At the Dublin Plant Protection Symposium in December 2021 Natalia Nogueira de Diego spoke on “Updates from the Southern Zone”. Natalia is the Head of the Spanish Plant Protection Products Register in the Ministry of Agriculture, Food and Fish (MAPA). Spain has just started chairing the Southern Member State Steering Committee (SMS SC) until December 2022.
Natalia began with an overview of the regulatory framework affecting the authorization and commercialization of PPP in Europe and in the Southern Zone. This was followed by some valuable insights into the SMS SC and the discussions taking place at its meetings. At the latest meeting, the committee reached a few agreements:
– VFS (vegetative filter strips) model. There was an agreement on the possibility of using this tool for PECsw calculation at the Member State (MS) level and for the proposal of risk mitigation measures (RMM) at the zonal level. Any applicant can now use this refinement in their dRR proposal in their application.
– Assessment of protected crops for which two dRR reports are needed in the application. An inter-zonal dRR will need to be evaluated at the inter-zonal level (with information and risk assessment for the protected structures that does not include agronomic and environmental conditions) and a zonal dRR will be evaluated at the zonal level (which does include agronomic and environmental conditions). When applicants submit applications for protected crops, they should cover the risk assessment for all types of structures.
– Article 43 harmonization for products containing two active substances. There was an agreement to wait for the second active substance renewal. For category 4 studies, when the identified category 4 studies are no longer required, the applicant has 3 months to submit the dRR.
Natalia closed her presentation by mentioning some ongoing issues or topics of discussion for the SMS SC in 2022 such as: allocations of the zonal rapporteur Member State (zRMS) for Article 33 applications when specific problems appear, allocations of zRMS for Article 43 renewals, harmonization on Article 34 cases, parallel imports and inconsistent requests for packaging information among different MS, and the application of Regulation 2021/383 on non-accepted co-formulants.
If you need assistance with an application in the Southern Zone, get in contact with Kerona’s expert team at email@example.com
If you would like a copy of the presentation, you can purchase the slides from the PPP Symposium here: https://kerona.es/product/dublin-plant-protection-symposium-2021-speakers-presentations/