Commission Implementing Regulation (EU) 2017/1491 of 21 August 2017 renewing the approval of the active substance 2,4-DB 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. )
Date: 2017-08-21
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: market approval, pesticide, plant health control








L_2017216EN.01001501.xml










22.8.2017   


EN


Official Journal of the European Union


L 216/15








            COMMISSION IMPLEMENTING REGULATION (EU) 2017/1491
of 21 August 2017
         
renewing the approval of the active substance 2,4-DB 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)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20(1) thereof,

Whereas:







(1)


Commission Directive 2003/31/EC (2) included 2,4-DB as an active substance in Annex I to Council Directive 91/414/EEC (3).












(2)


Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).












(3)


The approval of the active substance 2,4-DB, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 October 2017.












(4)


An application for the renewal of the approval of 2,4-DB was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.












(5)


The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.












(6)


The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (hereinafter ‘the Authority’) and the Commission on 3 June 2015.












(7)


The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.












(8)


On 13 May 2016, the Authority communicated to the Commission its conclusion (6) on whether 2,4-DB can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft renewal report for 2,4-DB to the Standing Committee on Plants, Animals, Food and Feed on 18 May 2017.












(9)


The applicant was given the opportunity to submit comments on the draft renewal report.












(10)


It has been established with respect to one or more representative uses of at least one plant protection product containing 2,4-DB that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to renew the approval of 2,4-DB.












(11)


The risk assessment for the renewal of the approval of 2,4-DB is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing 2,4-DB may be authorised. It is therefore appropriate to remove the restriction for use only as a herbicide.












(12)


Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.












(13)


Commission Implementing Regulation (EU) 2016/950 (7) extended the approval period of 2,4-DB to 31 October 2017 in order to allow the renewal process to be completed before the expiry of the approval of that substance.












(14)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,





HAS ADOPTED THIS REGULATION:



Article 1

Renewal of the approval of the active substance

The approval of the active substance 2,4-DB is renewed as set out in Annex I.


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 November 2017.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 21 August 2017.


For the Commission


The President

Jean-Claude JUNCKER
            





(1)  
            OJ L 309, 24.11.2009, p. 1.

(2)  Commission Directive 2003/31/EC of 11 April 2003 amending Council Directive 91/414/EEC to include 2,4-DB, beta-cyfluthrin, cyfluthrin, iprodione, linuron, maleic hydrazide and pendimethalin as active substances (OJ L 101, 23.4.2003, p. 3).

(3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

(4)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

(5)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

(6)  EFSA (European Food Safety Authority), 2016. Conclusion on the peer review of the pesticide risk assessment of the active substance 2,4-DB. EFSA Journal 2016;14(5):4500. Available online: www.efsa.europa.eu

(7)  Commission Implementing Regulation (EU) 2016/950 of 15 June 2016 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 2,4-DB, beta-cyfluthrin, carfentrazone ethyl, Coniothyrium minitans Strain CON/M/91-08 (DSM 9660), cyazofamid, deltamethrin, dimethenamid-P, ethofumesate, fenamidone, flufenacet, flurtamone, foramsulfuron, fosthiazate, imazamox, iodosulfuron, iprodione, isoxaflutole, linuron, maleic hydrazide, mesotrione, oxasulfuron, pendimethalin, picoxystrobin, silthiofam and trifloxystrobin (OJ L 159, 16.6.2016, p. 3).




ANNEX I










Common Name, Identification Numbers


IUPAC Name


Purity (1)



Date of approval


Expiration of approval


Specific provisions




2,4-DB
CAS No 94-82-6
CIPAC No 83


4-(2,4-dichlorophenoxy) butyric acid


≥ 940 g/kg
Impurities:
Free phenols (expressed as 2,4-dichlorophenol (2,4-DCP)): max. 15 g/kg.
Dibenzo-p-dioxins and polychlorinated dibenzofurans (TCDD toxic equivalents (TEQ)): max. 0,01 mg/kg.


1 November 2017


31 October 2032


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-DB, 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 protection of operators and workers,










—


the protection of consumers from products of animal origin,










—


the protection of wild mammals,










—


the protection of soil non-target organisms,










—


the protection of aquatic organisms,










—


the protection of non-target terrestrial plants.




Conditions of use shall include risk mitigation measures, where appropriate.






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





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






(1)


in Part A, the entry 47 on 2,4-DB is deleted;










(2)


in Part B, the following entry is added:











Number


Common Name, Identification Numbers


IUPAC Name


Purity (1)



Date of approval


Expiration of approval


Specific provisions




‘116


2,4-DB
CAS No 94-82-6
CIPAC No 83


4-(2,4-dichlorophenoxy) butyric acid


≥ 940 g/kg
Impurities:
Free phenols (expressed as 2,4-dichlorophenol (2,4-DCP)): max. 15 g/kg.
Dibenzo-p-dioxins and polychlorinated dibenzofurans (TCDD toxic equivalents (TEQ)): max. 0,01 mg/kg.


1 November 2017


31 October 2032


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-DB, 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 protection of operators and workers,










—


the protection of consumers from products of animal origin,










—


the protection of wild mammals,










—


the protection of soil non-target organisms,










—


the protection of aquatic organisms,










—


the protection of non-target terrestrial plants.




Conditions of use shall include risk mitigation measures, where appropriate.’










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