Commission Implementing Regulation (EU) 2017/187 of 2 February 2017 concerning the authorisation of a preparation of Bacillus subtilis (DSM 28343) as a feed additive for chickens for fattening (holder of authorisation Lactosan GmbH & Co. KG) (Text with EEA relevance. )

• CELEX: Implementing Regulation (EU) 2017/187
• Articles: 3

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 .

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

4b1825

Lactosan GmbH & Co. KG

Bacillus subtilis

(DSM 28343)

Additive composition

Preparation of Bacillus subtilis (DSM 28343) containing a minimum of 1 × 10 10 CFU/g of additive

Solid form

Characterisation of the active substance

Viable spores of Bacillus subtilis (DSM 28343)

Analytical method

( 1 )

Identification and enumeration of Bacillus subtilis (DSM 28343) in the feed additive, premixtures and feedingstuffs

—

Identification: Pulsed Field Gel Electrophoresis (PFGE)

—

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

Chickens for fattening

—

1 × 10 9

—

1.

In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.

2.

The use is permitted in feed containing the following authorised coccidiostats: diclazuril, nicarbazin, decoquinate, lasalocid A sodium, monensin sodium, robenidine hydrochloride, maduramicin ammonium or halofuginone hydrobromide.

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 breathing protection and skin protections.

23 February 2027

( 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