ORDER OF THE PRESIDENT OF THE GENERAL COURT
25 November 2010 (*)
(Application for interim measures – Directive 91/414/EEC – Decision concerning the non‑inclusion of napropamide in Annex I to Directive 91/414 – Extension of suspension of operation)
In Case T‑95/09 R III,
United Phosphorus Ltd, established in Warrington, Cheshire (United Kingdom), represented by C. Mereu and K. Van Maldegem, lawyers,
applicant,
v
European Commission, represented by L. Parpala and F. Wilman, acting as Agents,
defendant,
APPLICATION for the extension of the 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),
THE PRESIDENT OF THE GENERAL COURT
makes the following
Order
Facts, procedure and forms of order sought by the parties
1 By order of 28 April 2009 in Case T‑95/09 R United Phosphorus v Commission, not published in the ECR (‘the order of 28 April 2009’), the President of the Court granted the application for interim relief brought by the applicant, United Phosphorus Ltd, and ordered the suspension of operation, until 7 May 2010, 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, ‘the contested decision’). In the order of 28 April 2009, the parties were required to lodge observations on the course of the accelerated procedure instituted, in regard to napropamide, pursuant to Article 13 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414 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, ‘the accelerated assessment procedure’).
2 By document lodged at the Registry of the Court on 15 December 2009, the applicant applied for the suspension of operation to be extended ‘until November 2010, or at the earliest the date of entry into force of the ... Directive [establishing the inclusion of napropamide]’. The European Commission opposed that application, while requesting that, should the President of the Court grant the application, the suspension of operation should immediately cease in the case that the accelerated assessment procedure results in a negative decision for the applicant.
3 By order of 15 January 2010 in Case T‑95/09 R II United Phosphorus v Commission, not published in the ECR (‘the order of 15 January 2010’), the President of the Court granted an extension until 30 November 2010 of the suspension of operation laid down by the order of 28 April 2009, stating, however, that that suspension of operation was not to extend beyond the date of the formal conclusion of the accelerated assessment procedure.
4 By document lodged at the Registry of the Court on 2 November 2010, the applicant applied, pursuant to Article 108 of the Rules of Procedure of the General Court, for a further extension of the suspension of operation referred to above.
5 In support of its application, the applicant submits that the accelerated assessment procedure has been successful, since the Commission has embarked on the process of adopting a directive to include napropamide in Annex I to Directive 91/414. As is apparent from the draft directive (annexed to the application), the new directive is to enter into force on 1 January 2011, and the Member States will be required to transpose its provisions into national law by 30 June 2011. According to the applicant, should the suspension of operation referred to above not be extended beyond 30 November 2010, the contested decision would enter into force on 1 December 2010 and the Member States would be required to withdraw the authorisations for plant protection products containing napropamide before the new directive relating to its inclusion takes effect. According to the applicant, a further extension of the suspension of operation is therefore justified by the need to maintain its plant protection product authorisations in place pending full implementation of the new directive, in order to avoid any gap in the marketing of those products.
6 The applicant states that, unless such an extension is granted, it will have to reapply to the national authorities for authorisation for its plant protection products containing napropamide and submit new information on those products. The assessment of new data and the granting of new authorisations by the Member States could take more than a year to complete and, in the meantime, the applicant’s products containing napropamide will have been withdrawn from the market.
7 Accordingly, the applicant requests the President of the General Court to extend the suspension of operation of the contested decision until the applicant is granted new product authorisations under the new directive, or until the date of delivery of the decision in the main proceedings, if earlier, and to adopt any other measure required to preserve the effet utile of the orders of 28 April 2009 and 15 January 2010 granting and extending interim relief.
8 In its written observations lodged at the Registry of the Court on 11 November 2010, the Commission confirms that it is about to adopt a directive which provides for napropamide to be included in Annex I to Directive 91/414 and which is to enter into force on 1 January 2011, but contends that the present application should be dismissed. Should the application nevertheless be granted, the Commission takes the view that the duration of the additional period of suspension of operation should be clearly defined and as limited as possible, and that it should not depend on unilateral action by the applicant.
9 According to the Commission, the present application concerns not only the conclusion of the accelerated assessment procedure at European Union level but also the completion of many national procedures necessary in order to obtain authorisations for plant protection products containing napropamide. However, where the Commission has adopted a directive providing for the inclusion of an active substance in Annex I to Directive 91/414, it has no legal influence on the Member States as regards whether or not they should grant new authorisations for plant protection products containing that substance. The present application does not seek, therefore, merely to extend the period of suspension of operation already granted, but appears to be an entirely new request for interim measures.
10 The Commission states that if the present application were to be granted, the applicant would have the power to decide whether and when a European Union act becomes applicable. National authorisation procedures are commenced only at the applicant’s initiative. Consequently, if the applicant were to decide not to seek such authorisations, the suspension of operation requested would have a quasi-permanent effect, because the existing national authorisations would continue to be applicable. The Commission is therefore of the view that the date on which such interim measures are to lapse cannot depend on a series of vaguely described unilateral acts to be undertaken by the applicant.
Law
11 In the order of 28 April 2009 (paragraph 31), the President of the Court found that a prima facie case existed on the ground that the questions raised in the main action call for detailed examination, which must be the subject of the proceedings in the main action. That assessment is not called into question either by the applicant’s application of 2 November 2010 or by the Commission’s observations of 11 November 2010.
12 In addition, the President of the Court examined the condition of urgency (order of 28 April 2009, paragraphs 67 to 82) with regard to the specific circumstances of the present case. In that context, he considered to be conclusive the fact that, following the adoption of the contested decision, the applicant had instituted the accelerated assessment procedure – in the framework of which its chances of success appeared to be greater than they had been in the framework of the proceedings resulting in the contested decision – and that that accelerated assessment procedure was liable to be concluded only a few months after the date prescribed for the withdrawal from the market of products containing napropamide. He thus concluded that it would be unreasonable to allow the prohibition of the marketing of a substance in respect of which it was not improbable that its marketing would be authorised only a few months later.
13 It was stated, in paragraphs 83 to 87 of the order of 28 April 2009, that that conclusion was supported, on a balance of interests, by the finding that the Commission did not itself see any particular reason why napropamide should be withdrawn from the market as quickly as possible and by the circumstance that the contested decision provided for a period of 13 months for the sale of existing stocks, which indicated that the use of napropamide was hardly such as to involve serious risks to public health.
14 As regards the present application for a further extension, beyond 30 November 2010, of the suspension of operation of the contested decision, it is common ground that a Commission directive which is to enter into force on 1 January 2011 will amend Directive 91/414 so as to include napropamide in Annex I because the concerns that led to the non-inclusion of napropamide in accordance with the contested decision have been eliminated and no other scientific questions have arisen (recital 9 in the preamble to the future directive). It is apparent, therefore, that only eight months after the expiry of the period of grace granted under Article 3 of the contested decision to allow for the sale of existing stocks of products containing napropamide, that is 7 May 2010, the marketing of that active substance will be reauthorised.
15 It would be unreasonable to allow the prohibition from 1 December 2010 of the marketing of that substance when it is common ground that its marketing will be authorised from 1 January 2011. Therefore, the suspension of operation of the contested decision should be extended until 1 January 2011 in so far as the contested decision provides, under Article 1, that napropamide is not to be included as an active substance in Annex I to Directive 91/414.
16 With regard to plant protection products containing napropamide, it must be recalled, on the one hand, that Articles 2 and 3 of the contested decision required the Member States to withdraw authorisations for such products, while providing for the period of grace referred to in paragraph 14 above, and, on the other hand, that the orders of 28 April 2009 and 15 January 2010 suspended the operation of that withdrawal of authorisations for those products. In that context, the applicant stated, without being contradicted by the Commission, that even after the entry into force of the new directive concerning authorisation for napropamide, it will have to reapply to the national authorities for authorisation for its plant protection products containing that active substance, and that, before such authorisations are granted, the products in question will in any event have to be withdrawn from the market.
17 It must be noted that the new directive will effectively make authorisation of napropamide subject to certain conditions, namely the submission of certain further information, before the national authorities can authorise a plant protection product containing napropamide (recital 8 in the preamble to the future directive). Although the legality and effects of those conditions are not at issue in the present proceedings, it must be observed that the new directive will not contain any provision repealing the contested decision, with the result that that decision will order the withdrawal of product authorisations currently held by the applicant unless the suspension of operation already granted is extended. Furthermore, no account is taken in the new directive of the suspension of operation granted by the orders of 28 April 2009 or 15 January 2010 in order to prevent a gap in the marketing of the applicant’s plant protection products containing napropamide, by providing for a reasonable transitional period between the contested decision and implementation of the new directive.
18 In those circumstances, the suspension of operation granted by the orders of 28 April 2009 and 15 January 2010 should be extended beyond 1 January 2011 so far as concerns the withdrawal of authorisations for plant protection products containing napropamide, authorisations which the applicant currently holds. While such a measure in no way prejudges the decision as to the lawfulness of the contested decision, it takes into account the innocuousness of napropamide revealed following the accelerated assessment procedure.
19 That outcome is not affected by the fact that, in paragraph 88 of the order of 28 April 2009, the date on which the suspension of operation of the contested decision was to end was expressly linked to the conclusion of the accelerated assessment procedure or that, in paragraph 14 of the order of 15 January 2010, it was decided that any extension of that suspension of operation had imperatively to cease at the date of the formal conclusion of that procedure. Besides the fact that it is open to the President of the General Court in the context of a further application to amend, on the basis of new matters of fact and of law presented to him, the interim measures previously ordered, it is important to clarify that those restrictions on the suspension of operation granted were essentially determined by the prospect of a negative outcome for the applicant of the accelerated assessment procedure, as is apparent from paragraph 14 of the order of 15 January 2010 which provides for the suspension of operation to cease at the date of the formal conclusion of that procedure ‘regardless of the legal remedies to which the applicant may have recourse should the accelerated assessment procedure result in the non-inclusion of napropamide in Annex I to Directive 91/414’. Furthermore, when issuing the orders of 28 April 2009 and 15 January 2010, the President of the General Court was necessarily unaware of the precise content of the future directive authorising napropamide and could not, therefore, prejudge the detailed arrangements for authorisation that he would potentially have to take into consideration for the purpose or adjusting his interim measures.
20 As regards the length of the extension of the suspension of operation of the contested decision, it must be recalled that the applicant stated, without being contradicted by the Commission, that the national assessment procedures necessary, after the entry into force of the new directive, in order to obtain authorisations for plant protection products containing napropamide could take more than a year and that, in the meantime, those products would have to be withdrawn from the market unless an extension of the suspension of operation had already been granted. In those circumstances, it is appropriate to extend until 31 December 2011 the suspension of operation laid down in paragraph 1 of the operative part of the order of 28 April 2009. Moreover, that date corresponds to that laid down, in a comparable case, by Commission Regulation (EU) No 741/2010 of 17 August 2010 amending Regulations (EC) No 1490/2002 and (EC) No 2229/2004 as regards the date until which authorisations may continue to be in force in cases where the notifier has submitted an application in accordance with the accelerated procedure under Regulation (EC) No 33/2008 (OJ 2010 L 217, p. 2) (see recitals 2 and 4 in the preamble to Regulation No 741/2010).
On those grounds,
THE PRESIDENT OF THE GENERAL COURT
hereby orders:
1. The suspension of operation granted in paragraph 1 of the operative part of the order of the President of the Court of 28 April 2009 in Case T‑95/09 R United Phosphorus v Commission (not published in the ECR) is extended until 31 December 2011 or until the date of adoption of the decision in the main proceedings at the latest, if that decision is adopted earlier.
2. The costs shall be reserved.
Luxembourg, 25 November 2010.