Commission 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. )
Modified by
  • Commission Implementing Regulation (EU) 2019/849of 24 May 2019amending Implementing Regulation (EU) 2017/1492 as regards the maximum content of cholecalciferol (vitamin D3) in feed for salmonids(Text with EEA relevance), 32019R0849, May 27, 2019
Commission Implementing Regulation (EU) 2017/1492of 21 August 2017concerning the authorisation of cholecalciferol as a feed additive for all animal species(Text with EEA relevance)
Article 1AuthorisationThe 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 2DenialAuthorisation 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 3Transitional Measures1.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 4Entry into ForceThis 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
40 IU cholecalciferol = 0,001 mg cholecalciferolDetails of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reportsCategory of nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect.
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
IU of cholecalciferol/kg of complete feedingstuff with a moisture content of 12 %.
3a671—"Cholecalciferol" or "Vitamin D3"Additive compositionCholecalciferol.Characterisation of the active substanceCholecalciferolC27H44OCAS number: 67-97-0Cholecalciferol solid and resin form, produced by chemical synthesis.Purity criteria:Min. 80 % (cholecalciferol and precholecalciferol) and max. 7 % tachysterol.Method of analysisFor 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; orReverse-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——2000 IU1.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:≤ 5000 IU of vitamin D3 for chickens for fattening and turkeys for fattening,≤ 3200 IU for other poultry,≤ 2000 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——10000 IU
Bovines——4000 IU
Milk replacers for calves——10000 IU
Ovines——4000 IU
Chickens for fattening——5000 IU
Turkeys——5000 IU
Other poultry——3200 IU
Equines——4000 IU
Salmonids——60000 IU
Other fish species——3000 IU
Other animal species——2000 IU
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