
Article 1 
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 
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Article 3 
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 9 July 2020.
For the Commission
The President
Ursula VON DER LEYEN
ANNEX I

Common Name,Identification Numbers IUPAC Name Purity 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.
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.


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 giganteaSTRAIN: VRA 1985Culture collection: No DSM 16202STRAIN: VRA 1986Culture collection: No DSM 16203STRAIN: FOC PG B20/5Culture collection: No IMI 390096STRAIN: FOC PG SP log 6Culture collection: No IMI 390097STRAIN: FOC PG SP log 5Culture collection: No IMI 390098STRAIN: FOC PG BU 3Culture collection: No IMI 390099STRAIN: FOC PG BU 4Culture collection: No IMI 390100STRAIN: FOC PG97/1062/116/1.1Culture collection: No IMI 390102STRAIN: FOC PG B22/SP1287/3.1Culture collection: No IMI 390103STRAIN: FOC PG SH 1Culture collection: No IMI 390104STRAIN: FOC PG B22/SP1190/3.2Culture 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.'
