COMMISSION IMPLEMENTING REGULATION (EU) 2024/2388

| Official Journal of the European Union | EN L series ---|---|--- * * * | 2024/2388 | 10.9.2024 ---|---|--- COMMISSION IMPLEMENTING REGULATION (EU) 2024/2388 of 9 September 2024 concerning the renewal of the authorisation of a preparation of Pediococcus pentosaceus DSM 23689 as a feed additive for all animal species and amending Implementing Regulation (EU) No 84/2014 (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 and renewing such authorisation. ---|--- (2) | The preparation of Pediococcus pentosaceus DSM 23689 was authorised for a period of 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) No 84/2014 (2). ---|--- (3) | In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of the preparation of Pediococcus pentosaceus DSM 23689 as a feed additive for all animal species, requesting the additive to be classified in the additive category ‘technological additives’ and in the functional group ‘silage additives’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003. ---|--- (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 30 January 2024 (3) that the preparation of Pediococcus pentosaceus DSM 23689 remains safe for all animal species, the consumers and the environment under the conditions of use currently authorised. It also concluded that the additive should be considered a respiratory sensitiser. No conclusions could be drawn on the skin sensitisation, and skin and eye irritancy potential of the additive. The Authority also indicated that there is no need for assessing the efficacy of the additive as the application for renewal of its authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation which would have an impact on the efficacy of the additive. ---|--- (5) | The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessment carried out regarding the method of analysis of the preparation of Pediococcus pentosaceus DSM 23689 as a feed additive in the context of the previous authorisation are valid and applicable for the current application. In accordance with Article 5(4), point (c), of Commission Regulation (EC) No 378/2005 (4), an evaluation report of the Reference Laboratory is therefore not required. ---|--- (6) | In view of the above, the Commission considers that the preparation of Pediococcus pentosaceus DSM 23689 satisfies the conditions, as provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive should be renewed. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive. Those protective measures should be without prejudice to other workers’ safety requirements under Union law. ---|--- (7) | As a consequence of the renewal of the authorisation of the preparation of Pediococcus pentosaceus DSM 23689 as a feed additive, Implementing Regulation (EU) No 84/2014 should be amended accordingly. ---|--- (8) | 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 Renewal of the authorisation The authorisation of the preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, is renewed subject to the conditions laid down in that Annex. Article 2 Amendment to Implementing Regulation (EU) No 84/2014 In the Annex to Implementing Regulation (EU) No 84/2014, entry 1k1011 on ‘Pediococcus pentosaceus DSM 23689’ is deleted. Article 3 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, 9 September 2024. For the Commission The President Ursula VON DER LEYEN * * * (1) OJ L 268, 18.10.2003, p. 29, ELI: https://data.europa.eu/eli/reg/2003/1831/oj. (2) Commission Implementing Regulation (EU) No 84/2014 of 30 January 2014 concerning the authorisation of preparations of Pediococcus pentosaceus DSM 14021, Pediococcus pentosaceus DSM 23688 or Pediococcus pentosaceus DSM 23689 as feed additives for all animal species (OJ L 28, 31.1.2014, p. 30, ELI: http://data.europa.eu/eli/reg_impl/2014/84/oj). (3) EFSA Journal, 22(2), e8620. (4) Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (OJ L 59, 5.3.2005, p. 8, ELI: http://data.europa.eu/eli/reg/2005/378/oj). * * * ANNEX Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation ---|---|---|---|---|---|---|---|--- CFU/kg of fresh material Category: technological additives. Functional group: silage additives 1k1011 | Pediococcus pentosaceus DSM 23689 | Additive composition Preparation of Pediococcus pentosaceus DSM 23689 containing a minimum of 1 × 1011 CFU/g additive Solid form | All animal species | - | - | - | | 1. | In the directions for use of the additive and premixtures, the storage conditions shall be indicated. ---|--- 2. | The additive shall only be used in easy and moderately difficult to ensile fresh material (2). ---|--- 3. | Minimum dose of the additive when it is not used in combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material. ---|--- 4. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. ---|--- 30 September 2034 Characterisation of the active substance Viable cells of Pediococcus pentosaceus DSM 23689 Analytical method (1) Enumeration in the feed additive of Pediococcus pentosaceus DSM 23689: | — | Spread plate method using MRS Agar (EN 15786) ---|--- Identification of Pediococcus pentosaceus DSM 23689: — | Pulsed Field Gel Electrophoresis (PFGE) - CEN/TS 17697 or DNA sequencing methods ---|--- * * * (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 2008 on 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). * * * ELI: http://data.europa.eu/eli/reg_impl/2024/2388/oj ISSN 1977-0677 (electronic edition) * * *