Commission Implementing Regulation (EU) 2018/1265 of 20 September 2018 approving the active substance fenpicoxamid 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 Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance.)

• CELEX: Implementing Regulation (EU) 2018/1265
• Articles: 5

Article 1 Approval of active substance

The active substance fenpicoxamid, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

Article 2 Amendment 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

Fenpicoxamid

CAS No: 517875-34-2

CIPAC No: 991

(3 S ,6 S ,7 R ,8 R )-8-benzyl-3-{3-[(isobutyryloxy)methoxy]-4-methoxypyridine-2-carboxamido}-6-methyl-4,9-dioxo-1,5-dioxonan-7-yl isobutyrate

≥ 750 g/kg

11 October 2018

11 October 2028

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 fenpicoxamid, 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 impact of processing on the consumer risk assessment,

—

the risk to aquatic organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit 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 drinking water;

3.

the endocrine disrupting potential of fenpicoxamid as regards the thyroid modality/pathway, providing in particular mechanistic data to clarify according to 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 ) , whether the effects observed in the studies submitted for approval are or are not related to a thyroid endocrine disrupting mode of action.

The applicant shall submit to the Commission, the Member States and the Authority the information referred to in point 1 by 11 October 2019, in point 2 within 2 years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission and in point 3 by 10 November 2020.

( 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

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

No

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

‘126

Fenpicoxamid

CAS No: 517875-34-2

CIPAC No: 991

(3 S ,6 S ,7 R ,8 R )-8-benzyl-3-{3-[(isobutyryloxy)methoxy]-4-methoxypyridine-2-carboxamido}-6-methyl-4,9-dioxo-1,5-dioxonan-7-yl isobutyrate

≥ 750 g/kg

11 October 2018

11 October 2028

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 fenpicoxamid, 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 impact of processing on the consumer risk assessment,

—

the risk to aquatic organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit 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 drinking water;

3.

the endocrine disrupting potential of fenpicoxamid as regards the thyroid modality/pathway, providing in particular mechanistic data to clarify according to 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 ) , whether the effects observed in the studies submitted for approval are or are not related to a thyroid endocrine disrupting mode of action.

The applicant shall submit to the Commission, the Member States and the Authority the information referred to in point 1 by 11 October 2019, in point 2 within 2 years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission and in point 3 by 10 November 2020.’

( 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 ).