Commission Implementing Regulation (EU) 2019/481 of 22 March 2019 approving the active substance flutianil, 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) 2019/481
• Articles: 5

Article 1 Approval of active substance

The active substance flutianil, as specified in Annex I, is approved 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

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Flutianil

CAS No [958647-10-4]

CIPAC No 835

( Z )-[3-(2-methoxyphenyl)-1,3-thiazolidin-2-ylidene](α,α,α,4-tetrafluoro- m -tolylthio)acetonitrile

≥ 985 g/kg

14 April 2019

14 April 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 flutianil, 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 and workers,

—

the risk to aquatic organisms,

—

the risk to groundwater from metabolites, if the substance is applied under vulnerable soil or climatic conditions.

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 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;

3.

an updated assessment of the information submitted and, where relevant further information, confirming that flutianil is not an endocrine disruptor in accordance with Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, applying also the ECHA and EFSA guidance for identification of endocrine disruptors  ( 2 ) .

The applicant shall submit the information:

—

referred to in point 1 by 14 April 2020;

—

referred to in point 2 within two 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; and

—

referred to in point 3 by 14 April 2021.

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

( 2 )   Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009. EFSA Journal 2018;16(6):5311; ECHA-18-G-01-EN.

ANNEX II

ANNEX II

In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

‘133

Flutianil

CAS No [958647-10-4]

CIPAC No 835

( Z )-[3-(2-methoxyphenyl)-1,3-thiazolidin-2-ylidene](α,α,α,4-tetrafluoro- m -tolylthio)acetonitrile

≥ 985 g/kg

14 April 2019

14 April 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 flutianil, 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 and workers,

—

the risk to aquatic organisms,

—

the risk to groundwater from metabolites, if the substance is applied under vulnerable soil or climatic conditions.

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 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;

3.

an updated assessment of the information submitted and, where relevant further information, confirming that flutianil is not an endocrine disruptor in accordance with Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, applying also the ECHA and EFSA guidance for identification of endocrine disruptors  ( *1 ) .

The applicant shall submit the information:

—

referred to in point 1 by 14 April 2020;

—

referred to in point 2 within two years from the date of publication, from 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; and

—

referred to in point 3 by 14 April 2021.

( *1 )   Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009. EFSA Journal 2018;16(6):5311; ECHA-18-G-01-EN.’