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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)

Implementing Regulation (EU) 2022/1445 · Regulation · 3 articles

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 1

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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.

Article 2

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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

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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

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