Commission Implementing Regulation (EU) 2019/892 of 28 May 2019 concerning the authorisation of the preparation of Saccharomyces cerevisiae CNCM I-1079 as a feed additive for all pigs other than weaned piglets and sows and all minor porcine species (holder of authorisation Danstar Ferment AG represented by Lallemand SAS) (Text with EEA relevance)
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Address https://gelex.eu/eli/EU/regulation/2019/892@2019-05-28/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 the preparation of Saccharomyces cerevisiae CNCM I-1079. 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 the preparation of Saccharomyces cerevisiae CNCM I-1079 as a feed additive for all pigs other than weaned piglets and sows and all minor porcine species to be classified in the additive category zootechnical additives.
(4) That preparation was already authorised as a zootechnical additive for 10 years by Commission Implementing Regulation (EU) 2018/347 for use with weaned piglets and sows, and by Commission Implementing Regulation (EU) 2017/1905 for use with chickens for fattening and minor poultry species for fattening.
(5) The European Food Safety Authority (the Authority) concluded in its opinion of 28 November 2018 that, under the proposed conditions of use, the preparation of Saccharomyces cerevisiae CNCM I-1079 does not have an adverse effect on animal health, human health or the environment. It also concluded that the additive has the potential to be efficacious in all pigs. 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 CNCM I-1079 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, 28 May 2019. 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. 4d1703 Danstar Ferment AG represented by Lallemand SAS Saccharomyces cerevisiae CNCM I-1079 All pigs other than sows and weaned piglets All minor porcine species — 1 × 109 In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. 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 breathing protection. 18 June 2029
ANNEX Additive composition
Preparation of Saccharomyces cerevisiae CNCM I-1079 containing a minimum of:
1 × 1010 CFU/g of additive (coated form);
2 × 1010 CFU/g of additive (not-coated form).
Characterisation of the active substance
Viable cells of Saccharomyces cerevisiae CNCM I-1079
Analytical method
Enumeration: pour plate method using chloramphenicol dextrose yeast extract agar (EN15789:2009) Identification: polymerase chain reaction (PCR) method (CEN/TS) 15790:2008