COMMISSION IMPLEMENTING REGULATION (EU) 2017/194

4.2.2017 | EN | Official Journal of the European Union | L 31/18 ---|---|---|--- * * * COMMISSION IMPLEMENTING REGULATION (EU) 2017/194 of 3 February 2017 concerning the authorisation of the preparation of Lactobacillus diolivorans DSM 32074 as a feed additive for all animal species (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 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof, Whereas: (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. ---|--- (2) | In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of the preparation of Lactobacillus diolivorans DSM 32074. This application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. ---|--- (3) | This application concerns the authorisation of the preparation of Lactobacillus diolivorans DSM 32074 as a feed additive for all animal species to be classified in the category ‘technological additives’. ---|--- (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 12 July 2016 (2) that, under the proposed conditions of use, the preparation of Lactobacillus diolivorans DSM 32074 does not have an adverse effect on animal health, human health or the environment. However, the additive should be considered to have the potential to be a respiratory sensitiser. The Authority also concluded that the concerned preparation has the potential to improve the production of silage prepared from easy, moderately difficult and difficult to ensile material. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. ---|--- (5) | The assessment of the preparation of Lactobacillus diolivorans DSM 32074 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation. ---|--- (6) | 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: Article 1 Authorisation The preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex. Article 2 Entry into force 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, 3 February 2017. For the Commission The President Jean-Claude JUNCKER * * * (1) OJ L 268, 18.10.2003, p. 29. (2) EFSA Journal 2016; 14(9):4556. * * * ANNEX Identification number of the additive | Additive | Chemical formula, description, methods of analysis | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation ---|---|---|---|---|---|---|---|--- CFU of additive/kg of fresh material Technological additives: silage additives 1k20752 | Lactobacillus diolivorans DSM 32074 | Additive composition Preparation of Lactobacillus diolivorans DSM 32074 containing a minimum of 3 × 1011 CFU/g additive. Characterisation of the active substance Viable cells of Lactobacillus diolivorans DSM 32074. Analytical method (1) Enumeration in the feed additive: spread plate method on MRS agar (EN 15787). Identification of the feed additive: Pulsed Field Gel Electrophoresis (PFGE). | All animal species | — | — | — | | 1. | In the directions for use of the additive and premixture, indicate the storage conditions. ---|--- 2. | Minimum content of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material. ---|--- 3. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. ---|--- 24 February 2027 * * * (1) Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx * * *