Judgments nº T-380/06 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
• Decision Number: T-380/06

In Case T-380/06,

Vischim Srl, established in Cesano Maderno (Italy), represented by C. Mereu and K. Van Maldegem, lawyers,

applicant,

v

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

defendant,

APPLICATION for the annulment of the second paragraph of Article 2 of Commission Directive 2006/76/EC of 22 September 2006 amending Council Directive 91/414/EEC as regards the specification of the active substance chlorothalonil (OJ 2006 L 263, p. 9),

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

Judgment

Legal context

Directive 91/414/EEC

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 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,

- amendments to Annex I, where necessary,

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5 The first subparagraph of Article 8(2) of Directive 91/414 provides that, -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-.

6 The second subparagraph of Article 8(2) of Directive 91/414 states that within the same 12-year period the Commission is to commence a programme of work for the gradual examination of those active substances.

7 According to the fourth subparagraph of Article 8(2), -during [that] period - 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-. This provision adds that -the Member States shall ensure that the relevant authorisations are granted, withdrawn or varied, as appropriate, within a prescribed period-.

8 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 is to be assisted by a regulatory committee, the Standing Committee on the Food Chain and Animal Health (-the Committee-).

9 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

10 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 active substances, including chlorothalonil, with a view to their possible inclusion in Annex I to that directive.

11 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-.

12 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), governs the manner in which the dossiers submitted by notifiers are examined.

13 The fourth subparagraph of Article 8(3) of Regulation No 3600/92, as amended, states:

-After the examination - 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;

--

Background to the dispute

Inclusion of chlorothalonil in Annex I to Directive 91/414

14 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.

15 Only two notifiers in respect of chlorothalonil submitted their dossiers within the deadline, namely ISK Biotech Europe (which was replaced in the course of the assessment procedure by Zeneca Agrochemicals, which in turn became Syngenta) and the applicant.

16 On 16 September 2005, after those dossiers had been examined, the Commission adopted Directive 2005/53/EC amending Directive 91/414 to include chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl as active substances (OJ 2005 L 241, p. 51).

17 By virtue of Article 1 of Directive 2005/53 and the annex thereto, chlorothalonil was included under No 102 in the table in Annex I to Directive 91/414. The fourth column of that table, headed -Purity-, states: -Hexachlorobenzene: not more than 0.01g/kg-.

18 It is apparent from the review report for chlorothalonil (document SANCO/4343/2000 final of 14 February 2005; -the review report-) that that condition relating to the maximum content of hexachlorobenzene (HCB) was laid down having regard to the specification for chlorothalonil adopted by the FAO (Food and Agriculture Organisation of the United Nations) in February 2005.

19 Under Article 3(1) of Directive 2005/53, the Member States were obliged, where necessary, to amend or withdraw existing authorisations for plant protection products containing chlorothalonil by 31 August 2006, verifying whether the conditions in Annex I to Directive 91/414 were met and whether the holder of the authorisation had, or had access to, a dossier satisfying the requirements of Annex II to Directive 91/414 in accordance with the conditions of Article 13 of that directive.

20 Directive 2005/53 entered into force on 1 March 2006. Under the first and second paragraphs of Article 2, the Member States had to adopt and publish the provisions necessary in order to comply with Directive 2005/53 by 31 August 2006 at the latest, and to apply them from 1 September 2006.

21 On 25 November 2005, the applicant brought an action for, inter alia, the annulment of Directive 2005/53 (Case T-420/05).

22 In the context of that action, the applicant made two successive applications for interim measures, which were dismissed by orders of the President of the Court of First Instance of 4 April 2006 in Case T-420/05 R Vischim v Commission, not published in the ECR, and of 13 October 2006 in Case T-420/05 R II Vischim v Commission [2006] ECR II-4085, the latter order being upheld by order of the President of the Court of Justice of 3 April 2007 in Case C-459/06 P(R) Vischim v Commission, not published in the ECR.

Amendment of the entry in Annex I to Directive 91/414

23 In December 2005, the FAO published, on the basis of the information submitted by the applicant, a new specification for chlorothalonil increasing the maximum HCB content to 0.04g/kg.

24 The applicant informed the Commission of that new specification by letter of 16 December 2005.

25 In March 2006, the Commission asked the rapporteur Member State to evaluate the various versions of chlorothalonil conforming to the new FAO specification, including the applicant-s product.

26 Simultaneously, the Commission staff sent the Member States an email in the following terms:

--[The rapporteur Member State] has undertaken to examine the equivalence of the different sources (including Vischim-s). If the conclusion is that these are as safe as the reference source, the Commission would consider amending [Directive 91/414] as regards the purity levels for HCB. In...