Update from the Chair of the Central Zone Steering Committee

Update from the Chair of the Central Zone Steering Committee

Monika Pawlowicz from the Polish Ministry spoke at Kerona Scientific’s 4th Dublin PPP in November 2023.

Poland was the chair of the Central Zone Steering Committee (CZSC) in 2023, and Monika is the coordinator of the team responsible for risk management and regulatory decision on authorization and amendments of PPP in the Polish Ministry of Agriculture and Rural Development.

The CZSC had five meetings in 2023, and Czech Republic is the new CZSC chair for 2024.

The main points discussed by the CZSC during 2023 were:

• Preparation of a Manual for the Central Zone (CZ), where all the main points concerning the zone are addressed and updated regularly. The draft Manual was distributed to the Member States (MS) for commenting.
• The bullet points already published in CIRCABC in 2023 were:
  • How to present active substance (AS) studies in the reference list of the PPP dRR for Article 33 of Regulation (EU) 1107/2009. In force from 18^th July 2023, it was decided that the AS studies should always be mentioned whenever they are necessary for the evaluation of the PPP. Applicants cannot reference data protected AS studies from EU assessments unless they have the right to use these studies. Instead, alternative data matching studies, should be listed in the reference list.
  • The original implementation date for the final agreements of the 6^th Central Zone Workshop (CZWH) in Ecotoxicology of 2022, was September 2023; however, the date has been postponed for applicants to 1^st January 2024.
  • The CZ Evaluation Manual Ecotoxicology May 2021 was updated in August 2023 to version 2.0 due to new points.
• The unacceptable co-formulants according to Regulation (EU) 2023/574, applicable from the 3^rd of April of 2023. The procedure in the zonal assessment is still under discussion, and it is foreseen that the discussion will continue during 2024. Nevertheless, some points discussed already are:
  • Applicants must deliver all the necessary information on co-formulants in Part C.
  • If the applicant does not have access to the co-formulant information due to confidentiality, the authorities must directly request this information to the suppliers, resulting in two Part C documents: one for the applicant (without the confidential information) and the unredacted one for the MS authorities.
• It was decided that after every solution, agreement, or bullet point by the CZSC, it will be considered whether stakeholders should be involved via commenting or not.

For further details, on the many other topics discussed, a copy of the full presentation is available from the publications page at https://kerona.ie/product/dublin-ppp-symposium-2023-speakers-presentations/

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