
Article 1 
The active substance mandestrobin, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 18 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
MandestrobinCAS No: 173662-97-0CIPAC No: Not available (RS)-2-methoxy-N-methyl-2-[α-(2,5-xylyloxy)-o-tolyl]acetamide ≥ 940 g/kg (on a dry weight basis)Xylenes (ortho, meta, para), ethyl benzene max. 5 g/kg (TK) 9 December 2015 9 December 2025 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 mandestrobin, 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 risk to aquatic organisms,
— the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.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) including the relevance of some individual impurities;
((2)) the compliance of the toxicity batches with the confirmed technical specification.The applicant shall submit that information to the Commission, the Member States and the Authority by 9 June 2016.

ANNEX II

In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

 Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions
‘93 MandestrobinCAS No: 173662-97-0CIPAC No: Not available (RS)-2-methoxy-N-methyl-2-[α-(2,5-xylyloxy)-o-tolyl]acetamide ≥ 940 g/kg (on a dry weight basis)Xylenes (ortho, meta, para), ethyl benzene max. 5 g/kg (TK) 9 December 2015 9 December 2025 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 mandestrobin, 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 risk to aquatic organisms,
— the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.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) including the relevance of some individual impurities;
((2)) the compliance of the toxicity batches with the confirmed technical specification.The applicant shall submit that information to the Commission, the Member States and the Authority by 9 June 2016.’

