Action brought on 14 September 2012 - Xeda International and Others v Commission

(Case T-415/12)

Language of the case: English

Parties

Applicants: Xeda International SA (Saint-Andiol, France); Pace International LLC (Washington, United States); and Decco Iberica Post Cosecha, SAU (Paterna, Spain) (represented by: C. Mereu and K. Van Maldegem, lawyers)

Defendant: European Commission

Form of order sought

Declare the application admissible and well-founded ;

Annul Commission Implementing Regulation (EU) No 578/2012²; and

Order the defendant to pay the costs of the proceedings.

Pleas in law and main arguments

In support of the action, the applicants rely on three pleas in law.

First plea in law, alleging that the contested act is unlawful for manifest errors of appraisal. The Commission has erred as a matter of law in justifying the contested act on the grounds of hypothetical concerns: (i) the three unidentified metabolites and (ii) processed commodities. In relation to these concerns, the Commission also erred in law by asking the applicants for probatio diabolica, namely by asking for the identity of the unidentified metabolites in stored apples whereas this was technically impossible, and by asking the applicants to demonstrate an absence of risk in relation to low risk compounds found below the Limit of Quantification (LOQ) in processed commodities.

Second plea in law, alleging that the contested act is unlawful for violations of due process and right of defence. The contested act is based on a report from the European Food Safety Authority ("EFSA") which introduced a new requirement - the submission of a fully validated analytical method - at a very late stage of the evaluation procedure. The applicants submitted the requested data to the Rapporteur, who in turn evaluated it and prepared a conclusion whereby the data were sufficient to address the issue raised by EFSA. However, the Commission disregarded the new data. Moreover, the applicants were not given an opportunity to address the issue due to the Commission's misunderstanding of Commission Regulation (EC) No 33/2008 concerning the submission of new data.

Third plea in law, alleging that the contested act is unlawful because it is disproportionate. Even if it were accepted that the new studies could not be taken into consideration, the Commission could have adopted an inclusion decision with less restrictive measures, such as making it subject to confirmatory data.

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¹ - Commission Implementing Regulation (EU) No 578/2012 of 29 June 2012 concerning the non approval of the active substance diphenylamine, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ 2012 L 171, p. 2)

² - Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC 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 into its Annex I (OJ 2008 L 15, p. 5)