Commission Implementing Regulation (EU) No 427/2013 of 8 May 2013 concerning the authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R646 as a feed additive for all animal species and amending Regulations (EC) No 1750/2006, (EC) No 634/2007 and (EC) No 900/2009 as regards the maximum supplementation with selenised yeast Text with EEA relevance

• CELEX: Implementing Regulation (EU) No 427/2013
• Articles: 7

Article 1

The preparation specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

In column 9 in the Annex to Regulation (EC) No 1750/2006, the text in the line ‘3b8.10’ shall be replaced by the following:

‘1.

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

2.

For user safety: breathing protection, safety glasses and gloves should be worn during handling.

3.

Maximum supplementation with organic selenium: 0,20 mg Se/kg of complete feed with a moisture content of 12 %.’.

Article 3

In column 9 in the Annex to Regulation (EC) No 634/2007, the text in the line ‘3b8.11’ shall be replaced by the following:

‘1.

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

2.

For user safety: breathing protection, safety glasses and gloves should be worn during handling.

3.

Maximum supplementation with organic selenium: 0,20 mg Se/kg of complete feed with a moisture content of 12 %.’.

Article 4

In column 9 in the Annex to Regulation (EC) No 900/2009, the text in the line ‘3b8.12’ shall be replaced by the following:

‘1.

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

2.

For user safety: breathing protection, safety glasses and gloves should be worn during handling.

3.

Maximum supplementation with organic selenium: 0,20 mg Se/kg of complete feed with a moisture content of 12 %.’.

Article 5

The manufacturing of feed containing selenised yeast according to the existing maximum contents in Regulations (EC) No 1750/2006, (EC) No 634/2007 and (EC) No 900/2009 shall be brought in compliance with the new maximum contents as soon as possible and at the latest by 28 July 2013. Feed containing selenised yeast according to the existing maximum contents in Regulations (EC) No 1750/2006, (EC) No 634/2007 and (EC) No 900/2009 may be used up until stocks are exhausted.

Article 6

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

Maximum content of element (Se) in mg/kg of complete feed with a moisture content of 12 %

Category of nutritional additives. Functional group: compounds of trace elements

3b813

—

Selenomethionine produced by Saccharomyces cerevisiae NCYC R646

(Selenised yeast inactivated)

Characterisation of the additive

Preparation of organic selenium:

Content of selenium: 1 000 to 2 650  mg Se/kg

Organic selenium > 98 % of total selenium

Selenomethionine > 70 % of total selenium

Characterisation of the active substance

Selenomethionine produced by Saccharomyces cerevisiae NCYC R646

Analytical method

( 1 )

For the determination of selenomethionine in the feed additive:

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 mass spectrometry (ICPMS) after microwave digestion with HNO 3 /H 2 O 2 .

For the determination of total selenium in premixtures and feed:

Hydride generation atomic absorption spectrometry (HGAAS) after microwave digestion with HNO 3 /H 2 O 2 (EN 16159:2012)

All species

—

0,50 (total)

1.

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

2.

For user safety: breathing protection, safety glasses and gloves should be worn during handling.

3.

Maximum supplementation with organic selenium:

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

29 May 2023

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/authorisation/evaluation_reports/Pages/index.aspx