Judgments nº T-75/06 of Court of First Instance of the European Communities, September 09, 2008

• Resolution Date: September 09, 2008
• Issuing Organization: Court of First Instance of the European Communities
• Decision Number: T-75/06

In Case T-75/06,

Bayer CropScience AG, established in Monheim am Rhein (Germany),

Makhteshim-Agan Holding BV, established in Rotterdam (Netherlands),

Alfa Georgika Efodia AEVE, established in Athens (Greece),

Aragonesas Agro, SA, established in Madrid (Spain),

represented by C. Mereu and K. Van Maldegem, lawyers,

applicants,

supported by

European Crop Protection Association (ECPA), established in Brussels (Belgium), represented by D. Waelbroeck and N. Rampal, lawyers,

intervener,

v

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

defendant,

supported by

Kingdom of Spain, represented by J. Rodríguez Cárcamo, abogado del Estado,

intervener,

APPLICATION for the annulment of Commission Decision 2005/864/EC of 2 December 2005 concerning the non-inclusion of Endosulfan in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that active substance (OJ 2005 L 317, p. 25),

THE COURT OF FIRST INSTANCE OF THE EUROPEAN COMMUNITIES (Fourth Chamber),

composed of O. Czúcz (Rapporteur), President, J.D. Cooke and I. Labucka, Judges,

Registrar: C. Kristensen, Administrator,

having regard to the written procedure and further to the hearing on 12 February 2008,

gives the following

Judgment

Legal context

Treaty provisions

1 Article 95(3) EC provides that, in its proposals to the Council for measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market and which concern health, safety, environmental protection and consumer protection, the Commission is to take as a base a high level of protection, taking account in particular of any new development based on scientific facts.

2 Article 152(1) EC states that a high level of human health protection is to be ensured in the definition and implementation of all Community policies and activities.

Directive 91/414/EEC

3 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) lays down the Community rules applicable to the granting of authorisation to place plant protection products on the market and to the withdrawal of such authorisation.

4 Article 4 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 --.

5 The conditions for the inclusion of active substances in Annex I are specified in Article 5 of Directive 91/414:

-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).

2. For inclusion of an active substance in Annex I, the following shall be taken into particular account:

   (a) where relevant, an acceptable daily intake (ADI) for man;

   (b) an acceptable operator exposure level if necessary;

   (c) where relevant, an estimate of its fate and distribution in the environment as well as its impact on non-target species.

   --

   6 Article 6 of Directive 91/414 provides:

   -1. Inclusion of an active substance in Annex I shall be decided in accordance with the procedure laid down in Article 19.

   -

2. A Member State receiving an application for the inclusion of an active substance in Annex I shall without undue delay ensure that a dossier which is believed to satisfy the requirements of Annex II is forwarded by the applicant to the other Member States and to the Commission together with a dossier complying with Annex III on at least one preparation containing that active substance. The Commission shall refer the dossier to the Standing Committee on Plant Health referred to in Article 19 for examination.

3. Without prejudice to the provisions of paragraph 4, at the request of a Member State, and within three to six months after the date of referral to the committee mentioned in Article 19, it shall be established by the procedure laid down in Article 20 whether the dossier has been submitted in accordance with the requirements of Annexes II and III.

4. If the assessment of the dossier referred to in paragraph 2 shows that further information is necessary, the Commission may ask the applicant to submit such information. The applicant or his authorised representative may be asked by the Commission to submit his remarks to it, in particular whenever an unfavourable decision is envisaged.

   --

   7 Active substances which are not listed in Annex I to Directive 91/414 may, in certain circumstances, benefit from transitional arrangements permitting derogation. Thus, Article 8(2) of Directive 91/414 provides 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-. That 12-year period, which expired on 26 July 2003, was extended for certain substances by Commission Regulation (EC) No 2076/2002 of 20 November 2002 extending the time period referred to in Article 8(2) of Directive 91/414 and concerning the non-inclusion of certain active substances in Annex I to the directive and the withdrawal of authorisations for plant protection products containing these substances (OJ 2002 L 319, p. 3), as amended by Commission Regulation (EC) No 1335/2005 of 12 August 2005 which also amended Decisions 2002/928/EC, 2004/129/EC, 2004/140/EC, 2004/247/EC and 2005/303/EC as regards the time period referred to in Article 8(2) of Council Directive 91/414 and the continued use of certain substances not included in its Annex I (OJ 2005 L 211, p. 6). Under Regulation No 1335/2005, the 12-year period was extended until 31 December 2006, -unless a decision has been taken or is taken before the relevant date to include or not include the active substance concerned in Annex I to Directive 91/414/EEC-.

   8 Article 8(2) of Directive 91/414 provides that, during that transitional period, each active substance concerned must undergo a programme for its examination (or -review-), on conclusion of which it may be decided that the substance can be included in Annex I, or, if the substance does not satisfy the safety requirements laid down in Article 5 of Directive 91/414 or if the requisite information and data have not been submitted within the prescribed period, that the active substance will not be included. It is also stated that the examination of the active substance is to be carried out in accordance with the procedure referred to in Article 19 of Directive 91/414. That article, 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 a regulatory committee, the Standing Committee on the Food Chain and Animal Health (-the Committee-).

   Regulation (EEC) No 3600/92

   9 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 92/414 (OJ 1992 L 366, p. 10) regulates 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 endosulfan.

   10 The procedure established by Regulation No 3600/92 begins with a notification of interest, as provided for in Article 4(1) of that regulation, under which -[a]ny producer wishing to secure the inclusion of an active substance referred to in Annex I hereto, or any salts, esters or amines thereof, 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-.

   11 Article 5(2)(b) of Regulation No 3600/92 provides that, following the examination of the notifications of interest, a rapporteur Member State is to be designated for the assessment of each of the active substances concerned.

   12 Once the rapporteur Member State has been designated, it is the responsibility of each notifier to send to that Member State, in accordance with Article 6(1) of Regulation No 3600/92, a -summary dossier- and a -complete dossier-, as defined in paragraphs 2 and 3, respectively, of Article 6 of that regulation. The summary dossier must include, in particular, a copy of the notification; the recommended conditions for the use of the active substance; and summaries and results of trials for each point of Annex III to Directive 91/414 relevant to the assessment of the criteria referred to in Article 5 of that directive. That information must relate to one or more preparations which are representative for the recommended conditions of use in relation to the inclusion of the active substance in Annex I to the directive. The complete dossier must contain the protocols and the...