Commission Implementing Regulation (EU) 2024/1685 of 17 June 2024 concerning the authorisation of a preparation of glycosylated 1,25-dihydroxycholecalciferol from Solanum glaucophyllum extract as a feed additive for dairy cows

• CELEX: Implementing Regulation (EU) 2024/1685
• Articles: 3

Article 1 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, subject to the conditions laid down in that Annex.

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 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 of 1,25-dihydroxycholecalciferol/kg of complete feedingstuff

with a moisture content of 12 %

Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect. Subclassification: Vitamin D

3a673

Glycosylated 1,25-dihydroxycholecalciferol from Solanum glaucophylum extract

Additive composition

Preparation of Solanum glaucophylum extract with a minimum of 0,005 % of glycosylated 1,25- dihydroxycholecalciferol

Solid form

Characterisation of active substance

Glycosylated 1,25-dihydroxycholecalciferol

Chemical formula: C 27 H 44 O 3-× (C 6 H 10 O 5 ) n , where n = 1 to 12

CAS number: 89457-77-2

Produced by ethanolic extraction of leaves of Solanum glaucophyllum

Analytical method

( 1 )

—

For the quantification of glycosylated 1,25-dihydroxycholecalciferol in the feed additive and in the complementary feed (bolus):

—

Liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS).

Dairy cows

—

—

0,004

1.

The additive shall be only used for incorporation in a complementary feed (in the form of a bolus) to reduce the risk of milk fever and subclinical hypocalcaemia.

2.

The use of the additive shall be allowed only once during the pre-parturient period (from 9 days before calving to immediately before calving).

3.

The additive shall be orally administered once in the form of a bolus, with daily administration of:

—

a minimum of calcium of 60 g per cow during one week before calving and 84 g per cow until the end of the third week of lactation,

—

a minimum of magnesium of 18 g per cow during one week before calving and 26 g per cow until the end of the third week of lactation.

4.

The directions for use of the additive shall indicate the storage conditions.

5.

Maximum content of the combination of glycosylated 1,25-dihydroxycholecalciferol with vitamin D 3 (cholecalciferol) per kg of complete feed: 0,1 mg  ( 2 ) of cholecalciferol.

6.

Simultaneous use of the additive with 25-hydroxycholecalciferol shall not be permitted.

7.

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.

8 July 2034

( 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 D3) = 0,001 mg cholecalciferol (vitamin D3).