Commission Implementing Regulation (EU) 2020/161 of 5 February 2020 concerning the renewal of the authorisation of Bacillus subtilis DSM 17299 as a feed additive for chickens for fattening and repealing Regulation (EC) No 1137/2007 (holder of authorisation Chr. Hansen A/S) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/161
• Articles: 4

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’, is renewed subject to the conditions laid down in that Annex.

Article 2

Regulation (EC) No 1137/2007 is repealed.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.

Schedules & Appendices

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

Other provisions

End of period of authorisation

CFU/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: gut flora stabilisers

4b1821

Chr. Hansen A/S

Bacillus subtilis DSM 17299

Additive composition

Preparation of Bacillus subtilis DSM 17299, containing a minimum of 1,6 × 10 10 CFU/g of additive

Solid form

Chickens for fattening

—

8 × 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.

The use is permitted in feed containing one of the following authorised coccidiostats: diclazuril, halofuginone, robenidine, decoquinate, narasin/nicarbazin, lasalocid sodium, maduramycin ammonium, monensin sodium, narasin, salinomycin sodium or semduramycin sodium.

3.

The compatibility of this additive with formic acid has been shown.

4.

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, skin and eye protections.

26 February 2030

Characterisation of the active substance

Viable spore of Bacillus subtilis DSM 17299

Analytical method

( 1 )

Enumeration spread plate method using tryptone soya agar (EN 15784)

Identification of Bacillus subtilis DSM 17299 in the feed additive:

Pulsed Field Gel Electrophoresis (PFGE).

( 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