Navigating the New EU Regulation for Safeners and Synergists in PPPs

Navigating the New EU Regulation for Safeners and Synergists in PPPs

During the Southern European Plant Protection Conference organised by Kerona Scientific, Claudio Mereu, a European lawyer focussing on EU Regulatory law, provided an update on the new fundamental Regulation concerning the approval of safeners and synergists used in plant protection products (PPPs).

Claudio presented that the initiative is being implemented through Commission Regulation (EU) 2024/1487 and directly responds to a mandate set out in Article 26 of Regulation (EC) No. 1107/2009. Its main objectives are to establish a work programme for the gradual review of safeners and synergists already on the European market; to define both the data requirements and the procedure to be followed for the approval of these safeners and synergists within the EU; and importantly, to ensure the implementation of measures aimed at minimising animal testing.

One of the key consequences of this new regulatory framework is that going forward, safeners and synergists may not be used in PPPs unless an application for their approval has been submitted. If the substances do not gain approval under the new Regulation, this could trigger the withdrawal of authorisations for PPPs containing these substances. A positive aspect for companies is that data protection will be granted to studies submitted to support approval of safeners and synergists, unless they have been used to support a PPP authorisation in the past.

The Regulation sets out a detailed timeline for the review programme. A provisional list of safeners and synergists was published on July 19, 2024. The deadline to notify interest in participating in the EU approval process was June 19, 2025. The final list of safeners and synergists subject to approval will be available by December 19, 2025. The deadline for submission of approval applications is June 19, 2028. After this deadline, a transitional period of five years is foreseen, with the possibility of extensions.

Given the inherent complexity of the approval process under this new Regulation, Claudio recommended that joining a Task Force is the “most cost-effective option.” The main advantage of this strategy is the possibility of jointly investing in the approval of several safeners or synergists and, crucially, gaining ownership of the study results. Being part of a Task Force would allow most of the necessary work to be outsourced to consultants and legal advisors, who would handle any issues or complexities that arise during the process, thereby increasing the chances of success.

This new Regulation represents a significant shift in the EU’s approach to PPPs, requiring proactive measures from companies working with safeners and synergists to ensure their continued use.

If you need support for safeners and synergists in the EU, please do not hesitate to contact the regulatory team at info@kerona.ie