# L_2019027EN.01002601.xml

| 31.1.2019 | EN | Official Journal of the European Union | L 27/26 |
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31.1.2019

EN

Official Journal of the European Union

L 27/26

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/151

of 30 January 2019

renewing the approval of the active substance Clonostachys rosea strain J1446 as a low-risk active 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 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 2005/2/EC (2) included Clonostachys rosea strain J1446, under the old taxonomic name Gliocladium catenulatum strain J1446, as an active substance in Annex I to Council Directive 91/414/EEC (3). |
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(1)

Commission Directive 2005/2/EC (2) included Clonostachys rosea strain J1446, under the old taxonomic name Gliocladium catenulatum strain J1446, 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). |
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(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 Clonostachys rosea strain J1446, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2019. |
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(3)

The approval of the active substance Clonostachys rosea strain J1446, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2019.

| (4) | An application for the renewal of the approval of Clonostachys rosea strain J1446 was submitted by Verdera Oy (‘the applicant’) in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article. |
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(4)

An application for the renewal of the approval of Clonostachys rosea strain J1446 was submitted by Verdera Oy (‘the applicant’) 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. |
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(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 6 July 2016. |
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(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 6 July 2016.

| (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. |
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(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 21 June 2017 the Authority communicated to the Commission its conclusion (6) on whether Clonostachys rosea strain J1446 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 Clonostachys rosea strain J1446 to the Standing Committee on Plants, Animals, Food and Feed on 11 December 2017. |
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(8)

On 21 June 2017 the Authority communicated to the Commission its conclusion (6) on whether Clonostachys rosea strain J1446 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 Clonostachys rosea strain J1446 to the Standing Committee on Plants, Animals, Food and Feed on 11 December 2017.

| (9) | The applicant was given the possibility to submit comments on the renewal report. |
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(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 Clonostachys rosea strain J1446 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 Clonostachys rosea strain J1446. |
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(10)

It has been established with respect to one or more representative uses of at least one plant protection product containing Clonostachys rosea strain J1446 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 Clonostachys rosea strain J1446.

| (11) | The risk assessment for the renewal of the approval of Clonostachys rosea strain J1446 is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing Clonostachys rosea strain J1446 may be authorised. It is therefore appropriate not to maintain the restriction to use only as a fungicide. |
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(11)

The risk assessment for the renewal of the approval of Clonostachys rosea strain J1446 is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing Clonostachys rosea strain J1446 may be authorised. It is therefore appropriate not to maintain the restriction to use only as a fungicide.

| (12) | The Commission further considers that Clonostachys rosea strain J1446 is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Clonostachys rosea strain J1446 is not a substance of concern and fulfils the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009. |
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(12)

The Commission further considers that Clonostachys rosea strain J1446 is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Clonostachys rosea strain J1446 is not a substance of concern and fulfils the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009.

| (13) | It is therefore appropriate to renew the approval of Clonostachys rosea strain J1446 as a low-risk substance. |
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(13)

It is therefore appropriate to renew the approval of Clonostachys rosea strain J1446 as a low-risk 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 include certain conditions. |
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(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.

| (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. |
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(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) 2018/917 (7) extended the approval period of Clonostachys rosea strain J1446 to 31 July 2019 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 April 2019. |
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(16)

Commission Implementing Regulation (EU) 2018/917 (7) extended the approval period of Clonostachys rosea strain J1446 to 31 July 2019 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 April 2019.

| (17) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(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 Clonostachys rosea strain J1446, as specified in Annex I, is renewed subject to the conditions laid down in that Annex.

Clonostachys rosea

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.

Official Journal of the European Union

It shall apply from 1 April 2019.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 30 January 2019.

For the Commission

The President

Jean-Claude JUNCKER

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

1

(2)  Commission Directive 2005/2/EC of 19 January 2005 amending Council Directive 91/414/EEC to include Ampelomyces quisqualis and Gliocladium catenulatum as active substances (OJ L 20, 22.1.2005, p. 15).

2

(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).

3

(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).

4

(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).

5

(6)  EFSA Journal 2016;14(7):4517, 16 pp. Available online: www.efsa.europa.eu.

6

(7)  Commission Implementing Regulation (EU) 2018/917 of 27 June 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances alpha-cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, carvone, chlorpropham, cyazofamid, desmedipham, dimethoate, dimethomorph, diquat, ethephon, ethoprophos, etoxazole, famoxadone, fenamidone, fenamiphos, flumioxazine, fluoxastrobin, folpet, foramsulfuron, formetanate, Gliocladium catenulatum strain: J1446, isoxaflutole, metalaxyl-m, methiocarb, methoxyfenozide, metribuzin, milbemectin, oxasulfuron, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole, pymetrozine and s-metolachlor (OJ L 163, 28.6.2018, p. 13).

7

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ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Clonostachys rosea strain J1446
  Accession number in the culture collection of the German Collection of Microorganisms and Cell Cultures (DSMZ): DSM 9212 | Not applicable | Not applicable
  Gliotoxin content: max. 50 μg/kg in the technical grade of the MCPA. | 1 April 2019 | 31 March 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 Clonostachys rosea strain J1446, 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 specification of technical material as commercially manufactured in plant protection products, including full characterisation of potential metabolites of concern; |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Clonostachys rosea strain J1446

Accession number in the culture collection of the German Collection of Microorganisms and Cell Cultures (DSMZ): DSM 9212

Not applicable

Not applicable

Gliotoxin content: max. 50 μg/kg in the technical grade of the MCPA.

1 April 2019

31 March 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 Clonostachys rosea strain J1446, 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 specification of technical material as commercially manufactured in plant protection products, including full characterisation of potential metabolites of concern;

| — | the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use; |
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—

the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use;

| — | the studies or information from the scientific literature recently made available in relation to antifungal susceptibility of Clonostachys rosea J1446. |
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—

the studies or information from the scientific literature recently made available in relation to antifungal susceptibility of Clonostachys rosea J1446.

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 microbial contamination as referred to in the Working Document SANCO/12116/2012 (2).

Conditions of use shall include risk mitigation measures, where appropriate.

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

(2)  https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf

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ANNEX II

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

| (1) | in Part A, entry 98 on Gliocladium catenulatum strain J1446 is deleted; |
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(1)

in Part A, entry 98 on Gliocladium catenulatum strain J1446 is deleted;

| (2) | in Part D, the following entry is added:











  ‘15 | Clonostachys rosea strain J1446
  Accession number in the culture collection of the German Collection of Microorganisms and Cell Cultures (DSMZ): DSM 9212 | Not applicable | Not applicable
  Gliotoxin content: max. 50 μg/kg in the technical grade of the MCPA. | 1 April 2019 | 31 March 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 Clonostachys rosea strain J1446, 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 specification of technical material as commercially manufactured in plant protection products, including full characterisation of potential metabolites of concern; |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |

(2)

in Part D, the following entry is added:

‘15

Clonostachys rosea strain J1446

Accession number in the culture collection of the German Collection of Microorganisms and Cell Cultures (DSMZ): DSM 9212

Not applicable

Not applicable

Gliotoxin content: max. 50 μg/kg in the technical grade of the MCPA.

1 April 2019

31 March 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 Clonostachys rosea strain J1446, 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 specification of technical material as commercially manufactured in plant protection products, including full characterisation of potential metabolites of concern;

| — | the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use; |
| --- | --- |

—

the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use;

| — | the studies or information from the scientific literature recently made available in relation to antifungal susceptibility of Clonostachys rosea J1446. |
| --- | --- |

—

the studies or information from the scientific literature recently made available in relation to antifungal susceptibility of Clonostachys rosea J1446.

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 microbial contamination as referred to in the Working Document SANCO/12116/2012 (*1).

Conditions of use shall include risk mitigation measures, where appropriate.

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(*1)  https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf’

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