LegalizeCommission Implementing Regulation (EU) 2024/1070 of 12 April 2024 concerning the renewal of the authorisation of a preparation of 25-hydroxycholecalciferol produced by Saccharomyces cerevisiae CBS 146008 for chickens for fattening, turkeys for fattening, other poultry and pigs and the authorisation of that preparation for ruminants and repealing Commission Regulation (EC) No 887/2009
Article 1
Renewal of the authorisation
The authorisation of the preparation specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, is renewed for chickens for fattening, turkeys for fattening, other poultry and pigs, subject to the conditions laid down in that Annex.
Article 2
Authorisation
The preparation specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect,’ is authorised as an additive in animal nutrition for ruminants, subject to the conditions laid down in that Annex.
Article 3
Repeal
Regulation (EC) No 887/2009 is repealed.
Article 3a
Transitional measures
1.
The feed additive 25-hydroxycholecalciferol, as authorised by Regulation (EC) No 887/2009, and premixtures containing that additive, which are produced and labelled before 5 November 2024 in accordance with the rules applicable before 5 May 2024, may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for chickens for fattening, turkeys for fattening, other poultry and pigs.
2.
Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 5 May 2025 in accordance with the rules applicable before 5 May 2024, may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for chickens for fattening, turkeys for fattening, other poultry and pigs.
Article 4
Entry into force
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 feed additive | 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method. | Species or category of animal | Maximum age | mg active substance/kg of complete feed with a moisture content of 12 % | mg active substance/kg of complete feed with a moisture content of 12 % | Other provisions | End of period of authorisation | ||||||
| Category: Nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect | Category: Nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect | Category: Nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect | Category: Nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect | Category: Nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect | Category: Nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect | Category: Nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect | Category: Nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect | Category: Nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect | ||||||
| Sub classification: vitamin D | Sub classification: vitamin D | Sub classification: vitamin D | Sub classification: vitamin D | Sub classification: vitamin D | Sub classification: vitamin D | Sub classification: vitamin D | Sub classification: vitamin D | Sub classification: vitamin D | ||||||
| 3a670a | Additive | Composition, chemical formula, description, analytical method. | Species or category of animal | Maximum age | 25-Hydroxy cholecalciferol | Additive composition Preparation with a maximum content of 1,25 % of 25-hydroxycholecalciferol. Solid form Characterisation of the active substance 25-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.H2O CAS number: 63283-36-3 Purity criteria — 25-hydroxycholecalciferol > 94 % — other sterol derivatives ≤ 1 % each — erythrosine < 5 mg/kg Analytical method [^E0001] For 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) | Other provisions | End of period of authorisation | 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 [^E0002] (equivalent to 5 000 IU of cholecalciferol) for chickens for fattening and turkeys for fattening, — ≤ 0,080 mg (equivalent to 3 200 IU of cholecalciferol) for other poultry, — ≤ 0,050 mg (equivalent to 2 000 IU of cholecalciferol) for pigs, — ≤ 0,100 mg (equivalent to 4 000 IU of cholecalciferol) for milk replacers for calves, — ≤ 0,100 mg (equivalent to 4 000 IU of cholecalciferol) for bovines and ovines, — ≤ 0,050 mg (equivalent to 2 000 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 | ||
| 3a670a | Additive | Composition, chemical formula, description, analytical method. | Species or category of animal | Maximum age | 25-Hydroxy cholecalciferol | Additive composition Preparation with a maximum content of 1,25 % of 25-hydroxycholecalciferol. Solid form Characterisation of the active substance 25-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.H2O CAS number: 63283-36-3 Purity criteria — 25-hydroxycholecalciferol > 94 % — other sterol derivatives ≤ 1 % each — erythrosine < 5 mg/kg Analytical method [^E0001] For 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) | Other provisions | End of period of authorisation | Turkeys 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 [^E0002] (equivalent to 5 000 IU of cholecalciferol) for chickens for fattening and turkeys for fattening, — ≤ 0,080 mg (equivalent to 3 200 IU of cholecalciferol) for other poultry, — ≤ 0,050 mg (equivalent to 2 000 IU of cholecalciferol) for pigs, — ≤ 0,100 mg (equivalent to 4 000 IU of cholecalciferol) for milk replacers for calves, — ≤ 0,100 mg (equivalent to 4 000 IU of cholecalciferol) for bovines and ovines, — ≤ 0,050 mg (equivalent to 2 000 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 | ||
| 3a670a | Other poultry | 0,080 | 25-Hydroxy cholecalciferol | Additive composition Preparation with a maximum content of 1,25 % of 25-hydroxycholecalciferol. Solid form Characterisation of the active substance 25-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.H2O CAS number: 63283-36-3 Purity criteria — 25-hydroxycholecalciferol > 94 % — other sterol derivatives ≤ 1 % each — erythrosine < 5 mg/kg Analytical method [^E0001] For 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) | ||||||||||
| 3a670a | Pigs | 0,050 | 25-Hydroxy cholecalciferol | Additive composition Preparation with a maximum content of 1,25 % of 25-hydroxycholecalciferol. Solid form Characterisation of the active substance 25-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.H2O CAS number: 63283-36-3 Purity criteria — 25-hydroxycholecalciferol > 94 % — other sterol derivatives ≤ 1 % each — erythrosine < 5 mg/kg Analytical method [^E0001] For 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) | ||||||||||
| 3a670a | Bovines and ovines | 0,100 | 25-Hydroxy cholecalciferol | Additive composition Preparation with a maximum content of 1,25 % of 25-hydroxycholecalciferol. Solid form Characterisation of the active substance 25-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.H2O CAS number: 63283-36-3 Purity criteria — 25-hydroxycholecalciferol > 94 % — other sterol derivatives ≤ 1 % each — erythrosine < 5 mg/kg Analytical method [^E0001] For 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) | ||||||||||
| 3a670a | Ruminants other than bovines and ovines | 0,050 | 25-Hydroxy cholecalciferol | Additive composition Preparation with a maximum content of 1,25 % of 25-hydroxycholecalciferol. Solid form Characterisation of the active substance 25-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.H2O CAS number: 63283-36-3 Purity criteria — 25-hydroxycholecalciferol > 94 % — other sterol derivatives ≤ 1 % each — erythrosine < 5 mg/kg Analytical method [^E0001] For 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) |
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.
40 IU cholecalciferol (vitamin D3) = 0,001 mg cholecalciferol (vitamin D3).
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