Modification of active substance renewals rules
EU Regulatory Bulletin contents
On April 26 2012 Regulation (EU) No 380/2013 was published in the Official Journal; it amends Regulation (EU) No 1141/2010 which lays down the procedure for the renewal of the inclusion of active substances in Annex I to Council Directive 91/414. This means that as of 15 May 2013 all applicants for the renewal of authorisations for active substances have to submit a full dossier to the EFSA and not just a summary.
Under Regulation 1141/2010 an applicant was only required to submit a summary of the active substance dossier to EFSA, the other Member States and, on request, to the Commission as a supplement to the main dossier. However, in practice the vast majority of the dossiers for renewals were mainly evaluated by EFSA. In order to allow EFSA to give its conclusion on the entire risk assessment or on specific points, a summary of the active substance dossier was not sufficient. Therefore the submission of the complete dossier was in practice more useful. Regulation 1141/2010 was therefore amended accordingly.
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