COMMISSION IMPLEMENTING REGUL ATION (EU) 2023/1334 
of 29 June 2023
concer ning the renewal of the author isation of copper chelate of hydro xy analogue of methionine as 
a feed additiv e for all animal species and repealing Regulation (EU) No 349/2010 
(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 and renewing such author isation.
(2) The preparation of copper chelat e of hydro xy analogue of methionine was author ised for a period of 10 years as a 
feed additive for all animal species by Commission Regulation (EU) No 349/2010 (2).
(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of 
the author isation of copper chelat e of hydro xy analogue of methionine as a feed additive for all animal species, 
requesting the additive to be classifie d in the additive catego ry ‘nutr itional additives’ and in the functional group 
‘compounds of trace elements’. The application included a proposal for amending the conditions of the current 
author isation, consisting of the removal of the mineral oil from the additive, which is theref ore to be considered as 
a substance and no long er a preparation. In addition, the minimum content of copper in the additive has been 
slightly modif ied. That application was accompan ied by the particulars and documents required under Article 14(2) 
of that Regulation.
(4) The European Food Safety Author ity (‘the Author ity’) concluded in its opinion of 5 May 2021 (3)that the applicant 
has provided evidence that the additive, in its new composition, remains safe for all animal species, the consumers 
and the environment under the conditions of use currently author ised. It also concluded that the additive is 
considered as a skin and eye irritant and a skin sensitiser , while the risk of respirato ry sensitisation is considered 
low. The Author ity state d that the proposed modifi cation of the conditions of the original author isation does not 
have an impa ct on the efficacy of the additive. Finally , it did not consider that there is a need for specifi c 
requirements of post-market monitori ng.
(5) In accordance with Article 5(4), point (c), of Commission Regulation (EC) No 378/2005 (4), the Reference 
Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations 
reach ed in the previous assessment are valid and applicable for the current application.
(1)OJ L 268, 18.10.2003, p. 29.
(2)Commission Regulation (EU) No 349/2010 of 23 Apr il 2010 concer ning the author isation of copper chelate of hydro xy analogue of 
methionine as a feed additive for all animal species (OJ L 104, 24.4.2010, p. 31).
(3)EFSA Journal 2021;19(5):6618.
(4)Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implement ation of Regulation (EC) 
No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference 
Laborato ry concer ning applications for author isations of feed additives (OJ L 59, 5.3.2005, p. 8).EN Offi cial Jour nal of the European Union 30.6.2023 L 166/111  (6) The assessment of copper chelate of hydroxy analogue of methionine 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 author isation of that 
additive should be renewed. In addition, the Commission considers that appropr iate prot ective measures should be 
taken to prevent adverse effects on the health of the users of the additive.
(7) As a consequence of the renewal of the author isation of copper chelate of hydro xy analogue of methionine as a feed 
additive, Regulation (EU) No 349/2010 should be repealed.
(8) Since safet y reasons do not require the immediate application of the modifications to the conditions of author isation 
of copper chelate of hydroxy analogue of methionine, it is appropr iate to provid e for a transitional period for 
inter ested parties to prepare themselves to meet the new requirements resulting from the renewal of the 
author isation, with regard to the compo sition of the additive, which now consists of a substance, and the derived 
modifi cation of the identif ication number of the additive.
(9) 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
Renewal of the author isation
The author isation of the substance specified in the Annex, belonging to the additive cate gory ‘nutr itional additives’ and to 
the functional group ‘compounds of trace elements’, is renewed subject to the conditions laid down in that Annex.
Article 2
Repeal
Regulation (EU) No 349/2010 is repealed.
Article 3
Transitional measures
1. The additive specifi ed in the Annex and premixtures containing that additive, which are produced and labelled before 
20 Januar y 2024 in accordance with the rules applicable before 20 July 2023 may continue to be placed on the mark et and 
used until the existing stoc ks are exhaust ed.
2. Com pound feed and feed mate rials containing the additive specified in the Annex, whic h are produced and labelled 
before 20 July 2024 in accordance with the rules applicable before 20 July 2023 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. Com pound feed and feed mate rials containing the additive specified in the Annex, whic h are produced and labelled 
before 20 July 2025 in accordance with the rules applicable before 20 July 2023 may continue to be placed on the mark et 
and used until the existing stoc ks are exhausted if they are intende d for non-f ood producing animals.
Article 4
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.EN Offi cial Jour nal of the European Union L 166/112 30.6.2023  This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 June 2023 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 30.6.2023 L 166/113  ANNEX 
Identifica -
tion 
number of 
the 
additiveAdditiveCompo sition, chemical formula, 
descr iption, analytical methodSpecies or 
category of 
animalMaximum 
ageMinimum 
contentMaximum conten t
Other provi sionsEnd of period 
of 
author isation Content of the element (Cu) in mg/kg of 
compl ete feed with a moisture content of 12 %
Categor y of nutr itional additiv es. Functional group: compounds of trace elements
3b410i Copper chelat e 
of hydro xy 
analogue of 
methionineAdditive composition
Copper chelate of hydro xy analogue of 
methionine containing a minimum of 
16 % copper and a minimum of 78 % 
(2-h ydro xy-4-methylthio) butanoic 
acid
Maximum content of nick el: 20 ppm.
Solid formAll animal 
species- - Bovines:
— Bovines before the start of 
rumination: 15 (total);
— Other bovines: 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 wean ­
ing up to 8 weeks after 
weaning: 100 (total).
Crustaceans: 50 (total).
Other animals: 25 (total).1.The additive shall be incor porated 
into feed in the form of a premix ­
ture.
2.For users of the additive and pre­
mixtures, feed business operators 
shall establish operational proce ­
dures and organisational measures 
to address potential risks resulting 
from their use. Where those risks 
cannot be eliminate d by such pro­
cedures and measures, the additive 
and premixtures shall be used with 
personal breathing, eye and skin 
protective equipment.
3.The follo wing words shall be in­
cluded in the labelling:
— for feed for sheep if the level of 
copper in the feed exceed s 
10 mg/kg: ‘The level of copper 
in this feed may cause poison ­
ing in certain breeds of sheep.’
— of feed for bovin es 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 copper 
deficiencies in cattle grazing 
pastures with high cont ents of 
molybdenum or sulphur .’20 July 2033
Char acter isation of the activ e substances
Chemical formula: copper bis 
(-2-h ydro xy-4-methylthio)butanoat e:
Cu(CH 3S(CH 2)2-CH(OH)-COO) 2
CAS: 292140-30-8
Analytical methods (1)
For the quantifi cation of the hydroxy 
analogue of methionine cont ent in the 
feed additive: titrimetr y, 
pote ntiometr ic titration after 
oxidation reduction reaction.
For the quantifi cation of total copper 
in the feed additive:
— Inductively coupled plasma atomi c 
emission spectrometr y, ICP-AES 
(EN 15510 or EN 15621) orEN Offi cial Jour nal of the European Union L 166/114 30.6.2023  — Atomic absor ption spectrometr y, 
AAS (ISO 6869)
For the quantifi cation of total copper 
in premixtures:
— Inductively coupled plasma atomi c 
emission spectrometr y, ICP-AES 
(EN 15510 or EN 15621) or
— Atomic absor ption spectrometr y, 
AAS (ISO 6869) or
— Inductively coupled plasma mass 
spectrometr y, ICP-MS (EN 17053).
For the quantifi cation of total copper 
in compo und feed:
— Inductively coupled plasma atomi c 
emission spectrometr y, ICP-AES 
(EN 15510 or EN 15621) or
— Atomic absor ption spectrometr 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 tsEN Offi cial Jour nal of the European Union 30.6.2023 L 166/115