Commission Implementing Regulation (EU) 2017/842 of 17 May 2017 renewing the approval of the low-risk active substance Coniothyrium minitans strain CON/M/91-08 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: 2017-05-17
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: market approval, plant health control, plant health product








L_2017125EN.01001601.xml










18.5.2017   


EN


Official Journal of the European Union


L 125/16








            COMMISSION IMPLEMENTING REGULATION (EU) 2017/842
of 17 May 2017
         
renewing the approval of the low-risk active substance Coniothyrium minitans strain CON/M/91-08 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 22(1) in conjunction with Article 20(1) thereof,

Whereas:







(1)


Commission Directive 2003/79/EC (2) included Coniothyrium minitans strain CON/M/91-08 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 Coniothyrium minitans strain CON/M/91-08, 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 Coniothyrium minitans strain CON/M/91-08 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 29 May 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 8 June 2016 the Authority communicated to the Commission its conclusion (6) on whether Coniothyrium minitans strain CON/M/91-08 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 Coniothyrium minitans strain CON/M/91-08 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 renewal report.












(10)


It has been established with respect to one or more representative uses of at least one plant protection product containing Coniothyrium minitans strain CON/M/91-08 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 Coniothyrium minitans strain CON/M/91-08.












(11)


The risk assessment for the renewal of the approval of Coniothyrium minitans strain CON/M/91-08 is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing Coniothyrium minitans strain CON/M/91-08 may be authorised. It is therefore appropriate not to maintain the restriction to use only as a fungicide.












(12)


The Commission further considers that Coniothyrium minitans strain CON/M/91-08 is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Coniothyrium minitans strain CON/M/91-08 is not a substance of concern and fulfils the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009. Coniothyrium minitans strain CON/M/91-08 is a wild-type strain naturally occurring in the environment. It is not pathogenic to humans or animals. The additional exposure of humans, animals and the environment by the uses approved under Regulation (EC) No 1107/2009 is expected to be negligible compared to exposure expected through realistic natural situations.












(13)


It is therefore appropriate to renew the approval of Coniothyrium minitans strain CON/M/91-08 as a low-risk substance. In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.












(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.












(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) 2016/950 (7) extended the approval period of Coniothyrium minitans strain CON/M/91-08 to 31 October 2017 in order to allow the renewal process to be completed before the expiry date 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 August 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 active substance

The approval of the active substance Coniothyrium minitans strain CON/M/91-08, 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 August 2017.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 17 May 2017.


For the Commission


The President

Jean-Claude JUNCKER
            





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

(2)  Commission Directive 2003/79/EC of 13 August 2003 amending Council Directive 91/414/EEC to include Coniothyrium minitans as active substance (OJ L 205, 14.8.2003, p. 16).

(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 Journal 2016;14(7):4517, 16 pp. 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





Coniothyrium minitans strain CON/M/91-08
Accession number in the culture collection of the ‘Deutsche Sammlung von Mikroorganismen’ (DSM), Germany: DSM 9660
CIPAC No 614


Not applicable


Minimum content of viable spores:
1 × 1012 CFU/kg


1 August 2017


31 July 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 renewal report on Coniothyrium minitans strain CON/M/91-08, 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, taking into account that microorganisms are considered as potential sensitizers.




Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
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, entry 71 on Coniothyrium minitans strain CON/M/91-08 is deleted;










(2)


in Part D, the following entry is added:











Number


Common Name, Identification Numbers


IUPAC Name


Purity (1)



Date of approval


Expiration of approval


Specific provisions




‘11



Coniothyrium minitans strain CON/M/91-08
Accession number in the culture collection of the ‘Deutsche Sammlung von Mikroorganismen’ (DSM), Germany: DSM 9660
CIPAC No 614


Not applicable


Minimum content of viable spores:
1 × 1012 CFU/kg


1 August 2017


31 July 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 renewal report on Coniothyrium minitans strain CON/M/91-08, 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, taking into account that microorganisms are considered as potential sensitizers.




Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
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.