Commission Implementing Regulation (EU) 2016/104 of 27 January 2016 concerning the authorisation of a preparation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for minor ruminant species for fattening and dairy production (holder of the authorisation Prosol SpA) (Text with EEA relevance)
Grade B
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Address https://gelex.eu/eli/EU/regulation/2016/104@2016-01-27/en
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, 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 MUCL 39885. 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 MUCL 39885 as a feed additive for minor ruminant species for fattening and dairy production to be classified in the additive category zootechnical additives.
(4) The additive was already authorised for use in piglets by Commission Implementing Regulation (EU) No 170/2011, in dairy cows and horses by Commission Implementing Regulation (EU) No 1119/2010, in sows by Commission Implementing Regulation (EU) No 896/2009 and in cattle for fattening by Commission Implementing Regulation (EU) No 1059/2013
(5) The European Food Safety Authority (the Authority) concluded in its opinion of 9 July 2015 that, under the proposed conditions of use, the preparation of Saccharomyces cerevisiae MUCL 39885 is presumed not to have an adverse effect on animal health, human health or the environment. The Authority considered that the conclusions on efficacy drawn in previous opinions for the major species for fattening and for dairy production can be extrapolated to minor ruminant species for fattening and dairy production. 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) 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, 27 January 2016. For the Commission The President Jean-Claude Juncker
ANNEX
ANNEX 1.2.
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 Minor ruminants for fattening — 4 × 109 — In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting. For safety: glasses and gloves shall be used during handling. 17 February 2026 Minor ruminants for dairy production 2 × 109
ANNEX Additive composition
Preparation of Saccharomyces cerevisiae MUCL 39885 containing a minimum of: 1 × 1010 CFU/g of additive Solid form
Characterisation of the active substance
Viable cells of Saccharomyces cerevisiae MUCL 39885
Analytical method
Enumeration: Pour plate method using chloramphenicol glucose yeast extract agar (EN 15789:2009) Identification: Polymerase Chain Reaction (PCR) method