Annex-I-renewal fourth stage – AIR-4

Date: 7 April 2020

With AIR-4 the authorities introduced a new concept into the renewal of approval of a.s. Just as for AIR-3 (see previous Academy Article), the 213 a.s. of AIR-4 are subdivided into groups and batches. And just like AIR-3, groups 1 and 4 are grouped by the expiry dates of the respective a.s. But unlike AIR-1, AIR-2 and AIR-3 groups 2 and 3 differ from this criterion. Group 2 calls on a.s. which are “presumably low-risk substances” and Group 3 contains the a.s. that “may fail to satisfy the approval criteria”. And, while for groups 1 and 4 an extension of the a.s. expiry date is handled under the same prerequisites as for AIR-3, i.e. availability of an application (SANTE-2016-11734), the approval expiry dates for a.s. in groups 2 and 3 are only reluctantly extended, if at all (SANTE-2016-10616).

AIR-4 calls upon a.s. with approval expiry dates between 1 January 2019 and 31 December 2021 (Commission Implementing Decision 2016/C 357/05). The expiry dates of a.s. in AIR-4.4.1 (AIR-4 Group 4 Batch 1) have already been postponed for 2 years and those of AIR-4.4.2 by 3 years.

Under AIR-4 some dossiers have been submitted and are under evaluation by the authorities. Again the Rapporteur Member States cannot be chosen by the applicant, but are assigned (REGULATION (EU) No 2016/183).

Bernd Brielbeck