Commission Implementing Regulation (EU) 2018/296 of 27 February 2018 concerning the non-approval of the active substance Reynoutria sachalinensis extract, 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 (Text with EEA relevance. )
Date: 2018-02-27
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: market approval, plant health control, plant health product, withdrawal from the market








L_2018056EN.01003101.xml










28.2.2018   


EN


Official Journal of the European Union


L 56/31








            COMMISSION IMPLEMENTING REGULATION (EU) 2018/296
of 27 February 2018
         
concerning the non-approval of the active substance Reynoutria sachalinensis extract, 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
(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 13(2) thereof,

Whereas:







(1)


In accordance with Article 7(1) of Regulation (EC) No 1107/2009, on 3 November 2011, the United Kingdom received an application from Marrone Bio innovations for the approval of the active substance Reynoutria sachalinensis extract.












(2)


In accordance with Article 9(3) of that Regulation, the rapporteur Member State notified the applicant and the other Member States of the admissibility of the application on 21 March 2012 and notified the Commission and the European Food Safety Authority (‘the Authority’) thereof on 11 May 2012.












(3)


For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with Article 11(2) and (3) of that Regulation, for the use proposed by the applicant. The rapporteur Member State submitted a draft assessment report to the Commission and the Authority on 22 July 2014.












(4)


The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of that Regulation, it requested that the applicant supplies additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report.












(5)


The draft assessment report was reviewed by the Member States and the Authority. The Authority presented to the Commission its conclusion on the risk assessment of the active substance Reynoutria sachalinensis extract (2) on 31 August 2015.












(6)


By letter of 16 October 2017 Marrone Bio innovations withdrew its application for the approval of Reynoutria sachalinensis extract. Due to the withdrawal of the application, Reynoutria sachalinensis extract should not be approved pursuant to Article 13(2) of Regulation (EC) No 1107/2009.












(7)


This Regulation does not prejudice the submission of a further application for Reynoutria sachalinensis extract pursuant to Article 7 of Regulation (EC) No 1107/2009.












(8)


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

Non-approval of active substance

The active substance Reynoutria sachalinensis extract is not approved.


Article 2

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 27 February 2018.


For the Commission


The President

Jean-Claude JUNCKER
            





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

(2)  EFSA, 2015. Conclusion on the peer review of the pesticide risk assessment of the active substance Reynoutria sachalinensis extract. EFSA Journal 2015;13(9):4221, 73 pp. Available online: www.efsa.europa.eu/efsajournal