
Article 1 
The active substance Bacillus amyloliquefaciens strain MBI 600, as specified in Annex I, is approved 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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 26 August 2016.
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 amyloliquefaciens strain MBI 600.Accession number in the National Collection of Industrial, Marine and Food Bacteria Ltd (NCIMB), Scotland: NCIMB 12376Deposit number in the American Type Culture Collection (ATCC): SD-1414 Not applicable Minimum concentration:5,0 × 1014 CFU/kg 16 September 2016 16 September 2026 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 MBI 600, and in particular Appendices I and II thereto, 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, including full characterisation of impurities and metabolites;
((b)) the protection of operators and workers, taking into account that Bacillus amyloliquefaciens strain MBI 600 is to be considered as a potential sensitiser.Conditions of use shall include risk mitigation measures, where appropriate.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.

ANNEX II

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

 Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions
‘101 Bacillus amyloliquefaciens strain MBI 600.Accession number in the National Collection of Industrial, Marine and Food Bacteria Ltd (NCIMB), Scotland: NCIMB 12376Deposit number in the American Type Culture Collection (ATCC): SD-1414 Not applicable Minimum concentration:5,0 × 1014 CFU/kg 16 September 2016 16 September 2026 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 MBI 600, and in particular Appendices I and II thereto, 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, including full characterisation of impurities and metabolites;
((b)) the protection of operators and workers, taking into account that Bacillus amyloliquefaciens strain MBI 600 is to be considered as a potential sensitiser.Conditions of use shall include risk mitigation measures, where appropriate.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.’

