# L_2021188EN.01005601.xml

| 28.5.2021 | EN | Official Journal of the European Union | L 188/56 |
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28.5.2021

EN

Official Journal of the European Union

L 188/56

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COMMISSION IMPLEMENTING REGULATION (EU) 2021/853

of 27 May 2021

renewing the approval of the active substance Streptomyces strain K61 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 20(1) thereof,

Whereas:

| (1) | Commission Directive 2008/113/EC (2) included Streptomyces K61 (formerly ‘S. griseoviridis’) as an active substance in Annex I to Council Directive 91/414/EEC (3). |
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(1)

Commission Directive 2008/113/EC (2) included Streptomyces K61 (formerly ‘S. griseoviridis’) as an active substance in Annex I to Council Directive 91/414/EEC (3).

| (2) | The concerned active substance is a bacterium, that was first named ‘Streptomyces griseoviridis’. Subsequently, for scientific reasons, that name was changed into Streptomyces K61. More recently, it was changed again into its current name Streptomyces strain K61. |
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(2)

The concerned active substance is a bacterium, that was first named ‘Streptomyces griseoviridis’. Subsequently, for scientific reasons, that name was changed into Streptomyces K61. More recently, it was changed again into its current name Streptomyces strain K61.

| (3) | 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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(3)

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).

| (4) | The approval of the active substance Streptomyces strain K61, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 April 2022. |
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(4)

The approval of the active substance Streptomyces strain K61, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 April 2022.

| (5) | An application for the renewal of the approval of the active substance Streptomyces strain K61 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. |
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(5)

An application for the renewal of the approval of the active substance Streptomyces strain K61 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.

| (6) | 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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(6)

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.

| (7) | 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 15 January 2019. |
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(7)

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 15 January 2019.

| (8) | 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. |
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(8)

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.

| (9) | On 19 June 2020, the Authority communicated to the Commission its conclusion (6) on whether Streptomyces strain K61 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented a renewal report on the 3 December 2020 and a draft Regulation regarding Streptomyces strain K61 to the Standing Committee on Plants, Animals, Food and Feed on 25 January 2021. |
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(9)

On 19 June 2020, the Authority communicated to the Commission its conclusion (6) on whether Streptomyces strain K61 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented a renewal report on the 3 December 2020 and a draft Regulation regarding Streptomyces strain K61 to the Standing Committee on Plants, Animals, Food and Feed on 25 January 2021.

| (10) | The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with the third paragraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant submitted its comments, which have been carefully examined. |
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(10)

The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with the third paragraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant submitted its comments, which have been carefully examined.

| (11) | It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance Streptomyces strain K61 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 Streptomyces strain K61. |
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(11)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance Streptomyces strain K61 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 Streptomyces strain K61.

| (12) | The risk assessment for the renewal of the approval of the active substance Streptomyces strain K61 is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing Streptomyces strain K61 may be authorised. It is therefore appropriate not to maintain the restriction to use as a fungicide only. |
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(12)

The risk assessment for the renewal of the approval of the active substance Streptomyces strain K61 is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing Streptomyces strain K61 may be authorised. It is therefore appropriate not to maintain the restriction to use as a fungicide only.

| (13) | 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 therefore be amended accordingly. |
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(13)

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 therefore be amended accordingly.

| (14) | Commission Implementing Regulation (EU) 2021/566 (7) extended the approval period of Streptomyces strain K61 to 30 April 2022 in order to allow the renewal process to be completed before the expiry of that period. However, given that a decision on renewal is being taken ahead of the expiry of that extended approval period, this Regulation should start to apply earlier than that date. |
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(14)

Commission Implementing Regulation (EU) 2021/566 (7) extended the approval period of Streptomyces strain K61 to 30 April 2022 in order to allow the renewal process to be completed before the expiry of that period. However, given that a decision on renewal is being taken ahead of the expiry of that extended approval period, this Regulation should start to apply earlier than that date.

| (15) | 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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(15)

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 the active substance

The approval of the active substance Streptomyces strain K61, as specified in Annex I, is renewed subject to the conditions laid down in that Annex.

Streptomyces

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 July 2021.

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

Done at Brussels, 27 May 2021.

For the Commission

The President

Ursula VON DER LEYEN

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

1

(2)  Commission Directive 2008/113/EC of 8 December 2008 amending Council Directive 91/414/EEC to include several microorganisms as active substances (OJ L 330, 9.12.2008, p. 6).

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 2020;18(7):6182, 14 pp. doi:10.2903/j.efsa.2020.6182. Available online: www.efsa.europa.eu.

6

EFSA Journal

(7)  Commission Implementing Regulation (EU) 2021/566 of 30 March 2021 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) strain QST 713, Bacillus thuringiensis subsp. Aizawai strains ABTS-1857 and GC-91, Bacillus thuringiensis subsp. Israeliensis (serotype H-14) strain AM65-52, Bacillus thuringiensis subsp. Kurstaki strains ABTS 351, PB 54, SA 11, SA12 and EG 2348, Beauveria bassiana strains ATCC 74040 and GHA, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, fenpyroximate, fosetyl, mepanipyrim, Metarhizium anisopliae (var. anisopliae) strain BIPESCO 5/F52, metconazole, metrafenone, pirimicarb, Pseudomonas chlororaphis strain MA342, pyrimethanil, Pythium oligandrum M1, rimsulfuron, spinosad, Streptomyces K61 (formerly ‘
  S. griseoviridis
  ’), Trichoderma asperellum (formerly ‘
  T. harzianum
  ’) strains ICC012, T25 and TV1, Trichoderma atroviride (formerly ‘
  T. harzianum
  ’) strain T11, Trichoderma gamsii (formerly ‘
  T. viride
  ’) strain ICC080, Trichoderma harzianum strains T-22 and ITEM 908, triclopyr, trinexapac, triticonazole and ziram (OJ L 118, 7.4.2021, p. 1).

7

Bacillus subtilis

Bacillus thuringiensis

Bacillus thuringiensis

Bacillus thuringiensis

Beauveria bassiana

Cydia pomonella Granulovirus

Metarhizium anisopliae

Pseudomonas chlororaphis

Pythium oligandrum

Streptomyces

S. griseoviridis

Trichoderma asperellum

T. harzianum

Trichoderma atroviride

T. harzianum

Trichoderma gamsii

T. viride

Trichoderma harzianum

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ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Streptomyces strain K61 | Not applicable | No relevant impurities | 1 July 2021 | 30 June 2036 | 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 Streptomyces strain K61 and in particular Appendices I and II thereto, shall be taken into account.
  Member States shall pay particular attention to the protection of operators and workers, taking into account that microorganisms are considered as potential sensitisers, and shall ensure that adequate personal protective equipment is included as a condition of use.
  Producers shall ensure strict maintenance of environmental conditions and quality control analysis during the manufacturing process as laid down in Working Document SANCO/12116/2012 as regards the limits on microbiological contamination (2). |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Streptomyces strain K61

Not applicable

No relevant impurities

1 July 2021

30 June 2036

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 Streptomyces strain K61 and in particular Appendices I and II thereto, shall be taken into account.

Member States shall pay particular attention to the protection of operators and workers, taking into account that microorganisms are considered as potential sensitisers, and shall ensure that adequate personal protective equipment is included as a condition of use.

Producers shall ensure strict maintenance of environmental conditions and quality control analysis during the manufacturing process as laid down in Working Document SANCO/12116/2012 as regards the limits on microbiological contamination (2).

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(1)  Further details on the identity and the specification of the active substance are provided in the renewal 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 Commission Implementing Regulation (EU) No 540/2011 is amended as follows:

| (1) | in Part A, entry 203 on Streptomyces K61 (formerly S. griseoviridis) is deleted; |
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(1)

in Part A, entry 203 on Streptomyces K61 (formerly S. griseoviridis) is deleted;

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











  ‘145 | Streptomyces strain K61 | Not applicable | No relevant impurities | 1 July 2021 | 30 June 2036 | 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 Streptomyces strain K61 and in particular Appendices I and II thereto, shall be taken into account.
  Member States shall pay particular attention to the protection of operators and workers, taking into account that microorganisms are considered as potential sensitisers, and shall ensure that adequate personal protective equipment is included as a condition of use.
  Producers shall ensure strict maintenance of environmental conditions and quality control analysis during the manufacturing process as laid down in Working Document SANCO/12116/2012 as regards the limits on microbiological contamination (*1). |
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(2)

in Part B, the following entry is added:

‘145

Streptomyces strain K61

Not applicable

No relevant impurities

1 July 2021

30 June 2036

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 Streptomyces strain K61 and in particular Appendices I and II thereto, shall be taken into account.

Member States shall pay particular attention to the protection of operators and workers, taking into account that microorganisms are considered as potential sensitisers, and shall ensure that adequate personal protective equipment is included as a condition of use.

Producers shall ensure strict maintenance of environmental conditions and quality control analysis during the manufacturing process as laid down in Working Document SANCO/12116/2012 as regards the limits on microbiological contamination (*1).

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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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