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Commission Regulation (EC) No 33/2008Show full title
Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (Text with EEA relevance)
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Article 15Substantive and procedural requirements
1.The following substantive requirements shall apply:
(a)the specification of the active substance is the same as was the subject of the non-inclusion Decision. It may only be changed insofar as this is necessary, in the light of the reasons which gave rise to the non-inclusion Decision, to permit inclusion of that substance in Annex I to Directive 91/414/EEC;
(b)the supported uses are the same as those that were the subject of the non-inclusion Decision. They may only be changed insofar as this is necessary, in the light of the reasons which gave rise to the non-inclusion Decision, to permit inclusion of that substance in Annex I to Directive 91/414/EEC;
(c)it shall be for the applicant to demonstrate that the requirements in Article 5 of Directive 91/414/EEC are fulfilled.
2.With the application the applicant shall submit the following:
(a)the additional data necessary to address the specific issues that led to the adoption of the non-inclusion Decision concerned;
(b)any additional data reflecting the current scientific and technical knowledge and in particular changes to scientific and technical knowledge since the submission of the data which led to the non-inclusion decision;
(c)a supplement to the original dossier, where appropriate;
(d)a checklist demonstrating that the dossier is complete and indicating which data are new.
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