
Article 1 
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 
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Article 3 
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 3 July 2019.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX I

Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions
Dimethenamid-PCAS No 163515-14-8CIPAC No 638 (S)-2-chloro-N-(2,4-dimethyl-3-thienyl)-N-(2-methoxy1-methylethyl)acetamide ≥ 930 g/kgThe 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.

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 Date of approval Expiration of approval Specific provisions
‘137 Dimethenamid-PCAS No 163515-14-8CIPAC No 638 (S)-2-chloro-N-(2,4-dimethyl-3-thienyl)-N-(2-methoxy1-methylethyl)acetamide ≥ 930 g/kgThe 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.

