Commission Implementing Regulation (EU) 2024/3168 of 18 December 2024 concerning the authorisation of a preparation of zinc-L-selenomethionine as a feed additive for all animal species

• CELEX: Implementing Regulation (EU) 2024/3168
• Articles: 3

Article 1 Authorisation

The preparation specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, 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

Content of the element (Se) in mg/kg of complete feed with a moisture content of 12 %

Category: nutritional additives. Functional group: compounds of trace elements

3b818i

Zinc-L-selenomethionine

Characterisation of the additive

Solid preparation of Zinc-L-selenomethionine with a selenium content of 40-46 g/kg

Characterisation of the active substance

Organic selenium in form of zinc L-selenomethionine

Chemical formula: C 5 H 10 ClNO 2 SeZn

Crystalline powder with:

—

L-selenomethionine > 62 %;

—

selenium > 24,5 %:

—

zinc > 19 %; and

—

chloride > 20 %

Analytical methods

( 1 ) :

For the determination of selenomethionine in the feed additive:

—

high performance liquid chromatography with fluorescence detection (HPLC-FLD)

For the determination of total selenium in the feed additive:

—

inductively coupled plasma-atomic emission spectrometry (ICP-AES);

or

—

inductively coupled plasma-mass spectrometry (ICP-MS)

For the determination of total selenium in premixtures and compound feed:

—

hydride generation atomic absorption spectrometry (HGAAS) after microwave digestion – EN 16159; or

—

inductively coupled plasma-mass spectrometry (ICP-MS) – EN 17053

For the determination of total zinc in the feed additive:

—

inductively coupled plasma-atomic emission spectrometry (ICP-AES) – EN 15510; or

—

inductively coupled plasma-atomic emission spectrometry after pressure digestion, (ICP-AES) – EN 15621; or

—

atomic absorption spectrometry (AAS) – ISO 6869

All species

—

—

0,50

1.

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

2.

The additive shall be incorporated into feed in the form of a premixture.

3.

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.

4.

Maximum supplementation with organic selenium: 0,20 mg Se/kg of complete feed with a moisture content of 12 %

8 January 2035

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en