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.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
ANNEXSupplementary provisions
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
Selenium in mg/kg of complete feed with a moisture content of 12 %
Category of nutritional additives. Functional group: compounds of trace elements
3b817
—
Selenomethionine produced by Saccharomyces cerevisiae NCYC R645
(Selenised yeast inactivated)
Characterisation of the additive:
Preparation of organic selenium:
Content of selenium: 2 000 to 2 400 mg Se/kg
Organic selenium > 98 % of total selenium
Selenomethionine > 70 % of total selenium
Characterisation of the active substance:
Selenomethionine produced by Saccharomyces cerevisiae NCYC R645
Chemical formula: C 5 H 11 NO 2 Se
Analytical method
( 1 ) :
For the determination of selenomethionine in the feed additive:
—
reversed phase high performance liquid chromatography with UV detection (RP-HPLC-UV), or
—
high performance liquid chromatography and inductively coupled plasma mass spectrometry (HPLC-ICPMS) after triple proteolytic digestion.
For the determination of total selenium in the feed additive:
—
inductively coupled plasma atomic emission spectrometry (ICP-AES), or
—
inductively coupled plasma mass spectrometry (ICPMS).
For the determination of total selenium in premixtures, compound feed and feed materials: hydride generation atomic absorption spectrometry (HGAAS) after microwave digestion (EN 16159:2012).
All species
—
0,50(total)
1.
The additive shall be incorporated into feed in the form of a premixture.
2.
For user safety: breathing protection, safety glasses and gloves shall be worn during handling.
3.
Technological additives or feed materials included in the preparation of the additive shall ensure a dusting potential < 0,2 mg selenium/m 3 air.
4.
In the directions for use of the additive and premixtures, indicate the storage and stability conditions.
5.
Maximum supplementation with organic selenium:
0,20 mg Se/kg of complete feed with a moisture content of 12 %.
13 April 2025
( 1 ) Details of the analytical methods are available at the following address of the European Union Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/authorisation/evaluation_reports/Pages/index.aspx