JUDGMENT OF THE GENERAL COURT (Sixth Chamber)
10 September 2015 (*)
(Plant protection products — Active substance trifluralin — Non-inclusion in Annex I to Directive 91/414/EEC — Regulation (EC) No 33/2008 — Accelerated assessment procedure — Manifest error of assessment — Principle of non-discrimination — Proportionality)
In Case T‑446/10,
Dow AgroSciences Ltd, established in Hitchin (United Kingdom),
Dintec Agroquímica — Produtos Químicos, Lda, established in Funchal (Portugal),
represented by K. Van Maldegem and C. Mereu, lawyers,
applicants,
v
European Commission, represented initially by P. Ondrůšek and F. Wilman, and subsequently by P. Ondrůšek and G. von Rintelen, acting as Agents, and J. Stuyck, lawyer,
defendant,
APPLICATION for annulment of Commission Decision 2010/355/EU of 25 June 2010 concerning the non-inclusion of trifluralin in Annex I to Council Directive 91/414/EEC (OJ 2010 L 160, p. 30),
THE GENERAL COURT (Sixth Chamber),
composed of S. Frimodt Nielsen (Rapporteur), President, F. Dehousse and A.M. Collins, Judges,
Registrar: L. Grzegorczyk, Administrator,
having regard to the written procedure and further to the hearing on 25 March 2015,
gives the following
Judgment
Background to the dispute
1        Trifluralin is a plant protection substance which, in order to be authorised for use on the internal market, must be included in Annex I to 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). As it is covered by the second stage of the programme of work referred to in Article 8(2) of Directive 91/414, it is subject to the procedures put in place by Commission Regulation (EC) No 451/2000 of 28 February 2000 laying down the detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of Directive 91/414 (OJ 2000 L 55, p. 25), as amended by Commission Regulation (EC) No 1490/2002 of 14 August 2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414 and amending Regulation No 451/2000 (OJ 2002 L 224, p. 23).
2        On 20 September 2007, the Commission of the European Communities adopted Decision 2007/629/EC concerning the non-inclusion of trifluralin in Annex I to Directive 91/414 and the withdrawal of authorisations for plant protection products containing that substance (OJ 2007 L 255, p. 42).
3        It is stated in recital 5 in the preamble to that decision that, from the information available, a number of concerns remained unresolved. They related, first of all, to trifluralin’s high toxicity to aquatic organisms, in particular fish; next, to the fact that trifluralin is highly persistent in soil and has potential for accumulation; and, lastly, to the presence of trifluralin in places distant from application.
4        By application lodged at the Court Registry on 21 December 2007, 21 companies active in the manufacture or marketing of trifluralin or trifluralin-based products, including the applicants in the present case, Dow AgroSciences Ltd and Dintec Agroquímica — Produtos Químicos, Lda, brought an action for the annulment of Decision 2007/629 and a declaration that Article 3(3) of Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC (OJ 2004 L 158, p. 7) was illegal, an action which was registered as Case T‑475/07.
5        On 11 April 2008, the applicants informed the Commission of their intention to submit a new request for trifluralin to be included in Annex I to Directive 91/414, pursuant to Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Directive 91/414 as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that directive but have not been included into its Annex I (OJ 2008 L 15, p. 5).
6        Following that new request, an accelerated assessment procedure was launched, pursuant to Articles 13 to 19 of Regulation No 33/2008, which resulted in Commission Decision 2010/355/EU of 25 June 2010 concerning the non-inclusion of trifluralin in Annex I to Directive 91/414 (OJ 2010 L 160, p. 30) (‘the contested decision’). That decision repealed and replaced Decision 2007/629.
Contested decision
7        The statement of reasons provided in the contested decision for refusing to include trifluralin in Annex I to Directive 91/414 is as follows:
‘(1) By Commission Decision 2007/629/EC it was decided not to include the active substance trifluralin in Annex I to Directive 91/414/EEC. That Decision was taken within the framework of the second stage of the programme of work provided for in Commission Regulations (EC) No 451/2000 and (EC) No 703/2001 which lay down the detailed rules for the implementation of the second stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and which establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC.
(2) The original notifier submitted a new application pursuant to Article 6(2) of Directive 91/414/EEC and ... Regulation (EC) No 33/2008 .... It requested the application of the accelerated procedure pursuant to Articles 13 to 19 of Regulation (EC) No 33/2008 and submitted an updated dossier. The application was submitted to Greece, which had been designated rapporteur Member State by Regulation (EC) No 451/2000.
(3) That application complies with the substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008 and was submitted within the time period provided for in the second sentence of Article 13 of that Regulation.
(4) Greece evaluated the new information and data submitted by the notifier and prepared an additional report on 7 January 2009.
(5) The additional report was peer reviewed by the Member States and the European Food Safety Authority, hereinafter EFSA, and presented to the Commission on 14 July 2009 in the format of the EFSA Scientific Report for trifluralin. This report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 11 May 2010 in the format of the Commission review report for trifluralin.
(6) The new assessment by the rapporteur Member State and the new conclusion by the EFSA concentrated on the concerns that [led] to the non-inclusion, which were due to the high risk for aquatic organisms, especially fish, the toxicity of metabolites to sediment dwelling organisms, the consumer exposure for non-cereal applications, the high persistence in soil, the high potential for bioaccumulation, and the potential for long range transport via air.
(7) New data and information were submitted by the notifier in the updated dossier, in particular as regards the aquatic risk assessment, especially fish, the toxicity of metabolites to sediment dwelling organisms, the high persistence in soil and the high potential for bioaccumulation. In order to reduce the risk to consumers, the notifier, in the context of the resubmission, only supported applications on oil seed rape. As regards the potential for long range transport via air, the submitted data simply reproduced a monitoring report which already figured in the original dossier. A new assessment was performed, as included in the additional report and in the EFSA Scientific Report for trifluralin.
(8) However, the additional data and information provided by the notifier did not permit to eliminate all the specific concerns that led to the non-inclusion.
(9) In particular, the concern on potential high risk for aquatic organisms, especially fish, could not be solved due to shortcomings in the newly submitted studies. As a consequence, the surface water risk assessment could not be finalised. Furthermore, the potential for long range transport via air has not been adequately elucidated by the produced information which was of an obsolete nature.
(10) The Commission invited the notifier to submit its comments on the results of the peer review. Furthermore, in accordance with Article 21(1) [of] Regulation (EC) No 33/2008, the Commission invited the notifier to submit comments on the draft review report and in particular on the remaining concerns for the aquatic risk and the potential for long range transport. The notifier submitted its comments, which have been carefully examined.
(11) However, despite the arguments put forward by the notifier, the concerns identified could not be eliminated, and assessments made on the basis of the information submitted and evaluated during the EFSA expert meetings have not demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing trifluralin satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC.
(12) Trifluralin should therefore not be included in Annex I to Directive 91/414/EEC.’
Procedure and forms of order sought
8        By application lodged at the Registry on 17 September 2010, the applicants brought an action for the annulment of the contested decision.
9        By order of 13 April 2011, the President of the First Chamber ordered a stay of the present proceedings pending a ruling from the General Court in Case T‑475/07.
10      By judgment of 9 September 2011 in Dow AgroSciences and Others v Commission (T‑475/07, ECR, EU:T:2011:445), the General Court dismissed the action against Decision 2007/629.
11      On 21 November 2011, Dow AgroSciences and 11 other companies connected therewith brought an appeal against the judgment in Dow AgroSciences and Others v Commission cited in paragraph 10 above (EU:T:2011:445).
12      By order of 15 December 2011, the President of the First Chamber ordered a stay of the present proceedings pending a ruling from the Court of Justice on the appeal brought against the judgment in Dow AgroSciences and Others v Commission cited in paragraph 10 above (EU:T:2011:445).
13      By order of 7 May 2013 in Dow AgroSciences and Others v Commission (C‑584/11 P, EU:C:2013:281), the Court of Justice dismissed the appeal brought against the judgment in Dow AgroSciences and Others v Commission cited in paragraph 10 above (EU:T:2011:445).
14      By decision of 5 June 2013, the applicants were requested to lodge their reply and to submit their observations on the inferences to be drawn for the present case from the order in Dow AgroSciences and Others v Commission cited in paragraph 13 above (EU:C:2013:281).
15      The applicants complied with that request within the prescribed period, stating on that occasion, in essence, that they were withdrawing their plea in law alleging that the contested decision was unlawful as a result of the unlawfulness of Decision 2007/629, but that they intended to pursue the remainder of their action.
16      Following a change in the composition of the Chambers of the General Court, the present case was allocated to the Sixth Chamber.
17      Acting upon a report of the Judge-Rapporteur, the General Court (Sixth Chamber) decided to open the oral part of the procedure and, by way of measures of organisation of procedure under Article 64 of the Rules of Procedure of the General Court of 2 May 1991, put written questions to the parties, who filed their responses within the prescribed period.
18      The parties presented oral argument and answered the questions put to them by the Court at the hearing on 25 March 2015.
19      The applicants claim that the Court should:
–        annul the contested decision;
–        order the Commission to pay the costs.
20      The Commission contends that the Court should:
–        dismiss the action;
–        order the applicants to pay the costs.
Law
21      In support of their action, the applicants — having withdrawn one of the pleas initially put forward in support thereof (see paragraph 15 above) — rely on two pleas in law, alleging that the Commission erred in law in basing the contested decision on the potential for long-range transport via air (first plea) and on a potential high risk of chronic toxicity to fish (second plea).
22      The first plea in law is divided into three parts. The first part relates to a failure to take the information provided by the applicants into consideration, a lack of scientific justification for the contested decision, and a breach of both the principle of sound administration and the rights of the defence. The second and third parts relate to the discriminatory and disproportionate nature of the contested decision, respectively.
Fundamental considerations relating to the first plea in law
23      Pursuant to Article 191(1) and (2) TFEU, EU policy on the environment is to contribute to — inter alia — preserving, protecting and improving the quality of the environment and protecting human health, being based, in particular, on the precautionary principle. The precautionary principle constitutes a general principle of EU law, requiring the authorities in question, in the particular context of the exercise of the powers conferred on them by the relevant rules, to take appropriate measures to prevent specific potential risks to public health, safety and the environment, by giving precedence to the requirements related to the protection of those interests over economic interests (see judgment in Dow AgroSciences and Others v Commission, cited in paragraph 10 above, EU:T:2011:445, paragraph 144 and the case-law cited).
24      In addition, it is clear from recitals 5, 6 and 9 in the preamble thereto that Directive 91/414 aims to remove barriers to intra-Community trade in plant protection products, while maintaining a high level of protection of the environment and of human and animal health (see judgment of 22 December 2010 in Gowan Comércio Internacional e Serviços, C‑77/09, ECR, EU:C:2010:803, paragraph 54 and the case-law cited).
25      To enable it to accomplish effectively the task entrusted to it and having regard to the complex scientific assessments which it must make when, in the course of examining requests for the inclusion of active substances in Annex I to Directive 91/414, it assesses the risks posed by the use of those substances, the Commission must be allowed a wide discretion (judgment in Gowan Comércio Internacional e Serviços, cited in paragraph 24 above, EU:C:2010:803, paragraph 55).
26      The exercise of that discretion is not, however, excluded from review by the Court. The Court has consistently held that in the context of such a review the Courts of the European Union must verify whether the relevant procedural rules have been complied with, whether the facts admitted by the Commission have been accurately stated and whether there has been a manifest error of appraisal or a misuse of powers (see judgment in Gowan Comércio Internacional e Serviços, cited in paragraph 24 above, EU:C:2010:803, paragraph 56 and the case-law cited).
27      In particular, where a party claims that the institution competent in the matter has committed a manifest error of appraisal, the Courts of the European Union must verify whether that institution has examined, carefully and impartially, all the relevant facts of the individual case, facts which support the conclusions reached (see judgment in Gowan Comércio Internacional e Serviços, cited in paragraph 24 above, EU:C:2010:803, paragraph 57 and the case-law cited).
28      It is in the light of those fundamental considerations that the merits of the present plea in law must be examined.
First part of the first plea in law: a failure to take the information provided by the applicants into consideration, a lack of scientific justification for the contested decision and a breach of both the principle of sound administration and the rights of the defence
29      The applicants claim, in essence, that the information which they provided pursuant to Articles 13 and 15 of Regulation No 33/2008 was not taken into consideration during the new assessment procedure for trifluralin. They are referring to the information and arguments (supported by scientific references), supporting the conclusion that trifluralin has neither PBT (persistence, bioaccumulation and toxicity) nor POP (persistent organic pollutant) properties, contained in a 13-page document which they submitted in support of their request for inclusion. It follows that the contested decision was made without scientific justification and in breach of both the rights of the defence and the principle of sound administration.
30      The Commission contests those allegations. In essence, it contends that it took the document in question — which, moreover, contained no significantly relevant new evidence — into consideration during the accelerated assessment procedure. Furthermore, it gave the applicants several opportunities to make their arguments known. However, the applicants failed to reduce the remaining uncertainty regarding the issue of the long-range transport via air of trifluralin, even though that issue had been raised some seven years earlier.
31      Under Article 15(2)(a) of Regulation No 33/2008, in the context of a request for an accelerated procedure it is for the person making that request to submit ‘the additional data necessary to address the specific issues’ that resulted in the first non-inclusion decision.
32      In other words, it is the responsibility of the person making the request to communicate the data and information necessary to alleviate the concerns which led to the adoption of the first non-inclusion decision.
33      As indicated in paragraph 3 above, the reason given for the contested decision was the fact that a number of concerns remained unresolved, in particular in relation to trifluralin’s potential for long-range transport via air, having regard to the presence of that substance in places distant from application.
34      In that regard, the applicants argue that the information which they submitted to the rapporteur Member State supported the conclusion that trifluralin did not fulfil the PBT or POP criteria.
35      In the first place, it should be borne in mind that the evaluation of a substance in the light of the PBT and POP criteria under Regulation No 850/2004 is not to be confused with the evaluation of that substance under Directive 91/414. Therefore, the fact that a substance is not classified as fulfilling the PBT or POP criteria does not mean that it complies with Article 5 of Directive 91/414 (see, to that effect, judgment of 9 September 2008 in Bayer CropScience and Others v Commission, T‑75/06, ECR, EU:T:2008:317, paragraphs 183 to 187, and judgment in Dow AgroSciences and Others v Commission, cited in paragraph 10 above, EU:T:2011:445, paragraphs 175 to 182).
36      Article 5(1) of Directive 91/414 states that, in order for an active substance to be included in Annex I thereto, the use or residues of that substance, consequent on application consistent with good plant protection practice, must not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment.
37      In addition, Article 5(2)(c) of Directive 91/414 provides that, in order for an active substance to be included in Annex I, it is necessary for ‘particular account [to be taken,] where relevant, [of] an estimate of its fate and distribution in the environment as well as its impact on non-target species’. Moreover, point 7 of Part A of Annex II to that directive specifically covers the fate and behaviour of the substance in the environment and deals with the fate and behaviour of the substance in soil, water and air, as well as its bioaccumulation and biodegradability.
38      As regards the assessment of chemical products in the light of the POP criteria, it is apparent from Article 3(3) of Regulation No 850/2004 that the Member States and the Commission are to take into consideration the criteria set out in paragraph 1 of Annex D to the Stockholm Convention on Persistent Organic Pollutants, namely those relating to the persistence, bioaccumulation, potential for transport and adverse effects on human health and the environment of the products in question.
39      Therefore, it must be held that, although the two types of analysis may have certain elements in common, an analysis carried out solely having regard to the POP criteria under Regulation No 850/2004 is distinct from one carried out within the framework of Directive 91/414, which covers broader issues. Accordingly, an analysis concerning only the POP criteria would not necessarily be sufficient to fulfil the criteria set out in Directive 91/414.
40      In the second place, as the Commission rightly contends, the information provided by the applicants in the 13-page document to which they refer in fact amounts to no more than a reformulation, with some editorial changes and an additional conclusion, of the evidence contained in an earlier, 8-page version of the same document which had been submitted by the persons requesting the inclusion of trifluralin in Annex I to Directive 91/414 during the procedure which resulted in Decision 2007/629.
41      It is stated in the document in question that, despite the high volatility of trifluralin, its potential for long-range transport via air is considered to be low on account of its short lifetime in the atmosphere. The document acknowledges the existence of articles attesting to traces of trifluralin being found in places distant from application, but indicates that a more thorough assessment would need to be made in order for it to be possible to draw any conclusions regarding long-range transport. The conclusion of the document, constituting in essence its only additional element when compared with what had already been submitted by the applicants during the first assessment procedure, states that trifluralin is not regarded as fulfilling the PBT and POP criteria under the Stockholm Convention on Persistent Organic Pollutants and, accordingly, cannot be included in the list set out in the Protocol to the 1979 United Nations Convention on Long-Range Transboundary Air Pollution, which concerns persistent organic pollutants.
42      Therefore, that document does not provide, for the purposes of Article 15 of Regulation No 33/2008, additional data capable of alleviating the concerns which arose regarding the long-range transport via air of the substance when it was first assessed. Those concerns emerged in the light of, inter alia, the results of monitoring which showed that traces of trifluralin had been found in three Canadian monitoring stations in the Arctic. The information contained in the document submitted by the applicants does not establish, using conclusive evidence, the reasons why those monitoring data and the articles to which the applicants themselves refer do not constitute a valid basis for continuing concerns regarding the long-range transport of trifluralin.
43      In the third place, it can be seen from the file relating to the accelerated assessment procedure under Regulation No 33/2008 that the applicants were, on various occasions, given an opportunity to submit their observations and express their views on the issue of trifluralin’s long-range transport via air and on the fact that they had not provided the data necessary to address that issue.
44      Thus, they were requested to express their views, in particular following the observations submitted by the Kingdom of Sweden during the peer review of the additional report drawn up by the rapporteur Member State which referred to the monitoring data indicating the presence of trifluralin in the Arctic. In response, the applicants confined themselves to asserting that trifluralin did not fulfil the POP criteria.
45      Similarly, by letter from the Commission of 24 July 2009, the applicants were requested to submit their observations on the conclusions voiced by the European Food Safety Authority (‘the EFSA’) on 14 July 2009, according to which ‘[a]vailable monitoring data from the Arctic or other regions remote from agriculture should be provided to enable conclusions on the potential for long-range atmospheric transport to be drawn’. In response to that request, the applicants merely indicated, by letter of 3 September 2009, what the state of play was regarding the discussions on that subject in the context of the 1979 United Nations Convention on Long-Range Transboundary Air Pollution, without, however, providing any detailed scientific explanation regarding the detection of the substance in remote areas, in particular the Arctic.
46      In addition, in the context of their comments on the draft review report drawn up by the Commission pursuant to Article 21 of Regulation No 33/2008, addressed to the Commission by letter of 22 January 2010, the applicants merely repeated, regarding long-range transport via air, what they had stated in their letter of 3 September 2009 and maintained that ‘the potential for “Long-Range Transport” of trifluralin [was] minimal and [that] all concentrations detected [were] low and [that] no evidence of any significant adverse health and/or environmental effects [had] been identified’.
47      It follows from the foregoing that the information and comments submitted by the applicants regarding the long-range transport via air of trifluralin were taken into consideration throughout the accelerated assessment procedure. However, the applicants did not provide specific and conclusive responses to the concerns which were expressed with regard to such transport.
48      In those circumstances, it must be concluded that the applicants have not established that the Commission made a manifest error of assessment in deciding, on the basis of the scientific data available to it, not to authorise the inclusion of trifluralin in Annex I to Directive 91/414, nor that it breached the principle of sound administration and their rights of defence.
49      The first part of the first plea in law must, therefore, be rejected as unfounded.
Second part of the first plea in law: discriminatory nature of the contested decision
50      The applicants claim, in essence, that the Commission breached the principle of non-discrimination by refusing to include trifluralin in Annex I to Directive 91/414 even though the inclusion of the active substance clofentezine, which had potential for long-range transport via air, was authorised on the condition that a monitoring programme be put in place to assess the potential for transport.
51      The Commission contests those allegations, contending, in essence, that the situations of the two substances are dissimilar from both a technical and a legal point of view.
52      It should be borne in mind that, according to settled case-law, compliance with the principle of equal treatment or of non-discrimination requires that comparable situations must not be treated differently and that different situations must not be treated in the same way unless such treatment is objectively justified (judgment of 12 July 2012 in Association Kokopelli, C‑59/11, ECR, EU:C:2012:447, paragraph 70).
53      It must be found that, in the present case, trifluralin and clofentezine are not in comparable situations.
54      Indeed, as has been observed by the Commission and has not been called in question by the applicants, those substances differ, from a technical point of view, both in terms of their nature — the one (trifluralin) being a herbicide used on bare soil and the other (clofentezine) being an acaricide used by spraying — and in terms of their use, namely, regarding trifluralin, the cultivation of oil seed rape, sunflowers, cotton and winter cereals, and, regarding clofentezine, the cultivation of pome fruit, stone fruit, grapes, strawberries and ornamentals. They also differ as regards the risks which they pose, as trifluralin is a suspected carcinogenic substance which may lead to sensitisation by skin contact, whereas clofentezine is not classified as a carcinogen or as a sensitiser. Moreover, the figures relating to the persistence, volatility, bioconcentration and solubility of trifluralin are not only high but also significantly higher than the corresponding figures for clofentezine. Similarly, so far as acute toxicity to fish and chronic toxicity are concerned, the parameters for trifluralin are higher than those for clofentezine.
55      In addition, regarding the long-range transport via air of clofentezine, the parties agree that there is no evidence indicating that any migration of that substance is actually taking place, even if such transport is theoretically possible. Consequently, the purpose of the monitoring studies to which the inclusion of that substance in Annex I to Directive 91/414 was made subject is to examine more thoroughly whether the theoretical possibility of transport is also a practical reality.
56      By contrast, so far as trifluralin is concerned, its presence in the Arctic in particular has been attested to by the results of Canadian monitoring, and its long-range transport via air is therefore not purely hypothetical.
57      Lastly, each of those substances is subject to a different set of legal rules justifying different treatment: while trifluralin is covered by the second stage of the programme of work referred to in Article 8(2) of Directive 91/414, clofentezine is covered by the third stage of that programme and was thus considered to be an active substance clearly not having any harmful effects under Annex V to Regulation No 1490/2002, as amended.
58      Those differences are sufficient to justify the two substances being treated differently.
59      Therefore, the applicants cannot claim that trifluralin has been the subject of discriminatory treatment.
60      Consequently, the second part of the first plea in law must be rejected as unfounded.
Third part of the first plea in law: disproportionate nature of the contested decision
61      The applicants claim, in essence, that the refusal to include trifluralin in Annex I to Directive 91/414 owing to the potential for long-range transport via air is a disproportionate measure. According to the applicants, that potential was classed as a scientific concern purely because they did not provide data in relation to the traces of trifluralin found in Arctic regions, even though those data are in the public domain and could have been submitted within a few days. Therefore, a less onerous measure could have been adopted, namely a decision to include that substance subject to the submission of those data.
62      The Commission contests those arguments, contending, in essence, that, due to the high volatility of trifluralin and the data reporting the presence of trifluralin in the Arctic, the transport via air of that substance could actually endanger sensitive species. In those circumstances, in accordance with the principle of proportionality and the precautionary principle, no measure other than non-inclusion could have been taken.
63      According to settled case-law, the principle of proportionality is one of the general principles of EU law (see judgment of 8 June 2010 in Vodafone and Others, C‑58/08, ECR, EU:C:2010:321, paragraph 51 and the case-law cited). That principle requires that measures adopted by EU institutions must not exceed the limits of what is appropriate and necessary in order to attain the legitimate objectives pursued by the legislation in question; that, where there is a choice between several appropriate measures, recourse must be had to the least onerous; and that the disadvantages caused must not be disproportionate to the aims pursued (see judgment in Bayer CropScience and Others v Commission, cited in paragraph 35 above, EU:T:2008:317, paragraph 223 and the case-law cited).
64      With regard to judicial review of compliance with the requirements deriving from the principle of proportionality, it should be borne in mind that, having regard to the complex scientific assessments which it must make when, in the course of examining requests for the inclusion of active substances in Annex I to Directive 91/414, it assesses the risks posed by the use of those substances, the Commission must be allowed a wide discretion (judgment in Gowan Comércio Internacional e Serviços, cited in paragraph 24 above, EU:C:2010:803, paragraph 55).
65      Thus the criterion to be applied is not whether a measure adopted in such an area was the only or the best possible measure, since its legality can be affected only if the measure is manifestly inappropriate having regard to the objective which the competent institution is seeking to pursue (see judgment in Vodafone and Others, cited in paragraph 63 above, EU:C:2010:321, paragraph 52 and the case-law cited).
66      In addition, with regard to a decision not to include an active substance in Annex I to Directive 91/414 on the basis of considerations relating to the protection of the environment in particular, it should be borne in mind that, as stated in paragraph 23 above, the protection of the environment constitutes one of the essential objectives of the European Union. It has been held that the importance of the objectives pursued by Directive 91/414 may justify even substantial negative economic consequences for certain operators (see, to that effect, judgment of 12 December 2014 in Xeda International v Commission, T‑269/11, EU:T:2014:1069, paragraph 138 and the case-law cited).
67      In the present case, first, it is common ground that trifluralin is extremely volatile. In addition, as is rightly observed by the applicants themselves, it is necessary to take account of the specific method of application essential to the range of uses of trifluralin proposed in the request under the accelerated assessment procedure. It can be seen from the EFSA’s Scientific Report that the new request concerned the use of trifluralin as a herbicide incorporated into the soil after its spray application to bare soil. In those circumstances, the EFSA rightly considered that trifluralin was a substance likely to travel long distances via air, as had also been found by a study on the volatility of that substance.
68      Secondly, the presence of trifluralin has been reported by three monitoring stations in the Arctic, as the applicants themselves have acknowledged. However, as stated in paragraphs 43 to 48 above, the applicants have not provided responses explaining the presence of that substance; nor have they provided information allowing more in-depth quantitative assessments to be carried out or more detailed predictions to be made in that regard.
69      As the Commission rightly contends, the already-established presence of that substance may endanger sensitive species — not only aquatic organisms, but also plants, since trifluralin is a herbicide — and the particularly sensitive ecosystem of the Arctic for a long time, while no evidence has been adduced establishing that its transport via air could realistically be mitigated by other measures.
70      In those circumstances it is not established, having regard to the objective of the protection of the environment pursued by the contested decision and taking account of the genuine potential for trifluralin’s long-range transport via air, that that decision is manifestly inappropriate.
71      The applicants merely submit that the concern regarding long-range transport referred to in the grounds of the contested decision is simply an observation that they did not provide the data obtained by the Canadian monitoring stations on measurements of trifluralin in Arctic regions, data which are public and which the applicants could have communicated very quickly.
72      It must be pointed out that that is not the reason given by the Commission as its justification for the contested decision and that that assertion by the applicants is therefore inaccurate: as described in paragraphs 33 to 48 above, the reason given for the contested decision was the fact that a number of concerns remained unresolved, in particular regarding the presence of trifluralin in places distant from application, while the applicants did not provide the data necessary to dispel those concerns.
73      Therefore, in view of the potential for long-range transport via air, it was not sufficient — contrary to the applicants’ assertions — that the substance be authorised and a deadline be set for their submitting the data relating to the Canadian stations’ monitoring work, which, as noted in paragraphs 43 to 48 above, they could have done at any stage in the accelerated assessment procedure. Accordingly, it is not established that other measures less onerous than the non-inclusion of trifluralin in Annex I to Directive 91/414 could have been adopted by the Commission.
74      In the light of the foregoing, the third part of the first plea in law must be rejected, and, accordingly, that plea must be rejected in its entirety.
75      Regarding the second plea in law raised by the applicants, it follows from recital 9 of the contested decision that the refusal to include trifluralin in Annex I to Directive 91/414 is based on two separate grounds for concern which remained unresolved at the end of the accelerated assessment procedure, namely the ground relating to the potential for long-range transport via air and the ground relating to the potential high risk for aquatic organisms, especially fish.
76      Since either one of those grounds is a sufficient basis for the contested decision and since the first plea in law, which concerns the ground relating to the potential for long-range transport via air, has been rejected, there is no need to give a ruling on the second plea in law, which concerns the ground relating to the potential high risk for aquatic organisms.
77      Accordingly, the action must be dismissed in its entirety.
Costs
78      Under Article 134(1) of the Rules of Procedure of the General Court, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. As the applicants have been unsuccessful, they must be ordered to pay the costs in accordance with the form of order sought by the Commission.
On those grounds,
THE GENERAL COURT (Sixth Chamber)
hereby:
1.      Dismisses the action;
2.      Orders Dow AgroSciences Ltd and Dintec Agroquímica — Produtos Químicos, Lda to bear their own costs and to pay the costs incurred by the European Commission.
Frimodt Nielsen
Dehousse
Collins
Delivered in open court in Luxembourg on 10 September 2015.
[Signatures]
* Language of the case: English.