Review of safeners and synergists in pesticides
- Pesticides
Summary
Requirements for the approval of active substances used in plant protection products are given in Regulation 1107/2009. These requirements also apply to other substances used in plant protection products to eliminate or reduce phytotoxic effects (“safeners”), or to enhance the activity of the active substances (“synergists”).
Under this new Regulation 2024/1487, the European Commission has provided a work programme for a gradual review of safeners and synergists that are already on the EU market.
EU initiates review of safeners and synergists in pesticides
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
Update
Requirements for the approval of active substances used in plant protection products are given in Regulation 1107/2009. These requirements also apply to other substances used in plant protection products to eliminate or reduce phytotoxic effects (“safeners”), or to enhance the activity of the active substances (“synergists”).
Under this new Regulation 2024/1487, the European Commission has provided a work programme for a gradual review of safeners and synergists that are already on the EU market.
What is changing?
The EU has set out a review programme for safeners and synergists used in plant protection products as follows.
- By 19 July 2024: the European Commission must publish a list of all safeners and synergists known to be used in plant protection products in the EU.
- By 19 December 2024: any interested party may submit a notification of other safeners and synergists not listed by the Commission.
- By 19 June 2025: any interested party may submit a request for a listed safener or synergists to be included in the EU’s review programme. These interested parties will be considered (individually or collectively) as applicants for approval of the safeners/synergists. Where there is no request, the safeners or synergists will not be reviewed
- By December 2025: the Commission will adopt a work programme specifying safeners and synergists to be reviewed, and the EU Member State responsible for managing the review (rapporteur).
- By 19 June 2028: applicants must submit an application for approval to the rapporteur Member State.
Applications must fulfil the data requirements established for active substances in plant protection products (Regulation 1107/2009, Art. 8), and specific data requirements in Regulation 2024/1487 (Art. 11).
Why?
Safeners and synergists used in plant protection products must meet the same safety requirements as active substances used in those products. The original intention was to launch this review programme by the end of 2014, but the process has been delayed. As a result, while awaiting the review, it has been the responsibility of each EU Member State to ensure their safety.
Timeline
The Commission’s timeline for reviewing safeners and synergists is shown above.
Background
A relatively small number of safeners (21) and synergists (13) are reported to be used in plant protection products in the EU (PAN Europe 2024). There is currently no legal basis for establishing maximum residue levels (MRLs) for safeners and synergists; Regulation 396/2005, which gives the requirements for setting MRLs, does not include safeners and synergists.
Resources
European Commission: Approval of active substances, safeners and synergists
European Commission (2018) Study supporting the REFIT evaluation of the EU legislation on plant protection products and pesticide residues (Regulation (EC) No 1107/2009 and Regulation (EC) No 396/2005) – Executive summary.
PAN Europe (2024) Addressing the 9-years gap: the long-awaited proposal on safeners and synergists. Pesticides Action Network Europe, 18 January.
Sources
Commission Regulation (EU) 2024/1487 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
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EU initiates review of safeners and synergists in pesticides
Regulation
Commission Regulation (EU) 2024/1487 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
What is changing and why?
The EU has established a work programme for the review of “safeners” and “synergists” used in plant protection products. Safeners are substances used to reduce phytotoxic effects of plant protection products; and synergists are used to enhance the activity of active substances in these products.
Safeners and synergists will be reviewed and approved according to the same criteria used for active substances in Regulation 1107/2009, and specific data requirements in Regulation 2024/1487.
This new draft Regulation sets out the steps and timeline for the work programme.
Timeline
The European Commission’s detailed timeline for reviewing safeners and synergists is given in the full AGRINFO report.
Disclaimer: Under no circumstances shall COLEAD be liable for any loss, damage, liability or expense incurred or suffered that is claimed to have resulted from the use of information available on this website or any link to external sites. The use of the website is at the user’s sole risk and responsibility. This information platform was created and maintained with the financial support of the European Union. Its contents do not, however, reflect the views of the European Union.