Commission Implementing Regulation (EU) 2024/835 of 12 March 2024 renewing the approval of the active substance trinexapac, as trinexapac-ethyl, 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) 2024/835
• Articles: 5

Article 1 Renewal of the approval of the active substance

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

Article 2 Amendment 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 May 2024.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Trinexapac-ethyl

CAS No 95266-40-3

CIPAC No 732.202

ethyl (1 RS ,4 EZ )-4-cyclopropyl(hydroxy)methylene-3,5-dioxocyclohexanecarboxylate

≥ 950 g/kg

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

—

toluene: 3 g/kg

—

ethyl (1 RS )-3-hydroxy-5-oxocyclohex-3-ene-1-carboxylate (CGA158377): 6 g/kg

1 May 2024

30 April 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 trinexapac-ethyl, and in particular Appendices I and II thereof, shall be taken into account.

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

—

the specification of technical material used in plant protection products, in particular when carrying out assessments of equivalence in accordance with Article 38 of Regulation (EC) No 1107/2009;

—

the assessment of consumer intake from the diet taking into account the residues of the metabolites of trinexapac-ethyl and the impact of processing;

—

the levels of residues of the metabolites of trinexapac-ethyl, when straw is used as animal feeding stuff.

Conditions of use shall include restrictions for feeding of straw to animals and risk mitigation measures, where appropriate.

The applicant shall submit to the Commission, Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues of trinexapac-ethyl and its metabolites present in surface water, when surface water is abstracted for drinking water, by 1 April 2026.

( 1 )   Further details on identity and specification of 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, the entry 132 on trinexapac 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

‘169

Trinexapac-ethyl

CAS No 95266-40-3

CIPAC No 732.202

ethyl (1 RS ,4 EZ )-4-cyclopropyl(hydroxy)methylene-3,5-dioxocyclohexanecarboxylate

≥ 950 g/kg

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

—

toluene: 3 g/kg

—

ethyl (1 RS )-3-hydroxy-5-oxocyclohex-3-ene-1-carboxylate (CGA158377): 6 g/kg

1 May 2024

30 April 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 trinexapac-ethyl, and in particular Appendices I and II thereof, shall be taken into account.

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

—

the specification of technical material used in plant protection products, in particular when carrying out assessments of equivalence in accordance with Article 38 of Regulation (EC) No 1107/2009;

—

the assessment of consumer intake from the diet taking into account the residues of the metabolites of trinexapac-ethyl and the impact of processing;

—

the levels of residues of the metabolites of trinexapac-ethyl, when straw is used as animal feeding stuff.

Conditions of use shall include restrictions for feeding of straw to animals and risk mitigation measures, where appropriate.

The applicant shall submit to the Commission, Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues of trinexapac-ethyl and its metabolites present in surface water, when surface water is abstracted for drinking water, by 1 April 2026.’

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