Commission Implementing Regulation (EU) 2015/2033 of 13 November 2015 renewing the approval of the active substance 2,4-D 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) 2015/2033
• Articles: 5

Article 1 Renewal of the approval of active substance

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 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 January 2016.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name,

Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

2,4-D

CAS No: 94-75-7

CIPAC No: 1

(2,4-dichlorophenoxy)acetic acid

≥ 960 g/kg

Impurities:

Free phenols (expressed as 2,4-DCP): not more than 3 g/kg.

Sum of dioxins and furans (WHO-TCDD TEQ)  ( 2 ) : 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.

( 1 )   Further details on identity and specification of active substance are provided in the review report.

( 2 )   Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs), expressed as World Health Organisation (WHO) toxic equivalent (TEQ) using the WHO-toxic equivalency factors (WHO-TEFs)).

ANNEX II

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-D

CAS No: 94-75-7

CIPAC No: 1

(2,4-dichlorophenoxy) acetic acid

≥ 960 g/kg

Impurities:

Free phenols (expressed as 2,4-DCP): not more than 3 g/kg.

Sum of dioxins and furans (WHO-TCDD TEQ)  ( *1 ) : 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.

( *1 )   Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs), expressed as World Health Organisation (WHO) toxic equivalent (TEQ) using the WHO-toxic equivalency factors (WHO-TEFs)).’