Commission Implementing Regulation (EU) 2017/1114 of 22 June 2017 renewing the approval of the active substance pendimethalin, 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) 2017/1114
• Articles: 5

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

The approval of the active substance pendimethalin, 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 twentieth day following that of its publication in the Official Journal of the European Union .

It shall apply from 1 September 2017.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Pendimethalin

CAS No 40487-42-1

CIPAC No 357

N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidene

900 g/kg

1,2-dichloroethane

≤ 1 g/kg

Total N-Nitroso compounds: max 100 ppm, of which N-Nitroso-pendimethalin: < 45 ppm.

1 September 2017

31 August 2024

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 pendimethalin, and in particular Appendices I and II thereof, shall be taken into account.

In their overall assessment Member States shall pay particular attention to:

—

the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against the specification of the technical material,

—

the protection of operators,

—

the protection of birds, mammals and aquatic organisms.

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

In particular, personal protective equipment such as gloves, coverall and sturdy footwear has to be worn to ensure that the AOEL is not exceeded for the operator.

The applicant shall submit confirmatory information to the Commission, the Member States and the Authority as regards:

1.

the potential for bioaccumulation, in particular a reliable BCF value for bluegill sunfish ( Lepomis macrochirus );

2.

the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater are abstracted for drinking water.

The applicant shall submit the confirmatory information requested under point 1 by 31 December 2018. The applicant shall submit the confirmatory information requested under point 2 within a period of two years of the publication by the Commission of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.

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

ANNEX II

ANNEX II

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

(1)

in Part A, entry 53 on pendimethalin is deleted;

(2)

in Part E, the following entry is added:

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

‘7

Pendimethalin

CAS No 40487-42-1

CIPAC No 357

N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidene

900 g/kg

1,2-dichloroethane

≤ 1 g/kg

Total N-Nitroso compounds: max 100 ppm, of which N-Nitroso-pendimethalin: < 45 ppm.

1 September 2017

31 August 2024

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 pendimethalin, and in particular Appendices I and II thereof, shall be taken into account.

In their overall assessment Member States shall pay particular attention to:

—

the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against the specification of the technical material,

—

the protection of operators,

—

the protection of birds, mammals and aquatic organisms.

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

In particular, personal protective equipment such as gloves, coverall and sturdy footwear has to be worn to ensure that the AOEL is not exceeded for the operator.

The applicant shall submit confirmatory information to the Commission, the Member States and the Authority as regards:

1.

the potential for bioaccumulation, in particular a reliable BCF value for bluegill sunfish ( Lepomis macrochirus );

2.

the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater are abstracted for drinking water.

The applicant shall submit the confirmatory information requested under point 1 by 31 December 2018. The applicant shall submit the confirmatory information requested under point 2 within a period of two years of the publication by the Commission of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.’

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