OPINION OF ADVOCATE GENERAL
SZPUNAR
delivered on 1 February 2018 (1)
Case C‑325/16
Industrias Químicas del Vallés, SA
v
Administracíon General del Estado,
Sapec Agro, SA
(Request for a preliminary ruling
from the Tribunal Supremo (Supreme Court, Spain))
(Reference for a preliminary ruling — Agriculture — Approximation of laws — Directive 91/414/EEC — Directive 2010/28/EU — Placing of plant protection products on the market — Procedure for re-evaluation, by the Member States, of authorised plant protection products — Time limit — Extension)
I.      Introduction
1.        According to Directive 91/414/EEC, (2) plant protection products, which belong to the pesticide family, are active substances and preparations containing one or more active substances intended, inter alia, to protect plants or plant products against all harmful organisms or prevent the action of such organisms or to preserve plant products. Annex I to that directive lists the active substances authorised for incorporation in plant protection products marketed in the territory of the European Union. (3) Metalaxyl, for which, notably, only its uses as fungicide may be authorised, is one of the substances included in that Annex I.
2.        According to Article 3(1) of Directive 91/414, plant protection products may not be placed on the market and used in the territory of a Member State unless the competent authorities of that Member State have authorised the products in accordance with the provisions of that directive. To that end, Article 3(1) of Directive 2010/28/EU (4) laid down a time limit, expiring on 31 December 2010, so that the Member States could, where necessary, in accordance with Directive 91/414, amend or withdraw existing authorisations for plant protection products which contained metalaxyl as an active substance.
3.        In this reference for a preliminary ruling, the Tribunal Supremo (Supreme Court, Spain) is for the first time enquiring of the Court of Justice as to the interpretation of Article 3(1) of Directive 2010/28, and in particular the exact legal nature of the deadline which that article lays down.
II.    Legal context
A.      EU law
1.      Directive 91/414
4.        Article 6(2) of that directive provides:
‘A Member State receiving an application for the inclusion of an active substance in Annex I shall without undue delay ensure that a dossier which is believed to satisfy the requirements of Annex II is forwarded by the applicant to the other Member States and to the Commission together with a dossier complying with Annex III on at least one preparation containing that active substance. The Commission shall refer the dossier to the Standing Committee on Plant Health referred to in Article 19 for examination.’
5.        According to Article 8(2) of that directive:
‘By way of derogation from Article 4 and without prejudice to paragraph 3 or to Directive 79/117/EEC, a Member State may, during a period of 12 years following the notification of this Directive, authorise the placing on the market in its territory of plant protection products containing active substances not listed in Annex I that are already on the market two years after the date of notification of this Directive.
…’
6.        Under the final subparagraph of Article 8(2) of the same directive:
‘During the 12-year period referred to in the first subparagraph it may, following examination by the Committee referred to in Article 19 of such active substance, be decided by the procedure laid down in that Article that the substance can be included in Annex I and under which conditions, or, in cases where the requirements of Article 5 are not satisfied or the requisite information and data have not been submitted within the prescribed period, that such active substance will not be included in Annex I. The Member States shall ensure that the relevant authorisations are granted, withdrawn or varied, as appropriate, within a prescribed period.’
7.        Article 13(1), (a) and (b), Article 13(3)(d) and Article 13(6) of Directive 91/414 provide:
‘1.      Without prejudice to Article 10, Member States shall require that applicants for authorisation of a plant protection product submit with their application:
(a)      a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex III [“the Annex III dossier”];
and
(b)      for each active substance in the plant protection product, a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex II [“the Annex II dossier”].
…
3.      In granting authorisations, Member States shall not make use of the information referred to in Annex II for the benefit of other applicants:
…
(d)      for a period of five years from the date of a decision, following receipt of further information necessary for first inclusion in Annex I, which has been taken either to vary the conditions for, or to maintain, the inclusion of an active substance in Annex I, unless the five-year period expires before the period provided for in paragraphs 3(b) and (c), in which case the period of five years shall be extended so as to expire on the same date as those periods.
…
6.      By way of derogation from paragraph 1, for active substances already on the market two years after notification of this Directive, Member States may, with due regard for the provisions of the Treaty, continue to apply previous national rules concerning data requirements as long as such substances are not included in Annex I.’
2.      Directive 2010/28
8.        According to recitals 7 to 9 of Directive 2010/28:
‘(7)      A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.
(8)      Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of 6 months after inclusion to review existing authorisations of plant protection products containing metalaxyl to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.
(9)      The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Regulation (EEC) No 3600/92 (5) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I.’
9.        Article 3 of that directive provides:
‘1.      Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing metalaxyl as an active substance by 31 December 2010.
By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to metalaxyl are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13.
2.      By way of derogation from paragraph 1, for each authorised plant protection product containing metalaxyl as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 June 2010 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning metalaxyl. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
...’
10.      The wording of Article 4 of that directive is as follows:
‘This Directive shall enter into force on 1 July 2010.’
3.      Spanish law
11.      Article 49(3) of the Ley 30/1992 de Régimen Jurídico de las Administraciones Públicas y del Procedimiento Administrativo Común (Law 30/1992 on the legal provisions governing public authorities and ordinary administrative procedure) of 26 November 1992 (6) provides:
‘All applications from interested parties and decisions concerning extensions shall pre-date expiry of the relevant time limit. Under no circumstances shall a time limit which has already expired be extended …’
III. The facts giving rise to the main proceedings, the questions referred and the procedure before the Court of Justice
12.      Industrias Químicas del Vallés, SA (‘IQV’) is a company governed by Spanish law, whose economic activity is the production and marketing of chemical and plant protection products. In particular, IQV imports metalaxyl into Spain and markets products containing that active substance in a number of Member States.
13.      Sapec Agro, SA is a company governed by Portuguese law engaged in developing plant protection products and solutions and plant nutrients. It holds authorisations for plant protection products containing metalaxyl.
14.      On 2 May 2003 the Commission adopted Decision 2003/308/EC concerning the non-inclusion of metalaxyl in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing this active substance. (7)
15.      The Court of Justice annulled that decision in Industrias Químicas del Vallés. (8) As a result of that annulment, the Commission adopted Directive 2010/28, amending Directive 91/414, in order to include the active substance metalaxyl under that directive.
16.      On 30 April 2010 an ex officio process was commenced in Spain to review the marketing authorisations for plant protection products containing metalaxyl as an active substance, in accordance with Article 3(1) of Directive 2010/28.
17.      IQV accordingly submitted to the Spanish Government an application to re-register its plant protection products containing metalaxyl, together with a dossier which the Spanish authorities declared to be complete in the light of the requirements in Annex II to Directive 91/414.
18.      On 29 June 2010 Sapec Agro likewise submitted an application for re-registration of its plant protection products containing metalaxyl. (9)
19.      On 30 December 2010, that is to say, one day before the 31 December 2010 time limit under Article 3(1) of Directive 2010/28 expired, Sapec Agro asked the Spanish Government to give it more time to complete the dossier it had submitted, in the light of the requirements in Annex II to Directive 91/414. Sapec Agro founded its request on the difficulties it had encountered with the documentation relating to the dossier appraised by the Portuguese Republic as rapporteur Member State.
20.      On 3 March 2011 the Spanish Government granted Sapec Agro the extension sought.
21.      By a decision of 5 April 2011, the Dirección General de Recursos Agrícolas y Ganaderos (Directorate-General for Agricultural and Livestock Farming Resources, Spain) held that the dossier submitted by Sapec Agro relating to the active substance metalaxyl was complete in the light of the requirements in Annex II to Directive 91/414.
22.      On 9 May 2011 IQV brought an administrative appeal against that decision to the Secretaría General de Medio Rural del Ministerio de Medio Ambiente, y Medio Rural y Marino (Secretariat-General for the Rural Environment of the Ministry for Environmental, Rural and Marine Affairs, Spain). The decision of 7 November 2011 dismissed that appeal on the grounds that IQV lacked locus standi, holding that IQV’s interest was purely that of a competitor.
23.      IQV brought a contentious-administrative appeal against that dismissal decision, which the Tribunal Superior de Justicia de Madrid (High Court of Justice, Madrid, Spain) likewise dismissed, on 22 January 2014, on the grounds that IQV lacked locus standi.
24.      IQV appealed to the Tribunal Supremo (Supreme Court) arguing, in particular, that the fact that the time limit which expired on 31 December 2010 could not be extended not only emerged from the wording of Directive 2010/28, but was also justified by the need to protect the investments made in order to generate the information which had to be submitted for the Commission’s assessment of the active substance or the Member State’s assessment of the plant protection product.
25.      According to Sapec Agro and the competent government, the period in question can be extended, as emerges from the judgment delivered by the Court of Justice in IQV v Commission. (10)
26.      The referring court found it necessary, in order to resolve the dispute before it, to interpret Article 3(1) of Directive 2010/28 in the light of recital 8 of that directive. The referring court submits that the IQV v Commission judgment (11)appears to be the closest precedent and seems to suggest that the period can be extended.
27.      However, the referring court takes the view that, in contrast to that case, the facts at issue in the main proceedings relate not to contradictory behaviour by the authorities which caused confusion for the party concerned, but to a time limit which, as Directive 2010/28 repeatedly indicates, expired on 31 December 2010.
28.      Under those circumstances, the Tribunal Supremo (Supreme Court), in an order of 6 May 2016, lodged at the Court Registry on 9 June 2016, stayed the proceedings and referred the following questions for a preliminary ruling:
‘(1)      Is the deadline set in Directive 2010/28/EU by the use of the phrases “by 31 December 2010” in Article 3(1) and “by that date” in the second paragraph of Article 3(1), which also refers to 31 December 2010, in conjunction with the period of six months referred to in recital 8 of the preamble to Directive 2010/28/EU, a mandatory time limit by virtue of the purpose sought by the system established by Directive 91/414, and not susceptible of extension by the Member States, such that it must be calculated exclusively in accordance with the directive?
(2)      In the event that it is held that the time limit is capable of extension, is the decision concerning such an extension to be taken without regard to any specific procedural rules concerning applying for and granting the extension or does it fall within the competence of the Member States, which must decide the question in accordance with domestic legislation since they are the addressees of the provisions establishing the procedure under Article 3(1) of the Directive?’
29.      IQV, the Spanish Government and the European Commission filed written observations.
30.      IQV, Sapec Agro, the Spanish Government and the Commission presented oral observations at the hearing held on 9 November 2017.
IV.    Analysis
A.      Admissibility
31.      This case raises at the outset the issue of whether the reference for a preliminary ruling is admissible. Indeed, the referring court states that both the competent administrative authority and the first instance court found IQV to lack locus standi and that it has not yet examined that matter itself, and that the questions referred for a preliminary ruling are only raised if that locus standi is found to exist. The referring court nevertheless submits that the lack of locus standi adduced by the Spanish Government is irrelevant for the purposes of the reference for a preliminary ruling.
32.      I would point out that it is for the referring court to determine, in the light of its domestic law, whether or not a party continues to have locus standi in the main proceedings. It is not for the Court of Justice to judge that matter. The Court of Justice may refuse to rule on a question referred for a preliminary ruling by a national court only where it is quite obvious that the question is hypothetical. (12)
33.      In the present case there is relevance to the subject matter of the main proceedings, in so far as, in its written and oral observations to the Court, IQV has adduced the provisions of EU law referred to in the questions referred and in so far as Sapec Agro has disputed that line of argument in its oral observations. The questions of law raised can therefore be analysed in the light of the referring court’s statements about the facts and the law as it stands.
34.      I am therefore of the view that the request for a preliminary ruling is admissible.
B.      Substance
1.      Preliminary observations
35.      All aspects of this case were analysed in depth in the written and oral procedures. Before examining the nature of the relevant time limit laid down by Directive 2010/28, it therefore seems helpful to review the situation relating to Directive 91/414, and the directives on inclusion of an active substance in Annex I to that directive in general.
(a)    Directive 91/414
36.      It should be noted at the outset that Directive 2010/28 is an implementing directive under Directive 91/414. Directive 91/414 concerns the authorisation, placing on the market, use and control within the European Union of plant protection products in commercial form. The purpose of Directive 91/414 is to prevent plant protection products which have unacceptable adverse effects on plants and plant products, the environment, human or animal health or groundwater from being placed on the market.
37.      In order to achieve that objective, Directive 91/414 regulates in particular two separate types of authorisation: on the one hand, the authorisation and use of active substances as those substances are defined in Article 2(4) of that directive and, on the other, the authorisation of plant protection products in which those substances have been incorporated.
38.      The inclusion of active substances in Annex I to Directive 91/414 is governed by Article 6 of that directive. It is the Commission which is responsible for including those substances by means of ‘inclusion directives’ amending that Annex I (such as, in the present case, Directive 2010/28). Where necessary, under Article 5(4) of Directive 91/414, the Commission stipulates requirements for use of the substance in question. Applications to include active substances in Annex I must be accompanied by two separate technical dossiers: one, a very detailed dossier, which must satisfy the requirements listed in Annex II to Directive 91/414, (13)needed in order to evaluate the foreseeable risks the substance poses to humans, animals or the environment, and another which relates to at least one preparation containing that active substance and satisfies the requirements listed in Annex III to that directive. (14)
39.      In relation to the authorisation of plant protection products containing those active substances, under Article 4 of Directive 91/414, the Member States are to authorise the placing on the market only of those plant protection products whose ‘active substances are listed in Annex I’ and which fulfil the conditions listed in that Annex. (15)The Member States cannot otherwise authorise those products. Under Article 13(1) of Directive 91/414, any application for authorisation of those products must be accompanied by an Annex III dossier and, for each active substance contained in the plant protection product, an Annex II dossier.
40.      Directive 91/414 also establishes a series of transitional measures. Under Article 8(2) of that directive the Member States may therefore authorise the placing on the market of plant protection products which contain active substances not listed in Annex I that are already on the market two years after the date of notification of the directive, such as metalaxyl. (16)Specifically, Article 13(6) of Directive 91/414 contains a derogation from the obligation in Article 13(1) of that directive according to which applications for authorisation of a plant protection product must be accompanied by the Annex II and III dossiers under Directive 91/414 (unless the holders of existing authorisations have access to those dossiers). That derogation applies provided the active substance which is already on the market two years after notification of that directive is not included in Annex I.
41.      Those transitional measures cease to apply once an inclusion directive comes into force which includes an active substance in Annex I, and the applicable rule becomes once again that in Article 13(1) of Directive 91/414. From that time, the Member States must, on the one hand, ensure that applications for new authorisations are accompanied by the Annex II and III dossiers and, on the other, verify that the holders of existing authorisations have or have access to those dossiers.
(b)    The inclusion directives and Directive 2010/28
42.      As the Commission correctly pointed out in its written observations, immediate application of an inclusion directive would, overnight, radically change the legal situation of the holders of existing authorisations. To enable the Member States and the actors involved to take the necessary measures in relation to authorisations in force, the inclusion directives therefore establish a series of time limits.
43.      In the first place, an inclusion directive only comes into force several months after it is published. (17) Directive 2010/28 was published on 24 April 2010 and came into force on 1 July 2010. (18)
44.      In the second place, the Member States have six months from the time the inclusion directive comes into force in which to transpose it into domestic law. Article 2 of Directive 2010/28 required Member States to bring into force, by 31 December 2010 at the latest, the laws, regulations and administrative provisions necessary to comply with that directive. Adopting those national provisions entails complying fully with the obligations under Directive 91/414 once an active substance has been included in Annex I and, in particular, means that plant protection products containing the active substance in question must comply with that directive.
45.      Verifying that plant protection products containing the active substance comply with Directive 91/414 involves, first, verifying whether the variant used of the relevant substance satisfies the requirements laid down in Annex I, that is to say, those relating to purity and those established in part A (chemical substances) of the corresponding entry. (19)The period which the inclusion directives set, generally in Article 2, for their transposition into domestic law is therefore the same as the period which they set, usually in Article 3(1), in which to verify that the specific variant of the active substance contained in the product (here, metalaxyl) satisfies the requirements of Annex I to Directive 91/414.
46.      The Commission explains that the Member States may review the specific uses of the active substance relying on data they already have relating to the authorisations they granted under Article 8(2) of Directive 91/414 before the active substance was included in Annex I to that directive. (20)In contrast, they can only review the level of purity of the active substance on the basis of an Annex II dossier. (21) Articles 6(2) and 13(1)(b) of Directive 91/414 therefore require submission of that dossier for, respectively, approval of an active substance and authorisation of plant protection products containing it. The inclusion directives therefore set the same time limit for submitting the Annex II dossier and for verifying the Annex I requirements, that is to say, as indicated above, the deadline for transposing the inclusion directive, which is fixed at 31 December 2010. (22)
47.      Secondly, the verification referred to above requires verifying that the plant protection product itself, not merely the active substance it contains, complies with Directive 91/414 and, in particular, that it has been evaluated in accordance with the uniform principles set out in Annex VI to that directive and that it satisfies the requirements set out in Article 4(1)(b) to (e).
48.      According to the Commission, that ‘new evaluation’ should theoretically be ready at the time the inclusion directive is transposed. In practice, however, the number of plant protection products to be re-evaluated and the workload to which that new evaluation gives rise mean that the Member States cannot reasonably be expected to complete it within the transposition deadline (unless an extremely long transposition period is laid down). Accordingly, as the recitals of the inclusion directives, specifically recital 8 of Directive 2010/28, indicate, the actors involved and the Member States need to be given a longer period in which to submit and to evaluate, respectively, the complete Annex III dossier for each plant protection product and for each intended use of that product. As a general rule, that time limit expires four years after the inclusion directive comes into force. As regards Directive 2010/28, the deadline fixed at 30 June 2014 is contained in Article 3(2).
2.      The questions referred for a preliminary ruling
49.      By the questions it refers for a preliminary ruling, the Tribunal Supremo (Supreme Court) enquires how Article 3(1) of Directive 2010/28 should be interpreted in the light of recital 8 of that directive.
50.      In particular, by its first question the referring court enquires essentially whether the time limit of 31 December 2010 laid down in Article 3(1) of Directive 2010/28 is a mandatory time limit or whether the Member States can extend that time limit. In its second question the referring court seeks to identify the conditions under which such an extension should be granted. However, that latter question is only raised in the event that the time limit in question can be extended.
51.      It should be noted at the outset that, in their written observations, IQV and the Commission maintain that the deadline laid down in Article 3(1) of Directive 2010/28 is a mandatory time limit which the Member States cannot extend, whereas Sapec Agro and the Spanish Government share the view that the time limit established by that directive is not mandatory. The Spanish Government contends, accordingly, that the time limit in question can be extended in accordance with the rules of procedural law of the Member States, in all cases on duly justified grounds, having regard for the circumstances of each case and complying with the guiding principles of Directive 91/414.
3.      Analysis of the time limit under Article 3(1) of Directive 2010/28
52.      According to the Court’s settled case-law, in interpreting a provision of EU law, it is necessary to consider not only its wording but also the context in which it occurs and the objectives pursued by the rules of which it is part. (23)
(a)    A literal reading of Article 3(1) of Directive 2010/28
53.      Article 3(1) of Directive 2010/28 provides clearly that ‘Member States shall in accordance with Directive [91/414], amend or withdraw existing authorisations for plant protection products containing metalaxyl as an active substance by 31 December 2010’. Furthermore, the second paragraph of that article provides that ‘by that date [31 December 2010], [the Member States] shall in particular verify that the conditions in Annex I to that Directive relating to metalaxyl are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13’.
54.      The wording of that article is, prima facie, sufficient to indicate that 31 December 2010 is a mandatory time limit which cannot be extended by the Member States. It is nevertheless open to question whether or not the overall scheme, purpose and regulatory context of Directive 2010/28 corroborate that interpretation.
(b)    A contextualised reading of Article 3(1) of Directive 2010/28
55.      The time limit in Article 3(1) of Directive 2010/28 should also be interpreted in the light of the overall scheme of that directive.
56.      First, as noted in point 43 of this Opinion, Directive 2010/28 came into force on 1 July 2010. Article 2 provides that, by 31 December 2010 at the latest, Member States had to transpose that directive into their domestic law. That date was also the time limit which the Commission laid down in Article 3(1) of Directive 2010/28 in order to allow the Member States to review the existing authorisations of plant protection products containing metalaxyl as an active substance. Accordingly, as can be seen from points 45 and 46 of this Opinion, Directive 2010/28 sets the same deadline, that is to say, 31 December 2010, for transposing the directive (Article 2) and for the Member States to amend or withdraw existing authorisations of plant protection products containing metalaxyl as an active substance following submission of the Annex II dossier and once they have verified that the conditions in Annex I are met (Article 3(1)).
57.      It is therefore clear to my mind that allowing the Member States not to comply with the time limit under Article 3(1) of Directive 2010/28 would run counter to the very system underlying that directive according to which its transposition period should coincide with the period set for the Member States to amend or withdraw existing authorisations for plant protection products containing metalaxyl.
58.      Secondly, it also needs bearing in mind that if, on expiry of that period, the holder of an existing authorisation for a plant protection product containing metalaxyl had not successfully established that it satisfied the requirements under Article 3(1) of Directive 2010/28, including that it held or had access to an Annex II dossier, that authorisation would be amended or withdrawn as a result. The uniform framework established by that article of Directive 2010/28, throughout the European Union, which includes the circumstances in which the Member States amend or withdraw authorisations of plant protection products containing metalaxyl, and the obligations on the holders of those authorisations as regards submitting dossiers relating to those products, would be seriously undermined if the Member States could extend the 31 December 2010 deadline.
59.      Thirdly, the Spanish Government’s position needs to be analysed. The Spanish Government is of the view that the time limit under Article 3(1) of Directive 2010/28 can be extended by the Member States, in all cases on duly justified grounds.
60.      I do not find that approach persuasive.
61.      As emerges from points 47 and 48 of this Opinion, Article 3(2) of Directive 2010/28 establishes a re-evaluation procedure for authorised plant protection products containing metalaxyl as an active substance. That article sets a longer period for that procedure, ‘by way of derogation from paragraph 1’, expiring four years after the entry into force of that directive, that is to say, on 30 June 2014.
62.      It therefore seems legitimate to ask oneself: would that derogation be relevant if, as the Spanish Government states, the time limit under Article 3(1) of Directive 2010/28 could be extended by the Member States, in all cases on duly justified grounds?
63.      The answer to that question seems obvious, all the more so in so far as, I reiterate, that time limit is the same as the one set for transposing Directive 2010/28.
64.      Recital 8 of Directive 2010/28 corroborates that view, stating as it does that ‘without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of 6 months after inclusion to review existing authorisations of plant protection products containing metalaxyl to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. ...’. (24)
65.      Fourthly and lastly, regard should also be had for the last subparagraph of Article 8(2) of Directive 91/414, according to which, after the Commission has adopted the decision whether or not to include one of those active substances in Annex I, ‘the Member States shall ensure that the relevant authorisations [for plant protection products] are granted, withdrawn or varied, as appropriate, within a prescribed period’. (25)
66.      Indeed, the Member State’s obligations, and in particular the consequences of the holder of an authorisation stating that, by expiry of the time limit laid down in Article 3(1) of Directive 2010/28 for the Member State to take its decision, that it does not have or have access to an Annex II dossier under Directive 91/414, are clearly apparent from the aforementioned articles and recitals of Directive 2010/28, and from Articles 4 and 13 of Directive 91/414.
67.      Accordingly, put back into context, Article 3(1) of Directive 2010/28 must be interpreted as meaning that the date it lays down, 31 December 2010, is a mandatory time limit which cannot be extended by the Member States. In the light of the general scheme of Directive 91/414 and Directive 2010/28, it is not for the Member States to decide that they should adopt less restrictive measures than withdrawing a product’s marketing authorisation.
68.      That interpretation also makes it possible to achieve the objective pursued by Directive 2010/28, as I will explain below.
(c)    A teleological reading of Article 3(1) of Directive 2010/28
69.      I would note first of all that where an implementing directive requires interpretation, as Directive 2010/28 does, that interpretation must, as far as possible, be consistent with the provisions of the basic directive. (26)
70.      The fifth, sixth and ninth recitals of Directive 91/414 point out that the purpose of that directive is to remove barriers to trade in plant protection products between the Member States of the European Union, while maintaining a high level of protection of the environment and of human and animal health. (27)
71.      As already explained, that purpose is achieved, on the one hand, by the requirement which Directive 91/414 places on applicants to submit an Annex II dossier, both for the inclusion of an active substance in Annex I and for authorisation of plant protection products, (28) and, on the other hand, by the power available to the Commission to lay down conditions for the use of an active substance included in Annex I, in order to ensure safe use. (29) Failure to meet the deadline set in Article 3(1) of Directive 2010/28 — and, it is important to point out, of other inclusion directives — would therefore conflict with that purpose in so far as plant protection products containing active substances not satisfying the requirements of Annex I to Directive 91/414 and which might in particular contain toxic impurities exceeding the threshold laid down by the Commission could remain on the market beyond the date on which Directive 2010/28 is transposed into domestic law.
72.      It is therefore clear that the Member States are not entitled either to extend the time limit in question or to attach any consequence to its expiry other than that which the EU legislature has established uniformly for all Member States. (30) Authorising the Member States to extend the time limit for review established in Article 3(1) of Directive 2010/28 is in my view, therefore. contrary to the objective pursued by Directive 91/414.
73.      Furthermore, as the Commission correctly argued in its observations, more than eight months elapsed between the date on which Directive 2010/28 was adopted and expiry of the time limit established in Article 3(1) of that directive, a period intended precisely to enable the holders of authorisations to compile the necessary information and the Member States to take their decisions. Once the time limit for transposing Directive 2010/28 into domestic law and for adopting decisions after reviewing existing authorisations has expired, any product for which no Annex II dossier has been submitted must be withdrawn from the market. (31)
74.      Contrary to the Spanish Government’s assertion, my view is that the foregoing interpretation does not conflict in the slightest with the objective of Directive 91/414, since it both upholds the rights of the notifying party and ensures that plant protection products for which the necessary dossier has not been provided are not placed on the market.
75.      It is therefore apparent from points 69 to 74 of this Opinion that an interpretation of Article 3(1) of Directive 2010/28 according to which the Member States were entitled not to comply with the time limit laid down in that article would be contrary to the regulatory purpose pursued by the EU legislature.
4.      The Member States’ obligations in relation to the procedure for re-evaluating authorised plant protection products
76.      The Court of Justice has on several occasions already examined what obligations the Member States have in relation to existing authorisations for plant protection products once a substance has been included in Annex I to Directive 91/414. (32) The Court’s judgments delivered to date afford a number of helpful pointers for interpreting Article 3(1) of Directive 2010/28.
77.      In the first case, which gave rise to the IQV v Commission judgment, (33) the Court of Justice annulled Decision 2003/308.
78.      In the present case, unlike in IQV and the Commission, Sapec Agro argued at the hearing that, in that judgment, the Court ruled on whether the time limit in question could be extended having regard for the circumstances of the case, in that instance the contradictory behaviour of the competent authorities.
79.      It needs pointing out that this argument appears to be based on an incorrect understanding of the judgment in question.
80.      First, the case which gave rise to the IQV v Commission judgment concerned a time limit set by the Commission, in the context of the procedure before that institution to include an active substance in Annex I to Directive 91/414 (34) and whether it was possible for the Commission, as opposed to the Member States, to change that time limit. (35) In contrast, the case in the main proceedings, which relates to the procedure at Member State level, concerns whether the Member States can, unilaterally, extend a time limit set by the Commission. (36)
81.      Secondly, in the IQV v Commission judgment, the Court based itself on the fact that the competent authorities had placed the applicant in an unforeseen and complicated situation and had behaved in a contradictory manner, a circumstance which, according to the Court, was not taken into account when the Commission adopted the decision at issue and refused to extend that time limit. (37) In the main proceedings, in contrast, the applicant is alleging that it had difficulty in fully compiling a complete dossier, even though the obligation to submit a complete dossier was established at the outset of the procedure.
82.      Furthermore, the referring court underscores the fact that, in the case being heard before it, Sapec Agro was not caused any confusion whatsoever as the result of contradictory behaviour. (38)
83.      The second case, which gave rise to the Feinchemie Schwebda and Bayer CropScience judgment, (39) concerning Directive 91/414 and an inclusion directive, (40) whose Article 1 included the active substance ethofumesate in Annex I to that directive, turned on whether the Member States were required, within the time limit laid down by that inclusion directive, to terminate the existing authorisation of a plant protection product containing that substance on the grounds that the holder of that authorisation did not hold or have access to an Annex II dossier, for the purposes of reviewing that authorisation.
84.      Specifically, basing itself on the wording of the article in issue, (41) which did not state that the Member States were required, within the time limit laid down for reviewing existing authorisations for plant protection products, to verify whether the holders had or had access to the Annex II dossier, (42) the Court held that Article 4(1) of Directive 2002/37 should be interpreted as not requiring Member States to terminate, before the prescribed deadline, the authorisation of a plant protection product containing ethofumesate on the grounds that the holder of that authorisation did not hold, or have access to, an Annex II dossier. (43)
85.      However, the matter in dispute in that case was not whether the time limit set by the inclusion directive was mandatory for the Member States, for the purposes of verifying whether the obligations on holders of existing authorisations to hold or have access to an Annex II dossier were complied with, as it is in the present case, but what those Member States were required to do within that time limit.
86.      In the present case, Directive 2010/28, which refers to the Annex II dossier in Article 3(1) and in recital 9, expressly states that the Member States must verify that the holders of authorisations have such a dossier.
87.      Two final relevant aspects which the Commission clarified at the hearing are, in my view, worth mentioning: first, the obligations of the rapporteur Member State and, second, the possible suspension, to which Sapec Agro and the Spanish Government refer, of the effects of authorisations of plant protection products which have been placed on the market.
88.      As regards the obligations of the rapporteur Member State, the Portuguese Republic, Sapec Agro and the Spanish Government pointed out that the rapporteur Member State had itself, in their view, been late. (44)
89.      The Commission explained in that regard that, for each substance, a rapporteur Member State acts in the authorisation of active substances phase and draws up a first report. In the phase in which authorisations are reviewed by the Member States, on the other hand, Directive 2010/28 gives no role whatsoever to the rapporteur Member State. However, in the light of the fact that the rapporteur Member State is familiar with the substance in question, the Commission’s guidelines offer the Member States an informal arrangement under which the aforementioned rapporteur Member State can examine equivalence for all the substances on the market, even though in formal terms that obligation lies with each Member State individually. (45)
90.      That informal arrangement made between the Member States in order to facilitate their work — and which is not provided for by Directive 2010/28 — should therefore not be treated as a formal obligation of the rapporteur Member State. Accordingly, the Portuguese Republic had no obligations other than those referred to in the preceding points in respect of the authorisation phase.
91.      In relation to possible suspension of the effects of authorisations for plant protection products, the Spanish Government suggested, in its written and oral observations, that Sapec Agro’s authorisation could be suspended as an alternative to revoking it.
92.      Nevertheless, I would point out that neither Directive 2010/28 nor Directive 91/414 provides for any such suspension. Indeed, Article 8(2) of Directive 91/414, which is the relevant provision here, states that the Member States ‘shall ensure that the relevant authorisations are granted, withdrawn or varied, as appropriate, within a prescribed period’, but does not in any way envisage suspending the effects of the authorisations. (46)
93.      To my mind, it is clearly apparent from points 52 to 75 of this Opinion that the Member States cannot extend a time limit which the Commission has set for all the Member States which applies to all authorisations of plant protection products.
94.      I am therefore of the view that the reply to the first question referred for a preliminary ruling should be that 31 December 2010, the date laid down in Article 3(1) of Directive 2010/28, is a mandatory time limit and that a time limit of that nature cannot be extended by the Member States.
95.      In the light of my proposed reply to the first question, it is not necessary to answer the second.
V.      Conclusion
96.      In the light of all the foregoing considerations, I propose that the Court should reply as follows to the questions referred by the Tribunal Supremo (Supreme Court, Spain) for a preliminary ruling:
The date, 31 December 2010, laid down in Article 3(1) of Commission Directive 2010/28/EU of 23 April 2010 amending Council Directive 91/414/EEC to include metalaxyl as active substance, must be interpreted as being a mandatory time limit and a time limit of that nature cannot be extended by the Member States.
1      Original language: French.
2      Council Directive of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1). That directive was repealed by 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 (OJ 2009 L 309, p. 1).
3      According to Article 2(3) and (4) of Directive 91/414, active substances are chemical elements and their compounds, micro-organisms and viruses having general or specific action against harmful organisms or on plants, parts of plants or plant products.
4      Commission Directive of 23 April 2010 amending Council Directive 91/414/EEC to include metalaxyl as active substance (OJ 2010 L 104, p. 57).
5      Commission Regulation of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Directive 91/414 (OJ 1992 L 366, p. 10).
6      Ley 30/1992 de Régimen Jurídico de las Administraciones Públicas y del Procedimiento Administrativo Común (Law 30/1992 on the legal provisions governing public authorities and ordinary administrative procedure) of 26 November 1992 (BOE No 285 of 27 November 1992, p. 40300), as amended by Article 1(14) of Ley 4/1999 (Law 4/1999) of 13 January 1999 (BOE No 12 of 14 January 1999, p. 1739).
7      OJ 2003 L 113, p. 8.
8      Judgment of 18 July 2007, Industrias Químicas del Vallés v Commission (C‑326/05 P, EU:C:2007:443).
9      It is worth noting, as the Commission pointed out at the hearing, that although, in their written observations, the parties use the word ‘re-registration’, this was not a matter of re-registering the substance but of assessing whether it was equivalent in the light of the requirements under Annex II to Directive 91/414. The Member States had therefore either to amend or withdraw the authorisations.
10      Judgment of 18 July 2007, Industrias Químicas del Vallés v Commission (C‑326/05 P, EU:C:2007:443).
11      Judgment of 18 July 2007 (C‑326/05 P, EU:C:2007:443).
12      Judgment of 16 June 2015, Gauweiler and Others (C‑62/14, EU:C:2015:400, paragraph 25).
13      Annex II contains the requirements with respect to the provision of detailed information about the active substance.
14      Annex III contains the requirements relating to the plant protection product.
15      See Article 3(1) of Directive 91/414.
16      Transitional provision relating to the general rules under Article 4 of Directive 91/414 concerning the granting, review and withdrawal of authorisations of plant protection products by the Member States.
17      When an inclusion directive comes into force the Commission amends Annex I to Directive 91/414 to include the substance in question in that annex.
18      I would point out that recital 7 of Directive 2010/28 states that this time limit must permit Member States and the interested parties to carry out the necessary preparations.
19      With the exception of those identified in part B (micro-organisms and viruses) of the corresponding entry. The Commission clarifies in its written observations that, in order not to overburden the text, it does not systematically specify ‘with the exception of those identified in part B of the corresponding entry’ in subsequent paragraphs when it refers to verifying the requirements laid down by Annex I for the substance in question. Reference to those requirements must nevertheless be understood as containing that qualification.
20      See points 5 and 40 of this Opinion.
21      The dossier necessary to evaluate the foreseeable risks of the substance for humans, animals or the environment. See point 38 of this Opinion.
22      See recital 8 of Directive 2010/28.
23      See, amongst others, judgment of 16 July 2015, Lanigan (C‑237/15 PPU, EU:C:2015:474, paragraph 35).
24      My italics.
25      My italics.
26      Judgment of 22 May 2008, Feinchemie Schwebda and Bayer CropScience (C‑361/06, EU:C:2008:296, paragraph 49).
27      See, to that effect, judgments of 18 July 2007, Industrias Químicas del Vallés v Commission (C‑326/05 P, EU:C:2007:443, paragraph 74), and of 14 September 2006, Stichting Zuid-Hollandse Milieufederatie (C‑138/05, EU:C:2006:577, paragraph 43).
28      The Commission explains that the information in the Annex II dossier is necessary in order to demonstrate that the active substance and the plant protection product containing it are innocuous.
29      See points 36 to 39 of this Opinion.
30      See points 67 and 72 of this Opinion.
31      Without prejudice to the option of recommencing the authorisation procedure.
32      I note that, in the main proceedings, the issue of what any consequences might be for the Member States if they did not, within the time limit laid down by Directive 2010/28, amend or withdraw the authorisations of plant protection products containing metalaxyl which did not satisfy the requirements of Directive 91/414, was not raised either by the referring court or the interested parties, and it therefore does not need to be addressed.
33      Judgment of 18 July 2007 (C‑326/05 P, EU:C:2007:443).
34      See point 38 of this Opinion.
35      Judgment of 18 July 2007, Industrias Químicas del Vallés v Commission (C‑326/05 P, EU:C:2007:443).
36      See point 39 of this Opinion.
37      Judgment of 18 July 2007, Industrias Químicas del Vallés v Commission (C‑326/05 P, EU:C:2007:443, paragraphs 79 to 86).
38      See point 27 of this Opinion.
39      Judgment of 22 May 2008 (C‑361/06, EU:C:2008:296).
40      Commission Directive 2002/37/EC of 3 May 2002 amending Council Directive 91/414/EEC to include ethofumesate as an active substance (OJ 2002 L 117, p. 10).
41      Article 4(1) of Directive 2002/37. See judgment of 22 May 2008, Feinchemie Schwebda and Bayer CropScience (C‑361/06, EU:C:2008:296, paragraphs 44 and 45).
42      It was in fact only in 2005 that the Commission changed the wording of the inclusion directives. Since then, those directives do set out a requirement on Member States to verify, within the time limit which the inclusion directive lays down for the procedure to review authorisations of plant protection products, that the holders have or have access to an Annex II dossier under Directive 91/414. Judgment of 22 May 2008, Feinchemie Schwebda and Bayer CropScience (C‑361/06, EU:C:2008:296, paragraphs 53 and 54).
43      Judgment of 22 May 2008, Feinchemie Schwebda and Bayer CropScience (C‑361/06, EU:C:2008:296, paragraph 55).
44      See point 19 of this Opinion.
45      Guidance document on the procedures relating to the authorisation of plant protection products following inclusion of an existing active substance in Annex I to Council Directive 91/414/EEC, Sanco/10796/2003 — rev 10.4, 2 October 2009.
46      My italics.