Commission Implementing Regulation (EU) 2015/1201 of 22 July 2015 renewing the approval of the active substance fenhexamid 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)

Renewal of the approval of active substance

Article 1

The approval of the active substance fenhexamid, as specified in Annex I, is renewed, 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 and date of application

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 January 2016.

ANNEX ISupplementary provisions

ANNEX I Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions Fenhexamid CAS No: 126833-17-8 CIPAC No: 603 N-(2,3-dichloro-4-hydroxyphenyl)-1-methylcyclohexane-1-carboxamide ≥ 975 g/kg The following relevant impurity must not exceed a certain threshold in the technical material: — toluene: max. 1 g/kg, — 4-amino-2,3-dichlorophenol: max. 3 g/kg. 1 January 2016 31 December 2030 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 fenhexamid, 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 protection of operators during field crop handheld operations, — the protection of workers re-entering indoor-treated crops, — the risk to aquatic organisms, — the long-term risk to mammals for field uses. Conditions of use shall include risk mitigation measures, where appropriate. ( 1 )   Further details on identity and specification of active substance are provided in the review report.

ANNEX IISupplementary provisions

ANNEX II The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in Part A, entry 13 on fenhexamid is deleted; (2) in Part B, the following entry is added:   Common Name, Identification Numbers IUPAC Name Purity  ( *1 ) Date of approval Expiration of approval Specific provisions ‘85 Fenhexamid CAS No: 126833-17-8 CIPAC No: 603 N-(2,3-dichloro-4-hydroxyphenyl)-1-methylcyclohexane-1-carboxamide ≥ 975 g/kg The following relevant impurity must not exceed a certain threshold in the technical material: — toluene: max. 1 g/kg, — 4-amino-2,3-dichlorophenol: max. 3 g/kg. 1 January 2016 31 December 2030 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 fenhexamid, 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 protection of operators during field crop handheld operations, — the protection of workers re-entering indoor-treated crops, — the risk to aquatic organisms, — the long-term risk to mammals for field uses. Conditions of use shall include risk mitigation measures, where appropriate.’ ( *1 )   Further details on identity and specification of active substance are provided in the review report.