Commission Implementing Regulation (EU) 2020/646 of 13 May 2020 approving the active substance Lavandulyl senecioate as a low-risk substance 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 Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)
Date: 2020-05-13
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: market approval, plant health control, plant health product




L_2020151EN.01000301.xml










14.5.2020   


EN


Official Journal of the European Union


L 151/3








            COMMISSION IMPLEMENTING REGULATION (EU) 2020/646
of 13 May 2020
         
approving the active substance Lavandulyl senecioate as a low-risk substance 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 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 13(2) in conjunction with Article 22(1) thereof,

Whereas:







(1)


In accordance with Article 7(1) of Regulation (EC) No 1107/2009 Suterra Europe Biocontrol S.L. submitted to Italy on 17 July 2015 an application for the approval of the active substance Lavandulyl senecioate.












(2)


In accordance with Article 9(3) of that Regulation, Italy, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) of the admissibility of the application on 29 December 2016.












(3)


On 22 August 2017 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.












(4)


The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested that the applicant supply 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 on 9 October 2018.












(5)


On 4 January 2019 the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance Lavandulyl senecioate can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public.












(6)


On 22 October 2019 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for Lavandulyl senecioate and on 23 March 2020 a draft Regulation providing that Lavandulyl senecioate is approved.












(7)


The applicant was given the possibility to submit comments on the review report.












(8)


It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.












(9)


The Commission further considers that Lavandulyl senecioate is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Lavandulyl senecioate is not a substance of concern and fulfils the conditions set in point 5.1.3 of Annex II to Regulation (EC) No 1107/2009.












(10)


It is therefore appropriate to approve Lavandulyl senecioate as a low-risk substance.












(11)


In accordance with Article 13(2) 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 provide certain conditions.












(12)


In accordance with Article 13(4) of Regulation (EC) No 1107/2009, Commission Implementing Regulation (EU) No 540/2011 (3) should be amended accordingly.












(13)


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

Approval of the active substance

The active substance Lavandulyl senecioate, as specified in Annex I, is approved subject to the conditions laid down in that Annex.


Article 2

Amendments to Implementing Regulation (EU) No 540/2011

Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.


Article 3

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, 13 May 2020.


For the Commission


The President

Ursula VON DER LEYEN
            





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

(2)  
            EFSA Journal 2020;18(3):5588.

(3)  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).




ANNEX I










Common Name, Identification Numbers


IUPAC Name


Purity (1)



Date of approval


Expiration of approval


Specific provisions




Lavandulyl senecioate
CAS No: 23960-07-8
CIPAC No: n.a.


(RS)-5-methyl-2-(prop-1-en-2-yl)hex-4-en-1-yl 3-methylbut-2-enoate


≥ 894 g/kg


3 June 2020


3 June 2035


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 Lavandulyl senecioate, and in particular Appendices I and II thereto, shall be taken into account.
Member State shall assess any extension of the use pattern beyond passive dispensers, in order to establish whether the proposed extensions of use fulfil the requirements of Article 29(1) of Regulation (EC) No 1107/2009 and of the uniform principles laid down in Commission Regulation (EU) No 546/2011 (2).






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

(2)  Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products (OJ L 155, 11.6.2011, p. 127).





ANNEX II
In Part D of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:












‘19


Lavandulyl senecioate
CAS No: 23960-07-8
CIPAC No: n.a.


(RS)-5-methyl-2-(prop-1-en-2-yl)hex-4-en-1-yl 3-methylbut-2-enoate


≥ 894 g/kg


3 June 2020


3 June 2035


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 Lavandulyl senecioate, and in particular Appendices I and II thereto, shall be taken into account.
Member State shall assess any extension of the use pattern beyond passive dispensers, in order to establish whether the proposed extensions of use fulfil the requirements of Article 29(1) of Regulation (EC) No 1107/2009 and of the uniform principles laid down in Commission Regulation (EU) No 546/2011 (*1).







(*1)  Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products (OJ L 155, 11.6.2011, p. 127).’