17.11.2012   

EN

Official Journal of the European Union

C 355/34

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Declare the application admissible and well-founded;

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Annul Commission Implementing Regulation (EU) No 578/2012 (1); and

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Order the defendant to pay the costs of the proceedings.

1.

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.

2.

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 (2) concerning the submission of new data.

3.

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.