Commission Implementing Regulation (EU) 2019/337 of 27 February 2019 approving the active substance mefentrifluconazole 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 mefentrifluconazole, 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 Mefentrifluconazole CAS No: 1417782-03-6 CIPAC No: Not assigned (2RS)-2-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]-1-(1H-1,2,4-triazol-1-yl)propan-2-ol ≥ 970 g/kg The impurity N, N-dimethylformamide shall not exceed 0,5 g/kg in the technical material. The impurity toluene shall not exceed 1 g/kg in the technical material The impurity 1,2,4-(1H)-triazole shall not exceed 1 g/kg in the technical material 20 March 2019 20 March 2029 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 mefentrifluconazole, 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, ensuring that conditions of use include the application of adequate personal protective equipment; — the protection of aquatic organisms. Conditions of use shall include risk mitigation measures, such as buffer zones and/or vegetative strips, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: 1. the technical specification of the active substance as manufactured (based on commercial scale production) and the compliance of the toxicity batches with the confirmed technical specification; 2. the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or ground water is abstracted for drinking water. The applicant shall submit the information referred to in point 1 by 20 March 2020 and the information referred to in point 2 within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. ( 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 ‘132 Mefentrifluconazole CAS No: 1417782-03-6 CIPAC No: Not assigned (2RS)-2-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]-1-(1H-1,2,4-triazol-1-yl)propan-2-ol ≥ 970 g/kg The impurity N, N-dimethylformamide shall not exceed 0,5 g/kg in the technical material. The impurity toluene shall not exceed 1 g/kg in the technical material The impurity 1,2,4-(1H)-triazole shall not exceed 1 g/kg in the technical material 20 March 2019 20 March 2029 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 mefentrifluconazole, 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, ensuring that conditions of use include the application of adequate personal protective equipment; — the protection of aquatic organisms. Conditions of use shall include risk mitigation measures, such as buffer zones and/or vegetative strips, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: 1. the technical specification of the active substance as manufactured (based on commercial scale production) and the compliance of the toxicity batches with the confirmed technical specification; 2. the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or ground water is abstracted for drinking water. The applicant shall submit the information referred to in point 1 by 20 March 2020 and the information referred to in point 2 within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.’ ( 1 )   Further details on identity and specification of active substance are provided in the review report.