Commission Implementing Regulation (EU) 2016/952 of 15 June 2016 approving the low-risk active substance Saccharomyces cerevisiae strain LAS02 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)

Approval of a low-risk active substance

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.

Amendment to Implementing Regulation (EU) No 540/2011

Article 2

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Entry into force

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 .

ANNEX ISupplementary provisions

ANNEX I Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions Saccharomyces cerevisae strain LAS02 Accession 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 × 10 13 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. ( 1 )   Further details on identity and specification of active substance are provided in the review report.

ANNEX IISupplementary provisions

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  ( *1 ) Date of approval Expiration of approval Specific provisions ‘6 Saccharomyces cerevisae strain LAS02 Accession 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 × 10 13 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.’ ( *1 )   Further details on identity and specification of active substance are provided in the review report.