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

CHAPTER 1

SUBJECT MATTER

Article 1

Subject matter

This Regulation establishes:

(a) the work programme for the gradual review of the safeners and synergists already used in plant protection products on 19 June 2024 and procedures relating to that programme;

(b) the data requirements that an application for the approval of a safener or a synergist needs to fulfil.

CHAPTER 2

ESTABLISHMENT OF THE WORK PROGRAMME FOR THE GRADUAL REVIEW OF SAFENERS AND SYNERGISTS ALREADY ON THE MARKET, LIST THEREOF AND PROCEDURES FOR THEIR GRADUAL REVIEW

Article 2

Establishment of the work programme

The work programme for the gradual review of the safeners and synergists already used in plant protection products on 19 June 2024, set out in Annex I, is hereby established.

Article 3

List of safeners and synergists already on the market

The notification shall be submitted electronically to the Commission at the following address: sante-secteur-ppp@ec.europa.eu.

Member States and the Authority may provide their comments to the Commission within 2 months from the date of being informed by the Commission.

Article 4

Request for inclusion in the work programme for gradual review

The request shall be submitted electronically to the Commission at the following address: sante-secteur-ppp@ec.europa.eu, and contain the information listed in Annex II.

Article 5

Non-inclusion of a safener or a synergist in the work programme for gradual review

Where no request for inclusion in the work programme for gradual review is received for a safener or synergist listed in the list referred to in Article 3(1) within the deadline set out in Article 4(1), the Commission shall adopt a decision stating that the respective safener or synergist is not included in the work programme for gradual review.

Article 6

Adoption of the work programme

Article 7

Data sharing, notification of intended studies and pre-submission advice

Applicants for the approval of a safener or synergist shall take, where possible, measures to minimise animal testing. As part of the notification process mentioned in the preceding subparagraph, applicants shall inform the Authority if any conducted or commissioned study incorporates the utilisation of alternative testing methods. The notification shall include details on the alternative methods employed and the rationale for their use.

Article 8

Submission and content of the application for approval of safeners and synergists in the work programme for gradual review

Article 9

Procedure for the evaluation of the admissibility of applications for safeners and synergists in the work programme for gradual review

The rapporteur Member State shall deem an application admissible if it satisfies the following criteria:

(a) it has been submitted by the date set out, in accordance with the format and using the central submission system referred to in Article 8(1);

(b) it contains all the elements set out in Article 11;

(c) it contains all studies, in full, that have been previously notified in accordance with Article 32b of Regulation (EC) No 178/2002;

(d) the relevant fee as set by the rapporteur Member State in accordance with Article 74 of Regulation (EC) No 1107/2009 has been paid.

Article 10

Data protection and confidentiality

Article 59 (1) and (2) of Regulation (EC) No 1107/2009 shall apply.

Article 63 (2), (2a), (2b) and (3) of Regulation (EC) No 1107/2009 shall apply.

CHAPTER 3

DEFINITION OF DATA REQUIREMENTS FOR SAFENERS AND SYNERGISTS

Article 11

Data requirements for safeners and synergists

In addition to the data requirements set out in Article 8 of Regulation (EC) No 1107/2009, an application for the approval of a safeners or a synergist shall include:

(a) the data as required for active substances pursuant to Regulation (EU) No 283/2013, and the supplementary data listed in Annex III to this Regulation;

(b) the data as required for plant protection products pursuant to Commission Regulation (EU) No 284/2013 (³), and the supplementary data listed in Annex III to this Regulation;

(c) where relevant, the identification and proposal of a residue definition for the purposes of risk assessment;

(d) where relevant, a proposal for classification in one or more hazard classes in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (⁴);

(e) where relevant, a justification for any IUCLID Validation Assistant check failures;

(f) the summaries and results of scientific peer-reviewed open literature, as referred in Article 8(5) of Regulation (EC) No 1107/2009;

(g) an assessment according to the current scientific and technical knowledge of all information submitted;

(h) the identification and proposal for any necessary and appropriate risk mitigation measures;

(i) all relevant information related to the notification of the studies as required in accordance with Article 32b of Regulation (EC) No 178/2002.

CHAPTER 4

FINAL PROVISIONS

Article 12

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I

ANNEX II

Content of notification of interest to apply for the approval of a safener or synergist as referred to in Article 4(1)

1. Identification data on the notifying party:

1.1.manufacturer of the substance (name, address, including location of plant);

1.2.notifying company (name, address, etc.) (if different from 1.1):

1.2.1.acting as sole representative designated by the manufacturer?: Yes/No;

1.3.Identification of the contact person responsible for the notification and further engagements:

1.3.1.Name;

1.3.1.1.Postal address;

1.3.1.2.Email;

1.3.1.3.Primary phone number;

1.3.1.4.Alternative phone number.

2. Identification of the safener or synergist:

2.1.name of the safener or synergist;

2.2.CAS number safener or synergist;

2.3.EC number safener or synergist.

ANNEX III

Supplementary data requirements for submission of applications for the approval of safeners and synergists as referred to in Article 11(1), points (a) and (b)

1.A description of the intended purpose of the use of the safener or synergist and the dose and manner of their use or proposed use.

2.An evaluation of the nature and extent of benefits that accrue from the presence of the safener or synergist following use of the plant protection product, in comparison to an untreated control and in comparison to the use of the same plant protection product not containing the safener or synergist.

3.Reports in summary form of preliminary tests, including glasshouse and field studies, used to assess the activity or dose range finding of the safeners or synergists contained in a plant protection product, when requested by the competent authority. These reports must provide additional information for the competent authority in order to justify the recommended dose of the safener or synergist, and when several are used their ratio.

4.Sufficient information to permit an evaluation of the level, duration and consistency of control or protection or other intended effects of the plant protection product.

4.1.In case of safeners, the following three types of studies:

(a) an investigation of the effects of a treatment on a representative use with a plant protection product containing the relevant safener in relation to the control of the target crop and effect on the treated plants or plant products;

(b) an investigation of the effects of a treatment on a representative use with the same plant protection product without the relevant safener in relation to the control of the target crop and effect on the treated plants or plant products in order to prove that the safener eliminates or reduces phytotoxic effects of the plant protection product;

(c) an investigation of the effects of a treatment on a representative use with the same plant protection product containing the relevant safener but no active substance in order to prove that the safener has no efficacy on its own.

4.2.In case of synergists, the following three types of studies:

(a) an investigation of the effects of a treatment on a representative use with a plant protection product containing the relevant synergist in relation to the control of the target organism and effect on the treated plants or plant products;

(b) an investigation of the effects of a treatment on a representative use with the same plant protection product without the relevant 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 synergist increases the efficacy of the product against the treated pests;

(c) an investigation of the effects of a treatment on a representative use with the same plant protection product containing the relevant synergist but no active substance in order to prove that the synergist has no efficacy on its own.