JUDGMENT OF THE GENERAL COURT (Fourth Chamber)
6 September 2013 (*)
(Plant-protection products – Active substance flurprimidol – Non-inclusion of flurprimidol in Annex I to Directive 91/414/EEC – Regulation (EC) No 33/2008 – Accelerated assessment procedure – Manifest error of assessment – Rights of the defence – Proportionality – Obligation to state reasons)
In Case T‑483/11,
Sepro Europe Ltd, established in Harrogate (United Kingdom), represented by C. Mereu and K. Van Maldegem, lawyers,
applicant,
v
European Commission, represented by P. Ondrůšek and G. von Rintelen, acting as Agents,
defendant,
APPLICATION for annulment of Commission Implementing Decision 2011/328/EU of 1 June 2011 concerning the non-inclusion of flurprimidol in Annex I to Council Directive 91/414/EEC (OJ 2011 L 153, p. 192),
THE GENERAL COURT (Fourth Chamber),
composed of I. Pelikánová, President, K. Jürimäe (Rapporteur) and M. van der Woude, Judges,
Registrar: N. Rosner, Administrator,
having regard to the written procedure and further to the hearing on 13 March 2013,
gives the following
Judgment
Background to the dispute
1        The applicant, Sepro Europe Ltd, is a company that markets flurprimidol and flurprimidol-based products.
2        Flurprimidol is an active substance used as a plant growth regulator.
3        In November 2004, in accordance with the procedure laid down in 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), in 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) and in 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), the applicant submitted a dossier to the rapporteur Member State (‘the RMS’) designated in Annex I to Regulation No 451/2000, namely Finland, with a view to securing the inclusion of flurprimidol in Annex I to Directive 91/414.
4        In the dossier submitted with a view to securing the inclusion of flurprimidol in Annex I to Directive 91/414 and referred to in paragraph 3 above, the representative use of flurprimidol was the product Topflor. That use was defined as growth regulator for (glasshouse) protected container-grown ornamental plants, pot plants and bedding plants. The maximum application rate was fixed at 0.03 kg of active substance per hectare per treatment and the frequency of applications was fixed at two applications with a minimum interval of seven days.
5        At the close of the procedure laid down in Directive 91/414, Regulation No 451/2000 and Regulation No 1490/2002, the European Commission adopted Decision 2009/28/EC of 13 January 2009 concerning the non-inclusion of flurprimidol in Annex I to Directive 91/414 and the withdrawal of authorisations for plant production products containing that substance (OJ 2009 L 10, p. 25; ‘the first non-inclusion decision’).
6        The first non-inclusion decision provides, in Article 1, that flurprimidol is not to be included in Annex I to Directive 91/414. It therefore requires, in Article 2, that the authorisations granted for plant protection products containing flurprimidol are to be withdrawn by 13 July 2009 and that from the date of publication of that decision authorisations for such products are to be neither granted nor renewed. According to Article 4, the first non-inclusion decision is addressed to the Member States.
7        The grounds for the non-inclusion of flurprimidol in Annex I to Directive 91/414 are stated at recital 5 in the preamble to the first non-inclusion decision:
‘During the evaluation of this active substance, a number of concerns have been identified. In particular, based on the available information, the operator and worker exposure exceed the AOEL (acceptable operator exposure level) in all evaluated scenarios and conditions of use. Moreover, no data [were] available on the impurity profile of batches used in toxicological studies. Consequently, it was not possible to conclude on the basis of the information available that flurprimidol met the criteria for inclusion in Annex I to Directive [91/414].’
8        On 10 July 2009, following the adoption of the first non-inclusion decision, the applicant submitted a fresh request to the RMS for evaluation of flurprimidol, in application of the accelerated procedure provided for in Articles 13 to 22 of 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).
9        In connection with that submission, the applicant supplied new information and data in response to the concerns which led to the adoption of the first non-inclusion decision. On that basis, in response to the concern relating to worker exposure to flurprimidol, it supplied, in particular, a new study on dermal absorption carried out with Topflor, and reduced the maximum application to 0.0225 kg of active substance per hectare, with a maximum of two applications at an interval of 14 days.
10      On 10 March 2010 the RMS submitted its additional report to the European Food Safety Authority (EFSA). As regards worker exposure to flurprimidol, that report concluded that it was, in the case of a single application and even without wearing the personal protection equipment (‘PPE’), below the acceptable operator exposure level (‘AOEL’). However, that report recommended that flurprimidol should not be included in Annex I to Directive 91/414 until the mutagenicity status of the current specification had been resolved.
11      On 11 March 2010, the additional report was communicated by EFSA to the Member States and the applicant. The comments received were forwarded to the Commission on 26 April 2010.
12      On 18 August 2010 the RMS published a first addendum to the additional report. On 8 November 2011 the RMS published a second addendum to that additional report, in which, inter alia, it performed a revised modelling of worker exposure. In that respect, the RMS concluded, first, that the worker exposure level remained below the AOEL with a single application of the product and where PPE was worn and, second, that where two successive applications were carried out, that level was slightly above the AOEL. The RMS stated, however, that that conclusion might greatly overestimate the real exposure and that it was unlikely that the active substance would remain on leaves without any decomposition over the two-week period.
13      Following the Commission’s request for a peer review, in accordance with the second subparagraph of Article 20(1) of Regulation No 33/2008, on 16 December 2010 EFSA submitted its report entitled ‘Conclusion on the peer review of the pesticide risk assessment of the active substance flurprimidol’ (‘the EFSA report’).
14      In that report, EFSA identified two concerns. First, worker exposure to flurprimidol exceeds the AOEL when the worker makes two successive applications, even where PPE (either a long-sleeved shirt and long pants or gloves and a coverall) are worn. Exposure to flurprimidol is below the AOEL (53%) only where there is a single application and gloves and a coverall are worn. In addition, there appeared to be a data gap relating to the identification and relative toxicity of the isomer ratio to which the worker is exposed. Second, the data relating to the exposure of the environment to flurprimidol are insufficient for the purpose of carrying out an environmental risk assessment on the basis of any use of the active substance in conditions other than the use scenario proposed by the applicant in its request for an assessment of flurprimidol, namely in high-technology glasshouse production systems with irrigation water or excess water management systems that ensure the absence of distribution of contaminated water in the environment (‘high-technology greenhouses’).
15      On 21 January 2011 the applicant submitted its comments on the EFSA report (‘the comments of 21 January 2011’).
16      On the same date the Commission presented, in accordance with the first subparagraph of Article 21(1) of Regulation No 33/2008, a draft review report (‘the review report’) to the Standing Committee on the Food Chain and Animal Health. On that occasion, the Commission proposed that flurprimidol should not be included in Annex I to Directive 91/414 on the grounds that, first, the information available was insufficient to satisfy the requirements of that directive, owing, in particular, to the analytical methods for the monitoring of residues in soil and in surface and ground water, to the isomer ratio for the determination of worker exposure to flurprimidol and to the fate and behaviour of that active substance in the environment. Second, according to the review report, concerns had been identified with regard to worker exposure, the environment exposure and the impact on non‑target arthropods.
17      On 17 February 2011 the applicant submitted its comments on the review report (‘the comments of 17 February 2011’). On that occasion, it envisaged, in particular, a slight reduction of the maximum application in order to ensure that the AOEL for workers was not exceeded.
18      At the applicant’s request, a meeting was held on 21 February 2011, attended by representatives of the Commission and of the applicant (‘the meeting of 21 February 2011’). At that meeting, the questions relating to the reduction of the application dose or the number of applications per season, and also the problem of the exposure of the environment to flurprimidol, were addressed.
19      In that context, on 2 March 2011 the applicant submitted to the Commission a document entitled ‘Additional information on environmental fate and behaviour of flurprimidol’.
20      On 1 July 2011 the Commission adopted Implementing Decision 2011/328/EU concerning the non-inclusion of flurprimidol in Annex I to Directive 91/414 (OJ 2011 L 153, p. 192; ‘the contested decision’).
21      The contested decision provides, in Article 1, that flurprimidol is not to be included in Annex I to Directive 91/414 and, in Article 2, that the first non-inclusion decision is repealed. Under Article 3, the decision is addressed to the Member States.
22      The grounds for the non-inclusion of flurprimidol in Annex I to Directive 91/414 are stated at recitals 8 to 11 in the preamble to the contested decision.
‘(8) … [t]he additional information provided by the applicant did not permit to eliminate all of the specific concerns arising in respect of flurprimidol.
(9) In particular, based on the information available and calculated on the basis of the uses supported by the applicant, estimated worker exposure still exceeds the AOEL, irrespective of the use of personal protective equipment. The environmental data package was not sufficient to perform an environmental risk assessment for realistic scenarios and conditions of use. The described greenhouse uses [namely high-technology greenhouses], for which exposure would be acceptable, do not reflect normal greenhouse practice and therefore cannot be considered to be representative.
(10) The Commission invited the applicant to submit its comments on the conclusion by [EFSA]. Furthermore, in accordance with Article 21(1) [of] Regulation (EC) No 33/2008, the Commission invited the applicant to submit comments on the draft review report. The applicant submitted its comments, which have been carefully examined.
(11) However, despite the arguments put forward by the applicant, the concerns identified could not be eliminated, and assessments made on the basis of the information submitted and evaluated during the expert meetings of [EFSA] have not demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing flurprimidol satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414 …’
Procedure and forms of order sought
23      By application lodged at the Court Registry on 5 September 2011, the applicant brought the present action.
24      The applicant claims that the Court should:
–        declare the application admissible and well-founded;
–        annul the contested decision;
–        order the Commission to pay the costs.
25      The Commission contends that the Court should:
–        dismiss the action as unfounded;
–        order the applicant to pay the costs.
Admissibility
26      The Commission contends that the contested decision is not a regulatory act and that it requires implementing measures at Member State level. However, it also acknowledges that the contested decision is of direct and individual concern to the applicant.
27      The applicant claims that its action is admissible.
28      Under the fourth paragraph of Article 263 TFEU, any natural or legal person may institute proceedings against an act addressed to that person or which is of direct and individual concern to them and against a regulatory act which is of direct concern to them and which does not entail implementing measures.
29      In the present case, it is common ground that the contested decision is not addressed to the applicant, which is therefore not an addressee of that measure. In those circumstances, under the fourth paragraph of Article 263 TFEU, the applicant can bring an action for annulment of that measure only if the latter is either a regulatory act which is of direct concern to the applicant and entails no implementing measures or a decision of direct and individual concern to the applicant (Case T‑262/10 Microban International and Microban (Europe) v Commission [2011] ECR II‑0000, paragraph 19).
30      It should be borne in mind that, as the applicant is the person who made the request under Article 13 of Regulation No 33/2008 aimed at the inclusion of flurprimidol in Annex I to Directive 91/414, the contested decision, in which the Commission refused to include that substance in the annex in question, is of direct and individual concern to the applicant (Case T‑326/07 Cheminova and Others v Commission [2009] ECR II‑2685, paragraph 66), which the Commission does not dispute.
31      In those circumstances, the action must be held to be admissible without there being any need to consider whether the contested decision is a regulatory act which does not entail any implementing measures.
Substance
32      In support of its application, the applicant puts forward four pleas in law. They allege, first, manifest errors of assessment in the examination of worker and environment exposure to flurprimidol; second, breach of the rights of the defence and of the right to be heard; third, breach of the principle of proportionality; and, fourth, breach of the obligation to state reasons.
First plea, alleging manifest errors of assessment of worker and environment exposure to flurprimidol
33      The first plea is divided into two parts, alleging, first, a manifest error of assessment in the examination of worker exposure to flurprimidol and, second, a manifest error of assessment in the examination of environment exposure to that substance.
34      It is appropriate to examine, first of all, the second part of the first plea.
35      In this part, the applicant puts forward, in essence, three arguments. First, it maintains that, as the plant protection product at issue in the present case is used in individual pots kept in greenhouses, the environmental concerns are irrelevant. Second, the uses in high‑technology greenhouses are representative, as confirmed by the affidavit of the President of Danish Horticulture annexed to the pleadings. Third, it is within the Commission’s discretion to make the inclusion of flurprimidol in Annex I to Directive 91/414 subject to the provision of confirmatory data or to its use being restricted to high-technology greenhouses.
36      The Commission disputes the merits of the applicant’s arguments. In particular, it claims that, under Article 4(1)(b) of Directive 91/414, to which Article 5(1)(b) of that directive refers, it must take into consideration all normal conditions in which the plant protection product containing the active substance may be included. In the present case, the Commission was unable to consider that the use of flurprimidol in high-technology greenhouses would represent normal conditions of use, since greenhouses are generally not a closed environment.
37      In that regard, it should be borne in mind that Directive 91/414 is intended to eliminate barriers to intracommunity trade in plant protection products, while maintaining a high level of protection of the environment and of human and animal health, as may be seen from the fifth, sixth and ninth recitals in the preamble thereto.
38      In that context, if the Commission is to be able to pursue effectively the objective assigned to it, account being taken of the complex technical assessments which it must undertake, it must be recognised as enjoying a broad discretion (Case C‑326/05 P Industrias Químicas del Vallés v Commission [2007] ECR I‑6557, paragraphs 74 and 75).
39      The exercise of that discretion is not, however, excluded from judicial review. In that regard, it is settled case-law that, in the context of such a review, the Courts of the European Union must verify whether the relevant procedural rules have been followed, whether the facts admitted by the Commission have been accurately stated and whether there has been a manifest error of assessment of those facts or a misuse of powers (Case 98/78 Racke [1979] ECR 69, paragraph 5; Case C‑16/90 Nölle [1991] ECR I-5163, paragraph 12; and Case T‑75/06 Bayer CropScience and Others v Commission [2008] ECR II‑2081, paragraph 83).
40      In particular, where a party claims that the institution competent in the matter has made a manifest error of assessment, the Courts of the European Union must examine whether that institution has examined, carefully and impartially, all the relevant facts of the individual case which support the conclusions reached (Case C‑269/90 Technische Universität München [1991] ECR I‑5469, paragraph 14, and Bayer CropScience and Others v Commission, cited at paragraph 39 above, paragraph 84).
41      It should further be borne in mind that it is apparent from the ninth recital in the preamble to Directive 91/414 that the provisions governing the authorisation of plant protection products must ensure a high level of protection, aimed in particular at preventing the authorisation of plant protection products whose risks to health, groundwater and the environment have not been the subject of appropriate research (Case T‑334/07 Denka International v Commission [2009] ECR II‑4205, paragraph 114).
42      In that context, Article 5(1)(b) of Directive 91/414 provides that for an active substance to be included in Annex I to that directive, it must be possible to expect that, in the light of current scientific and technical knowledge, the use of plant protection products containing that substance, consequent on application consistent with good plant protection practice, will not have any harmful effects on human or animal health and that it will not have any unacceptable influence on the environment, as provided for in Article 4(1)(b)(iv) and (v) of that directive.
43      It is apparent from Article 4(1)(b) of Directive 91/414 that, where the Commission examines an active substance with a view to its inclusion in Annex I to that directive, it must have regard to all normal conditions in which the plant protection product may be used. It follows that, for the purposes of that examination, it must be satisfied of the representative and realistic nature of the use scenario notified by the person who has requested the inclusion of that substance (‘the notifier’).
44      In addition, Article 5(1)(b) of Directive 91/414 must be interpreted in conjunction with the precautionary principle. In application of that principle, where there is scientific uncertainty as to the existence or extent of risks to human health or the environment, the EU institutions may take protective measures without having to wait until the reality and seriousness of those risks become fully apparent (Case T‑13/99 Pfizer Animal Health v Council [2002] ECR II‑3305, paragraph 139).
45      It is in the light of the foregoing considerations that the Court must examine the second part of the first plea.
46      In that respect, it should be observed that, as regards the exposure of the environment to flurprimidol, as stated at paragraph 22 above, the Commission observes at recital 9 in the preamble to the contested decision that the environmental data supplied are insufficient and did not permit an environmental risk assessment for realistic scenarios and conditions of use. In the Commission’s view, at the same recital, the described greenhouse uses, for which exposure would be acceptable, do not reflect normal greenhouse practice and therefore cannot be considered to be representative.
47      It follows that the concern relating to the environment is based on the insufficiency of the data relating to conditions of use other than those described by the applicant in its request for inclusion, which were deemed by the Commission to be unrealistic and unrepresentative.
48      In that regard, in the first place, it should be observed that the applicant does not deny in the present action that it did not supply data concerning conditions of use other than in high-technology greenhouses.
49      In those circumstances, in the second place, in the light of the considerations set out at paragraph 43 above, the Court must ascertain whether, in the present case, the uses in high-technology greenhouses constitute a realistic and representative scenario, as the applicant maintains.
50      In that respect, in support of the assertion that use in high-technology greenhouses is a representative scenario, the applicant refers to the literature relating to its industry. However, it does not provide either a precise reference or an extract from that literature. It also produces an affidavit by the President of Danish Horticulture, a trade association representing the interests of the Danish horticultural industry, who asserts that the European undertakings which use products such as Topflor are specialised growers using sophisticated high‑technology greenhouses with closed irrigation systems. The applicant does not rely on any other evidence, although it is apparent from the minutes of the meeting of 21 February 2011 that the Commission requested it to provide further information and also to prove the use of the active substance in high-technology greenhouses.
51      In support of its contention that use in high-technology greenhouses cannot be considered to fall within normal conditions of use, within the meaning of Article 4(1)(b), as referred to at paragraph 43 above, as greenhouses are not generally a closed environment, the Commission adduces two pieces of evidence.
52      First, the Commission relies on EFSA’s 2010 ‘Scientific Opinion on emissions of plant protection products from greenhouses and crops grown under cover: outline of a new guidance’, EFSA Journal 2010, 8(4): 1567; ‘the 2010 emissions opinion’. It is apparent from that opinion that closed-circuit irrigation systems, specific to high-technology greenhouses, are not normal practice in the Member States, with the exception of the Netherlands, where closed-circuit systems are compulsory. In addition, in the same opinion, EFSA casts doubt on the closed nature of greenhouses, even if they are high-technology greenhouses.
53      Second, the Commission relies on EFSA’s 2012 ‘Scientific Opinion on clustering and ranking of emissions of plant protection products from protected crops (greenhouses and crops grown under cover) to relevant environmental compartments’, EFSA Journal 2012, 10(3): 2611; ‘the 2012 emissions opinion’. In that opinion, EFSA confirms the reservations expressed in the 2010 emissions opinion about the ability of greenhouses to constitute closed environments.
54      In the light of those factors, the applicant cannot be considered to have shown that the use of flurprimidol in high-technology greenhouses is a realistic and representative scenario of use. The 2010 and 2012 emissions opinions, which were drawn up by experts and are based on abundant scientific documentation, constitute strong evidence in support of the argument that uses in high-technology greenhouses are neither representative nor realistic. The affidavit provided by the applicant, based solely on the experience of the president of a trade association, cannot call those opinions into question.
55      Accordingly, it must be concluded that it has not been established that the Commission made a manifest error of assessment in asserting that high‑technology greenhouses were not representative.
56      In the third place, as regards the argument that the environmental concerns are not relevant, since the plant protection product at issue in the present case is used in individual pots kept in greenhouses, it should be borne in mind that it was concluded at paragraph 55 above that the applicant has not established that the Commission made a manifest error of assessment in asserting that use in high-technology greenhouses was a scenario that was neither representative nor realistic. Accordingly, the fact that the plant protection product at issue in the present case is used in individual pots kept in greenhouses cannot eliminate the environmental concern.
57      Furthermore, as was mentioned at paragraphs 46 and 47 above, the environmental concern is based not only on the unrepresentative nature of the scenario of use described by the applicant but also on the insufficiency of the data supplied relating to conditions of use other than in high-technology greenhouses. It was observed, at paragraph 48 above, that the applicant does not deny that it did not supply data relating to those conditions of use. Accordingly, the applicant cannot validly assert that it has eliminated the environmental concern.
58      In the fourth place, it should be stated that the argument that the Commission could have made the inclusion of flurprimidol in Annex I to Directive 91/414 subject to the provision of confirmatory data or to its use being restricted to high‑technology greenhouses, even on the assumption that it were well founded, is not such as to establish that the Commission made a manifest error of assessment in relation to the environmental impact assessment of flurprimidol. That argument must therefore be rejected in the context of the present plea. In so far as it is raised in support of the third plea, alleging breach of the principle of proportionality, it will be examined at paragraphs 82 to 99 below.
59      In the light of the foregoing considerations, it must be concluded that the Commission did not make a manifest error of assessment as regards the exposure of the environment to flurprimidol. It follows that the second part of the first plea must be rejected as unfounded in part and as ineffective in part.
60      Furthermore, it follows from recital 9 to the contested decision, as cited at paragraph 22 above, that the contested decision is based on two concerns, first, the exposure of workers to flurprimidol and, second, the exposure of the environment to that substance.
61      Under Article 5(1) of Directive 91/414, the inclusion of an active substance in Annex I to that directive is subject to its being shown that its use will be harmless, which assumes that two cumulative conditions are satisfied, namely, first, the absence of a harmful effect on human or animal health and, second, the absence of an unacceptable influence on the environment. Consequently, the inclusion of the active substance in question in Annex I to Directive 91/414 must be refused if either of those conditions is not satisfied (see, to that effect and by analogy, Joined Cases T‑134/03 and T‑135/03 Common Market Fertilizers v Commission [2005] ECR II‑3923, paragraph 148 and the case-law cited).
62      Accordingly, since, as was stated at paragraph 59 above, it has not been established that the Commission’s environmental impact assessment of flurprimidol was vitiated by a manifest error of assessment, there is no need to examine the first part of the first plea, alleging a manifest error of assessment with respect to the analysis of worker exposure to flurprimidol. Accordingly, the first plea must be rejected.
Second plea, alleging breach of the rights of the defence and of the right to be heard
63      In the context of the second plea, the applicant maintains that the Commission breached its rights of defence and its right to be heard. It puts forward, in essence, three complaints. First, although, in the context of the procedure introduced by Regulation No 33/2008, EFSA identified the isomer ratio of flurprimidol as a new concern, the purpose of that procedure is to allow the notifier to address the concerns identified in the non-inclusion decision and not to deal with new issues. Second, the applicant was not given the opportunity to undertake studies and to respond in full, that is to say with new data, to the abovementioned concern associated with the isomer ratio, which was identified at a late stage in the procedure, namely in the EFSA report. Third, the observations which the applicant submitted following the review report, and in particular its proposal to reduce the number of applications of flurprimidol, was not carefully examined by the Commission, since the Commission failed to state its reasons for rejecting that proposal. In that regard, the applicant cannot be required, as the Commission claims, to prove a negative, namely that the Commission did not take the applicant’s comments into account.
64      The Commission disputes the merits of the applicant’s arguments.
65      It should be borne in mind that, according to settled case‑law, observance of the rights of the defence is, in all procedures initiated against a person which are liable to culminate in a measure adversely affecting that person, a fundamental principle of EU law which must be guaranteed even in the absence of any rules governing the procedure in question. That principle requires that the addressees of decisions which significantly affect their interests should be placed in a position in which they may effectively make known their views (see, to that effect, Case C‑28/05 Dokter and Others [2006] ECR I‑5431, paragraph 74; Bayer CropScience and Others v Commission, cited at paragraph 39 above, paragraph 130; and Cheminova and Others v Commission, cited at paragraph 30 above, paragraph 244).
66      The right to be heard in an administrative procedure taken against a specific person is a corollary of the rights of the defence, which must be observed even in the absence of any rules governing the procedure in question (see, to that effect, Case T‑70/99 Alpharma v Council [2002] ECR II‑3495, paragraph 388 and the case-law cited).
67      In the present case, it should first be stated that the contested decision adversely affects the applicant, since it refuses the latter’s request that flurprimidol should be included in Annex I to Directive 91/414 and, consequently, prohibits the applicant from marketing plant protection products containing that active substance.
68      Next, it should be stated that the applicant was able to comment in good time. It is apparent from the documents in the file that the Commission received the applicant’s comments on both the EFSA report and the review report. Thus, by letter of 12 January 2011, the Commission invited the applicant to submit its comments on the EFSA report, which the applicant did by letter of 21 January 2011. Likewise, by e-mail of 7 February 2011, the Commission invited the applicant to submit its comments on the review report. The applicant submitted its comments by letter of 17 February 2011. Furthermore, the applicant was heard by the Commission at the meeting of 21 February 2011, when both the concern relating to the isomer ratio and the possibility of reducing the number of applications were addressed.
69      It follows that the applicant was invited to make comments and that it did make comments, both in writing and at the hearing with the Commission’s services. In those circumstances, it must be held not only that the Commission did not infringe the rights of the defence but also that the applicant did exercise those rights of defence.
70      That conclusion cannot be called into question by the arguments which the applicant has put forward.
71      First, as regards the argument relating to the procedure introduced by Regulation No 33/2008, it should be observed that the applicant explained, both in its written pleadings and at the hearing, that that argument was not connected to the fact that the concern relating to the isomer ratio of flurprimidol was expressed during the assessment carried out pursuant to that regulation, but related to the fact that the applicant did not have a proper opportunity to address that concern. Accordingly, the applicant does not dispute the possibility of taking into consideration, during the accelerated assessment procedure provided for by that regulation, concerns which are new by comparison with those giving rise to the adoption of a first non‑inclusion decision.
72      In any event, it should be borne in mind that, as the Commission contends, the choice of the accelerated procedure as established in Articles 13 to 22 of Regulation No 33/2008 does not have the effect of altering the substantive requirements laid down in Article 5(1) of Directive 91/414. It is expressly stated in Article 15(1)(c) of Regulation No 33/2008 that it is to be for the notifier to demonstrate that the requirements in Article 5 of Directive 91/414 are fulfilled. It follows that the accelerated procedure cannot mean that the scope of the assessment is limited solely to the concerns identified in a first non-inclusion decision.
73      Second, as regards the complaint that the applicant was not given the opportunity to carry out a study and to respond in full, that is to say, with new data, to the isomer ratio problem, it should be observed that, unlike the EFSA report and the review report, which explicitly identified the inadequacy of data relating to the isomer ratio, the contested decision makes no mention of that problem. Accordingly, even on the assumption that it were well founded, that complaint could not entail the annulment of the contested decision. It must therefore be rejected as ineffective.
74      In any event, that complaint cannot succeed. The applicant was able to address the concern relating to the isomer ratio in its comments of 21 January 2011 and also in those of 17 February 2011; furthermore, it was able to address that concern with the Commission’s representatives at the meeting of 21 February 2011.
75      In addition, in so far as the applicant maintains that it was unable to submit new data relating to the isomer ratio, it should be borne in mind that the applicable regulatory provisions lay down no obligation to provide a notifier with the opportunity to submit data during the assessment procedure by the RMS and EFSA. At most, according to Article 18(3) of Regulation No 33/2008 and Article 20(2) of that regulation, the RMS and EFSA may invite the notifier to submit, within specified periods, additional data that are deemed necessary in order to clarify the dossier. Nor does Regulation No 33/2008 make any provision for those additional data to be supplied after EFSA has finalised its report (see, by analogy, Denka International v Commission, cited at paragraph 41 above, paragraphs 129 and 130).
76      Third, as regards the complaint relating to the proposal to reduce the number of applications of flurprimidol, which the applicant claims was not examined carefully, it should be observed that in recitals 10 and 11 to the contested decision, the Commission stated that the applicant’s comments, including the proposal in question, had been carefully examined but that it considered that the concerns identified could not be eliminated.
77      While the applicant calls into question the veracity of the statements made in recitals 10 and 11 to the contested decision, it bases its arguments in that regard on the fact that the Commission did not provide the reasons why it rejected that proposal. The applicant cannot confuse failure to observe the rights of the defence with breach of the Commission’s obligation to state reasons.
78      In addition, as regards the argument relating to the impossible negative proof, the applicant cannot merely assert that the Commission did not take its comments into account without providing the slightest evidence to demonstrate the veracity of that assertion, since the fact that the Commission did not accept that proposal is in any event insufficient to demonstrate that it did not carefully examine the proposal. The applicant cannot confuse failure to observe the rights of the defence with failure to obtain the desired result by the exercise of those rights (see, to that effect, Cheminova and Others v Commission, cited at paragraph 30 above, paragraph 247).
79      Accordingly, this complaint must be rejected as unfounded.
80      In the light of the foregoing considerations, it must be concluded that the applicant’s rights of defence and its right to be heard during the procedure preceding the adoption of the contested decision were observed. Consequently, the second plea must be rejected as unfounded.
Third plea, alleging breach of the principle of proportionality
81      In the context of the third plea, the applicant claims that the Commission has breached the principle of proportionality. First, the contested decision places on the applicant the disproportionate burden of having to submit a new dossier for flurprimidol, which entails significant losses of commercial revenue and additional costs. Second, the objective of worker and environment protection could have been achieved by alternative, less restrictive measures. The Commission could have included flurprimidol in Annex I to Directive 91/414 subject, in accordance with Article 5(4) and Article 6(1) of that directive, to certain conditions, such as, so far as the exposure of workers to flurprimidol is concerned, the reduction of the number of applications to a single application and, so far as the exposure of the environment to that substance is concerned, the use of the product in specific high-technology greenhouses or the provision of confirmatory data.
82      The Commission disputes the merits of the applicant’s arguments.
83      In that regard, it should be borne in mind that the principle of proportionality requires that measures adopted by the EU institutions should not exceed the limits of what is appropriate and necessary in order to attain the legitimate objectives pursued by the legislation in question, and where there is a choice between several appropriate measures, recourse must be had to the least onerous, and the disadvantages caused must not be disproportionate to the aims pursued (see Case C‑174/05 Zuid-Hollandse Milieufederatie and Natuur en Milieu [2006] ECR I‑2443, paragraph 28 and the case-law cited).
84      It follows that, within the context of judicial review of the application of that principle, in view of the broad discretion which the Commission enjoys in adopting decisions relating to the inclusion of active substances in Annex I to Directive 91/414, the lawfulness of a measure can be affected only if the measure is manifestly inappropriate in relation to the objective which it is intended to attain (Bayer CropScience and Others v Commission, cited at paragraph 39 above, paragraph 224).
85      As regards 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 human health and the protection of the environment, it should be borne in mind, first, that the protection of human health takes precedence over economic considerations (see Case T‑475/07 Dow AgroSciences and Others v Commission [2011] ECR II‑5937, paragraph 143 and the case-law cited) and, second, that the protection of the environment constitutes one of the essential objectives of the European Union (see Case C‑86/03 Greece v Commission [2005] ECR I‑10979, paragraph 96 and the case-law cited). It has been held that the importance of the objectives pursued may justify even substantial negative economic consequences for certain operators (Case C‑127/07 Arcelor Atlantique et Lorraine and Others [2008] ECR I‑9895, paragraph 59, and Dow AgroSciences and Others v Commission, paragraph 143).
86      In the present case, in the first place, as regards the allegedly disproportionate consequences of the contested decision, namely the need to submit a new dossier and significant losses of commercial revenue, it is sufficient to state that the applicant did not establish during the procedure for the assessment of the active substance that the active substance whose inclusion in Annex I to Directive 91/414 it sought was harmless. As was shown in the examination of the second part of the first plea, it has not been established that the Commission made a manifest error of assessment in its examination of the influence of flurprimidol on the environment.
87      In those circumstances, given the importance of the objective of environment protection and in the light of the case-law cited at paragraph 86 above, it must be held that neither the preparation of a new dossier with a view to the inclusion of flurprimidol in Annex I to Directive 91/414 nor the alleged significant losses of commercial revenues, even on the assumption that they were established, constitute a disproportionate burden.
88      Accordingly, the argument that the contested decision has disproportionate consequences must be rejected as unfounded.
89      In the second place, as regards the argument that the objective pursued by the non-inclusion decision could have been achieved by the alternative, less restrictive measures proposed by the applicant, it is appropriate to examine, first of all, the alternative measures proposed in order to deal with the concern relating to the exposure of the environment to flurprimidol.
90      In that regard, the applicant maintains that the inclusion of flurprimidol in Annex I to Directive 91/414 would have been possible on condition that it was used in high-technology greenhouses (‘the first alternative measure proposed’) or subject to the provision of confirmatory data (‘the second alternative measure proposed’), in accordance with Article 5(4) of Directive 91/414 and Article 6(1) of that directive.
91      First, as regards the first alternative measure proposed, it should be borne in mind that Article 5(4) of Directive 91/414, which provides that the inclusion of an active substance in Annex I to that directive may be subject to certain restrictions on use, has the effect of permitting the inclusion of active substances which do not fulfil the requirements of Article 5(1) of that directive, subject to certain restrictions which exclude problematic uses of the substance in question (Case T‑229/04 Sweden v Commission [2007] ECR II‑2437, paragraph 169, and Cheminova and Others v Commission, cited at paragraph 30 above, paragraph 200).
92      Since that provision is to be regarded as a limitation on Article 5(1) of Directive 91/414, it must be interpreted in the light of the precautionary principle. Consequently, before a substance is included in Annex I to that directive, it must be established beyond all reasonable doubt that the restrictions on the use of the substance in question make it possible to ensure that use of that substance will be in accordance with the requirements laid down in Article 5(1) of that directive (Sweden v Commission, cited at paragraph 91 above, paragraph 170, and Cheminova and Others v Commission, cited at paragraph 30 above, paragraph 201).
93      In the present case, it must be held that the applicant has not established beyond all reasonable doubt that the proposed restriction, namely use in high-technology greenhouses, made it possible to ensure that the substance in question will be used in accordance with the requirements laid down in Article 5(1) of Directive 91/414. First, it is clear from paragraph 55 above it has not been established that the Commission made a manifest error of assessment in asserting that high‑technology greenhouses are not within a realistic and representative scenario of use; and, second, it is apparent from the 2010 emissions opinion that such a restriction may prove difficult to implement in practice. In those circumstances, it must be concluded that the Commission did not err in not including flurprimidol in Annex I to Directive 91/414 while imposing certain restrictions on its use, in application of Article 5(4) of that directive.
94      Second, as regards the second alternative measure proposed, it should be borne in mind that Article 6(1) of Directive 91/414 provides for the possibility of including an active substance in Annex I to that directive, subject to compliance with certain conditions. In practice, the Commission has, in particular, made inclusion in Annex I to Directive 91/414 subject to the provision of confirmatory data. None the less, in the light of the precautionary principle and where confirmatory data are concerned, the active substance in question must be able, in general and subject to confirmation with the help of the data to be supplied following its inclusion in Annex I to Directive 91/414, to be considered to satisfy the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414 (see, to that effect, Cheminova and Others v Commission, cited at paragraph 30 above, paragraph 216).
95      In the present case, the Commission concluded, on the basis of the EFSA report, that flurprimidol did not satisfy those requirements. In that respect, it should be made clear that it is not apparent from that report that EFSA considered that it was able to conclude that that substance was harmless, subject to the provision of confirmatory data. On the contrary, it is clear from the documents in the file, in particular the minutes of the meeting of 21 February 2011, that concerns linked to the exposure of the environment remained and that additional information was necessary in order to address those concerns. In addition, as was concluded at paragraph 55 above, it has not been established that the contested decision was vitiated by a manifest error of assessment, in that the Commission concluded in that decision that a concern linked with the exposure of the environment to flurprimidol could not be eliminated. Consequently, it must be held that the applicant has not shown that that substance is harmless. In those circumstances, the Commission did not err in not conditionally including flurprimidol in Annex I to Directive 91/414, in accordance with Article 6(1) of that directive.
96      It follows that it must be concluded that, in the circumstances of the present case, the Commission could not made the inclusion of flurprimidol in Annex I to Directive 91/414 conditional on the adoption of alternative measures, contrary to the applicant’s contention. Accordingly, the second argument, in that it consists in proposing alternative measures in order to deal with the concern linked with the exposure of the environment to flurprimidol, must be rejected as unfounded.
97      In the third place, it should be emphasised that the considerations set out at paragraphs 60 to 62 above in the context of the first part of the first plea are also valid in relation to the third plea. Accordingly, there is no further need to adjudicate on the applicant’s argument that the Commission could have adopted alternative measures in order to address the concern linked with the exposure of workers to flurprimidol.
98      In the light of all of the preceding considerations, the third plea must be rejected as unfounded.
Fourth plea, alleging breach of the obligation to state reasons
99      In the context of its fourth plea, the applicant maintains that the reasoning supplied is not adequate, since, first, the Commission did not provide any evidence or reasoning to justify its decision not to accept the applicant’s proposal to limit the number of applications of the product. Second, none of the other concerns on which the Commission relied is mentioned in the contested decision. Third, as regards the exposure of the environment to flurprimidol, the Commission merely asserted, without further explanation, that high-technology greenhouses are not common in the European Union, which is not correct.
100    The Commission disputes the merits of the applicant’s arguments.
101    It should be borne in mind that, according to settled case-law, the statement of reasons required by the second paragraph of Article 296 TFEU must be appropriate to the measure at issue and must disclose in a clear and unequivocal fashion the reasoning followed by the institution which adopted the measure in question in such a way as to enable the persons concerned to ascertain the reasons for the measure and to enable the competent Court to exercise its power of review. The requirement to state reasons must be assessed by reference to the circumstances of the case. It is not necessary for the reasoning to go into all the relevant facts and points of law, since the question whether the statement of reasons for a measure meets the requirements of the second paragraph of Article 296 TFEU must be assessed with regard not only to its wording but also to its context and to all the legal rules governing the matter in question. In particular, the Commission is not obliged to adopt a position on all the arguments relied on before it by the parties concerned, but it is sufficient if it sets out the facts and the legal considerations having decisive importance in the context of the decision (see Dow AgroSciences and Others v Commission, cited at paragraph 85 above, paragraph 246 and the case-law cited).
102    In the present case, it should be observed that, at recital 9 to the contested decision, cited at paragraph 22 above, the Commission mentioned two concerns identified in the EFSA report, namely worker exposure to flurprimidol and also the exposure of the environment to that substance. In addition, the Commission stated, at recitals 10 and 11 to the contested decision, that the comments submitted by the applicant had not allowed those concerns to be eliminated, since the applicant had not demonstrated that the conditions laid down in Article 5(1)(a) and (b) of Directive 91/414 were satisfied.
103    Accordingly, it must be held that the Commission explained in the contested decision the concerns that led to its adoption, in what was, admittedly, a succinct, but none the less precise, fashion. That statement of reasons enabled both the applicant and the Court to understand why flurprimidol was not included in Annex I to Directive 91/414.
104    In those circumstances, it must be concluded that the Commission did not breach its obligation to state the reasons on which the contested decision is based.
105    That conclusion is not called into question by the applicant’s arguments.
106    First, the argument that the Commission provided no evidence or reasoning to justify its conclusion not to accept the applicant’s proposal to limit the number of applications of the product cannot succeed. In the light of the case-law cited at paragraph 102 above, the Commission was not required to set out in the contested decision the specific reasons which had led it to reject the proposal to use a single application. It is sufficiently clear from the contested decision that the arguments and comments submitted by the applicant and referred to at recitals 10 and 11 to the contested decision, which included, inter alia, the proposal to reduce the number of applications of flurprimidol, did not allow it to be established that, in the proposed conditions of use, the plant protection products containing flurprimidol satisfied, in a general way, the conditions laid down in Article 5(1)(a) and (b) of Directive 91/414.
107    Furthermore, as regards the alleged absence of evidence, that argument cannot call into question the sufficiency of the reasoning set out in the contested decision. The complaint alleging infringement of the second paragraph of Article 296 TFEU is separate from the complaint alleging absence of evidence in support of the contested decision. While the former, which alleges absence of reasons or inadequacy of the reasons stated, goes to an issue of breach of essential procedural requirements within the meaning of the second paragraph of Article 296 TFEU and constitutes a matter of public policy which must be raised by the Courts of the European Union of their own motion, the latter, which goes to the substantive legality of a decision, is concerned with the breach of a rule of law relating to the application of the Treaty, again within the meaning of the second paragraph of Article 296 TFEU, and can be examined by the Courts of the European Union only if it is raised by the applicant. The obligation to state reasons is thus a separate question from that of the merits of the contested decision (see, to that effect, Dow AgroSciences and Others v Commission, cited at paragraph 85 above, paragraph 245 and the case-law cited).
108    Accordingly, the argument alleging absence of evidence and of reasons to justify the rejection of the proposal to limit the number of applications of flurprimidol must be rejected as unfounded.
109    Second, as regards the argument that none of the other concerns on which the contested decision was based was mentioned in that decision, it is sufficient to state that there is no indication that that decision was based on reasons other than those set out at recital 9 to the contested decision. Accordingly, that argument must be rejected as unfounded.
110    Third, the argument that the Commission merely asserted that high‑technology greenhouses are not common, which in the applicant’s submission is not correct, cannot succeed. Even on the assumption that that argument must be understood as taking issue with the Commission for not having stated the reasons which led it to assert that high‑technology greenhouses were not representative, the Commission was not required to state in the contested decision the specific reasons that led it to that conclusion. It is apparent from the clear and precise wording of recital 9 to the contested decision that, as regards the concern relating to the exposure of the environment to flurprimidol, it is based on the absence of sufficient data relating to the realistic conditions of use and that the uses in high-technology greenhouses are not considered to be representative, which is sufficient in the light of the case‑law cited at paragraph 102 above.
111    Furthermore, in so far as the applicant calls into question the merits of the conclusion that high-technology greenhouses are not representative, it must be held that, in the light of the case-law cited at paragraph 108 above, that assertion, which goes to the substantive legality of the contested decision, is not capable of affecting the sufficiency of the reasoning. That argument must therefore be rejected as unfounded.
112    Accordingly, the fourth plea must be rejected as unfounded, as must the action in its entirety.
Costs
113    Under Article 87(2) of the Rules of Procedure of the Court, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the applicant has been unsuccessful, it must be ordered to pay the costs, in accordance with the form of order sought by the Commission.
On those grounds,
THE GENERAL COURT (Fourth Chamber)
hereby:
1.      Dismisses the action;
2.      Orders Sepro Europe Ltd to bear its own costs and to pay those incurred by the European Commission.
Pelikánová
Jürimäe
Van der Woude
Delivered in open court in Luxembourg on 6 September 2013.
[Signatures]
Table of contents
Background to the dispute
Procedure and forms of order sought
Admissibility
Substance
First plea, alleging manifest errors of assessment of worker and environment exposure to flurprimidol
Second plea, alleging breach of the rights of the defence and of the right to be heard
Third plea, alleging breach of the principle of proportionality
Fourth plea, alleging breach of the obligation to state reasons
Costs
* Language of the case: English.