LegalizeCommission Implementing Regulation (EU) 2017/1492 of 21 August 2017 concerning the authorisation of cholecalciferol as a feed additive for all animal species (Text with EEA relevance. )
Article 1
Authorisation
The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, provitamins and chemically well-defined substances having similar effect’, is authorised as a feed additive in animal nutrition subject to the conditions laid down in that Annex.
Article 2
Denial
Authorisation of cholecalciferol, as an additive belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, provitamins and chemically well-defined substances having similar effect’, is denied for its use in water for drinking.
Article 3
Transitional Measures
1.
The substance specified in the Annex and premixtures containing that substance, which are produced and labelled before 11 March 2018 in accordance with the rules applicable before 11 September 2017 may continue to be placed on the market and used until the existing stocks are exhausted.
2.
Compound feed and feed materials containing the substance as specified in the Annex which are produced and labelled before 11 September 2018 in accordance with the rules applicable before 11 September 2017 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
3.
Compound feed and feed materials containing the substance as specified in the Annex which are produced and labelled before 11 September 2019 in accordance with the rules applicable before 11 September 2017 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
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 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | IU of cholecalciferol [^E0001]/kg of complete feedingstuff with a moisture content of 12 %. | IU of cholecalciferol [^E0001]/kg of complete feedingstuff with a moisture content of 12 %. | Other provisions | End of period of authorisation | ||||||
| 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 | Category of nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect. | Category of nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect. | Category of nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect. | Category of nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect. | Category of nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect. | Category of nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect. | Category of nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect. | Category of nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect. | Category of nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect. | Category of nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect. |
| 3a671 | — | ‘Cholecalciferol’ or ‘Vitamin D3’ | Additive composition Cholecalciferol. Characterisation of the active substance Cholecalciferol C27H44O CAS number: 67-97-0 Cholecalciferol solid and resin form, produced by chemical synthesis. Purity criteria: Min. 80 % (cholecalciferol and precholecalciferol) and max. 7 % tachysterol. Method of analysis [^E0002] — For the determination of Vitamin D3 in the feed additive: High Performance Liquid Chromatography coupled to UV detection (HPLC-UV, 254 nm) - European Pharmacopoeia method 01/2008:0574,0575,0598. — For the determination of Vitamin D3 in premixtures: High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV) - VDLUFA 1997, Methodenbuch, Method 13.8.1. — For the determination of vitamin D3 in feedingstuffs: — — High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV)-VDLUFA 1997, Methodenbuch, Method 13.8.1; or — Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. — For the determination of vitamin D3 in water: Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. | Pigs | — | — | 2 000 IU | Other provisions | End of period of authorisation | 1. Vitamin D3 may be placed on the market and used as an additive consisting of a preparation. 2. The additive shall be incorporated into the feed in the form of a premixture. 3. In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated. 4. Maximum content of the combination of 25-hydroxycholecalciferol with cholecalciferol per kg of complete feedingstuff: — ≤ 5 000 IU of vitamin D3 for chickens for fattening and turkeys for fattening, — ≤ 3 200 IU for other poultry, — ≤ 2 000 IU for pigs. 5. Simultaneous use with Vitamin D2 is not allowed. 6. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the very hazardous effects of vitamin D3 by inhalation. Where the risks associated to those very hazardous effects 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. | 11 September 2027 | ||||
| 3a671 | — | ‘Cholecalciferol’ or ‘Vitamin D3’ | Additive composition Cholecalciferol. Characterisation of the active substance Cholecalciferol C27H44O CAS number: 67-97-0 Cholecalciferol solid and resin form, produced by chemical synthesis. Purity criteria: Min. 80 % (cholecalciferol and precholecalciferol) and max. 7 % tachysterol. Method of analysis [^E0002] — For the determination of Vitamin D3 in the feed additive: High Performance Liquid Chromatography coupled to UV detection (HPLC-UV, 254 nm) - European Pharmacopoeia method 01/2008:0574,0575,0598. — For the determination of Vitamin D3 in premixtures: High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV) - VDLUFA 1997, Methodenbuch, Method 13.8.1. — For the determination of vitamin D3 in feedingstuffs: — — High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV)-VDLUFA 1997, Methodenbuch, Method 13.8.1; or — Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. — For the determination of vitamin D3 in water: Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. | Milk replacers for piglets | — | — | 10 000 IU | ||||||||
| 3a671 | — | ‘Cholecalciferol’ or ‘Vitamin D3’ | Additive composition Cholecalciferol. Characterisation of the active substance Cholecalciferol C27H44O CAS number: 67-97-0 Cholecalciferol solid and resin form, produced by chemical synthesis. Purity criteria: Min. 80 % (cholecalciferol and precholecalciferol) and max. 7 % tachysterol. Method of analysis [^E0002] — For the determination of Vitamin D3 in the feed additive: High Performance Liquid Chromatography coupled to UV detection (HPLC-UV, 254 nm) - European Pharmacopoeia method 01/2008:0574,0575,0598. — For the determination of Vitamin D3 in premixtures: High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV) - VDLUFA 1997, Methodenbuch, Method 13.8.1. — For the determination of vitamin D3 in feedingstuffs: — — High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV)-VDLUFA 1997, Methodenbuch, Method 13.8.1; or — Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. — For the determination of vitamin D3 in water: Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. | Bovines | — | — | 4 000 IU | ||||||||
| 3a671 | — | ‘Cholecalciferol’ or ‘Vitamin D3’ | Additive composition Cholecalciferol. Characterisation of the active substance Cholecalciferol C27H44O CAS number: 67-97-0 Cholecalciferol solid and resin form, produced by chemical synthesis. Purity criteria: Min. 80 % (cholecalciferol and precholecalciferol) and max. 7 % tachysterol. Method of analysis [^E0002] — For the determination of Vitamin D3 in the feed additive: High Performance Liquid Chromatography coupled to UV detection (HPLC-UV, 254 nm) - European Pharmacopoeia method 01/2008:0574,0575,0598. — For the determination of Vitamin D3 in premixtures: High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV) - VDLUFA 1997, Methodenbuch, Method 13.8.1. — For the determination of vitamin D3 in feedingstuffs: — — High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV)-VDLUFA 1997, Methodenbuch, Method 13.8.1; or — Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. — For the determination of vitamin D3 in water: Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. | Milk replacers for calves | — | — | 10 000 IU | ||||||||
| 3a671 | — | ‘Cholecalciferol’ or ‘Vitamin D3’ | Additive composition Cholecalciferol. Characterisation of the active substance Cholecalciferol C27H44O CAS number: 67-97-0 Cholecalciferol solid and resin form, produced by chemical synthesis. Purity criteria: Min. 80 % (cholecalciferol and precholecalciferol) and max. 7 % tachysterol. Method of analysis [^E0002] — For the determination of Vitamin D3 in the feed additive: High Performance Liquid Chromatography coupled to UV detection (HPLC-UV, 254 nm) - European Pharmacopoeia method 01/2008:0574,0575,0598. — For the determination of Vitamin D3 in premixtures: High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV) - VDLUFA 1997, Methodenbuch, Method 13.8.1. — For the determination of vitamin D3 in feedingstuffs: — — High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV)-VDLUFA 1997, Methodenbuch, Method 13.8.1; or — Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. — For the determination of vitamin D3 in water: Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. | Ovines | — | — | 4 000 IU | ||||||||
| 3a671 | — | ‘Cholecalciferol’ or ‘Vitamin D3’ | Additive composition Cholecalciferol. Characterisation of the active substance Cholecalciferol C27H44O CAS number: 67-97-0 Cholecalciferol solid and resin form, produced by chemical synthesis. Purity criteria: Min. 80 % (cholecalciferol and precholecalciferol) and max. 7 % tachysterol. Method of analysis [^E0002] — For the determination of Vitamin D3 in the feed additive: High Performance Liquid Chromatography coupled to UV detection (HPLC-UV, 254 nm) - European Pharmacopoeia method 01/2008:0574,0575,0598. — For the determination of Vitamin D3 in premixtures: High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV) - VDLUFA 1997, Methodenbuch, Method 13.8.1. — For the determination of vitamin D3 in feedingstuffs: — — High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV)-VDLUFA 1997, Methodenbuch, Method 13.8.1; or — Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. — For the determination of vitamin D3 in water: Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. | Chickens for fattening | — | — | 5 000 IU | ||||||||
| 3a671 | — | ‘Cholecalciferol’ or ‘Vitamin D3’ | Additive composition Cholecalciferol. Characterisation of the active substance Cholecalciferol C27H44O CAS number: 67-97-0 Cholecalciferol solid and resin form, produced by chemical synthesis. Purity criteria: Min. 80 % (cholecalciferol and precholecalciferol) and max. 7 % tachysterol. Method of analysis [^E0002] — For the determination of Vitamin D3 in the feed additive: High Performance Liquid Chromatography coupled to UV detection (HPLC-UV, 254 nm) - European Pharmacopoeia method 01/2008:0574,0575,0598. — For the determination of Vitamin D3 in premixtures: High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV) - VDLUFA 1997, Methodenbuch, Method 13.8.1. — For the determination of vitamin D3 in feedingstuffs: — — High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV)-VDLUFA 1997, Methodenbuch, Method 13.8.1; or — Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. — For the determination of vitamin D3 in water: Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. | Turkeys | — | — | 5 000 IU | ||||||||
| 3a671 | — | ‘Cholecalciferol’ or ‘Vitamin D3’ | Additive composition Cholecalciferol. Characterisation of the active substance Cholecalciferol C27H44O CAS number: 67-97-0 Cholecalciferol solid and resin form, produced by chemical synthesis. Purity criteria: Min. 80 % (cholecalciferol and precholecalciferol) and max. 7 % tachysterol. Method of analysis [^E0002] — For the determination of Vitamin D3 in the feed additive: High Performance Liquid Chromatography coupled to UV detection (HPLC-UV, 254 nm) - European Pharmacopoeia method 01/2008:0574,0575,0598. — For the determination of Vitamin D3 in premixtures: High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV) - VDLUFA 1997, Methodenbuch, Method 13.8.1. — For the determination of vitamin D3 in feedingstuffs: — — High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV)-VDLUFA 1997, Methodenbuch, Method 13.8.1; or — Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. — For the determination of vitamin D3 in water: Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. | Other poultry | — | — | 3 200 IU | ||||||||
| 3a671 | — | ‘Cholecalciferol’ or ‘Vitamin D3’ | Additive composition Cholecalciferol. Characterisation of the active substance Cholecalciferol C27H44O CAS number: 67-97-0 Cholecalciferol solid and resin form, produced by chemical synthesis. Purity criteria: Min. 80 % (cholecalciferol and precholecalciferol) and max. 7 % tachysterol. Method of analysis [^E0002] — For the determination of Vitamin D3 in the feed additive: High Performance Liquid Chromatography coupled to UV detection (HPLC-UV, 254 nm) - European Pharmacopoeia method 01/2008:0574,0575,0598. — For the determination of Vitamin D3 in premixtures: High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV) - VDLUFA 1997, Methodenbuch, Method 13.8.1. — For the determination of vitamin D3 in feedingstuffs: — — High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV)-VDLUFA 1997, Methodenbuch, Method 13.8.1; or — Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. — For the determination of vitamin D3 in water: Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. | Equines | — | — | 4 000 IU | ||||||||
| 3a671 | — | ‘Cholecalciferol’ or ‘Vitamin D3’ | Additive composition Cholecalciferol. Characterisation of the active substance Cholecalciferol C27H44O CAS number: 67-97-0 Cholecalciferol solid and resin form, produced by chemical synthesis. Purity criteria: Min. 80 % (cholecalciferol and precholecalciferol) and max. 7 % tachysterol. Method of analysis [^E0002] — For the determination of Vitamin D3 in the feed additive: High Performance Liquid Chromatography coupled to UV detection (HPLC-UV, 254 nm) - European Pharmacopoeia method 01/2008:0574,0575,0598. — For the determination of Vitamin D3 in premixtures: High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV) - VDLUFA 1997, Methodenbuch, Method 13.8.1. — For the determination of vitamin D3 in feedingstuffs: — — High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV)-VDLUFA 1997, Methodenbuch, Method 13.8.1; or — Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. — For the determination of vitamin D3 in water: Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. | Salmonids | — | — | 60 000 IU | ||||||||
| 3a671 | — | ‘Cholecalciferol’ or ‘Vitamin D3’ | Additive composition Cholecalciferol. Characterisation of the active substance Cholecalciferol C27H44O CAS number: 67-97-0 Cholecalciferol solid and resin form, produced by chemical synthesis. Purity criteria: Min. 80 % (cholecalciferol and precholecalciferol) and max. 7 % tachysterol. Method of analysis [^E0002] — For the determination of Vitamin D3 in the feed additive: High Performance Liquid Chromatography coupled to UV detection (HPLC-UV, 254 nm) - European Pharmacopoeia method 01/2008:0574,0575,0598. — For the determination of Vitamin D3 in premixtures: High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV) - VDLUFA 1997, Methodenbuch, Method 13.8.1. — For the determination of vitamin D3 in feedingstuffs: — — High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV)-VDLUFA 1997, Methodenbuch, Method 13.8.1; or — Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. — For the determination of vitamin D3 in water: Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. | Other fish species | — | — | 3 000 IU | ||||||||
| 3a671 | — | ‘Cholecalciferol’ or ‘Vitamin D3’ | Additive composition Cholecalciferol. Characterisation of the active substance Cholecalciferol C27H44O CAS number: 67-97-0 Cholecalciferol solid and resin form, produced by chemical synthesis. Purity criteria: Min. 80 % (cholecalciferol and precholecalciferol) and max. 7 % tachysterol. Method of analysis [^E0002] — For the determination of Vitamin D3 in the feed additive: High Performance Liquid Chromatography coupled to UV detection (HPLC-UV, 254 nm) - European Pharmacopoeia method 01/2008:0574,0575,0598. — For the determination of Vitamin D3 in premixtures: High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV) - VDLUFA 1997, Methodenbuch, Method 13.8.1. — For the determination of vitamin D3 in feedingstuffs: — — High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV)-VDLUFA 1997, Methodenbuch, Method 13.8.1; or — Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. — For the determination of vitamin D3 in water: Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821. | Other animal species | — | — | 2 000 IU |
40 IU cholecalciferol = 0,001 mg cholecalciferol
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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