Commission Implementing Regulation (EU) 2019/1605 of 27 September 2019 approving the low-risk active substance Bacillus subtilis strain IAB/BS03, 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) 2019/1605
• Articles: 5

Article 1 Approval of the active substance

The active substance Bacillus subtilis strain IAB/BS03, 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

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 subtilis strain IAB/BS03

Accession number in the Spanish Type Culture Collection (CECT), Spain: CECT 7254

Accession number in the German Type Culture Collection (DSMZ), Germany: DSM 24682

Not applicable

Minimum concentration:

1 × 10 13 CFU/kg

Maximum concentration:

5 × 10 13 CFU/kg

20 October 2019

20 October 2034

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 subtilis strain IAB/BS03, and in particular Appendices I and II thereof, shall be taken into account.

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

a)

the specification of the technical material as commercially manufactured used in plant protection products, including full characterisation of relevant secondary metabolites;

b)

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

Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in OECD Issue Paper on Microbial Contaminant Limits for Microbial Pest Control Products, contained in the Working Document SANCO/12116/2012  ( 2 ) .

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.

( 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

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

‘17

Bacillus subtilis strain IAB/BS03

Accession number in the Spanish Type Culture Collection (CECT), Spain: CECT 7254

Accession number in the German Type Culture Collection (DSMZ), Germany: DSM 24682

Not applicable

Minimum concentration:

1 × 10 13 CFU/kg

Maximum concentration:

5 × 10 13 CFU/kg

20 October 2019

20 October 2034

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 subtilis strain IAB/BS03, and in particular Appendices I and II thereof, shall be taken into account.

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

a)

the specification of the technical material as commercially manufactured used in plant protection products, including full characterisation of relevant secondary metabolites;

b)

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

Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in OECD Issue Paper on Microbial Contaminant Limits for Microbial Pest Control Products, contained in the Working Document SANCO/12116/2012  ( 1 ) .

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

( 1 )   https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf’