Case T-158/03 Spain v Commission
By judgement dated 28 June 2005, the ECJ has rejected an application by the Spanish chemical company, Industrias Quimicas del Valles (IQV) to have the pesticide metalaxyl reinstated on the EU market.
The Plant Protection Products Directive (Directive 91/414/EEC) introduced a Community wide system for the granting and withdrawal of authorisation for plant protection products.
Products shall not be authorised unless its active substances are contained within Annex I to the Directive.
Since February 1994 IQV had imported metalaxyl into Spain and marketed products containing that active substance in Italy, Spain, Greece and Portugal, and also in several States outside the Community.
Following introduction of the Plant Protection Products Directive, IQV subsequently notified the Commission of their intention to submit a dossier with a view to the inclusion of that substance in Annex I to the Directive.
Another undertaking, Syngenta, also submitted a separate dossier, requesting metalaxyl to be included within the Directive Annex I though three years later, withdrew from the procedure for the evaluation of metalaxyl.
During this period IQV had sought to complete their application for which numerous requests for further information had been made by the Portuguese authorities.
The process was not straightforward, with the information submitted continuing to fail to meet the requirements and thus involving protracted transition periods.
Also following the withdrawal of Syngenta, IQV were to be allowed to make use of the studies previously submitted by Syngenta, though a number remained protected.
A number of years passed in which the Portuguese authorities and subsequently the Commission continued to request various studies and information from IQV, but by 2001, an updated summary dossier still had not been provided to the Commission.
As a result, the Commission intended to present a decision not to include metalaxyl in Annex I to Directive 91/414/EEC.
This was eventually adopted in 2003 (Decision 2003/308/EC concerning the non-inclusion of metalaxyl in Annex I to Directive 91/414/EEC).
The present action was brought by IQV in 2003, seeking annulment of Decision 2003/308/EEC.
However the ECJ, in its judgement of 28 June 2005, has dismissed the action in its entirety, therefore dismissing all the complaints raised by IQV in respect of how the Commission has handled its dossier for inclusion of metalaxyl in Directive Annex I.
For details see the link.