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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 DBVPG 48 SF as a feed additive. 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 DBVPG 48 SF as a feed additive for horses, ruminants and all pigs, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’ as regards horses, and in the functional group ‘other zootechnical additives’ as regards ruminants and pigs.
(4)The preparation of Saccharomyces cerevisiae DBVPG 48 SF was authorised for 10 years as a feed additive for horses, dairy ruminants and pigs by Commission Implementing Regulation (EU) 2023/2734note.
(5)The European Food Safety Authority (‘the Authority’) concluded in its opinions of 23 March 2023note and 13 March 2024note that, under the proposed conditions of use, the preparation of Saccharomyces cerevisiae DBVPG 48 SF is safe for the target species, consumers and the environment. It also concluded that the preparation of Saccharomyces cerevisiae DBVPG 48 SF is not irritant to the eyes and skin but should be considered a respiratory sensitiser, while it could not conclude on the skin sensitisation potential of the preparation. The Authority further concluded that the preparation of Saccharomyces cerevisiae DBVPG 48 SF has the potential to be efficacious for all ruminants at the proposed condition of use. 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 additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(6)In view of the above, the Commission considers that the preparation of Saccharomyces cerevisiae DBVPG 48 SF satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003 for ruminants other than dairy. Accordingly, the use of that preparation should be authorised for ruminants other than dairy. 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 1Authorisation#
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical 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 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 of zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters) | |||||||||
| 4d24 | Mazzoleni S.p.A. | Saccharomyces cerevisiae DBVPG 48 SF | Additive compositionPreparation of Saccharomyces cerevisiae DBVPG 48 SF with a minimum concentration of:1 × 109 CFU/g of additive.Solid forms.Characterisation of the active substanceViable cells of Saccharomyces cerevisiae DBVPG 48 SF.Analytical methodnoteIdentification: polymerase chain reaction (PCR) method – CEN/TS 15790Enumeration in the feed additive, premixtures and compound feed: pour or spread plate method (EN 15789) | Ruminants, other than dairy cows and minor dairy ruminants | — | 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 breathing and skin protective equipment. | 20 February 2035 |
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