Commission Implementing Regulation (EU) 2024/1070 of 12 April 2024 concerning the renewal of the authorisation of a preparation of 25-hydroxycholecalciferol produced by Saccharomyces cerevisiae CBS 146008 for chickens for fattening, turkeys for fattening, other poultry and pigs and the authorisation of that preparation for ruminants and repealing Commission Regulation (EC) No 887/2009

• CELEX: Implementing Regulation (EU) 2024/1070
• Articles: 5

Article 1 Renewal of the authorisation

The authorisation of the preparation specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, is renewed for chickens for fattening, turkeys for fattening, other poultry and pigs, subject to the conditions laid down in that Annex.

Article 2 Authorisation

The preparation specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect,’ is authorised as an additive in animal nutrition for ruminants, subject to the conditions laid down in that Annex.

Article 3 Repeal

Regulation (EC) No 887/2009 is repealed.

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 feed additive

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

mg active substance/kg of complete feed with a moisture content of 12 %

Category: Nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect

Sub classification: vitamin D

3a670a

25-Hydroxy cholecalciferol

Additive composition

Preparation with a maximum content of 1,25 % of 25-hydroxycholecalciferol.

Solid form

Characterisation of the active substance

25-Hydroxycholecalciferol. Its precursor compound, 5,7,24-cholestatrienol, is produced with Saccharomyces cerevisiae CBS 146008. After extraction, the precursor is converted chemically to 25-hydroxy-pro-vitamin D 3 , which is further transformed photochemically to 25-hydroxycholecalfciferol.

C 27 H 44 O 2 .H 2 O

CAS number: 63283-36-3

Purity criteria

—

25-hydroxycholecalciferol > 94 %

—

other sterol derivatives ≤ 1 % each

—

erythrosine < 5 mg/kg

Analytical method

( 1 )

For the determination of 25-hydroxycholecalciferol in the feed additive: Ultra Performance Liquid Chromatography coupled to spectrophotometric detection (UPLC-UV)

For the determination of 25-hydroxycholecalciferol in premixtures: High Performance Liquid Chromatography coupled to spectrophotometric detection (HPLC-UV)

For the determination of 25-hydroxycholecalciferol in compound feed and in low concentrated premixtures: High Performance Liquid Chromatography coupled to tandem mass spectrometry (HPLC-MS/MS)

Chickens for fattening

0,100

1.

The additive shall be incorporated in feedingstuffs via the use of a premixture.

2.

In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.

3.

Maximum content of the combination of 25-hydroxycholecalciferol with cholecalciferol (vitamin D 3 ) per kg of complete feedingstuff:

—

≤ 0,125  mg  ( 2 ) (equivalent to 5 000 IU of cholecalciferol) for chickens for fattening and turkeys for fattening,

—

≤ 0,080  mg (equivalent to 3 200 IU of cholecalciferol) for other poultry,

—

≤ 0,050  mg (equivalent to 2 000 IU of cholecalciferol) for pigs,

—

≤ 0,100  mg (equivalent to 4 000 IU of cholecalciferol) for milk replacers for calves,

—

≤ 0,100 mg (equivalent to 4 000 IU of cholecalciferol) for bovines and ovines,

—

≤ 0,050  mg (equivalent to 2 000 IU of cholecalciferol) for ruminants other than bovines and ovines.

4.

The simultaneous use of the additive with glycosylated 1,25-dihydroxycholecalciferol from Solanum glaucophylum extract shall not be permitted.

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing and skin protective equipment.

5 May 2034

Turkeys for fattening

0,100

Other poultry

0,080

Pigs

0,050

Bovines and ovines

0,100

Ruminants other than bovines and ovines

0,050

( 1 )   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 .

( 2 )   40 IU cholecalciferol (vitamin D 3 ) = 0,001 mg cholecalciferol (vitamin D 3 ).