Commission Implementing Regulation (EU) 2020/1762 of 25 November 2020 concerning the authorisation of a preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 as a feed additive for all poultry species for fattening or reared for laying or reared for breeding (holder of authorisation Chr. Hansen A/S) (Text with EEA relevance)

Article 1

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX

Identification number of the feed additive	Name of the holder of authorisation	Name of the 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
Category: zootechnical additives. Functional group: gut flora stabilisers.
4b1894	Chr. Hansen A/S	Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840	Additive composition Preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 containing a minimum of 3,2 × 10⁹ CFU/g additive (1,6 × 10⁹ CFU B. subtilis DSM 32324/g; 1,0 × 10⁹ CFU B. subtilis DSM 32325/g and 0,6 × 10⁹ CFU B. amyloliquefaciens DSM 25840/g) (ratio 1.6:1.0:0.6) Solid forms Characterisation of the active substance Viable spores of cells of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840. Analytical method⁽¹⁾ Identification: DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) (CEN/TS 17697) Enumeration in the feed additive, premixtures, compound feed and water for drinking: Spread plate method on tryptone soya agar (EN 15784).	All poultry species for fattening or reared for laying or reared for breeding	-	1,6 × 10⁹	-	5,4 × 10⁸	-	The additive may be used via water for drinking. In the directions for use of the additive and premixtures, the storage conditions, the stability to heat treatment and the stability in water for drinking shall be indicated. The additive may be used simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: diclazuril, decoquinate, halofuginone, monensin, salinomycin, narasin, a combination of nicarbazin and narasin, or lasalocid. 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 breathing protection, glasses and gloves.	16.12.2030

Identification number of the feed additive

Name of the holder of authorisation

Name of the 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 feed with a moisture content of 12 %

CFU/l of water for

drinking

Category: zootechnical additives. Functional group: gut flora stabilisers.

4b1894

Chr. Hansen A/S

Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840

Additive composition

Preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 containing a minimum of 3,2 × 10⁹ CFU/g additive (1,6 × 10⁹ CFU B. subtilis DSM 32324/g; 1,0 × 10⁹ CFU B. subtilis DSM 32325/g and 0,6 × 10⁹ CFU B. amyloliquefaciens DSM 25840/g) (ratio 1.6:1.0:0.6)

Solid forms

Characterisation of the active substance

Viable spores of cells of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840.

Analytical method⁽¹⁾

Identification: DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) (CEN/TS 17697)

Enumeration in the feed additive, premixtures, compound feed and water for drinking: Spread plate method on tryptone soya agar (EN 15784).

All poultry species for fattening or reared for laying or reared for breeding

-

1,6 × 10⁹

-

5,4 × 10⁸

-

The additive may be used via water for drinking.
In the directions for use of the additive and premixtures, the storage conditions, the stability to heat treatment and the stability in water for drinking shall be indicated.
The additive may be used simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: diclazuril, decoquinate, halofuginone, monensin, salinomycin, narasin, a combination of nicarbazin and narasin, or lasalocid.
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 breathing protection, glasses and gloves.

16.12.2030