
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and (EU) No 212/2011, as well as Implementing Regulations (EU) No 95/2013, (EU) No 413/2013 and (EU) 2017/2299 are repealed.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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 4 February 2020.
For the Commission
The President
Ursula VON DER LEYEN
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 compositionPreparation of Pediococcus acidilactici CNCM I-4622containing a minimum of 1 × 1010 CFU/gSolid 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 substanceViable cells of Pediococcus acidilactici CNCM I-4622 All avian species
Analytical methodEnumeration of the active substance in feed additive, premixtures, feedingstuffs and water: spread platemethod 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 compositionPreparation 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 substanceViable cells of Pediococcus acidilactici CNCM I-4622 All crustaceans
Analytical methodEnumeration of the active substance in feed additive, premixtures, feedingstuffs and water: spread platemethod using MRS agar (EN 15786:2009).Identification: Pulsed Field Gel Electrophoresis (PFGE) method. 
