Commission Implementing Regulation (EU) 2023/1001 of 23 May 2023 renewing the approval of the active substance Bacillus amyloliquefaciens strain QST 713 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/1001
• Articles: 5

Article 1 Renewal of the approval of the active substance

The approval of the active substance Bacillus amyloliquefaciens strain QST 713, as specified in Annex I to this Regulation, 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 July 2023.

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 QST 713

n.a.

The nominal content of Bacillus amyloliquefaciens strain QST 713 in the technical product and formulation is Minimum: 1 × 10 12 CFU/kg

Maximum: 3 × 10 13 CFU/kg

No relevant impurities

1 July 2023

30 June 2038

When authorising plant protection products containing Bacillus amyloliquefaciens strain QST 713 for spray applications outdoors, in order to ensure the protection of non-target organisms, including bees, Member States shall:

—

only authorise field applications in flowering crops or in presence of flowering weed in the field outside the daily foraging period of bees;

—

implement risk mitigation measures which aim to reduce drift to off-field areas (e.g. considering the application of buffer zones and drift reduction nozzles).

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 Bacillus amyloliquefaciens strain QST 713, and in particular Appendices I and II thereof, shall be taken into account.

In addition, Member States shall pay particular attention to:

—

the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012  ( 2 ) ;

—

the specification of the technical material as commercially manufactured used in plant protection products;

—

the protection of operators and workers, taking into account that micro-organisms are per se considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use.

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

( 2 )   pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (europa.eu).

ANNEX II

ANNEX II

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

(1)

in Part A, entry 138 on Bacillus subtilis (Cohn 1872) strain QST 713 is deleted.

(2)

in Part B, the following entry is added:

No.

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

‘158

Bacillus amyloliquefaciens strain QST 713

n.a.

The nominal content of Bacillus amyloliquefaciens strain QST 713 in the technical product and formulation is Minimum: 1 × 10 12 CFU/kg

Maximum: 3 × 10 13 CFU/kg

No relevant impurities

1 July 2023

30 June 2038

When authorising plant protection products containing Bacillus amyloliquefaciens strain QST 713 for spray applications outdoors, in order to ensure the protection of non-target organisms, including bees, Member States shall:

—

only authorise field applications in flowering crops or in presence of flowering weed in the field outside the daily foraging period of bees;

—

implement risk mitigation measures which aim to reduce drift to off-field areas (e.g. considering the application of buffer zones and drift reduction nozzles).

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 Bacillus amyloliquefaciens strain QST 713, and in particular Appendices I and II thereof, shall be taken into account.

In addition, Member States shall pay particular attention to:

—

the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012  ( 2 )

—

the specification of the technical material as commercially manufactured used in plant protection products;

—

the protection of operators and workers, taking into account that micro-organisms are per se considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use.’

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

( 2 )   pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (europa.eu).