Commission Implementing Regulation (EU) 2026/168 of 26 January 2026 concerning the renewal of the authorisation of a preparation of Saccharomyces cerevisiae CBS 493.94 as a feed additive for ruminants for milk production or reproduction, young ruminants for fattening except lambs for fattening and ruminants for fattening except sheep for fattening (holder of authorisation: All-Technology (Ireland) Limited [Alltech Ireland]) and repealing Implementing Regulation (EU) No 1109/2014

Official Journal EN of the European Union L series 2026/168 27.1.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/168 of 26 January 2026 concerning the renewal of the authorisation of a preparation of Saccharomyces cerevisiaeCBS 493.94 as a feed additive for ruminants for milk production or reproduction, young ruminants for fattening except lambs for fattening and ruminants for fattening except sheep for fattening (holder of

authorisation: All-Technology (Ireland) Limited [Alltech Ireland]) and repealing Implementing Regulation (EU) No 1109/2014 (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 an authorisation.

(2) A preparation of Saccharomyces cerevisiaeCBS 493.94, was authorised for a period of 10 years as a feed additive for cattle for fattening, minor ruminant species for fattening, dairy cows and minor dairy ruminant species by Commission Implementing Regulation (EU) No 1109/2014(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 Saccharomyces cerevisiaeCBS 493.94 as a feed additive for dairy cows, minor dairy ruminant species, cattle for fattening and minor ruminant species for fattening, requesting the additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘gut flora stabilisers’. 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 19 March 2025(3) that the preparation of Saccharomyces cerevisiae CBS 493.94 remains safe for the target species, the consumers and the environment under the conditions of use currently authorised. It also concluded that the preparation of Saccharomyces cerevisiaeCBS 493.94, in larger prills form is non-irritant to the skin or eyes while in prills form is not irritant to the skin but irritant to the eyes. The additive in both formulations should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. The Authority also stated that the application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additives. Therefore, it concluded that there is no need for assessing the efficacy of the preparation in the context of the renewal of the authorisation. The Authority did not consider that there is a need for specific requirements of post-market monitoring.

(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.

(2) Commission Implementing Regulation (EU) No 1109/2014 of 20 October 2014 concerning the authorisation of the preparation of Saccharomyces cerevisiaeCBS 493.94 as a feed additive for cattle for fattening, minor ruminant species for fattening, dairy cows and minor dairy ruminant species and amending Regulations (EC) No 1288/2004 and (EC) No 1811/2005 (holder of authorisation Alltech France) (OJ L 301, 21.10.2014, p. 19, ELI: http://data.europa.eu/eli/reg_impl/2014/1109/oj).

(3) EFSA Journal, 2025;23:e9354 (https://doi.org/10.2903/j.efsa.2025.9354).

ELI: http://data.europa.eu/eli/reg_impl/2026/168/oj 1/3EN OJ L, 27.1.2026

(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 Saccharomyces cerevisiae CBS 493.94 as a feed additive in the context of the previous authorisations 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 Saccharomyces cerevisiaeCBS 493.94 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 Saccharomyces cerevisiaeCBS 493.94 as a feed additive, Implementing Regulation (EU) No 1109/2014 should be repealed.

(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 ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is renewed subject to the conditions laid down in that Annex.

Article 2 Repeal Implementing Regulation (EU) No 1109/2014 is repealed.

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, 26 January 2026.

For the Commission The President Ursula VON DER LEYEN

(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).

2/3 ELI: http://data.europa.eu/eli/reg_impl/2026/168/ojANNEX Minimum Maximum Identification Name of the Species or content content End of period number of Name of the Composition, chemical formula, Maximum holder of category of Other provisions of the feed additive description, analytical method age authorisation animal CFU/kg of complete feed with authorisation additive a moisture content of 12 %

Category: zootechnical additives. Functional group: gut flora stabilisers.

4a1704 All- Saccharomyces Additive composition Ruminants — 1 × 107 1. In the directions for 16 February Technology cerevisiae Preparation of Saccharomyces for milk use of the additive and 2036

(Ireland) CBS 493.94 cerevisiaeCBS 493.94 production or premixtures, the Limited containing a minimum of 1 × reproduction storage conditions and [Alltech 109CFU/g additive stability to heat Young 1 × 108 Ireland] Solid form treatment shall be ruminants for indicated.

Characterisation of the active fattening substance except lambs 2. For users of the Viable cells of Saccharomyces for fattening additive and cerevisiaeCBS 493.94 and premixtures, feed Analytical method(1) ruminants for business operators

Enumeration: Pour plate fattening shall establish method using yeast extract except sheep operational dextrose chloramphenicol for fattening procedures and

(CGYE) agar – EN 15789 organisational

Identification: Polymerase measures to address Chain Reaction (PCR) (CEN/TS potential risks

15790) resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal eye (only in prills form), breathing and skin protective equipment.

(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.

ELI:

http://data.europa.eu/eli/reg_impl/2026/168/oj 3/3 OJ L,

27.1.2026 EN