Commission Implementing Regulation (EU) 2020/2117 of 16 December 2020 concerning the renewal of the authorisation of selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399 with the new name ‘selenised yeast Saccharomyces cerevisiae CNCM I-3399’ as a feed additive for all animal species, and repealing Regulation (EC) No 900/2009 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/2117
• Articles: 5

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Regulation (EC) No 900/2009 is repealed.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.

Schedules & Appendices

ANNEX

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 cerevisia e CNCM I-3399, inactivated

Additive composition :

Preparation of organic selenium:

Content of selenium: 2 000 to 3 500 mg Se/kg

Organic selenium > 97 to 99 % of total selenium

Selenomethionine > 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-3399

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-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).

( 1 )   Details of the analytical methods are available at the following address of the European Union Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports