Judgments nº T-429/13 of Tribunal General de la Unión Europea, May 17, 2018

• Resolution Date: May 17, 2018
• Issuing Organization: Tribunal General de la Unión Europea
• Decision Number: T-429/13

(Plant protection products - Active substances clothianidin, thiamethoxam and imidacloprid - Review of approval - Article 21 of Regulation (EC) No 1107/2009 - Prohibition of the use and sale of seeds treated with plant protection products containing the active substances in question - Article 49(2) of Regulation No 1107/2009 - Precautionary principle - Proportionality - Right to be heard - Non-contractual liability)

In Cases T-429/13 and T-451/13,

Bayer CropScience AG, established in Monheim am Rhein (Germany), represented by K. Nordlander, lawyer, and P. Harrison, Solicitor,

applicant in Case T-429/13,

Syngenta Crop Protection AG, established in Basel (Switzerland), and the other applicants whose names appear in the annex, (1) represented initially by D. Waelbroek, I. Antypas, lawyers, and D. Slater, Solicitor, and subsequently by D. Waelbroek and I. Antypas,

applicants in Case T-451/13,

supported by

Association générale des producteurs de maïs et autres céréales cultivées de la sous-famille des panicoïdées (AGPM), established in Montardon (France), represented by L. Verdier and B. Trouvé, lawyers,

by

The National Farmers’ Union (NFU), established in Stoneleigh (United Kingdom), represented by H. Mercer QC, and N. Winter, Solicitor,

by

Association européenne pour la protection des cultures (ECPA), established in Brussels (Belgium), represented by D. Abrahams, Barrister, I. de Seze and É. Mullier, lawyers,

by

Rapool-Ring GmbH Qualitätsraps deutscher Züchter, established in Isernhagen (Germany), represented initially by C. Stallberg and U. Reese, and subsequently by U. Reese and J. Szemjonneck, lawyers,

by

European Seed Association (ESA), established in Brussels, represented initially by P. de Jong, P. Vlaemminck and B. Van Vooren, and subsequently by P. de Jong, K. Claeyé and E. Bertolotto, lawyers,

and by

Agricultural Industries Confederation Ltd, established in Peterborough (United Kingdom), represented initially by P. de Jong, P. Vlaemminck and B. Van Vooren, and subsequently by P. de Jong, K. Claeyé and E. Bertolotto, lawyers,

interveners in Cases T-429/13 and T-451/13,

v

European Commission, represented by P. Ondrůšek and G. von Rintelen, acting as Agents,

defendant in Cases T-429/13 and T-451/13,

supported by

Kingdom of Sweden, represented by A. Falk, C. Meyer-Seitz, U. Persson, E. Karlsson, L. Swedenborg and C. Hagerman, acting as Agents,

by

Union nationale de l’apiculture française (UNAF), established in Paris (France), represented, in Case T-429/13, by B. Fau and J.-F. Funke, lawyers, and, in Case T-451/13, by B. Fau,

by

Deutscher Berufs- und Erwerbsimkerbund eV, established in Soltau (Germany),

and

Österreichischer Erwerbsimkerbund, established in Grof‌lebersdorf (Austria),

represented by A. Willand and B. Tschida, lawyers,

by

Pesticide Action Network Europe (PAN Europe), established in Brussels,

Bee Life European Beekeeping Coordination (Bee Life), established in Louvain-la-Neuve (Belgium),

and

Buglife - The Invertebrate Conservation Trust, established in Peterborough,

represented by B. Kloostra, lawyer,

and by

Stichting Greenpeace Council, established in Amsterdam (Netherlands), represented by B. Kloostra,

interveners in Cases T-429/13 and T-451/13,

APPLICATION (i) pursuant to Article 263 TFEU for annulment of Commission Implementing Regulation (EU) No 485/2013 of 24 May 2013 amending Implementing Regulation (EU) No 540/2011, as regards the conditions of approval of the active substances clothianidin, thiamethoxam and imidacloprid, and prohibiting the use and sale of seeds treated with plant protection products containing those active substances (OJ 2013 L 139, p. 12), and (ii) in Case T-451/13, pursuant to Article 268 TFEU for compensation for the damage which the applicants claim to have suffered,

THE GENERAL COURT (First Chamber, Extended Composition)

composed of H. Kanninen, President, I. Pelikánová (Rapporteur), E. Buttigieg, S. Gervasoni and L. Calvo-Sotelo Ibáñez-Martín, Judges,

Registrar: S. Spyropoulos, Administrator,

having regard to the written part of the procedure and further to the hearings on 15 and 16 February 2017,

gives the following

Judgment

1. Legal Framework

   1. Directive 91/414/EEC

      1 Before 14 June 2011, the placing of plant protection products on the market was governed 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).

      2 Article 4(1) of Directive 91/414 provided that a plant protection product could not be authorised by a Member State unless, inter alia, its active substances were listed in Annex I to the directive.

      3 Article 5(1) of Directive 91/414 stated, in particular:

      ‘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.

      ...’

   2. Regulation (EC) No 1107/2009

      4 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414 (OJ 2009 L 309, p. 1) entered into force on 14 June 2011. It was adopted on the basis of Article 37(2) EC (now, after amendment, Article 43(1) TFEU) concerning the common agricultural policy, Article 95 EC (now Article 114 TFEU) concerning the approximation of laws which have as their object the internal market, in relation, notably, to the environment, and Article 152(4)(b) EC (now, after amendment, Article 168(4)(b) TFEU) concerning public health.

      5 Under Article 28(1) of Regulation No 1107/2009, a plant protection product is not to be placed on the market or used unless it has been authorised in the Member State concerned in accordance with that regulation.

      6 In accordance with Article 29(1)(a) of Regulation No 1107/2009, authorisation of a plant protection product by a Member State presupposes, inter alia, that its active substances have been approved at EU level.

      7 Article 4 of Regulation No 1107/2009, entitled ‘Approval criteria for active substances’, sets out, in particular, the following criteria:

      ‘1. An active substance shall be approved in accordance with Annex II if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance meet the requirements provided for in paragraphs 2 and 3.

      The assessment of the active substance shall first establish whether the approval criteria set out in points 3.6.2 to 3.6.4 and 3.7 of Annex II are satisfied. If these criteria are satisfied the assessment shall continue to establish whether the other approval criteria set out in points 2 and 3 of Annex II are satisfied.

      2. The residues of the plant protection products, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, shall meet the following requirements:

         (a) they shall not have any harmful effects on human health, including that of vulnerable groups, or animal health, taking into account known cumulative and synergistic effects where the scientific methods accepted by the [European Food Safety Authority (EFSA)] to assess such effects are available, or on groundwater;

         (b) they shall not have any unacceptable effect on the environment.

         For residues which are of toxicological, ecotoxicological, environmental or drinking water relevance, there shall be methods in general use for measuring them. Analytical standards shall be commonly available.

      3. A plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, shall meet the following requirements:

         (a) it shall be sufficiently effective;

         (b) it shall have no immediate or delayed harmful effect on human health, including that of vulnerable groups, or animal health, directly or through drinking water (taking into account substances resulting from water treatment), food, feed or air, or consequences in the workplace or through other indirect effects, taking into account known cumulative and synergistic effects where the scientific methods accepted by [EFSA] to assess such effects are available; or on groundwater;

         (c) it shall not have any unacceptable effects on plants or plant products;

         (d) it shall not cause unnecessary suffering and pain to vertebrates to be controlled;

         (e) it shall have no unacceptable effects on the environment, having particular regard to the following considerations where the scientific methods accepted by [EFSA] to assess such effects are available:

         (i) its fate and distribution in the environment, particularly contamination of surface waters, including estuarine and coastal waters, groundwater, air and soil taking into account locations distant from its use...