Commission Implementing Regulation (EU) 2019/1137 of 3 July 2019 renewing the approval of the active substance dimethenamid-P 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) 2019/1137
• Articles: 5

Article 1 Renewal of the approval of active substance

The approval of the active substance dimethenamid-P, 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 September 2019.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Dimethenamid-P

CAS No 163515-14-8

CIPAC No 638

(S)-2-chloro-N-(2,4-dimethyl-3-thienyl)-N-(2-methoxy1-methylethyl)acetamide

≥ 930 g/kg

The following impurity is of toxicological concern and must not exceed the following level in the technical material:

1,1,1,2-Tetrachloroethane (TCE): ≤ 1,0 g/kg

1 September 2019

31 August 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 dimethenamid-P, 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 operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment;

—

the protection of groundwater, in particular regarding the metabolites of dimethenamid-P;

—

the protection of aquatic organisms and small herbivorous mammals.

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 ground water is abstracted for drinking water.

The applicant shall submit the requested information within two years from the date of 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 renewal report.

ANNEX II

ANNEX II

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

(1)

in Part A, entry 67 on dimethenamid-P is deleted;

(2)

in Part B, the following entry is added:

No

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

‘137

Dimethenamid-P

CAS No 163515-14-8

CIPAC No 638

(S)-2-chloro-N-(2,4-dimethyl-3-thienyl)-N-(2-methoxy1-methylethyl)acetamide

≥ 930 g/kg

The following impurity is of toxicological concern and must not exceed the following level in the technical material:

1,1,1,2-Tetrachloroethane (TCE): ≤ 1,0 g/kg

1 September 2019

31 August 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 dimethenamid-P, 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 operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment;

—

the protection of groundwater, in particular regarding the metabolites of dimethenamid-P;

—

the protection of aquatic organisms and small herbivorous mammals.

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 ground water is abstracted for drinking water.

The applicant shall submit the requested information within two years from the date of 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 renewal report.’