Commission Implementing Regulation (EU) 2024/2390 of 6 September 2024 renewing the approval of the active substance metrafenone in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011

• CELEX: Implementing Regulation (EU) 2024/2390
• Articles: 5

Article 1 Renewal of the approval of the active substance

The approval of the active substance metrafenone, as specified in Annex I to this Regulation, is renewed, subject to the conditions laid down in that Annex.

Article 2 Amendments to Implementing Regulation (EU) No 540/2011

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Article 3 Entry into force and date of application

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

It shall apply from 1 November 2024.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Metrafenone

CAS No: 220899-03-6

CIPAC No: 752

3′-bromo-2,3,4,6′-tetramethoxy-2′,6-dimethylbenzophenone

≥ 980 g/kg

The impurity dimethyl sulphate shall not exceed 0,01 g/kg in the technical material.

1 November 2024

31 October 2039

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on metrafenone, and in particular Appendices I and II thereto, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

—

the protection of operators and workers;

—

the consumer exposure assessment with regards to residues that may be present in food.

Conditions of use shall include risk mitigation measures, where appropriate.

1)

An updated assessment for point 3.8.2 of Annex II to Regulation (EC) No 1107/2009 to confirm the absence of endocrine activity concerning the T-modality of non-target organisms other than mammals, including where relevant, further information.

2)

An updated assessment of the genotoxicity of the metabolites CL 1500834 and CL 3000402.

The applicant shall submit the information related to point 1 by 29 March 2026 and the information related to point 2 by 29 December 2024.

( 1 )   Further details on the identity and specification of the active substance are provided in the renewal report.

ANNEX II

ANNEX II

The Annex to Commission Implementing Regulation (EU) No 540/2011 is amended as follows:

(1)

in Part A, entry 137 on metrafenone is deleted;

(2)

in Part B, the following entry is added:

No

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

‘171

Metrafenone

CAS No: 220899-03-6

CIPAC No: 752

3′-bromo-2,3,4,6′-tetramethoxy-2′,6-dimethylbenzophenone

≥ 980 g/kg

The impurity dimethyl sulphate shall not exceed 0,01 g/kg in the technical material.

1 November 2024

31 October 2039

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on metrafenone, and in particular Appendices I and II thereto, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

—

the protection of operators and workers;

—

the consumer exposure assessment with regards to residues that may be present in food.

Conditions of use shall include risk mitigation measures, where appropriate.

1)

An updated assessment for point 3.8.2 of Annex II to Regulation (EC) No 1107/2009 to confirm the absence of endocrine activity concerning the T-modality of non-target organisms other than mammals, including where relevant, further information.

2)

An updated assessment of the genotoxicity of the metabolites CL 1500834 and CL 3000402.

The applicant shall submit the information related to point 1 by 29 March 2026 and the information related to point 2 by 29 December 2024.’

( 1 )   Further details on the identity and specification of the active substance are provided in the renewal report.