Commission Implementing Regulation (EU) 2022/1459 of 2 September 2022 amending Implementing Regulation (EU) 2019/804 as regards the terms of authorisation of the organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060 as feed additive for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2022/1459
• Articles: 3

Article 1

In the Annex to Implementing Regulation (EU) No 2019/804, the entry 3b810 for the organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060 is amended in accordance with the Annex to this Regulation.

Article 2

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

‘3b810

-

Selenised yeast Saccharomyces cerevisia e 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

All species

-

0,50

(total)

1.

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

2.

The directions for use of the additive and premixtures shall 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. 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 %.

9 June 2029

Characterisation of the active substance

Selenomethionine produced by Saccharomyces cerevisiae CNCM I-3060

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-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).

3b810i

-

Selenised yeast Saccharomyces cerevisia e CNCM I-3060, inactivated

Additive composition

Preparation of organic selenium:

Content of selenium 3 000 -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.

The directions for use of the additive and premixtures shall 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. 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.

4.

Maximum supplementation with organic selenium:

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

5.

The dusting potential of the additive shall ensure a maximal Se exposure of 0,2 mg Se/m 3

9 June 2029

Characterisation of the active substance

Selenomethionine produced by Saccharomyces cerevisiae CNCM I-3060

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-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).

( 1 )   Details of the analytical methods are available at the following address of the European Union Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en’