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EAR expert comment on improvements of the quality of the PPP zonal dossiers

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Here, our Senior Regulatory Expert Caroline Ville, comments on the recent EU activity regarding the quality of Plant Protection Product Zonal Dossiers...

The SZ SC (Southern Zone Steering Committee), part of the EU Commission, recently conducted a survey in order to assess the quality of PPP zonal dossiers and recommend improvements based on the feedback of the survey. 

The aim was to collect Member State (MS) practices and to give feedback to the IZSC for discussion.

The conclusions provided by the survey were as follows:

  • The scope of the initial check is only administrative and for checking the compliance with the data requirements
  • There is no technical or scientific evaluation at this stage
  • An update of the dossier is still possible after the initial check in all MS
  • The timelines are between 10 days and 2 months to provide further information
  • There are differences depending upon the role of the MS in the procedure:
    • administrative checks for all procedures
    • technical completeness checks for the zRMS
    • technical evaluation limited to dRR commenting phase for the MS

The zonal steering committee is formed from representatives of the competent authorities of each Member State in the zone.

Following REFIT report (Analysis conducted with the objective of simplifying procedures and shorten approval times for AI’s. and PPPs), from the EU Commission, the zonal steering committees were asked in 2022 to further discuss this action, to collect MSs practices and feed back to IZSC for discussion on best practices.

The SMS Steering Committee undertakes several tasks including: Coordination of the work sharing activities and allocation of the zonal Rapporteur Member State (zRMS) Development and review of the guidance for the harmonisation of procedures and risk assessment within the zone Ensuring transparency and provides a formal feedback of its work to all MS in the zone.

The steering committee has telephone conferences approximately every second month and face-to-face meetings at least once a year. The steering committee is normally chaired by one country for one year on a rotational basis. Chairs are responsible for drafting the agendas of the meeting of the steering committee, minutes of the meetings as well as to coordinate updating the list of applications with agreed ZRMS and timelines.

It appears that the dossiers are mainly rejected because of a lack of studies, on-going studies and endpoints not updated.

Several proposals were then made for improving the quality of the dossiers:

  • The guidance documents should be regularly updated and easily available;
  • Training for applicants is needed;
  • A pre-submission procedure has to be implemented in all MS (1 year before submission);
  • The access at national level regarding the accepted risk mitigation measures, endpoints to be used, specific requirements and art 60 list should be harmonized.

It is expected that these improvements will be implemented rapidly, which should result in an overall improvement in the quality of PPP dossiers – or provide a different conclusion.

For more information, get in contact.