
Article 1 
The active substance flumetralin is approved as set out in Annex I as a candidate for substitution.
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.
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 20 November 2015.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX I

Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions
FlumetralinCAS No 62924-70-3CIPAC No 971 N-(2-chloro-6-fluorobenzyl)-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine 980 g/kgThe 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.

ANNEX II

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

 Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions
1 FlumetralinCAS No 62924-70-3CIPAC No 971 N-(2-chloro-6-fluorobenzyl)-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine 980 g/kgThe 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.

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