EUROPE : Publication of AIR 4 working document

The AIR 4 working document has just been published by DG SANTE. This document provides an overview of indicative submission dates for supplementary dossiers for the renewal of substances expiring between 1 January 2019 and 31 December 2021. It is foreseen that the document will be updated regularly.

For group 1 (51 substances with expiry date before 30/04/2019), the expiry dates will not be postponed since they have the earliest expiration dates.

Substances from group 2 (38 presumed low-risk substances)  have priority. However, because the majority of substances in both Group 1 and Group 2 have expiry dates in 2019, all substances in Group 2 will be postponed by one year. Further extensions are still possible.

For group 3 (15 substances that may be expected to fall under the “cut-off” criteria of Regulation 1107/2009) the expiry dates will not be postponed.

The group 4 (110 substances with current expiry dates between 31/07/2019 and 31/12/2021) is divided to even out the workload. Indeed, 43 substances are postponed by 2 years and 67 substances are postponed by 3 years. A Regulation will be prepared to set new expiry dates.

To be noted:

The applicant must submit an application for renewal 3 years before the current deadline if they wish to renew the approval of the substance. Only when an application is received will the Commission take action and extend the current approval period. If an application is not received, the current expiry date will remain.  

To download:

Draft working document AIR IV renewal programme – SANTE-2016-10616–rev 3 (July 2016)

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