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Nov 30, 2017

Last Thursday, 23 November, the Court of Justice has ruled on the appeals brought by Bionorica and Diapharm in relation to the on-hold status of botanical claims. The latter two started proceedings against the European Commission claiming it failed its obligation to include botanical claims in the Union list of authorized claims.

Summarizing the key facts, the Commission had requested EFSA to suspend the evaluation of botanical claims. However the on-hold situation still applies up until today. For that reason, Bionorica and Diapharm demanded the Commission to proceed with the assessment of botanical claims and to instruct EFSA to proceed with their evaluation. The Commission replied by stating it should be allowed the time and context necessary to identify the best course of action. Following the Commission’s answer, Bionorica and Diapharm sought a declaration by the General Court that the Commission had failed its obligation to act. The General Court argued the Commission’s response was sufficient to end its failure to act. Furthermore, the General Court continued its reasoning by stating that action was inadmissible due to lack of interest by the applicants. It argued the on-hold regime allowing for the provisional use of botanical claims which have not been assessed did not negatively affect the rights of food business operators.

In their appeal before the Court of Justice, Bionorica and Diapharm argued that the letter from the Commission did not constitute a sufficiently defined position because it merely confirmed the ‘on hold’ situation. The ECJ affirmed that the Commission did not define what action it considered necessary to continue with the assessment of the pending claims. Thus, in the view of the Court the letters did not bring an end to the failure to act. Moreover, the Court disagreed with the General Court that the end of the on-hold status of botanical claims would provide no benefit to economic operators. The Court argued that even the rejection of a health claim could procure a benefit in terms of legal certainty.

That said, the failure to act by the Commission has not been established in the Judgement as the case was eventually dismissed due to the lack of legal standing of both parties.

Case C-596/15 P (Bionorica v Commission) of 23 November 2017 (link).

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