
Article 1 
The approval of the active substance lambda-cyhalothrin, as a candidate for substitution, is renewed as set out in Annex I.
Article 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.
It shall apply from 1 April 2016.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 4 February 2016.
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
Lambda-CyhalothrinCAS No 91465-08-6CIPAC No 463 A 1:1 mixture of:(R)-α-cyano-3-phenoxybenzyl (1S,3S)-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate or of (R)-α-cyano-3-phenoxybenzyl (1S)-cis-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3-phenoxybenzyl (1R)-cis-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate 900 g/kg 1 April 2016 31 March 2023 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 lambda-cyhalothrin, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to the:
((a)) protection of operators, workers and bystanders;
((b)) metabolites potentially formed in processed commodities;
((c)) risk to aquatic organisms, mammals and non-target arthropods.Conditions of use shall include risk mitigation measures, where appropriate.The applicants shall submit confirmatory information as regards:
1.. a systematic review to assess the evidence available as regards potential sperm effects linked to exposure to lambda-cyhalothrin using guidance available (e.g. EFSA GD on Systematic Review methodology, 2010);
2.. toxicological information to assess the toxicological profile of the metabolites V (PBA) and XXIII (PBA(OH)).The applicants shall submit those information to the Commission, the Member States and the Authority by 1 April 2018.

ANNEX II

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

((1)) in Part A, entry 12 on lambda-cyhalothrin is deleted;
((2)) in Part E, the following entry is added:

 Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions
‘5 Lambda-CyhalothrinCAS No 91465-08-6CIPAC No 463 A 1:1 mixture of:(R)-α-cyano-3-phenoxybenzyl (1S,3S)-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate or of (R)-α-cyano-3-phenoxybenzyl (1S)-cis-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3-phenoxybenzyl (1R)-cis-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate 900 g/kg 1 April 2016 31 March 2023 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 lambda-cyhalothrin, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to the:
((a)) protection of operators, workers and bystanders;
((b)) metabolites potentially formed in processed commodities;
((c)) risk to aquatic organisms, mammals and non-target arthropods.Conditions of use shall include risk mitigation measures, where appropriate.The applicants shall submit confirmatory information as regards:
1.. a systematic review to assess the evidence available as regards potential sperm effects linked to exposure to lambda-cyhalothrin using guidance available (e.g. EFSA GD on Systematic Review methodology, 2010);
2.. toxicological information to assess the toxicological profile of the metabolites V (PBA) and XXIII (PBA(OH)).The applicants shall submit those information to the Commission, the Member States and the Authority by 1 April 2018.’

