LegalizeCommission Implementing Regulation (EU) 2024/980 of 2 April 2024 concerning the authorisation of a preparation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for cats (holder of authorisation: Prosol S.p.A)
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| Image omitted; see official source | Official Journal of the European Union | EN L series |
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| 2024/980 | 3.4.2024 |
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.
- (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 MUCL 39885. 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 MUCL 39885 as a feed additive for cats, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘gut flora stabilisers’.
- (4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 23 June 2021 2 and of 26 September 2023 3 that, under the proposed conditions of use, the preparation of Saccharomyces cerevisiae MUCL 39885 is safe for cats. It also concluded that the preparation of Saccharomyces cerevisiae MUCL 39885 is considered a potential skin and eye irritant and a skin and respiratory sensitiser. The Authority further concluded that the preparation of Saccharomyces cerevisiae MUCL 39885, has the potential to be efficacious as a zootechnical additive for cats when added to feed at 7 × 1010 CFU/kg complete feed. It did not consider that there is a need for specific requirements of post-market monitoring.
- (5) In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005 4, the Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in a previous assessment concerning the same additive are valid and applicable for the current application.
- (6) In view of the above, the Commission considers that the preparation of Saccharomyces cerevisiae MUCL 39885 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for cats. 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) 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 to 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
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, 2 April 2024.
For the Commission
The President
Ursula VON DER LEYEN
OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
EFSA Journal 2021;19(7):6699.
EFSA Journal 2023;21(10):8358.
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 |
| 4b1710 | Prosol S.p.A | Saccharomyces cerevisiae MUCL 39885 | Additive composition Preparation of Saccharomyces cerevisiae MUCL 39885 containing a minimum of: 1 × 109 CFU/g of additive Solid form Characterisation of the active substance Viable cells of Saccharomyces cerevisiae MUCL 39885 Analytical method 5 Identification: polymerase chain reaction (PCR) method – CEN/TS 15790. Enumeration in feed additive and compound feed: Pour or spread plate method (EN 15789). | Cats | — | 7 × 1010 | — | 1. In the directions for use of the additive and premixture, 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, eye and skin protective equipment. | 23 April 2034 |
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/2024/980/oj
ISSN 1977-0677 (electronic edition)
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