Commission Implementing Regulation (EU) 2019/49 of 4 January 2019 concerning the authorisation of sodium selenite, coated granulated sodium selenite and zinc-L-selenomethionine as feed additives for all animal species (Text with EEA relevance.)

Authorisation

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.

Transitional measures

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.

Entry into force

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 .

ANNEXSupplementary provisions

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 Characterisation of the additive Sodium selenite, as a powder, with a minimum content of 45 % selenium Characterisation of the active substance Sodium selenite Chemical formula: Na 2 SeO 3 CAS number 10102-18-8 Einecs number 233-267-9 Analytical method  ( 1 ) 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 Characterisation of the additive 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 % Characterisation of the active substance Sodium selenite Chemical formula: Na 2 SeO 3 CAS number 10102-18-8 Einecs number 233-267-9 Analytical method  ( 1 ) 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 Characterisation of the additive Solid preparation of Zinc-L-selenomethionine with a selenium content of 1-2 g/kg Characterisation of the active substance Organic selenium in form of zinc L-selenomethionine Chemical formula: C 5 H 10 ClNO 2 SeZn Crystalline powder with   L-selenomethionine > 62 %,   selenium > 24,5 %,   zinc > 19 % and   chloride > 20 % Analytical method  ( 1 ) 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. Maximum supplementation with organic selenium: 0,20 mg Se/kg of complete feed with a moisture content of 12 %. 3 February 2029 ( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports