3a670a | 25-Hydroxy cholecalciferol | Additive compositionPreparation with a maximum content of 1,25 % of 25-hydroxycholecalciferol.Solid formCharacterisation of the active substance25-Hydroxycholecalciferol. Its precursor compound, 5,7,24-cholestatrienol, is produced with Saccharomyces cerevisiae CBS 146008. After extraction, the precursor is converted chemically to 25-hydroxy-pro-vitamin D3, which is further transformed photochemically to 25-hydroxycholecalfciferol.C27H44O2.H2OCAS number: 63283-36-3Purity criteria- 25-hydroxycholecalciferol > 94 %
- other sterol derivatives ≤ 1 % each
- erythrosine < 5 mg/kg
Analytical methodFor the determination of 25-hydroxycholecalciferol in the feed additive: Ultra Performance Liquid Chromatography coupled to spectrophotometric detection (UPLC-UV)For the determination of 25-hydroxycholecalciferol in premixtures: High Performance Liquid Chromatography coupled to spectrophotometric detection (HPLC-UV)For the determination of 25-hydroxycholecalciferol in compound feed and in low concentrated premixtures: High Performance Liquid Chromatography coupled to tandem mass spectrometry (HPLC-MS/MS) | Chickens for fattening | | | 0,100 | - 1.The additive shall be incorporated in feedingstuffs via the use of a premixture.
- 2.In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.
- 3.Maximum content of the combination of 25-hydroxycholecalciferol with cholecalciferol (vitamin D3) per kg of complete feedingstuff:
- ≤ 0,125 mg (equivalent to 5000 IU of cholecalciferol) for chickens for fattening and turkeys for fattening,
- ≤ 0,080 mg (equivalent to 3200 IU of cholecalciferol) for other poultry,
- ≤ 0,050 mg (equivalent to 2000 IU of cholecalciferol) for pigs,
- ≤ 0,100 mg (equivalent to 4000 IU of cholecalciferol) for milk replacers for calves,
- ≤ 0,100 mg (equivalent to 4000 IU of cholecalciferol) for bovines and ovines,
- ≤ 0,050 mg (equivalent to 2000 IU of cholecalciferol) for ruminants other than bovines and ovines.
- 4.The simultaneous use of the additive with glycosylated 1,25-dihydroxycholecalciferol from Solanum glaucophylum extract shall not be permitted.
- 5.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the 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.
| 5 May 2034 |