New Regulation on Safeners and Synergists used in Plant Protection Products
New Regulation on Safeners and Synergists used in Plant Protection Products
On the 19th of June 2024, the new Commission Regulation (EU) 2024/1487 came into force. This Regulation establishes a work programme for the gradual review of safeners and synergists on the market in accordance with Regulation (EC) No 1107/2009. Moreover, the Regulation also outlines the requirements that need to be fulfilled for the approval of a safener or synergist for use in a plant protection product (PPP).
The European Commission (EC) in July published a non-exhaustive list of safeners and synergists contained in plant protection products (PPPs), and by the 19th of December 2024 any interested party can submit a notification of further substances or preparations potentially used as safeners or synergists in PPPs. A window of opportunity up to one year (December 19th, 2025) will be in place for this list to be updated, for the EC to adopt the work programme (specifying the safeners and synergists included) and for the designation of rapporteur and co-rapporteur Member States. This will culminate in the deadline of June 19th, 2028, whereby applications must be submitted for approval to the respective rapporteur Member State (rMS) in standard IUCLID data format via the central submission system (CSS). An application is admissible if it is submitted by the specified date, in the correct format and using the CSS; contains all data requirements; includes all studies under Article 32b of Regulation (EC) No 178/2002 and finally when the relevant fee have been paid. The rMS will inform relevant parties of the receipt and admissibility of the application within 45 days of the specified date.
Three key practical issues have been identified regarding Commission Regulation (EU) 2024/1487. Issues around data protection and confidentiality may arise when applying Article 59 and 63 of Regulation (EC) No 1107/2009 to data submitted to support the approval of safeners or synergists. Applicants are questioning “when will this data protection start?” and “will old data used for product authorisations be eligible?”. Secondly, competent Authorities may not be able to cope with the extra workload of evaluation, approval and new guidance that may be adopted. Finally, there might be a domino effect having a direct impact on product authorisations. The work program may trigger processes for review of existing national authorisations and pose challenges for the renewal of future authorisations.
With all these doubts and anxieties regarding its implementation, the EC hopes to achieve a robust but flexible work programme that allows joint submission and data sharing; an emphasis on minimising animal testing by using new alternative testing methods where possible and a five-year grace period giving companies time to adapt products on the market to align with the new Regulation.
Regulatory transitional periods like this one can cause concern and uncertainty but Kerona Scientific Ltd will be happy to address any questions you may have regarding this topic and can provide support with the registration of plant protection products in Europe. Please do not hesitate in contacting one of our regulatory consultants at info@kerona.ie