Commission Implementing Regulation (EU) 2015/2105 of 20 November 2015 approving the active substance flumetralin, as a candidate for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2015/2105
• Articles: 5

Article 1 Approval of the active substance as a candidate for substitution

The active substance flumetralin is approved as set out in Annex I as a candidate for substitution.

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

1.   In Article 1 of Implementing Regulation (EU) No 540/2011 the second paragraph is replaced by the following paragraph:

‘The active substances approved under Regulation (EC) No 1107/2009 are as set out in Part B of the Annex to this Regulation. The basic substances approved under Regulation (EC) No 1107/2009 are as set out in Part C of the Annex to this Regulation. The low-risk active substances approved under Regulation (EC) No 1107/2009 are as set out in Part D of the Annex to this Regulation. The candidates for substitution approved under Regulation (EC) No 1107/2009 are as set out in Part E of the Annex to this Regulation.’

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

Article 3 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 .

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Flumetralin

CAS No 62924-70-3

CIPAC No 971

N -(2-chloro-6-fluorobenzyl)- N -ethyl-α,α,α-trifluoro-2,6-dinitro- p -toluidine

980 g/kg

The impurity Nitrosamine (calculated as nitroso-dimethylamine) shall not exceed 0,001 g/kg in the technical material.

11 December 2015

11 December 2022

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

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

(a)

the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate;

(b)

the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;

(c)

the risk to herbivorous mammals;

(d)

the risk to aquatic organisms.

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

The applicant shall submit confirmatory information as regards:

1.

the technical specification of the active substance as manufactured (based on commercial scale production);

2.

the compliance of the toxicity batches with the confirmed technical specification.

The applicant shall submit to the Commission, the Member States and the Authority the information referred to in points 1 and 2 by 11 June 2016.

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

ANNEX II

ANNEX II

In the Annex to Implementing Regulation (EU) No 540/2011 the following Part E is added:

‘PART E

Candidates for substitution

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

1

Flumetralin

CAS No 62924-70-3

CIPAC No 971

N -(2-chloro-6-fluorobenzyl)- N -ethyl-α,α,α-trifluoro-2,6-dinitro- p -toluidine

980 g/kg

The impurity Nitrosamine (calculated as nitroso-dimethylamine) shall not exceed 0,001 g/kg in the technical material.

11 December 2015

11 December 2022

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

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

(a)

the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate;

(b)

the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;

(c)

the risk to herbivorous mammals;

(d)

the risk to aquatic organisms.

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

The applicant shall submit confirmatory information as regards:

1.

the technical specification of the active substance as manufactured (based on commercial scale production);

2.

the compliance of the toxicity batches with the confirmed technical specification.

The applicant shall submit to the Commission, the Member States and the Authority the information referred to in points 1 and 2 by 11 June 2016.

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