COMMISSION IMPLEMENTING REGUL ATION (EU) 2022/1472 
of 5 September 2022
concer ning the author isation of manganese lysinate sulphate 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 manganese lysinate sulphat e. That application was accompan ied 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 manganese lysinate sulphate as a feed additive for all animal species, to 
be classif ied in the additive categor y ‘nutr itional additives’ and the functional group ‘comp ounds of trace elements’.
(4) The European Food Safety Author ity (‘the Author ity’) concluded in its opinion of 27 Januar y 2022 (2)that, under the 
proposed conditions of use, manganese lysinate sulphate does not have an adverse effect on animal health, consumer 
safety or the envi ronment. The Author ity further concluded that the handling of the substance poses a risk to users 
by inhalation and that it is irritant to eyes and skin and should be considered a dermal sensitiser . Theref ore, the 
Commission considers that appropr iate prot ective measures should be take n to prevent adverse effects on human 
health, in particular as regards the users of the additive. The Author ity also concluded that the substance is 
efficacious in chick ens for fattening; this conclusion can be extended to all other animal species. The Auth ority does 
not consider that there is a need for specific requirements of post-market monitori ng. 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 manganese lysinate sulphat e shows that the conditions for author isation, as provi ded 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 specif ied 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,
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 
‘compounds of trace elements’, is author ised as an additive in animal nutr ition, subject to the conditions laid down in that 
Annex.
(1)OJ L 268, 18.10.2003, p. 29.
(2)EFSA Journal 2022;20(3):7165.EN Offi cial Jour nal of the European Union L 231/116 6.9.2022  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 6.9.2022 L 231/117  ANNEX 
Identifica -
tion 
number of 
the additiveName of the 
holder of 
author isationAdditiveCompo sition, chem ical formula, 
descr iption, analytical methodSpecies or 
categor y of 
animalMaximum 
ageMinimum 
contentMaximum content
Other provisi onsEnd of period of 
author isation Content of element (Mn) in mg/kg 
of complet e feed with a moisture 
conten t of 12 %
Categor y of nutr itional additiv es. Functional group: compounds of trace elements.
3b511 - Mangan ese 
lysinate 
sulphateAdditive composition
Mangan ese and amino acid L-lys ine: 
ratio of 1:1
(monohydr ate) having a cont ent of:
— manganese 16 % – 18 %;
— lysine 44 % – 47 %;
— sulphate 27 % – 31 % (calculat ed 
from sulphur),
Solid form (≤ 10 % moisture)All animal 
species other 
than fish- - 150 (total) 1.The additive shall be in­
corporat ed into feed in 
the form of a premixture.
2.For users of the additive 
and premixtures, feed 
business operators shall 
establish operational pro­
cedures and appropr iate 
organisational measures 
to address the potential 
risks. Where risks cannot 
be reduced to an accepta ­
ble level by these proce ­
dures and measures, the 
additive and premixtures 
shall be used with appro ­
priate personal protect ive 
equipment, including 
breathing, skin and eye 
protection.26.9.2032
Char acter isation of the active substances
Chemical formulas:
C6H16MnN 2O7S
IUPAC: 
monoaquamonolysinat omanganese 
(II) sulphateFish 100 (total)
Analytical methods (1)
For the quantification of total 
manganese in the feed additive, 
premixtures and feedingstuffs:
—Atomic Absor ption Spectrome ­
try (AAS) – ISO 6869; or
— Inductively Coupled Plasma- 
Atomic Emission Spectrometr y 
after pressure diges tion (ICP - 
AES) – EN 15621; orEN Offi cial Jour nal of the European Union L 231/118 6.9.2022  — Inductively Coupled Plasma- 
Atomic Emission Spectrometr y 
(ICP -AES) – EN 15510; or
— Inductively Coupled Plasma- 
Mass Spectrometr y (ICP -MS) – 
EN 17053 (for premixtures and 
feedingstuffs only); or
—Atomic Absor ption Spectrome ­
try (AAS) – Commission Regula ­
tion (EC) No 152/2009 (for fee­
dingstuffs only)
For the quantifi cation of lysine in the 
feed additive:
— ion-ex chang e chromat ography 
coupled to post-column derivati ­
sation and optical detection 
(IEC- VIS/FLD) – EN ISO 17180
For the identification of sulphate in 
the feed additive:
—European Phar macopoeia mono ­
graph 20301
(1)Details of the analytical methods are available at the follo wing address of the Reference Laboratory : https://joint-research-centre.ec.europa.eu/eurl-f a-eurl-f eed-additives/eurl-fa-author isation/eurl-f a-evaluation- 
repor ts_enEN Offi cial Jour nal of the European Union 6.9.2022 L 231/119