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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 Saccharomyces cerevisiae NBRC 0203 and Lacticaseibacillus rhamnosus NBRC 3425. 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 Saccharomyces cerevisiae NBRC 0203 and Lacticaseibacillus rhamnosus NBRC 3425 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 18 September 2025note that the preparation consisting of Saccharomyces cerevisiae NBRC 0203 and Lacticaseibacillus rhamnosus NBRC 3425 is safe for all animal species, consumers and the environment. Regarding user safety, the Authority concluded that the preparation should be considered a skin and respiratory sensitiser, and any exposure through the skin and respiratory tract is considered a risk. However, the Authority could not conclude on its eye irritation potential. Furthermore, the Authority concluded that the addition of the preparation at a minimum level of 4 × 102 CFU of Saccharomyces cerevisiae NBRC 0203 and 3,2 × 106 CFU of Lacticaseibacillus rhamnosus NBRC 3425/kg fresh plant material has the potential to improve the production of silage made from easy and moderately difficult to ensile fresh 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 Saccharomyces cerevisiae NBRC 0203 and Lacticaseibacillus rhamnosus NBRC 3425 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 | ||||||||
| 1k1803 | Saccharomyces cerevisiae NBRC0203 and Lacticaseibacillus rhamnosus NBRC 3425 | Additive compositionPreparation of Saccharomyces cerevisiae NBRC 0203 and Lacticaseibacillus rhamnosus NBRC 3425 containing a minimum of 5 × 103 CFU of Saccharomyces cerevisiae NBRC 0203 and 4 × 102 CFU of Lacticaseibacillus rhamnosus NBRC 3425/mL additiveLiquid formCharacterisation of the active substanceViable cells of Saccharomyces cerevisiae NBRC 0203 and Lacticaseibacillus rhamnosus NBRC 3425Analytical methodnoteIdentification of Saccharomyces cerevisiae NBRC 0203:DNA sequencing methods or Polymerase Chain Reaction (PCR) – CEN/TS 15790Identification of Lacticaseibacillus rhamnosus NBRC 3425:DNA sequencing methods or Pulsed-Field Gel Electrophoresis (PFGE) – CEN/TS 17697Enumeration of Saccharomyces cerevisiae NBRC 0203 in the feed additive:Pour or spread plate method on YGC agar – EN 15789Enumeration of Lacticaseibacillus rhamnosus NBRC 3425 in the feed additive:Pour or spread 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 and/or enzymes as silage additives: 4,0 × 102 CFU of Saccharomyces cerevisiae NBRC 0203 and 3,2 × 106 CFU of Lacticaseibacillus rhamnosus NBRC 3425/kg fresh plant material.3. The additive shall only be used with easy and moderately difficult to ensile fresh plant 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. | 28 May 2036 |
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