AIR procedure – when, how and why you have to apply for a renewal of approval of active substances (REGULATION (EU) No 844/2012)

Date: 3 April 2020

The AIR procedure or AIR programmes describe the renewal of approval of active substances used in plant protection products. The first AIR programme was initiated in 2007 and covers substances listed in Annex 1 of Directive 91/414/EEC, hence the name Annex 1 Renewal (AIR). The subsequent renewal programmes are also named ‘AIR’ and a consecutive number, e.g. AIR-2, AIR-3 is added to separate the different programs from each other. Currently, 4 programmes have been initiated, and a 5th program, covering substances that expire between January, 1st 2022 and December, 31st 2024 is already established. Implementation of an AIR-6 program is envisioned and under preparation.
The approval of active substances is usually granted for 10 years and rules for the approval of an active substance are provided in Articles 14 20 of REGULATION (EC) No 1107/2009. For more information on this regulation, please refer to the academy article published previously. The whole procedure from dossier submission to re-approval of an active substance can be expected to take roughly 2.5 years. This does, however, not include submission of an application describing the intention to renew the approval of the respective active substance. This document needs to be submitted at least 6 months prior to dossier submission.
IMPORTANT: On January, 17th 2020 submission deadlines for supplementary dossiers (renewal of approval of active substances) have been shifted forward by 3 months for all substances with an expiry date on or after May, 13th 2023 (REGULATION (EU) No 2020/103). Hence, dossiers need to be submitted at least 36 months prior to the date of expiration.

Alexander Rücker