Commission Implementing Regulation (EU) No 121/2014 of 7 February 2014 concerning the authorisation of L-selenomethionine as a feed additive for all animal species Text with EEA relevance

• CELEX: Implementing Regulation (EU) No 121/2014
• Articles: 3

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

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

3b815

—

L-selenomethionine

Characterisation of the additive

Solid preparation of L-selenomethionine with a selenium content < 40 g/kg

Characterisation of the active substance

Organic selenium in form of L-selenomethionine (2-amino-4-methylselanyl-butanoic acid) from chemical synthesis

Chemical formula: C 5 H 11 NO 2 Se

CAS number: 3211-76-5

Crystalline powder with L-selenomethionine > 97 % and

Selenium > 39 %

Analytical method

( 1 )

For the determination of L-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), or inductively coupled plasma atomic emission spectrometry (ICP-AES).

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 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 shall be worn during handling.

3.

Technological additives or feed materials included in the preparation of the additive shall ensure a dusting potential < 0,2 mg selenium/m 3 air.

4.

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

5.

Maximum supplementation with organic selenium:

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

6.

If the preparation contains a technological additive or feed materials for which a maximum content is set or which is subject to other restrictions, the feed additive manufacturer shall provide this information to the customers.

28 February 2024

( 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