Orders nº T-31/07 of Court of First Instance of the European Communities, July 19, 2007

• Resolution Date: July 19, 2007
• Issuing Organization: Court of First Instance of the European Communities
• Decision Number: T-31/07

(Applications for interim measures – Application for suspension of operation of a measure – Directive 91/414/EEC – Admissibility – Prima facie case – Urgency – Balance of interests)

In Case T‑31/07 R,

Du Pont de Nemours (France) SAS, established in Puteaux (France),

Du Pont Portugal – Serviços, Sociedada Unipessoal L^da, established in Lisbon (Portugal),

Du Pont Ibérica SL, established in Barcelona (Spain),

Du Pont de Nemours (Belgium) BVBA, established in Mechelen (Belgium),

Du Pont de Nemours Italiana Srl, established in Milan (Italy),

Du Pont De Nemours (Nederland) BV, established in Dordrecht (Netherlands),

Du Pont de Nemours (Deutschland) GmbH, established in Bad Homburg vor der Höhe (Germany),

DuPont CZ s.r.o., established in Prague (Czech Republic),

DuPont Magyarország Kereskedelmi kft, established in Budaors (Hungary),

DuPont Poland sp. z o.o., established in Warsaw (Poland),

DuPont Romania Srl, established in Bucharest (Romania),

DuPont (UK) Ltd, established in Stevenage (United Kingdom),

Dy-Pont Agkro Ellas AE, established in Halandri (Greece),

DuPont International Operations SARL, established in Grand Saconnex (Switzerland),

DuPont Solutions (France) SAS, established in Puteaux,

represented by D. Waelbroeck and N. Rampal, lawyers,

applicants,

v

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

defendant,

APPLICATION for the suspension of certain provisions of Commission Directive 2006/133/EC of 11 December 2006 amending Council Directive 91/414/EEC to include flusilazole as active substance (OJ 2006 L 349, p. 27),

THE PRESIDENT OF THE COURT OF FIRST INSTANCE OF THE

EUROPEAN COMMUNITIES

makes the following

Order

Legal context

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) introduces, inter alia, the Community system for the granting and withdrawal of marketing authorisation for plant protection products.

2 Article 4(1)(a) 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 Active substances which are not included in Annex I to Directive 91/414 may, under certain conditions, enjoy transitional derogating measures. Article 8(2) of Directive 91/414 provides therefore that ‘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’.

4 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) lays down the evaluation procedure for several substances with a view to their possible inclusion in Annex I to Directive 91/414. One of those substances is flusilazole.

5 The procedure introduced by Regulation No 3600/92 begins with a notification of interest, provided for under Article 4(1) of that regulation, sent to the Commission by the producer wishing to secure the inclusion of a substance in Annex I to Directive 91/414.

6 Following the examination of the notifications of interest, Article 5(2)(b) of Regulation No 3600/92 provides that a rapporteur Member State is to be appointed in order to evaluate each of the active substances concerned. In the present case, Ireland was appointed as the rapporteur Member State with regard to flusilazole (‘the rapporteur Member State’), under Commission 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).

7 Once the rapporteur Member State has been appointed, Article 6(1) of Regulation No 3600/92 provides that it is for the notifiers to send to it a ‘summary dossier’ and a ‘complete dossier’, as defined in Article 6(2) and (3).

8 Article 19(1) of Directive 91/414, as amended by Council Regulation (EC) No 806/2003 of 14 April 2003 adapting to Decision 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of its implementing powers laid down in Council instruments adopted in accordance with the consultation procedure (qualified majority) (OJ 2003 L 122, p. 1), provides that the Commission is to be assisted by the Standing Committee on the Food Chain and Animal Health (‘the Committee’).

9 Article 7(3A) of Regulation No 3600/92, inserted by Commission Regulation (EC) No 1199/97 of 27 June 1997 amending Regulation No 3600/92 (OJ 1997 L 170, p. 19) provides that after the examination by the Committee of the summary dossier and the report drawn up by the rapporteur Member State, such examination being provided for in Article 7(3), the Commission is to present to the Committee a draft directive to include the active substance in Annex I to Directive 91/414, a draft decision to withdraw the authorisations of plant protection products containing the active substance in question, a draft decision relating to such a withdrawal, with the option of reconsidering the inclusion of the active substance in Annex I to the directive after submission of the results of additional trials or of additional information, or, finally, a draft decision to postpone inclusion of the active substance pending the submission of the results of additional trials or information.

10 Article 5(1) of Directive 91/414 provides that:

‘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).’

11 Article 5(5) of Directive 91/414 provides that:

‘On request, the inclusion of a substance in Annex I may be renewed once or more for periods not exceeding 10 years; such inclusion may be reviewed at any time if there are indications that the criteria referred to in paragraphs 1 and 2 are no longer satisfied. Renewal shall be granted for the period necessary to complete a review, where an application has been made for such renewal in sufficient time, and in any case not less than two years before the entry is due to lapse, and shall be granted for the period necessary to provide information requested in accordance with Article 6(4).’

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

‘1. 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,

– removal of an active substance from Annex I if it no longer satisfies the requirements of Article 5(1) and (2).’

13 The adoption of a decision or directive in accordance with Article 7(3A) of Regulation No 3600/92 brings the transitional system of derogations provided for in Article 8(2) of Directive 91/414 to an end.

14 Commission Directive 2006/133/EC of 11 December 2006 amending Council Directive 91/414/EEC to include flusilazole as active substance (OJ 2006 L 349, p. 27; ‘the contested directive’), which entered into force on 1 January 2007, amends Annex I of Directive 91/414 to include flusilazole.

15 Article 1 of the contested directive provides:

‘Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.’

16 Part A of the specific provisions in the Annex to the contested directive provides as follows:

‘Only uses as fungicide on the following crops may be authorised:

– cereals other than rice,

– maize,

– rape seed,

– sugar beet,

at rates not exceeding 200 g active substance per hectare per application.

The following uses must not be authorised:

– air application,

– knapsack and hand-held applications, neither by amateur nor by professional users,

– home gardening.

– Member States shall ensure that all appropriate risk mitigation measures are applied. …’

17 Article 2 of the contested directive provides that:

‘Member States shall adopt and publish by 30 June 2007 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

They shall apply those provisions from 1 July 2007.

…’

18 Article 3 of the contested directive provides that:

‘1. Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing flusilazole as an active substance by 30 June 2007. By that date they shall in particular verify that the conditions in Annex I to that Directive relating to flusilazole are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that directive in accordance with the conditions of Article 13.

2. By derogation...