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.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.