Commission Implementing Regulation (EU) 2019/899 of 29 May 2019 concerning the renewal of the authorisation of Saccharomyces cerevisiae CNCM I-4407 as a feed additive for lambs for fattening, dairy goats, dairy sheep, dairy buffaloes, horses and pigs for fattening and repealing Regulations (EC) No 1447/2006, (EC) No 188/2007, (EC) No 232/2009, (EC) No 186/2007 and (EC) No 209/2008 (holder of authorisation S.I. Lesaffre) (Text with EEA relevance.)

Article 1

The authorisation of the additive specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’ when it is used for lambs for fattening, dairy goats, dairy sheep, dairy buffaloes and pigs for fattening; and to the functional group ‘digestibility enhancers’ when it is used for horses, is renewed subject to the conditions laid down in that Annex.

Article 2

Saccharomyces cerevisiae NCYC Sc47as feed additive under the conditions laid down in the Annex to this Regulation, Regulations (EC) No 1447/2006, (EC) No 186/2007, (EC) No 188/2007, (EC) No 209/2008 and (EC) No 232/2009, and premixtures and compound feed containing it, labelled in accordance with those Regulations before the entry into force of this Regulation, may be continued to be placed on the market until the existing stocks are exhausted.

Article 3

Regulations (EC) No 1447/2006, (EC) No 186/2007, (EC) No 188/2007, (EC) No 209/2008 and (EC) No 232/2009 are repealed.

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 .

ANNEX

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
4b1702
S.I. Lesaffre
Saccharomyces cerevisiae CNCM I-4407
Additive composition:
Preparation of Saccharomyces cerevisiae CNCM I-4407 with a minimum concentration of 5 × 10 9 CFU/g.
Solid form
Characterisation of the active substance:
Viable dried cells of Saccharomyces cerevisiae CNCM I-4407
Analytical method
( 1 )
Enumeration: pour plate method using chloramphenicol dextrose yeast extract agar (EN 15789:2009).
Identification: polymerase chain reaction (PCR) method CEN/TS 15790:2008.
Lambs for fattening
—
1,4 × 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.
Recommended doses (CFU/head/day) for:
—
dairy goats: 3 × 10 9
—
dairy sheep: 2 × 10 9
3.
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 eye and breathing protection.
23 June 2029
Dairy goats and dairy sheep
7 × 10 8
Pigs for fattening
1,25 × 10 9
Dairy buffaloes
5 × 10 8
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: digestibility enhancers
4b1702
S.I. Lesaffre
Saccharomyces cerevisiae CNCM I-4407
Additive composition:
Preparation of Saccharomyces cerevisiae CNCM I-4407 with a minimum concentration of 5 × 10 9 CFU/g.
Solid form
Characterisation of the active substance:
Viable dried cells of Saccharomyces cerevisiae CNCM I-4407
Analytical method
( 2 )
Enumeration: pour plate method using chloramphenicol dextrose yeast extract agar (EN 15789:2009).
Identification: polymerase chain reaction (PCR) method CEN/TS 15790:2008.
Horses
—
8 × 10 8
—
1.
In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.
2.
Recommended doses (CFU/head/day) for:
—
horses: 1,25 × 10 10 – 6 × 10 10
3.
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 eye and breathing protection.
23 June 2029
( 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
( 2 )   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

Schedules & Appendices

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