
Article 1 
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 
In column 9 in the Annex to Regulation (EC) No 1750/2006, the text in the line ‘3b8.10’ shall be replaced by the following:
'
1.. The additive shall be incorporated in feed in the form of a premixture.
2.. For user safety: breathing protection, safety glasses and gloves should be worn during handling.
3.. Maximum supplementation with organic selenium: 0,20 mg Se/kg of complete feed with a moisture content of 12 %.'.
Article 3 
In column 9 in the Annex to Regulation (EC) No 634/2007, the text in the line ‘3b8.11’ shall be replaced by the following:
'
1.. The additive shall be incorporated in feed in the form of a premixture.
2.. For user safety: breathing protection, safety glasses and gloves should be worn during handling.
3.. Maximum supplementation with organic selenium: 0,20 mg Se/kg of complete feed with a moisture content of 12 %.'.
Article 4 
In column 9 in the Annex to Regulation (EC) No 900/2009, the text in the line ‘3b8.12’ shall be replaced by the following:
'
1.. The additive shall be incorporated in feed in the form of a premixture.
2.. For user safety: breathing protection, safety glasses and gloves should be worn during handling.
3.. Maximum supplementation with organic selenium: 0,20 mg Se/kg of complete feed with a moisture content of 12 %.'.
Article 5 
The manufacturing of feed containing selenised yeast according to the existing maximum contents in Regulations (EC) No 1750/2006, (EC) No 634/2007 and (EC) No 900/2009 shall be brought in compliance with the new maximum contents as soon as possible and at the latest by 28 July 2013. Feed containing selenised yeast according to the existing maximum contents in Regulations (EC) No 1750/2006, (EC) No 634/2007 and (EC) No 900/2009 may be used up until stocks are exhausted.
Article 6 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 8 May 2013.
For the Commission
The President
José Manuel BARROSO
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
Maximum content of element (Se) in mg/kg of complete feed with a moisture content of 12 %
Category of nutritional additives. Functional group: compounds of trace elements
3b813 — Selenomethionine produced by Saccharomyces cerevisiae NCYC R646(Selenised yeast inactivated) 
 Characterisation of the additive
Preparation of organic selenium:
 Content of selenium: 1 000 to 2 650 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 R646
 Analytical method
 For the determination of selenomethionine in the feed additive:
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 mass spectrometry (ICPMS) after microwave digestion with HNO3/H2O2.
 For the determination of total selenium in premixtures and feed:
Hydride generation atomic absorption spectrometry (HGAAS) after microwave digestion with HNO3/H2O2 (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 should be worn during handling.
3.. Maximum supplementation with organic selenium:
0,20 mg Se/kg of complete feed with a moisture content of 12 %. 29 May 2023
