Commission Implementing Regulation (EU) 2018/347 of 5 March 2018 concerning the authorisation of the preparation of Saccharomyces cerevisiae CNCM I-1079 as a feed additive for piglets and sows and amending Regulations (EC) No 1847/2003 and (EC) No 2036/2005 (holder of authorisation Danstar Ferment AG represented by Lallemand SAS) (Text with EEA relevance. )
Authorisation
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.
Amendment to Regulation (EC) No 1847/2003
Regulation (EC) No 1847/2003 is amended as follows:
(1)
Article 2 is deleted;
(2)
Annex II is deleted.
Amendment to Regulation (EC) No 2036/2005
In Annex I to Regulation (EC) No 2036/2005, entry E1703 is deleted.
Transitional measures
The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 29 September 2018 in accordance with the rules applicable before 29 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted.
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
Supplementary provisions
ANNEXSupplementary provisions
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
4d1703
Danstar Ferment AG represented by Lallemand SAS
Saccharomyces cerevisiae CNCM I-1079
Additive composition:
Preparation of Saccharomyces cerevisiae CNCM I-1079 containing a minimum of:
—
1 × 10 10 CFU/g of additive (coated form);
—
2 × 10 10 CFU/g of additive (not-coated form);
Characterisation of the active substance:
Viable cells of Saccharomyces cerevisiae CNCM I-1079
Analytical method
( 1 )
Enumeration: pour plate method using chloramphenicol dextrose yeast extract agar (EN15789:2009)
Identification: polymerase chain reaction (PCR) method 15790:2008.
Sows
Weaned piglets
—
1 × 10 9
—
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 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.
3.
For use in sows in order to have a benefit for suckling piglets.
4.
For use in weaned piglets until approximately 35 kg.
29 March 2028
( 1 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.