Commission Implementing Regulation (EU) 2018/1079 of 30 July 2018 concerning the authorisation of a preparation of Bacillus subtilis DSM 28343 as a feed additive for weaned piglets (holder of authorisation Lactosan GmbH & Co. KG) (Text with EEA relevance.)

• CELEX: Implementing Regulation (EU) 2018/1079
• 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 )

For identification of Bacillus subtilis DSM 28343 in the feed additive, premixtures and feedingstuffs:

—

Identification: Pulsed Field Gel Electrophoresis (PFGE)

For enumeration of Bacillus subtilis DSM 28343 in the feed additive, premixtures and feedingstuffs:

—

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

Piglets (weaned)

—

1 × 10 9

—

1.

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

2.

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

3.

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

20.8.2028

( 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