Commission Implementing Regulation (EU) 2019/849 of 24 May 2019 amending Implementing Regulation (EU) 2017/1492 as regards the maximum content of cholecalciferol (vitamin D3) in feed for salmonids (Text with EEA relevance.)

• CELEX: Implementing Regulation (EU) 2019/849
• Articles: 3

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 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 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 )

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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.

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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.

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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.

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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

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:

—

≤ 5 000 IU of vitamin D 3 for chickens for fattening and turkeys for fattening,

—

≤ 3 200 IU for other poultry,

—

≤ 2 000 IU 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

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

( 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