Commission Implementing Regulation (EU) 2015/502 of 24 March 2015 concerning the authorisation of the preparation of Saccharomyces cerevisiae NCYC R404 as a feed additive for dairy cows (holder of the authorisation Micro Bio-System Ltd)  Text with EEA relevance
Date: 2015-03-24
Institutions: European Commission
Subjects: animal feedingstuffs, dairy cow, food safety, food supplement, market approval




L_2015079EN.01005701.xml










25.3.2015   


EN


Official Journal of the European Union


L 79/57








            COMMISSION IMPLEMENTING REGULATION (EU) 2015/502
of 24 March 2015
         
concerning the authorisation of the preparation of Saccharomyces cerevisiae NCYC R404 as a feed additive for dairy cows (holder of the authorisation Micro Bio-System Ltd)
(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 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 NCYC R404. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.












(3)


That application concerns the authorisation of a preparation of Saccharomyces cerevisiae NCYC R404 as a feed additive for dairy cows to be classified in the additive category ‘zootechnical additives’.












(4)


The European Food Safety Authority (‘the Authority’) concluded in its opinion of 11 September 2014 (2) that, under the proposed conditions of use, the preparation of Saccharomyces cerevisiae NCYC R404 does not have an adverse effect on animal health, human health or the environment. It was also concluded that the additive has the potential to improve milk production of dairy cows. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.












(5)


The assessment of the preparation of Saccharomyces cerevisiae NCYC R404 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.












(6)


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 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
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, 24 March 2015.


For the Commission


The President

Jean-Claude JUNCKER
            





(1)  
            OJ L 268, 18.10.2003, p. 29.

(2)  EFSA Journal 2014; 12(9):3830.




ANNEX














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






4b1871


Micron Bio-Systems Ltd



Saccharomyces cerevisiae NCYC R404



Additive composition

Preparation of Saccharomyces cerevisiae NCYC R404 containing a minimum of:
solid form 1 × 1010 CFU/g additive

Characterisation of the active substance


Saccharomyces cerevisiae NCYC R404

Analytical method
 (1)

Identification: Polymerase Chain Reaction (PCR)






—


Enumeration: Pour plate method using yeast extract dextrose chloramphenicol (CGYE) agar — EN 15789






Dairy cows


—


4,4 × 108



—








1.


In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting.










2.


Recommended dose of the additive: 1 × 1010 CFU/head/day.










3.


For safety: breathing and skin protection shall be used during handling.






14 April 2025






(1)  Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports