
Article 1 
The Annex to Implementing Regulation (EU) 2017/1492 is replaced by the text set out in the Annex to this Regulation.
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.Done at Brussels, 24 May 2019.
For the Commission
The President
Jean-Claude JUNCKER
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
IU of cholecalciferol/kg of complete feedingstuff with a moisture content of 12 %.
Category of nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect.
3a671 — ‘Cholecalciferol’ or ‘Vitamin D3’ 
Cholecalciferol.

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.


— 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 
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. 

— ≤ 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
Milk replacers for piglets — — 10 000 IU
Bovines — — 4 000 IU
Milk replacers for calves — — 10 000 IU
Ovines — — 4 000 IU
Chickens for fattening — — 5 000 IU
Turkeys — — 5 000 IU
Other poultry — — 3 200 IU
Equines — — 4 000 IU
Salmonids — — 60 000 IU
Other fish species — — 3 000 IU
Other animal species — — 2 000 IU

