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)

Approval of the active substance as a candidate for substitution

Article 1

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

Amendments to Implementing Regulation (EU) No 540/2011

Article 2

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.

Entry into force

Article 3

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

ANNEX ISupplementary provisions

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 IISupplementary provisions

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.’