Criminal proceedings against Mathieu Blaise and Others.
Date: 2019-10-01
34


It must be borne in mind that, in accordance with the Court’s settled case-law, in the context of the cooperation between the Court and the national courts provided for in Article 267 TFEU, it is solely for the national court before which a dispute has been brought, and which must assume responsibility for the subsequent judicial decision, to determine in the light of the particular circumstances of the case both the need for a preliminary ruling in order to enable it to deliver judgment and the relevance of the questions which it submits to the Court. Consequently, where the questions submitted concern the interpretation or the validity of a rule of EU law, the Court is in principle bound to give a ruling (see, to that effect, judgments of 16 June 2015, Gauweiler and Others, C‑62/14, EU:C:2015:400, paragraph 24, and of 4 December 2018, Minister for Justice and Equality and Commissioner of An Garda Síochána, C‑378/17, EU:C:2018:979, paragraph 26).
35


It follows that questions relating to EU law enjoy a presumption of relevance. The Court may refuse to give a ruling on a question referred by a national court only where it is quite obvious that the interpretation, or the determination of validity, of a rule of EU law that is sought bears no relation to the actual facts of the main action or its purpose, where the problem is hypothetical, or where the Court does not have before it the factual or legal material necessary to give a useful answer to the questions submitted to it (see, to that effect, judgments of 16 June 2015, Gauweiler and Others, C‑62/14, EU:C:2015:400, paragraph 25, and of 4 December 2018, Minister for Justice and Equality and Commissioner of An Garda Síochána, C‑378/17, EU:C:2018:979, paragraph 27).
37


In those circumstances, given that, first, in the procedure under Article 267 TFEU, the interpretation of national law is exclusively for the referring court (see, to that effect, judgment of 13 November 2018, Čepelnik, C‑33/17, EU:C:2018:896, paragraph 24 and the case-law cited), and, second, Regulation No 1107/2009 establishes the rules whereby the harmfulness to human health or to animal health or to the environment of such products and the active substances of which those products are composed must be assessed before they can be authorised by a Member State, it cannot be held that questions seeking an examination of the compliance of that regulation with the precautionary principle manifestly bear no relation to the actual facts of the main action or its purpose.
41


It must be noted, first, that, while Article 191(2) TFEU provides that the policy on the environment is to be based on, inter alia, the precautionary principle, that principle is also applicable in the context of other EU policies, in particular the policy on the protection of public health and where the EU institutions adopt, under the common agricultural policy or the policy on the internal market, measures for the protection of human health (see, to that effect, judgments of 2 December 2004, Commission v Netherlands, C‑41/02, EU:C:2004:762, paragraph 45; of 12 July 2005, Alliance for Natural Health and Others, C‑154/04 and C‑155/04, EU:C:2005:449, paragraph 68; and of 22 December 2010, Gowan Comércio Internacional e Serviços, C‑77/09, EU:C:2010:803, paragraphs 71 and 72).
42


There is therefore an obligation on the EU legislature, when it adopts rules governing the placing on the market of plant protection products, such as those laid down in Regulation No 1107/2009, to comply with the precautionary principle, in order to ensure, in particular, in accordance with Article 35 of the Charter of Fundamental Rights of the European Union and Article 9 and Article 168(1) TFEU, a high level of protection of human health (see, by analogy, judgment of 4 May 2016, Pillbox 38, C‑477/14, EU:C:2016:324, paragraph 116).
43


That principle entails that, where there is uncertainty as to the existence or extent of risks to human health, protective measures may be taken without having to wait until the reality and seriousness of those risks become fully apparent. Where it proves to be impossible to determine with certainty the existence or extent of the alleged risk because the results of studies conducted are inconclusive, but the likelihood of real harm to public health persists should the risk materialise, the precautionary principle justifies the adoption of restrictive measures (see, to that effect, judgments of 22 December 2010, Gowan ComércioInternacional e Serviços, C‑77/09, EU:C:2010:803, paragraphs 73 and 76; of 17 December 2015, Neptune Distribution, C‑157/14, EU:C:2015:823, paragraphs 81 and 82; and of 22 November 2018, Swedish Match, C‑151/17, EU:C:2018:938, paragraph 38).
46


A correct application of that principle in the area covered by Regulation No 1107/2009 presupposes, first, identification of the potentially negative consequences for health of the use of the active substances and plant protection products falling within its scope, and, second, a comprehensive assessment of the risk to health based on the most reliable scientific data available and the most recent results of international research (see, by analogy, judgments of 8 July 2010, Afton Chemical, C‑343/09, EU:C:2010:419, paragraph 60, and of 22 December 2010, Gowan Comércio Internacional e Serviços, C‑77/09, EU:C:2010:803, paragraph 75).
48


It must also be recalled that the validity of a provision of EU law is to be assessed according to the characteristics of those provisions themselves and cannot depend on the particular circumstances of a given case (judgment of 29 May 2018, Liga van Moskeeën en Islamitische Organisaties Provincie Antwerpen and Others, C‑426/16, EU:C:2018:335, paragraph 72).
50


It must, moreover, be added that, in view of the need to strike a balance between several objectives and principles, and of the complexity of the application of the relevant criteria, judicial review by the Court must necessarily be limited to whether the EU legislature, in adopting Regulation No 1107/2009, committed a manifest error of assessment (see, to that effect, judgment of 21 December 2016, Associazione Italia Nostra Onlus, C‑444/15, EU:C:2016:978, paragraph 46).
55


Second, it follows from Article 33 of that regulation that an applicant who wishes to place a plant protection product on the market must apply for an authorisation, and his application must contain the information required for the processing of that application. In particular, Article 33(3)(b) of that regulation provides that an application for authorisation of such a product must be accompanied, for each active substance contained in that product, by a complete and a summary dossier in respect of each point of the data requirements that apply to the active substance.
63


In that regard, it must be emphasised that Regulation No 1107/2009 makes provision for both a procedure for the approval of active substances, governed by Chapter II of that regulation, and a procedure for authorisation of plant protection products, governed by Chapter III of that regulation.
64


Those two procedures are closely linked, in that, in particular, the authorisation of a plant protection product presupposes, pursuant to Article 29(1)(a) of that regulation, that its active substances have previously been approved.
66


In accordance with Article 11(2) and Article 36(1) of Regulation No 1107/2009, the Member State dealing with an application for approval of an active substance or for authorisation of a plant protection product must undertake an independent, objective and transparent assessment of that application in the light of current scientific and technical knowledge.
78


It is apparent, admittedly, from Article 7(1) and from Article 8(1) and (2) of Regulation No 1107/2009, that the tests, studies and analyses required to permit the approval of an active substance must be provided by the applicant. The same is true in the procedure for authorisation of a plant protection product, pursuant to Article 33(3)(a) and (b) of that regulation, read together with Article 8(1) and (2) thereof.
94


With that in mind, it is the duty of the competent authorities, in particular, to take account of the most reliable scientific data available and the most recent results of international research and not to give in all cases preponderant weight to the studies provided by the applicant.
106


Third, Article 63(3) of Regulation No 1107/2009 states that that article is to be without prejudice to the application of Directive 2003/4, which means that requests for access by third parties to the information contained in authorisation application dossiers are subject to the general provisions of that directive (see, to that effect, judgment of 23 November 2016, BayerCropScience and Stichting De Bijenstichting, C‑442/14, EU:C:2016:890, paragraph 44).
108


That specific rule is applicable, in particular, to a great extent, to the studies designed to assess the harm that may be caused by the use of a plant protection product or the presence in the environment of residues after the application of that product (see, to that effect, judgment of 23 November 2016, Bayer CropScience and Stichting De Bijenstichting, C‑442/14, EU:C:2016:890, paragraphs 79, 87, 91 and 95).