COMMISSION IMPLEMENTING REGUL ATION (EU) 2022/1469 
of 5 September 2022
concer ning the author isation of L-lysine sulphate produced by Escherichia coli CGMCC 7.398 as a 
feed additiv e for all animal species 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng rega rd to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 Sept ember 2003 on 
additives for use in animal nutr ition (1), and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provid es for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting such an author isation.
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the author isation 
of L-lysine sulphate produced by Escher ichia coli CGMCC 7.398. The application was accompanied by the particulars 
and documents required under Article 7(3) of that Regulation.
(3) The application concer ns the author isation of L-lysine sulphate produced by Escher ichia coli CGMCC 7.398 as a feed 
additive for all animal species, to be classifie d in the additive catego ry ‘nutr itional additives’, functional group ‘amino 
acids, their salts and analogues’.
(4) The European Food Safety Author ity (‘the Author ity’) concluded in its opinion of 23 March 2022 (2)that, under the 
proposed conditions of use L-lysine sulphat e produced by Escher ichia coli CGMCC 7.398, when supplement ed to 
diets in appropr iate amounts, does not have an adverse effect on animal health, consumer safet y or the 
environment. With respect to the safety of the user of that additive, the Auth ority could not conclude on the 
poten tial of L-lysine sulphat e to be irritant to skin or eyes, or on its poten tial to be a dermal sensitiser . The 
endoto xin activity of the additive represents a risk of exposure by inhalation to endoto xins for persons handling the 
additive. Theref ore, the Commission considers that appropr iate prote ctive measures should be take n to prevent 
adverse effects on human health, in particular as regards the users of the additive. Further , the Author ity concluded 
that the additive is considered an efficacious source of the essential amino acid L-lysine for animal nutr ition and 
that in order to be efficacious in ruminants, it should be prote cted against degradation in the rumen. The Author ity 
does not consider that there is a need for specific requirements of post-market monitori ng. It also verified the repor ts 
on the method of analysis of the feed additive in feed submitte d by the Reference Laboratory set up by Regulation 
(EC) No 1831/2003.
(5) The assessment of L-lysine sulphate produced by Escher ichia coli CGMCC 7.398 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 substance should be author ised as specified in the Annex to this Regulation.
(6) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
(1)OJ L 268, 18.10.2003, p. 29.
(2)EFSA Journal 2022;20(4):7246.EN Offi cial Jour nal of the European Union 6.9.2022 L 231/105  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 a feed additive in animal nutr ition subject to the conditions laid 
down in that Annex.
Article 2
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 States.
Done at Brussels, 5 Sept ember 2022 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 231/106 6.9.2022  ANNEX 
Identification 
number of the 
additiveName of the 
holder of 
author isationAdditiveCom position, chemical formula, descr iption, 
analytical method.Species or categor y 
of animalMaxi -
mum 
ageMini -
mum 
contentMaximum 
content
Other provisionsEnd of period of 
author isation mg additive/kg of 
complet e feed with a 
moisture content of 
12 %
Categor y: nutr itional additiv es. Functional group: amino acids, their salts and analogues.
3c323i L-lysine sulphate Additive composition
Preparation of L-lysine with a cont ent of:
— lysine ≥ 55,0 %
— sulphat e ≥ 18,0 %
Solid formAll species - - 10 000 1.The L-lysine cont ent shall be 
indicated on the labelling of 
the additive.
2.Declarations to be made on the 
labelling of the additive and 
premixtures: ‘The supplemen ­
tation with L-lysine should 
take into account all essential 
and conditional essential ami­
no acids in order to avoid im­
balances.’
3.The endoto xin conte nt of the 
additive and its dusting poten ­
tial shall ensure a maximal en­
doto xin exposure of 1 600 IU 
endoto xins/m3 air(2).
4.For users of the additive and 
premixtures, feed business op­
erators shall establish opera ­
tional procedures and orga ni­
sational measures to address 
poten tial risks by inhalation. 
Where those risks cannot be 
eliminated or reduced to a 
minimum level by such proce ­
dures and measures, the addi ­26.9.2032
Char acter isation of the activ e substance
L-lysine sulphate produced by 
fermentation with Escher ichia coli 
CGMCC 7.398
Chemical formula: C12H28N4O4-O 4S
CAS number : 60343-69-3
Analytical methods (1)
For the quantif ication of lysine in the feed 
additive and premixtures containing 
more than 10 % lysine:
— ion exchange chromatograph y 
coupled with post-column derivati ­
sation and optical detection 
(IEC- VIS/FLD) – EN ISO 17180
For the identif ication of sulphat e in the 
feed additive:
—European Phar macopoeia Mono ­
graph 20301EN Offi cial Jour nal of the European Union 6.9.2022 L 231/107  tive and premixtures shall be 
used with personal prot ective 
equipment, including skin, 
eyes and breathing protection.For the quantifi cation of lysine in 
premixtures, compo und feed and feed 
mat erials:
— ion exchange chromatograph y 
coupled with post-column derivati ­
sation and optical detec tion (IEC- 
VIS) – Commission Regulation (EC) 
No 152/2009 (Annex III, F).
(1)Details of the analytical methods are available at the following address of the Reference Laborato ry: https://joint-research-c entre.ec.europa.eu/eurl-fa-eurl-f eed-additives/eurl-fa-author isation/eurl-f a-evaluation- 
repor ts_en
(2)Exposure calculated based on the endoto xin level and the dusting potential of the additive according to the method used by EFSA (EFSA Journal 2018;16(10):5458); analytical method: European 
Phar macopoeia 2.6.14. (bacterial endoto xins).EN Offi cial Jour nal of the European Union L 231/108 6.9.2022