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)

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’ for all porcine species for fattening and for breeding other than sows, all birds, and to the functional group ‘other zootechnical additives’ for all fish and all crustaceans is renewed subject to the conditions laid down in that Annex.

Article 2

Regulations (EC) No 911/2009, (EU) No 1120/2010 and (EU) No 212/2011, as well as Implementing Regulations (EU) No 95/2013, (EU) No 413/2013 and (EU) 2017/2299 are repealed.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.

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
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 × 10 10 CFU/g
Solid not-coated and coated forms
All porcine species for fattening and for breeding, other than sows
-
1 x 10 9
-
5 x 10 8
-
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
( 1 )
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 × 10 10 CFU/g
All fish spicies
-
1 x 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.
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.
( 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

Schedules & Appendices

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