COMMISSION IMPLEMENTING REGUL ATION (EU) 2019/8 
of 3 Januar y 2019 
concer ning the author isation of hydro xy analogue of methionine and its calcium salt as a feed 
additiv e 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. 
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitte d for the author is­
ation of hydroxy analogue of methionine and its calcium salt as a feed additive for use in feed for all animal 
species. That application was accompanied by the particulars and documents required under Article 7(3) of 
Regulation (EC) No 1831/2003. 
(3)  The application concer ns the author isation of hydroxy analogue of methionine and its calcium salt as a feed 
additive for all animal species to be classifie d in the additive cate gory ‘nutr itional additives ’. 
(4)  The European Food Safety Authority (‘the Author ity’) concluded in its opinion of 20 Febr uary 2018 (2) that, 
under the proposed conditions of use, hydro xy analogue of methionine and its calcium salt does not have an 
adverse effect on animal health, human health or the environment. 
(5)  The Authority also concluded that the additive is an effective source of methionine for all animal species and 
that, even though the ruminal degradation of the additive in ruminants is lower than that of DL-methionine, the 
additive should be protect ed again st degradation in the rumen. 
(6)  The Auth ority does not consider that there is a need for specifi c requirements of post-market monitor ing. It also 
verified the repor t on the method of analysis of the feed additive in feed submitted by the Reference Laborat ory 
set up by Regulation (EC) No 1831/2003. 
(7)  The assessment of this additive 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 this additive should be author ised as 
specified in the Annex to this Regulation. 
(8)  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 substance specifi ed in the Annex, belonging to the additive categor y ‘nutr itional additive s’ and to the functional group 
‘amino acids, their salts and analogues ’ is author ised as a feed additive in animal nutr ition subject to the conditions laid 
down in that Annex. 
Article 2 
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. 4.1.2019 L 2/6 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(2)EFSA Journal 2018;16(3):5198. This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 3 Januar y 2019. 
For the Commission 
The President 
Jean-Claude JUNCK ER  4.1.2019 L 2/7 Official Jour nal of the European Union EN     ANNEX 
Identifica ­
tion 
number of 
the additive Name of 
the holder 
of 
author isa­
tion 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 isa­
tion mg/kg of complet e feed 
with a moisture content of 
12 % 
Categor y of nutr itional additiv es. Functional group: amino acids, their salts and analogues 
3c310 — Hydro xy 
analogue of 
methionine 
and its 
calcium salt Additive composition: 
Preparation of hydroxy analogue of 
methionine and calcium salt of hy­
droxy analogue of methionine, having 
a minimum content of hydro xy ana­
logue of methionine of 88 % and 
a minimum content of calcium of 8 %. 
Char acter isation of the activ e substances: 
Hydro xy analogue of methionine: 
IUPAC name: 2-hydro xy-4-(meth ylthio) 
butanoic acid 
CAS number 583-91-5 
Chemical formula: C5H10O3S 
calcium salt of hydroxy analogue of 
methionine: 
IUPAC name 2-hydro xy-4-(meth ylthio) 
butanoic acid, calcium salt 
CAS number 4857-44-7 
Chemical formula: (C5H9O3S)2Ca 
Analytical method (1): 
For the determination of hydroxy ana­
logue of methionine in the additive: 
—  Titrimetr y, potentiometr ic titration 
after oxidation reduction reaction.  All animal 
species — — — 1.  For users of the additive and 
premixtures, feed business op­
erators shall establish opera ­
tional procedures and organisa ­
tional measures to address 
poten tial risks resulting from 
its use, in particular consider ­
ing that it is corrosive to skin 
and eyes. Where those risks 
cannot be eliminate d or re­
duced to a minimum by such 
procedures and measures, the 
additive and premixtures shall 
be used with personal prot ec­
tive equipment, including 
safet y glasses and gloves. 
2.  In the directions for use of the 
additive and premixture, the 
storage conditions and the 
stability to heat treatment shall 
be indicated. 
3.  Declaration to be made on the 
label of the additive and pre­
mixture: content of hydroxy 
analogue of methionine.  24 Januar y 
2029 4.1.2019 L 2/8 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of 
author isa­
tion 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 isa­
tion mg/kg of complet e feed 
with a moisture content of 
12 % 
For the determination of hydroxy ana­
logue of methionine in premixtures, 
compo und feed and feed mate rials: 
—High-P erformance Liquid Chroma ­
tography and photometr ic detec­
tion (HPLC-UV). 
For the determination of total calcium 
in the additive: 
—  Atomic Absor ption Spectrometr y, 
AAS (EN ISO 6869); or 
—  Inductively Coupled Plasma – 
Atomic Emission Spectrometr y, 
ICP-AES (EN 15510); or 
—  Inductively Coupled Plasma – 
Atomic Emission Spectrometr y 
after pressure diges tion, ICP-AES 
(EN 15621).  4.  The labelling of feed mater ials 
and compo und feed, into 
whic h the additive has been in­
corporate d, shall contain in the 
listing of additives information 
as regards: 
—  Name of the additive, 
—  Amount of the hydroxy 
analogue of methionine 
added. 
(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   4.1.2019 L 2/9 Official Jour nal of the European Union EN