Commission Implementing Regulation (EU) 2017/806 of 11 May 2017 approving the low-risk active substance Bacillus amyloliquefaciens strain FZB24, 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) 2017/806
• Articles: 5

Article 1 Approval of active substance

The active substance Bacillus amyloliquefaciens strain FZB24, as specified in Annex I, is approved 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

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Bacillus amyloliquefaciens strain FZB24.

Accession number in the culture collection of the ‘Deutsche Sammlung von Mikroorganismen’ (DSM), Germany: 10271

Accession number at the Agricultural Research Service Culture Collection (NRRL), USA: B-50304

Not applicable

Minimum concentration:

2 × 10 14 CFU/kg

1 June 2017

1 June 2032

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 Bacillus amyloliquefaciens strain FZB24, and in particular Appendices I and II thereof, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

—

specification of the technical material as commercially manufactured, including full characterisation of impurities and metabolites;

—

the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers.

Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.

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

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

ANNEX II

ANNEX II

In Part D of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

‘10

Bacillus amyloliquefaciens strain FZB24.

Accession number in the culture collection of the ‘Deutsche Sammlung von Mikroorganismen’ (DSM), Germany: 10271

Accession number at the Agricultural Research Service Culture Collection (NRRL), USA: B-50304

Not applicable

Minimum concentration:

2 × 10 14 CFU/kg

1 June 2017

1 June 2032

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 Bacillus amyloliquefaciens strain FZB24, and in particular Appendices I and II thereof, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

—

specification of the technical material as commercially manufactured, including full characterisation of impurities and metabolites;

—

the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers.

Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.

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

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