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Understanding Safeners and Synergists Registration Data
Manufacturers of plant protection products (PPPs), and other products that contain safeners and synergists, have been seeking clarification on data requirements for approval and registration. Commission Regulation (EU) 283/2013 clearly defined what data was required for the approval and sale of active substances, but failed to adequately address safeners and synergists, leading to confusion and inconsistent approaches to testing and data generation.
European Commission Legislation for PPPs
In accordance with Regulation (EC) 1107/2009, a long-awaited legislation was approved to provide clarity and guidance for safeners and synergists already on the market:
- Commission Regulation (EU) 2024/1487 of 29 May 2024 defining data requirements for the approval of safeners and synergists and establishing a work programme for the gradual review of safeners and synergists on the market in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council.
Safeners and Synergists Definitions and Timelines
European Commission (EC) Regulation 1107/2009 defines safeners and synergists as follows:
- Safeners (SF) - substances or preparations to eliminate or reduce phytotoxic effects of the plant protection product on certain plants.
- Synergists (SY) - substances or preparations which, while showing no or only weak activity, can give enhanced activity to the active substance(s) in a plant protection product.
The process for the gradual review of safeners and synergists already on the market is outlined as follows:
| June 2024 | A list was published by the European Commission of safeners and synergists currently in use within plant protection products. |
| December 2024 | Deadline for interested parties to submit additional safeners and synergists currently on the market to be considered for inclusion in the list. |
| March 2025 | The Commission will update the list with relevant substances from notifications received. |
| June 2025 | Deadline for submitting a request for inclusion for safeners and synergists that are present on the list for inclusion in the work program. Within one month the Commission will update the list of safeners and synergists for which a request for inclusion in the work programme has been made. |
| December 2025 | Deadline that the final list and work program will be adopted – substances will be assigned across Member States for review. |
| June 2028 | Deadline to apply for approval of any substances in the work program. Any required studies need to be completed and IUCLID dossiers prepared by this date. |
Implications for Manufacturers Using Safeners and Synergists
Firstly, manufacturers will need to familiarize themselves with the list of safeners and synergists to be assessed first under the work program to understand if their current portfolio is impacted.
- Where formulations contain one of the listed substances a grace period of five years applies to the existing authorizations. Addressing data gaps before the dossier submission therefore becomes a priority to keep the products on the market.
- Manufacturers selling new PPPs or preparations containing safeners and synergists not included in the work program will need to consider in their testing plans for the generation of data on these substances, since these products can only be authorized once the safeners and synergists have been approved.
With extensive experience in residue identification and measurement, field trials, environmental fate, and toxicology including ecotoxicology, plus the essential physical chemical studies, method development, and analytical support in-house, Charles River are experts in designing and executing testing programs for data generation for active substances, safeners and synergists, and plant protection products.
In addition, our regulatory affairs consultants are on hand to help you navigate the regulatory landscape. Offering services including data gap analysis, dossier compilation and sanitization, hazard and risk assessment, communications with authorities, in silico modelling, read-across and testing program design.
Learn more about future-proofing your existing product portfolio or implications for your new products and formulations.