Commission Implementing Regulation (EU) 2019/158 of 31 January 2019 renewing the approval of the active substance methoxyfenozide, as a candidate for substitution, 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) 2019/158
• Articles: 5

Article 1 Renewal of the approval of the active substance as a candidate for substitution

The approval of the active substance methoxyfenozide, as a candidate for substitution, is renewed as set out in Annex I.

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 third day following that of its publication in the Official Journal of the European Union .

It shall apply from 1 April 2019.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Methoxyfenozide

CAS No 161050-58-4

CIPAC No 656

N-tert-Butyl-N′-(3-methoxy-o-toluoyl)-3,5-xylohydrazide

≥ 970 g/kg

The following impurities must not exceed the following levels in the technical material:

Tert-butylhydrazine < 0,001 g/kg

RH-116267 < 2 g/kg

1 April 2019

31 March 2026

Only uses in greenhouses shall be authorised.

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 methoxyfenozide, and in particular Appendices I and II thereto, shall be taken into account.

In their 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 climate conditions;

—

the risk of accumulation in soil;

—

the protection of non-target arthropods, sediment dwelling and aquatic organisms;

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.

a comparative in vitro metabolism study on methoxyfenozide, by 1 April 2020;

2.

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, within 2 years after adoption of a guidance document on 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 of the information submitted and, where relevant, further information to confirm the absence of thyroid endocrine activity in accordance with Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605  ( 2 ) , by 1 February 2021.

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

( 2 )   Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties ( OJ L 101, 20.4.2018, p. 33 ).

ANNEX II

ANNEX II

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

(1)

in Part A, entry 96 on methoxyfenozide is deleted;

(2)

in Part E, the following entry is added:

No.

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

‘11

Methoxyfenozide

CAS No 161050-58-4

CIPAC No 656

N-tert-Butyl-N′-(3-methoxy-o-toluoyl)-3,5-xylohydrazide

≥ 970 g/kg

The following impurities must not exceed the following levels in the technical material:

Tert-butylhydrazine < 0,001 g/kg

RH-116267 < 2 g/kg

1 April 2019

31 March 2026

Only uses in greenhouses shall be authorised.

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 methoxyfenozide, and in particular Appendices I and II thereto, shall be taken into account.

In their 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 climate conditions;

—

the risk of accumulation in soil;

—

the protection of non-target arthropods, sediment dwelling and aquatic organisms;

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.

a comparative in vitro metabolism study on methoxyfenozide, by 1 April 2020;

2.

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, within 2 years after adoption of a guidance document on 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 of the information submitted and, where relevant, further information to confirm the absence of thyroid endocrine activity in accordance with Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605  ( 2 ) by 1 February 2021.

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

( 2 )   Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties. ( OJ L 101, 20.4.2018, p. 33 ).’