
Article 1 
The approval of the active substance pendimethalin, as a candidate for substitution, is renewed as set out in Annex I.
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 2017.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 22 June 2017.
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
PendimethalinCAS No 40487-42-1CIPAC No 357 N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidene 900 g/kg1,2-dichloroethane≤ 1 g/kgTotal 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.

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 Date of approval Expiration of approval Specific provisions
‘7 PendimethalinCAS No 40487-42-1CIPAC No 357 N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidene 900 g/kg1,2-dichloroethane≤ 1 g/kgTotal 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.’

