Commission Implementing Regulation (EU) 2018/1060 of 26 July 2018 renewing the approval of the active substance trifloxystrobin 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 trifloxystrobin is renewed as set out in Annex I.

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 third day following that of its publication in the Official Journal of the European Union . It shall apply from 1 August 2018.

ANNEX ISupplementary provisions

ANNEX I Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions Trifloxystrobin CAS No 141517-21-7 CIPAC No 617 methyl (E)-methoxyimino-{(E)-α-[1-(α,α,α-trifluoro-m-tolyl)ethylideneaminooxyl]-o-tolyl}acetate ≥ 975 g/kg AE 1344136 (max. 4 g/kg) 1 August 2018 31 July 2033 For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on trifloxystrobin, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of groundwater when the substance is applied in regions with vulnerable soil and/or climate conditions; — the protection of aquatic organisms, bees, and of fish-eating birds and mammals. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: (1) the relevance of metabolites that may occur in groundwater, taking into account any relevant classification for trifloxystrobin in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council  ( 2 ) , in particular as toxic for reproduction category 2; (2) the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater is abstracted for drinking water. The applicant shall submit the information requested under point (1) within one year after the publication, on the website of the European Chemicals Agency (ECHA), of the opinion adopted by the Committee for Risk Assessment of the ECHA in accordance with Article 37(4) of Regulation (EC) No 1272/2008 with respect to trifloxystrobin. The applicant shall submit the information requested under point (2) within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission. ( 1 )   Further details on identity and specification of active substance are provided in the review report. ( 2 )   Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p. 1 ).

ANNEX IISupplementary provisions

ANNEX II The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in Part A, the entry 59 on trifloxystrobin is deleted; (2) in Part B, the following entry is added: No Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions ‘124 Trifloxystrobin CAS No 141517-21-7 CIPAC No 617 methyl (E)-methoxyimino-{(E)-α-[1-(α,α,α-trifluoro-m-tolyl)ethylideneaminooxyl]-o-tolyl}acetate ≥ 975 g/kg AE 1344136 (max. 4 g/kg) 1 August 2018 31 July 2033 For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on trifloxystrobin, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of groundwater when the substance is applied in regions with vulnerable soil and/or climate conditions; — the protection of aquatic organisms, bees, and of fish-eating birds and mammals. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: (1) the relevance of metabolites that may occur in groundwater, taking into account any relevant classification for trifloxystrobin in accordance with Regulation (EC) No 1272/2008, in particular as toxic for reproduction category 2; (2) the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater is abstracted for drinking water. The applicant shall submit the information requested under point (1) within one year after the publication, on the website of the European Chemicals Agency (ECHA), of the opinion adopted by the Committee for Risk Assessment of the ECHA in accordance with Article 37(4) of Regulation (EC) No 1272/2008 with respect to trifloxystrobin. The applicant shall submit the information requested under point (2) within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.’ ( 1 )   Further details on identity and specification of active substance are provided in the review report.