Annex-I-renewal third stage – AIR-3

Date: 6 April 2020

As you have heard in previous postings, the Annex-I-inclusion of an active substance (a.s.), is granted only for a limited time period. Thereafter, it needs to be renewed. This is done in individual stages and today, as AIR-1 and AIR-2 are – in principle – completed, we will be looking at AIR-3. Starting with AIR-3, the regulatory and legal stipulations are provided in COMMISSION IMPLEMENTING REGULATION (EU) No 844/2012. Unlike AIR-1 (7 a.s.) and AIR-2 (31 a.s. of which 29 were originally defended), AIR-3 called up 150 a.s. with expiry dates between 31.01.2013 to 31.12.2018 of which 136 a.s. were originally defended by applicants. Due to the large number and the amount of work associated, AIR-3 was separated into 4 Groups consisting in turn of individual batches, which had the same submission dates (SANCO/2012/11284). The only criteria for the grouping were the original expiry dates of the a.s.

For Annex-I-renewals, the applicant is not free to choose his Rapporteur Member State (RMS), but each a.s. is assigned to a specific Member State (REGULATION (EU) No 686/2012). The assessments across AIR-3 a.s. are currently in all stages of the process: preparation of the Renewal-Assessment-Report, EFSA conclusion, Renewal Report and Amending regulation – and there are delays for each of the evaluation stages. A very significant proportion of the evaluations under review in AIR-3 are still pending.

If there is an extension of the submission deadline for the dossier (and in most cases up to now there was!), only those a.s. are eligible, for which an application was submitted. The received applications are listed in SANCO/10148/2014. As the time for evaluation is not affected by these extensions, the expiry date of the approval of the respective a.s. is also postponed.

Bernd Brielbeck