Judgments nº T-420/05 of Court of First Instance of the European Communities, October 07, 2009
|Resolution Date:||October 07, 2009|
|Issuing Organization:||Court of First Instance of the European Communities|
Plant protection products - Active substance chlorothalonil - Inclusion in Annex I to Directive 91/414/EEC - Assessment procedure - Directive 2005/53/EC - Application for annulment - Application for a declaration of failure to act - Application for damages
In Case T-420/05,
Vischim Srl, established in Cesano Maderno (Italy), represented by C. Mereu and K. Van Maldegem, lawyers,
Commission of the European Communities, represented by B. Doherty and L. Parpala, acting as Agents,
APPLICATION for annulment, with regard to the inclusion of the active substance chlorothalonil, of Commission Directive 2005/53/EC of 16 September 2005 amending Council Directive 91/414/EEC to include chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl as active substances (OJ 2005 L 241, p. 51), for annulment of the review report for chlorothalonil (document SANCO/4343/2000 final of 14 February 2005), for a declaration of failure to act and for damages,
THE COURT OF FIRST INSTANCE OF THE EUROPEAN COMMUNITIES (Sixth Chamber),
composed of A.W.H. Meij, President, F. Dehousse and V. Vadapalas (Rapporteur), Judges,
Registrar: C. Kantza, Administrator,
having regard to the written procedure and further to the hearing on 25 September 2008,
gives the following
1 As provided in Article 4(1)(a) 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), -Member States shall ensure that a plant protection product is not authorised unless its active substances are listed in Annex I and any conditions laid down therein are fulfilled-.
2 Article 5(1) of Directive 91/414 states that, -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 - conditions- which are then set out and relate to the products not being harmful for human or animal health or the environment.
3 By virtue of the first and second indents of Article 5(4) of Directive 91/414, an active substance-s inclusion may be subject to requirements relating to -the minimum degree of purity of the active substance- and to -the nature and maximum content of certain impurities-.
4 Article 8(2) of Directive 91/414 provides:
-By way of derogation from Article 4 -, a Member State may, during a period of 12 years following the notification of this Directive, authorise the placing on the market in its territory of plant protection products containing active substances not listed in Annex I that are already on the market two years after the date of notification of this Directive.
After the adoption of this Directive, the Commission shall commence a programme of work for the gradual examination of these active substances within the 12-year period referred to in the foregoing subparagraph. This programme may require interested parties to submit all requisite data to the Commission and the Member States within a period provided for in the programme. A regulation, adopted according to the procedure laid down in Article 19, will set out all the provisions necessary for the implementation of the programme.
During the 12-year period referred to in the first subparagraph it may, following examination by the Committee referred to in Article 19 of such active substance, be decided by the procedure laid down in that Article that the substance can be included in Annex I and under which conditions, or, in cases where the requirements of Article 5 are not satisfied or the requisite information and data have not been submitted within the prescribed period, that such active substance will not be included in Annex I. The Member States shall ensure that the relevant authorisations are granted, withdrawn or varied, as appropriate, within a prescribed period.-
5 Article 19 of Directive 91/414, as amended by Council Regulation (EC) No 806/2003 of 14 April 2003 (OJ 2003 L 122, p. 1), provides that the Commission of the European Communities is to be assisted by a regulatory committee, the Standing Committee on the Food Chain and Animal Health (-the Committee-).
6 As regards the active substance chlorothalonil, the period referred to in Article 8(2) of Directive 91/414, which was to expire on 26 July 2003, was extended, initially until 31 December 2005, by Commission Regulation (EC) No 2076/2002 of 20 November 2002 (OJ 2002 L 319, p. 3), then until 31 December 2006, by Commission Regulation (EC) No 1335/2005 of 12 August 2005 (OJ 2005 L 211, p. 6), unless a decision on its inclusion in Annex I to Directive 91/414 was taken before that date.
Regulation (EEC) No 3600/92
7 Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Directive 91/414 (OJ 1992 L 366, p. 10) sets out the procedure for the assessment of a number of substances with a view to their possible inclusion in Annex I to Directive 91/414. One of those substances is chlorothalonil.
8 Article 4(1) of Regulation No 3600/92 states that -any producer wishing to secure the inclusion of an active substance - in Annex I to - Directive [91/414] shall so notify the Commission within six months of the date of entry into force of this Regulation-.
9 According to Article 5 of Regulation No 3600/92, the Commission, after examining the notifications, is to draw up, in the form of a regulation, the list of active substances adopted for assessment, designate a rapporteur Member State for each of those active substances and indicate, for each of them, the names of the producers who have presented a notification and the deadline for the submission to the rapporteur Member State of the dossiers referred to in Article 6 of the regulation.
10 Article 6 of Regulation No 3600/92, as supplemented by Commission Regulation (EC) No 2266/2000 of 12 October 2000 (OJ 2000 L 259, p. 27), provides that the notifiers are, individually or collectively, to send the summary dossier and the complete dossier to the rapporteur Member State, and it specifies the content of those dossiers.
11 Article 7(1) and (2) of Regulation No 3600/92, as amended by Commission Regulation (EC) No 1199/97 of 27 June 1997 (OJ 1997 L 170, p. 19), provides:
-1. For each active substance for which it has been designated rapporteur, the Member State shall:
(a) examine the dossiers referred to in Article 6(2) and (3), in the order in which they are received -;
(b) immediately after examining a dossier, ensure that notifiers submit the updated summary dossier to the other Member States and to the Commission;
(c) send the Commission - a report of its assessment of the dossier, including a recommendation:
- to include the active substance in Annex I to Directive [91/414], stating the conditions for its inclusion, or
- to remove the active substance from the market, or
(d) in particular, include in the report a reference to each test and study report, for each point of Annex II to - Directive [91/414], relied on for the assessment in the form of a list of test and study reports including the title, the author(s), the date of the study or test and the date of publication, the standard to which the test or study was conducted, the holder-s name and, if any, the claim made by the holder or notifier for data protection.
From the start of the examination referred to in paragraph 1, the rapporteur Member State may request the notifiers to improve their dossiers, or add to them. --
12 Article 7(3) of Regulation No 3600/92, as amended by Regulation No 1199/97, provides:
-After receiving the summary dossier and the report referred to in paragraph 1, the Commission shall refer the dossier and the report to the Committee for examination.
Before the dossier and report are referred to the Committee, a consultation of experts from the Member States may be organised and the Commission may consult some or all of the notifiers - on the report or parts of the report on the relevant active substance.-
13 Article 7(3A) of Regulation No 3600/92, as added by Regulation No 1199/97, states:
-After the examination referred to in paragraph 3, the Commission shall - present 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;
14 Under Article 7(6) of Regulation No 3600/92, as added by Regulation No 1199/97, -where the Commission presents a draft directive or a draft decision in accordance with paragraph 3A or a draft in accordance with paragraph 5, it shall at the same time present the conclusions of the Committee-s examination in the format of an updated review report to be noted in the summary record of the meeting-.
Background to the dispute
15 On 8 July 1993 the applicant, Vischim Srl, an Italian company producing chlorothalonil, informed the Commission of its wish to secure the inclusion of that active substance in Annex I to Directive 91/414.
16 By Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the rapporteur Member States for the implementation of Regulation No 3600/92 (OJ 1994 L 107, p. 8), the Commission issued a list of the active substances to be assessed in the first stage of the programme of work referred to in Article 8(2) of Directive 91/414. In the case of chlorothalonil, the list indicates 16 notifiers, including the applicant. The deadline for the submission of the dossiers to the rapporteur Member State was set in Article 2 of that regulation, as amended by Commission Regulation (EC) No 2230/95 of 21 September 1995 (OJ 1995 L 225, p. 1).
17 Only two notifiers in respect of chlorothalonil submitted their dossiers within the deadline, namely ISK Biotech...
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