Commission Implementing Regulation (EU) 2017/2308 of 13 December 2017 concerning the authorisation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for suckling piglets (holder of authorisation Chr. Hansen A/S) (Text with EEA relevance. )

• CELEX: Implementing Regulation (EU) 2017/2308
• Articles: 3

Article 1 Authorisation

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 Entry into force

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

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

4b1700i

Chr.Hansen A/S

Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749)

Additive composition

Preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis  (DSM 5749) containing a minimum of 3,2 × 10 10 CFU/g of additive

(1:1 ratio)

Solid form

Characterisation of the active substance

Viable spores of Bacillus subtilis

(DSM 5750) and Bacillus licheniformis (DSM 5749)

Analytical method

( 1 )

Identification and enumeration of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) in the feed additive, premixtures, feedingstuffs and water:

—

Identification: Pulsed Field Gel Electrophoresis (PFGE)

—

Enumeration: Spread plate method using tryptone soya agar — EN 15784.

Suckling piglets

—

1,3 × 10 9

—

6,5 × 10 8

—

1.

In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.

2.

The additive may be used in water for drinking.

3.

For use of the additive in water for drinking a homogeneous dispersion of the additive shall be ensured.

4.

Indicate in the instructions for use:

‘The additive shall be fed to lactating sows and suckling piglets simultaneously’

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their 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 and skin protection.

3 January 2028

( 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