Commission Implementing Regulation (EU) 2020/1755 of 24 November 2020 concerning the authorisation of a preparation of Bacillus coagulans DSM 32016 as a feed additive for suckling and weaned Suidae piglets, poultry for fattening and ornamental birds (holder of authorisation Biochem Zusatzstoffe Handels- und Produktionsges. mbH) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/1755
• 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

4b1900

Biochem Zusatzstoffe Handels- und Produktionsges. mbH

Bacillus coagulans DSM 32016

Additive composition

Preparation of Bacillus coagulans DSM 32016 containing a minimum of 2 × 10 10 CFU/g additive

Solid form

Suckling and weaned Suidae piglets

-

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.

May be used in feed containing the following permitted coccidiostats: halofuginone and diclazuril.

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.

15.12.2030

Characterisation of the active substance

Viable spores of cells of Bacillus coagulans DSM 32016

Poultry for fattening

Analytical method

( 1 )

Enumeration in the feed additive, premixtures and feedingstuffs: Spread plate method on MRS agar (based on EN 15787 method).

Identification: Pulsed Field Gel Electrophoresis (PFGE).

Ornamental birds

( 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