Annex

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

1. 1..

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

2. 2..

   In the directions for use of the additive and premixtures, indicate the storage and stability conditions.

3. 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. 4..

   Maximum supplementation with organic selenium:

   0,2 mg Se/kg of complete feed with a moisture content of 12 %.

Characterisation of the active substance:

Selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399

Chemical formula: C₅H₁₁NO₂Se

Analytical method ^f1:

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).