Commission Implementing Regulation (EU) 2015/2085 of 18 November 2015 approving the active substance mandestrobin, 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 the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

Approval of active substance

Article 1

The active substance mandestrobin, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

Amendments to Implementing Regulation (EU) No 540/2011

Article 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 Mandestrobin CAS No: 173662-97-0 CIPAC 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. ( 1 )   Further details on identity and specification of active substance are provided in the review report.

ANNEX IISupplementary provisions

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  ( *1 ) Date of approval Expiration of approval Specific provisions ‘93 Mandestrobin CAS No: 173662-97-0 CIPAC 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.’ ( *1 )   Further details on identity and specification of active substance are provided in the review report.