Commission Implementing Regulation (EU) 2020/1096 of 24 July 2020 concerning the renewal of the authorisation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for dairy cows and horses and repealing Regulation (EU) No 1119/2010 (holder of authorisation Prosol S.p.A.) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/1096
• Articles: 4

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’, is renewed subject to the conditions laid down in that Annex.

Article 2

Regulation (EU) No 1119/2010 is repealed.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

Powder and granulated form containing a minimum of 1 × 10 9 CFU/g additive

Horses

-

3 × 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 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 skin, eyes and breathing protection.

16.8.2030

Characterisation of active substance

Viable cells of Saccharomyces cerevisiae MUCL 39885

Dairy cows

2 × 10 9

Analytical method

( 1 )

Enumeration: pour plate method using chloramphenicol glucose yeast extract agar (EN 15789:2009).

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