COMMI SSION IMPLEMENTING REGUL ATION (EU) 2015/897 
of 11 June 2015 
concer ning the author isation of thiamine hydrochlorid e and thiamine mononitrate 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 provides 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 provides for the 
re-evaluation of additives author ised pursuant to Council Directive 70/524/EEC (2). 
(2)  Thiamine hydrochlori de and thiamine mononitrate were author ised without a time limit in accordance with 
Directive 70/524/EEC as feed additives for all animal species. Those products were subsequently entered in the 
Regist er of feed additives as existing products, 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, three 
applications were submitted for the re-evaluation of thiamine hydroch loride and thiamine mononitrate as feed 
additives for all animal species and, in accordance with Article 7 of that Regulation, for a new use in water for 
drinking. The applicants request ed these additives to be classifie d 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. 
(4)  The European Food Safety Authority (‘the Author ity’) concluded in its opinions of 11 October 2011 (3) that, 
under the proposed conditions of use in feed, thiamine hydroc hlor ide and thiamine mononitrate do not have 
adverse effects on animal health, human health or the environment. The Author ity further concluded that 
thiamine hydroc hlor ide and thiamine mononitrate are effective sources of vitamin B1 and that no safety concer ns 
would arise for users. The Author ity does not consider that there is a need for specifi c requirements of post- 
mark et monit oring. It also verified the repor t on the method of analysis of the feed additives in feed submitted by 
the Reference Laboratory set up by Regulation (EC) No 1831/2003. 
(5)  The assessment of thiamine hydroch loride and thiamine mononitrate shows that the conditions for author isation, 
as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. According ly, the use of these 
substances should be author ised as specifi ed in the Annex to this Regulation. 
(6) Since safety reasons do not require the immediate application of the modifications to the conditions of author i­
sation, 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. 
(7)  The measures provided for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
The substances specifi ed in the Annex, belonging to the additive categor y ‘nutr itional additives ’ and to the functional 
group ‘vitamins, pro-vitamins and chemical ly well-def ined substances having similar effect’, are author ised as feed 
additives in animal nutr ition subject to the conditions laid down in that Annex. 12.6.2015 L 147/8 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 feed ingstuffs (OJ L 270, 14.12.1970, p. 1). 
(3)EFSA Jour nal 2011;9(11):2411; EFSA Jour nal 2011;9(11):2412; EFSA Jour nal 2011;9(11):2413. Article 2 
1. The substances specifi ed in the Annex and premixtures containing those substances, whic h are produced and 
labelled before 2 Januar y 2016 in accordance with the rules applicable before 2 July 2015 may continue to be placed on 
the mark et and used until the existing stoc ks are exhaust ed. 
2. Com pound feed and feed mate rials containing the substances specified in the Annex which are produced and 
labelled before 2 July 2016 in accordance with the rules applicable before 2 July 2015 may continue to be placed on the 
mark et and used until the existing stoc ks are exhaust ed if they are intended for food-producing animals. 
3. Com pound feed and feed mate rials containing the substances specified in the Annex which are produced and 
labelled before 2 July 2017 in accordance with the rules applicable before 2 July 2015 may continue to be placed on the 
mark et and used until the existing stoc ks are exhaust ed if they are intended for non-f ood-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 State s. 
Done at Brussels, 11 June 2015. 
For the Commission 
The Presid ent 
Jean-Claude JUNCKER  12.6.2015 L 147/9 Official Jour nal of the European Union EN     ANNEX 
Identification 
number of 
the additive Name of 
the holder 
of the 
author isa­
tion Additive Composition, chemical formula, descr iption, analytical 
method Species or 
category of 
animal Maximum 
age Minimum 
content Maximum 
content 
Other provisions End of period 
of author isa­
tion mg of active substance/ 
kg of complet e feed ing­
stuff with a moisture 
conten t of 12 % or mg 
of the active substance/l 
of water. 
Nutr itional additiv es: Vitamin s, provitamins and chemically well-def ined subst ances having similar effect 
3a820  ‘Thiamine hydro ­
chlor ide’ or ‘Vita ­
min B1’ Additive composition 
Thiamine hydroc hlor ide 
Char acter isation of the active substance 
Thiamine hydroc hlor ide 
C12H17ClN4OS•HCl 
CAS No 67-03-8 
Thiamine hydroc hlor ide, solid form, produced by 
chemical synthesis. 
Purity crieria: min. 98,5 % on anhydrous basis. 
Analytical methods (1): 
For the charact erisation of thiamine hydrochlor ­
ide in the feed additive: 
—  high performa nce liquid chromat ography 
with UV detection (HPLC-UV) — US Phar ma­
copeia 32 (‘thiamine hydroch loride’ mono ­
graph). 
For the quantification of thiamine hydrochloride 
in premixtures: 
—ion-exc hange high performa nce liquid chro­
matograph y coupled to UV detector (HPL C- 
UV) — VDL UFA Bd. III, 13.9.1, or  All animal 
species — — — 1.  In the directions 
for use of the addi ­
tive and premix ­
ture, indicate the 
storag e and the 
stability condi ­
tions. 
2.Thiamine hydro­
chlor ide may be 
used via water for 
drinking. 
3.For safety: breath ­
ing protection, 
safety glasses and 
gloves shall be 
wor n during hand ­
ling. 2 July 2025 12.6.2015 L 147/10 Official Jour nal of the European Union EN     Identification 
number of 
the additive Name of 
the holder 
of the 
author isa­
tion Additive Composition, chemical formula, descr iption, analytical 
method Species or 
category of 
animal Maximum 
age Minimum 
content Maximum 
content 
Other provisions End of period 
of author isa­
tion mg of active substance/ 
kg of complet e feed ing­
stuff with a moisture 
conten t of 12 % or mg 
of the active substance/l 
of water. 
—reversed phase high performa nce liquid chro­
matograph y coupled to fluorescence detection 
(HPLC-FL) — decree 20.2.2006, Official Ita­
lian Jour nal No 50, 1.3.2006. 
For the quantification of thiamine hydrochloride 
in feedingstuffs: 
—reversed phase high performa nce liquid chro­
matograph y coupled to fluorescence detection 
(HPLC-FL) — decree 20.2.2006, Official Ita­
lian Jour nal No 50, 1.3.2006. 
For the quantification of thiamine hydrochloride 
in wate r: 
—reversed phase high performa nce liquid chro­
matograph y (HPLC) with post-column deriva­
tisation and fluorescence detec tion. 
(1)  Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-repor ts  12.6.2015 L 147/11 Official Jour nal of the European Union EN     Identification 
number of 
the additive Name of 
the holder 
of the 
author isa­
tion Additive Composition, chemical formula, descr iption, analytical 
method Species or 
category of 
animal Maximum 
age Minimum 
content Maximum 
content 
Other provisions End of period 
of author isa­
tion mg of active substance/ 
kg of complet e feed ing­
stuff with a moisture 
conten t of 12 % or mg 
of the active substance/l 
of water 
Nutr itional additiv es: Vitamin s, provitamins and chemically well-def ined subst ances having similar effect 
3a821  ‘Thiamine mono ­
nitrat e’ or ‘Vita ­
min B1’ Additive composition 
Thiamine mononitrate 
Char acter isation of the active substance 
Thiamine mononitrate 
C12 H17N4OS•NO3 
CAS number: 532-43-4 
Thiamine mononitrate, solid form, produced by 
chemical synthesis. 
Purity criteria: min. 98 %, on anhydrous basis. 
Analytical methods (1): 
For the charact erisation of thiamine mononitrate 
in the feed additive: 
—  high performa nce liquid chromat ography 
with UV detection (HPLC-UV) — US Phar ma­
copeia 32 (‘thiamine mononitrate’ mono ­
graph). 
For the quantification of thiamine mononitrate in 
premixtures: 
—ion-exc hange high performa nce liquid chro­
matograph y coupled to UV detector (HPL C- 
UV) — VDL UFA Bd. III, 13.9.1, or  All animal 
species — — — 1.Thiamine mononi ­
trate may be 
placed on the mar ­
ket and used as an 
additive consisting 
of a preparation. 
2.  In the directions 
for use of the addi ­
tive and premix ­
ture, indicate the 
storag e and stabi ­
lity conditions. 
3.Thiamine mononi ­
trate may be used 
via wate r for 
drinking. 
4.For safety: breath ­
ing protection, 
safety glasses and 
gloves shall be 
wor n during hand ­
ling. 2 July 2025 12.6.2015 L 147/12 Official Jour nal of the European Union EN     Identification 
number of 
the additive Name of 
the holder 
of the 
author isa­
tion Additive Composition, chemical formula, descr iption, analytical 
method Species or 
category of 
animal Maximum 
age Minimum 
content Maximum 
content 
Other provisions End of period 
of author isa­
tion mg of active substance/ 
kg of complet e feed ing­
stuff with a moisture 
conten t of 12 % or mg 
of the active substance/l 
of water 
—reversed phase high performa nce liquid chro­
matograph y coupled to fluorescence detection 
(HPLC-FL) — decree 20.2.2006, Official Ita­
lian Jour nal No 50, 1.3.2006. 
For the quantification of thiamine mononitrate in 
feedingstuffs: 
—reversed phase high performa nce liquid chro­
matograph y coupled to fluorescence detection 
(HPLC-FL) — decree 20.2.2006, Official Ita­
lian Jour nal No 50, 1.3.2006. 
For the quantification of thiamine mononitrate in 
water: 
—reversed phase high performa nce liquid chro­
matograph y (HPLC) with post-column deriva­
tisation and fluorescence detec tion. 
(1)  Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-repor ts   12.6.2015 L 147/13 Official Jour nal of the European Union EN