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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 Enterococcus lactis NCIMB 10415, previously identified as Enterococcus faecium NCIMB 10415. 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 a preparation of Enterococcus lactis, NCIMB 10415 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’) concluded in its opinion of 16 September 2025note that the preparation of Enterococcus lactis NCIMB 10415 is safe for all animal species, consumers and the environment. Regarding user safety, the Authority concluded that the preparation is considered an irritant to eyes and a skin and respiratory sensitiser, and any exposure is considered a risk. Furthermore, the Authority concluded that the addition of the preparation of Enterococcus lactis NCIMB 10415 at a minimum level of 1 × 108 CFU/kg fresh plant material has the potential to improve the production and fermentation quality of silage made from all types of plant material. 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 Enterococcus lactis NCIMB 10415 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for all animal species. 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 | ||||||||
| 1k20601 | Enterococcus lactisNCIMB 10415 | Additive compositionPreparation of Enterococcus lactisNCIMB 10415 containing a minimum of 1 × 1010 CFU/g additive.Solid form---------------------------------Characterisation of the active substanceViable cells of Enterococcus lactisNCIMB 10415----------------------------------Analytical methodnoteIdentification of Enterococcus lactisNCIMB 10415 in the feed additive:Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods.Enumeration of Enterococcus lactisNCIMB 10415 in the feed additive:Spread plate (or pour plate) method using Bile Esculin Azide Agar (EN 15788) | 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 and/or enzymes as silage additives: 1 × 108 CFU/kg fresh plant 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, eye and breathing protective equipment. | 28 May 2036 |
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