Court of Justice of the European Communities (including Court of First Instance Decisions)

JUDGMENT OF THE GENERAL COURT (Ninth Chamber)

12 December 2014 (*)

(Plant protection products — Active substance ethoxyquin — Non-inclusion in Annex I to Directive 91/414/EEC — Withdrawal of authorisations for plant protection products containing that substance — Regulation (EC) No 2229/2004 — Regulation (EC) No 33/2008 — Accelerated assessment procedure — Manifest error of assessment — Rights of the defence — Proportionality — Legitimate expectations)

In Case T‑269/11,

Xeda International SA, established in Saint-Andiol (France), represented by C. Mereu and K. Van Maldegem, lawyers,

applicant,

v

European Commission, represented by D. Bianchi, G. von Rintelen and P. Ondrůšek, acting as Agents,

defendant,

ACTION for the annulment of Commission Decision 2011/143/EU of 3 March 2011 concerning the non-inclusion of ethoxyquin in Annex I to Council Directive 91/414/EEC and amending Commission Decision 2008/941/EC (OJ 2011 L 59, p. 71),

THE GENERAL COURT (Ninth Chamber),

composed of G. Berardis, President, O. Czúcz and A. Popescu (Rapporteur), Judges,

Registrar: S. Spyropoulos, Administrator,

having regard to the written procedure and further to the hearing on 18 September 2014,

gives the following

Judgment

 Legal context

1        The present case concerns the application of 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), of Commission Regulation (EC) No 1112/2002 of 20 June 2002 laying down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Directive 91/414 (OJ 2002 L 168, p. 14), of Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Directive 91/414 (OJ 2004 L 379, p. 13), and 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 in its Annex I (OJ 2008 L 15, p. 5).

2        Directive 91/414 seeks to harmonise the rules for the evaluation and approval of plant protection products and their active substances in the European Union. It provides that a plant protection product containing an active substance may not be placed on the market in a Member State unless, firstly, its active substance, after being evaluated at EU level on the basis of the criteria set out in that directive, has been included in Annex I to that directive and, secondly, that product has been registered at national level.

3        In order to make possible a gradual evaluation of all ‘existing’ active substances, in other words, substances that were already on the EU market two years after the date of notification of Directive 91/414, that is to say, on 25 July 1993, Article 8(2) of that directive established a transitional regime during which the Commission of the European Communities was to initiate a programme of work for the gradual examination of those active substances.

 Background to the dispute

4        The applicant, Xeda International SA, manufactures and sells chemical products in the sector of post-harvest treatments for fruit and vegetables.

5        Ethoxyquin, the active substance that is the subject of this case, is a man-made chemical designed to be used, inter alia, to limit certain physiological disorders, such as browning, of pears stored in refrigerated areas or controlled atmospheres.

6        Ethoxyquin is one of the 295 active substances evaluated during the fourth stage of the programme of work referred to in Article 8(2) of Directive 91/414.

7        The list of active substances falling within the fourth stage of the programme of work is set out in Annex I to Regulation No 2229/2004. That annex designates the Federal Republic of Germany as the Rapporteur Member State (‘RMS’) entrusted with the submission of a draft assessment report (‘DAR’) on ethoxyquin to the European Food Safety Authority (‘EFSA’), with a view to its possible inclusion in Annex I to Directive 91/414.

8        In accordance with the procedure laid down by Directive 91/414, Regulation No 1112/2002 and Regulation No 2229/2004, the applicant lodged its dossier with the RMS with a view to having ethoxyquin included in Annex I to Directive 91/414.

9        The RMS drew up the DAR which EFSA sent to the applicant on 13 March 2008. That report concluded that ethoxyquin should not be included in Annex I to Directive 91/414.

10      Within two months of the receipt of the DAR, the applicant voluntarily withdrew its support for the inclusion of ethoxyquin in Annex I to Directive 91/414, in accordance with Article 24e of Regulation No 2229/2004. On 8 December 2008, the Commission adopted Decision 2008/941/EC concerning the non-inclusion of certain active substances in Annex I to Directive 91/414 and the withdrawal of authorisations for plant protection products containing those active substances (OJ 2008 L 335, p. 91; ‘the first non-inclusion decision’).

11      Pursuant to Article 13 of Regulation No 33/2008, the applicant submitted a new application for the inclusion of ethoxyquin in accordance with the accelerated procedure laid down in Articles 14 to 19 of that regulation. On 12 June 2009, the applicant sent an updated dossier concerning ethoxyquin to the RMS, providing further information and data to address the concerns identified in the DAR which had led to the adoption of the first non-inclusion decision.

12      The RMS evaluated the new data provided by the applicant and drafted an additional report (‘the additional report’) which it sent to EFSA and the Commission on 16 October 2009. In that additional report, the RMS concluded inter alia that, as things stood, the inclusion of ethoxyquin in Annex I to Directive 91/414 could not be proposed because certain questions remained unresolved, inter alia with respect to the residue behaviour and the toxicological relevance for consumer health of the degradation products of ethoxyquin. According to the RMS, the definition of the residue in plant material and the consumer risk assessment could not be finally concluded. The RMS stated that further toxicological and ecotoxicological data were necessary with regard to an impurity in the technical specifications — referred to, for reasons of confidentiality, as ‘impurity 7’ (‘impurity 7’) — in order to support the proposed maximum level and to set a reference specification.

13      EFSA then communicated the additional report to the other Member States and the applicant for comments and forwarded the comments which it received from the applicant to the Commission on 21 November 2009.

14      Following the Commission’s request for a peer review, in accordance with Article 20(1) of Regulation No 33/2008, EFSA, on 20 August 2010, submitted to the Commission its report entitled ‘Conclusion on the peer review of the pesticide risk assessment of the active substance ethoxyquin’ (‘the EFSA conclusion report’).

15      In its conclusion report, EFSA identified the following four critical areas of concern:

–        the fact that, as the genotoxic potential of impurity 7 in the technical material had not been addressed, the technical specification was not covered by the toxicological assessment;

–        the fact that, owing to the limited toxicological data package, no reference values could be set for the Acceptable Daily Intake (‘ADI’), the Acute Reference Dose (‘ARfD’) or the Acceptable Operator Exposure Level (‘AOEL’);

–        the fact that the operator and worker risk assessment could not be conducted since an AOEL could not be set;

–        the fact that the consumer risk assessment could not be conducted, as it had not been possible for residue definitions and reference values to be set for ethoxyquin and its metabolites.

16      By letter of 26 August 2010, the Commission invited the applicant to submit comments on the EFSA conclusion report.

17      On 29 September 2010, the applicant submitted its comments on the EFSA conclusion report. Those comments were then communicated to the Member States and presented three times to the Standing Committee on the Food Chain and Animal Health.

18      The DAR, the additional report and the EFSA conclusion report were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 28 January 2011 in the format of the Commission review report for ethoxyquin (‘the review report’). On that occasion, the Commission proposed that ethoxyquin should not be included in Annex I to Directive 91/414.

19      On 17 November 2010, the applicant submitted its comments on the review report, which it did by simply providing again the letter in which it had submitted its comments of 29 September 2010 (see paragraph 17 above).

20      All of those documents were presented to the Standing Committee on the Food Chain and Animal Health, which, at its meeting on 27 and 28 January 2011, delivered a favourable opinion on the draft decision presented by the Commission.

21      On 3 March 2011, the Commission adopted Decision 2001/143/EU concerning the non-inclusion of ethoxyquin in Annex I to Directive 91/414 and amending Decision 2008/941 (OJ 2011 L 59, p. 71; ‘the contested decision’).

22      Recitals 6 to 8 in the preamble to the contested decision set out the reasons for the non-inclusion of ethoxyquin in Annex I to Directive 91/414 in the following terms:

‘(6)      During the evaluation of this active substance, a number of concerns have been identified. In particular, it was not possible to perform a reliable consumer, operator and worker exposure assessment, due to the limited toxicological data package, considered insufficient to set the [ADI], [ARfD] and the [AOEL]. Furthermore, the data submitted were insufficient to set a residue definition for ethoxyquin and its metabolites. In addition, data were missing to conclude on the genotoxic potential and the ecotoxicity of [impurity 7]. Finally, the data available were not sufficient to fully assess the risks to the environment and to non-target organisms. Consequently, it was not possible to conclude, on the basis of the information available, that ethoxyquin met the criteria for inclusion in Annex I to Directive 91/414/EEC.

(7)      The Commission invited the applicant 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 applicant to submit comments on the draft review report. The applicant submitted its comments, which have been carefully examined.

(8)      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 [EFSA] expert meetings have not demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing ethoxyquin satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC.’

23      Moreover, recital 10 in the preamble to the contested decision made it clear that the latter ‘does not prejudice the submission of a further application for ethoxyquin pursuant to Article 6(2) of Directive 91/414 and Chapter II of Regulation (EC) No 33/2008’.

24      The operative part of the contested decision states, inter alia, the following:

‘Article 1

Ethoxyquin shall not be included as [an] active substance in Annex I to Directive 91/414/EEC.

Article 2

Member States shall ensure that:

(a)       authorisations for plant protection products containing ethoxyquin are withdrawn by 3 September 2011;

(b)       no authorisations for plant protection products containing ethoxyquin are granted or renewed from the date of publication of this Decision.

Article 3

Any period of grace granted by Member States in accordance with the provisions of Article 4(6) of Directive 91/414/EEC shall be as short as possible and shall expire on 3 September 2012 at the latest.’

 Procedure and forms of order sought

25      By application lodged at the Court Registry on 23 May 2011, the applicant brought an action for the annulment of the contested decision.

26      By a separate document lodged at the Court Registry on 1 July 2011, the applicant lodged an application for interim relief, seeking suspension of the operation of the contested decision and the adoption of appropriate interim measures.

27      By order of 15 November 2011 in Xeda International v Commission (T‑269/11 R, EU:T:2011:665), the President of the Court dismissed that application for interim relief and reserved the costs.

28      By way of measures of organisation of procedure, the Court (Ninth Chamber) requested the parties to answer a question and the Commission to produce certain documents. The parties complied with those requests.

29      Upon hearing the report of the Judge-Rapporteur, the Court decided to open the oral procedure. At the hearing held on 18 September 2014, the parties presented their oral arguments and answered the oral questions asked by the Court.

30      The applicant claims that the Court should:

–        declare the action admissible and well founded;

–        annul the contested decision;

–        order the Commission to pay the costs;

–        order any other measure deemed appropriate.

31      The Commission contends that the Court should:

–        dismiss the action;

–        order the applicant to pay the costs.

 Law

 Admissibility

32      The applicant maintains that its action is admissible since, as the sole notifier for ethoxyquin, it is directly and individually concerned by the contested decision and, in any event, that decision is a regulatory act that requires no implementing measures and concerns the applicant directly.

33      In this regard, it should be recalled that, as a notifier under Article 13 of Regulation No 33/2008 seeking the inclusion of ethoxyquin in Annex I to Directive 91/414, the applicant is directly and individually concerned by the contested decision refusing that inclusion (see, to that effect, judgment of 3 September 2009 in Cheminova and Others v Commission, T‑326/07, ECR, EU:T:2009:299, paragraph 66); that is not disputed by the Commission.

34      In those circumstances, the action must be held to be admissible.

 Substance

35      The applicant puts forward three pleas in law in support of its action, alleging, first, manifest errors of assessment, secondly, breach of the rights of the defence and infringement of essential procedural requirements and, thirdly, breach of fundamental principles of EU law.

 The first plea, alleging manifest errors of assessment

36      The first plea falls into two parts, alleging, first, a manifest error of assessment in that the contested decision is based on a matter of hypothetical concern, namely the genotoxic potential of impurity 7 and the risks for the environment and non-target organisms and, secondly, a manifest error of assessment in that the contested decision fails to take into account all the scientific evidence available, which the applicant duly submitted.

37      As a preliminary point, it should be noted that the non-inclusion of ethoxyquin in Annex I to Directive 91/414 is based, according to recitals 6 to 8 in the preamble to the contested decision, on the EFSA conclusion report, which constitutes the scientific basis for the contested decision.

38      It is apparent from recital 6 in the preamble to the contested decision that the EFSA conclusion identified ‘a number of concerns’ and that ‘it was not possible to perform a reliable consumer, operator and worker exposure assessment’ because of the insufficiency of the available data or their incomplete nature (see paragraph 22 above).

39      As mentioned in paragraph 15 above, the concerns identified in recital 6 in the preamble to the contested decision are the following:

–        the fact that, as the genotoxic potential of impurity 7 in the technical material had not been addressed, the technical specification was not covered by the toxicological assessment;

–        the fact that, owing to the limited toxicological data package, no reference values (ADI, ARfD or AOEL) could be set;

–        the fact that the operator and worker risk assessment could not be conducted since an AOEL could not be set;

–        the fact that the consumer risk assessment could not be conducted, as it had not been possible for residue definitions and reference values to be set for ethoxyquin and its metabolites.

40      According to recitals 7 and 8 in the preamble to the contested decision (see paragraph 22 above), it was concluded that the concerns identified persisted despite the comments submitted by the applicant on the EFSA conclusion report, that the assessments made on the basis of the information submitted and evaluated during the EFSA expert meetings had not demonstrated that, under the proposed conditions of use, plant protection products containing ethoxyquin satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414 and that, consequently, that active substance should not be included in Annex I to Directive 91/414.

41      In order to assess whether the concerns identified in the contested decision, in particular the concern relating to the genotoxic potential of impurity 7, are merely hypothetical and do not take account of all available scientific evidence or are insufficient to justify a non-inclusion decision, as claimed by the applicant, it must be recalled that Directive 91/414, as is clear from the fifth, sixth and ninth recitals in the preamble thereto, 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. 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 (see, to that effect, judgments of 9 September 2008 in Bayer CropScience and Others v Commission, T‑75/06, ECR, EU:T:2008:317, paragraphs 81 and 82, and of 19 January 2012 in Xeda International and Pace International v Commission, T‑71/10, EU:T:2012:18, paragraph 69).

42      The exercise of that discretion is not, however, excluded from judicial review. According to settled case-law, 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 assessment of the facts or a misuse of powers (judgment in Xeda International and Pace International v Commission, paragraph 41 above, EU:T:2012:18, paragraph 70).

43      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 (see judgment in Xeda International and Pace International v Commission, paragraph 41 above, EU:T:2012:18, paragraph 71 and the case-law cited).

44      It is also important to recall 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 standard of protection, which seeks, in particular, to prevent the authorisation of plant protection products the risks of which to health, groundwater and the environment have not been the subject of appropriate research (judgment of 19 November 2009 in Denka International v Commission, T‑334/07, ECR, EU:T:2009:453, paragraph 114).

45      It is in the light of those considerations that the arguments put forward by the applicant must be examined.

–       The first part of the first plea, relating to the hypothetical nature of the genotoxic potential of impurity 7 and the risks to the environment and to non-target organisms

46      The applicant submits, in the first place, that the contested decision is based on one identified concern, namely the potential genotoxicity of impurity 7, and that all the other issues stem from an alleged lack of data. The applicant claims that, if there had been no such data gaps, ethoxyquin’s inclusion in Annex I to Directive 91/414 would have been supported. That position is confirmed, according to the applicant, by the fact that the concern surrounding impurity 7 is unsupported and merely reflects the overly cautious position taken by the Commission throughout the review process.

47      In the second place, the applicant claims that the genotoxic potential and ecotoxicity of impurity 7 did not become an issue of critical concern until November 2009, at the stage of comments on the submission of the additional report. According to the applicant, the fact that this matter became a concern during the procedure relating to the submission of a new application for inclusion, which normally focuses on the points identified by the RMS in the DAR, deprives the relevant provisions of Regulation No 33/2008 of their effet utile and demonstrates that this concern is in itself unwarranted and based on pure conjecture. All of the evidence submitted during the commenting stage relating to the additional report confirms this.

48      The applicant submits, in particular, that the ‘quantitative structure activity relationship’ analysis (‘the QSAR analysis’) permitted it to be predicted that impurity 7 is not genotoxic, which, combined with the negative results from experiments in vivo into the genotoxicity of ethoxyquin containing impurity 7, proves beyond all reasonable doubt that the impurity is not genotoxic. Moreover, that conclusion is corroborated by the fact that ethoxyquin, the chemical structure of which is almost identical to that of impurity 7, does not show any risk of genotoxicity.

49      In its reply, the applicant adds that the Commission attempted to discredit the QSAR analysis in its defence, seeking to rely on the guidelines which it had formulated in its Guidance Document on the assessment of the equivalence of technical materials of substances regulated under Directive 91/414 (‘the guidance document’). However, the applicant notes that, in that document, the Commission itself stated that ‘close structural similarity might be used to support an argument of similar toxicity’. The applicant claims that, as is apparent from the judgment of 21 July 2011 in Nickel Institute (C‑14/10, ECR, EU:C:2011:503), such ‘read-across’ methods, founded on the principle of extrapolation from existing data relating to certain substances in order to assess substances having a similar structure and about which there are very limited or no data, have been relied on by the Commission in the past and are generally recognised within the European Union. Lastly, the applicant claims that the Commission is relying on ‘out of date’ information to draw its conclusions on the QSAR analysis.

50      In the third place, the applicant claims that, notwithstanding the EU authorities’ conclusion that the genotoxicity of impurity 7 gives rise to concern, that should not have prevented the inclusion of ethoxyquin in Annex I to Directive 91/414 in the light of the earlier decision to include hexachlorobenzene. In addition, the applicant claims that the alleged concern pertaining to the potential risks to the environment and non-target organisms is also purely hypothetical, given the representative use notified to the competent authorities, namely the post-harvest treatment of pears in storage rooms. Indeed, such a risk, as repeatedly stated by EFSA in its conclusions on the pesticide peer review, is negligible.

51      In the fourth place, the applicant takes issue with the Commission on the ground that it failed to take account of information relating to monomers. The applicant complains, in essence, that the RMS stated that the applicant’s data were unsatisfactory in that those data did not take into account the toxicological relevance of dimers and a residue definition could therefore not be set, although review reports prepared by the Joint Meetings of the Food and Agricultural Organisation of the United Nations (FAO) and the World Health Organisation (WHO) on Pesticides Residues (‘the JMPR’) mentioned a risk assessment for the toxicological relevance of monomers, which are considered to be more toxic than dimers because of their lower molecular weight and greater bioavailability.

52      The Commission disputes the merits of the applicant’s arguments.

53      In this regard, it should be recalled that Article 5(1)(b) of Directive 91/414 provides that, before an active substance can be included in Annex I to that directive, it must be possible to expect that, in the light of current scientific and technical knowledge, plant protection products containing that active substance will fulfil the following conditions:

–        their residues, consequent on application consistent with good plant protection practice, do not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment, and those residues, in so far as they are of toxicological or environmental significance, can be measured by methods in general use;

–        their use, consequent on application consistent with good plant protection practice, does not have any harmful effects on human or animal health or any unacceptable influence on the environment as provided for in Article 4(1)(b)(iv) and (v) of that directive.

54      It follows from that provision, interpreted in combination with the precautionary principle, that, in the domain of human health, the existence of solid evidence which, while not resolving scientific uncertainty, may reasonably raise doubts as to the safety of an active substance justifies, in principle, the refusal to include that active substance in Annex I to Directive 91/414. The precautionary principle is designed to prevent potential risks (judgments of 11 July 2007 in Sweden v Commission, T‑229/04, ECR, EU:T:2007:217, paragraph 161, and Xeda International and Pace International v Commission, paragraph 41 above, EU:T:2012:18, paragraph 75).

55      However, it is also clear from the case-law that a preventive measure cannot properly be based on a purely hypothetical approach to the risk, founded on mere conjecture which has not yet been scientifically verified (see judgment in Xeda International and Pace International v Commission, paragraph 41 above, EU:T:2012:18, paragraph 76 and the case-law cited).

56      Although they may not take a purely hypothetical approach to risk and may not base their decisions on a ‘zero-risk’, the EU institutions must nevertheless take account of their obligation under Article 168(1) TFEU to ensure a high level of human health protection, which, in order to be compatible with that provision, does not necessarily have to be the highest that is technically possible (judgment in Xeda International and Pace International v Commission, paragraph 41 above, EU:T:2012:18, paragraph 77).

57      Consequently, if it is not to adopt arbitrary measures, which cannot in any event be rendered legitimate by the precautionary principle, the competent public authority must ensure that any measures that it takes, even preventive measures, are based on as thorough a scientific risk assessment as possible, account being taken of the particular circumstances of the case at issue. Notwithstanding the existing scientific uncertainty, the scientific risk assessment must enable the competent public authority to ascertain, on the basis of the best available scientific data and the most recent results of international research, whether matters have gone beyond the level of risk that it deems acceptable for society. That is the basis on which that authority must decide whether preventive measures are called for (see judgment in Xeda International and Pace International v Commission, paragraph 41 above, EU:T:2012:18, paragraph 78 and the case-law cited).

58      In the present case, in the first place, it must be held that the applicant’s assertion that the concern relating to the genotoxic potential of impurity 7 was the only concern, in the absence of which the Commission would have adopted a decision to include ethoxyquin in Annex I to Directive 91/414, cannot be accepted, in particular because it has no basis in the contested decision. It is apparent from recital 6 in the preamble to that decision that the genotoxic potential and the ecotoxicity of impurity 7 are only one of the concerns cited. In addition, it must be noted that it does not in any way follow from the material in the case file that there is a hierarchy between all of the concerns raised. On the contrary, it appears that, having regard in particular to the EFSA conclusion report and recital 6 in the preamble to the contested decision, the four concerns raised appear to be of equal importance, and it was appropriate to examine all of those concerns in order to carry out a full and reliable evaluation and thereby to eliminate any risk to consumers.

59      Consequently, as the Commission observes, it is apparent both from the file and from the contested decision that each of the concerns, referred to as ‘critical areas of concern’ in the EFSA conclusion report and reproduced in recital 6 in the preamble to the contested decision, was capable of justifying the adoption of a decision not to include ethoxyquin in Annex I to Directive 91/414.

60      In the second place, it is necessary to reject the argument that the genotoxic potential and ecotoxicity of impurity 7 did not become an issue of critical concern until November 2009 during the new examination procedure, thus depriving the relevant provisions of Regulation No 33/2008 of their effet utile (see paragraph 47 above).

61      It must be observed that that argument, which is also relied on in support of the second plea relating to breach of the rights of the defence, is tantamount, in essence, to submitting that the procedure relating to the new application for inclusion provided for in Regulation No 33/2008 is limited to the issues raised within the context of the initial procedure. However, such an argument cannot succeed.

62      It must be borne in mind that 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 (see judgment of 6 September 2013 in Sepro Europe v Commission, T‑483/11, EU:T:2013:407, paragraph 72).

63      Consequently, contrary to what the applicant suggests by its argument, the fact that (i) the issue relating to impurity 7 was not referred to as a critical area of concern before the additional report was drawn up or that (ii) that issue is alleged to have become a new concern during the new examination procedure did not preclude the competent authorities from not including ethoxyquin in Annex I to Directive 91/414. Therefore, it cannot validly be argued that this deprives Regulation No 33/2008 of its effet utile.

64      By contrast, it appears that it is the interpretation contended for by the applicant that is liable to deprive that regulation of effet utile. As is apparent from the case file and from paragraph 10 above, within two months of the receipt of the DAR the applicant voluntarily withdrew its support for the inclusion of ethoxyquin, in accordance with Article 24e of Regulation No 2229/2004. That withdrawal of the application for inclusion led to the adoption of the first non-inclusion decision and to the suspension of the procedure for assessing ethoxyquin under Regulation No 2229/2004. As the Commission submits, at the time of that suspension the DAR had not yet been examined by EFSA and the applicant had not yet received additional information or observations as to the appropriateness of the data which it had submitted, including with regard to impurity 7. In those circumstances, if, as the applicant claims, the assessment of that active substance within the context of the new procedure had to confine itself to the DAR, that would amount to abolishing the EFSA peer review, contrary to the requirements of Regulation No 2229/2004 and Regulation No 33/2008.

65      In any event, it is important to note that, contrary to what the applicant maintains, the issue relating to impurity 7 had already been expressly mentioned prior to November 2009 as constituting a matter of concern. As the Commission correctly states, although impurity 7 was not actually detected in the pilot plant production, it was detected in the technical material (active substance) from the large scale production. That was duly stated in the DAR published on 15 November 2007, which also identified, at the same time, data gaps in the sections on the toxicology and ecotoxicology for that impurity. In its reply, the applicant makes clear that it does not dispute that that issue already appeared in the DAR in the sense indicated above. By contrast, the applicant disputes the way in which the issue was raised, stating that it was not referred to in the DAR as being a critical area of concern such as to prevent inclusion in Annex I to Directive 91/414.

66      In this regard, whilst it is correct that the DAR does not refer to the issue relating to impurity 7 as being a critical area of concern, it is sufficient to refer to paragraphs 62 and 63 above in order to reject that argument. It follows from those paragraphs that the fact that that issue was not referred to as being a critical area of concern before the additional report was drawn up did not preclude the competent authorities from not including ethoxyquin in Annex I to Directive 91/414.

67      In the third place, the argument relating to the QSAR analysis (see paragraphs 48 and 49 above) must be rejected.

68      It must be observed at the outset that that argument is made up of a series of assertions which, in part, are unsubstantiated and, in part, have already been relied on and rejected.

69      Such is the case, in particular, with regard to the applicant’s main assertion that the QSAR analysis, combined with the negative results from experiments in vivo into the genotoxicity of ethoxyquin containing impurity 7, rules out the genotoxicity of impurity 7, especially as ethoxyquin, the chemical structure of which is almost identical to that of impurity 7, does not show any risk of genotoxicity (see paragraph 48 above). As the Commission rightly observes, that assertion, put forward in almost identical terms by the applicant in particular in its observations of 29 September 2010, had been taken into account and rejected in detail by the RMS, which had stated, inter alia, that the QSAR analysis was not sufficient to remove toxicological concerns over impurities and that additional toxicological data were needed to support the level of impurity 7. EFSA agreed with that view and endorsed it in its conclusion report and eventually listed the issue as being a critical area of concern. It should be noted that the applicant does not put forward any arguments capable of casting doubt on that conclusion.

70      Furthermore, the Court takes the view that it is necessary to reject the applicant’s arguments that (i) in the guidance document, the Commission itself stated that ‘close structural similarity might be used to support an argument of similar toxicity’ and (ii) the Commission is relying on ‘out of date’ information in drawing its conclusions on the QSAR analysis since that document refers to a view expressed by the European Centre for Ecotoxicology and Toxicology of Chemicals (Ecetoc) which dates from 2003.

71      As regards the first argument, it should be observed that, even though the Commission states in the guidance document that structural similarity might be used to support an argument of similar toxicity, that does not alter the fact that, according to that document, ‘most QSARs available are suitable only for predicting toxicity, but not for the absence of it’. As regards the second argument, the mere fact that the version of the programme used by the applicant is six years more recent than the guidance document is not sufficient to establish that the guidance document is based on ‘out of date’ data or, in any event, to show that the Commission made a manifest error of assessment. As the Commission rightly observes, the reference to the view held by Ecetoc falls within the margin of discretion which it enjoys.

72      Lastly, the Court must reject the assertion that the case which gave rise to the judgment in Nickel Institute, paragraph 49 above (EU:C:2011:503), militates in favour of taking into account the QSAR analysis inasmuch as it shows that ‘read-across’ methods have been relied on by the Commission in the past and have been generally recognised within the European Union (see paragraph 49 above).

73      Irrespective of the unsubstantiated nature of that assertion, the Court takes the view that the reference to the judgment in Nickel Institute, paragraph 49 above (EU:C:2011:503), is not capable of supporting the applicant’s argument.

74      It must be noted that the case which gave rise to the judgment in Nickel Institute, paragraph 49 above (EU:C:2011:503), differs significantly from the present case in that it did not concern the issue of the inclusion or approval of the active substances used in plant protection products, but rather the classification of certain nickel-based substances as dangerous substances within the meaning of the European legislation on the classification, packaging and labelling of dangerous substances. As submitted by the Commission, it cannot be argued that the approach which it adopted pursuant to the European legislation on the classification, packaging and labelling of dangerous substances is automatically applicable to the present case.

75      In any event, it must be held that there is no obligation on the Commission to apply to the legal framework established by Directive 91/414 the approach developed in the regulations mentioned in paragraph 63 of the judgment in Nickel Institute, paragraph 49 above (EU:C:2011:503), namely (i) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1) and (ii) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1).

76      In the fourth place, the Court must reject the applicant’s argument that, notwithstanding the EU authorities’ conclusion that the genotoxicity of impurity 7 gives rise to concern, that should not have prevented the inclusion of ethoxyquin in Annex I to Directive 91/414 in the light of the earlier decision to include hexachlorobenzene (see paragraph 50 above).

77      Without it being necessary to rule on the question whether, as the Commission submits, that argument has no factual basis on the ground that it is apparent from Regulation No 1272/2008 that hexachlorobenzene is not genotoxic, it must be held that the applicant’s argument is a mere unsubstantiated assertion. It is necessary to state that, as the Commission contended at the hearing, despite the specific nature of each examination procedure, which makes comparisons particularly difficult, the applicant has not adduced any evidence to show how the situation which led to the decision relating to the inclusion of hexachlorobenzene could be relevant for the purposes of the inclusion of ethoxyquin and how it reveals a manifest error of assessment on the part of the Commission.

78      In the fifth place, the Court must reject the applicant’s argument that the risk to the environment and to non-target organisms is purely hypothetical, given the representative use referred to by the applicant in its application for inclusion, namely the post-harvest treatment of pears in a confined space (see paragraph 50 above).

79      In order to prove that that argument is well founded, the applicant cites, in the application, the following extract from the EFSA conclusion report:

‘Since the exposure of the environment via volatilization and deposition of photolytic transformation products cannot be excluded, and because reliable estimations were not available, a data gap was identified for assessments of exposure for all of the environmental compartments. On balance, it is noted, however, that, considering the method of application indoors, where light levels are expected to be low, the process of photolysis, and thus formation of transformation products (which may or may not be volatile), is expected to be low, although there is currently no reliable information to confirm these assumptions.’

80      According to the applicant, even if a strict interpretation of the precautionary principle were applied, it would follow from that extract from the conclusion report that the hypothetical concern is at the very worst low, if not non-existent.

81      Irrespective of the unsubstantiated nature of that assertion, firstly, it must be stated that it follows expressly from the extract from the EFSA conclusion report cited by the applicant that EFSA stated clearly that ‘a data gap was identified for assessments of exposure for all of the environmental compartments’. Secondly, it must be noted that it is apparent from other passages from the EFSA conclusion report that EFSA took the view that ‘the exposure of soils … and deposition [of ethoxyquin outside cannot be excluded]’; that ‘based on the outcome of the data gap to consider environmental exposure of potentially volatile photolytic transformation products of ethoxyquin …, an environmental risk assessment for non-target organisms may be required’; and, lastly, that ‘[n]o ecotoxicological data were available for impurity 7, therefore a data gap was identified to address the risk to non-target organisms’.

82      For the sake of completeness, it should be added that the applicant did not contest, in its reply, the Commission’s argument that the applicant had overlooked the fact that it is the operators and the workers in the confined space who may be at risk and that, since it was impossible to set reference values for the ADI, the ARfD and the AOEL, it had not been possible to assess the risk to operators, workers and consumers.

83      Lastly, in the sixth place, the Court must reject the applicant’s argument that the Commission made a manifest error of assessment on the ground that it failed to take account of information relating to monomers (see paragraph 51 above).

84      Irrespective of the unsubstantiated nature of that argument, it is clear that it has no factual basis. Contrary to what the applicant claims, that argument, which was submitted during the initial assessment which led to the adoption of the first non-inclusion decision and also during the procedure for the resubmission of the application for inclusion, was taken into account during the assessment of ethoxyquin. It is apparent from the file that the RMS took the view, first of all, that ‘[a]n argumentation regarding toxicity of [dimers] based on lower bioavailability due to higher molecular masses is not deemed to be sufficiently robust’, secondly, that the approach taken by the JMPR experts in the 2008 evaluation referred to by the applicant was not considered to address the matter in a satisfactory manner and, lastly, that, if the JMPR approach had been followed, that would imply an unacceptable acute risk to children on the ground that, following the German dietary model, the ARfD would be exceeded by 109% for children eating pears which had been subject to the use of pesticides considered by JMPR.

85      Lastly, it must be observed that, in any event, for the purposes of the procedure of evaluation of active substances at EU level as established by Directive 91/414 and Regulations No 1112/2002, No 2229/2004 and No 33/2008, only the conclusions of EFSA, which can arrange a consultation of experts, are taken into account by the Commission. Accordingly, the JMPR conclusions, relied on by the applicant to support its argument that the Commission should have taken account of information relating to monomers, cannot in any way be binding on the Commission in its assessment. The JMPR can make scientific evaluations concerning the toxicological and residue behaviour of active substances only for the purpose of the setting of international maximum residue levels of pesticides in food and feed by the Codex Alimentarius Commission of the FAO and the WHO. Those recommendations, made within a procedure which is distinct from that for the inclusion of active substances in Annex I to Directive 91/414, cannot be compared to the EFSA conclusions, which constitute the scientific basis of the contested decision (see, to that effect, the judgment in Xeda International and Pace International v Commission, paragraph 41 above, EU:T:2012:18, paragraph 116 and the case-law cited).

86      Having regard to all of the foregoing considerations, it must be held that none of the applicant’s arguments put forward in support of the first part of the first plea is capable of establishing that the Commission committed a manifest error of assessment.

87      Consequently, the first part of the first plea in law must be rejected.

–       The second part of the first plea, alleging failure to examine all the scientific evidence available

88      First of all, the applicant argues that the contested decision fails to take into account all of the available scientific evidence which it duly submitted as part of the risk assessment process for ethoxyquin. In particular, it submits, the Commission failed to consider studies published by the JMPR and by the United States Environmental Protection Agency (‘the EPA’). The applicant claims that those studies demonstrated that it was possible to establish a residue definition as well as exposure assessments.

89      The applicant goes on to note that ethoxyquin, listed in Part A of Annex I to Regulation No 2229/2004, is subject to the provisions of that regulation. Consequently, the applicant was required, in its capacity as notifier, to provide, as part of its dossier, in addition to the information listed in Article 6 of Regulation No 2229/2004, available assessment reports from any country of the Organisation for Economic Cooperation and Development (OECD), in accordance with Article 9(1) of that regulation. The applicant emphasises that the EPA reports clearly come within that category of available reports from an OECD country and that the JMPR reports, drafted by distinguished international experts, ought to have been given appropriate attention by the EU authorities in their assessment of ethoxyquin and should not have been ignored. The applicant relies, in this connection, on Article 15 of Regulation No 2229/2004, which makes it clear that the RMS must evaluate all dossiers submitted to it. It also asserts that that obligation extends to all bodies consulted by the RMS with a view to evaluating the dossier submitted by the applicant, including EFSA, and to those intervening in the procedure relating to the submission of a new application for inclusion.

90      The applicant also argues that two factors reinforce the obligation to consider the JMPR and EPA reports. First, it argues that, because ethoxyquin was part of the fourth stage of the review programme, less stringent requirements were imposed for the inclusion of the substance in Annex I to Directive 91/414. In support of that assertion, it relies on recital 14 in the preamble to Regulation No 2229/2004. Secondly, it argues, in essence, that there is a precedent showing that, when setting the conditions for including an active substance in Annex I to Directive 91/414, the Commission follows the opinions of international bodies.

91      Lastly, in its reply, the applicant asserts that the Commission acknowledged in its defence that toxicological reference values were set by both the EPA and the JMPR, but that the Commission chose to ignore those facts and dismiss the data as insufficient, stating that the role of the EU institutions was not to rubber stamp the opinions of such internationally recognised bodies.

92      The Commission contests the merits of the applicant’s arguments.

93      It should be noted that, by the arguments referred to in paragraphs 88 to 91 above, the applicant claims (i) that the Commission failed to consider the JMPR and EPA reports or that it did not examine them carefully and (ii) that the Commission was under an obligation to consider those reports.

94      As for the argument that the Commission failed to consider those reports, this must be rejected since it is apparent from several documents in the case file that those reports were clearly taken into account and carefully examined.

95      Firstly, in the DAR and in the additional report, the RMS had considered those reports, but had in particular identified a number of gaps.

96      Secondly, it is apparent from the EFSA peer review report of 30 August 2010, concerning ethoxyquin, that EFSA in essence stated, with regard to the JMPR and EPA reports, that no information showed the equivalence of the active substance subject to examination by the European Union with that referred to by the JMPR and EPA assessment for the purpose of its decision.

97      Lastly and thirdly, it is apparent from the same EFSA peer review report of 30 August 2010 that the RMS took the view that the JMPR approach, as defined in their 2008 report, could not be considered to be appropriate to address, in a satisfactory manner, the issue of the toxicity of metabolites.

98      As for the argument that the Commission was under an obligation to consider those reports, on the ground, inter alia, that ethoxyquin was subject to less stringent examination requirements and that the Commission had already in the past followed the opinions of international bodies, this argument must be rejected.

99      First of all, it is apparent from paragraph 85 above that the conclusions of bodies such as the JMPR and the EPA are in no way binding on the Commission in its assessment on the ground that the recommendations, made within the context of a procedure distinct from that for the inclusion of active substances in Annex I to Directive 91/414, cannot be compared to the EFSA conclusions, which constitute the scientific basis of the contested decision. Consequently, the applicant cannot claim that, since the JMPR and the EPA are internationally recognised bodies which themselves set toxicological reference values, the Commission had no other choice than to follow their conclusions.

100    Next, contrary to what the applicant claimed in its written pleadings and at the hearing, ethoxyquin was not subject to less stringent examination requirements. It must be borne in mind, in this regard, that 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 (see paragraph 62 above). It therefore appears that the applicant proceeds to an erroneous interpretation on the ground that Regulation No 2229/2004 extended, for notifiers of active substances included in Part A of Annex I, the scope of evidence which may be provided to the RMS in order to demonstrate that the active substance concerned meets the criteria of Directive 91/414. Although the formal requirements are simplified, the substantive requirements remain the same.

101    Lastly, the Court takes the view that that conclusion cannot be called into question by the precedent, relating to chlorothalonil, which has been relied on by the applicant (see paragraph 90 above). The mere fact that the Commission has already followed the opinion of bodies such as the JMPR or the EPA cannot suffice to establish that the Commission is under an obligation to follow automatically the opinions of such bodies.

102    In view of the foregoing considerations, the second part of the first plea must be rejected, as, accordingly, must the first plea in its entirety.

 The second plea, alleging breach of the rights of the defence and infringement of essential procedural requirements

103    According to the applicant, the contested decision infringes the applicable procedure under Regulation No 33/2008 relating to the submission of a new application for the inclusion of an active substance in Annex I to Directive 91/414, as well as its right of defence and its right to be heard. The Commission, it contends, did not give the applicant sufficient opportunity and time to submit studies addressing the objection relating to insufficient or incomplete data in support of the proposed maximum level for impurity 7.

104    With regard, in particular, to the procedure relating to a new application for inclusion, the applicant argues that the purpose of that procedure is to allow the notifier to address the concerns identified in the non-inclusion decision and reverse that decision. However, in the present case, in addition to outstanding issues, the additional report identified a new critical area of concern. It was not until November 2009 that the data gap in respect of impurity 7 became a formal data requirement. It was subsequently labelled as a critical area of concern in the EFSA conclusion report and in the review report prepared by the Commission. The applicant submits that there were no grounds for it to suspect, much less to anticipate, that the data gap in respect of impurity 7 would become a critical issue and would require new studies until very late in the procedure.

105    The applicant also claims that the contested decision infringes its rights of defence and its right to be heard in that that decision failed to examine carefully the JMPR and EPA reports submitted by the applicant with its comments on the EFSA conclusion report and the additional report.

106    The Commission disputes the merits of the applicant’s arguments.

107    According to settled case-law, respect for the rights of the defence is, in all proceedings 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 proceedings 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 judgments in Bayer CropScience and Others v Commission, paragraph 41 above, EU:T:2008:317, paragraph 130, and in Cheminova and Others v Commission, paragraph 33 above, EU:T:2009:299, paragraph 244).

108    The right to be heard in an administrative procedure taken against a specific person is a corollary of the rights of the defence (see judgment in Sepro Europe v Commission, paragraph 62 above, EU:T:2013:407, paragraph 66).

109    In the present case, firstly, it must be stated that the contested decision adversely affects the applicant since it refuses to grant the applicant’s application to have ethoxyquin included in Annex I to Directive 91/414 and therefore prevents the applicant from marketing plant protection products containing that active substance.

110    Secondly, it is important to note that the applicant was able to submit its comments in sufficient time throughout the procedure for assessing ethoxyquin. It is apparent from the documents in the case file that EFSA sent, on 13 March 2008, the DAR to the applicant and that the latter voluntarily withdrew its support for the inclusion of ethoxyquin, in accordance with Article 24e of Regulation No 2229/2004. It is also apparent from those documents that the Commission received the applicant’s comments on the additional report (see paragraph 13 above), the EFSA conclusion report and the review report. By letter of 26 August 2010, the Commission invited the applicant to submit its comments on the EFSA conclusion report, which it did by letter of 29 September 2010. Similarly, the Commission invited the applicant to submit comments on the review report, which the applicant did on 17 November 2010.

111    Since the applicant was invited to submit its comments, and since it did so, it must be held not only that the Commission did not commit any infringement of the rights of defence, but, in addition, that the applicant did in fact exercise those rights.

112    That conclusion cannot be called into question by the applicant’s arguments.

113    Firstly, the Court must reject the argument relating to the procedure established by Regulation No 33/2008 and to the fact that the authorities in charge of the examination of the application for inclusion were concerned for the first time with respect to impurity 7 only during the new procedure (see paragraph 104 above). In that regard, without there being any need to rule on the question whether such an argument lacks a factual basis, it is sufficient to recall that, in any event, the choice of the accelerated procedure does not have the effect of altering the substantive requirements laid down in Article 5(1) of Directive 91/414 and 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 (see paragraphs 62 and 100 above).

114    Consequently, as is apparent from paragraph 63 above, the fact that (i) the issue relating to impurity 7 — which the applicant acknowledges was raised in the DAR — was not referred to as a critical area of concern before the additional report was drawn up or that (ii) that issue is alleged to have become a new concern during the new procedure did not preclude the competent authorities from not including ethoxyquin in Annex I to Directive 91/414.

115    Secondly, as regards the argument that the Commission did not give the applicant sufficient opportunity or time to submit studies addressing the objection relating to insufficient or incomplete data in support of the proposed maximum level for impurity 7 (see paragraph 103 above), it must be held, first of all, that the applicant had the opportunity to respond to the concern relating to impurity 7 in its comments of 21 November 2009, 29 September 2010 and 17 November 2010 (see paragraphs 13, 17 and 19 above).

116    Next, with particular regard to the applicant’s argument that it was unable to submit new data, it must be borne in mind that the applicable regulatory provisions do not impose any obligation to provide a notifier with the opportunity to submit data during the assessment procedure by the RMS and EFSA. At most, under Article 18(3) and the second subparagraph of Article 20(2) of Regulation No 33/2008, 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, to that effect, judgment in Sepro Europe v Commission, paragraph 62 above, EU:T:2013:407, paragraph 75).

117    Lastly, for the sake of completeness, if the applicant’s argument were to be understood as meaning that the applicant complains that Regulation No 33/2008 imposes overly strict time constraints which prevented it from responding to the concern raised, it would be necessary to find that such constraints are in accordance with the objectives highlighted (i) in recital 3 in the preamble to that regulation, according to which the detailed rules for the resubmission of applications must avoid duplication of work, maintain a high safety standard and ensure that a decision is taken quickly, and (ii) in recital 6 in the preamble to that regulation, according to which additional data should be taken into account only if they are submitted within the time period set, which implies that such data may not be produced spontaneously or outside the period set.

118    Thirdly, with regard to the argument that the Commission failed carefully to examine the JMPR and EPA review reports, this must be rejected.

119    First, it should be noted that that argument is identical to the argument put forward and rejected in the context of the second part of the first plea (see paragraphs 93 to 97 above).

120    Second, it is important to emphasise that, as the applicant accepts, it submitted the JMPR and EPA reports in its comments of 21 November 2009 on the additional report and in its comments of 29 September 2010 on the EFSA conclusion report. The Commission stated in recital 7 in the preamble to the contested decision that the applicant’s comments were carefully examined. It is apparent from recital 8 in the preamble to the contested decision (see paragraphs 22 and 40 above) that the Commission concluded, however, that the concerns identified persisted despite the comments submitted by the applicant, in particular the comments submitted on 29 September 2010 on the EFSA conclusion report, and that the assessments made on the basis of the information submitted and evaluated during the EFSA expert meetings had not demonstrated that, under the proposed conditions of use, plant protection products containing ethoxyquin satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414 and that, consequently, that active substance should not be included in Annex I to Directive 91/414. It is therefore clear from this that the applicant’s comments, including those of 29 September 2010, which included the JMPR and EPA reports, were carefully examined by the Commission and that the Commission took the view that the concerns identified continued to exist.

121    In view of the foregoing considerations, it must be concluded that the applicant’s rights of defence, and in particular its right to be heard during the procedure preceding the adoption of the contested decision, were respected. Consequently, the second plea must be rejected as being unfounded.

 The third plea, alleging breach of fundamental principles of EU law

122    This plea falls into two parts, alleging, first, breach of the principles of legal certainty and of the protection of legitimate expectations and, secondly, breach of the principle of proportionality.

–       The first part of the third plea, alleging breach of the principles of legal certainty and of the protection of legitimate expectations

123    The applicant submits, in essence, that, having regard to the procedure relating to the submission of a new application for inclusion provided for in Regulation No 33/2008, the contested decision was adopted in disregard of the principles of legal certainty and of the protection of legitimate expectations.

124    The applicant argues that, in the light of those two principles, when it decided to support the inclusion of ethoxyquin in Annex I to Directive 91/414 and subsequently to resubmit its application for inclusion pursuant to the provisions of Regulation No 33/2008, it had the following legitimate expectations:

–        that, as a low-risk compound listed in Part A of Annex I to Regulation No 2229/2004, ethoxyquin would be subjected to less stringent conditions during the review process, as indicated in recital 14 in the preamble to that regulation; this expectation was reinforced by the reference to the absence of clear indications of harmful effects of ethoxyquin in the first non-inclusion decision;

–        that it was sufficient to submit the JMPR and EPA reports, a view which is supported by Article 9 of Regulation No 2229/2004;

–        that the procedure relating to the submission of a new application for inclusion of ethoxyquin would focus solely on the issues of critical concern originally identified by the RMS in its DAR, a view which is implicitly supported by Article 15 of Regulation No 33/2008, without the need for further studies to be carried out.

125    According to the applicant, all of those legitimate expectations were directly and blatantly disregarded by the Commission when it adopted the contested decision.

126    The Commission disputes the merits of the applicant’s arguments.

127    It must be borne in mind that, according to settled case-law, the principle of legal certainty — which is one of the general principles of EU law — requires, particularly, that rules of law be clear, precise and predictable in their effects, in particular where they may have negative consequences for individuals and undertakings (see judgment of 18 November 2008 in Förster, C‑158/07, ECR, EU:C:2008:630, paragraph 67 and the case-law cited).

128    Furthermore, according to settled case-law, the right to rely on the principle of the protection of legitimate expectations extends to any individual who is in a situation in which it is clear that the EU authorities have, by giving him precise assurances, led him to entertain legitimate expectations (judgments of 15 July 2004 in Di Lenardo and Dilexport, C‑37/02 and C‑38/02, ECR, EU:C:2004:443, paragraph 70; of 17 December 1998 in Embassy Limousines & Services v Parliament, T‑203/96, ECR, EU:T:1998:302, paragraph 74; see also, to that effect, the judgment in Bayer CropScience and Others v Commission, paragraph 41 above, EU:T:2008:317, paragraph 153). Regardless of the form in which it is communicated, precise, unconditional and consistent information which comes from authorised and reliable sources constitutes such assurances. However, a person may not plead a breach of that principle unless he has been given precise assurances by the administration (judgments of 24 November 2005 in Germany v Commission, C‑506/03, EU:C:2005:715, paragraph 58, and of 22 June 2006 in Belgium and Forum 187 v Commission, C‑182/03 and C‑217/03, ECR, EU:C:2006:416, paragraph 147). Moreover, only assurances which comply with the applicable rules may give rise to legitimate expectations (judgments of 30 June 2005 in Branco v Commission, T‑347/03, ECR, EU:T:2005:265, paragraph 102; of 23 February 2006 in Cementbouw Handel & Industrie v Commission, T‑282/02, ECR, EU:T:2006:64, paragraph 77; and in Denka International v Commission, paragraph 44 above, EU:T:2009:453, paragraph 132).

129    In the light of the explanations set out within the context of the second plea, in particular in paragraph 113 above, the applicant’s arguments in support of the first part of the third plea must be rejected.

130    It is evident from paragraph 113 above that 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. Moreover, it has been stated that Article 15(1)(c) of Regulation No 33/2008 expressly provides that it is 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 or by the RMS in the DAR, as the applicant claims by its third argument. Similarly, the applicant cannot reasonably argue that ethoxyquin was subject to less stringent requirements during the new procedure, regardless of the content of the first non-inclusion decision. The applicant also has no basis on which to support its claim that it was sufficient for it to submit the JMPR and EPA reports. Indeed, it should be noted in this respect that Article 9 of Regulation No 2229/2004 in no way supports the applicant’s argument. Although that provision provides for the possibility of providing assessment reports such as those relied on by the applicant, it does not in any way follow therefrom that such reports can suffice to justify the inclusion of the active substance at issue. That provision expressly provides that, in any event, the notifier must provide the information required under Articles 5 and 6(2) of that regulation.

131    Consequently, the first part of the third plea must be rejected.

–       The second part of the third plea, alleging breach of the principle of proportionality

132    The applicant submits that the contested decision is disproportionate given the choice of measures available to the Commission and the disadvantages caused in relation to the objectives pursued.

133    The applicant claims, firstly, that the failure to take account of the data which it provided is disproportionate. According to it, those data were submitted in support of the inclusion in Annex I to Directive 91/414 of an active substance which formed part of the fourth stage of the review programme, in other words, in support of a low-risk compound. Consequently, the applicant takes the view that the continuous demand for further information and clarification in regard to matters that had already been addressed elevated the data requirements beyond what was necessary or expected to achieve the objectives pursued by the contested decision. In that regard, the conclusions of the JMPR and EPA reports were sufficient. The applicant claims that treating ethoxyquin as if it were an active substance belonging to the second or third stage of the review programme was contrary to Regulation No 2229/2004.

134    Secondly, the applicant expresses the view that the Commission could have opted for other less restrictive measures which would have achieved the objectives sought without imposing on the applicant the disproportionate burden of having to submit a new dossier for the review of ethoxyquin and without consequently entailing a significant loss of commercial revenue and additional expenditure. The applicant takes the view that the Commission could have approved ethoxyquin subject to conditions, such as the submission of confirmatory data, as it has done in the case of other substances in respect of which areas of potential concern had not been fully addressed. The applicant relies, in this connection, on Article 6(1) of Directive 91/414, which provides that the inclusion of an active substance in Annex I may be subject to certain conditions, and on the document bearing the reference SANCO/5634/2009, entitled ‘Guidance document on the procedures for submission and assessment of confirmatory data following inclusion of an active substance in Annex I to Council Directive 91/414/EEC’.

135    The Commission disputes the merits of the applicant’s arguments.

136    In this regard, it must be borne in mind that the principle of proportionality requires that measures adopted by EU institutions do not exceed the limits of what is appropriate and necessary in order to attain the legitimate objectives pursued by the legislation in question; when 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 judgment of 9 March 2006 in Zuid-Hollandse Milieufederatie and Natuur en Milieu, C‑174/05, ECR, EU:C:2006:170, paragraph 28 and the case-law cited).

137    It follows that, within the context of judicial review of the application of such a 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 that measure is manifestly inappropriate in relation to the objective which it is intended to attain (judgment in Bayer CropScience and Others v Commission, paragraph 41 above, EU:T:2008:317, paragraph 224).

138    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 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 and, second, that 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 in the present case may justify even substantial negative economic consequences for certain operators (judgment in Sepro Europe v Commission, paragraph 62 above, EU:T:2013:407, paragraph 85).

139    In the first place, with regard to the argument that the contested decision infringes the principle of proportionality on the ground that it treated ethoxyquin as if it were an active substance belonging to the second or third stage of the review programme, this argument cannot be upheld.

140    Regardless of the fact that it has already been stated in paragraph 113 above that 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, suffice it to state that that argument finds no basis in Regulation No 2229/2004.

141    On the contrary, as the Commission rightly notes, it follows clearly from Article 9(1) and Article 10(1) and (2)(a) of Regulation No 2229/2004 that, irrespective of whether an active substance is included in Part A or in Parts B to G of Annex I to that regulation, and pursuant to Article 6(1) and (2) of that regulation, the applicant was under an obligation to submit a dossier for ethoxyquin including ‘a limited range of representative uses of [that] substance, in respect of which the data submitted by the [applicant] in the dossier shall demonstrate that, for one or more preparations, the requirements set out in Article 5 of Directive 91/414 … for inclusion of the active substance in Annex I to that Directive may be met’.

142    It therefore appears that the applicant is engaging in an erroneous interpretation by reason of the fact that Regulation No 2229/2004 extended, for notifiers of active substances included in Part A of Annex I, the scope of evidence which may be provided to the RMS in order to show that the active substance concerned meets the criteria of Directive 91/414. The fact that, pursuant to Article 9(1)(b) of Regulation No 2229/2004, available assessment reports from any OECD country constitute permissible documents in the dossier for an active substance does not mean that the Commission, the RMS or EFSA are released from their obligation to assess whether those reports, the data which they contain or the entire dossier show that the requirements of Article 5 of Directive 91/414 are met.

143    In the second place, as regards the argument derived from the allegedly disproportionate consequences of the contested decision, namely the resubmission of a new application for inclusion and significant losses of commercial revenue, it is sufficient to state that the applicant did not establish, during the assessment procedure, the safety of the active substance which it sought to have included in Annex I to Directive 91/414. As follows from the examination of the first plea, it has not been established that the Commission committed a manifest error of assessment in respect of the examination of ethoxyquin’s influence.

144    In those circumstances, having regard to the importance of the objective of protecting the environment and in view of the case-law cited in paragraph 138 above, it must be held that neither the preparation of a new dossier for the purpose of ethoxyquin’s inclusion in Annex I to Directive 91/414 nor the alleged losses of commercial revenue, even if they were established, constitute a disproportionate burden.

145    Consequently, the argument derived from the allegedly disproportionate consequences of the contested decision must be rejected as unfounded.

146    In the third place, as regards the argument that the objective pursued by the non-inclusion decision could have been achieved by less restrictive alternative measures, it must be noted that the applicant does not propose any specific and precise alternative measure and that it merely makes reference to examples of the application of Article 6(1) of Directive 91/414.

147    In addition, so far as concerns the active substances referred to by the applicant as examples of the application of Article 6(1) of Directive 91/414, which were approved subject to the production of confirmatory data of a similar nature to those required in the present case, it must be stated that, as has already been repeatedly held, the Commission has recourse to that provision only where the active substance being assessed could be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414 (see, to that effect, judgment in Xeda International and Pace International v Commission, paragraph 41 above, EU:T:2012:18, paragraph 131 and the case-law cited).

148    In the present case, however, it has been concluded that ethoxyquin did not satisfy those requirements in view of the fact that it presented various risks which had not been adequately addressed in the applicant’s dossier. Article 6(1) of Directive 91/414 was for that reason not applicable.

149    It follows that the active substances cited by the applicant cannot be compared to ethoxyquin, even though the concerns raised with regard to those active substances display similarities with the present procedure.

150    Furthermore, even if the applicant’s argument concerning examples of decisions adopted on the basis of Article 6(1) of Directive 91/414 could be understood as being essentially a claim of a breach of the principle of equal treatment which has allegedly led the Commission to adopt a disproportionate decision, it must be borne in mind that that principle 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 (see, to that effect, judgment in Xeda International and Pace International v Commission, paragraph 41 above, EU:T:2012:18, paragraph 138 and the case-law cited).

151    However, it must be held that, having regard in particular to the specific nature of each review procedure, which makes comparisons extremely difficult, and also to the Commission’s discretion as to how it conducts investigations of such a technical and complex nature, the applicant has failed to establish that the differences in the manner in which the evaluation procedures subject to comparison took place were not objectively justified (see, to that effect, judgment in Xeda International and Pace International v Commission, paragraph 41 above, EU:T:2012:18, paragraph 139 and the case-law cited).

152    Finally, with regard to the guidance document SANCO/5634/2009 (see paragraph 134 above) on which the applicant relies, it must be held that this is not intended to produce legally binding effects. As is stated in the preamble to that document, it was produced by the Commission Services in cooperation with the Member States with the aim of providing straightforward guidance to notifiers in respect of whom a decision for inclusion in Directive 91/414 had been adopted, in relation to data required in order to confirm that the active substances evaluated have no harmful effects (judgment in Xeda International and Pace International v Commission, paragraph 41 above, EU:T:2012:18, paragraph 141).

153    Consequently, the second part of the third plea and the third plea must be rejected and the action must be dismissed in its entirety.

 Costs

154    Under Article 87(2) 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. Since the applicant has been unsuccessful, it must be ordered to pay the costs, including those of the proceedings for interim relief, in accordance with the form of order sought by the Commission.

On those grounds,

THE GENERAL COURT (Ninth Chamber)

hereby:

1.      Dismisses the action;

2.      Orders Xeda International SA to bear its own costs and to pay the costs incurred by the European Commission, including those relating to the proceedings for interim relief.

Delivered in open court in Luxembourg on 12 December 2014.

[Signatures]

Table of contents

Legal context

Background to the dispute

Procedure and forms of order sought

Law

Admissibility

Substance

The first plea, alleging manifest errors of assessment

– The first part of the first plea, relating to the hypothetical nature of the genotoxic potential of impurity 7 and the risks to the environment and to non-target organisms

– The second part of the first plea, alleging failure to examine all the scientific evidence available

The second plea, alleging breach of the rights of the defence and infringement of essential procedural requirements

The third plea, alleging breach of fundamental principles of EU law

– The first part of the third plea, alleging breach of the principles of legal certainty and of the protection of legitimate expectations

– The second part of the third plea, alleging breach of the principle of proportionality

Costs

* Language of the case: English.

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