Commission Implementing Regulation (EU) 2018/660 of 26 April 2018 renewing the approval of the active substance bentazone 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 the active substance

Article 1

The approval of the active substance bentazone 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 twentieth day following that of its publication in the Official Journal of the European Union . It shall apply from 1 June 2018.

ANNEX ISupplementary provisions

ANNEX I Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions Bentazone CAS No 25057-89-0 CIPAC No 366 3-isopropyl-1 H -2,1,3-benzothiadiazin-4(3 H )-one 2,2- dioxide ≥ 960 g/kg 1,2-dichloroethane < 3 mg/kg 1 June 2018 31 May 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 bentazone, and in particular Appendices I and II thereof, shall be taken into account. In their overall assessment Member States shall pay particular attention to: — the technical specification, — the protection of operators and workers, — the risk to birds and mammals, — the protection of groundwater, particularly but not only in drinking water protected areas, and shall carefully consider the timing of application, soil and/or climatic conditions. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit by 1 February 2019 to the Commission, the Member States and the Authority confirmatory information as regards Level 2/3 tests as currently indicated in the OECD Conceptual Framework investigating the potential for endocrine-mediated effects of bentazone. ( 1 )   Further details on the identity and specification of the 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 11 on bentazone is deleted; (2) in Part B, the following entry is added: Number Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions ‘120 Bentazone CAS No 25057-89-0 CIPAC No 366 3-isopropyl-1 H -2,1,3-benzothiadiazin-4(3 H )-one 2,2- dioxide ≥ 960 g/kg 1,2-dichloroethane < 3 mg/kg 1 June 2018 31 May 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 bentazone, and in particular Appendices I and II thereof, shall be taken into account. In their overall assessment Member States shall pay particular attention to: — the technical specification, — the protection of operators and workers, — the risk to birds and mammals, — the protection of groundwater, particularly but not only in drinking water protected areas, and shall carefully consider the timing of application, soil and/or climatic conditions. Conditions of use shall include risk mitigation measures where appropriate. The applicant shall submit by 1 February 2019 to the Commission, the Member States and the Authority confirmatory information as regards Level 2/3 tests as currently indicated in the OECD Conceptual Framework investigating the potential for endocrine-mediated effects of bentazone.’ ( 1 )   Further details on the identity and specification of the active substance are provided in the review report.