REGUL ATIONS 
COMMISSION IMPLEMENTING REGUL ATION (EU) 2019/49 
of 4 Januar y 2019 
concer ning the author isation of sodium selenite, coated granulated sodium selenite and zinc-L - 
selenomethionine as feed additiv es for all animal species 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regar d to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 
on additives for use in animal nutr ition (1), and in particular Article 9(2) thereof, 
Whereas: 
(1)  Regulation (EC) No 1831/2003 provi des for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting such author isation. Article 10 of that Regulation provid es for the re- 
evaluation of additives author ised pursuant to Council Directive 70/524/EEC (2). 
(2)  Sodium selenit e was author ised without a time limit as a feed additive for all animal species in accordance with 
Directive 70/524/EEC. This substance was subsequently entered in the Register of feed additives as an existing 
product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. 
(3)  In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an 
application was submitted for the re-evaluation of sodium selenit e as a feed additive for all animal species. In the 
framew ork of the re-evaluation an application was submitted also for a coated granulate d form of sodium 
selenit e. 
(4) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitt ed for the author isa­
tion of zinc-L-selenomethionine as a feed additive for all animal species. 
(5)  The applicants requeste d that sodium selenite, coated granulat ed sodium selenit e and zinc-L-selenomethionine be 
classified in the additive catego ry ‘nutr itional additives ’. Those applications were accompan ied by the particulars 
and documents required under Article 7(3) of Regulation (EC) No 1831/2003. 
(6)  The European Food Safety Author ity (‘the Auth ority’) concluded in its opinions of 20 Octobe r 2015 (3), 
28 Januar y 2016 (4), 8 March 2016 (5) and 20 Febr uary 2018 (6) that, under the proposed conditions of use, 
sodium selenit e, coated granulat ed sodium selenit e and zinc-L-selenomethionine do not have adverse effects on 
animal health, human health or the envi ronment. With respect to the limitation of the supplementation with 
organic selenium established for other organic compounds of selenium, the Auth ority concluded that it should 
also apply to zinc-L-selenomet hionine. Moreover , the Authority concluded that sodium selenit e, coated 
granulat ed sodium selenit e and zinc-L-selenomethionine may be considered as efficient sources of selenium for all 
animal species. The Author ity does not consider that there is a need for specific requirements of post-market 
monitoring. It also verified the repor ts on the method of analysis of the feed additives in feed submitted by the 
Reference Laboratory set up by Regulation (EC) No 1831/2003. 
(7)  The assessment of sodium selenit e, coated granulat ed sodium selenit e and zinc-L-selenomethionine shows that 
the conditions for author isation, as provid ed for in Article 5 of Regulation (EC) No 1831/2003, are satisfi ed. 14.1.2019 L 10/2 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(2)Council Directive 70/524/EEC of 23 November 1970 concer ning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1). 
(3)EFSA Journal 2015;13(11):4271. 
(4)EFSA Journal 2016;14(2):4398. 
(5)EFSA Journal 2016;14(3):4442. 
(6)EFSA Journal 2018;16(3):5197. (8) Since safety reasons do not require the immediate application of the modifi cations to the conditions of author isa­
tion for the substance sodium selenite, it is appropr iate to allow a transitional period for inter ested parties to 
prepare themselves to meet the new requirements resulting from the author isation. 
(9)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Author isation 
The substances specifi ed in the Annex, belonging to the additive categor y ‘nutr itional additives ’ and to the functional 
group ‘compounds of trace elements’, are author ised as feed additives in animal nutr ition, subject to the conditions laid 
down in that Annex. 
Article 2 
Transitional measures 
1. Sodium selenit e and premixtures containing that substance, whic h are produced and labelled before 3 August 
2019 in accordance with the rules applicable before 3 Febr uary 2019 may continue to be placed on the mark et and 
used until the existing stoc ks are exhausted. 
2. Feed mat erials and compound feed containing sodium selenite whic h are produced and labelled before 3 Febr uary 
2020 in accordance with the rules applicable before 3 Febr uary 2019 may continue to be placed on the mark et and 
used until the existing stoc ks are exhausted if they are intended for food-producing animals. 
3. Feed mat erials and compound feed containing sodium selenite whic h are produced and labelled before 3 Febr uary 
2021 in accordance with the rules applicable before 3 Febr uary 2019 may continue to be placed on the mark et and 
used until the existing stoc ks are exhausted if they are intended for non-f ood-producing animals. 
Article 3 
Entr y into force 
This Regulation shall enter into force on the twentieth day followi ng 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 State s. 
Done at Brussels, 4 Januar y 2019. 
For the Commission 
The President 
Jean-Claude JUNCK ER  14.1.2019 L 10/3 Official Jour nal of the European Union EN     ANNEX 
Identi ­
fication 
number of 
the additive Name of the 
holder of 
author isation Additive Composition, chemical formula, descr iption, 
analytical method Species or 
categor y of 
animal Maximum 
age Minimum 
content Maximum 
conten t 
Other provisions End of 
period of 
author isation Selenium in mg/kg of 
complet e feed with a  
moisture content of 12 % 
Categor y of nutr itional additiv es. Functional group: compounds of trace elements 
3b801  Sodium 
selenit e Char acter isation of the additiv e 
Sodium selenit e, as a powder , with 
a minimum cont ent of 45 % selenium 
Char acter isation of the activ e substance 
Sodium selenit e 
Chemical formula: Na2SeO3 
CAS number 10102-18-8 
Einecs number 233-267-9 
Analytical method (1) 
For the charact erisation of sodium sele­
nite: 
—Titrimetr y — European Phar maco ­
poeia Monograph 01/2008:1677; 
and/or 
—  Gravimetr y 
For the quantifi cation of total sodium 
in sodium selenit e: 
—  Atomic Absor ption Spectrometr y 
(AAS) - EN ISO 6869:2000; or 
—  Inductively Coupled Plasma Atomic 
Emission Spectrometr y (ICP -AES) - 
EN:15510:2007 
For the quantification of total selenium 
in premixtures feed mate rials and com ­
pound feed: 
—Hydr ide Generation Atomic Ab­
sorption Spectrometr y (HGAAS) 
after microwa ve digestion — EN 
16159:2012 All species —  0,50  
(total) 1.  Sodium selenit e may be 
placed on the mark et and 
used as an additive consist ­
ing of a preparation. 
2.The additive shall be incor ­
porat ed into feed in the 
form of a premixture. 
3.  For users of the additive and 
premixture, feed business 
operat ors shall establish 
operational procedures and 
organisational measures to 
address poten tial 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 appropr iate personal 
prote ctive equipment. 3 Febr uary 
2029 14.1.2019 L 10/4 Official Jour nal of the European Union EN     Identi ­
fication 
number of 
the additive Name of the 
holder of 
author isation Additive Composition, chemical formula, descr iption, 
analytical method Species or 
categor y of 
animal Maximum 
age Minimum 
content Maximum 
conten t 
Other provisions End of 
period of 
author isation Selenium in mg/kg of 
complet e feed with a  
moisture content of 12 % 
3b802  Coat ed 
granulat ed 
sodium 
selenit e Char acter isation of the additiv e 
Coated granulat ed preparation of So­
dium selenit e with 
—  a selenium content of 1 % - 4,5 % 
and 
—  coating agents and dispersants 
(poly oxyethylene (20) sorbitan mo­
nolaurate (E 432), glycerol poly ­
ethylen eglycol ricinoleat e (E 484), 
polyet hyleneg lycol 300, sorbitol 
(E 420ii) or maltodext rin) up to 
5 % 
and 
—granulating agents (calcium magne ­
sium carbonate, calcium carbonate, 
corn cobs) up to 100 % w/w . 
Particles < 50 µm: below 5 % 
Char acter isation of the activ e substance 
Sodium selenit e 
Chemical formula: Na2SeO3 
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 Spectrometr y (ICP -AES); 
or 
—  Inductively Coupled Plasma Mass 
Spectrometr y (ICP -MS)  All species —  0,50  
(total) 1.The additive shall be incor ­
porat ed into feed in the 
form of a premixture. 
2.  For users of the additive and 
premixture, feed business 
operat ors shall establish 
operational procedures and 
organisational measures to 
address poten tial 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 appropr iate personal 
prote ctive equipment. 3 Febr uary 
2029 14.1.2019 L 10/5 Official Jour nal of the European Union EN     Identi ­
fication 
number of 
the additive Name of the 
holder of 
author isation Additive Composition, chemical formula, descr iption, 
analytical method Species or 
categor y of 
animal Maximum 
age Minimum 
content Maximum 
conten t 
Other provisions End of 
period of 
author isation Selenium in mg/kg of 
complet e feed with a  
moisture content of 12 % 
For the quantifi cation of total sodium 
in the feed additive (film granulated 
preparation): 
—  Atomic Absor ption Spectrometr y 
(AAS) - EN ISO 6869:2000; or 
—  Inductively Coupled Plasma Atomic 
Emission Spectrometr y (ICP -AES) - 
EN:15510:2007 
For the quantification of total selenium 
in premixtures, feed mat erials and 
compound feed: 
—Hydr ide Generation Atomic Ab­
sorption Spectrometr y (HGAAS) 
after microwa ve digestion — EN 
16159:2012           
3b818 — Zinc-L-sele ­
nomethio ­
nine Char acter isation of the additiv e 
Solid preparation of Zinc-L-seleno ­
methionine with a selenium conte nt of 
1-2 g/kg 
Char acter isation of the activ e substance 
Organic selenium in form of zinc L-se­
lenomethionine 
Chemical formula: C5H10ClNO2SeZn 
Crystalline powder with 
L-selenomethionine > 62 %, 
selenium > 24,5 %, 
zinc > 19 % and 
chlor ide > 20 %  All species —  0,50  
(total) 1.The additive shall be incor ­
porat ed into feed in the 
form of a premixture. 
2.  For users of the additive and 
premixture, feed business 
operat ors shall establish 
operational procedures and 
organisational measures to 
address poten tial 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 appropr iate personal 
prote ctive equipment.  3 Febr uary 
2029 14.1.2019 L 10/6 Official Jour nal of the European Union EN     Identi ­
fication 
number of 
the additive Name of the 
holder of 
author isation Additive Composition, chemical formula, descr iption, 
analytical method Species or 
categor y of 
animal Maximum 
age Minimum 
content Maximum 
conten t 
Other provisions End of 
period of 
author isation Selenium in mg/kg of 
complet e feed with a  
moisture content of 12 % 
Analytical method (1) 
For the deter mination of selenomethio ­
nine in the feed additive: 
—high performa nce liquid chromat o­
graphy with fluorescence detec tion 
(HPL C-FLD) 
For the deter mination of total selenium 
in the feed additive: 
—  inductively coupled plasma-atomic 
emission spectrometr y (ICP -AES); 
or 
—  inductively coupled plasma-mass 
spectrometr y (ICP -MS) 
For the deter mination of total selenium 
in premixtures, feed mat erials and 
compound feed: 
—hydride generation atomic absor p­
tion spectrometr y (HGAAS) after 
micro wave digestion – EN 16159 
For the quantifi cation of total zinc in 
the feed additive: 
—  inductively coupled plasma-atomic 
emission spectrometr y (ICP -AES) – 
EN 15510; or 
—  inductively coupled plasma-atomic 
emission spectrometr y after press ­
ure digestion, (ICP -AES) – EN 
15621  3.  In the directions for use of 
the additive and premixture, 
the storage conditions and 
the stability to heat treat ­
ment shall be indicated. 
4.  Maximum supplementation 
with organic selenium: 
0,20 mg Se/kg of compl ete 
feed with a moisture conte nt 
of 12 %. 
(1)  Details of the analytical methods are available at the following address of the Reference Laborato ry: https://ec.europa.eu/jrc/en/eurl/feed-addi tives/evaluation-repor ts   14.1.2019 L 10/7 Official Jour nal of the European Union EN