COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/1378 
of 1 Oct ober 2020 
concer ning the author isation of copper chelate of lysine and glutamic acid 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 author isation. 
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the author isation 
of copper chelate of lysine and glutamic acid. That application was accompanied by the particulars and documents 
required under Article 7(3) of that Regulation. 
(3) That application concer ns the author isation of copper chelate of lysine and glutamic acid as a feed additive for all 
animal species to be classified in the additive cate gory ‘nutr itional additives ’. 
(4) The European Food Safety Auth ority (‘the Author ity’) concluded in its opinion of 15 May 2019 (2) that, under the 
proposed conditions of use, copper chelat e of lysine and glutamic acid does not have an adverse effect on animal 
health and consumer safety . It also concluded that the additive is an eye irritant, skin and respirator y sensitizer , and 
state d a risk for the users of the additive upon inhalation. Theref ore, the Commission considers that appropr iate 
prote ctive measures should be taken to prevent adverse effects on human health, in particular as regar ds the users 
of the additive. The Authority also concluded that that additive does not pose an additional risk for the 
environment compar ed to other compo unds of copper and that it is an efficacious source of copper for all animal 
species. The Author ity does not consider that there is a need for specif ic 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 Laborator y 
set up by Regulation (EC) No 1831/2003. 
(5) The assessment of that additive shows that the conditions for author isation, as provid ed for in Article 5 of 
Regulation (EC) No 1831/2003, are, subject to the relevant prot ective measures for the users of the additive, 
satisfied. According ly, the use of that additive 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 Jour nal 2019;17(6):5728. EN Offi cial Jour nal of the European Union L 319/32                                                                                                                                         2.10.2020   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, 1 October 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union 2.10.2020                                                                                                                                         L 319/33   ANNEX 
Identifica-
tion 
number of 
the additive Name of the 
holder of 
author isation Additive Composition, chem ical formula, 
descr iption, analytical method Species or 
category of 
animal Maximum 
age Minimum 
content Maximum conten t 
Other provisions End of period of 
author isation Content of element (Cu) in mg/kg of 
complet e feed with a moisture 
content of 12 % 
Categor y of nutr itional additiv es. Functional group: compounds of trace elements 
3b415 — Copper chelate of 
lysine  
and glutamic acid Additive composition 
Mixture of chelat e of copper with 
lysine and chelat e of copper with 
glutamic acid in a ratio of 1:1 as a 
powder with 
a copper content between 17 
and 19 %, 
a lysine conte nt between 19 
and 21 %, 
a glutamic acid content between 
19 and 21 % and a maximum of 
3 % moisture All  
animal spe­
cies — — Bovin es: 
— Bovin es before 
the start of rumi­
nation: 15 (total); 
— Other bovines: 
30 (total). 
— Ovines: 15 (total). 
Capr ines: 35 (total) 
Piglets: 
— suckling and 
weaned up to 4 
weeks after wean­
ing: 150 (total). 
— from 5-th week 
after weaning up 
to 8 weeks after 
weaning: 100 (to­
tal). 
Crustaceans: 50 (to­
tal). 
Other animals: 25 
(total). 1.The additive shall be in­
corporated into feed in 
the form of a premixture. 
2.Copper chelate of lysine 
and glutamic acid may 
be placed on the mark et 
and used as an additive 
consisting of a prepara­
tion. 
3.For users of the additive 
and premixtures, feed 
business operators 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 content of heavy me­
tals including nick el. 
Where risks cannot be re­
duced to an acceptable le­
vel by these procedures 
and measures, the addi­
tive and premixtures shall 
be used with appropr iate 
personal prot ective 
equipment. 
4.The followi ng words shall 
be included in the label­
ling: 
— For feed for ovines if the 
level of copper in the feed 
exceed s 10 mg/kg: 22 October 
2030 
Char acter isation of the activ e sub­
stances 
Chemical formulas: 
Copper -2,6-diaminohexanoic 
acid, chlor ide and hydrogen sul­
fate salt: C6H15ClCuN 2O6S 
Copper -2-aminopentanedioic 
acid, sodium and hydrogen sul­
fate salt: C5H9CuNNaO 8.5S 
Analytical methods (1) 
For the quantifi cation of the ly­
sine and glutamic acid content in 
the feed additive: 
—ion exchange chromat ogra­
phy coupled with post-col­
umn derivatisation and 
photomet ric detec tion (IEC- 
VIS) 
For the quantifi cation of total Cu 
in the feed additive: 
— inductively coupled plasma 
atomi c emission spectrome­
try, ICP-AES (EN 15621) or EN Offi cial Jour nal of the European Union L 319/34                                                                                                                                         2.10.2020   Identifica-
tion 
number of 
the additive Name of the 
holder of 
author isation Additive Composition, chem ical formula, 
descr iption, analytical method Species or 
category of 
animal Maximum 
age Minimum 
content Maximum conten t 
Other provisions End of period of 
author isation Content of element (Cu) in mg/kg of 
complet e feed with a moisture 
content of 12 %  
‘The level of copper in 
this feed may cause poi­
soning in certain breeds 
of sheep.’ 
— For feed for bovines after 
the start of rumination if 
the level of copper in the 
feed is less than 20 mg/kg:  
‘The level of copper in 
this feed may cause cop­
per deficiencies in cattle 
grazing pastures with 
high contents of molyb­
denum or sulphur .’ —atomi c absor ption spectro­
metr y, AAS (ISO 6869) 
For proving the chelated struc­
ture of the feed additive: 
—mid-infrared (IR) spectrome­
try together with the determi­
nation of the cont ent of the 
trace element and lysine and 
glutamic acid in the feed ad­
ditive 
For the quantifi cation of total Cu 
in premixtures: 
— inductively coupled plasma 
atomi c emission spectrome­
try, ICP-AES (EN 15510 or 
EN 15621) or 
—atomi c absor ption spectro­
metr y, AAS (ISO 6869) or 
— inductively coupled plasma 
mass spectrometr y, ICP-MS 
(EN 17053) 
For the quantifi cation of total Cu 
in feed mate rials and compo und 
feed: 
— inductively coupled plasma 
atomi c emission spectrome­
try, ICP-AES (EN 15510 or 
EN 15621) or 
—atomi c absor ption spectro­
metr y, AAS (Commission 
Regulation (EC) 
No 152/2009, Annex IV-C 
or ISO 6869) or 
— inductively coupled plasma 
mass spectrometr y, ICP-MS 
(EN 17053) 
(1) 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 ts   EN Offi cial Jour nal of the European Union 2.10.2020                                                                                                                                         L 319/35