
Article 1 
The substances specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, are authorised as feed additives in animal nutrition, subject to the conditions laid down in that Annex.
Article 2 

1. Sodium selenite and premixtures containing that substance, which are produced and labelled before 3 August 2019 in accordance with the rules applicable before 3 February 2019 may continue to be placed on the market and used until the existing stocks are exhausted.
2. Feed materials and compound feed containing sodium selenite which are produced and labelled before 3 February 2020 in accordance with the rules applicable before 3 February 2019 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
3. Feed materials and compound feed containing sodium selenite which are produced and labelled before 3 February 2021 in accordance with the rules applicable before 3 February 2019 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 4 January 2019.
For the Commission
The President
Jean-Claude JUNCKER
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
3b801  Sodium selenite 
Sodium selenite, as a powder, with a minimum content of 45 % selenium

Sodium selenite

Chemical formula: Na2SeO3

CAS number 10102-18-8

Einecs number 233-267-9

For the characterisation of sodium selenite:


— Titrimetry — European Pharmacopoeia Monograph 01/2008:1677; and/or
— Gravimetry

For the quantification of total sodium in sodium selenite:


— Atomic Absorption Spectrometry (AAS) - EN ISO 6869:2000; or
— Inductively Coupled Plasma Atomic Emission Spectrometry (ICP-AES) - EN:15510:2007

For the quantification of total selenium in premixtures feed materials and compound feed:


— Hydride Generation Atomic Absorption Spectrometry (HGAAS) after microwave digestion — EN 16159:2012
 All species —  0,50 (total) 
1. Sodium selenite may be placed on the market and used as an additive consisting of a preparation.

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

3. For users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixture shall be used with appropriate personal protective equipment.
 3 February 2029
3b802  Coated granulated sodium selenite 
Coated granulated preparation of Sodium selenite with


— a selenium content of 1 % - 4,5 % and
— coating agents and dispersants (polyoxyethylene (20) sorbitan monolaurate (E 432), glycerol polyethyleneglycol ricinoleate (E 484), polyethyleneglycol 300, sorbitol (E 420ii) or maltodextrin) up to 5 %
and
— granulating agents (calcium magnesium carbonate, calcium carbonate, corn cobs) up to 100 % w/w.

Particles < 50 μm: below 5 %

Sodium selenite

Chemical formula: Na2SeO3

CAS number 10102-18-8

Einecs number 233-267-9

For the quantification of total selenium in the feed additive (film granulated preparation):


— Inductively Coupled Plasma Atomic Emission Spectrometry (ICP-AES); or
— Inductively Coupled Plasma Mass Spectrometry (ICP-MS)

For the quantification of total sodium in the feed additive (film granulated preparation):


— Atomic Absorption Spectrometry (AAS) - EN ISO 6869:2000; or
— Inductively Coupled Plasma Atomic Emission Spectrometry (ICP-AES) - EN:15510:2007

For the quantification of total selenium in premixtures, feed materials and compound feed:


— 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 users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixture shall be used with appropriate personal protective equipment.
 3 February 2029
3b818 — Zinc-L-selenomethionine 
Solid preparation of Zinc-L-selenomethionine with a selenium content of 1-2 g/kg

Organic selenium in form of zinc L-selenomethionine

Chemical formula: C5H10ClNO2SeZn

Crystalline powder with


 L-selenomethionine > 62 %,
 selenium > 24,5 %,
 zinc > 19 % and
 chloride > 20 %

For the determination of selenomethionine in the feed additive:


— high performance liquid chromatography with fluorescence detection (HPLC-FLD)

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, feed materials and compound feed:


— hydride generation atomic absorption spectrometry (HGAAS) after microwave digestion – EN 16159

For the quantification of total zinc in the feed additive:


— inductively coupled plasma-atomic emission spectrometry (ICP-AES) – EN 15510; or
— inductively coupled plasma-atomic emission spectrometry after pressure digestion, (ICP-AES) – EN 15621
 All species —  0,50 (total) 
1. The additive shall be incorporated into feed in the form of a premixture.

2. For users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixture shall be used with appropriate personal protective equipment.

3. In the directions for use of the additive and premixture, the storage conditions and the stability to heat treatment shall be indicated.

4. 
0,20 mg Se/kg of complete feed with a moisture content of 12 %.
 3 February 2029
