
Article 1 
The active substance Saccharomyces cerevisiae strain LAS02, 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, 15 June 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
Saccharomyces cerevisae strain LAS02Accession number in the collection of the ‘Collection Nationale de Cultures de Microorganismes’ (CNCM) of the Pasteur Institute: CNCM I-3936 Not applicable Minimum concentration: 1 × 1013 CFU/kg 6 July 2016 6 July 2031 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 Saccharomyces cerevisiae strain LAS02, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Saccharomyces cerevisiae strain LAS02 is to be considered as a potential sensitizer. 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 D of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

Number Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions
‘6 Saccharomyces cerevisae strain LAS02Accession number in the collection of the ‘Collection Nationale de Cultures de Microorganismes’ (CNCM) of the Pasteur Institute: CNCM I-3936 Not applicable Minimum concentration: 1 × 1013 CFU/kg 6 July 2016 6 July 2031 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 Saccharomyces cerevisiae strain LAS02, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Saccharomyces cerevisiae strain LAS02 is to be considered as a potential sensitizer. 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.’

