Commission Implementing Regulation (EU) 2019/1675

Contents

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^note, and in particular Article 20(1) in conjunction with Article 22(1) thereof,Whereas:

(1)Commission Directive 2008/113/EC^note included Verticillium albo-atrum (formerly Verticillium dahlia) strain WCS850 as an active substance in Annex I to Council Directive 91/414/EEC^note.

(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^note.

(3)The approval of the active substance Verticillium albo-atrum strain WCS850, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011 expires on 30 April 2020.

(4)An application for the renewal of the approval of Verticillium albo-atrum strain WCS850 was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012^note 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 draft 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 1 November 2017.

(7)The Authority communicated the draft 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 19 December 2018, the Authority communicated to the Commission its conclusion^note on whether Verticillium albo-atrum strain WCS850 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented an initial draft renewal report for Verticillium albo-atrum strain WCS850 to the Standing Committee on Plants, Animals, Food and Feed on 22 March 2019.

(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 Verticillium albo-atrum strain WCS850 that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

(11)The risk assessment for the renewal of the approval of Verticillium albo-atrum strain WCS850 is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing Verticillium albo-atrum strain WCS850 may be authorised. It is therefore appropriate not to maintain the restriction to use as a fungicide.

(12)The Commission considers that Verticillium albo-atrum strain WCS850 is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Verticillium albo-atrum strain WCS850 is not a substance of concern and fulfils the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009. Verticillium albo-atrum strain WCS850 is a micro-organism. Following the assessment by the rapporteur Member State and the Authority and taking into account the intended uses it is expected to pose a low-risk for humans, animals and the environment. In particular, the potential transfer or acquisition of resistance to antimicrobials in fungi such as Verticillium albo-atrum strain WCS850 is multifactorial and is not coded by a single gene, thus horizontal transfer of anti-microbial resistance genes between fungal species appears to be very rare and is not associated with specific mechanisms, as described for bacteria. Therefore, the Commission considers that multiple resistance to anti-microbials used in human and veterinary medicine is not demonstrated.

(13)It is therefore appropriate to renew the approval of Verticillium albo-atrum WCS850 as a low-risk active substance.

(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 provide for certain conditions.

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

(16)Commission Implementing Regulation (EU) 2019/168^note extended the expiry date of Verticillium albo-atrum strain WCS850 to 30 April 2020 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 that extended expiry date, this Regulation should start to apply earlier than that date.

(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 1Renewal of the approval of the active substance#

The approval of the active substance Verticillium albo-atrum strain WCS850 is renewed as set out in Annex I.

Article 2Amendments 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 3Entry 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 2019.

Annex I

Common Name, Identification Numbers	IUPAC Name	Purity^note	Date of approval	Expiration of approval	Specific provisions
Verticillium albo-atrum strain WCS850 (culture collection No CBS 276.92)	Not applicable	Minimum concentration:0,7 × 10⁷ CFU/ml distilled waterMaximum concentration:1,5 × 10⁷ CFU/ml distilled waterNo relevant impurities.	1 November 2019	31 October 2034	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 Verticillium albo-atrum strain WCS850, and in particular Appendices I and II thereto, 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 Verticillium albo-atrum strain WCS850 is to be considered as a potential sensitiser.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in OECD Issue Paper on Microbial Contaminant Limits for Microbial Pest Control Products, contained in the Commission Working Document SANCO/12116/2012^note

Annex II

(1)in Part A, entry 209 on Verticillium albo-atrum is deleted;

(2)in Part D, the following entry is added:No. | Common Name, Identification Numbers | IUPAC Name | Purity | Date of approval | Expiration of approval | Specific provisions18 | Verticillium albo-atrum strain WCS850 (culture collection No CBS 276.92) | Not applicable | Minimum concentration:0,7 × 107 CFU/ml distilled waterMaximum concentration:1,5 × 107 CFU/ml distilled waterNo relevant impurity | 1 November 2019 | 31 October 2034 | 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 Verticillium albo-atrum strain WCS850, and in particular Appendices I and II thereto, 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 Verticillium albo-atrum strain WCS850 is to be considered as a potential sensitiser.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in OECD Issue Paper on Microbial Contaminant Limits for Microbial Pest Control Products, contained in the Commission Working Document SANCO/12116/2012.

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

Commission Implementing Regulation (EU) 2019/1675

Article 1Renewal of the approval of the active substance#

Article 2Amendments to Implementing Regulation (EU) No 540/2011#

Article 3Entry into force and date of application#

Annex I

Annex II

Connections

Key facts

History · 2 versions

Article 1Renewal of the approval of the active substance#

Article 2Amendments to Implementing Regulation (EU) No 540/2011#

Article 3Entry into force and date of application#

Annex I

Annex II