Commission Implementing Regulation (EU) 2020/151Dangos y teitl llawn

Commission Implementing Regulation (EU) 2020/151 of 4 February 2020 concerning the authorisation of Pediococcus acidilactici CNCM I-4622 as a feed additive for all porcine species for fattening and for breeding other than sows, all avian species, all fish species and all crustaceans and repealing Regulations (EC) No 911/2009, (EU) No 1120/2010 and (EU) No 212/2011 and Implementing Regulations (EU) No 95/2013, (EU) No 413/2013 and (EU) 2017/2299 (holder of authorisation Danstar Ferment AG represented in the Union by Lallemand SAS) (Text with EEA relevance)

ANNEXU.K.

a

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

Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentMinimum contentMaximum contentOther provisionsEnd of period of authorisation
CFU/kg of complete feedingstuff with a moisture content of 12 %CFU/l of water for drinking
Category of zootechnical additives. Functional group: gut flora stabilisers
4d1712Danstar Ferment AG represented in the Union by Lallemand SAS Pediococcus acidilactici CNCM I-4622

Additive composition

Preparation of Pediococcus acidilactici CNCM I-4622

containing a minimum of 1 × 1010 CFU/g

Solid not-coated and coated forms

All porcine species for fattening and for breeding, other than sows-1 x 109-5 x 108-
1.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

2.

For use of the additive in water for drinking the homogenous dispersion of the additive shall be ensured.

3.

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.

25 February 2030

Characterisation of the active substance

Viable cells of Pediococcus acidilactici CNCM I-4622

All avian species

Analytical method a

Enumeration of the active substance in feed additive, premixtures, feedingstuffs and water: spread plate

method using MRS agar (EN 15786:2009).

Identification: Pulsed Field Gel Electrophoresis (PFGE) method.

Category of zootechnical additives. Functional group: other zootechnical additives (favourably affect growth)
4d1712Danstar Ferment AG represented in the Union by Lallemand SAS Pediococcus acidilactici CNCM I-4622

Additive composition

Preparation of Pediococcus acidilactici CNCM I-4622 containing a minimum of 1 × 1010 CFU/g

All fish spicies-1 x 109--
1.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

2.

The additive shall only be used in solid feed.

3.

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.

Characterisation of the active substance

Viable cells of Pediococcus acidilactici CNCM I-4622

All crustaceans

Analytical method

Enumeration of the active substance in feed additive, premixtures, feedingstuffs and water: spread plate

method using MRS agar (EN 15786:2009).

Identification: Pulsed Field Gel Electrophoresis (PFGE) method.