Commission Implementing Regulation (EU) 2022/1382 of 8 August 2022 concerning the authorisation of a preparation of Propionibacterium freudenreichii DSM 33189 and Lentilactobacillus buchneri DSM 12856 as a feed additive for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2022/1382
• Articles: 3

Article 1

The preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

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

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 of additive/kg of fresh material

Category: technological additives

Functional group: silage additives

1k1801

Propionibacterium freudenreichii DSM 33189 and Lentilactobacillus buchneri DSM 12856

Additive composition

Preparation of Propionibacterium freudenreichii DSM 33189 and Lentilactobacillus buchneri DSM 12856 containing a minimum of 5 × 10 11 CFU/g additive, with a ratio of 1:4 (1×10 11 CFU P. freudenreichii DSM 33189/g and 4×10 11 CFU L. buchneri DSM 12856/g)

Solid form

Characterisation of the active substance

Viable cells of Propionibacterium freudenreichii DSM 33189 and Lentilactobacillus buchneri DSM 12856

Analytical method

( 1 )

For the identification of Propionibacterium freudenreichii DSM 33189 and Lentilactobacillus buchneri DSM 12856:

—

Pulsed-Field Gel Electrophoresis (PFGE) or DNA sequencing methods

For the enumeration of Lentilactobacillus buchneri DSM 12856 in the feed additive:

—

Spread plate method on MRS agar (EN 15787)

For the enumeration of Propionibacterium freudenreichii DSM 33189 in the feed additive:

—

Pour plate method on caseine peptone, yeast extract, sodium lactate and L-cysteine agar

All animal species

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-

-

1.

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

2.

Minimum content of the additive when used without combination with other micro-organisms as silage additives: 1×10 8 CFU/kg of easy and moderately difficult to ensile fresh material  ( 2 ) .

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, including skin and breathing protection.

29 August 2032

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

( 2 )   Easy to ensile forage: > 3 % soluble carbohydrates in fresh material; moderately difficult to ensile forage: 1,5-3,0 % soluble carbohydrates in the fresh material in accordance with Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives ( OJ L 133, 22.5.2008, p. 1 ).