Judgments nº T-334/07 of Court of First Instance of the European Communities, November 19, 2009

Resolution Date:November 19, 2009
Issuing Organization:Court of First Instance of the European Communities
Decision Number:T-334/07
SUMMARY

Plant-protection products – Active substance dichlorvos – Non-inclusion in Annex I to Directive 91/414/EEC – Evaluation procedure – Opinion of an EFSA Scientific Panel – Plea of illegality – Article 20 of Regulation (EC) No 1490/2002 – Submission of new studies and data during the evaluation procedure – Article 8 of Regulation (EC) No 451/2000 – Article 28(1) of Regulation (EC) No 178/2002 –... (see full summary)

 
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In Case T‑334/07,

Denka International BV, established in Barneveld (Netherlands), represented by C. Mereu and K. Van Maldegem, lawyers,

applicant,

v

Commission of the European Communities, represented by B. Doherty and L. Parpala, acting as Agents,

defendant,

APPLICATION for annulment of Commission Decision 2007/387/EC of 6 June 2007 concerning the non-inclusion of dichlorvos in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (OJ 2007 L 145, p. 16),

THE COURT OF FIRST INSTANCE OF THE EUROPEAN COMMUNITIES (Second Chamber),

composed of I. Pelikánová, President, K. Jürimäe (Rapporteur) and S. Soldevila Fragoso, Judges,

Registrar: C. Kantza, Administrator,

having regard to the written procedure and further to the hearing on 3 March 2009,

gives the following

Judgment

Legal context

Directive 91/414/EEC

1 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) lays down the Community rules applicable to the granting of authorisation to place plant protection products on the market and to the withdrawal of such authorisation.

2 Article 4(1) of Directive 91/414 provides that ‘Member States shall ensure that a plant protection product is not authorised unless … its active substances are listed in Annex I …’.

3 The conditions for the inclusion of active substances in Annex I are specified in Article 5 of Directive 91/414:

‘1. In the light of current scientific and technical knowledge, an active substance shall be included in Annex I for an initial period not exceeding 10 years, if it may be expected that plant protection products containing the active substance will fulfil the following conditions:

(a) 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 the said residues, in so far as they are of toxicological or environmental significance, can be measured by methods in general use;

(b) 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).

…’

4 Article 6(1) of Directive 91/414 provides:

‘Inclusion of an active substance in Annex I shall be decided in accordance with the procedure laid down in Article 19.

The following shall also be decided in accordance with that procedure:

– any conditions for inclusion,

…’

5 Active substances which are not listed in Annex I to Directive 91/414 may, in certain circumstances, benefit from transitional arrangements permitting derogation. Under Article 8(2) of Directive 91/414 a Member State could, during a period of 12 years following the notification of Directive 91/414, authorise the placing on its domestic market of plant protection products containing active substances not listed in Annex I that were already on the market two years after the date of notification of Directive 91/414, namely 25 July 1993. The Commission of the European Communities was to commence a programme of work for the gradual examination of those active substances. Subsequently, it could be decided whether or not the substance would be included in Annex I to the directive. The Member States were to ensure that the relevant authorisations would be granted, withdrawn or varied, as appropriate.

6 That 12-year period was extended by Article 1 of Commission Regulation (EC) No 1335/2005 of 12 August 2005 amending Regulation (EC) No 2076/2002 and Decisions 2002/928/EC, 2004/129/EC, 2004/140/EC, 2004/247/EC and 2005/303/EC as regards the time period referred to in Article 8(2) of Directive 91/414 and the continued use of certain substances not included in its Annex I (OJ 2005 L 211, p. 6) until 30 September 2007 for the active substances which are assessed in the framework of the second stage under Commission Regulation (EC) No 451/2000 of 28 February 2000 laying down the detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of Directive 91/414 (OJ 2000 L 55, p. 25).

Regulation No 451/2000

7 Regulation No 451/2000, as amended by Commission Regulation (EC) No 1490/2002 of 14 August 2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414 and amending Regulation No 451/2000 (OJ 2002 L 224, p. 23), organises the procedure for evaluation of various substances with a view to their possible inclusion in Annex I to Directive 91/414. Dichlorvos is one of those substances.

8 The procedure introduced by Regulation No 451/2000 begins with a notification of interest, provided for under Article 4(1) of the regulation, which, as regards dichlorvos, was to be sent by 31 August 2000, at the latest, to the rapporteur Member State (‘the RMS’) designated in Annex I to the regulation, namely the Italian Republic, by any producer who wished to secure its inclusion in Annex I to Directive 91/414.

9 Pursuant to Article 6(1) of Regulation No 451/2000, each notifier has the task of sending to the RMS a summary dossier and a complete dossier, as defined in Article 6(2) and (3) of the regulation.

10 The time-limit for the submission of those dossiers and of relevant information which could contribute to the evaluation of the active substances was set at 30 April 2002, by virtue of Article 5(4)(c) and (d) of Regulation No 451/2000, in conjunction with Article 2 of Commission Regulation (EC) No 703/2001 of 6 April 2001 laying down the active substances of plant protection products to be assessed in the second stage of the work programme referred to in Article 8(2) of Directive 91/414 and revising the list of Member States designated as rapporteurs for those substances (OJ 2001 L 98, p. 6).

11 As set out in Article 7(1) of Regulation No 451/2000, the RMS is required to report to the Commission on the completeness of the dossiers, at the latest six months after the receipt of all dossiers for an active substance. In the case of active substances for which a dossier is considered to be complete, the RMS then evaluates the dossier.

12 The evaluation proper of the active substances is governed by Article 8 of Regulation No 451/2000, as amended by Article 20 of Regulation No 1490/2002.

13 Article 8(1) of Regulation No 451/2000 provides:

‘The [RMS] shall evaluate and report only on those active substances for which at least one dossier has been determined to be complete … It shall send a draft report of its assessment of the dossier to the European Food Safety Authority … as quickly as possible, and at the latest 12 months after the dossier was determined to be complete…

At the same time, the [RMS] shall make a recommendation to the Commission either:

– to include the active substance in Annex I to … Directive [91/414], stating the conditions for inclusion,

– not to include the active substance in Annex I to … Directive [91/414], stating the reasons for the non-inclusion.

…’

14 At that stage of the evaluation, Article 8(2) of Regulation No 451/2000, as amended, provides that ‘submission of new studies shall not [as a rule] be accepted’, but that ‘[the RMS] may request the notifiers to submit further data which are necessary to clarify the dossier’ and that it ‘shall set a time-limit within which [that] information should be provided’.

15 Under the first subparagraph of Article 8(5) of Regulation No 451/2000, as amended, ‘the [European Food Safety Authority] shall circulate the rapporteur’s draft assessment report to the Member States and may organise a consultation of experts including [the RMS]’. At that stage of the procedure, the second subparagraph of Article 8(5) of Regulation No 451/2000, as amended, provides:

‘Without prejudice to Article 7 of Directive [91/414], submission of new studies shall not be accepted. The [RMS], with the agreement of the [European Food Safety Authority], may request the notifiers to submit within specified periods further data considered by the [RMS] or the [European Food Safety Authority] necessary to clarify the dossier.’

16 Article 8(7) of Regulation No 451/2000 provides:

‘The [European Food Safety Authority] shall evaluate the rapporteur’s draft assessment report and deliver its opinion on whether the active substance can be expected to meet the safety requirements of … Directive [91/414] to the Commission at the latest one year after receipt of the [RMS’s] draft assessment report. Where appropriate, the [European Food Safety Authority] shall give its opinion on the available options claimed to meet the safety requirements …’

17 Article 8(8) of Regulation No 451/2000 provides:

‘At the latest six months after receipt of the [European Food Safety Authority] opinion referred to in paragraph 7, the Commission shall submit the draft review report… [I]t shall submit to the Committee:

(a) a draft directive to include the active substance in Annex I to … Directive [91/414], setting out where appropriate the conditions, including the time-limit, for such inclusion, or

(b) a draft decision addressed to the Member States to withdraw the authorisations of plant-protection products containing the active substance, pursuant to the fourth subparagraph of Article 8(2) of … Directive [91/414], whereby that active substance is not included in Annex I to … Directive [91/414], mentioning the reasons for the non-inclusion.

…’

Regulation (EC) No 178/2002

18 Article 28(1) of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the...

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