Commission Implementing Regulation (EU) 2025/364 of 21 February 2025 concerning the authorisation of a preparation of Saccharomyces cerevisiae CNCM I-4407 as a feed additive for cattle for fattening (holder of authorisation: S.I. Lesaffre) and amending Regulation (EC) No 316/2003
Date: 2025-02-21
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, cattle, fattening, market approval, texture agent




L_202500364EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/364


24.2.2025







            COMMISSION IMPLEMENTING REGULATION (EU) 2025/364
of 21 February 2025
         
concerning the authorisation of a preparation of Saccharomyces cerevisiae CNCM I-4407 as a feed additive for cattle for fattening (holder of authorisation: S.I. Lesaffre) and amending Regulation (EC) No 316/2003
(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 such an authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).












(2)


The preparation of Saccharomyces cerevisiae CNCM I-4407 (previously taxonomically identified as Saccharomyces cerevisiae NCYC Sc 47) was authorised without a time limit pursuant to Directive 70/524/EEC as a feed additive for cattle for fattening by Commission Regulation (EC) No 316/2003 (3). That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1), point (b), of Regulation (EC) No 1831/2003.












(3)


In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the authorisation of the preparation of Saccharomyces cerevisiae CNCM I-4407 as a feed additive for cattle for fattening. The applicant requested the additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘gut flora stabilisers’. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.












(4)


The European Food Safety Authority (‘the Authority’) concluded in its opinions of 22 January 2019 (4) and 13 March 2024 (5) that, under the proposed conditions of use, the preparation of Saccharomyces cerevisiae CNCM I-4407 is considered safe for cattle for fattening, consumers and the environment. Regarding the safety for the user, in the absence of data, the Authority could not conclude on the potential of the preparation of Saccharomyces cerevisiae CNCM I-4407 to be irritant to eyes or its dermal sensitisation potential due to the lack of data but concluded that that additive is not a skin irritant and that inhalation exposure is unlikely. The Authority concluded that the preparation of Saccharomyces cerevisiae CNCM I-4407 is efficacious as a zootechnical additive in cattle for fattening at the concentration of 4 × 109 CFU/kg complete feed. It did not consider that there is a need for specific requirements of post-market monitoring. The Authority also verified the report on the methods of analysis of the feed additives 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 CNCM I-4407 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003 for use in cattle for fattening. Accordingly, the use of that preparation should be authorised for cattle for fattening. 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)


Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of Saccharomyces cerevisiae CNCM I-4407, it is appropriate to provide for a transitional period for the interested parties to prepare themselves to meet the new requirements resulting from the authorisation.












(7)


As a consequence of the authorisation of the preparation of Saccharomyces cerevisiae CNCM I-4407 as a feed additive for cattle for fattening, Regulation (EC) No 316/2003 should be amended accordingly.












(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

Authorisation

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.


Article 2

Amendment to Regulation (EC) No 316/2003

Regulation (EC) No 316/2003 is amended as follows:






(1)


Article 1 is deleted;










(2)


Annex I is deleted.






Article 3

Transitional measures


1.   The feed additive Saccharomyces cerevisiae NCYC Sc 47 (E 1702), as authorised by Regulation (EC) No 316/2003, and premixtures containing that additive, which are intended for cattle for fattening, and which are produced and labelled before 16 September 2025 in accordance with the rules applicable before 16 March 2025 may continue to be placed on the market and used until the stocks concerned are exhausted.


2.   Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are intended for cattle for fattening, and which are produced and labelled before 16 March 2026 in accordance with the rules applicable before 16 March 2025 may continue to be placed on the market and used until the stocks concerned are exhausted.



Article 4

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, 21 February 2025.


For the Commission


The President

Ursula VON DER LEYEN
            





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

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs(OJ L 270, 14.12.1970, p. 1, ELI: http://data.europa.eu/eli/dir/1970/524/oj).

(3)  Commission Regulation (EC) No 316/2003 of 19 February 2003 concerning the permanent authorisation of an additive in feedingstuffs and the provisional authorisation of a new use of an additive already authorised in feedingstuffs (OJ L 46, 20.2.2003, p. 15, ELI: http://data.europa.eu/eli/reg/2003/316/oj).

(4)  
            EFSA Journal, 2019; 17(3):5600.

(5)  
            EFSA Journal, 2024; 22:e8727.




ANNEX














Identification number of the feed additive


Name of the holder of authorisation


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 complete feedingstuff with a moisture content of 12 %





Category: zootechnical additives. Functional group: gut flora stabilisers





4b1702


S.I. Lesaffre



Saccharomyces cerevisiae CNCM I-4407



Additive composition

Preparation of Saccharomyces cerevisiae CNCM I-4407 containing a minimum of 5 × 109 CFU/g
Solid form.

Characterisation of the active substance

Viable yeast cells of Saccharomyces cerevisiae CNCM I-4407

Analytical method
 (1)

Enumeration in the feed additive, premixtures and compound feed: pour or spread plate method using chloramphenicol dextrose yeast extract agar (EN 15789).
Identification: polymerase chain reaction (PCR) method (CEN/TS 15790).


Cattle for fattening


—


4 × 109



—








1.


In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.










2.


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 eye and skin protective equipment.






16 March 2035






(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/2025/364/oj
ISSN 1977-0677 (electronic edition)