Case T-326/07

Cheminova and Others

v

Commission of the European Communities

‛Plant-protection products — Active substance ‘malathion’ — Non-inclusion in Annex I to Directive 91/414/EEC — Action for annulment — Locus standi — Admissibility — Evaluation procedure — Assessment by EFSA — Plea of illegality — Article 20 of Regulation (EC) No 1490/2002 — Submission of new studies — Article 8(2) and (5) of Regulation (EC) No 451/2000 — Legitimate expectation — Proportionality — Equal treatment — Principle of sound administration — Rights of the defence — Principle of subsidiarity — Article 95(3) EC, Articles 4(1) and 5(1) of Directive 91/414’

Judgment of the Court of First Instance (Eighth Chamber), 3 September 2009   II ‐ 2692

Summary of the Judgment

1. Acts of the institutions — Temporal application — Procedural rules

   (Commission Regulations Nos 451/2000, Art. 8, and 1490/2002)

2. Agriculture — Approximation of laws — Placing of plant protection products on the market — Directive 91/414

   (Council Directive 91/414)

3. Agriculture — Approximation of laws — Placing of plant protection products on the market — Directive 91/414

   (Commission Regulation No 451/2000, Arts 6(1), (2)(d) and (3), 7(1)(a) and 8(2) and (5); Council Directive 91/414, Art. 5(1))

4. Agriculture — Approximation of laws — Placing of plant protection products on the market — Directive 91/414

   (Art. 95(3) EC; Council Directive 91/414, Arts 4(1)(b)(iv) and (v) and 5(1), and Annex I)

5. Agriculture — Approximation of laws — Placing of plant protection products on the market — Directive 91/414

   (Council Directive 91/414, Art. 5(1))

6. Community law — Principles — Protection of legitimate expectations — Conditions

   (Commission Regulation No 451/2000, Art. 8(2) and (5))

7. Community law — Principles — Proportionality

   (Arts 34 EC to 37 EC)

8. Agriculture — Approximation of laws — Placing of plant protection products on the market — Directive 91/414

   (Commission Regulation No 451/2000, Art. 8(7); Council Directive 91/414, Art. 8(2))

9. Agriculture — Approximation of laws — Placing of plant protection products on the market — Directive 91/414

   (Council Directive 91/414, Arts 5(1) and (4))

10. Agriculture — Approximation of laws — Placing of plant protection products on the market — Directive 91/414

    (Commission Regulation No 451/2000, Art. 4; Council Directive 91/414, Art. 13)

1.  In contrast to substantive Community law, which must be interpreted as not applying, in principle, to situations existing before its entry into force, procedural rules are of direct application. The provisions of Regulation No 1490/2002 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, which provide for the European Food Safety Authority’s involvement in active substance evaluation procedures, are procedural rules which are of direct application, without requiring any specific statement of reasons in that regard in Regulation No 1490/2002. Consequently, the immediate application of the amended provisions of Article 8 of Regulation No 451/2000 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 to existing active substance evaluation procedures could not be illegal.

   (see paras 78-80)

2.  As is clear from recitals 5, 6 and 9 in its preamble, Directive 91/414 concerning the placing of plant protection products on the market seeks 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.

   However, the exercise of that discretion is not excluded from judicial review. As part of such a review, the Community judicature must determine whether the relevant procedural rules have been complied with, whether the facts established by the Commission are correct and whether there has been a manifest error of appraisal of those facts or a misuse of powers.

   (see paras 106, 107)

3.  In the system established by Regulation No 451/2000 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, the primary responsibility for checking the completeness of the dossier for the active substances in question rests with the notifier. Indeed, under Article 6(2)(d) of that regulation, the summary dossier is to include ‘a check by the notifier of the completeness of the dossier’. That is confirmed by Article 7(1)(a) of the regulation, which requires the Rapporteur Member State (‘the RMS’) to examine the dossiers and assess ‘the completeness check(s) provided by the notifiers’.

   Thus, the fact that the dossier has been declared complete by the RMS for the purposes of Article 6(1) of Regulation No 451/2000 does not guarantee necessarily that it contains all the information enabling the RMS, the European Food Safety Authority (‘EFSA’) and the Commission to adopt a position on the ‘harmful effects’ of the active substance concerned, under Article 5(1) of Directive 91/414 concerning the placing of plant protection products on the market. In that regard, a dossier which contains the studies and reports required by Article 6(3) of Regulation No 451/2000 will be regarded as complete by the RMS, which does not exclude, however, that some or other data which would enable the RMS and/or EFSA to carry out their scientific evaluation of the active substance in question could be missing. For that reason, Article 8(2) and (5) of Regulation No 451/2000 provides for the possibility, for the RMS and EFSA respectively, to ask notifiers to submit further data necessary to clarify the dossier. However, since the notifier must ensure that the dossier submitted is complete, Article 8(2) and (5) give the notifier no right to complete its dossier on its own initiative.

   (see paras 154, 155)

4.  Article 5(1)(b) of Directive 91/414 concerning the placing of plant protection products on the market, 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, use of plant protection products containing that active substance, consequent on application consistent with good plant protection practice, will not, in accordance with Article 4(1)(b)(iv) and (v) of that directive, have any harmful effects on human or animal health or any unacceptable influence on the environment.

   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 a substance, justifies, in principle, the refusal to include that substance in Annex I to Directive 91/414. The precautionary principle is designed to prevent potential risks.

   (see paras 165, 166)

5.  The reference in Article 5(1) of Directive 91/414 concerning the placing of plant protection products on the market to ‘current scientific and technical knowledge’ cannot support the inference that undertakings which have notified an active substance and which are faced with the likelihood of a decision not to include that substance in Annex I to that directive should have the possibility of submitting new studies and data for as long as doubts persist regarding the safety of that active substance. Such an interpretation of that provision would run counter to the objective of a high level of protection of human and animal health and of the environment which underlies Article 5(1), in that it would be tantamount to granting to the notifier — on whom the burden of proof lies as regards the safety of the active substance and who has a better knowledge of that substance — a right of veto over the adoption of a decision not to include that substance in Annex I to Directive 91/414.

   (see para. 169)

6.  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 Community authorities have, by giving him precise assurances, led him to entertain legitimate expectations. Regardless of the form in which it is communicated, information that is precise, unconditional and consistent which comes from an authorised and reliable source constitutes such assurance. However, a person may not plead infringement of the principle unless he has been given precise assurances by the authorities.

   As part of the procedure for evaluating an active substance for the purposes of its inclusion in or omission from Annex I to Directive 91/414 concerning the placing of plant protection products on the market, which is provided for in Article 8 of Regulation No 451/2000 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, even if the European Food Safety Authority (‘EFSA’) or the Commission give precise assurances in respect of the taking into account of a new test, those assurances cannot found a legitimate expectation on the part of the notifier since Article 8(2) and (5) of Regulation No 451/2000 provide expressly that new studies are not, in principle, to be accepted, once the Rapporteur Member State or EFSA respectively has commenced its evaluation of the active substance. Only assurances which comply with the applicable rules may give rise to legitimate expectations.

   (see paras 179, 180, 186)

7.  The principle of proportionality, which is one of the general principles of Community law, requires that acts adopted by Community 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; 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.

   None the less, in agricultural matters, judicial review of compliance with the principle of proportionality is special in so far as the Court of Justice and the Court of First Instance recognise that the Community legislature has a discretionary power which corresponds to the political responsibilities given to it by Articles 34 EC to 37 EC in that field. Consequently, the legality of such a measure can be affected only if the measure is manifestly inappropriate in terms of the objective which the competent institution is seeking to pursue.

   (see paras 194, 195)

8.  Even if the time-limit of one year under Article 8(7) of Regulation No 451/2000 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, for evaluation by the European Food Safety Authority of the Rapporteur Member State’s draft assessment report and for delivery of its opinion on whether the active substance in question could be expected to meet the safety requirements of Directive 91/414 is mandatory, its being exceeded could not affect the legality of a decision unless it was established that the decision could have been different if that irregularity had not occurred.

   (see paras 207, 208)

9.  Article 5(4) of Directive 91/414 concerning the placing of plant protection products on the market permits inclusion of active substances which do not fulfil the requirements of Article 5(1) thereof subject to certain restrictions which exclude problematic uses of the substance involved. Even though, for the purposes of the restrictions imposed, a certain role may be attributed to the Member States, the fact remains that the definitive evaluation concerning the active substance’s compliance with the requirements of Article 5(1) of that directive is a matter for the Community authorities alone. Thus, even if Article 5(4) of Directive 91/414 applies, it is for the Commission, or if appropriate the Council, to establish beyond a reasonable doubt that the restrictions on the use of the substance involved make it possible to ensure that use of that substance will be in accordance with the requirements laid down in Article 5(1) of Directive 91/414.

   (see para. 260)

10.  Article 13 of Directive 91/414 concerning the placing of plant protection products on the market provides that the Member States must protect the confidentiality of data included in the dossier which accompanied the application for authorisation to place a plant protection product on the market. That protection applies, under Article 13(3) and (4) of Directive 91/414, only where the Member States ‘grant an authorisation’.

    Even if the provisions of Article 13 apply, mutatis mutandis, to the dossier notified under Article 4 of Regulation No 451/2000 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, for the purpose of securing the inclusion of an active substance in Annex I to Directive 91/414, in any event, the data protection requirement under Article 13 could not apply, since the active substance has not been the subject of any ‘authorisation’.

    (see paras 264, 265)