Commission Implementing Regulation (EU) 2020/1003 of 9 July 2020 renewing the approval of the active substances Phlebiopsis gigantea strains VRA 1835, VRA 1984 and FOC PG 410.3 as low-risk substances 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)

• CELEX: Implementing Regulation (EU) 2020/1003
• Articles: 5

Article 1 Renewal of the approval of the active substance

The approval of the active substances Phlebiopsis gigantea strains VRA 1835, VRA 1984 and FOC PG 410.3, as specified in Annex I, is renewed subject to the conditions laid down in that Annex.

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 .

It shall apply from 1 September 2020.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name,

Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Phlebiopsis gigantea strain VRA 1835

Not applicable

No relevant impurities

1 September 2020

31 August 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 renewal report on Phlebiopsis gigantea strain VRA 1835, 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.

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 ) .

Phlebiopsis gigantea strain VRA 1984

Not applicable

No relevant impurities

1 September 2020

31 August 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 renewal report on Phlebiopsis gigantea strain VRA 1984, 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.

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.

Phlebiopsis gigantea strain FOC PG 410.3

Not applicable

No relevant impurities

1 September 2020

31 August 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 renewal report on Phlebiopsis gigantea strain FOC PG 410.3, 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.

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 )   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

ANNEX II

ANNEX II

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

(1)

in Part A, entry 201 on Phlebiopsis gigantea strains is replaced as follows:

‘201

Phlebiopsis gigantea

STRAIN: VRA 1985

Culture collection: No DSM 16202

STRAIN: VRA 1986

Culture collection: No DSM 16203

STRAIN: FOC PG B20/5

Culture collection: No IMI 390096

STRAIN: FOC PG SP log 6

Culture collection: No IMI 390097

STRAIN: FOC PG SP log 5

Culture collection: No IMI 390098

STRAIN: FOC PG BU 3

Culture collection: No IMI 390099

STRAIN: FOC PG BU 4

Culture collection: No IMI 390100

STRAIN: FOC PG97/1062/116/1.1

Culture collection: No IMI 390102

STRAIN: FOC PG B22/SP1287/3.1

Culture collection: No IMI 390103

STRAIN: FOC PG SH 1

Culture collection: No IMI 390104

STRAIN: FOC PG B22/SP1190/3.2

Culture collection: No IMI 390105

Not applicable

No relevant impurities

1 May 2009

30 April 2020

PART A Only uses as fungicide may be authorised.

PART B 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 Phlebiopsis gigantea (SANCO/1863/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures.’

(2)

in Part D, the following entries are added:

‘21

Phlebiopsis gigantea strain VRA 1835

Not applicable

No relevant impurities

1 September 2020

31 August 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 renewal report on Phlebiopsis gigantea strain VRA 1835, 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.

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.

22

Phlebiopsis gigantea strain VRA 1984

Not applicable

No relevant impurities

1 September 2020

31 August 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 renewal report on Phlebiopsis gigantea strain VRA 1984, 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.

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.

23

Phlebiopsis gigantea strain FOC PG 410.3

Not applicable

No relevant impurities

1 September 2020

31 August 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 renewal report on Phlebiopsis gigantea strain FOC PG 410.3, 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.

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.’