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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 such an authorisation.
(2)In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of Lacticaseibacillus huelsenbergensis DSM 115424. 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 Lacticaseibacillus huelsenbergensis DSM 115424 as a feed additive for all animal species, requesting that additive to be classified in the category ‘technological additives’ and in the functional group ‘silage additives’.
(4)The European Food Safety Authority (‘the Authority’) in its opinion of 6 May 2025note concluded that the use of Lacticaseibacillus huelsenbergensis DSM 115424 as a silage additive is safe for all animal species, consumers and the environment. Regarding user safety, the Authority concluded that the additive should be considered as a potential skin and respiratory sensitiser, and that inhalation and dermal exposure are considered a risk. It further concluded that the addition of Lacticaseibacillus huelsenbergensis DSM 115424 at a minimum level of 1 × 108 CFU/kg fresh plant material has the potential to improve the production of silages from all fresh plant materials by enhancing the preservation of nutrients. The Authority also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5)In view of the above, the Commission considers that the preparation of Lacticaseibacillus huelsenbergensis DSM 115424 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised. 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.
(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 1Authorisation#
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 2Entry 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 additive | Name of the 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 | ||||||||
| 1k21702 | Lacticaseibacillus huelsenbergensis DSM 115424 | Additive compositionPreparation of Lacticaseibacillus huelsenbergensis DSM 115424, containing a minimum of 4 × 1011 CFU/g additive.Solid form—————————Characterisation of the active substanceViable cells of Lacticaseibacillus huelsenbergensis DSM 115424—————————Analytical methodnoteIdentification of Lacticaseibacillus huelsenbergensis DSM 115424 in the feed additive:Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods.Enumeration of Lacticaseibacillus huelsenbergensis DSM 115424 in the feed additive:Spread plate (or pour plate) method on MRS agar (EN 15787) | 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 micro-organisms as silage additives: 1 × 108 CFU/kg fresh plant material.3.If used as a cryoprotectant, polyethylene glycol (PEG 4000) shall be used up to a maximum concentration of 0,025 mg/kg silage.4.Cryoprotectants used in the preparation of Lacticaseibacillus huelsenbergensis DSM 115424 may include inter alia:sodium citrate,mannitol,sodium glutamate monohydrate.5.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. | 10 March 2036 |
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