CZSC Update: Key Clarifications for PPP Applicants

CZSC Update: Key Clarifications for PPP Applicants

The Central Zone Steering Committee (CZSC) has recently clarified two practical issues relevant to plant protection product (PPP) applications: significant formulation changes during the frozen period and storage stability of PPPs containing microorganisms.

In principle, an EU Member State (MS) may allow a formulation change during the frozen period where this is necessary to avoid withdrawal of a product due to an unacceptable co-formulant. Such changes will be considered on a case-by-case basis. For significant formulation changes, ecotoxicological comparability between the original and revised formulations may be demonstrated through bridging studies or a scientifically justified bridging concept. This should demonstrate that the same or similar endpoints remain applicable, or, where justified, that higher endpoints apply. Importantly, this approach does not automatically require a new risk assessment. Therefore, the new Birds & Mammals Guidance Document does not need to be considered solely as a consequence of the formulation change.

For PPPs containing microorganisms, an accelerated storage stability study may not be appropriate, as the elevated temperatures used could adversely affect or destroy the microorganisms. The CZSC has therefore agreed that interim results from an ambient storage stability study may be accepted. The product label can reflect the stability period supported by the available interim data. The final ambient storage stability report must subsequently be provided to the individual MS in accordance with Article 45 of Regulation (EC) No 1107/2009.

These clarifications provide useful flexibility while maintaining the need for sound scientific justification. Applicants should consider a robust bridging approach for significant formulation changes and for microbial PPPs applicants should rely on ambient storage data rather than assuming accelerated storage can provide an equivalent basis.

At Kerona, we support applicants in navigating these evolving requirements, from early gap analysis to full dossier preparation and regulatory strategy. With the shortened transition window, early planning is key to avoiding delays and ensuring submissions remain fully compliant under the new system.

For assistance with the regulation of PPP in the EU and the UK the Kerona Regulatory team can be contacted at info@kerona.ie