COMMI SSION IMPLEMENTING REGUL ATION (EU) 2018/1039 
of 23 July 2018 
concer ning the author isation of Copper(II) diacetat e monoh ydrate, Copper(II) carbonate dihy droxy 
monohydrat e, Copper(II) chlor ide dihyd rate, Copper(II) oxide, Copper(II) sulphate penta hydrate, 
Copper(II) chelate of amino acids hydrate, Copper(II) chelate of protein hydrolysates, Copper(II) 
chelate of glycine hydrate (solid) and Copper(II) chelate of glycine hydrate (liquid) as feed additiv es 
for all animal species and amending Regulations (EC) No 1334/2003, (EC) No 479/2006 and (EU) 
No 349/2010 and Implementing Regulations (EU) No 269/2012, (EU) No 1230/2014 and (EU) 
2016/2261 
(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 provi des for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting such author isation. Article 10 of that Regulation provid es for the re- 
evaluation of additives author ised pursuant to Council Directive 70/524/EEC (2). 
(2)  The copper compo unds cupr ic acetate, monohydrat e, basic cupr ic carbonate, monoh ydrate , cupr ic chlor ide, 
dihy drate, cupr ic oxide, cupr ic sulphate, pentahydrat e, cupr ic chelat e of amino acids, hydrat e and cupr ic chelate 
of glycine hydrat e were author ised without a time limit as feed additives for all animal species by Commission 
Regulation (EC) No 1334/2003 (3) and Commission Regulation (EC) No 479/2006 (4) in accordance with 
Directive 70/524/EEC. Those substances were subsequently entered in the Regist er of feed additives as existing 
products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. 
(3)  In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, 
applications were submitt ed for the re-evaluation of cupr ic acetate , monoh ydrate, basic cupr ic carbonate , 
monoh ydrate, cupr ic chlor ide, dihydrat e, cupr ic oxide, cupr ic sulphate , pentahydra te, cupr ic chelate of amino 
acids, hydrat e and cupr ic chelat e of glycine hydrate as feed additives for all animal species. The applicants 
request ed that those additives be classified in the additive catego ry ‘nutr itional additives ’. Those applications were 
accompan ied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. 
(4)  Due to scientific considerations, the European Food Safety Author ity (‘the Author ity’) recommended in its 
opinions of 14 November 2012 (5), 31 Januar y 2013 (6) and 11 March 2015 (7) to replace ‘Cupr ic’ by ‘Copper(II)’ 
in order to avoid poten tial misunderstandings. The Author ity also recommended splitting Copper(II) chelate of 
amino acids into the follo wing two groups, in view of its chemical characteri stics: Copper(II) chelate of amino 
acids hydrat e and Copper(II) chelate of prot ein hydrolysates. 
(5)  The Author ity concluded that, under the proposed conditions of use, Copper(II) diacetate monohydrat e, 
Copper(II) carbonate dihydro xy monohydrat e, Copper(II) chlor ide dihydrat e, Copper(II) oxide, Copper(II) sulphate 
pentahydr ate, Copper(II) chelat e of amino acids hydrate, Copper(II) chelat e of protein hydrolysate s, Copper(II) 
chelate of glycine hydrate (solid) and Copper(II) chelate of glycine hydrate (liquid) (‘substances concer ned’) do not 
have an adverse effect on animal health, consumer safety and the environment. Consider ing the capacities 24.7.2018 L 186/3 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(2)Council Directive 70/524/EEC of 23 November 1970 concer ning additives in feeding-stuffs (OJ L 270, 14.12.1970, p. 1). 
(3)Commission Regulation (EC) No 1334/2003 of 25 July 2003 amending the conditions for author isation of a number of additives in 
feed ingstuffs belonging to the group of trace elements (OJ L 187, 26.7.2003, p. 11). 
(4)Commission Regulation (EC) No 479/2006 of 23 March 2006 as regar ds the author isation of certain additives belonging to the group 
compo unds of trace elements (OJ L 86, 24.3.2006, p. 4). 
(5)EFSA Journal 2012;10(12):2969. 
(6)EFSA Journal 2013;11(2):3107. 
(7)EFSA Journal 2015;13(4):4057. to be respirato ry, eye and skin irritants, appropr iate protective measures should be taken with respect to the 
handling of the additives concer ned and premixtures containing them, in order to avoid that safety concer ns for 
the users would arise. 
(6)  With respect to the nick el content of the additives, in particular in Copper(II) sulphate pentahydrat e, certain 
batch es of the additive might qualify for requirements set out in Regulation (EC) No 1907/2006 of the European 
Parliament and of the Council (1). The feed business operat or placing on the market such additives should compl y 
with the relevant requirements. The Auth ority further concluded that the ‘substances concer ned’ are efficacious in 
meeting animal copper requirements. 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 ts on the method of analysis of the feed 
additives in feed submitt ed by the Reference Laboratory set up by Regulation (EC) No 1831/2003. 
(7)  The assessment of the ‘substances concer ned’ shows that the conditions for author isation, as provid ed for in 
Article 5 of Regulation (EC) No 1831/2003, are satisfi ed. However , the author ity has concer ns with respect to 
the strict adherence to the maximum quantity of copper administ ered to the animal if copper is added to wate r 
for drinking. According ly, the use of the substances concer ned should be author ised as specifi ed in the Annex to 
this Regulation and their use via water for drinking should be prohibited. 
(8)  With respect to the potential impacts on the environment, the Authority was request ed to deliver a scientifi c 
opinion for a revision of the currently author ised maximum copper cont ent in compl ete feed. The Author ity 
recommended in its opinion of 13 July 2016 (2) to amend the author ised maximum copper contents in compl ete 
feed for differ ent target species. These new levels should be adopt ed. However , for piglets the drastic 
recommended decrease to 25 mg/kg directly after weaning should not be done in one step, in order not to put at 
risk meeting the physiological needs of animals, particularly in that sensitive period, and to avoid any other 
negat ive impacts on the health of piglets. With the objective of a further reduction when the maximum contents 
are next reviewed to meet the maximum of 25 mg/kg for piglets directly after weaning, feed business operators 
and research institute s should be encourag ed to collect new scientific data about the impact s of the levels 
recommended by the Author ity on the health and welfare status of piglets and to prom ptly explore the use and 
effectiveness of alternatives to supplementation with copper as mentioned by the Authority. 
(9)  As a result of the granting of new author isations for cupr ic acetat e, monohydrat e, basic cupr ic carbonat e, 
monoh ydrate, cupr ic chlor ide, dihydrat e, cupr ic oxide, cupr ic sulphate , pentahydra te, cupr ic chelate of amino 
acids, hydrat e and cupr ic chelate of glycine hydrate, the complet e entr ies for these substances in Regulations (EC) 
No 1334/2003 and (EC) No 479/2006 should be delet ed. The author isation for copperlysine sulphat e expired on 
31 March 2004. For reasons of legal certainty , it is appropr iate to delet e the entr y concer ning that substance 
from Regulation (EC) No 1334/2003. 
(10)  Commission Regulation (EU) No 349/2010 (3) and Commission Implemen ting Regulations (EU) No 269/2012 (4), 
(EU) No 1230/2014 (5) and (EU) 2016/2261 (6) author ised several copper compo unds as nutr itional feed 
additives. In order to take into account the conclusions of the Author ity in its opinion of 13 July 2016, which 
were also the scientific basis for the provis ions concer ning the total copper cont ent in compo und feed for the 
additives author ised by this Regulation and which are mainly refer ring to the envi ronmental impact of feed 
supplementation with copper , it is appropr iate to align the maximum cont ents of copper in Regulation (EU) 
No 349/2010 and Implementing Regulations (EU) No 269/2012, (EU) No 1230/2014 and (EU) 2016/2261 with 
the provisions of this Regulation as regards the copper content in compo und feed. Regulation (EU) No 349/2010 
and Implementing Regulations (EU) No 269/2012, (EU) No 1230/2014 and (EU) 2016/2261 should theref ore be 
amended according ly. 
(11) Since safety reasons do not require the immediate application of the modifi cations to the conditions of author is­
ation for cupr ic acetate , monoh ydrate , basic cupr ic carbonate, monoh ydrate , cupr ic chloride, dihy drate, cupr ic 
oxide, cupr ic sulphat e, pentah ydrate, cupr ic chelate of amino acids, hydrat e and cupr ic chelate of glycine hydrate 24.7.2018 L 186/4 Official Jour nal of the European Union EN     
(1)Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concer ning the Registration, 
Evaluation, Authorisatio n and Restr iction of Chemicals (REA CH), establishing a European Chemicals Agency , amending Directive 
1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council 
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1). 
(2)EFSA Journal 2016;14(8):4563. 
(3)Commission Regulation (EU) No 349/2010 of 23 Apr il 2010 concer ning the author isation of copper chelat e of hydro xy analogue of 
methionine as a feed additive for all animal species (OJ L 104, 24.4.2010, p. 31). 
(4)Commission Implementing Regulation (EU) No 269/2012 of 26 March 2012 concer ning the author isation of dicopper chlorid e 
trihydro xide as feed additive for all animal species (OJ L 89, 27.3.2012, p. 3). 
(5)Commission Implementing Regulation (EU) No 1230/2014 of 17 November 2014 concer ning the author isation of copper bilysinate as 
a feed additive for all animal species (OJ L 331, 18.11.2014, p. 18). 
(6)Commission Implementing Regulation (EU) 2016/2261 of 15 December 2016 concer ning the author isation of copper(I) oxide as a feed 
additive for all animal species (OJ L 342, 16.12.2016, p. 18). and the copper compounds author ised by Regulation (EU) No 349/2010 and Implementing Regulations (EU) 
No 269/2012, (EU) No 1230/2014 and (EU) 2016/2261, it is appropr iate to allow a transitional period for 
inter ested parties to prepare themselves to meet the new requirements resulting from the author isation. 
(12)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Author isation 
The substances specifi ed in the Annex, belonging to the additive categor y ‘nutr itional additives ’ and to the functional 
group ‘compounds of trace elements’, are author ised as feed additives in animal nutr ition, subject to the conditions laid 
down in that Annex. 
Article 2 
Special conditions of use 
The author ised substances specified in the Annex as additives belonging to the additive catego ry ‘nutr itional additives ’ 
and to the functional group ‘compounds of trace elements’ shall not be used in water for drinking. 
Article 3 
Amendment to Regulation (EC) No 1334/2003 
In the Annex to Regulation (EC) No 1334/2003, the following additives are delet ed from entr y E4 for the element 
Copper -Cu: ‘cupr ic acetat e, monoh ydrate , basic cupr ic carbonate, monoh ydrate , cupr ic chloride, dihydrat e, cupr ic oxide, 
cupr ic sulphate, pentahydrat e, copperlysine sulphate and cupr ic chelate of amino acids, hydrat e’. 
Article 4 
Amendment to Regulation (EC) No 479/2006 
In the Annex to Regulation (EC) No 479/2006, the entr y E4 for the additive ‘Cupr ic chelate of glycine hydrat e’ is 
delet ed. 
Article 5 
Amendment to Regulation (EU) No 349/2010 
In the Annex to Regulation (EU) No 349/2010, in the line 3b4.10 the text of the eighth column is replaced by the 
follo wing: 
‘Bovines: 
—  Bovines before the start of rumination: 15 (total); 
—  Other bovine s: 30 (total). 
Ovines: 15 (total). 
Capr ines: 35 (total) 
Piglets: 
—  suckling and weaned up to 4 weeks after weaning: 150 (total); 
—  from 5-th week after weaning up to 8 weeks after weaning: 100 (total). 
Crustaceans: 50 (total). 
Other animals: 25 (total)’. 24.7.2018 L 186/5 Official Jour nal of the European Union EN     Article 6 
Amendment to Implementing Regulation (EU) No 269/2012 
In the Annex to Implementing Regulation (EU) No 269/2012, in the line 3b409 the text of the eighth column is 
replaced by the follo wing: 
‘Bovines: 
—  Bovines before the start of rumination: 15 (total); 
—  Other bovine s: 30 (total). 
Ovines: 15 (total). 
Capr ines: 35 (total) 
Piglets: 
—  suckling and weaned up to 4 weeks after weaning: 150 (total); 
—  from 5-th week after weaning up to 8 weeks after weaning: 100 (total). 
Crustaceans: 50 (total). 
Other animals: 25 (total)’. 
Article 7 
Amendment to Implementing Regulation (EU) No 1230/2014 
In the Annex to Implementing Regulation (EU) No 1230/2014, in the line 3b411 the text of the eighth column is 
replaced by the follo wing: 
‘Bovines: 
—  Bovines before the start of rumination: 15 (total); 
—  Other bovine s: 30 (total). 
Ovines: 15 (total). 
Capr ines: 35 (total) 
Piglets: 
—  suckling and weaned up to 4 weeks after weaning: 150 (total); 
—  from 5-th week after weaning up to 8 weeks after weaning: 100 (total). 
Crustaceans: 50 (total). 
Other animals: 25 (total’. 
Article 8 
Amendment to Implementing Regulation (EU) 2016/2261 
In the Annex to Implementing Regulation (EU) 2016/2261, in the line 3b412 the text of the eighth column is replaced 
by the followi ng: 
‘Bovines: 
—  Bovines before the start of rumination: 15 (total); 
—  Other bovine s: 30 (total). 
Ovines: 15 (total). 
Capr ines: 35 (total) 
Piglets: 
—  suckling and weaned up to 4 weeks after weaning: 150 (total); 
—  from 5-th week after weaning up to 8 weeks after weaning: 100 (total). 
Crustaceans: 50 (total). 
Other animals: 25 (total’. 24.7.2018 L 186/6 Official Jour nal of the European Union EN     Article 9 
Transitional measures 
1. The substances ‘cupr ic acetat e, monohydrat e’, ‘basic cupr ic carbonate, monohydrat e’, ‘cupr ic chlor ide, dihydrat e’, 
‘cupr ic oxide ’, ‘cupr ic sulphat e, pentahydra te’, ‘cupr ic chelate of amino acids, hydrate’ and ‘cupr ic chelat e of glycine 
hydrate’ as author ised by Regulation (EC) No 1334/2003 and Regulation (EC) No 479/2006 and the copper compo unds 
author ised by Regulation (EU) No 349/2010 and Implementing Regulations (EU) No 269/2012, (EU) No 1230/2014 
and (EU) 2016/2261, and premixtures containing those substances, whic h are produced and labelled before 13 Febr uary 
2019 in accordance with the rules applicable before 13 August 2018 may continue to be placed on the mark et and 
used until the existing stoc ks are exhausted. 
2. Feed mate rials and compo und feed containing the substances referred to in paragraph 1 which are produced and 
labelled before 13 August 2019 in accordance with the rules applicable before 13 August 2018 may continue to be 
placed on the mark et and used until the existing stoc ks are exhausted if they are intende d for food-producing animals. 
3. Feed mate rials and compo und feed containing the substances referred to in paragraph 1 which are produced and 
labelled before 13 August 2020 in accordance with the rules applicable before 13 August 2018 may continue to be 
placed on the mark et and used until the existing stocks are exhaust ed if they are intende d for non-f ood-producing 
animals. 
Article 10 
Entr y into force 
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 State s. 
Done at Brussels, 23 July 2018. 
For the Commission 
The President 
Jean-Claude JUNCK ER  24.7.2018 L 186/7 Official Jour nal of the European Union EN     ANNEX 
Identifica ­
tion 
number  
of the 
additive Name of 
the holder 
of author ­
isation Additive Compo sition, chemical formula, 
descr iption, analytical method Species or 
categor y 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  
conten t of 12 % 
Categor y of nutr itional additiv es. Functional group: compounds of trace elements 
3b401 — Copper(II) 
diacetate 
monoh y­
drate Additiv e composition 
Copper(II) diacetate monohydrat e 
as a powder with a minimum 
content of 31 % copper 
Char acter isation of the activ e sub­
stance 
Chemical formula: Cu(C H3COO)2 · 
H2O 
CAS Number: 6046-93-1 
Analytical methods (1) 
For the identification of Copper(II) 
diacetate monoh ydrate in the feed 
additive: 
—  European Phar macopoeia 
Monographs 2146 and 20301 
For the crystallographic charact er­
isation of the feed additive: 
—  X-Ray diffraction 
For the determination of total Cu 
content in the feed additive and 
premixtures: 
—  inductively coupled plasma 
atomic emission spectrometr y, 
ICP-AES (EN 15510 or 
CEN/TS 15621)  All animal 
species — — Bovines: 
—  Bovines before the 
start of rumination: 
15 (total); 
—Other bovines: 30 (to­
tal). 
Ovines: 15 (total). 
Capr ines: 35 (total) 
Piglets: 
—  suckling and weaned 
up to 4 weeks after 
weaning: 150 (total). 
—  from 5-th week after 
weaning up to 8 weeks 
after weaning: 100 
(total). 
Crustaceans: 50 (total). 
Other animals: 25 (total). 1.The additive shall be incor ­
porat ed into feed in the 
form of a premixture.  
2. For users of the additive 
and premixtures, feed busi ­
ness operat ors shall estab ­
lish operational procedures 
and appropr iate organisa ­
tional measures to address 
the poten tial risks by inha ­
lation, dermal contact or 
eyes contact, in particular 
due to the content of heavy 
metals including nick el. 
Where risks cannot be re­
duced to an acceptable level 
by these procedures and 
measures, the additive and 
premixtures shall be used 
with appropr iate personal 
prot ective equipment.  13 August 
2028 24.7.2018 L 186/8 Official Jour nal of the European Union EN     Identifica ­
tion 
number  
of the 
additive Name of 
the holder 
of author ­
isation Additive Compo sition, chemical formula, 
descr iption, analytical method Species or 
categor y 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  
conten t of 12 % 
Deter mination of total Cu content 
in feed mater ials and compo und 
feed: 
—atomic absor ption spectrome ­
try, AAS (Commission Regu ­
lation (EC) No 152/2009 (2), 
Annex IV-C) or 
—  inductively coupled plasma 
atomic emission, ICP-AES (EN 
15510 or CEN/TS 15621)  3. The followi ng words shall 
be included in the labelling: 
—  For feed for ovines 
if the level of copper 
in the feed exceeds 
10 mg/kg: 
‘The level of copper in 
this feed may cause 
poisoning in certain 
breeds of sheep.’ 
—  For feed for bovines 
after the start of rumi ­
nation if the level of 
copper in the feed is 
less than 20 mg/kg: 
‘The level of copper in 
this feed may cause 
copper deficiencies in 
cattle grazing pastures 
with high cont ents of 
molybdenum or sul­
phur .’           
3b402 — Copper(II) 
carbonate 
dihy droxy 
monoh y­
drate Additiv e composition 
Copper(II) carbonat e dihydro xy 
monohydrat e as a powder with 
a minimum content of 52 % cop­
per 
Char acter isation of the activ e sub­
stance 
Chemical formula: CuCO3 · 
Cu(OH)2 · H2O 
CAS Number: 100742-53-8  All animal 
species — — Bovines: 
—  Bovines before the 
start of rumination: 
15 (total); 
—Other bovines: 30 (to­
tal). 
Ovines: 15 (total). 
Capr ines: 35 (total)  1.The additive shall be incor ­
porat ed into feed in the 
form of a premixture.  13 August 
2028 24.7.2018 L 186/9 Official Jour nal of the European Union EN     Identifica ­
tion 
number  
of the 
additive Name of 
the holder 
of author ­
isation Additive Compo sition, chemical formula, 
descr iption, analytical method Species or 
categor y 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  
conten t of 12 % 
Analytical methods (1) 
For the identif ication of carbonate 
in the feed additive: 
—  European Phar macopoeia 
Monograph 20301 
For the determination of total Cu 
in the feed additive and premix ­
tures: 
—  inductively coupled plasma 
atomic emission spectrometr y, 
ICP-AES (EN 15510 or 
CEN/TS 15621) 
For the determination of total Cu 
in feed mater ials and compo und 
feed: 
—atomic absor ption spectrome ­
try, AAS (Regulation (EC) 
No 152/2009, Annex IV-C) or 
—  inductively coupled plasma 
atomic emission spectrometr y, 
ICP-AES (EN 15510 or 
CEN/TS 15621)  Piglets: 
—  suckling and weaned 
up to 4 weeks after 
weaning: 150 (total). 
—  from 5-th week after 
weaning up to 8 weeks 
after weaning: 100 
(total). 
Crustaceans: 50 (total). 
Other animals: 25 (total).  2. For users of the additive 
and premixtures, feed busi ­
ness operat ors shall estab ­
lish operational procedures 
and appropr iate organisa ­
tional measures to address 
the poten tial risks by inha ­
lation, dermal contact or 
eyes contact, in particular 
due to the content of heavy 
metals including nick el. 
Where risks cannot be re­
duced to an acceptable level 
by these procedures and 
measures, the additive and 
premixtures shall be used 
with appropr iate personal 
prot ective equipment.  
3. The followi ng words shall 
be included in the labelling: 
—  For feed for ovines 
if the level of copper 
in the feed exceeds 
10 mg/kg: 
‘The level of copper in 
this feed may cause 
poisoning in certain 
breeds of sheep.’ 24.7.2018 L 186/10 Official Jour nal of the European Union EN     Identifica ­
tion 
number  
of the 
additive Name of 
the holder 
of author ­
isation Additive Compo sition, chemical formula, 
descr iption, analytical method Species or 
categor y 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  
conten t of 12 % 
—  For feed for bovines 
after the start of rumi ­
nation if the level of 
copper in the feed is 
less than 20 mg/kg: 
‘The level of copper in 
this feed may cause 
copper deficiencies in 
cattle grazing pastures 
with high cont ents of 
molybdenum or sul­
phur .’           
3b403 — Copper(II) 
chlor ide 
dihy drate Additiv e composition 
Copper(II) chlor ide dihydrat e as 
a powder with a minimum con­
tent of 36 % copper 
Char acter isation of the activ e sub­
stance 
Chemical formula: CuCl2 · 2H2O 
CAS Number: 10125-13-0 
Analytical methods (1) 
For the identif ication of chlor ide 
in the feed additive: 
—  European Phar macopoeia 
Monograph 20301 
For the crystallographic charact er­
isation of the feed additive: 
—  X-Ray diffraction  All animal 
species — — Bovines: 
—  Bovines before the 
start of rumination: 
15 (total); 
—Other bovines: 30 (to­
tal). 
Ovines: 15 (total). 
Capr ines: 35 (total) 
Piglets: 
—  suckling and weaned 
up to 4 weeks after 
weaning: 150 (total). 
—  from 5-th week after 
weaning up to 8 weeks 
after weaning: 100 
(total). 
Crustaceans: 50 (total). 
Other animals: 25 (total). 1.The additive shall be incor ­
porat ed into feed in the 
form of a premixture.  
2. For users of the additive 
and premixtures, feed busi ­
ness operat ors shall estab ­
lish operational procedures 
and appropr iate organisa ­
tional measures to address 
the poten tial risks by inha ­
lation, dermal contact or 
eyes contact, in particular 
due to the content of heavy 
metals including nick el. 
Where risks cannot be re­
duced to an acceptable level 
by these procedures and 
measures, the additive and 
premixtures shall be used 
with appropr iate personal 
prot ective equipment.  13 August 
2028 24.7.2018 L 186/11 Official Jour nal of the European Union EN     Identifica ­
tion 
number  
of the 
additive Name of 
the holder 
of author ­
isation Additive Compo sition, chemical formula, 
descr iption, analytical method Species or 
categor y 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  
conten t of 12 % 
For the determination of total Cu 
in the feed additive and premix ­
tures: 
—  inductively coupled plasma 
atomic emission spectrometr y, 
ICP-AES (EN 15510 or 
CEN/TS 15621) 
For the determination of total Cu 
in feed mater ials and compo und 
feed: 
—atomic absor ption spectrome ­
try, AAS (Regulation (EC) 
No 152/2009, Annex IV-C) or 
—  inductively coupled plasma 
atomic emission spectrometr y, 
ICP-AES (EN 15510 or 
CEN/TS 15621)  3. The followi ng words shall 
be included in the labelling: 
—  For feed for ovines 
if the level of copper 
in the feed exceeds 
10 mg/kg: 
‘The level of copper in 
this feed may cause 
poisoning in certain 
breeds of sheep.’ 
—  For feed for bovines 
after the start of rumi ­
nation if the level of 
copper in the feed is 
less than 20 mg/kg: 
‘The level of copper in 
this feed may cause 
copper deficiencies in 
cattle grazing pastures 
with high cont ents of 
molybdenum or sul­
phur .’           
3b404 — Copper(II) 
oxide Additiv e composition 
Copper(II) oxide as a powder with 
a minimum content of 77 % cop­
per 
Char acter isation of the activ e sub­
stance 
Chemical formula: CuO 
CAS Number: 1317-38-0  All animal 
species — — Bovines: 
—  Bovines before the 
start of rumination: 
15 (total); 
—Other bovines: 30 (to­
tal). 
Ovines: 15 (total). 
Capr ines: 35 (total)  1.The additive shall be incor ­
porat ed into feed in the 
form of a premixture.  13 August 
2028 24.7.2018 L 186/12 Official Jour nal of the European Union EN     Identifica ­
tion 
number  
of the 
additive Name of 
the holder 
of author ­
isation Additive Compo sition, chemical formula, 
descr iption, analytical method Species or 
categor y 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  
conten t of 12 % 
Analytical methods (1) 
For the crystallographic charact er­
isation of the feed additive: 
—  X-Ray diffraction 
For the determination of total Cu 
in the feed additive and premix ­
tures: 
—  inductively coupled plasma 
atomic emission spectrometr y, 
ICP-AES (EN 15510 or 
CEN/TS 15621) 
For the determination of total Cu 
in feed mater ials and compo und 
feed: 
—atomic absor ption spectrome ­
try, AAS (Regulation (EC) 
No 152/2009, Annex IV-C) or 
—  inductively coupled plasma 
atomic emission spectrometr y, 
ICP-AES (EN 15510 or 
CEN/TS 15621)  Piglets: 
—  suckling and weaned 
up to 4 weeks after 
weaning: 150 (total). 
—  from 5-th week after 
weaning up to 8 weeks 
after weaning: 100 
(total). 
Crustaceans: 50 (total). 
Other animals: 25 (total).  2. For users of the additive 
and premixtures, feed busi ­
ness operat ors shall estab ­
lish operational procedures 
and appropr iate organisa ­
tional measures to address 
the poten tial risks by inha ­
lation, dermal contact or 
eyes contact, in particular 
due to the content of heavy 
metals including nick el. 
Where risks cannot be re­
duced to an acceptable level 
by these procedures and 
measures, the additive and 
premixtures shall be used 
with appropr iate personal 
prot ective equipment.  
3. The followi ng words shall 
be included in the labelling: 
—  For feed for ovines 
if the level of copper 
in the feed exceeds 
10 mg/kg: 
‘The level of copper in 
this feed may cause 
poisoning in certain 
breeds of sheep.’ 24.7.2018 L 186/13 Official Jour nal of the European Union EN     Identifica ­
tion 
number  
of the 
additive Name of 
the holder 
of author ­
isation Additive Compo sition, chemical formula, 
descr iption, analytical method Species or 
categor y 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  
conten t of 12 % 
—  For feed for bovines 
after the start of rumi ­
nation if the level of 
copper in the feed is 
less than 20 mg/kg: 
‘The level of copper in 
this feed may cause 
copper deficiencies in 
cattle grazing pastures 
with high cont ents of 
molybdenum or sul­
phur .’           
3b405 — Copper(II) 
sulphate 
pentahy ­
drate Additiv e composition 
Copper(II) sulphate pentahydr ate 
as a powder with a minimum 
content of 24 % copper 
Char acter isation of the activ e sub­
stance 
Chemical formula: CuSO4 · 5H2O 
CAS Number: 7758-99-8 
Analytical methods (1) 
For the identification of Copper(II) 
sulphate pentahydr ate in the feed 
additive: 
—  European Phar macopoeia 
Monographs 0894 and 20301 
For the crystallographic charact er­
isation of the feed additive: 
—  X-Ray diffraction  All animal 
species — — Bovines: 
—  Bovines before the 
start of rumination: 
15 (total); 
—Other bovines: 30 (to­
tal). 
Ovines: 15 (total). 
Capr ines: 35 (total) 
Piglets: 
—  suckling and weaned 
up to 4 weeks after 
weaning: 150 (total). 
—  from 5-th week after 
weaning up to 8 weeks 
after weaning: 100 
(total). 
Crustaceans: 50 (total). 
Other animals: 25 (total). 1.Copper(II) sulphate penta ­
hydrate may be placed on 
the mark et and used as an 
additive consisting of 
a preparation. 
2.The additive shall be incor ­
porat ed into feed in the 
form of a premixture.  13 August 
2028 24.7.2018 L 186/14 Official Jour nal of the European Union EN     Identifica ­
tion 
number  
of the 
additive Name of 
the holder 
of author ­
isation Additive Compo sition, chemical formula, 
descr iption, analytical method Species or 
categor y 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  
conten t of 12 % 
For the determination of total Cu 
in the feed additive and premix ­
tures: 
—  inductively coupled plasma 
atomic emission spectrometr y, 
ICP-AES (EN 15510 or 
CEN/TS 15621) 
For the determination of total Cu 
in feed mater ials and compo und 
feed: 
—atomic absor ption spectrome ­
try, AAS (Regulation (EC) 
No 152/2009, Annex IV-C) or 
—  inductively coupled plasma 
atomic emission spectrometr y, 
ICP-AES (EN 15510 or 
CEN/TS 15621)  3. For users of the additive 
and premixtures, feed busi ­
ness operat ors shall estab ­
lish operational procedures 
and appropr iate organisa ­
tional measures to address 
the poten tial risks by inha ­
lation, dermal contact or 
eyes contact, in particular 
due to the content of heavy 
metals including nick el. 
Where risks cannot be re­
duced to an acceptable level 
by these procedures and 
measures, the additive and 
premixtures shall be used 
with appropr iate personal 
prot ective equipment.  
4. The followi ng words shall 
be included in the labelling: 
—  For feed for ovines 
if the level of copper 
in the feed exceeds 
10 mg/kg: 
‘The level of copper in 
this feed may cause 
poisoning in certain 
breeds of sheep.’  24.7.2018 L 186/15 Official Jour nal of the European Union EN     Identifica ­
tion 
number  
of the 
additive Name of 
the holder 
of author ­
isation Additive Compo sition, chemical formula, 
descr iption, analytical method Species or 
categor y 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  
conten t of 12 % 
—  For feed for bovines 
after the start of rumi ­
nation if the level of 
copper in the feed is 
less than 20 mg/kg: 
‘The level of copper in 
this feed may cause 
copper deficiencies in 
cattle grazing pastures 
with high cont ents of 
molybdenum or sul­
phur .’           
3b406 — Copper(II) 
chelate of 
amino acids 
hydrate Additiv e composition 
Copper(II) amino acid compl ex 
where the copper and the amino 
acids derived from soya prot ein 
are chelat ed via coordinate cova ­
lent bonds, as a powder with 
a minimum content of 10 % cop­
per 
Char acter isation of the activ e sub­
stance 
Chemical formula: Cu(x)1–3 · 
nH2O, x = anion of any amino 
acid from soya protein hydroly ­
sate. 
Maximum of 10 % of the mole ­
cules exceed ing 1 500 Da  All animal 
species  — Bovines: 
—  Bovines before the 
start of rumination: 
15 (total); 
—Other bovines: 30 (to­
tal). 
Ovines: 15 (total). 
Capr ines: 35 (total) 
Piglets: 
—  suckling and weaned 
up to 4 weeks after 
weaning: 150 (total). 
—  from 5-th week after 
weaning up to 8 weeks 
after weaning: 100 
(total). 
Crustaceans: 50 (total). 
Other animals: 25 (total).  1. Copper(II) chelat e of amino 
acids hydrate may be placed 
on the mark et and used as 
an additive consisting of 
a preparation. 
2.The additive shall be incor ­
porat ed into feed in the 
form of a premixture.  13 August 
2028 24.7.2018 L 186/16 Official Jour nal of the European Union EN     Identifica ­
tion 
number  
of the 
additive Name of 
the holder 
of author ­
isation Additive Compo sition, chemical formula, 
descr iption, analytical method Species or 
categor y 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  
conten t of 12 % 
Analytical methods (1) 
For the quantifi cation of the 
amino acid cont ent in the feed ad­
ditive: 
—  ion exchang e chromatograph y 
combined with post-column 
ninhydr in derivatisation and 
photometr ic detection (Regu ­
lation (EC) No 152/2009, An­
nex III-F) 
For the determination of total Cu 
in the feed additive and premix ­
tures: 
—  inductively coupled plasma 
atomic emission spectrometr y, 
ICP-AES (EN 15510 or 
CEN/TS 15621) 
For the determination of total Cu 
in feed mater ials and compo und 
feed: 
—atomic absor ption spectrome ­
try, AAS (Regulation (EC) 
No 152/2009, Annex IV-C) or 
—  inductively coupled plasma 
atomic emission spectrometr y, 
ICP-AES (EN 15510 or 
CEN/TS 15621)   3. For users of the additive 
and premixtures, feed busi ­
ness operat ors shall estab ­
lish operational procedures 
and appropr iate organisa ­
tional measures to address 
the poten tial risks by inha ­
lation, dermal contact or 
eyes contact, in particular 
due to the content of heavy 
metals including nick el. 
Where risks cannot be re­
duced to an acceptable level 
by these procedures and 
measures, the additive and 
premixtures shall be used 
with appropr iate personal 
prot ective equipment.  
4. The followi ng words shall 
be included in the labelling: 
—  For feed for ovines 
if the level of copper 
in the feed exceeds 
10 mg/kg: 
‘The level of copper in 
this feed may cause 
poisoning in certain 
breeds of sheep.’ 24.7.2018 L 186/17 Official Jour nal of the European Union EN     Identifica ­
tion 
number  
of the 
additive Name of 
the holder 
of author ­
isation Additive Compo sition, chemical formula, 
descr iption, analytical method Species or 
categor y 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  
conten t of 12 % 
—  For feed for bovines 
after the start of rumi ­
nation if the level of 
copper in the feed is 
less than 20 mg/kg: 
‘The level of copper in 
this feed may cause 
copper deficiencies in 
cattle grazing pastures 
with high cont ents of 
molybdenum or sul­
phur .’           
3b407 — Copper(II) 
chelate of 
prote in hy­
drolysate s Additiv e composition 
Copper(II) chelate of prote in hy­
drolysates as a powder with 
a minimum content of 10 % cop­
per and a minimum of 50 % cop­
per chelate d 
Char acter isation of the activ e sub­
stance 
Chemical formula: Cu(x)1–3 · 
nH2O, x = anion of any amino 
acid from soya protein hydroly ­
sate 
Analytical methods (1) 
For the quantifi cation of prot ein 
hydrolysat es content in the feed 
additive: 
—  ion exchang e chromatograph y 
combined with post-column 
ninhydr in derivatisation and 
photometr ic detection (Regu ­
lation (EC) No 152/2009, An­
nex III-F)  All animal 
species — — Bovines: 
—  Bovines before the 
start of rumination: 
15 (total); 
—Other bovines: 30 (to­
tal). 
Ovines: 15 (total). 
Capr ines: 35 (total) 
Piglets: 
—  suckling and weaned 
up to 4 weeks after 
weaning: 150 (total). 
—  from 5-th week after 
weaning up to 8 weeks 
after weaning: 100 
(total). 
Crustaceans: 50 (total). 
Other animals: 25 (total). 1.The additive shall be incor ­
porat ed into feed in the 
form of a premixture.  13 August 
2028 24.7.2018 L 186/18 Official Jour nal of the European Union EN     Identifica ­
tion 
number  
of the 
additive Name of 
the holder 
of author ­
isation Additive Compo sition, chemical formula, 
descr iption, analytical method Species or 
categor y 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  
conten t of 12 % 
For the qualitative verification of 
the chelation of the copper in the 
feed additive: 
—  Four ier Transf ormed Infrared 
(FTIR) spectroscop y followe d 
by multivar iate regression 
methods 
For the determination of total Cu 
in the feed additive and premix ­
tures: 
—  inductively coupled plasma 
atomic emission spectrometr y, 
ICP-AES (EN 15510 or 
CEN/TS 15621) 
For the determination of total Cu 
in feed mater ials and compo und 
feed: 
—atomic absor ption spectrome ­
try, AAS (Regulation (EC) 
No 152/2009, Annex IV-C) or 
—  inductively coupled plasma 
atomic emission spectrometr y, 
ICP-AES (EN 15510 or 
CEN/TS 15621)  2. For users of the additive 
and premixtures, feed busi ­
ness operat ors shall estab ­
lish operational procedures 
and appropr iate organisa ­
tional measures to address 
the poten tial risks by inha ­
lation, dermal contact or 
eyes contact, in particular 
due to the content of heavy 
metals including nick el. 
Where risks cannot be re­
duced to an acceptable level 
by these procedures and 
measures, the additive and 
premixtures shall be used 
with appropr iate personal 
prot ective equipment.  
3. The followi ng words shall 
be included in the labelling: 
—  For feed for ovines 
if the level of copper 
in the feed exceeds 
10 mg/kg: 
‘The level of copper in 
this feed may cause 
poisoning in certain 
breeds of sheep.’  24.7.2018 L 186/19 Official Jour nal of the European Union EN     Identifica ­
tion 
number  
of the 
additive Name of 
the holder 
of author ­
isation Additive Compo sition, chemical formula, 
descr iption, analytical method Species or 
categor y 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  
conten t of 12 % 
—  For feed for bovines 
after the start of rumi ­
nation if the level of 
copper in the feed is 
less than 20 mg/kg: 
‘The level of copper in 
this feed may cause 
copper deficiencies in 
cattle grazing pastures 
with high cont ents of 
molybdenum or sul­
phur .’           
3b413 — Copper(II) 
chelate of 
glycine hy­
drate (solid) Additiv e composition 
Copper(II) chelate of glycine, hy­
drate, as a powder with a mini ­
mum cont ent of 15 % copper and 
a maximum of 13 % moisture 
Char acter isation of the activ e sub­
stance 
Chemical formula: Cu(x)1-3 · 
nH2O, x = anion of glycine 
Analytical methods (1) 
For the quantification of the gly­
cine conte nt in the feed additive: 
—  ion exchang e chromatograph y 
combined with post-column 
ninhydr in derivatisation and 
photometr ic detection (Regu ­
lation (EC) No 152/2009, An­
nex III-F)  All animal 
species — — Bovines: 
—  Bovines before the 
start of rumination: 
15 (total); 
—Other bovines: 30 (to­
tal). 
Ovines: 15 (total). 
Capr ines: 35 (total) 
Piglets: 
—  suckling and weaned 
up to 4 weeks after 
weaning: 150 (total). 
—  from 5-th week after 
weaning up to 8 weeks 
after weaning: 100 
(total). 
Crustaceans: 50 (total). 
Other animals: 25 (total). 1.The additive shall be incor ­
porat ed into feed in the 
form of a premixture.  13 August 
2028 24.7.2018 L 186/20 Official Jour nal of the European Union EN     Identifica ­
tion 
number  
of the 
additive Name of 
the holder 
of author ­
isation Additive Compo sition, chemical formula, 
descr iption, analytical method Species or 
categor y 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  
conten t of 12 % 
For the determination of total Cu 
in the feed additive and premix ­
tures: 
—  inductively coupled plasma 
atomic emission spectrometr y, 
ICP-AES (EN 15510 or 
CEN/TS 15621) 
For the determination of total Cu 
in feed mater ials and compo und 
feed: 
—atomic absor ption spectrome ­
try, AAS (Regulation (EC) 
No 152/2009, Annex IV-C) or 
—  inductively coupled plasma 
atomic emission spectrometr y, 
ICP-AES (EN 15510 or 
CEN/TS 15621)  2. For users of the additive 
and premixtures, feed busi ­
ness operat ors shall estab ­
lish operational procedures 
and appropr iate organisa ­
tional measures to address 
the poten tial risks by inha ­
lation, dermal contact or 
eyes contact, in particular 
due to the content of heavy 
metals including nick el. 
Where risks cannot be re­
duced to an acceptable level 
by these procedures and 
measures, the additive and 
premixtures shall be used 
with appropr iate personal 
prot ective equipment.  
3. The followi ng words shall 
be included in the labelling: 
—  For feed for ovines 
if the level of copper 
in the feed exceeds 
10 mg/kg: 
‘The level of copper in 
this feed may cause 
poisoning in certain 
breeds of sheep.’  24.7.2018 L 186/21 Official Jour nal of the European Union EN     Identifica ­
tion 
number  
of the 
additive Name of 
the holder 
of author ­
isation Additive Compo sition, chemical formula, 
descr iption, analytical method Species or 
categor y 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  
conten t of 12 % 
—  For feed for bovines 
after the start of rumi ­
nation if the level of 
copper in the feed is 
less than 20 mg/kg: 
‘The level of copper in 
this feed may cause 
copper deficiencies in 
cattle grazing pastures 
with high cont ents of 
molybdenum or sul­
phur .’           
3b414 — Copper(II) 
chelate of 
glycine hy­
drate (liquid) Additiv e composition 
Copper(II) chelate of glycine, hy­
drate, as a liquid with a minimum 
content of 6 % copper 
Char acter isation of the activ e sub­
stance 
Chemical formula: Cu(x)1-3 · 
nH2O, x = anion of glycine 
Analytical methods (1) 
For the quantification of the gly­
cine conte nt in the feed additive: 
—  ion exchang e chromatograph y 
combined with post-column 
ninhydr in derivatisation and 
photometr ic detection (Regu ­
lation (EC) No 152/2009, An­
nex III-F)     Bovines: 
—  Bovines before the 
start of rumination: 
15 (total); 
—Other bovines: 30 (to­
tal). 
Ovines: 15 (total). 
Capr ines: 35 (total) 
Piglets: 
—  suckling and weaned 
up to 4 weeks after 
weaning: 150 (total). 
—  from 5-th week after 
weaning up to 8 weeks 
after weaning: 100 
(total). 
Crustaceans: 50 (total). 
Other animals: 25 (total).  1. Copper(II) chelate of glycine 
hydrate (liquid) may be 
placed on the mark et and 
used as an additive consist ­
ing of a preparation. 
2.The additive shall be incor ­
porat ed into feed in the 
form of a premixture.  13 August 
2028 24.7.2018 L 186/22 Official Jour nal of the European Union EN     Identifica ­
tion 
number  
of the 
additive Name of 
the holder 
of author ­
isation Additive Compo sition, chemical formula, 
descr iption, analytical method Species or 
categor y 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  
conten t of 12 % 
For the determination of total Cu 
in the feed additive and premix ­
tures: 
—  inductively coupled plasma 
atomic emission spectrometr y, 
ICP-AES (EN 15510 or 
CEN/TS 15621) 
For the determination of total Cu 
in feed mater ials and compo und 
feed: 
—atomic absor ption spectrome ­
try, AAS (Regulation (EC) 
No 152/2009, Annex IV-C) or 
—  inductively coupled plasma 
atomic emission spectrometr y, 
ICP-AES (EN 15510 or 
CEN/TS 15621)  3. For users of the additive 
and premixtures, feed busi ­
ness operat ors shall estab ­
lish operational procedures 
and appropr iate organisa ­
tional measures to address 
the poten tial risks by inha ­
lation, dermal contact or 
eyes contact, in particular 
due to the content of heavy 
metals including nick el. 
Where risks cannot be re­
duced to an acceptable level 
by these procedures and 
measures, the additive and 
premixtures shall be used 
with appropr iate personal 
prot ective equipment.  
4. The followi ng words shall 
be included in the labelling: 
—  For feed for ovines 
if the level of copper 
in the feed exceeds 
10 mg/kg: 
‘The level of copper in 
this feed may cause 
poisoning in certain 
breeds of sheep.’  24.7.2018 L 186/23 Official Jour nal of the European Union EN     Identifica ­
tion 
number  
of the 
additive Name of 
the holder 
of author ­
isation Additive Compo sition, chemical formula, 
descr iption, analytical method Species or 
categor y 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  
conten t of 12 % 
—  For feed for bovines 
after the start of rumi ­
nation if the level of 
copper in the feed is 
less than 20 mg/kg: 
‘The level of copper in 
this feed may cause 
copper deficiencies in 
cattle grazing pastures 
with high cont ents of 
molybdenum or sul­
phur .’ 
(1)  Details of the analytical methods are available at the following address of the Reference Laborato ry: https://ec.europa.eu/jrc/en/eurl/feed-addi tives/evaluation-repor ts 
(2)  Commission Regulation (EC) No 152/2009 of 27 Januar y 2009 laying down the methods of samplin g and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1).   24.7.2018 L 186/24 Official Jour nal of the European Union EN