
Article 1 
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 
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 27 September 2019.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX I

Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions
Bacillus subtilis strain IAB/BS03Accession number in the Spanish Type Culture Collection (CECT), Spain: CECT 7254Accession number in the German Type Culture Collection (DSMZ), Germany: DSM 24682 Not applicable Minimum concentration:1 × 1013 CFU/kgMaximum concentration:5 × 1013 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.Conditions of use shall include risk mitigation measures, where appropriate.


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/BS03Accession number in the Spanish Type Culture Collection (CECT), Spain: CECT 7254Accession number in the German Type Culture Collection (DSMZ), Germany: DSM 24682 Not applicable Minimum concentration:1 × 1013 CFU/kgMaximum concentration:5 × 1013 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.Conditions of use shall include risk mitigation measures, where appropriate.

