Article 1
In the Annex to Implementing Regulation (EU) 2018/1039, the entry of copper (II) chelate of amino acids hydrate is amended in accordance with the Annex to this Regulation.
Commission Implementing Regulation (EU) 2022/1445 of 31 August 2022 amending Implementing Regulation (EU) 2018/1039 as regards the terms of authorisation of copper (II) chelate of amino acids hydrate as a feed additive for all animal species (Text with EEA relevance)
Commission Implementing Regulation (EU) 2022/1445 of 31 August 2022 amending Implementing Regulation (EU) 2018/1039 as regards the terms of authorisation of copper (II) chelate of amino acids hydrate as a feed additive for all animal species (Text with EEA relevance)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Supplementary provisions
ANNEXSupplementary provisions
ANNEX Identification number of the additive Name of the holder of authorisation Additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation Content of element (Cu) in mg/kg of complete feed with a moisture content of 12 % Category of nutritional additives. Functional group: compounds of trace elements ‘3b406 - Copper (II) chelate of amino acids hydrate Additive composition Preparation of copper(II) amino acid complex where the copper and the amino acids derived from soya protein are chelated via coordinate covalent bonds, as a powder with a minimum content of 10 % copper All animal species - - Bovines before the start of rumination: 15 (total); Other bovines: 30 (total). Ovines: 15 (total). Caprines: 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 incorporated into feed in the form of a premixture. 2. The following 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 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 contents of molybdenum or sulphur.’ 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks by inhalation, dermal contact or eyes contact, in particular due to the content of heavy metals. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment. 13 August 2028 Characterisation of the active substance Chemical formula: Cu(x) 1–3 · nH 2 O, x = anion of any amino acid from soya protein hydrolysate. Maximum 10 % of molecules exceeding 1 500 Da. Analytical methods ( 1 ) For the quantification of amino acid content in the feed additive: — ion exchange chromatography with post-column derivatisation and optical detection (IEC-VIS/FLD) For the quantification of total copper in the feed additive: — inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or — atomic absorption spectrometry, AAS (ISO 6869) atomic absorption spectrometry, AAS For the quantification of total copper in premixtures: — inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or — atomic absorption spectrometry, AAS (ISO 6869) or — inductively coupled plasma-mass spectrometry, ICP-MS (EN 17053) For the quantification of total copper in feed materials and compound feed: — inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or — atomic absorption spectrometry, AAS (Commission Regulation (EC) No 152/2009 (Annex IV-C) or ISO 6869) or — inductively coupled plasma-mass spectrometry, ICP-MS (EN 17053) 3b406i - Copper (II) chelate of amino acids hydrate Additive composition Preparation of copper (II) amino acid complex, where the copper and the amino acids are chelated via coordinate covalent bonds, as a powder with a content of 10-11 % copper and a minimum of 18 % free amino acids. All animal species - - Bovines before the start of rumination: 15 (total); Other bovines: 30 (total). Ovines: 15 (total). Caprines: 35 (total) Piglets: suckling and weaned up to 4 weeks after weaning: 150 (total). from 5th week after weaning up to 8 weeks after weaning: 100 (total). Crustaceans: 50 (total). Other animals: 25 (total). 1. The additive shall be incorporated into feed in the form of a premixture. 2. The following 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 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 contents of molybdenum or sulphur.’ 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks by inhalation, dermal contact or eyes contact, in particular due to the content of heavy metals. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment including skin, eye and breathing protection. 4. For additives produced from hydrolysis of animal protein, the animal origin ( avian species ) shall be indicated on the label of the additive and premixtures.’ 13 August 2028’ Characterisation of the active substance Chemical formula: Cu(x) 1-3 •nH 2 O, where x is equal to any amino acid coming from hydrolysed protein sources from feathers or plants; Maximum 10 % of molecules exceeding 1 500 Da. Analytical methods ( 1 ) For the quantification of amino acid content in the feed additive: — ion exchange chromatography with post-column derivatisation and optical detection (IEC-VIS/FLD), Commission Regulation 152/2009 (Annex III,F) and EN ISO 17180 For the quantification of total copper in the feed additive: — inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or — atomic absorption spectrometry, AAS (ISO 6869) For the quantification of total copper in premixtures: — inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or — atomic absorption spectrometry, AAS (ISO 6869) or — inductively coupled plasma-mass spectrometry, ICP-MS (EN 17053) For the quantification of total copper in feed materials and compound feed: — inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or — atomic absorption spectrometry, AAS (Commission Regulation (EC) No 152/2009 (Annex IV-C) or ISO 6869) or — inductively coupled plasma-mass spectrometry, ICP-MS (EN 17053) ( 1 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
Other acts of the same type
Commission Implementing Regulation (EU) 2019/1880 of 4 November 2019 conferring protection under Article 99 of Regulation (EU) No 1308/2013 of the European Parliament and of the Council on the name Vera de Estenas (PDO)Commission Implementing Regulation (EU) 2019/1841 of 31 October 2019 entering a name in the register of protected designations of origin and protected geographical indications Vlees van het rood ras van West-Vlaanderen (PDO)Commission Implementing Regulation (EU) 2019/1842 of 31 October 2019 laying down rules for the application of Directive 2003/87/EC of the European Parliament and of the Council as regards further arrangements for the adjustments to free allocation of emission allowances due to activity level changesCommission Implementing Regulation (EU) 2019/1856 of 31 October 2019 approving amendments to the specification for a Protected Designation of Origin or a Protected Geographical Indication (Izsáki Arany Sárfehér (PDO))Commission Delegated Regulation (EU) 2020/22 of 31 October 2019 amending Annexes I and III to Regulation (EU) 2019/631 of the European Parliament and of the Council as regards the monitoring of CO2 emissions from new light commercial vehicles type-approved in a multi-stage process (Text with EEA relevance)Commission Delegated Regulation (EU) 2019/1827 of 30 October 2019 amending Directive 2014/23/EU of the European Parliament and of the Council in respect of the threshold for concessions (Text with EEA relevance)Commission Delegated Regulation (EU) 2019/1828 of 30 October 2019 amending Directive 2014/24/EU of the European Parliament and of the Council in respect of the thresholds for public supply, service and works contracts, and design contests (Text with EEA relevance)Commission Delegated Regulation (EU) 2019/1829 of 30 October 2019 amending Directive 2014/25/EU of the European Parliament and of the Council in respect of the thresholds for supply, service and works contracts, and design contests (Text with EEA relevance)Commission Delegated Regulation (EU) 2019/1830 of 30 October 2019 amending Directive 2009/81/EC of the European Parliament and of the Council in respect of the thresholds for supply, service and works contracts (Text with EEA relevance)Commission Implementing Regulation (EU) 2019/1852 of 30 October 2019 approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications Gall del Penedès (PGI)Commission Delegated Regulation (EU) 2020/11 of 29 October 2019 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures as regards information relating to emergency health response (Text with EEA relevance)Commission Implementing Regulation (EU) 2020/1225 of 29 October 2019 laying down implementing technical standards with regard to the format and standardised templates for making available the information and details of a securitisation by the originator, sponsor and SSPE (Text with EEA relevance)
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
What to look at next
Browse all EU Legal ActsEvery instrument by type and year, full text free to read section by sectionEuropean Union legislationEU Legal Acts by type and yearGrouped by instrument type and year of enactment, so you can find others of the same kindBrowse by type and yearEuropean Union: what this database coversWhich datasets are here, which official source they come from, and how current they areEuropean Union overview