
Article 1 
The authorisation of the additive specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is renewed subject to the conditions laid down in that Annex.
Article 2 

1. Selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399 and premixtures containing this additive, which are produced and labelled before 6 July 2021 in accordance with the rules applicable before 6 January 2021 may continue to be placed on the market and used until the existing stocks are exhausted.
2. Feed materials and compound feed containing selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399, which are produced and labelled before 6 January 2022 in accordance with the rules applicable before 6 January 2021 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
3. Feed materials and compound feed containing selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399, which are produced and labelled before 6 January 2023 in accordance with the rules applicable before 6 January 2021 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
Article 3 
Regulation (EC) No 900/2009 is repealed.
Article 4 
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, 16 December 2020.
For the Commission
The President
Ursula VON DER LEYEN
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
3b812 — Selenised yeast Saccharomyces cerevisiae CNCM I-3399, inactivated Additive composition:Preparation of organic selenium:Content of selenium: 2 000 to 3 500 mg Se/kgOrganic selenium > 97 to 99 % of total seleniumSelenomethionine > 63 % of total selenium All species -  0,50 (total) 
1.. The additive shall be incorporated into feed in the form of a premixture.
2.. In the directions for use of the additive and premixtures, indicate the storage and stability conditions.
3.. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation and skin contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment.
4.. Maximum supplementation with organic selenium:
0,2 mg Se/kg of complete feed with a moisture content of 12 %. 6 January 2031
Characterisation of the active substance:Selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399Chemical formula: C5H11NO2Se
Analytical method: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-ICP-MS) 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 (ICP-MS).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).
