Category of nutritional additives. Functional group: compounds of trace elements| 3b401 | — | Copper(II) diacetate monohydrate | Additive compositionCopper(II) diacetate monohydrate as a powder with a minimum content of 31 % copperCharacterisation of the active substanceChemical formula: Cu(CH3COO)2 · H2OCAS Number: 6046-93-1Analytical methodsFor 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, 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 compositionCopper(II) carbonate dihydroxy monohydrate as a powder with a minimum content of 52 % copperCharacterisation of the active substanceChemical formula: CuCO3 · Cu(OH)2 · H2OCAS Number: 100742-53-8Analytical methodsFor 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 compositionCopper(II) chloride dihydrate as a powder with a minimum content of 36 % copperCharacterisation of the active substanceChemical formula: CuCl2 · 2H2OCAS Number: 10125-13-0Analytical methodsFor 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 compositionCopper(II) oxide as a powder with a minimum content of 77 % copperCharacterisation of the active substanceChemical formula: CuOCAS Number: 1317-38-0Analytical methodsFor 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 compositionCopper(II) sulphate pentahydrate as a powder with a minimum content of 24 % copperCharacterisation of the active substanceChemical formula: CuSO4 · 5H2OCAS Number: 7758-99-8Analytical methodsFor 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 compositionPreparation 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 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.
| 13 August 2028 |
| Characterisation of the active substanceChemical formula: Cu(x) 1–3 · nH2O, x = anion of any amino acid from soya protein hydrolysate.Maximum 10 % of molecules exceeding 1500 Da. |
Analytical methodsFor 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, AASFor 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 compositionPreparation 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 substanceChemical formula: Cu(x)1-3•nH2O, where x is equal to any amino acid coming from hydrolysed protein sources from feathers or plants;Maximum 10 % of molecules exceeding 1500 Da. |
Analytical methodsFor 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)
|
| 3b407 | — | Copper(II) chelate of protein hydrolysates | Additive compositionCopper(II) chelate of protein hydrolysates as a powder with a minimum content of 10 % copper and a minimum of 50 % copper chelatedCharacterisation of the active substanceChemical formula: Cu(x)1–3 · nH2O, x = anion of any amino acid from soya protein hydrolysateAnalytical methodsFor 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 compositionCopper(II) chelate of glycine, hydrate, as a powder with a minimum content of 15 % copper and a maximum of 13 % moistureCharacterisation of the active substanceChemical formula: Cu(x)1-3 · nH2O, x = anion of glycineAnalytical methodsFor 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 |
| 3b414 | — | Copper(II) chelate of glycine hydrate (liquid) | Additive compositionCopper(II) chelate of glycine, hydrate, as a liquid with a minimum content of 6 % copperCharacterisation of the active substanceChemical formula: Cu(x)1-3 · nH2O, x = anion of glycineAnalytical methodsFor 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)
| | | | 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 glycine hydrate (liquid) 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 |