COMMISSION IMPLEMENTING REGUL ATION (EU) 2021/1425 
of 31 August 2021
concer ning the author isation of manganese chelate of lysine and glut amic acid as 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 author isation.
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the author isation 
of manganese chelat e of lysine and glutamic acid. The 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 the preparation of manga nese chelate of lysine and glutamic acid as a 
feed additive for all animal species to be classifie d in the additive categor y ‘nutr itional additives ’ and the functional 
group ‘com pounds of trace elements’.
(4) The European Food Safety Author ity (‘the Author ity’) concluded in its opinions of 10 Januar y 2020 (2)and 
27 Januar y 2021 (3)that, under the proposed conditions of use, mang anese chelat e of lysine and glutamic acid does 
not have an adverse effect on animal health, consumer safety or the envi ronment. The Author ity concluded that the 
handling of the additive poses a risk to users by inhalation and that it should be considered as an eye irritant, skin 
and respirato ry sensitiser . Theref ore, the Commission considers that appropr iate prot ective measures should be 
taken to prevent adverse effects on human health, in particular as regar ds the users of the additive. The Author ity 
concluded that the additive is efficacious in chick ens for fattening; this conclusion can be extende d to all other 
animal species. The Author ity 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 submitte d by the 
Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5) The assessment of manganese chelat e of lysine and glutamic acid shows that the conditions for author isation, as 
provid ed for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. According ly, the use of that preparation 
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,
HAS ADOPTED THIS REGUL ATION:
Article 1
The preparation specified in the Annex, belonging to the additive catego ry ‘nutr itional additives ’ and to the functional 
group ‘comp ounds 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 Jour nal 2020;18(2):6001.
(3)EFSA Jour nal 2021;19(3):6454.EN Offi cial Jour nal of the European Union L 307/12                                                                                                                                           1.9.2021  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, 31 August 2021 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 1.9.2021                                                                                                                                          L 307/13  ANNEX 
Identifica -
tion 
number of 
the additiveName of 
the holder 
of 
author isa-
tionAdditiveComposition, chemical formula, 
descr iption, analytical methodSpecies or 
categ ory of 
animalMaximum 
ageMinimum 
conten tMaximum conten t
Other provisionsEnd of period of 
author isation Content of element (Mn) in  
mg/kg of complet e feed with a 
moisture content of 12 %
Categor y: nutr itional additiv es
Functional group: compounds of trace elements
3b509 - Mangan ese 
chelate of lysine 
and glutamic acidAdditive composition:
Preparation of chelate s of manganese 
with lysine and chelat es of mang anese 
with glutamic acid in a ratio of 1:1 as a 
powder with
a manganese content between 15 
and 17 %,
a lysine cont ent between 20 
and 21,5 %,
a glutamic acid cont ent between 22 
and 24 %,
a maximum of 3,5 % moisture and
a maximum of 4 ppm nick el.All animal 
species- - Fish: 100 (total)
Other species: 
150 (total)1.The additive shall be in­
corporated into feed in 
the form of a premixture.
2.For users of the additive 
and premixtures, feed 
business operat ors shall 
establish operational pro­
cedures and appropr iate 
organisational measures 
to address the poten tial 
risks by inhalation, der­
mal contact or eyes con­
tact, in particular due to 
the cont ent of heavy me­
tals including nick el. 
Where risks cannot be re­
duced to an accept able le­
vel by these procedures 
and measures, the addi ­
tive and premixtures shall 
be used with appropr iate 
personal prot ective 
equipment, including 
eyes, skin and breathing.21 Septembe r 
2031
Char acter isation of the activ e substances:
Chemical formulas:
Mang anese-2,6- diaminohexanoic 
acid, chlor ide and hydrog en sulfate 
salt:
C6H19ClN 2O8SMn
Mang anese-2-aminopentanedioic 
acid, sodium and hydrog en sulfat e salt:EN Offi cial Jour nal of the European Union L 307/14                                                                                                                                           1.9.2021  C5H10NNaO 9SMn
Analytical methods (*):
For the quantifi cation of total 
mang anese in the feed additive and 
premixtures:
— 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 digestion, ICP-AES 
(EN 15621);
For the quantifi cation of total 
mang anese in feed mater ials and 
compo und feed:
— Atomic Absor ption Spectrometr y, 
AAS (Commission Regulation (EC) 
No 152/2009, Annex IV-C); or
— 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 digestion, ICP-AES 
(EN 15621).
For the quantif ication of the lysine and 
glutamic acid conte nt in the feed 
additive:EN Offi cial Jour nal of the European Union 1.9.2021                                                                                                                                          L 307/15  — ion exchange chromat ography 
coupled with post-column deriva­
tisation and photom etric detection 
(IEC- VIS)
For proving the chelat ed structure of 
the feed additive:
— mid-infrared (IR) spectrometr y 
together with the deter mination 
of the content of the trace element 
and lysine and glutamic acid in the 
feed additive
(*)Details of the analytical methods are avail able at the follo wing address of the Reference Laboratory : https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-repor tsEN Offi cial Jour nal of the European Union L 307/16                                                                                                                                           1.9.2021