
Article 1 
The approval of the active substance 2,4-D, 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 January 2016.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 13 November 2015.
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
2,4-DCAS No: 94-75-7CIPAC No: 1 (2,4-dichlorophenoxy)acetic acid ≥ 960 g/kgImpurities:
 Free phenols (expressed as 2,4-DCP): not more than 3 g/kg.
 Sum of dioxins and furans (WHO-TCDD TEQ): not more than 0,01 mg/kg. 1 January 2016 31 December 2030 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 2,4-D, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms, terrestrial organisms and consumers in cases of uses above 750 g/ha.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority:
((1)) confirmatory information in the form of the submission of the complete results from the existing extended one-generation study;
((2)) confirmatory information in the form of the submission of the Amphibian Metamorphosis Assay (AMA) (OECD (2009) Test No 231) as to verify the potential endocrine properties of the substance.The information set out in point (1) shall be submitted by 4 June 2016 and the information set out in point (2) by 4 December 2017.


ANNEX II

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

((1)) in Part A, entry 27 on 2,4-D is deleted;
((2)) in Part B, the following entry is added:

‘94 2,4-DCAS No: 94-75-7CIPAC No: 1 (2,4-dichlorophenoxy) acetic acid ≥ 960 g/kgImpurities:
 Free phenols (expressed as 2,4-DCP): not more than 3 g/kg.
 Sum of dioxins and furans (WHO-TCDD TEQ): not more than 0,01 mg/kg. 1 January 2016 31 December 2030 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 2,4-D, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms, terrestrial organisms and consumers in cases of uses above 750 g/ha.Conditions of use shall include risk mitigation measures, where appropriate.The notifier shall submit to the Commission, the Member States and the Authority:
((1)) confirmatory information in the form of the submission of the complete study results from the existing extended one-generation study;
((2)) confirmatory information in the form of the submission of the Amphibian Metamorphosis Assay (AMA) (OECD (2009) Test No 231) as to verify the potential endocrine properties of the substance.The information set out in point (1) shall be submitted by 4 June 2016 and the information set out in point (2) by 4 December 2017.

