EUROPE – COM: New renewal procedure for active substances

Commission Regulation (EU) 2020/1740 of 20 November 2020 repeals Commission Regulation (EU) 844/2012 and sets out the new provisions necessary for the implementation of the renewal procedure for active substances. This follows the adoption of Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in all areas of the food chain where the European Food Safety Authority (EFSA) conducts a scientific risk assessment. Both regulations will apply from 27 March 2021.

The main changes deal with the schedule of the different steps of the renewal procedure, in particular:

• the provision of pre-submission advice on intended tests and studies for the purposes of a renewal, preceded by a specific notification by the potential applicant and consultation of third parties;
• the submission of renewal applications on a central online system via the IUCLID software at least three years before the expiry of the approval period of an active substance.

Regulation (EU) 2020/1740 applies for all active substances whose approval period expires on or after 27 March 2024.

In this context, for several active substances, the approval periods have been extended by Regulation (EU) 2020/2007 of 8 December 2020 to allow applicants to prepare and submit their dossiers in the required format.

To download: 

Commission Implementing Regulation (EU) 2020/1740 of 20 November 2020

Commission Implementing Regulation (EU) 2020/2007 of 8 December 2020

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