Commission Implementing Regulation (EU) 2024/1749 of 24 June 2024 renewing the approval of the active substance metconazole as a candidate for substitution 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) 2024/1749
• Articles: 6

Article 1 Renewal of the approval of the active substance

The approval of the active substance metconazole, 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 Amendment to Implementing Regulation (EU) 2015/408

The entry for metconazole is deleted from the Annex to Implementing Regulation (EU) 2015/408.

Article 4 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 September 2024.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

metconazole

CAS No: 125116-23-6 (unstated stereochemistry)

CIPAC No: 706

(1RS,5RS:1RS,5SR)-5-(4-chlorobenzyl)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol

≥ 940 g/kg (sum of cis- and trans-isomers), with cis-metconazole (CL 354801) level not less than 800 g/kg and not more than 950 g/kg

The following impurities shall not exceed the following levels in the technical material:

—

toluene: 2 g/kg

—

ethylcyclohexane: 2 g/kg

1 September 2024

31 August 2031

Use shall be limited to professional users.

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 metconazole, 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 consumer exposure assessment with regards to residues that may be present in the primary crops and succeeding crops grown in rotation;

—

the protection of operators and bystanders/residents;

—

the protection of aquatic organisms.

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

The applicant shall submit confirmatory information as regards:

1.

the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water;

2.

the general toxicity profile of the metabolites M11 and M21 should be further investigated in order to confirm the appropriate toxicological reference values applicable to them. Moreover, confirmation of the presence of M11 and M21 and their ratio among the monohydroxylated metconazole compounds in crops, in order to confirm the residue definition for risk assessment.

The applicant shall submit the confirmatory information referred to in point 1 by 15 July 2026 and in point 2 by 15 July 2026 to the Commission, Member States and the Authority.

( 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 134 on metconazole is deleted;

(2)

in Part E, the following entry is added:

No

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

‘15

metconazole

CAS No: 125116-23-6 (unstated stereochemistry)

CIPAC No: 706

(1RS,5RS:1RS,5SR)-5-(4-chlorobenzyl)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol

≥ 940 g/kg (sum of cis- and trans-isomers), with cis-metconazole (CL 354801) level not less than 800 g/kg and not more than 950 g/kg

The following impurities shall not exceed the following levels in the technical material:

—

toluene: 2 g/kg

—

ethylcyclohexane: 2 g/kg

1 September 2024

31 August 2031

Use shall be limited to professional users.

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 metconazole, 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 consumer exposure assessment with regards to residues that may be present in the primary crops and succeeding crops grown in rotation;

—

the protection of operators and bystanders/residents;

—

the protection of aquatic organisms.

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

The applicant shall submit confirmatory information as regards:

1.

the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water;

2.

the general toxicity profile of the metabolites M11 and M21 should be further investigated in order to confirm the appropriate toxicological reference values applicable to them. Moreover, confirmation of the presence of M11 and M21 and their ratio among the monohydroxylated metconazole compounds in crops, in order to confirm the residue definition for risk assessment.

The applicant shall submit the confirmatory information referred to in point 1 by 15 July 2026 and in point 2 by 15 July 2026 to the Commission, Member States and the Authority.’

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