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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 nutritionnote, 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 Levilactobacillus brevis DSM 23231 (previously taxonomically identified as Lactobacillus brevis DSM 23231) was authorised for a period of 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) No 399/2014note.
(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 Levilactobacillus brevis DSM 23231 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 15 November 2023note that the preparation of Levilactobacillus brevis DSM 23231 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 and that on the basis of the studies submitted regarding user safety it was shown not to be a skin or eye irritant. The Authority was not in the position to conclude on the skin sensitisation potential of the additive. It 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 Levilactobacillus brevis DSM 23231 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 378/2005note, an evaluation report of the Reference Laboratory is therefore not required.
(6)In view of the above, the Commission considers that the preparation of Levilactobacillus brevis DSM 23231 satisfies the conditions 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 Levilactobacillus brevis DSM 23231 as a feed additive, Implementing Regulation (EU) No 399/2014 should be amended.
(8)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of Levilactobacillus brevis DSM 23231, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.
(9)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 1Renewal 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 2Amendment to Implementing Regulation (EU) No 399/2014#
In the Annex to Implementing Regulation (EU) No 399/2014, entry 1k20744 on ‘Lactobacillus brevis DSM 23231’ is deleted.
Article 3Transitional measures#
The preparation specified in the Annex and feed containing it, which are produced and labelled before 15 July 2025 in accordance with the rules applicable before 15 July 2024 may continue to be placed on the market and used until the existing stocks are exhausted.
Article 4Entry 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.
| 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 | ||||||||
| 1k20744 | Levilactobacillus brevis DSM 23231 | Additive compositionPreparation of Levilactobacillus brevis DSM 23231 containing a minimum of 1 × 1010 CFU/g additiveSolid formCharacterisation of the active substanceViable cells of Levilactobacillus brevis DSM 23231Analytical methodnoteEnumeration in the feed additive of Levilactobacillus brevis DSM 23231:Spread plate method on MRS agar (EN 15787)Identification of Levilactobacillus brevis DSM 23231:Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods | All animal species | — | — | 1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. Minimum dose of the additive when it is not used in combination with other microorganisms as silage additives: 5 × 107 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 their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin and breathing protective equipment. | 15 July 2034 |
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