Case T-420/05

Vischim Srl

v

Commission of the European Communities

‛Plant protection products — Active substance chlorothalonil — Inclusion in Annex I to Directive 91/414/EEC — Assessment procedure — Directive 2005/53/EC — Application for annulment — Application for a declaration of failure to act — Application for damages’

Judgment of the Court of First Instance (Sixth Chamber), 7 October 2009 II ‐ 3845

Summary of the Judgment

In the context of the assessment procedure envisaged by Article 8(2) of Directive 91/414 concerning the placing of plant protection products on the market, a notifier, having submitted the dossier and participated in the assessment procedure, is individually concerned by the Commission measure bringing the procedure to an end. He is just as concerned by a directive authorising the active substance subject to conditions as he would be by a decision to refuse authorisation. In laying down the conditions for placing chlorothalonil on the Community market, which relate in particular to the maximum hexachlorobenzene (HCB) content, Directive 2005/53 amending Directive 91/414 to include certain active substances directly affects the legal situation of the company that manufactures chlorothalonil. Furthermore, the action which the Member States must take to verify within the prescribed period that the authorisations for plant protection products containing that substance comply with the conditions upon which it has been included in Annex I to Directive 91/414 is purely automatic, the Member States having no discretion as to the maximum HCB content. In those circumstances, Directive 2005/53 directly affects the applicant company’s legal situation. (see paras 71, 72, 76-78)

Under the procedure for the assessment of active substances that is envisaged by Regulation No 3600/92 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Directive 91/414 concerning the placing of plant protection products on the market, a notifier who has submitted an individual dossier is obliged to supply all the data necessary for the assessment of the notified active substance. Even if the Commission has the option of taking account of the totality of the data derived from the various dossiers, the fact remains that, in so far as the notifiers do not submit a joint dossier, each notifier has the task of making sure that his individual dossier is complete. If the dossier submitted by a notifier does not contain sufficient information, the Commission does not commit a procedural irregularity in assessing that active substance on the basis of another notifier’s dossier. (see paras 93, 94, 110, 118)

In the context of a procedure involving a reassessment of an existing product on the market on the basis of a dossier which the manufacturer concerned submits for assessment by the rapporteur Member State and the Commission, that manufacturer can invoke the right to be informed of the main gaps in his dossier which stand in the way of authorisation of the active substance concerned. On the other hand, in the absence of any express procedural provision to such effect, the Commission cannot be required to inform notifiers of the content of the measure proposed to the committee. (see paras 140, 142, 143)