Case T-429/13: Action brought on 19 August 2013 — Bayer CropScience v Commission
Date: 2013-08-19
Institutions: General Court
Subjects: market approval, pharmaceutical industry, plant health product, seed, withdrawal from the market








C_2013325EN.01003701.xml










9.11.2013   


EN


Official Journal of the European Union


C 325/37





Action brought on 19 August 2013 — Bayer CropScience v Commission
(Case T-429/13)
2013/C 325/62
Language of the case: English

Parties


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

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:






—


Declare its application admissible;










—


Annul Commission’s 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 L 139, 25.5.2013, p.12); and










—


Order the Commission to pay the Applicant’s costs.





Pleas in law and main arguments

In support of the action, the applicant relies on six pleas in law.






1.


First plea in law, alleging that by adopting the Contested Measure, the Commission exceeded the powers granted to it under Regulation 1107/2009 (1) (the ‘Enabling Regulation’), and that the Contested Measure therefore lacks a proper legal basis, because:






—


the Commission breached Article 21 of the Enabling Regulation by: (i) failing to take into account monitoring data showing that the active substances in question did not pose unacceptable risks to bees; and (ii) concluding, erroneously, that there existed new and relevant scientific information such as to give the Commission competence to act; and










—


the Commission breached Article 49 of the Enabling Regulation by banning the sale of seeds treated with the active substances in question without establishing ‘substantial concerns’ that the treated seeds are ‘likely to constitute a serious risk to human or animal health or to the environment’ that ‘cannot be contained satisfactorily’ through other measures.














2.


Second plea in law, alleging that the Contested Measure was adopted in a manner that breached Article 12(2) and Annex II point 3.8.3. of the Enabling Regulation, and denied the Applicant’s legitimate expectations, because:






—


the Enabling Regulation mandated that, and the Applicant had legitimate expectations that, existing and applicable guidance would be used in the conduct of the risk assessments that gave rise to the Contested Measure, but that existing and applicable guidance was ignored in favour of a scientific opinion that did not constitute guidance and a draft guidance document that was neither available nor agreed.














3.


Third plea in law, alleging that the Commission’s application of the Enabling Regulation in adopting the Contested Measure constituted a breach of the Applicant’s fundamental rights to property and to conduct its business, because:






—


the decisions to remove (and amend) approvals for the Applicant’s products were based on an unlawful application of the Enabling Regulation that failed adequately to take into account the long history of safe use of the active substances in question or the value and significance of the Applicant’s intellectual property in, and long-term investments in, the active substances.














4.


Fourth plea in law, alleging that the Contested Measure was adopted following a procedure that failed to respect the Applicant’s right to be heard, because:






—


the conduct of the relevant risk assessments on the basis of a scientific opinion and a draft guidance document (as opposed to the existing and applicable guidance) automatically led to the identification of ‘data gaps’ that the Applicant had never had the opportunity to address.














5.


Fifth plea in law, alleging that the adoption of the Contested Measure breaches the principle of proportionality, because:






—


in a number of areas (including in its restrictions on foliar, amateur and indoor uses of the Applicant’s products), the Contested Measure goes beyond what is appropriate to the achievement of its legitimate objectives and may even undermine them, and the Commission failed to consider less restrictive options for regulation that were available to it.














6.


Sixth plea in law, alleging that that the adoption of the Contested Measure breaches the precautionary principle, because:






—


inter alia, it involved the Commission, as risk manager, taking a purely hypothetical approach to risk, which was founded on mere conjecture and which was not scientifically verified (a result, in large part of the risk assessments not constituting a thorough scientific assessment), and it involved the Commission refusing to conduct any analysis of the potential benefits and costs of its actions.










(1)  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/EEC