Commission Implementing Regulation (EU) 2022/43 of 13 January 2022 renewing the approval of the active substance flumioxazin 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 Annexes to Commission Implementing Regulation (EU) No 540/2011 and to Implementing Regulation (EU) 2015/408 (Text with EEA relevance)

Renewal of the approval of the active substance

Article 1

The approval of the active substance flumioxazin 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.

Amendment to Implementing Regulation (EU) 2015/408

Article 3

The entry for flumioxazine is deleted from the Annex to Implementing Regulation (EU) 2015/408.

Entry into force and date of application

Article 4

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 March 2022.

ANNEX ISupplementary provisions

ANNEX I Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions Flumioxazin CAS No 103361-09-7 CIPAC No 578 N -(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2 H -1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboximide ≥ 960 g/kg 1 March 2022 28 February 2037 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 flumioxazin, 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 specification of the technical material that is authorised for use in plant protection products; — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; — the protection of non-target plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority an updated assessment of the information submitted and, where relevant, further information to confirm the absence of endocrine disrupting properties in accordance with points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605  ( 2 ) by 1 March 2024. ( 1 )   Further details on the identity and the specification of the active substance are provided in the renewal report. ( 2 )   https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018R0605&from=EN

ANNEX IISupplementary provisions

ANNEX II The Annex to Commission Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in Part A, entry 39 on flumioxazine 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 ‘ 149 Flumioxazin CAS No 103361-09-7 CIPAC No 578 N -(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2 H -1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboximide ≥ 960 g/kg 1 March 2022 28 February 2037 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 flumioxazin, 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 specification of the technical material that is authorised for use in plant protection products; — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; — the protection of non-target plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority an updated assessment of the information submitted and, where relevant, further information to confirm the absence of endocrine disrupting properties in accordance with points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605  ( 2 ) by 1 March 2024.’ ( 1 )   Further details on the identity and the specification of the active substance are provided in the renewal report. ( 2 )   https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018R0605&from=EN