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

3b401 — Copper(II) diacetate monohydrate Additive composition Copper(II) diacetate monohydrate as a powder with a minimum content of 31 % copper Characterisation of the active substance Chemical formula: Cu(CH3COO)2 · H2O CAS Number: 6046-93-1 Analytical methods (1) For the identification of Copper(II) diacetate monohydrate in the feed additive: — European Pharmacopoeia Monographs 2146 and 20301 For the crystallographic characterisation 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 spectrometry, ICP-AES (EN 15510 or CEN/TS 15621) Determination of total Cu content in feed materials and compound feed: — atomic absorption spectrometry, AAS (Commission Regulation (EC) No 152/2009 (2), Annex IV-C) or — inductively coupled plasma atomic emission, ICP-AES (EN 15510 or CEN/TS 15621) All animal species — — Bovines: — 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. 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 including nickel. 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. 3. 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.’ 13 August 2028

3b402 — Copper(II) carbonate dihydroxy monohydrate Additive composition Copper(II) carbonate dihydroxy monohydrate as a powder with a minimum content of 52 % copper Characterisation of the active substance Chemical formula: CuCO3 · Cu(OH)2 · H2O CAS Number: 100742-53-8 Analytical methods (1) For the identification of carbonate in the feed additive: — European Pharmacopoeia Monograph 20301 For the determination of total Cu in the feed additive and premixtures: — inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or CEN/TS 15621) For the determination of total Cu in feed materials and compound feed: — atomic absorption spectrometry, AAS (Regulation (EC) No 152/2009, Annex IV-C) or — inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or CEN/TS 15621) All animal species — — Bovines: — 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. 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 including nickel. 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. 3. 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.’ 13 August 2028

3b403 — Copper(II) chloride dihydrate Additive composition Copper(II) chloride dihydrate as a powder with a minimum content of 36 % copper Characterisation of the active substance Chemical formula: CuCl2 · 2H2O CAS Number: 10125-13-0 Analytical methods (1) For the identification of chloride in the feed additive: — European Pharmacopoeia Monograph 20301 For the crystallographic characterisation of the feed additive: — X-Ray diffraction For the determination of total Cu in the feed additive and premixtures: — inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or CEN/TS 15621) For the determination of total Cu in feed materials and compound feed: — atomic absorption spectrometry, AAS (Regulation (EC) No 152/2009, Annex IV-C) or — inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or CEN/TS 15621) All animal species — — Bovines: — 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. 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 including nickel. 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. 3. 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.’ 13 August 2028

3b404 — Copper(II) oxide Additive composition Copper(II) oxide as a powder with a minimum content of 77 % copper Characterisation of the active substance Chemical formula: CuO CAS Number: 1317-38-0 Analytical methods (1) For the crystallographic characterisation of the feed additive: — X-Ray diffraction For the determination of total Cu in the feed additive and premixtures: — inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or CEN/TS 15621) For the determination of total Cu in feed materials and compound feed: — atomic absorption spectrometry, AAS (Regulation (EC) No 152/2009, Annex IV-C) or — inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or CEN/TS 15621) All animal species — — Bovines: — 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. 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 including nickel. 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. 3. 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.’ 13 August 2028

3b405 — Copper(II) sulphate pentahydrate Additive composition Copper(II) sulphate pentahydrate as a powder with a minimum content of 24 % copper Characterisation of the active substance Chemical formula: CuSO4 · 5H2O CAS Number: 7758-99-8 Analytical methods (1) For the identification of Copper(II) sulphate pentahydrate in the feed additive: — European Pharmacopoeia Monographs 0894 and 20301 For the crystallographic characterisation of the feed additive: — X-Ray diffraction For the determination of total Cu in the feed additive and premixtures: — inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or CEN/TS 15621) For the determination of total Cu in feed materials and compound feed: — atomic absorption spectrometry, AAS (Regulation (EC) No 152/2009, Annex IV-C) or — inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or CEN/TS 15621) All animal species — — Bovines: — 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. Copper(II) sulphate pentahydrate may be placed on the market and used as an additive consisting of a preparation. 2. The additive shall be incorporated into feed in the form of a premixture. 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 including nickel. 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. 4. 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.’ 13 August 2028

3b406 — Copper(II) chelate of amino acids hydrate Additive composition 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 Characterisation of the active substance Chemical formula: Cu(x)1–3 · nH2O, x = anion of any amino acid from soya protein hydrolysate. Maximum of 10 % of the molecules exceeding 1 500 Da Analytical methods (1) For the quantification of the amino acid content in the feed additive: — ion exchange chromatography combined with post-column ninhydrin derivatisation and photometric detection (Regulation (EC) No 152/2009, Annex III-F) For the determination of total Cu in the feed additive and premixtures: — inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or CEN/TS 15621) For the determination of total Cu in feed materials and compound feed: — atomic absorption spectrometry, AAS (Regulation (EC) No 152/2009, Annex IV-C) or — inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or CEN/TS 15621) All animal species — Bovines: — 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. Copper(II) chelate of amino acids hydrate may be placed on the market and used as an additive consisting of a preparation. 2. The additive shall be incorporated into feed in the form of a premixture. 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 including nickel. 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. 4. 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.’ 13 August 2028

3b407 — Copper(II) chelate of protein hydrolysates Additive composition Copper(II) chelate of protein hydrolysates as a powder with a minimum content of 10 % copper and a minimum of 50 % copper chelated Characterisation of the active substance Chemical formula: Cu(x)1–3 · nH2O, x = anion of any amino acid from soya protein hydrolysate Analytical methods (1) For the quantification of protein hydrolysates content in the feed additive: — ion exchange chromatography combined with post-column ninhydrin derivatisation and photometric detection (Regulation (EC) No 152/2009, Annex III-F) For the qualitative verification of the chelation of the copper in the feed additive: — Fourier Transformed Infrared (FTIR) spectroscopy followed by multivariate regression methods For the determination of total Cu in the feed additive and premixtures: — inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or CEN/TS 15621) For the determination of total Cu in feed materials and compound feed: — atomic absorption spectrometry, AAS (Regulation (EC) No 152/2009, Annex IV-C) or — inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or CEN/TS 15621) All animal species — — Bovines: — 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. 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 including nickel. 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. 3. 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.’ 13 August 2028

3b413 — Copper(II) chelate of glycine hydrate (solid) Additive composition Copper(II) chelate of glycine, hydrate, as a powder with a minimum content of 15 % copper and a maximum of 13 % moisture Characterisation of the active substance Chemical formula: Cu(x)1-3 · nH2O, x = anion of glycine Analytical methods (1) For the quantification of the glycine content in the feed additive: — ion exchange chromatography combined with post-column ninhydrin derivatisation and photometric detection (Regulation (EC) No 152/2009, Annex III-F) For the determination of total Cu in the feed additive and premixtures: — inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or CEN/TS 15621) For the determination of total Cu in feed materials and compound feed: — atomic absorption spectrometry, AAS (Regulation (EC) No 152/2009, Annex IV-C) or — inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or CEN/TS 15621) All animal species — — Bovines: — 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. 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 including nickel. 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. 3. 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.’ 13 August 2028