1 This request for a preliminary ruling concerns the interpretation of Article 3(1) of Commission Directive 2010/28/EU of 23 April 2010 amending Council Directive 91/414/EEC to include metalaxyl as an active substance (OJ 2010 L 104, p. 57).
2 The request has been made in proceedings between Industrias Químicas del Vallés SA (‘IQV’), on the one hand, and the Administración General del Estado (General State Administration, Spain) and Sapec Agro SA, on the other, concerning the procedure for the re-evaluation of marketing authorisations for plant protection products containing metalaxyl.
3 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1) was repealed by Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the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 (OJ 2009 L 309, p. 1). However, having regard to the fact that the repeal took effect from 14 June 2011 and the facts at issue in the main proceedings arose before that date, it is therefore necessary to have regard to Directive 91/414, as amended by Directive 2010/28. The fifth to seventh and ninth recitals of Directive 91/414 stated: ‘Whereas, in view of the hazards, there are rules in most Member States governing the authorisation of plant health products; whereas these rules present differences which constitute barriers not only to trade in plant protection products but also to trade in plant products, and thereby directly affect the establishment and operation of the internal market; Whereas it is therefore desirable to eliminate such barriers by harmonising the provisions laid down in the Member States; Whereas uniform rules on the conditions and procedures for the authorisation of plant protection products must be applied by the Member States; … Whereas the provisions governing authorisation must ensure a high standard of protection, which, in particular, must prevent the authorisation of plant protection products whose risks to health, groundwater and the environment [have not been researched properly]; … human and animal health should take priority over the objective of improving plant production’.
4 Article 8(2), first and fourth subparagraphs, of the directive provided: ‘By way of derogation from Article 4 and without prejudice to paragraph 3 or to [Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances (OJ 1979 L 33, p. 36)], 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. … 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.’
5 Article 13(1) of that directive provided: ‘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; 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.’
6 Annex I of the same directive contained a list of active substances which could be included in the composition of plant protection products for marketing purposes. That annex was the object of numerous amendments, including by Directive 2010/28, which added metalaxyl. Annexes II and III to Directive 91/414/EEC laid down the requirements that the dossier for the inclusion of an active substance in Annex I and the dossier for the authorisation of a plant protection product were required to satisfy.
7 Recital 8 of Directive 2010/28 states: ‘Without prejudice to the obligations defined by Directive [91/414] 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], 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]. 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].’
8 Article 1 of that directive provides: ‘Annex I to Directive [91/414] is amended as set out in the Annex to this Directive.’
9 Article 3 of that directive provides: ‘1. Member States shall in accordance with Directive [91/414], 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] 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], 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]. Following that determination Member States shall: (a) in the case of a product containing metalaxyl as the only active substance, where necessary, amend or withdraw the authorisation by 30 June 2014 at the latest; or (b) in the case of a product containing metalaxyl as one of several active substances, where necessary, amend or withdraw the authorisation by 30 June 2014 or by the date fixed for such an amendment or withdrawal in the respective directive or directives which added the relevant substance or substances to Annex I to Directive [91/414], whichever is the latest.’
10 Article 4 of that directive provides: ‘This Directive shall enter into force on 1 July 2010.’
11 IQV is a company governed by Spanish law, the activities of which include the production and marketing of chemical products and plant protection products. IQV imports, in particular, metalaxyl into Spain and markets products containing that active substance in a number of Member States.
12 Sapec Agro is a company governed by Portuguese law, engaged in developing plant protection products and solutions and plant nutrients. That company is the proprietor of authorisations for plant protection products containing metalaxyl.
13 On 2 May 2003 the Commission adopted Decision 2003/308/EC concerning the non-inclusion of metalaxyl in Annex I to Directive 91/414 and the withdrawal of authorisations for plant protection products containing this active substance (OJ 2003 L 113, p. 8). The Court of Justice annulled that decision by its judgment of 18 July 2007, Industrias Químicas del Vallés v Commission (C‑326/05 P, EU:C:2007:443). As a result of that annulment, Directive 2010/28 was adopted. It entered into force on 1 July 2010 and, consequently, metalaxyl was included in Annex I to Directive 91/414.
14 On 30 April 2010, an ex officio re-evaluation procedure was commenced in Spain regarding the marketing authorisations of plant protection products containing metalaxyl as an active substance, in accordance with Article 3(1) of Directive 2010/28.
15 In that regard, IQV lodged an application for the re-evaluation of its plant protection products containing metalaxyl with the competent Spanish authority, together with a dossier that that authority declared to be complete as regards the requirements laid down in Annex II to Directive 91/414.
16 On 29 June 2010, Sapec Agro also lodged an application for the re-evaluation of its plant protection products containing metalaxyl.
17 On 30 December 2010, namely the day before the deadline of 31 December 2010 laid down in Article 3(1) of Directive 2010/28, Sapec Agro asked the competent Spanish authority to grant it further time to complete the dossier that it had submitted, having regard to the requirements of Annex II to Directive 91/414.
18 On 3 March 2011, the Dirección General de Recursos Agrícolas y Ganaderos (Directorate General for Agricultural and Livestock Farming Resources, Spain) granted Sapec Agro the extension of time sought.
19 By decision of 5 April 2011, the Directorate General for Agricultural and Livestock Farming Resources declared that the dossier submitted by Sapec Agro on the active substance metalaxyl was complete as regards Annex II to Directive 91/414.
20 IQV contested that decision before 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). That appeal was dismissed by decision of 7 November 2011, for lack of standing to bring proceedings.
21 IQV brought a contentious-administrative appeal against that dismissal decision, which was also dismissed by the Tribunal Superior de Justicia de Madrid (High Court of Justice, Madrid, Spain) for lack of standing to bring proceedings.
22 IQV appealed on a point of law before the Tribunal Supremo (Supreme Court, Spain), the referring court, submitting, inter alia, that the decision to grant Sapec Agro further time beyond 31 December 2010 to allow it to complete its dossier was unlawful, not only having regard to the wording of Directive 2010/28 but also taking into account the need to protect investments in order to generate the information that had to be submitted for the purpose of the Commission’s evaluation of the active substance or the evaluation of the plant protection product by the Member State concerned.
23 The referring court considers that it is necessary, in order to adjudicate on the case before it, to interpret Article 3(1) of Directive 2010/28 in the light of recital 8 of that directive. The referring court states that the judgment of 18 July 2007, Industrias Químicas del Vallés v Commission (C‑326/05 P, EU:C:2007:443) appears to be relevant and appears to rule in favour of the lawfulness of the extension of time granted by the Directorate General for Agricultural and Livestock Farming Resources.
24 However, the referring court considers that unlike the facts in the case that gave rise to that judgment, the facts at issue in the case pending before it do not concern contradictory conduct by the authorities resulting in confusion for the party concerned, and that the deadline at issue, as Directive 2010/28 repeatedly specifies, expired on 31 December 2010.
25 In those circumstances, the Tribunal Supremo (Supreme Court) decided to stay the proceedings and to refer the following questions to the Court for a preliminary ruling: ‘(1) Is the deadline set in Directive [2010/28] 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], a mandatory time limit by virtue of the purpose sought by the system established by Council Directive [91/414] which cannot be extended 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 may be extended, 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 Directive [2010/28]?’
26 By its first question, the referring court asks, in essence, whether Article 3(1) of Directive 2010/28 must be interpreted as meaning that the time limit that it lays down, which expired on 31 December 2010, in order to allow Member States to amend or withdraw, in accordance with Directive 91/414, existing authorisations for plant protection products containing metalaxyl as an active substance, is a mandatory time limit or whether it may be extended by those Member States.
27 In that regard, it must be recalled that, in accordance with the Court’s established case-law, when 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 (see, to that effect, judgments of 22 June 2016, Thomas Philipps, C‑419/15, EU:C:2016:468, paragraph 18, and of 26 July 2017, Jafari, C‑646/16, EU:C:2017:586, paragraph 73 and the case-law cited).
28 As regards, in the first place, the wording of Article 3(1) of Directive 2010/28, the first paragraph thereof provides that ‘Member States shall in accordance with Directive [91/414], where necessary, amend or withdraw existing authorisations for plant protection products containing metalaxyl as an active substance by 31 December 2010’. The second paragraph of that provision provides that ‘by that date, [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’.
29 According to that wording, the date referred to there, 31 December 2010, appears to be included as a deadline in respect of which no possibility of extension is provided for.
30 As regards, in the second place, the context of the provision in question, the examination thereof leads to the conclusion that the deadline laid down there is mandatory and therefore not capable of being extended.
31 First, the first paragraph of Article 3(1) sets out clearly the consequences of a failure to meet, by 31 December 2010, the conditions laid down in the second paragraph of that article, in particular the obligation for the holder of an existing authorisation for a plant protection product containing metalaxyl to possess, or have access to, a dossier that meets the requirements of Annex II of Directive 91/414 by that date. Those consequences consist of the amendment or withdrawal of such an authorisation by the Member State concerned.
32 Article 3(1) of Directive 2010/28 therefore established, in accordance with the objective referred to in the seventh recital of Directive 91/414, a framework that was uniform throughout the European Union comprising the conditions under which the Member States amended or withdrew authorisations for plant protection products containing metalaxyl, and also the obligations imposed on the holders of those authorisations as to the submission of the dossiers relating to those products. To authorise Member States to derogate from the deadline of 31 December 2010 would jeopardise the uniform nature of that framework and respect for the equal treatment of the holders of those existing authorisations.
33 Secondly, Article 3(2) of Directive 2010/28 provides, by way of derogation from paragraph 1 of that article, time limits longer than that provided for in paragraph 1 in order to enable Member States to carry out the re-evaluation of authorised plant protection products containing metalaxyl as either the only active substance or as one of several active substances. If, as the Spanish Government submits, Member States were entitled to extend the time limit laid down in Article 3(1) of Directive 2010/28 on duly justified grounds, the inclusion, in paragraph 2 of that article, of such an express derogation from the time limit laid down in paragraph 1 would have been unnecessary.
34 Thirdly, the non-extendible nature of the time limit laid down in Article 3(1) of Directive 2010/28 is also corroborated by the text of the fourth paragraph of Article 8(2) of Directive 91/414. As the Advocate General observed in point 65 of his opinion, that provision provides that, following the decision of the Commission to include, or not to include, an active substance in Annex I to that directive, the Member States are to ensure that the relevant authorisations are granted, withdrawn or varied as appropriate, ‘within a prescribed period’. That period must be understood as the period that expires on the date referred to in Article 3(1) of Directive 2010/28, namely 31 December 2010.
35 As regards, in the third and final place, the aim of Directive 2010/28, it must be noted that it is a directive which implements Directive 91/414. It must therefore, in accordance with the settled case-law of the Court, be interpreted, as far as possible, consistently with the provisions of the basic directive, namely Directive 91/414 (see, to that effect, the judgments of 22 May 2008, Feinchemie Schwebda and Bayer CropScience, C‑361/06, EU:C:2008:296, paragraph 49, and of 26 July 2017, Czech Republic v Commission, C‑696/15 P, EU:C:2017:595, paragraph 33).
36 According to its fifth, sixth and ninth recitals, Directive 91/414 seeks to remove barriers to intra-Community trade in plant products, while maintaining a high level of protection of the environment and of human and animal health (judgment of 18 July 2007, Industrias Químicas del Vallés v Commission, C‑326/05 P, EU:C:2007:443, paragraph 74).
37 In that context, to permit the extension of the time limit prescribed in Article 3(1) of Directive 2010/28 would result in a risk that plant protection products containing the active substance metalaxyl that did not meet the requirements stemming from Annex I to Directive 91/414, as amended by Directive 2010/28, in particular the purity level laid down, remaining on the market beyond the date of 31 December 2010. Such a consequence would be contrary to the pursued objective of ensuring a high level of protection for the environment and human and animal health.
38 It follows from the considerations in paragraphs 29 to 37 above that the deadline laid down in Article 3(1) of Directive 2010/28 is a mandatory deadline, which cannot be extended by the Member States.
39 That conclusion is not called into question by the judgment of 18 July 2007, Industrias Químicas del Vallés v Commission (C‑326/05 P, EU:C:2007:443). In that regard, it must be recalled, first, as the Advocate General observed in paragraph 80 of his opinion, that the case that gave rise to that judgment concerned a time limit set by the Commission in the context of the procedure for the inclusion of metalaxyl in Annex I to Directive 91/414 and the possibility for that institution, and not for the Member States, of changing that time limit. By contrast, the case in the main proceedings, which concerns the procedure of re-evaluation by the Member States of existing marketing authorisations for plant protection products containing metalaxyl, raises the question of whether, as regards a time limit set by the Commission and included in the provisions of a Directive, Member States may, unilaterally, extend that time limit.
40 Second, in the judgment of 18 July 2007, Industrias Químicas del Vallés v Commission (C‑326/05 P, EU:C:2007:443), the Court relied on the fact that the party concerned had been placed in a position that made it impossible for it to submit a complete dossier within the time limit owing partly to the contradictory conduct of the competent authorities, including the Commission. It is clear from the order for reference that, contrary the situation that arose in the case that gave rise to that judgment, Sapec Agro was not, in the present case, affected by that kind of circumstance beyond its control. On the contrary, the obligation to possess, or have access to, within the prescribed time limit, a dossier that met the requirements laid down in Annex II to Directive 91/414 was clearly established from the beginning of the procedure, since it was provided for in Article 3(1) of Directive 2010/28.
41 Having regard to all the foregoing considerations, the answer to the question referred is that Article 3(1) of Directive 2010/28 must be interpreted as meaning that the time limit that it lays down, expiring on 31 December 2010, to allow Member State to amend or withdraw, in accordance with Directive 91/414, existing authorisations for plant protection products containing metalaxyl as an active substance, is a mandatory time limit, which cannot be extended by those Member States.
42 The second question is based on the premiss that the date of 31 December 2010, laid down in Article 3(1) of Directive 2010/28, is a time limit that may be extended by the Member States. However, it is clear from the answer to the first question that the date in question cannot be extended by those states.
43 It follows that there is no need to answer the second question.
44 Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.