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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 and renewing such authorisation.
(2)The preparation of Saccharomyces cerevisiae MUCL 39885 was authorised for 10 years as a feed additive for sows by Commission Regulation (EC) No 896/2009note.
(3)In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted by the holder of that authorisation for the renewal of the authorisation of the preparation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for sows, requesting that additive to be classified in the additive category ‘zootechnical additives’. 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 14 May 2019note that the applicant has provided data demonstrating that the additive complies with the conditions of authorisation. The Authority concluded that Saccharomyces cerevisiae MUCL 39885 does not have an adverse effect under the authorised conditions of use for the animal health, consumers, or the environment. The Authority also concluded that the additive is considered a potential skin and eye irritant and a potential skin and respiratory sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive.
(5)The assessment of Saccharomyces cerevisiae MUCL 39885 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of that additive should be renewed as specified in the Annex to this Regulation.
(6)As a consequence of the renewal of the authorisation of Saccharomyces cerevisiae MUCL 39885 as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EC) No 896/2009 should be repealed.
(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#
The authorisation of the additive 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#
Regulation (EC) No 896/2009 is repealed.
Article 3#
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 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: gut flora stabilisers. | |||||||||
| 4b1710 | ProsolS.p.A. | Saccharomyces cerevisiaeMUCL 39885 | Additive compositionPreparation of Saccharomyces cerevisiaeMUCL 39885Powder and granulated form containing a minimum of 1 × 109 CFU/g additive | Sows | - | 6,4 × 109 | - | 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eyes and breathing protection. | 16.8.2030 |
| Characterisation of active substanceViable cells of Saccharomyces cerevisiae MUCL 39885 | |||||||||
| Analytical methodnoteEnumeration: pour plate method using chloramphenicol glucose yeast extract agar (EN 15789:2009).Identification: polymerase chain reaction (PCR) method |
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