Commission Implementing Regulation (EU) 2023/59 of 5 January 2023 concerning the authorisation of a preparation of Pediococcus pentosaceus DSM 32292 as a feed additive for all animal species (Text with EEA relevance)

L 5/16 EN Official Journal of the European Union 6.1.2023 COMMISSION IMPLEMENTING REGULATION (EU) 2023/59 of 5 January 2023 concerning the authorisation of a preparation of Pediococcus pentosaceus DSM 32292 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 2003on 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 an authorisation. (2) In accordance with Article 7(1) of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of Pediococcus pentosaceus DSM 32292. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. (3) The application concerns the authorisation of the preparation of Pediococcus pentosaceus DSM 32292 as a feed additive for all animal species, to be classified in the additive category ‘technological additives’ and in the functional group ‘silage additives’. (4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 29 June 2022(2)that, under the proposed conditions of use, the preparation of Pediococcus pentosaceus DSM 32292 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that it should be considered a respiratory sensitiser and noted that no conclusions could be drawn on its eye and skin irritancy or skin sensitisation potential. The Authority further concluded that the additive, at the proposed concentration, has the potential to improve the preservation of nutrients in silage prepared with moderately difficult to ensile material. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. (5) The assessment of the preparation of Pediococcus pentosaceus DSM 32292 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of the preparation should be authorised. The Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. (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 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. (1) OJ L 268, 18.10.2003, p. 29. (2) EFSA Journal 2022;20(7):7426.6.1.2023 EN Official Journal of the European Union L 5/17 Article 2 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, 5 January 2023. For the Commission The President Ursula VON DER LEYENANNEX Identifica- Minimum Maximum Species or tion Composition, chemical formula, description, Maximum content content End of period of Additive category of Other provisions number of analytical method age authorisation animal the additive CFU/kg of fresh material Category of technological additives. Functional group: silage additives 1k1018 Pediococcus Additive composition: All animal - - - 1. In the directions for use of the additive 26.1.2033 pentosaceus DSM species and premixtures, the storage conditions Preparation of Pediococcus pentosaceus DSM 32292 shall be indicated. 32292 containing a minimum of 1 × 1010 CFU/g additive 2. Minimum content of the additive when used without combination with other mi­ Characterisation of the active substance: cro-organisms as silage additives: 5×107 CFU/kg of easy and moderately difficult Viable cells of Pediococcus pentosaceus DSM to ensile fresh material(2). 32292 3. For users of the additive and premixtures, Analytical method(1): feed business operators shall establish op­ Enumeration in the feed additive: Spread erational procedures and organisational plate method on MRS agar (EN 15786) measures to address potential risks result­ ing from its use. Where those risks cannot Identification: Pulsed-Field Gel be eliminated or reduced to a minimum Electrophoresis (PFGE) or DNA sequencing by such procedures and measures, the ad­ methods ditive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. (1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation- reports_en. (2) Easy to ensile forage: > 3 % soluble carbohydrates in fresh material; moderately difficult to ensile forage: 1,5-3,0 % soluble carbohydrates in the fresh material, in accordance with Commission Regulation (EC) No 429/2008 of 25 April 2008on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1). L 5/18 EN Official Journal of the European Union 6.1.2023