Commission Implementing Regulation (EU) 2021/508 of 23 March 2021 concerning the renewal of the authorisation of a preparation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for weaned piglets and repealing Regulation (EU) No 170/2011 (holder of authorisation: Prosol S.p.A.) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/508
• Articles: 4

Article 1

The authorisation of the preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is renewed subject to the conditions laid down in that Annex.

Article 2

Regulation (EU) No 170/2011 is repealed.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Schedules & Appendices

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

4b1710

Prosol S.p.A.

Saccharomyces cerevisiae MUCL 39885

Additive composition

Preparation of Saccharomyces cerevisiae MUCL 39885 containing a minimum of 1 × 10 9 CFU/g

Weaned piglets

-

3 × 10 9

-

1.

In the directions for use of the additive and premixtures, 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 resulting from its 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 skin, eye and breathing protection.

13.4.2031

Characterisation of the active substance:

Viable cells of Saccharomyces cerevisiae MUCL 39885

Analytical method

( 1 )

Enumeration: pour plate method using yeast extract glucose chloramphenicol agar (CGYE) (EN 15789)

Identification: polymerase chain reaction (PCR) method

( 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