COMMI SSION IMPLEMENTING REGUL ATION (EU) 2017/439 
of 13 March 2017 
concer ning the author isation of L-lysine sulphate produced by Escherichia coli 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 provides for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting such author isation. 
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitte d for the author is­
ation of L-lys ine sulphat e as a feed additive. That application was accompanied by the particulars and documents 
required under Article 7(3) of Regulation (EC) No 1831/2003. 
(3)  That application concer ns the author isation of L-lysine sulphat e produced by fermentation with Escher ichia coli 
CGMCC 3705 as a feed additive for all animal species to be classified in the additive cate gory ‘nutr itional 
additives’. 
(4)  The European Food Safet y Author ity (‘the Author ity’) concluded in its opinions of 16 June 2015 (2) and 
26 Januar y 2017 (3) that, under the proposed conditions of use, L-lysine sulphate produced by fermentation with 
Escher ichia coli CGMCC 3705 does not have an adverse effect on animal health, human health or the environment 
and that it is an effective source of the amino acid lysine for all animal species. It also concluded that for the 
supplemental L-lysine sulphat e to be fully efficacious in ruminants, it should be prote cted against degradation in 
the rumen. The Auth ority does not consider that there is a need for specific requirements of post-market 
monitoring. It also verified the repor t on the method of analysis of the feed additive in feed submitted by the 
Reference Laboratory set up by Regulation (EC) No 1831/2003. 
(5)  The assessment of that substance shows that the conditions for author isation, as provided for in Article 5 of 
Regulation (EC) No 1831/2003, are satisfi ed. According ly, the use of that substance should be author ised as 
specified in the Annex to this Regulation. 
(6)  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 substance specifi ed in the Annex, belonging to the additive categor y ‘nutr itional additives ’ and to the functional 
group ‘amino acids, their salts and analogues’, is author ised as an additive in animal nutr ition subject to the conditions 
laid down in that Annex. 14.3.2017 L 67/70 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(2)EFSA Journal 2015; 13(7):4155. 
(3)EFSA Journal 2017; 15(2):4714. Article 2 
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, 13 Marc h 2017. 
For the Commission 
The Presid ent 
Jean-Claude JUNCKER  14.3.2017 L 67/71 Official Jour nal of the European Union EN     ANNEX 
Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author is­
ation Additive Compo sition, chemical formula, 
descr iption, analytical method. Species or 
category of 
animal Maximum 
age Minimum 
conten t Maximum 
content 
Other provisions End of period 
of author is­
ation mg additive/kg of compl ete 
feed with a moisture 
content of 12 % 
Categor y of nutr itional additiv es. Functional group: amino acids, their salts and analogues 
3c323  L-lysine sulphat e Additiv e composition 
Granulate with a minimum L-ly­
sine cont ent of 55 % and a maxi ­
mum conte nt of 
—  4 % moisture and 
—  22 % sulphate. 
Char acter isation of the activ e sub­
stance 
L-lysine sulphate produced by fer­
mentation with Escher ichia coli 
CGMCC 3705 
Chemical formula: C12H28N4O4 · 
H2SO4/[NH2-(CH2)4-CH (NH2)- 
COOH]2SO4 
CAS number: 60343-69-3 
Analytical methods (1) 
For the quantifi cation of L-lysine 
in the feed additive: 
—  ion exchang e chromatograph y 
coupled with post-column de­
rivatisation and photome tric 
detec tion (IEC-UV/FD) — EN 
ISO 17180  All species — — 10 000 1.  The L-lysine conte nt shall 
be indicate d on the label ­
ling of the additive. 
2.  L-lysine sulphate may be 
placed on the mark et and 
used as an additive con­
sisting of a preparation. 
3.  For users of the additive 
and premixtures, feed 
business operat ors shall 
establish operational pro­
cedures and organisation ­
al measures to address 
potential risks by inhala ­
tion. Where those risks 
cannot be eliminated or 
reduced to a minimum 
level by such procedures 
and measures, the additive 
and premixtures shall be 
used with personal pro­
tective equipment, includ ­
ing breathing protection. 2 Apr il 
2027 14.3.2017 L 67/72 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author is­
ation Additive Compo sition, chemical formula, 
descr iption, analytical method. Species or 
category of 
animal Maximum 
age Minimum 
conten t Maximum 
content 
Other provisions End of period 
of author is­
ation mg additive/kg of compl ete 
feed with a moisture 
content of 12 % 
For the identif ication of sulphate 
in the feed additive: 
—  European Phar macopoeia 
Monograph 20301 
For the quantifi cation of L-lysine 
in compound feed and feed mate ­
rials: 
—  ion exchang e chromatograph y 
coupled with post-column de­
rivatisation and photome tric 
detec tion (IEC-UV) — Com ­
mission Regulation (EC) 
No 152/2009 (2)  
(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-repor ts 
(2)  Commission Regulation (EC) No 152/2009 of 27 Januar y 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1).   14.3.2017 L 67/73 Official Jour nal of the European Union EN