EUROPE – COM: Adoption of Data Requirements and Gradual Review of Safeners and Synergists

Following the public consultation held in winter 2023, the European Commission adopted on 29 May 2024 the Regulation (EU) 2024/1487 to define the data requirements for the approval of safeners and synergists used in plant protection products (PPP) and to establish a work program for the gradual review of those compounds which are already on the market.

The regulation will enter into force on 19 June 2024.

A non-exhaustive list of safeners and synergists contained in PPP authorised for the placing on the market in Member States on the date of entry into force of the Regulation will be made available by 19 July 2024.

Any interested party may submit a notification of further substances or preparations potentially used as safeners or synergists in PPP authorised for the placing on the market in at least one Member State on the date of entry into force of the Regulation by 19 December 2024. The Commission will update the first list by 19 March 2025.

Any interested party wishing to submit an application for the approval of a safener or synergist included in the issued list shall submit a request for inclusion of that safener or synergist in the gradual review programme by 19 June 2025. The work programme, specifying the list of safeners and synergists included and designating for each of them a rapporteur Member State (RMS) and co-rapporteur Member State (co-RMS) will be adopted by 19 December 2025.

The application dossier for the approval of a substance included in the work programme will have to be submitted, via IUCLID, to the assigned RMS and co-RMS at the latest by 19 June 2028.

Data requirements are described in Article 11 of Regulation (EU) 2024/1487 (see also our previous post).

As a transitional measure as provided for in Regulation (EC) No 1107/2009 (Article 81 (1)), Member States may, for a period of 5 years following the adoption of the gradual review programme, authorise PPP containing a safener or synergist where it is included in the programme.

In the case of a safener or synergist not included in the gradual review programme, it will be possible to submit an application for approval at any time. PPP containing that safener or synergist can only be authorised once the corresponding safener/synergist is approved.

To download:

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 of the European Parliament and of the Council

Consultation page with the feedback received

See also our previous articles: 

EUROPE: Public Consultation on Data Requirements and Gradual Review of Safeners and Synergists

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