LegalizeCommission Implementing Regulation (EU) 2016/898 of 8 June 2016 concerning the authorisation of a preparation of Bacillus licheniformis (ATCC 53757) and its protease (EC 3.4.21.19) as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species for fattening and reared for laying and ornamental birds (holder of authorisation Novus Europe SA/NV) (Text with EEA relevance)
Article 1
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, 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/Units of active substance/kg of complete feedingstuff with a moisture content of 12 % | |||||||||
| Category of zootechnical additives. Functional group: other zootechnical additives (improvement of zootechnical performance) | |||||||||
| 4d12 | Novus Europe NV | Bacillus licheniformis ATCC 53757 and its protease EC 3.4.21.19 | Additive composition Preparation of Bacillus licheniformis (ATCC 53757) and its protease EC 3.4.21.19 and containing a minimum of: — Bacillus licheniformis (ATCC 53757): — 1 × 109 CFU/g of additive — protease 6 × 105 U/g of additive (1) — Solid form Characterisation of the active substance Viable spores of Bacillus licheniformis (ATCC 53757) and its protease EC 3.4.21.19 Analytical method (2) Identification and enumeration of Bacillus licheniformis ATCC 53757 in the feed additive, premixtures and feedingstuffs: — Identification: Pulsed field gel electrophoresis (PFGE) — Enumeration: Spread plate method using tryptone soya agar — EN 15784 Quantification of protease in the feed additive, premixtures and feedingstuffs: — Colorimetric method measuring para-nitroaniline (pNA) released by the enzymatic reactionof protease on Suc-Ala-Ala-Pro-Phe-pNA substrate at 37 °C | Chickens for fattening and reared for laying Minor poultry species for fattening and reared for laying Ornamental birds | — | 5 × 108 CFU Bacillus licheniformis 3 × 105 U protease | — | 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. 2. Recommended minimum dose 500 mg of additive/kg of complete feed. 3. For users of the additive and premixtures in a feed business, operational procedures and appropriate organisational measures shall be established to address hazards by inhalation, dermal contact or eye contact. Where the dermal, inhalator or eye exposure cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment 4. The use is permitted in feed containing the following authorised coccidiostats: diclazuril, nicarbazin, decoquinate, semduramycin sodium, lasalocid sodium, monensin sodium robenidine hydrochloride, maduramicin ammonium, narasin or salinomycin sodium 5. Recommended use in protein-reduced rations. | 29 June 2026 |
| (1) 1 U is the amount of protease that liberates 1 micromole of para-nitroaniline (pNA) from the Succinyl-Ala-Ala-Pro-Phe-pNA (C30H36N6O9) substrate per minute at pH 8,0 and 37 °C. (2) 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 |
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