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

The European commission has launched a public consultation from 22 November to 20 December 2023 on a draft Commission Regulation 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, in accordance with Regulation (EC) No. 1107/2009.

A summary of the provisions and steps considered in this draft Regulation is presented below:

List of safeners and synergists 

• Publication by the Commission of a listing of all substances / preparations known as being used as safeners or synergists in at least one EU-authorised PPP (by 1 month from the entry into force);
• Notification by stakeholders of any further substances / preparations potentially used as safeners or synergists in PPP in at least one Member State (by 6 months from the entry into force);
• Sharing of the received notifications with Member States and EFSA for commenting;
• Update and finalisation of the list (by 9 months from the entry into force).

Request for inclusion in the work programme for gradual review

• Stakeholders interested in submitting an application for the approval of a safener or synergist included on the list shall submit a request for inclusion of that compound in the work programme (by 12 months from the entry into force);
• The Commission shall indicate the compounds requested for inclusion and shall share the contact details of different stakeholders interested in supporting the same safener / synergist;
• For those compounds for which no request for inclusion was received, the Commission shall adopt a decision stating that they will not be included in the programme.

Applicants and sharing of data, establishment of the work programme, notification of intended studies and pre-submission advice

• Stakeholders that submitted a request for inclusion in the programme will be considered as applicants. Applicants for the approval of the same safener / synergist shall undertake all reasonable efforts to make a joint application or to share relevant data;
• Following consultation with Member States, the Commission shall adopt the work programme by amending Annex I of the draft Regulation, specifying the compounds included in the programme and the associated rapporteur and co-rapporteur Member States((co)-RMS) (by 18 months from the entry into force);
• Following the amendment of Annex I, without delay, applicants shall proceed to the study notification to EFSA, in accordance with Article 32b(2) of Reg. (EC) No. 178/2002, for any study commissioned or carried out by them to support the application;
• Upon specific request of an applicant in accordance with Article 32a(1) of Reg. (EC) No. 178/2002, EFSA and the RMS shall jointly provide general pre-submission advice.

Submission and content of the application

• An application supporting the approval of a safener / synergist shall be submitted in standard IUCLID data format via the central submission system provided for active substances (by 48 months from the entry into force).

Evaluation of the admissibility of applications

• The RMS shall assess the admissibility of the application within 45 days following the submission.

The draft Regulation also contains specific timelines and rules in case of missing elements or study not notified to EFSA (see draft Article 8).

Data requirements 

• The data requirements as for active substances dossiers shall apply to safener / synergist submissions (e.g. the provisions of Article 8 of Reg. (EC) No. 1107/2009, of Reg. (EU) No. 283/2013 and 284/2013; see draft Article 9 for details);
• In addition, specific data related to the efficacy of the safener / synergist (as listed in draft Annex III) shall also be submitted. Those include:
  • a description of the intended purpose, dosage and proposed use(s);
  • an evaluation of the nature and extent of benefits from the presence of the safener / synergist in a PPP, compared to an untreated control condition and to a condition where the same PPP but without the safener / synergist is tested;
  • reports in summary form of preliminary tests used to assess the activity or dose range finding of the safener / synergist contained in a PPP, when requested by the competent authority to justify the recommended dose and the ratio of safeners or synergists when several are used;
  • sufficient information on the following points:
    • an investigation of the effects of a treatment on a representative use with a PPP containing the relevant safener / synergist in relation to the control of the target organism and effect on the treated plants or plant products;
    • an investigation of the effects of a treatment on a representative use with the same PPP without the relevant safener / synergist in relation to the control of the target organism and effect on the treated plants or plant products in order to prove that the safener eliminates or reduces phytotoxic effects of the PPP / the synergist increases the efficacy of the PPP ;
    • an investigation of the effects of a treatment on a representative use with the same PPP containing the relevant safener / synergist but no active substance in order to prove that the safener / synergist has no efficacy on its own against target pests.

Interested parties are invited to submit comments on the draft documents via the dedicated consultation page. The adoption of the regulation by the Commission is planned for Q1 2024.

To download: 

Draft Commission Regulation No. 2023/2195 and the Annexes, 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 – version for public consultation (22/11/2023)

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