Commission Implementing Regulation (EU) 2017/1114 of 22 June 2017 renewing the approval of the active substance pendimethalin, as a candidate for substitution, 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: 2017-06-22
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: market approval, plant health control, plant health product








L_2017162EN.01003201.xml










23.6.2017   


EN


Official Journal of the European Union


L 162/32








            COMMISSION IMPLEMENTING REGULATION (EU) 2017/1114
of 22 June 2017
         
renewing the approval of the active substance pendimethalin, as a candidate for substitution, 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 24 in conjunction with Article 20(1) thereof,

Whereas:







(1)


Commission Directive 2003/31/EC (2) included pendimethalin 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 pendimethalin, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2017.












(4)


An application for the renewal of the approval of pendimethalin 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 (‘the Authority’) and the Commission on 4 February 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 17 March 2016 the Authority communicated to the Commission its conclusion on whether pendimethalin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 (6). The Commission presented the draft renewal report for pendimethalin to the Standing Committee on Plants, Animals, Food and Feed on 6 December 2016.












(9)


The applicant was given the possibility 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 pendimethalin 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 pendimethalin.












(11)


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












(12)


The Commission however considers that pendimethalin is a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009. Pendimethalin is a persistent and toxic substance in accordance with points 3.7.2.1 and 3.7.2.3 respectively, of Annex II to Regulation (EC) No 1107/2009, given that the half-life in soil is greater than 120 days and the long-term no-observed-effect concentration for freshwater organisms is less than 0,01 mg/L. Pendimethalin therefore fulfils the condition set in the second indent of point 4 of Annex II to Regulation (EC) No 1107/2009.












(13)


It is therefore appropriate to renew the approval of pendimethalin as a candidate for substitution.












(14)


In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. In particular, it is appropriate to require further confirmatory information.












(15)


In accordance with Article 20(3) of Regulation (EC) No 1107/2009, in conjunction with Article 13(4) thereof, the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.












(16)


Commission Implementing Regulation (EU) 2017/841 (7) extended the approval period pendimethalin to 31 July 2018 in order to allow the renewal process to be completed before the expiry of the approval of that substance. However, given that a decision on renewal has been taken ahead of this extended expiry date, this Regulation shall apply from 1 September 2017.












(17)


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 as a candidate for substitution

The approval of the active substance pendimethalin, as a candidate for substitution, 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 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
            





(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 pendimethalin. EFSA Journal 2016;14(3):4420, 212 pp. doi:10.2903/j.efsa.2016.4420; Available online: www.efsa.europa.eu

(7)  Commission Implementing Regulation (EU) 2017/841 of 17 May 2017 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances alpha-cypermethrin, Ampelomyces quisqualis-strain aq 10, benalaxyl, bentazone, bifenazate, bromoxynil, carfentrazone ethyl, chlorpropham, cyazofamid, desmedipham, diquat, DPX KE 459 (flupyrsulfuron-methyl), etoxazole, famoxadone, fenamidone, flumioxazine, foramsulfuron, Gliocladium catenulatum strain j1446, imazamox, imazosulfuron, isoxaflutole, laminarin, metalaxyl-M, methoxyfenozide, milbemectin, oxasulfuron, pendimethalin, phenmedipham, pymetrozine, S-metolachlor and trifloxystrobin (OJ L 125, 18.5.2017, p. 12).




ANNEX I










Common Name, Identification Numbers


IUPAC Name


Purity (1)



Date of approval


Expiration of approval


Specific provisions




Pendimethalin
CAS No 40487-42-1
CIPAC No 357


N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidene


900 g/kg
1,2-dichloroethane
≤ 1 g/kg
Total 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.






(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, entry 53 on pendimethalin is deleted;










(2)


in Part E, the following entry is added:











 


Common Name, Identification Numbers


IUPAC Name


Purity (1)



Date of approval


Expiration of approval


Specific provisions




‘7


Pendimethalin
CAS No 40487-42-1
CIPAC No 357


N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidene


900 g/kg
1,2-dichloroethane
≤ 1 g/kg
Total 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.’










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