Orders nº T-95/09 of Court of First Instance of the European Communities, April 28, 2009

• Resolution Date: April 28, 2009
• Issuing Organization: Court of First Instance of the European Communities
• Decision Number: T-95/09

Application for interim relief – Directive 91/414/EEC – Decision concerning the non-inclusion of napropamide in Annex I to Directive 91/414 – Application for suspension of operation and for interim measures – Prima facie case – Urgency – Balance of interests)

In Case T‑95/09 R,

United Phosphorus Ltd, established in Warrington, Cheshire (United Kingdom), represented by C. Mereu and K. Van Maldegem, lawyers,

applicant,

v

Commission of the European Communities, represented by L. Parpala and N. Rasmussen, acting as Agents, assisted by J. Stuyck, lawyer,

defendant,

APPLICATION, first, for suspension of operation of Commission Decision 2008/902/EC of 7 November 2008 concerning the non-inclusion of napropamide in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (OJ 2008 L 326, p. 35), until delivery of the judgment in the main action, and, second, for interim relief,

THE PRESIDENT OF THE COURT OF FIRST INSTANCEOF THE EUROPEAN COMMUNITIES

makes the following

Order

Background to the dispute

1 The present order for interim relief falls within a complex legal framework laid down by 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; ‘the Directive’), by 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 the Directive (OJ 2000 L 55, p. 25), and 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 the Directive and amending Regulation No 451/2000 (OJ 2002 L 224, p. 23) (for an exposition of the provisions concerned, see the order of the President of 17 December 2007 in Case T‑367/07 R Dow AgroSciences and Others v Commission, not published in the ECR, paragraphs 1 to 8 and 10 to 20).

2 The Directive 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 cannot be marketed in a Member State unless: (i) its active substance has first been evaluated at Community level on the basis of the criteria set out in the Directive and has then been included in Annex I to the Directive; and (ii) the plant protection product containing that active substance has subsequently been registered at national level.

3 In order to make possible a gradual evaluation of all ‘existing’ active substances, that is to say, substances which were already on the European Union market two years after the date of notification of the Directive, that is to say, on 25 July 1993, Article 8(2) of the Directive established a transitional regime during which the Commission was to commence a programme of work for the gradual examination of those active substances. Napropamide, the active substance which is the subject of the present proceedings, was notified and evaluated pursuant to those rules.

4 United Phosphorus Ltd, the applicant in the present case, is active in the development, manufacture and distribution of plant protection products. It is a wholly-owned subsidiary of United Phosphorus Limited (UPL), a company which has its registered office in Mumbai (India). The applicant sells napropamide and formulated products containing napropamide. Upstream, napropamide is manufactured in [confidential] (1) by UPL and transported to [confidential], where it is either used by the applicant in the manufacture of herbicides and sold essentially under the brand names ‘Devrinol’ and ‘Colzamid’ or processed and sold to an agro-industrial group [confidential] for use in the manufacture of a separate herbicide marketed by that group. The applicant sells its herbicides containing napropamide directly to consumers in all the countries of the European Union, with the exception of [confidential]. Napropamide is principally used in pre-emergence weed control in fields of oil seed rape.

5 With regard to the procedure for the assessment of napropamide, Denmark was designated as the Rapporteur Member State to carry out the evaluation on behalf of the Commission. The applicant (‘the notifier’) notified napropamide in May 2003 and submitted its dossiers to the Rapporteur Member State on 27 November 2003, that is to say, within the period laid down by Article 7(1) of Regulation No 1490/2002. A meeting was held in December 2003 to establish whether the dossier was complete and the Rapporteur Member State confirmed that it contained no substantial data gaps.

6 The European Food Safety Authority (EFSA) received the draft assessment report from the Rapporteur Member State on 6 September 2005 for the purposes of a peer review by the Member States and EFSA. On the basis of the available data, the Rapporteur Member State recommended that napropamide be included in Annex I to the Directive.

7 On 26 March 2008 – more than 18 months after the expiry of the period prescribed – EFSA concluded the peer review and submitted to the Commission its ‘conclusion regarding the peer review of the pesticide risk assessment of the active substance napropamide’. In that conclusion EFSA identified a number of matters of concern.

8 On 20 May 2008, the Commission published its final review report on napropamide. By letter of 8 July 2008, the applicant requested the Commission to review its submissions on the existence of safe uses for napropamide. No reply was received to that letter. The conclusions of EFSA were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised, on 11 July 2008, in the format of the Commission review report for napropamide.

9 On 7 November 2008, after receiving observations from the notifier, the Commission, in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, adopted Decision 2008/902/EC concerning the non-inclusion of napropamide in Annex I to the Directive and the withdrawal of authorisations for plant protection products containing that substance (OJ 2008 L 326, p. 35; ‘the contested decision’), the operative part of which reads as follows:

‘Article 1

Napropamide shall not be included as [an] active substance in Annex I to [the Directive].

Article 2

Member States shall ensure that:

(a) authorisations for plant protection products containing napropamide are withdrawn by 7 May 2009;

(b) no authorisations for plant protection products containing napropamide 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 [the Directive] shall be as short as possible and shall expire on 7 May 2010 at the latest.

Article 4

This Decision is addressed to the Member States.’

10 The non-inclusion of napropamide as an active substance in Annex I to the Directive is justified in the contested decision by the fact that, during the evaluation of that active substance, a number of concerns were identified. Thus, the contested decision states that it was not possible, on the basis of the available data, to perform a reliable risk assessment for the leaching of the metabolite NOPA (Naphthyloxypropionic acid) to groundwater. Moreover, the available data did not demonstrate that the risks to aquatic organisms and fish-eating birds and mammals were acceptable. Consequently, it was not possible to conclude, on the basis of the information available, that napropamide met the criteria for inclusion in Annex I to the Directive (recital 5 in the preamble to the contested decision).

11 Notwithstanding the arguments put forward by the notifier, the Commission took the view that there were still matters of concern. It considered 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 napropamide satisfied in general the requirements laid down in the Directive (recital 6 in the preamble to the contested decision).

12 Following the adoption of the contested decision, the applicant, on 16 December 2008, resubmitted an application for assessment of napropamide pursuant to the accelerated procedure set out in Article 13 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of the Directive 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).

Procedure and forms of order sought by the parties

13 By application lodged at the Registry of the Court on 26 February 2009, the applicant brought an action seeking annulment of the contested decision.

14 By a separate document lodged at the Registry of the Court on 9 March 2009, the applicant brought the present application for interim relief, in which, in essence, it requests the President of the Court to:

– suspend the contested decision pursuant to Article 105(2) of the Court’s Rules of Procedure, without prejudice to the applicant’s resubmission of the application for assessment of napropamide pursuant to Regulation No 33/2008;

– in any event, suspend the contested decision, without prejudice to the aforementioned resubmission;

– order the Commission to instruct the Member States immediately to reinstate any authorisations that have been cancelled, withdrawn or refused as a result of the contested decision;

– grant any other interim measures as appropriate;

– order the Commission to pay the costs, including interest at 8%;

– order a hearing to be held.

15 In its...