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. )

• CELEX: Implementing Regulation (EU) 2017/1492
• Articles: 5

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 .

Schedules & Appendices

ANNEX

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 or mg of cholecalciferol  ( 1 ) /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 D 3 ’

Additive composition

Cholecalciferol.

Characterisation of the active substance

Cholecalciferol

C 27 H 44 O

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

( 2 )

—

For the determination of Vitamin D 3 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 D 3 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 D 3 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 D 3 in water: Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821.

Pigs

2 000 IU

0,05 mg

1.

Vitamin D 3 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:

—

≤ 0,125 mg  ( 1 ) (equivalent to 5 000  IU of vitamin D 3 ) for chickens for fattening and turkeys for fattening,

—

≤ 0,080 mg for other poultry,

—

≤ 0,050 mg for pigs.

5.

Simultaneous use with Vitamin D 2 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 D 3 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

0,25 mg

Bovines

4 000 IU

0,1 mg

Milk replacers for calves

10 000 IU

0,25 mg

Ovines

4 000 IU

0,1 mg

Chickens for fattening

5 000 IU

0,125 mg

Turkeys

5 000 IU

0,125 mg

Other poultry

3 200 IU

0,080 mg

Equines

4 000 IU

0,1 mg

Fish species

3 000 IU

0,075 mg

Other species

2 000 IU

0,05 mg

( 1 )   40 IU cholecalciferol= 0,001 mg cholecalciferol.

( 2 )   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