Xeda lost case seeking to annul EU’s withdrawal decision on ethoxyquin

Xeda International SA, a French company who offers the most complete and innovative range of post-harvest chemicals, has recently lost a court case expecting to annul a Decision made by European Commission in 2011 concerning the non-inclusion of fungicide ethoxyquin in Annex I to Council Directive 91/414/EEC. According to the Decision, ethoxyquin must be phased out before September 2012. The Court of Justice of the European Communities dismissed Xeda’s appeal and concluded that ethoxyquin did not satisfy requirements in view of the fact that it presented various risks which had not been adequately addressed in Xeda’s dossier.

 

Ethoxyquin is a post-harvest fungicide to be used to limit certain physiological disorders, such as browning, of pears stored in refrigerated areas or controlled atmospheres.

 

Xeda put forward three pleas in law in support of its action, alleging, first, manifest errors of assessment, secondly, breach of the rights of the defence and infringement of essential procedural requirements and, thirdly, breach of fundamental principles of EU law.
 

The first plea falls into two parts, alleging, first, a manifest error of assessment in that the contested decision is based on a matter of hypothetical concern, namely the genotoxic potential of impurity 7 and the risks for the environment and non-target organisms and, secondly, the contested decision fails to take into account all the scientific evidence available, which the applicant duly submitted. The Court’s conclusion identified ‘a number of concerns’ and that ‘it was not possible to perform a reliable consumer, operator and worker exposure assessment’ because of the insufficiency of the available data or their incomplete nature.
 

Xeda also claimed that Commission did not give the applicant sufficient opportunity and time to submit studies addressing the objection relating to insufficient or incomplete data in support of the proposed maximum level for impurity. The Court stated that ‘in the present case, in addition to outstanding issues, the additional report identified a new critical area of concern. It was not until November 2009 that the data gap in respect of impurity became a formal data requirement. It was subsequently labelled as a critical area of concern in the EFSA conclusion report and in the review report prepared by the Commission. The applicant submits that there were no grounds for it to suspect, much less to anticipate, that the data gap in respect of impurity would become a critical issue and would require new studies until very late in the procedure.’

 

Xeda takes the view that the Commission could have approved ethoxyquin subject to conditions, such as the submission of confirmatory data, as it has done in the case of other substances in respect of which areas of potential concern had not been fully addressed. The Court concluded that, in view of the broad discretion which the Commission enjoys in adopting decisions relating to the inclusion of active substances in Annex I to Directive 91/414, the lawfulness of a measure can be affected only if that measure is manifestly inappropriate in relation to the objective which it is intended to attain. Not to include an active substance in Annex I is on the basis of considerations relating to the protection of human health and the protection of the environment, it should be borne in mind, first, that the protection of human health takes precedence over economic considerations and, second, that the protection of the environment constitutes one of the essential objectives of the European Union. It has been held that the importance of the objectives pursued in the present case may justify even substantial negative economic consequences for certain operators.