EU Adoption of Data Requirements for Safeners and Synergists 

Following on from our post in February reporting on the formal opinion on data requirements for safeners and synergists, the EC have now formally adopted the data requirements for the approval of safeners and synergists, similar to those for active substances under Regulation (EC) No 1107/2009, but with additional studies required to demonstrate the efficacy of the safener or synergists.  

Commission Regulation (EU) 2024/1487 will come into force on 19 June 2024.

A list of safeners and synergists currently authorised on the market, in at least one PPP, shall be published in the public domain by 19 July 2024. Any interested party may submit a notification of further substances or preparations potentially used as safeners or synergists in plant protection products authorised for the placing on the market in at least one Member State by 19 December 2024.

Any party wishing to submit an application for the approval of a safener or synergist included in the published list has until 19 June 2025 to submit a request for inclusion of that substance in the review programme. A work programme, specifying the list of safeners and synergists included and rMS and co-rMS will be adopted by 19 December 2025.

All applicants have until 19 June 2028, to submit their application for the approval of the safener or synergist, via IUCLID, to the rMS and co-rMS.
The data required for approval must be the same as required for Reg (EU) No 283/2013 and No 284/2013 and include where relevant:

  • The identification and proposal of a residue definition for the purposes of risk assessment.
  • A proposal for classification in one or more hazard classes in accordance with Regulation (EC) No 1272/2008.
  • A justification for any IUCLID Validation Assistant check failures.
  • Summaries and results of scientific peer-reviewed open literature.
  • An assessment according to the current scientific and technical knowledge of all information submitted.

Supplementary data must be provided from glasshouse and field studies describing the purpose, dose, and manner of the proposed use along with additional efficacy studies supporting the use of the safener or synergist in combination with the plant protection product in the target crop or organism.

Currently, CRD has issued no communication regarding their approach to evaluating and approving safeners or synergists in GB.