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Commission Implementing Regulation (EU) 2019/804Show full title

Commission Implementing Regulation (EU) 2019/804 of 17 May 2019 concerning the renewal of the authorisation of organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060 and of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 as feed additives for all animal species and repealing Regulations (EC) No 1750/2006 and (EC) No 634/2007 (Text with EEA relevance)

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ANNEXU.K.

a

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

Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical method.Species or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd 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
3b810Selenised yeast Saccharomyces cerevisiae CNCM I-3060, inactivated

Additive composition

Preparation of organic selenium:

  • Content of selenium: 2 000 to 2 400 mg Se/kg

  • Organic selenium > 97 to 99 % of total selenium

  • Selenomethionine > 63 % of total selenium

Characterisation of the active substance

Selenomethionine produced by Saccharomyces cerevisiae CNCM I-3060

Chemical formula: C5H11NO2Se

Analytical method a

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 species0,50 (total)

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

2.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation. 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, including breathing protection.

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

4.Maximum supplementation with organic selenium:

0,20 mg Se/kg of complete feed with a moisture content of 12 %.

9 June 2029
3b811Selenised yeast Saccharomyces cerevisiae NCYC R397, inactivated

Additive composition

Preparation of organic selenium:

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

  • Organic selenium > 98 % of total selenium

  • Selenomethionine > 63 % of total selenium

Characterisation of the active substance

Selenomethionine produced by Saccharomyces cerevisiae NCYC R397

Chemical formula: C5H11NO2Se

Analytical method a

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 species0,50 (total)

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

2.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal, mucosae or eye 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, including breathing protection, safety glasses and gloves.

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

4.Maximum supplementation with organic selenium:

0,20 mg Se/kg of complete feed with a moisture content of 12 %.

9 June 2029

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