LegalizeCommission Implementing Regulation (EU) 2021/2051 of 24 November 2021 concerning the authorisation of a preparation of Bacillus velezensis PTA-6507, Bacillus velezensis NRRL B-50013 and Bacillus velezensis NRRL B-50104 as a feed additive for turkeys for fattening (holder of authorisation: Danisco Animal Nutrition represented by Genencor International B.V.) (Text with EEA relevance)
Current text a fecha 2024-09-23
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: zootechnical additives Functional group: gut flora stabilisers | |||||||||
| 4b1827i | Genencor International B.V. | Bacillus velezensis PTA-6507, Bacillus. velezensis NRRL B-50013 and Bacillus. velezensis NRRL B-50104 | Additive composition Preparation of Bacillus velezensis PTA-6507, Bacillus. velezensis NRRL B-50013 and Bacillus. velezensis NRRL B-50104 containing a minimum 2,5 × 109 CFU/g additive (total) with a minimum of bacterial concentration of 8,3 × 108 of each strain/g additive. Solid form | Turkeys for fattening | - | 7,5 × 107 | - | 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: lasalocid A sodium, monensin sodium 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 December 2031 |
| Characterisation of the active substance Viable spores of Bacillus velezensis PTA-6507, Bacillus. velezensis NRRL B-50013 and Bacillus. velezensis NRRL B-50104 | |||||||||
| Analytical method (1) Identification and enumeration of Bacillus velezensis PTA-6507, Bacillus. velezensis NRRL B-50013 and Bacillus. velezensis NRRL B-50104 in the feed additive, premixtures and feedingstuffs — Identification: Pulsed Field Gel Electrophoresis (PFGE) — Enumeration: Spread plate method following heat treatment – EN 15784 | |||||||||
| (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 |