Commission Implementing Regulation (EU) No 1059/2013 of 29 October 2013 concerning the authorisation of a preparation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for cattle for fattening and amending Regulation (EC) No 492/2006 (holder of the authorisation Prosol SpA)  Text with EEA relevance
Date: 2013-10-29
Institutions: European Commission
Subjects: animal feedingstuffs, cattle, food safety, food supplement, market approval




L_2013289EN.01003001.xml










31.10.2013   


EN


Official Journal of the European Union


L 289/30








            COMMISSION IMPLEMENTING REGULATION (EU) No 1059/2013
of 29 October 2013
         
concerning the authorisation of a preparation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for cattle for fattening and amending Regulation (EC) No 492/2006 (holder of the authorisation Prosol SpA)
(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. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).












(2)


A preparation of Saccharomyces cerevisiae MUCL 39885 was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for use on cattle for fattening by Commission Regulation (EC) No 492/2006 (3). That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.












(3)


The preparation of Saccharomyces cerevisiae MUCL 39885 was also authorised for 10 years for sows by Commission Regulation (EC) No 896/2009 (4), for dairy cows and horses by Commission Regulation (EU) No 1119/2010 (5), and for weaned piglets by Commission Regulation (EU) No 170/2011 (6).












(4)


In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, an application was submitted for the re-evaluation of that preparation as a feed additive for cattle for fattening, requesting that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.












(5)


The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 March 2013 (7) that, under the proposed conditions of use, the preparation of Saccharomyces cerevisiae MUCL 39885 does not have an adverse effect on animal health, human health or the environment and it has the potential to improve the final body weight, the feed to gain ratio and the average daily gain. 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.












(6)


The assessment of the preparation 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 use of that preparation should be authorised as specified in the Annex to this Regulation.












(7)


As a consequence of the granting of a new authorisation under Regulation (EC) No 1831/2003, the provisions on Saccharomyces cerevisiae MUCL 39885 contained in Regulation (EC) No 492/2006 should be deleted. Regulation (EC) No 492/2006 should therefore be amended accordingly.












(8)


Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.












(9)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,





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
In Annex II to Regulation (EC) No 492/2006 the entry on E 1710, Saccharomyces cerevisiae MUCL 39 885 is deleted.


Article 3
The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 19 May 2014 in accordance with the rules applicable before 19 November 2013 may continue to be placed on the market and used until the existing stocks are exhausted.


Article 4
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, 29 October 2013.


For the Commission


The President

José Manuel BARROSO
            





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

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feeding-stuffs (OJ L 270, 14.12.1970, p. 1).

(3)  Commission Regulation (EC) No 492/2006 of 27 March 2006 concerning the provisional and permanent authorisation of certain additives in feedingstuffs (OJ L 89, 28.3.2006, p. 6).

(4)  Commission Regulation (EC) No 896/2009 of 25 September 2009 concerning the authorisation of a new use of Saccharomyces cerevisiae MUCL 39885 as a feed additive for sows (holder of the authorisation Prosol SpA) (OJ L 256, 29.9.2009, p. 6).

(5)  Commission Regulation (EU) No 1119/2010 of 2 December 2010 concerning the authorisation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for dairy cows and horses and amending Regulation (EC) No 1520/2007 (holder of the authorisation Prosol SpA) (OJ L 317, 3.12.2010, p. 9).

(6)  Commission Regulation (EU) No 170/2011 of 23 February 2011 concerning the authorisation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for piglets (weaned) and amending Regulation (EC) No 1200/2005 (holder of authorisation Prosol SpA) (OJ L 49, 24.2.2011, p. 8).

(7)  
            EFSA Journal 2013; 11(4):3174.




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






4b1710


Prosol SpA



Saccharomyces cerevisiae MUCL 39885








 



Additive composition

Preparation of Saccharomyces cerevisiae MUCL 39885
containing a minimum of:
Powder: 1 × 109 CFU/g of additive
Solid form










 



Characterisation of the active substance

Viable cells of Saccharomyces cerevisiae MUCL 39885










 



Analytical method
 (1)

Enumeration: pour plate method using chloramphenicol glucose yeast extract agar (EN15789:2009)
Identification: polymerase chain reaction (PCR) method






Cattle for fattening


—


4 × 109



—








1.


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










2.


Minimum recommended content of additive for head per day: 3,6 × 1010 CFU.










3.


For safety: glasses and gloves shall be used during handling.






19 November 2023






(1)  Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx