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

Minimum content

Maximum content

Other provisions

End 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

4d1712

Danstar 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. 1.

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

  2. 2.

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

  3. 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 method9

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)

4d1712

Danstar 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. 1.

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

  2. 2.

    The additive shall only be used in solid feed.

  3. 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.

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