Commission Implementing Regulation (EU) 2019/717 of 8 May 2019 renewing the approval of the active substance isoxaflutole 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.)

• CELEX: Implementing Regulation (EU) 2019/717
• Articles: 5

Article 1 Renewal of the approval of active substance

The approval of the active substance isoxaflutole, as specified in Annex I, is renewed subject to the conditions laid down in that Annex.

Article 2 Amendments to Implementing Regulation (EU) No 540/2011

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Article 3 Entry into force and date of application

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 August 2019.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Isoxaflutole

CAS No 141112-29-0

CIPAC No 575

(5-cyclopropyl-1,2-oxazol-4-yl)(α,α,α-trifluoro-2-mesyl-p-tolyl)methanone

≥ 972 g/kg

1 August 2019

31 July 2034

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 isoxaflutole, 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 climatic conditions,

—

the protection of aquatic organisms, wild mammals and non-target terrestrial plants.

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 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 this information within 2 years from the date of publication, by the Commission, of a guidance document on the evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.

The applicant shall also provide an updated assessment to confirm that isoxaflutole is not an endocrine disruptor within the meaning of 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 and in accordance with the guidance for the identification of endocrine disruptors  ( 2 ) by 10 May 2021.

( 1 )   Further details on the identity and the specification of the active substance are provided in the renewal report.

( 2 )   Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 https://efsa.onlinelibrarv.wilev.eom/doi/epdt710.2903/i.efsa.2018.5311

ANNEX II

ANNEX II

The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

(1)

in Part A, entry 63 on isoxaflutole is deleted;

(2)

in Part B, the following entry is added:

‘134

Isoxaflutole

CAS No 141112-29-0

CIPAC No 575

(5-cyclopropyl-1,2-oxazol-4-yl)(α,α,α-trifluoro-2-mesyl-p-tolyl)methanone

≥ 972 g/kg

1 August 2019

31 July 2034

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 isoxaflutole, 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 climatic conditions,

—

the protection of aquatic organisms, wild mammals and non-target terrestrial plants.

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 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 this information within 2 years from the date of publication, by the Commission, of a guidance document on the evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.

The applicant shall also provide an updated assessment to confirm that isoxaflutole is not an endocrine disruptor within the meaning of 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 and in accordance with the guidance for identification of endocrine disruptors  ( *1 ) by 10 May 2021.

( *1 )   Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 https://efsa.onlinelibrarv.wilev.eom/doi/epdt710.2903/i.efsa.2018.5311’.