
Article 1 
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 7 February 2018.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX

The column ‘Specific provisions’ of row 55, penflufen, of Part B of the Annex to Implementing Regulation (EU) No 540/2011 is replaced by the following:
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PART A Only uses to treat seeds or other propagating materials before or during sowing or planting, may be authorised, limited to one application every third year on the same field.

PART B 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 penflufen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 and of the addendum to the review report on penflufen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 13 December 2017 shall be taken into account.
In this overall assessment Member States shall pay particular attention to:

((a)) the protection of operators;
((b)) the long-term risk to birds;
((c)) the protection of groundwater, when the substance is applied to regions with vulnerable soil and/or climatic conditions;
((d)) to the residues in surface water abducted for drinking water purposes, in or from areas where products containing penflufen are used.
Conditions of use shall include risk mitigation measures, where appropriate.
The applicant shall submit confirmatory information as regards the relevance of the metabolite M01 (penflufen-3-hydroxy-butyl) for groundwater if penflufen is classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council as “carcinogen category 2”. That information shall be submitted to the Commission, the Member States and the Authority within 6 months from the notification of the classification decision concerning that substance.
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