LegalizeCommission Implementing Regulation (EU) 2017/2312 of 13 December 2017 concerning the authorisation of a new use of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for sows, suckling piglets and dogs (holder of the authorisation Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office) (Text with EEA relevance. )
Bacillus velezensis DSM 15544 as a feed additive for sows, suckling piglets and dogs (holder of the authorisation Asahi Biocycle Co. Ltd., represented in the European Union by Pen & Tec Consulting S.L.U.) (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 | 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 | |||||||||
| 4b1820 | Asahi Biocycle Co. Ltd., represented in the European Union by Pen & Tec Consulting S.L.U. | Bacillus velezensis DSM 15544 | Additive composition Preparation of Bacillus velezensis DSM 15544 containing a minimum of 1 × 1010 CFU/g additive in solid form Characterisation of the active substance Viable cells of Bacillus velezensis DSM 15544 Analytical method Enumeration: spread plate method using tryptone soya agar in all target matrices (EN 15784:2009) Identification: pulsed-field gel electrophoresis (PFGE). | Sows Suckling piglets | — | 3 × 108 | — | 1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. 2. Indicate in the instruction for the use: ‘The additive shall be fed to lactating sows and suckling piglets simultaneously’ 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. | 3 January 2028 |
| Dogs | 1 × 109 |
Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.