Commission Implementing Regulation (EU) 2017/219 of 8 February 2017 concerning the authorisation of a preparation of Bacillus subtilis (DSM 27273) as a feed additive for weaned piglets and weaned minor porcine species (holder of authorisation Chr. Hansen A/S) (Text with EEA relevance. )

• CELEX: Implementing Regulation (EU) 2017/219
• 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/Units of active substance/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: gut flora stabilisers

4b1826

Chr.Hansen A/S

Bacillus subtilis

DSM 27273

Additive composition

Preparation of Bacillus subtilis

DSM 27273 containing a minimum of 1,6 × 10 9 CFU/g of additive

Solid form

Characterisation of the active substance

Viable spores of Bacillus subtilis

DSM 27273

Analytical method

( 1 )

Identification and enumeration of Bacillus subtilis DSM 27273 in the feed additive, premixtures and feedingstuffs:

—

Identification: Pulsed Field Gel Electrophoresis (PFGE)

—

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

Weaned piglets

—

4 × 10 8

—

1.

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

2.

For use in weaned piglets up to 35 kg of body weight.

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, eyes and skin protections.

1 March 2027

Weaned minor porcine species

—

4 × 10 8

( 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