A major update to the SANCO guidance document on zonal evaluation, mutual recognition, withdrawal and amendment of authorisations under Regulation (EC) No 1107/2009 (SANCO/13169/2010 Rev. 11) was published on 25 January 2021. This guidance document was last updated in 2010 and the latest version is a major revision which applies to all applications submitted from 01 March 2021.
Amongst the many changes to the guidance document, this new revision provides greater detail on Article 34 applications claiming exemption from the submission of studies (for instance by reference to unprotected data from a comparable reference product). The procedures for placing on the market of low-risk plant protection products according to Article 47 are also clarified, and further details on the procedures to be followed for withdrawals or amendments of an authorisation (Articles 44 and 45) and grace periods under Article 46 is provided. Implementation of the Plant Protection Products Application Management System (PPPAMS) is ongoing and applicants are encouraged to use PPAMS to submit their applications (PPAMS is already suitable for Art. 33, Art. 40-42 and Art. 53 applications).
A copy of the guidance document is available on the European Commission (EUROPA) website:
If you have any questions in relation to zonal applications in the EU, please don’t hesitate to contact a member of our plant protection team at firstname.lastname@example.org