Commission Implementing Regulation (EU) 2020/1374 of 1 October 2020 concerning the authorisation of the preparation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive for calves, all minor ruminant species (for rearing) other than lambs and camelids (for rearing) (holder of authorisation Danstar Ferment AG represented by Lallemand SAS) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/1374
• Articles: 3

Article 1 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.

Article 2 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.

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.

4b1711

Danstar Ferment AG represented in the Union by Lallemand SAS

Saccharomyces

cerevisiae

CNCM I-1077

Additive composition

Preparation of Saccharomyces cerevisiae

CNCM I-1077 containing a minimum of:

—

1 × 10 10 CFU/g additive (coated form)

—

2 × 10 10 CFU/g additive

(not-coated form)

Calves

All minor ruminant species (for rearing) other than lambs

Camelids

(for rearing)

-

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 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.

22.10.2030

Characterisation of active substance

Viable cells of Saccharomyces cerevisiae CNCM I-1077

Analytical method

( 1 )

Enumeration: pour plate method

using chloramphenicol dextrose yeast

extract agar (EN 15 789 :2009).

Identification: polymerase chain

reaction (PCR) method (CEN/TS 15 790 :2008)

( 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