Commission Implementing Regulation (EU) 2025/833 of 5 May 2025 renewing the approval of the active substance lenacil in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulations (EU) No 540/2011 and (EU) 2015/408

• CELEX: Implementing Regulation (EU) 2025/833
• Articles: 6

Article 1 Renewal of the approval of the active substance

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

The entry for lenacil 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 July 2025.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Lenacil

CAS No: 2164-08-01

CIPAC No: 163

3-cyclohexyl-6,7-dihydro-1H-cyclopenta[d]pyrimidine-2,4(3H,5H)-dione

or

3-cyclohexyl-1,5,6,7-tetrahydrocyclopentapyrimidine-2,4(3H)-dione

975 g/kg

1 July 2025

30 June 2040

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 lenacil, and in particular Appendices I and II thereto, shall be taken into account.

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

In this overall assessment Member States shall pay particular attention to the possible need for additional rotational crop field trials and a livestock exposure assessment until the required confirmatory information has been assessed by the rapporteur Member State and evaluated by the Authority.

By 25 March 2027, the applicant shall submit to the Commission, the Member States and the Authority confirmatory information on rotational crops field trials, including analysis for known and possible new metabolites. If new metabolites are found, the applicant is requested to perform toxicological studies assessing these metabolites. The applicant is requested to perform an appropriate livestock exposure assessment if necessary.

( 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 Implementing Regulation (EU) No 540/2011 is amended as follows:

(1)

in Part A, entry 176 on lenacil 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

‘175

Lenacil

CAS No: 2164-08-01

CIPAC No: 163

3-cyclohexyl-6,7-dihydro-1H-cyclopenta[d]pyrimidine-2,4(3H,5H)-dione

or

3-cyclohexyl-1,5,6,7-tetrahydrocyclopentapyrimidine-2,4(3H)-dione

975 g/kg

1 July 2025

30 June 2040

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 lenacil, and in particular Appendices I and II thereto, shall be taken into account.

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

In this overall assessment Member States shall pay particular attention to the possible need for additional rotational crop field trials and a livestock exposure assessment until the required confirmatory information has been assessed by the rapporteur Member State and evaluated by the Authority.

By 25 March 2027, the applicant shall submit to the Commission, the Member States and the Authority confirmatory information on rotational crops field trials, including analysis for known and possible new metabolites. If new metabolites are found, the applicant is requested to perform toxicological studies assessing these metabolites. The applicant is requested to perform an appropriate livestock exposure assessment if necessary.’

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