classification of metalaxyl as a ‘candidate for substitution’, or on the legal regime established by Regulation No 1107/2009 for that category of substances, is irrelevant. As the General Court indicated in paragraph 59 of the order under appeal, the appellant could invoke, as an incidental matter, the unlawfulness of the classification of metalaxyl as a ‘candidate for substitution’ and of the legal regime established by Regulation No 1107/2009 for those substances.
            
         
               36.
            
            
               Lastly, the Commission submits that the fact that Member States may carry out a comparative assessment of plant protection products containing metalaxyl without a prior application for authorisation or renewal makes no difference, since such a decision by the Member States could be challenged before the national courts if it altered the appellant’s legal position. In addition, if the comparative assessment were negative for one or more products and could, consequently, harm the appellant’s interests, the Member State would withdraw the authorisation granted to it. That withdrawal would take the form of an act which could also be challenged.
            
         
         2. Analysis
      
      
         (a) Preliminary observation on the interpretation of the final limb of the fourth paragraph of Article 263 TFEU
      
      
               37.
            
            
               In its appeal, IQV submits that the classification of metalaxyl as a ‘candidate for substitution’ and the consequent application of the regime established in Regulation No 1107/2009 occur in an ‘immediate and direct’ manner, and do not require any implementing measure. (
                     11
                  )
            
         
               38.
            
            
               The issue of interpretation before the Court therefore consists in determining whether making metalaxyl subject to the specific rules provided for in Regulation No 1107/2009 constitutes a mere ‘effect’ of the regulation at issue, which would thus not require any implementing measure in the strict sense, or whether, on the contrary, acts taken by the Commission or Member States pursuant to the specific rules of Regulation No 1107/2009 must be regarded as measures implementing the regulation at issue, since it is only by means of those acts that those rules have practical effects vis-à-vis the appellant.
            
         
               39.
            
            
               From a more theoretical perspective, the question is whether the verb ‘entail’ used in the final limb of the fourth paragraph of Article 263 TFEU refers solely to implementing measures adopted on the immediate basis of regulatory act ‘B’ or whether its scope may be extended to acts adopted on the basis of an earlier regulation ‘A’, but on account of the adoption of regulation ‘B’, which is essential for its application, that is to say in an indirect sequential chain or, in effect, as a repercussion.
            
         
               40.
            
            
               It is not necessary to recall that the fourth paragraph of Article 263 was amended by the Lisbon Treaty so as to provide a third direct route of access to the courts in their role as arbiters of legality. Now, ‘any natural or legal person may … institute proceedings against an act addressed to that person or which is of direct and individual concern to them, and against a regulatory act which is of direct concern to them and does not entail implementing measures’ (
                     12
                  ).
            
         
               41.
            
            
               While the Court has acknowledged that that third limb of the fourth paragraph of Article 263 TFEU ‘relaxed the conditions of admissibility of actions for annulment brought by natural and legal persons’, (
                     13
                  ) it nevertheless adopted a restrictive interpretation of it.
            
         
               42.
            
            
               First, in interpreting the concept of ‘regulatory act’, it stated that ‘the purpose of the alteration to the right of natural and legal persons to institute legal proceedings, laid down in the fourth paragraph of Article 230 EC, was to enable those persons to bring, under less stringent conditions, actions for annulment of acts of general application other than legislative acts’. (
                     14
                  )
            
         
               43.
            
            
               Next, as regards the condition relating to the absence of implementing measures, a general framework of analysis was defined in the case that gave rise to the judgment of 19 December 2013, Telefónica v Commission (C-274/12 P, EU:C:2013:852):
               
                        –
                     
                     
                        first, the Court considers that where a regulatory act entails implementing measures, ‘judicial review of compliance with the European Union legal order is ensured irrespective of whether those measures are adopted by the European Union or the Member States’. (
                              15
                           ) An individual may, in the first case, challenge the implementing measures directly before the Courts of the European Union and plead in support of its action the illegality of the basic act, pursuant to Article 277 TFEU, and, in the second case, call into question the validity of the basic act before the national court which may request a preliminary ruling from the Court pursuant to Article 267 TFEU; (
                              16
                           )
                     
                  
                        –
                     
                     
                        Secondly, the Court limits its assessment of the existence of implementing measures ‘to the position of the person pleading the right to bring proceedings under the final limb of the fourth paragraph of Article 263 TFEU. It is therefore irrelevant whether the act in question entails implementing measures with regard to other persons’, (
                              17
                           ) and
                     
                  
                        –
                     
                     
                        thirdly, ‘reference should be made exclusively to the subject-matter of the action and, where an applicant seeks only the partial annulment of an act, it is solely any implementing measures which that part of the act may entail that must, as the case may be, be taken into consideration’. (
                              18
                           )
                     
                  
         
               44.
            
            
               The Court continued to apply a restrictive interpretation with the judgment of 28 April 2015, T & L Sugars and Sidul Açúcares v Commission (C-456/13 P, EU:C:2015:284), taking the view that the allegedly mechanical nature of the measures taken at national level is a question which is ‘irrelevant in ascertaining whether [the] regulations [at issue] entail implementing measures within the meaning of the final limb of the fourth paragraph of Article 263 TFEU’. (
                     19
                  ) Specifically, that means that ‘the condition relating to the absence of implementing measures is distinct from that of direct concern’. (
                     20
                  )
            
         
               45.
            
            
               By excluding legislative acts from the concept of ‘regulatory act’ and by including any act adopted by the European Union or by a Member State on the basis of an act of general application of EU law within the concept of ‘implementing measure’, the Court reduced the scope of the final limb of the fourth paragraph of Article 263 TFEU to its most simple expression.
            
         
               46.
            
            
               Moreover, if the term ‘entail’ had to be interpreted as meaning that it covers any act adopted following an EU act, I would then have to concur with those who without hesitation concluded that the interpretation of the final limb of the fourth paragraph of Article 263 recalled in points 42 to 44 of this Opinion made practically no change to an individual’s access to the Court on the basis of the fourth paragraph of Article 263 TFEU. (
                     21
                  )
            
         
               47.
            
            
               As the Court again recently recalled in order to support its jurisdiction in matters relating to common foreign and security policy, first, ‘Article 47 of the Charter, which constitutes a reaffirmation of the principle of effective judicial protection, requires, in its first paragraph, that any person whose rights and freedoms guaranteed by EU law are violated should have the right to an effective remedy before a tribunal in compliance with the conditions laid down in that article [and, secondly,] the very existence of effective judicial review designed to ensure compliance with provisions of EU law is of the essence of the rule of law’. (
                     22
                  ) In that regard, it is clear from the case-law of the Court that procedural disadvantages, in terms, inter alia, of cost, duration and the rules of representation, are not irrelevant when assessing whether effective judicial protection has been ensured, at least in relation to Member States. (
                     23
                  ) I cannot imagine that different rules apply for the European Union. Undoubtedly, to require an individual to exercise an indirect remedy — supposing one exists — when a direct remedy could be permitted, without infringing the conditions of the treaty, would result in such procedural disadvantages.
            
         
         (b) The term ‘entail’
      
      
               48.
            
            
               The conclusion of my preliminary observation leads me to take the view that the verb ‘entail’ used in the final limb of the fourth paragraph of Article 263 must be interpreted as referring solely to implementing measures that must necessarily be adopted on the immediate basis of a regulatory act.
            
         
               49.
            
            
               Its literal interpretation, the objective pursued by the amendment to Article 230 EC and the principle of legal certainty lend weight to that interpretation of the term ‘entail’.
            
         
               50.
            
            
               First, considering the meaning of the word used in the French version, I note that ‘comporter’ (‘entail’ in the English version) means ‘inclure en soi’ (‘to include within itself’). (
                     24
                  ) A regulatory act that does not entail an implementing measure is therefore an act whose implementation does not require or necessitate any supplementary act, that is to say a self-contained act. (
                     25
                  )
            
         
               51.
            
            
               This does not mean therefore that merely identifying a measure as having been taken following the regulatory act at issue is sufficient to dismiss the action brought against it. On the contrary, since an act of general application actionable on the basis of the final limb of the fourth paragraph of Article 263 TFEU must be sufficient in itself to be directly challenged on that basis, the use of the word ‘entail’ requires that the measure identified has an immediate causal link with the rule of general application. (
                     26
                  ) If no such link exists between the two acts, it cannot be claimed that the second is required or made necessary by the first.
            
         
               52.
            
            
               In order to avoid, as far as possible, any controversy or difficulty, that causal link must be treated in the same way as the legal basis. Unlike the interpretation of the legal link necessary for the application of Article 277 TFEU, an indirect interference by the contested act in the process of adopting the executive measure identified cannot suffice. (
                     27
                  ) In the present case, the regulation at issue is only indirectly applicable to the case which was brought following measures possibly adopted on the direct basis of Regulation No 1107/2009 by the Commission and the Member States.
            
         
               53.
            
            
               Furthermore, the objective pursued by adding to the fourth paragraph of Article 263 TFEU a third channel of access to the courts in their role as arbiters of legality confirms that interpretation. As the Court stated in paragraph 60 in its judgment of 3 October 2013, Inuit Tapiriit Kanatami and Others v Parliament and Council (C-583/11 P, EU:C:2013:625), the purpose of the alteration to the right of natural and legal persons to institute legal proceedings, laid down in the fourth paragraph of Article 230 EC, was to enable those persons to bring actions for annulment under less stringent conditions. It is ‘in order to strengthen the judicial protection of natural or legal persons with regard to acts of the European Union [that] the Treaty of Lisbon broadened the conditions of admissibility of an action for annulment, through the adoption of the fourth paragraph of Article 263 TFEU, which authorises such an action against a regulatory act which directly concerns such a person and does not entail implementing measures’. (
                     28
                  )
            
         
               54.
            
            
               The more the scope of the condition relating to the existence of implementing measures is broadened, the more the scope of the extension inserted into the fourth paragraph of Article 263 TFEU is reduced.
            
         
               55.
            
            
               Lastly, a concern for legal certainty reinforces the need to limit the scope of the term ‘entail’. It must be remembered that, in accordance with the judgment of 9 March 1994, TWD Textilwerke Deggendorf (C-188/92, EU:C:1994:90), a person who would unquestionably have had standing to bring proceedings under the fourth paragraph of Article 263 TFEU for the annulment of an act of the European Union cannot, after the expiry of the time limit for bringing proceedings laid down in the sixth paragraph of Article 263 TFEU, contest the validity of that act before the national courts. The same rule applies to the objection of illegality established in Article 277 TFEU. (
                     29
                  ) The Court recently had occasion to confirm that the broadening of the conditions of admissibility of an action for annulment established by the Treaty of Lisbon was not accompanied by any corresponding abandonment of that case-law. (
                     30
                  )
            
         
               56.
            
            
               Consequently, the more distant the link between the regulatory act and the implementing measure, the harder it is for an individual to determine whether he is able to challenge that regulatory act before the General Court on the basis of the fourth paragraph of Article 263 TFEU. This uncertainty constitutes not only a risk for an individual — who may find that the General Court declares his action for annulment of the regulatory act inadmissible or that a national court refuses to make a reference for a preliminary ruling — but also an uncertainty within the legal order of the European Union, as the identification of an implementing measure in connection with the regulatory act at issue may vary from individual to individual or from court to court.
            
         
               57.
            
            
               In conclusion, the literal and teleological interpretations, as well as the principle of legal certainty, lead me to take the view that the verb ‘entail’ used in the final limb of the fourth paragraph of Article 263 TFEU must be interpreted as referring solely to implementing measures which are necessarily adopted on the immediate basis of a regulatory act.
            
         
               58.
            
            
               It is true that an isolated interpretation of the regulation at issue could seem artificial. There is no doubt that if the list of candidates for substitution had been annexed to Regulation No 1107/2009 and not to a separate regulation, the issue of the existence of implementing measures would probably not arise, since the effects of classifying metalaxyl as a ‘candidate for substitution’ would necessarily be defined by implementing measures for that single regulation. However, that consideration cannot, to my mind, influence the analysis. Without prejudice to any misuse of powers or the infringement of a rule conferring competency which would invalidate the act at issue, the choice of legal instrument falls within the exclusive competence of the author of the act and not of the Court.
            
         
         (c) The application of the final limb of the fourth paragraph of Article 263 TFEU by the General Court
      
      
               59.
            
            
               The General Court held that the regulation at issue constituted a regulatory act within the meaning of the final limb of the fourth paragraph of Article 263 TFEU. That classification is not disputed.
            
         
               60.
            
            
               As the General Court usefully stated in paragraphs 31 and 32 of the order under appeal, the regulation at issue is an act of general application which applies to objectively determined situations and which produces legal effects with respect to categories of persons envisaged in general and in the abstract. Moreover, the regulation at issue must be regarded as a non-legislative act since, according to the criteria applied by the Court for the application of the final member of the fourth paragraph of Article 263 TFEU, it was not adopted in accordance with an ordinary or special legislative procedure.
            
         
               61.
            
            
               However, I take the view that the General Court erred in law in concluding, in paragraphs 41, 44 and 48 of the order under appeal, respectively that:
               
                        –
                     
                     
                        ‘the effects of the … regulation [at issue] on the period of validity of the approval renewal for a previously-approved substance which is a candidate for substitution, such as metalaxyl, will affect [IQV] only through a regulation adopted by the Commission in the course of renewing that approval’, such a regulation thus constituting an implementing measure within the meaning of the final limb of the fourth paragraph of Article 263 TFEU;
                     
                  
                        –
                     
                     
                        ‘the effects of the … regulation [at issue] relating to the Member States’ performance of a comparative assessment of the health or environmental risks of plant protection products containing metalaxyl, as compared to an alternative or a non-chemical method of pest control or prevention, will affect [IQV] only through measures adopted by the competent authorities of the Member States’, such measures accordingly constituting implementing measures within the meaning of the final limb of the fourth paragraph of Article 263 TFEU; and that,
                     
                  
                        –
                     
                     
                        ‘the effects of the … regulation [at issue] relating to the mutual recognition of marketing authorisations for plant protection products containing a candidate for substitution concern solely the discretion left to the Member States to decide on an application. Those effects will, as the case may be, affect [IQV] only through measures adopted by the national authorities deciding on applications for mutual recognition submitted by [IQV]’, such measures accordingly being implementing measures within the meaning of the final limb of the fourth paragraph of Article 263 TFEU.
                     
                  
         
               62.
            
            
               Contrary to the General Court’s decision, I consider that the various measures cited above do not constitute measures implementing the regulation at issue within the meaning of the final limb of the fourth paragraph of Article 263 because they are not adopted on the immediate basis of it. Rather, as the Commission itself appears to acknowledge, the legal basis of each of those measures will be a provision of Regulation No 1107/2009. (
                     31
                  )
            
         
               63.
            
            
               It is true that the adoption of the regulation at issue was a necessary condition of the application of provisions of Regulation No 1107/2009 relating to candidates for substitution. However, once the active substance has been included on the list of candidates for substitution by the regulation at issue, the provisions of Regulation No 1107/2009 specific to those substances apply automatically. The regulation at issue therefore does not constitute the immediate basis of the measures which will be adopted by the Commission or Member States.
            
         
               64.
            
            
               On the contrary, as IQV correctly submits, the regulation at issue produces its specific effects per se. It is, in other words, self-contained: the inclusion of metalaxyl as a candidate for substitution is immediate and direct merely upon application of the regulation at issue.
            
         
               65.
            
            
               That inclusion is precisely the subject of the action for annulment brought by IQV. Therefore, since the measures that the Commission or Member States will adopt, where appropriate, on the basis of Regulation No 1107/2009 in respect of metalaxyl will not have any effect on the inclusion of that substance on the list of candidates for substitution, there is no need to take them into account. In assessing the admissibility of an action brought pursuant to the final limb of the fourth paragraph of Article 263, the assessment should be limited exclusively to the position of the person pleading the right to bring proceedings and reference should be made exclusively to the subject matter of the action. (
                     32
                  )
            
         
               66.
            
            
               Furthermore, I cannot subscribe to the Commission’s conclusion that acts adopted on the basis of Regulation No 1107/2009 are implementing measures within the meaning of the fourth paragraph of Article 263 TFEU ‘since they … provide a means of accessing a court, in accordance with the logic of that provision’. (
                     33
                  )
            
         
               67.
            
            
               It is true that the fourth paragraph of Article 263 TFEU was amended to avoid a situation whereby an individual would be obliged to infringe EU law to access a court. However, that concern and the subsequent amendment of the Treaty must be viewed within the overall framework of the system of legal remedies as envisaged by the Court, the coherence of which ensures completeness of the system of review of legality established by the Treaty.
            
         
               68.
            
            
               The Court’s statement that ‘the FEU Treaty has established, by Articles 263 and 277, on the one hand, and Article 267, on the other, a complete system of legal remedies and procedures designed to ensure judicial review of the legality of European Union acts, and has entrusted such review to the Courts of the European Union’ (
                     34
                  ) is attributable to a corrective logic. The Court asserts that the system is complete because, as a result of the plea of illegality and the reference for a preliminary ruling on validity, ‘natural and legal persons are thus protected against the application to them of general measures which they cannot contest directly before the Court by reason of the special conditions of admissibility laid down in [the fourth paragraph of Article 263 TFEU]’. (
                     35
                  ) The indirect mechanisms for reviewing legality therefore have a compensatory function. (
                     36
                  )
            
         
               69.
            
            
               I consider that widening the scope of one of the conditions imposed in the fourth paragraph of Article 263 TFEU in such a way as to exclude the Court’s jurisdiction to annul measures in favour of an indirect remedy would be to overturn the logic of the system. It is not the conditions of admissibility in the fourth paragraph of Article 263 TFEU that must be interpreted in the light of a hypothetical compensatory legal remedy. Rather, it is the conditions of the compensatory remedies which must, where appropriate, be interpreted broadly because direct access to the Courts of the European Union is not possible.
            
         
               70.
            
            
               To my mind, that approach was confirmed by the Court in the case which gave rise to the order of 16 November 2000, Schiocchet v Commission (C-289/99 P, EU:C:2000:641). In that order, the Court confirms that the possibility which Article 277 TFEU affords of invoking the inapplicability of a regulation can constitute only a plea in support of an action and not the subject matter of the action and that ‘therefore the admissibility of the action itself must be assessed by reference to the relief claimed in it, irrespective of any pleas of illegality which might be raised in support of it’. (
                     37
                  )
            
         
               71.
            
            
               Consequently, since IQV has put forward a plea of illegality against Regulation No 1107/2009, it is not, in my view, illogical to refer to the rules of that regulation in the examination of the substance of the application for annulment of the regulation at issue but not taking it into account for assessing the admissibility of that action. In the present case, IQV seems to me, therefore, to have fully respected the relationship between the legal remedies by contesting, on the one hand, the regulation at issue and by raising, on the other hand, in support of its action, a plea of illegality against Regulation No 1107/2009. (
                     38
                  )
            
         
               72.
            
            
               That procedural choice distinguishes, moreover, the present case from that which gave rise to the judgment of 28 April 2015, T & L Sugars and Sidul Açúcares v Commission (C-456/13 P, EU:C:2015:284).
            
         
               73.
            
            
               At first sight, the latter case may seem to be concerned with a similar mechanism, that is to say a situation where a factor that is essential for the application of implementing regulation X, on the basis of which implementing measures will be adopted, is determined by implementing regulation Y.
            
         
               74.
            
            
               However, the applicants in that case did not raise a plea of illegality but were seeking the annulment of two regulations. The implementing measures identified by the Court in paragraph 40 of that judgment are based expressly on the two regulations in question: although the applications for certificates are based on Commission Implementing Regulation (EU) No 302/2011 of 28 March 2011 opening an exceptional import tariff quota for certain quantities of sugar in the 2010/11 marketing year, (
                     39
                  ) the decisions of national authorities following those applications apply the coefficients fixed by Commission Implementing Regulation (EU) No 393/2011 of 19 April 2011 fixing the allocation coefficient for the issuing of import licences applied for from 1 to 7 April 2011 for sugar products under certain tariff quotas and suspending submission of applications for such licences. (
                     40
                  )
            
         
               75.
            
            
               In paragraph 40 of the judgment of 28 April 2015, T & L Sugars and Sidul Açúcares v Commission (C-456/13 P, EU:C:2015:284) the Court held that ‘Implementing Regulations No 302/2011 and No 393/2011 produce their legal effects vis-à-vis the appellants only through the intermediary of acts taken by the national authorities following the submission of applications for certificates on the basis of Implementing Regulation No 302/2011’. However, the Court took care to specify that ‘the decisions of the national authorities granting such certificates … apply the coefficients fixed by Implementing Regulation No 393/2011 to the operators concerned’, which is why ‘the decisions refusing such certificates in full or in part therefore constitute implementing measures within the meaning of the final limb of the fourth paragraph of Article 263 TFEU’.
            
         
               76.
            
            
               By contrast, in the present case, IQV is not seeking the annulment of the regulation on the basis of which any implementing measures will be adopted.
            
         
         3. Conclusion on the first ground of appeal
      
      
               77.
            
            
               Since the implementing measures identified by the General Court are measures which are based not immediately on the regulation at issue but on Regulation No 1107/2009, I consider that the first ground of appeal relied upon by IQV must be upheld. The order under appeal should therefore be set aside in so far as the General Court held that the regulation at issue entailed implementing measures within the meaning of the final limb of the fourth paragraph of Article 263 TFEU.
            
         
               78.
            
            
               Consequently, I shall examine the second and third grounds of appeal only in the alternative.
            
         
         B. 
            The third ground of appeal, relating to the individual concern of IQV
         
      
      
               79.
            
            
               I shall first examine the third ground of appeal. The second ground of appeal is concerned with the question of the absence of effective judicial protection of the appellant in the event that it had no direct right to bring an action before the Courts of the European Union. The third ground of appeal concerns the condition of individual concern to the appellant. Consequently, if the third ground of appeal were held to be well founded, the action for annulment brought by IQV before the General Court could still be upheld, provided that IQV is also directly concerned by the regulation at issue.
            
         
               80.
            
            
               The question whether IQV’s right to effective judicial protection is affected by the order under appeal therefore arises only if the General Court declared IQV’s action inadmissible on the basis of a correct interpretation of the fourth paragraph of Article 263 TFEU. It therefore seems more logical to examine the second and third grounds of appeal in reverse order. (
                     41
                  )
            
         
         1. Arguments of the parties
      
      
               81.
            
            
               By its third ground of appeal, the appellant complains that the General Court held, in paragraphs 28 and 29 of the order under appeal, that the regulation at issue was not of individual concern to the appellant.
            
         
               82.
            
            
               In support of that ground of appeal, the appellant refers to the fact that it was the sole notifier of metalaxyl and, accordingly, that it alone supported the authorisation process for that substance in the European Union. The previous actions brought before the General Court and before the Court also play a role in distinguishing the appellant individually since they led to the annulment of an initial negative decision of the Commission and to the adoption of a directive concerning the inclusion of metalaxyl. (
                     42
                  )
            
         
               83.
            
            
               Accordingly, since IQV is the only undertaking in the European Union to have advocated for the inclusion of metalaxyl during the adoption of the regulation at issue and, consequently, the only undertaking responsible for that inclusion, that regulation is of individual concern to it. That factual circumstance distinguishes IQV, as regards metalaxyl, from any other person.
            
         
               84.
            
            
               The appellant adds that it follows from recital 4 of the regulation at issue that that regulation was adopted, inter alia, on the basis of substance review reports. In one of those reports, it is indicated that the appellant was the sole notifier of metalaxyl.
            
         
               85.
            
            
               The Commission submits that the third ground of appeal is inadmissible because the appellant does not raise any arguments from which it might be concluded that the General Court erred in holding that the fact that the appellant was the only undertaking to apply for the inclusion of metalaxyl on the list of active substances set out in Regulation No 1107/2009 was not enough to distinguish it individually as regards the regulation at issue.
            
         
               86.
            
            
               The ground of appeal is, in any event, unfounded since the appellant is concerned, as indicated in paragraph 28 of the order under appeal, only due to its objective position as an importer of metalaxyl and a vendor of products containing that substance, on the same ground as any other operator which is, currently or potentially, in an identical situation.
            
         
         2. Analysis
      
      
               87.
            
            
               I agree with the Commission’s observations concerning the admissibility of the third ground of appeal raised by the appellant in support of its appeal.
            
         
               88.
            
            
               According to Article 169 of the Rules of Procedure of the Court of Justice, the pleas in law relied on must ‘identify precisely those points in the grounds of the decision of the General Court which are contested’. According to settled case-law, this means that an appeal must indicate precisely the contested elements of the judgment which the appellant seeks to have set aside and also the legal arguments specifically advanced in support of the appeal. (
                     43
                  ) Consequently, a ground of appeal which does not contain any legal argument to demonstrate the manner in which the General Court allegedly erred in law and which merely constitutes a request to have the action brought at first instance reexamined does not meet those requirements. (
                     44
                  )
            
         
               89.
            
            
               In the present case, the appellant identifies the paragraphs of the order which it seeks to contest. However, it has not put forward any legal argument to demonstrate an error of law in paragraphs 28 and 29 of the order under appeal. IQV merely reiterates the factual circumstances which, in its submission, distinguish it individually and which it already submitted before the General Court, itself specifying the relevant paragraphs of the application, (
                     45
                  ) without in any way criticising the legal reasoning on which the order under appeal is based.
            
         
               90.
            
            
               Thus, the third ground of appeal actually seeks to have the Court merely reexamine arguments put forward before the General Court and carry out a new assessment of the facts. It must therefore be rejected as manifestly inadmissible.
            
         
         C. 
            The second ground of appeal, relating to effective judicial protection for IQV
         
      
      
         1. Arguments of the parties
      
      
               91.
            
            
               By its second ground of appeal, the appellant criticises the General Court for having considered that the rejection of its action as inadmissible did not deprive it of its right to effective judicial protection.
            
         
               92.
            
            
               The appellant submits that it is not able to contest a national implementing measure allowing it to challenge the effects of the regulation at issue. As long as a national authority does not make a decision on the substitution of metalaxyl, that active substance must be subject to periodic comparative assessments. If the national authority does not make a decision on the substitution of metalaxyl following those comparative assessments, the appellant claims that it will be unable to appeal against those ‘decisions’ because it will have no legal interest in bringing proceedings against an act which does not adversely affect it.
            
         
               93.
            
            
               The appellant would then be obliged to prompt the adoption of a negative decision by the national authorities, in order to be able to bring an action against it and challenge, within the context of that action, the classification of metalaxyl as a ‘candidate for substitution’.
            
         
               94.
            
            
               The Commission contends that the ground of appeal is inadmissible because IQV merely reiterates the arguments put forward before the General Court without identifying any error of law in the order under appeal. In the alternative, it contends that the ground of appeal is unfounded.
            
         
         2. Analysis
      
      
               95.
            
            
               I would, a priori, also be inclined to agree with the Commission’s observations concerning the admissibility of the second ground relied on by the appellant in support of its appeal.
            
         
               96.
            
            
               Contrary to the requirements that follow from Article 169 of the Rules of Procedure and from the case-law cited in point 88 above, the appellant does not identify the paragraphs of the order under appeal to which the second ground relates.
            
         
               97.
            
            
               However, it is clear that its criticism concerns all of the General Court’s reasoning relating to the judicial protection of the appellant, that is to say paragraphs 51 to 59 of the order under appeal. It is the conclusion drawn by the General Court from that reasoning which, according to the appellant, constitutes an error of law.
            
         
               98.
            
            
               The second ground of appeal could therefore be held to be admissible. If so, I must state that the General Court did not, in any event, commit an error of law. Although the case-law in question has been widely criticised in the legal literature, since the ‘completeness’ of the system is sometimes illusory, the General Court was simply applying the settled case-law of the Court that the FEU Treaty has established, by Articles 263 and 277, on the one hand, and Article 267, on the other, a complete system of legal remedies and procedures designed to ensure judicial review of the legality of European Union acts, and has entrusted such review to the Courts of the European Union. (
                     46
                  )
            
         
               99.
            
            
               In that context, natural or legal persons who are unable, because of the conditions governing admissibility laid down in the fourth paragraph of Article 263 TFEU, to challenge a regulatory act of the European Union directly before the European Union judicature are protected against the application to them of such an act by the ability to challenge the implementing measures which the act entails. (
                     47
                  )
            
         
               100.
            
            
               ‘Where responsibility for the implementation of those acts lies with the institutions of the European Union …, [natural or legal] persons are entitled to bring a direct action before the Courts of the European Union against the implementing measures under the conditions stated in the fourth paragraph of Article 263 TFEU, and to plead, pursuant to Article 277 TFEU, in support of that action, the illegality of the general act at issue. Where that implementation is a matter for the Member States, such persons may plead the invalidity of the European Union act at issue before the national courts and tribunals and cause the latter to request a preliminary ruling from the Court of Justice, pursuant to Article 267 TFEU.’ (
                     48
                  )
            
         
               101.
            
            
               In the present case, should the Court choose not to adopt my interpretation of a regulatory act ‘which does not entail implementing measures’, the General Court was fully entitled to find that the regulation at issue entails implementing measures within the meaning of the final limb of the fourth paragraph of Article 263 TFEU.
            
         
               102.
            
            
               In those circumstances, it should have been possible indirectly to review both Regulation No 1107/2009 and the regulation at issue. It is true that the regulation at issue will not be the legal basis, in the strict sense, of the implementing measures. However, the case-law of the Court does not require such rigour in the determination of the legal link which must exist between the contested act and the act which is the subject of the plea of illegality in order for Article 277 TFEU to be applicable. (
                     49
                  ) In examining the admissibility of a plea of illegality, the question which arises is whether it would have been possible to adopt the contested act in the absence of the rule to which the plea of illegality refers. (
                     50
                  )
            
         
               103.
            
            
               In the present case, it is clear that any implementing measures that will be adopted on the basis of Regulation No 1107/2009 could not be laid down if metalaxyl had not first been included on the list of candidates for substitution by the regulation at issue.
            
         
               104.
            
            
               Furthermore, rejecting the plea of illegality against the regulation at issue would grant that regulation immunity from any judicial review since a direct action before the Court would be precluded on account of the implementing measures which that regulation ‘entails’. Such immunity would undoubtedly be contrary to a European Union based on the rule of law, which seeks to ensure that the acts of the institutions of the European Union are subject to review by the Court of their compatibility with EU law and, in particular, with the FEU Treaty and the general principles of law. (
                     51
                  ) Such immunity would therefore constitute a lacuna in the system of legal remedies and procedures established by the FEU Treaty in order to confer on the Court the jurisdiction to review the legality of European Union acts. That system would, consequently, no longer be complete.
            
         
         3. Conclusion on the second ground of appeal and supplementary remarks on the impact of Article 19 TEU
      
      
               105.
            
            
               It follows from the foregoing observations that, if the Court considers that the first ground of appeal is unfounded, the General Court did not err in law in holding, in paragraph 58 of the order under appeal, that it was necessary to reject the appellant’s argument that it would be deprived of effective judicial protection if its action were rejected as inadmissible. Even if IQV cannot, as a result of the conditions of admissibility referred to in the fourth paragraph of Article 263 TFEU, bring a direct action against the regulation at issue before the Courts of the European Union, it may, as the General Court noted, in essence, in paragraph 59 of that order, claim in an indirect manner that that regulation is invalid before the courts having jurisdiction.
            
         
               106.
            
            
               That conclusion cannot be called into question by the argument that the appellant will not be able to contest the comparative assessment performed by Member States so long as the national authorities decide to renew the approval of a plant protection product containing metalaxyl, since such a decision would not alter the legal situation of the appellant and would therefore not be accepted as an actionable act by the Spanish courts.
            
         
               107.
            
            
               As the General Court held, in essence, in paragraph 57 of the order under appeal, the second subparagraph of Article 19(1) TEU requires Member States to provide remedies sufficient to ensure effective judicial protection in the fields covered by EU law.
            
         
               108.
            
            
               Furthermore, the case-law of the Tribunal Supremo (Supreme Court, Spain) and of the Tribunal Constitucional (Constitutional Court, Spain) concerning the requirement of an interest in bringing proceedings referred to by IQV in support of its appeal is not such as to alter the scope of Article 263 TFEU.
            
         
               109.
            
            
               Since subparagraph 2 of Article 19(1) TEU imposes an obligation as to the result to be achieved on Member States, ‘it is for the national courts to interpret the conditions of admissibility and the procedural rules governing actions brought before them, such as the requirement for there to be a legal interest in bringing proceedings, in such a way as to enable those rules, wherever possible, to be implemented in such a manner as to contribute to the attainment of the objective, referred to in Article 47 of the Charter of Fundamental Rights of the European Union, of ensuring effective judicial protection of an individual’s rights under EU law’. (
                     52
                  )
            
         
               110.
            
            
               Moreover, if such an interpretation was not possible, it should then be held that ‘the structure of the domestic legal system concerned [was] such that there was no remedy making it possible, even indirectly, to ensure respect for the rights which individuals derive from EU law’. (
                     53
                  ) In those circumstances, it would be for the Member State concerned to create new remedies before the national courts to ensure the observance of EU law. (
                     54
                  )
            
         
               111.
            
            
               It is true that the solutions outlined in the two previous points appear somewhat paradoxical as regards the rigour with which the Court interprets the conditions of admissibility of an action for annulment. (
                     55
                  ) They are nevertheless consistent with the logic behind Article 19 TEU and are the only solutions capable of ensuring that there is no lacuna in the judicial protection enjoyed by the citizens of the European Union.
            
         
               112.
            
            
               In conclusion, having regard to the foregoing considerations, I consider that the second ground of appeal put forward by the appellant in support of its appeal must be rejected as unfounded.
            
         
         VII. The admissibility of the appeal and referral of the case back to the General Court
      
      
               113.
            
            
               Having completed my analysis of the grounds of appeal relied on by the appellant in support of its appeal, I consider that the first ground of appeal must be upheld. The order under appeal should therefore be set aside in so far as the General Court held that the regulation at issue entailed implementing measures within the meaning of the final limb of the fourth paragraph of Article 263 TFEU.
            
         
               114.
            
            
               In accordance with the first paragraph of Article 61 of the Statute of the Court of Justice of the European Union, the Court may, after quashing the decision of the General Court, itself give final judgment in the matter, where the state of the proceedings so permits, or refer the case back to the General Court for judgment.
            
         
               115.
            
            
               In the present case, since the General Court dismissed the action at the stage of the examination of admissibility, the Court cannot itself give a ruling on the substance of the action. However, it has the necessary elements to be able to give a definitive ruling on the plea of inadmissibility raised by the Commission in the procedure at first instance. Both IQV and the Commission submitted observations on the question whether IQV was directly concerned by the regulation at issue. Since it is established and not disputed that the regulation at issue is a regulatory act, that is the only condition imposed in the final limb of the fourth paragraph of Article 263 TFEU which has not yet been examined.
            
         
               116.
            
            
               The appellant submits that it is directly concerned by the regulation at issue. In particular, it notes, first, that the regulation at issue classifies the active substance metalaxyl as an active substance which is a candidate for substitution, making it directly subject to the substantive provisions contained in Regulation No 1107/2009. Accordingly, metalaxyl is subject to more restrictive conditions than those applicable to active substances which are not candidates for substitution. Moreover, that consequence results directly from the regulation at issue and does not afford the Commission, in future procedures for the renewal of approval of metalaxyl, or national authorities, in procedures for the renewal of national authorisations for plant protection products containing metalaxyl or requests for mutual recognition, any discretion as to the classification of metalaxyl as a ‘candidate for substitution’.
            
         
               117.
            
            
               However, the Commission submits that the appellant would be directly concerned by the regulation at issue only if it affected the appellant’s legal situation. The appellant does not specify what effects the classification of a metalaxyl as a ‘candidate for substitution’ has on its legal situation. It is unable to do so since the consequences referred to by the appellant stem not directly from the inclusion of metalaxyl on the list in question but from any subsequent decisions by the Commission or Member States, the adoption of which involves considerable discretion.
            
         
               118.
            
            
               According to the settled case-law of the Court, a natural or legal person is directly concerned by an EU measure if it affects ‘directly the legal situation of the individual and leave[s] no discretion to its addressees, who are entrusted with the task of implementing it, such implementation being purely automatic and resulting from [Union] rules without the application of other intermediate rules’. (
                     56
                  )
            
         
               119.
            
            
               In the present case, contrary to what the Commission claims, the regulation at issue produces a direct effect on the legal situation of the appellant, without there being any need for the European Union or the national authorities of a Member State to intervene. On account of the mere fact that metalaxyl has been included on the list of candidates for substitution by the regulation at issue, the legal rules governing that substance have been amended.
            
         
               120.
            
            
               Although the Commission and the Member States possess a certain margin of discretion in the context of applications for renewal of approval of an active substance or renewal of authorisations for plant protection products and in connection with the comparative assessment provided for in Article 50 of Regulation No 1107/2009, they have no discretion as regards the classification of metalaxyl as a ‘candidate for substitution’ or, consequently, concerning the legal rules applicable. The discretion of the Commission and Member States will apply only in the context of the application of Regulation No 1107/2009. However, that regulation is not the one which the appellant is seeking to have annulled.
            
         
               121.
            
            
               Consequently, I am of the view that the appellant is entitled to bring an action for annulment of the regulation at issue on the basis of the final limb of the fourth paragraph of Article 263 TFEU since it is a regulatory act which concerns the appellant directly and which does not entail implementing measures within the meaning of that provision.
            
         
         VIII. Conclusion
      
      
               122.
            
            
               It seems indisputable that a person such as the IQV would not be entitled to bring proceedings against Regulation No 1107/2009. Two of the three conditions contained in the final limb of the fourth paragraph of Article 263 TFEU would not be fulfilled. First, despite being regulatory in nature for the purposes of the fourth paragraph of Article 263 TFEU, that regulation necessarily entails implementing measures. Secondly, it does not alter the legal situation of the persons concerned unless the Commission or Member States exercise their discretion.
            
         
               123.
            
            
               The appellant seems to me, therefore, to have fully respected the interplay between the remedies established by the treaty and consistently recalled by the Court. It is bringing an action for annulment of a regulation which leads, for it, to the application of legal rules which are detrimental to it and is relying, in the context of that direct action, on the illegality of the regulation establishing that derogation on the basis of Article 277 TFEU. That dynamic between the available remedies is such as to ensure both the effective judicial protection of the appellant and also the certainty of the legal order of the European Union. It provides a uniform solution to an issue of legality by means of a single procedure, which is quicker and less costly than a multitude of hypothetical and future references for a preliminary ruling.
            
         
               124.
            
            
               In the light of the foregoing considerations, I therefore propose that the Court:
               – Primarily:
               
                        (1)
                     
                     
                        Set aside the order of the General Court of the European Union of 16 February 2016, Industrias Químicas del Vallés v Commission (T-296/15, not published, EU:T:2016:79);
                     
                  
                        (2)
                     
                     
                        Declare admissible the action for annulment brought by Industrias Químicas del Vallés SA against Commission Implementing Regulation (EU) 2015/408 of 11 March 2015 on implementing Article 80(7) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and establishing a list of candidates for substitution;
                     
                  
                        (3)
                     
                     
                        Refer the case back to the General Court of the European Union for a ruling on the substance;
                     
                  
                        (4)
                     
                     
                        Order that the costs be reserved.
                     
                  – In the alternative, in the event that the Court finds the first ground of appeal to be unfounded:
               
                        (1)
                     
                     
                        Dismiss the appeal;
                     
                  
                        (2)
                     
                     
                        Order Industrias Químicas del Vallés SA to bear the costs.
                     
                  
         (
            1
         )	Original language: French.
      (
            2
         )	OJ 2015 L 67, p. 18.
      (
            3
         )	See, also, the appeal brought against the order of the General Court of the European Union of 27 April 2016, European Union Copper Task Force v Commission (T‑310/15, not published, EU:T:2016:265) (Case C-384/16 P, European Union Copper Task Force v Commission) and my Opinion delivered on the same day in that case.
      (
            4
         )	OJ 1991 L 230, p. 1.
      (
            5
         )	OJ 2010 L 104, p. 57.
      (
            6
         )	OJ 2009 L 309, p. 1.
      (
            7
         )	OJ 2011 L 153, p. 1.
      (
            8
         )	OJ 2003 L 113, p. 8.
      (
            9
         )	Judgment of 18 July 2007, Industrias Químicas del Vallés v Commission (C‑326/05 P, EU:C:2007:443).
      (
            10
         )	See paragraph 12 of the Commission’s response.
      (
            11
         )	See paragraph 33 of the appeal.
      (
            12
         )	Fourth paragraph of Article 263 TFEU. Emphasis added.
      (
            13
         )	Judgment of 3 October 2013, Inuit Tapiriit Kanatami and Others v Parliament and Council (C-583/11 P, EU:C:2013:625, paragraph 57).
      (
            14
         )	Judgment of 3 October 2013, Inuit Tapiriit Kanatami and Others v Parliament and Council (C-583/11 P, EU:C:2013:625, paragraph 60; emphasis added). As I have already had occasion to point out, that interpretation leads to the paradox that the case which gave rise to the judgment of 25 July 2002, Unión de Pequeños Agricultores v Council (C-50/00 P, EU:C:2002:462) would again result in a finding of inadmissibility, even though it gave rise to the amendment of the fourth paragraph of Article 263 TFEU (see point 58 of my Opinion in Stichting Woonpunt and Others v Commission (C-132/12 P, EU:C:2013:335)).
      (
            15
         )	Judgment of 19 December 2013, Telefónica v Commission (C-274/12 P, EU:C:2013:852, paragraph 28).
      (
            16
         )	See, to that effect, judgment of 19 December 2013, Telefónica v Commission (C-274/12 P, EU:C:2013:852, paragraph 29).
      (
            17
         )	Judgment of 19 December 2013, Telefónica v Commission (C-274/12 P, EU:C:2013:852, paragraph 30).
      (
            18
         )	Judgment of 19 December 2013, Telefónica v Commission (C-274/12 P, EU:C:2013:852, paragraph 31).
      (
            19
         )	Paragraph 42. See also, judgments of 10 December 2015, Canon Europa v Commission (C-552/14 P, not published, EU:C:2015:804, paragraph 47) and of 10 December 2015, Kyocera Mita Europe v Commission (C-553/14 P, not published, EU:C:2015:805, paragraph 46).
      (
            20
         )	Order of 14 July 2015, Forgital Italy v Council (C-84/14 P, not published, EU:C:2015:517, paragraph 43).
      (
            21
         )	See, to that effect, Mastroianni, R., and Pezza, A., ‘Striking the Right Balance: Limits on the Right to Bring an Action under Article 263(4) of the Treaty on the Functioning of the European Union’, American University International Law Review, 2015, (30:4), pp. 443 to 795, in particular p. 793. Those authors go so far as to state that the Court’s interpretation of the concept of ‘implementing measures’ within the meaning of the final limb of the fourth paragraph of Article 263 TFEU ‘makes it practically impossible for private applicants … to bring a case before EU courts’.
      (
            22
         )	Judgment of 28 March 2017, Rosneft (C-72/15, EU:C:2017:236, paragraph 73).
      (
            23
         )	Thus the Court held that ‘the provisions of the framework agreement [on fixed-term work, concluded on 18 March 1999, which is set out in the annex to Council Directive 1999/70/EC of 28 June 1999 concerning the framework agreement on fixed-term work concluded by ETUC, UNICE and CEEP], read in conjunction with the principle of effectiveness, must be interpreted as precluding national procedural rules which require a fixed-term worker to bring a new action in order to determine the appropriate penalty where abuse resulting from the use of successive fixed-term employment contracts has been established by a judicial authority, to the extent that it results in procedural disadvantages for that worker, in terms, inter alia, of cost, duration and the rules of representation, liable to render excessively difficult the exercise of the rights conferred on him by EU law’ (judgment of 14 September 2016, Martínez Andrés and Castrejana López (C-184/15 and C-197/15, EU:C:2016:680, paragraph 64; emphasis added). Although the Court examines the problem in the light of the principle of effectiveness, it recalls in paragraph 59 of that judgment that the requirements of equivalence and effectiveness ‘embody the general obligation on the Member States to ensure judicial protection of an individual’s rights under EU law’ (emphasis added).
      (
            24
         )	See Dixel Dictionnaire — Le Robert, 2011 Edition.
      (
            25
         )	See, to that effect (regarding paragraph 4 of Article III-365 of the Treaty establishing a Constitution for Europe, identical to the fourth paragraph of Article 263 TFEU), Coutron, L., La contestation incidente des actes de l’Union européenne, Bruylant, 2007, p. 488. See also, Blumann, C., ‘L’amélioration de la protection juridictionnelle effective des personnes physiques et morales résultant du traité de Lisbonne’, in L’homme et le droit. En hommage au professeur Jean-François Flauss, Éditions Pedone, 2014, pp. 77 to 100, in particular p. 98. Other language versions of the Treaty better translate that idea. Accordingly, the English version uses the word ‘entail’ which is a synonym of the verbs ‘necessitate’, ‘make necessary’, ‘require’, ‘need’ and ‘demand’ (see Oxford Thesaurus of English, Second Edition, Oxford University Press, 2004). See, also, the Polish version ‘nie wymagają środków wykonawczych’ or the Portuguese version ‘que não necessitem de medidas de execução’ (emphasis added).
      (
            26
         )	See, to that effect, Rhimes, M., ‘The EU Courts Stand Their Ground: Why Are the Standing Rules for Direct Actions Still So Restrictive?’, European Journal of Legal Studies, 2016, vol. 9, No 1, pp. 103 to 172, in particular, p. 124.
      (
            27
         )	Since the judgment of 13 July 1966, Italy v Council and Commission (32/65, EU:C:1966:42), the Court has held that the rule of general application, the legality of which is called into question on the basis of Article 277 TFEU, must be applicable ‘directly or indirectly to the issue with which the application is concerned’ (ECR. p. 594; emphasis added). The General Court continues to apply that rule (see, inter alia, judgment of 12 June 2015, Plantavis and NEM v Commission and EFSA (T-334/12, EU:T:2015:376, paragraph 51)).
      (
            28
         )	Judgment of 14 March 2017, A and Others (C‑158/14, EU:C:2017:202, paragraph 68).
      (
            29
         )	See, to that effect, judgment of 6 March 1979, Simmenthal v Commission (92/78, EU:C:1979:53, paragraph 39).
      (
            30
         )	Judgment of 14 March 2017, A and Others (C-158/14, EU:C:2017:202, paragraph 69).
      (
            31
         )	‘The appellant merely alleges that those measures will not be measures implementing the regulation at issue, but rather Regulation No 1107/2009 (paragraphs 34, 42 and 45 of the appeal). While it is true that the legal basis of the measures in question would not be the regulation at issue but rather Regulation No 1107/2009, it is nevertheless the case that those measures, which alone give rise to the effects which the appellant invoked at first instance, are implementing measures within the meaning of the fourth paragraph of Article 263 TFEU since they provide the appellant a means of accessing a court, in accordance with the logic of that provision’ (paragraph 12 of the Commission’s response; emphasis added).
      (
            32
         )	See, to that effect, judgment of 19 December 2013, Telefónica v Commission (C‑274/12 P, EU:C:2013:852, paragraphs 30 and 31).
      (
            33
         )	Paragraph 12 of the Commission’s response.
      (
            34
         )	Judgment of 3 October 2013, Inuit Tapiriit Kanatami and Others v Parliament and Council (C-583/11 P, EU:C:2013:625, paragraph 92). That assertion appears for the first time in paragraph 23 of the judgment of 23 April 1986, Les Verts v Parliament (294/83, EU:C:1986:166). Since then it has been repeated on numerous occasions. See, inter alia, judgments of 25 July 2002, Unión de Pequeños Agricultores v Council (C-50/00 P, EU:C:2002:462, paragraph 40); of 19 December 2013, Telefónica v Commission (C-274/12 P, EU:C:2013:852, paragraph 57); of 28 April 2015, T & L Sugars and Sidul Açúcares v Commission (C-456/13 P, EU:C:2015:284, paragraph 45), and of 28 March 2017, Rosneft (C-72/15, EU:C:2017:236, paragraph 66).
      (
            35
         )	Judgment of 23 April 1989, Les Verts v Parliament (294/83, EU:C:1986:166, paragraph 23). Emphasis added.
      (
            36
         )	See, to that effect, Berrod, F., La systématique des voies de droit communautaires, Dalloz, Paris, 2003, No 294 regarding the reference for a preliminary ruling and No 834 regarding the plea of illegality, and Coutron, L., La contestation incidente des actes de l’Union européenne, Bruylant, Brussels, 2007, pp. 129 and 213.
      (
            37
         )	Paragraph 25, emphasis added.
      (
            38
         )	See paragraph 13 of the order under appeal.
      (
            39
         )	OJ 2011 L 81, p. 8.
      (
            40
         )	OJ 2011 L 104, p. 39.
      (
            41
         )	See, to that effect, judgment of 19 December 2013, Telefónica v Commission (C-274/12 P, EU:C:2013:852, paragraph 18).
      (
            42
         )	See judgment of the Court of 18 July 2007, Industrias Químicas del Vallés v Commission (C‑326/05 P, EU:C:2007:443), and judgment of the General Court of 28 June 2005, Industrias Químicas del Vallés v Commission (T-158/03, EU:T:2005:253).
      (
            43
         )	See, inter alia, judgments of 13 September 2007, Il Ponte Finanziaria v OHIM (C-234/06 P, EU:C:2007:514, paragraph 44), and of 5 March 2015, Ezz and Others v Council (C‑220/14 P, not published, EU:C:2015:147, paragraph 111).
      (
            44
         )	See, to that effect, judgment of Il Ponte Finanziaria v OHIM (C-234/06 P, EU:C:2007:514, paragraphs 45 and 46).
      (
            45
         )	See paragraphs 56 and 59 of IQV’s appeal.
      (
            46
         )	See, to that effect, point 68 of this Opinion and the case-law cited in footnote 34. Among numerous commentaries, see, in particular, Meij, A., ‘Standing in Direct Actions in the EU Courts after Lisbon’ in De Rome à Lisbonne: les juridictions de l’Union européenne à la croisée des chemins — Mélanges en l’honneur de Paolo Mengozzi, Brussels, Bruylant, 2013, pp. 301 to 312; Turmo, A., ‘Nouveau refus d’élargir l’accès des particuliers au recours en annulation contre les actes de l’Union européenne’, R.A.E, 2013, pp. 825 to 835; Waelbroeck, D. and Bombois, T., ‘Des requérants “privilégiés” et des autres … À propos de l’arrêt Inuit et de l’exigence de protection juridictionnelle effective des particuliers en droit européen’, Cahiers de droit européen, 2014/1, pp. 21 to 76; Van Malleghem, P.-A. and Baeten, N., ‘Before the Law Stands a Gatekeeper — Or, What is a “Regulatory Act” in Article 263(4) TFEU? Inuit Tapiriit Kanatami’, Common Market Law Review, 2014, vol. 51, pp. 1187 to 1216.
      (
            47
         )	See, to that effect, judgments of 19 December 2013, Telefónica v Commission (C-274/12 P, EU:C:2013:852, paragraph 28), and of 28 April 2015, T & L Sugars and Sidul Açúcares v Commission (C-456/13 P, EU:C:2015:284, paragraph 30).
      (
            48
         )	Judgment of 3 October 2013, Inuit Tapiriit Kanatami and Others v Parliament and Council (C-583/11 P, EU:C:2013:625, paragraph 93). See, also, judgments of 19 December 2013, Telefónica v Commission (C-274/12 P, EU:C:2013:852, paragraph 29), and of 28 April 2015, T & L Sugars and Sidul Açúcares v Commission (C-456/13 P, EU:C:2015:284, paragraph 31).
      (
            49
         )	For an example where the Court agreed to examine a plea of illegality against an act that was not the legal basis of the measure being challenged, see judgment of 28 June 2005, Dansk Rørindustri and Others v Commission (C-189/02 P, C-202/02 P, C-205/02 P to C-208/02 P and C-213/02 P, EU:C:2005:408).
      (
            50
         )	See, to that effect, Barav, A., ‘The Exception of Illegality in Community Law: a Critical Analysis’, Common Market Law Review, 1974, pp. 366 to 386, especially p. 374.
      (
            51
         )	See, inter alia, to that effect, judgment of 29 June 2010, E and F (C-550/09, EU:C:2010:382, paragraph 44).
      (
            52
         )	Order of 14 July 2015, Forgital Italy v Council (C-84/14 P, not published, EU:C:2015:517, paragraph 66).
      (
            53
         )	Judgment of 3 October 2013, Inuit Tapiriit Kanatami and Others v Parliament and Council (C-583/11 P, EU:C:2013:625, paragraph 104).
      (
            54
         )	See, to that effect, judgment of 3 October 2013, Inuit Tapiriit Kanatami and Others v Parliament and Council (C-583/11 P, EU:C:2013:625, paragraph 103 read in conjunction with paragraph 104).
      (
            55
         )	See, to that effect, Arnull, A., ‘Arrêt “Inuit”: la recevabilité des recours en annulation introduits par des particuliers contre des actes réglementaires’, Journal de droit européen, 2014, pp. 14 to 16, in particular p. 15. The author speaks of a ‘paradox’ because ‘the Court imposes upon national courts requirements which it is not prepared to take on itself’.
      (
            56
         )	Judgment of 13 March 2008, Commission v Infront WM (C-125/06 P, EU:C:2008:159, paragraph 47). While the Court set out that interpretation in respect of the second limb of the fourth paragraph of Article 263 TFEU, I see no reason why it should not also apply to the third limb. See, in that regard, point 66 and footnote 21 of my Opinion in Stichting Woonpunt and Others v Commission (C-132/12 P, EU:C:2013:335).