LegalizeCommission Implementing Regulation (EU) 2021/1410 of 27 August 2021 concerning the authorisation of a preparation of Bacillus licheniformis DSM 28710 as a feed additive for laying hens, minor poultry species for laying, poultry species for breeding and ornamental birds (holder of authorisation Huvepharma NV) (Text with EEA relevance)
Current text a fecha 2022-02-25
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 | |||||||||
| 4b1828 | Huvepharma NV | Bacillus licheniformis DSM 28710 | Additive composition Preparation of Bacillus licheniformis DSM 28710 containing a minimum of: 3,2 × 109 CFU/g of additive Solid form Characterisation of the active substance Viable spores of Bacillus licheniformis DSM 28710 Analytical method (1) For the enumeration of Bacillus licheniformis DSM 28710 in additive, premixture and feedingstuffs: — Spread plate method EN 15784 For the identification of Bacillus licheniformis DSM 28710: — Pulsed Field Gel Electrophoresis (PFGE) | Laying hens Minor poultry species for laying Poultry species for breeding Ornamental birds | - | 1,6 × 109 | - | 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: diclazuril and lasalocid A sodium. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address hazards by inhalation, dermal contact or eyes contact. Where the dermal, inhalation or eyes exposure cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including skin, eyes and breathing protection. | 19.9.2031 |
| (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 |