Dublin PP Symposium 2024 – Update from the Chair of the Central Zone Steering Committee
Dublin PP Symposium 2024 – Update from the Chair of the Central Zone Steering Committee
On November 20th –and 21st 2024, Kerona Scientific held the Dublin Plant Protection Symposium, which dealt with key regulatory aspects relevant to the registration of plant protection products (PPPs) and active substances. On the second day of the symposium, Lucie Váňová from the Plant Protection Products Division at the Central Institute for Supervising and Testing in Agriculture in the Czech Republic, presented an update from the chair of the Central Zone Steering Committee (CZSC).
Lucie summarised the some of the main points from the face-to-face meeting of the CZSC, which only happens once a year. Lucie explained that for the next year (2025) the chair of the CZSC will be Germany.
The first topic Lucie discussed was on the publishing of proposed guidance for the central zone in the form of a manual, summarising the main points agreed. The CZSC will allow stakeholders to comment on the draft manual before its publication at the end of 2024 or start of 2025. This manual for the Central Zone is based on the Guidance drafted by Kerona Scientific back in 2022.
Next, Lucie highlighted the topic of unacceptable co-formulants. The meeting first discussed which part of the dRR should contain the evaulation of coformulants (B0 or part C). It was concluded that since this information is about the formulation of a product, it is considered confidential, so it should be presented in part C. It was agreed in the CZSC meeting that co-formulants which may be regarded as unacceptable are to be assessed following criteria outlined in Regulation (EU) 2023/574. Additionally, the evaluation of co-formulants should be conducted by the zonal Rapporteur Member State (zRMS) in the case of applications submitted according to Article 33 and Article 43.
Lucie also outlined the topic of ECJ rulings C-308/22, C-309/22 AND C-3610/22, and that the Member States (MS) have discussed how these rulings could affect the evaluation of PPPs. This topic is still under discussion at different levels.
Lastly, Lucie mentioned the subject of data protection regarding used studies in the evaluation of PPPs. In the meeting, the presentation of studies for the active substance in the dRR was discussed. It was reiterated that the guidance can be found in SANCO/12580/2012, but also in the bullet point published on CIRCABC in 2023 regarding this issue. The MS again clarified the procedures on how to present the list of studies. It was also mentioned that if data protection is claimed for an active substance (a.s.) or a product study, a justification should be provided as to why the study is necessary for the product application.
If you missed the Dublin Plant Protection Symposium, a copy of the presentations is available on the Kerona website For assistance with the Regulation of PPP in the EU and UK the Kerona Regulatory team can be contacted at info@kerona.ie