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)
Commission Implementing Regulation (EU) 2016/952of 15 June 2016approving 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)THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EECOJ L 309, 24.11.2009, p. 1., and in particular Article 22(1) in conjunction with Article 13(2) thereof,Whereas:(1)In accordance with Article 7(1) of Regulation (EC) No 1107/2009, France received on 9 April 2013 an application from Agrolevures et Dérivés for the approval of the active substance Saccharomyces cerevisiae strain LAS02. In accordance with Article 9(3) of that Regulation, France, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (hereinafter "the Authority") of the admissibility of the application on 15 October 2013.(2)On 4 December 2014, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.(3)The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report on 14 September 2015.(4)On 3 December 2015, the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance Saccharomyces cerevisiae strain LAS02 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009EFSA Journal 2015;13(12):4322. Available online: www.efsa.europa.eu. The Authority made its conclusion available to the public.(5)On 7 March 2016, the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for Saccharomyces cerevisiae strain LAS02 and a draft Regulation providing that Saccharomyces cerevisiae strain LAS02 is approved as a low-risk active substance.(6)The applicant was given the possibility to submit comments on the review report.(7)It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. Those approval criteria are therefore deemed to be satisfied. It is therefore appropriate to approve Saccharomyces cerevisiae strain LAS02.(8)The Commission further considers that Saccharomyces cerevisiae strain LAS02 is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Saccharomyces cerevisiae strain LAS02 is not a substance of concern and fulfils the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009. Saccharomyces cerevisiae strain LAS02 is a naturally occurring yeast, which is widely used in food. It is also widely present in the environment. The additional exposure of humans, animals and the environment by the uses approved under Regulation (EC) No 1107/2009 is expected to be negligible compared to exposure expected through realistic natural situations.(9)It is therefore appropriate to approve Saccharomyces cerevisiae strain LAS02 as a low-risk substance for a period of 15 years. In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1). should be amended accordingly.(10)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,HAS ADOPTED THIS REGULATION: