LegalizeCommission Implementing Regulation (EU) 2025/275 of 12 February 2025 concerning the renewal of the authorisation of a preparation of Saccharomyces cerevisiae CNCM I-4407 as a feed additive for rabbits other than suckling and breeding rabbits (holder of authorisation: S. I. Lesaffre) and repealing Implementing Regulation (EU) No 334/2012
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| Image omitted; see official source | Official Journal of the European Union | EN L series |
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| 2025/275 | 13.2.2025 |
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 cerevisiae CNCM I-4407 was authorised for 10 years as a feed additive for rabbits for fattening and non-food producing rabbits by Commission Implementing Regulation (EU) No 334/2012 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 cerevisiae CNCM I-4407 as a feed additive. 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 27 June 2024 3 that the applicant has provided evidence that the preparation of Saccharomyces cerevisiae CNCM I-4407 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 cerevisiae CNCM I-4407 is not irritant to skin and eyes, but it should be considered a skin and respiratory sensitiser. It also indicated that there is no need for assessing the efficacy of the preparation of Saccharomyces cerevisiae CNCM I-4407 as 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 additive. The Authority did not consider that there is a need for specific requirements of post-market monitoring.
- (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 CNCM I-4407 as a feed additive in the context of the previous authorisation 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 cerevisiae CNCM I-4407 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.
- (7) As a consequence of the renewal of the authorisation of the preparation of Saccharomyces cerevisiae CNCM I-4407 as a feed additive, Implementing Regulation (EU) No 334/2012 should be repealed.
- (8) 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 interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.
- (9) 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 334/2012 is repealed.
Article 3
Transitional measures
The feed additive Saccharomyces cerevisiae CNCM I-4407, as authorised by Implementing Regulation (EU) No 334/2012, and premixtures containing that additive, which are intended for rabbits for fattening and non-food producing rabbits, and which are produced and labelled before 5 September 2025 in accordance with the rules applicable before 5 March 2025 may continue to be placed on the market and used until the stocks concerned are exhausted.
Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are intended for rabbits for fattening and non-food producing rabbits, and which are produced and labelled before 5 March 2026 in accordance with the rules applicable before 5 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, 12 February 2025.
For the Commission
The President
Ursula VON DER LEYEN
Commission Implementing Regulation (EU) No 334/2012 of 19 April 2012 concerning the authorisation of a preparation of Saccharomyces cerevisiae CNCM I-4407 as a feed additive for rabbits for fattening and non food-producing rabbits and amending Regulation (EC) No 600/2005 (holder of the authorisation Société Industrielle Lesaffre) (OJ L 108, 20.4.2012, p. 6, ELI: http://data.europa.eu/eli/reg_impl/2012/334/oj).
EFSA Journal. 2024;22:e8910.
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).
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 |
|---|---|---|---|---|---|---|---|---|---|
| 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 | CFU/kg of complete feedingstuff with a moisture content of 12 % | CFU/kg of complete feedingstuff with a moisture content of 12 % | Other provisions | End of period of authorisation |
| Category: zootechnical additives. Functional group: gut flora stabilisers | Category: zootechnical additives. Functional group: gut flora stabilisers | Category: zootechnical additives. Functional group: gut flora stabilisers | Category: zootechnical additives. Functional group: gut flora stabilisers | Category: zootechnical additives. Functional group: gut flora stabilisers | Category: zootechnical additives. Functional group: gut flora stabilisers | Category: zootechnical additives. Functional group: gut flora stabilisers | Category: zootechnical additives. Functional group: gut flora stabilisers | Category: zootechnical additives. Functional group: gut flora stabilisers | 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 Dried cells of Saccharomyces cerevisiae CNCM I-4407 Analytical method 5 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). | Rabbits other than suckling and breeding rabbits | - | 5 × 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 breathing and skin protective equipment. | 5 March 2035 |
Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/system/files/2013-02/FinRep-FAD-2010-0038.pdf.
ELI: http://data.europa.eu/eli/reg_impl/2025/275/oj
ISSN 1977-0677 (electronic edition)
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