LegalizeCommission 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)
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX
| Identification number of the additive | Name of the holder of authorisation | Name of the 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 feed with a moisture content of 12 % | |||||||||
| Category: zootechnical additives. Functional group: gut flora stabilisers | |||||||||
| 4b1900 | Biochem Zusatzstoffe Handels- und Produktionsges. mbH | Weizmannia faecalis DSM 32016 | Additive composition Preparation of Weizmannia faecalis DSM 32016 containing a minimum of 2 × 1010 CFU/g additive Solid form Characterisation of the active substance Viable spores of cells of Weizmannia faecalis DSM 32016 Analytical method (1) Identification: DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697. Enumeration in the feed additive, premixtures, compound feed and water for drinking: Spread plate method on MRS agar (based on EN 15787 method). | Suckling and weaned Suidae piglets Poultry for fattening Ornamental birds | - | 1 × 109 | - | 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 2. The additive may be used simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: halofuginone, diclazuril, monensin sodium, robenidine hydrochloride, salinomycin sodium, amprolium, a combination of monensin sodium with nicarbazin and a combination of narasin and nicarbazin. 3. 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 by such procedures and measures, the additive and premixtures shall be used with personal breathing and skin protective equipment. | 15.12.2030 |
| (1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en. |
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