Contents
Article 1Authorisation#
The substances specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.
Article 2Amendment to Regulation (EC) No 1334/2003#
In the Annex to Regulation (EC) No 1334/2003, from the entry E6 on the element Zinc-Zn the following additives: ‘Zinc acetate dihydrate’, ‘Zinc oxide’, ‘Zinc sulphate heptahydrate’, ‘Zinc sulphate monohydrate’, ‘Zinc chelate of amino acids hydrate’, and their chemical formulas and descriptions are deleted.
Article 3Amendment to Regulation (EC) No 479/2006#
In the Annex to Regulation (EC) No 479/2006, the entry E6 on the additive ‘Zinc chelate of glycine hydrate’ is deleted.
Article 4Amendment to Regulation (EU) No 335/2010#
In the Annex to Regulation (EU) No 335/2010, in the line 3b6.10 the eighth column is replaced by the following:‘Dogs and cats: 200 (total)Salmonids and milk replacers for calves: 180 (total)Piglets, sows, rabbits and all fish species other than salmonids: 150 (total)Other species and categories: 120 (total)’.
Article 5Amendment to Implementing Regulation (EU) No 991/2012#
In the Annex to Implementing Regulation (EU) No 991/2012, in the line 3b609 the eighth column is replaced by the following:‘Dogs and cats: 200 (total)Salmonids and milk replacers for calves: 180 (total)Piglets, sows, rabbits and all fish species other than salmonids: 150 (total)Other species and categories: 120 (total)’.
Article 6Amendment to Implementing Regulation (EU) No 636/2013#
In the Annex to Commission Implementing Regulation (EU) No 636/2013, in the line 3b611 the eighth column is replaced by the following:‘Dogs and cats: 200 (total)Salmonids and milk replacers for calves: 180 (total)Piglets, sows, rabbits and all fish species other than salmonids: 150 (total)Other species and categories: 120 (total)’.
Article 7Transitional measures#
1.Zinc acetate dihydrate, Zinc oxide, Zinc sulphate heptahydrate, Zinc sulphate monohydrate, Zinc chelate of amino acids hydrate and Zinc chelate of glycine hydrate and the zinc compounds authorised by Regulation (EU) No 335/2010 and Implementing Regulations (EU) No 991/2012 and (EU) No 636/2013 and premixtures containing them, which are produced and labelled before 27 January 2017 in accordance with the rules applicable before 27 July 2016 may continue to be placed on the market and used until the existing stocks are exhausted.
2.Feed materials and compound feed containing the substances referred to in paragraph 1 which are produced and labelled before 27 July 2017 in accordance with the rules applicable before 27 July 2016 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food producing animals.
3.Feed materials and compound feed containing the substances referred to in paragraph 1 which are produced and labelled before 27 July 2018 in accordance with the rules applicable before 27 July 2016 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food producing animals.
Article 8Entry into force#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
| 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 (Zn) in mg/kg of complete feed with a moisture content of 12 % | |||||||||
| 3b601 | — | Zinc acetate dihydrate | Additive compositionZinc acetate dihydrate, as a powder with a minimum content of 29,6 % zinc.Characterisation of the active substanceChemical formula: Zn(CH3COO)2 · 2H2OCAS Number: 5970-45-6Analytical methodsnoteFor the quantification of the zinc acetate dihydrate in the feed additive:titration with sodium edetate (European Pharmacopoeia Monograph 1482).For the quantification of total zinc in the feed additive and premixtures:EN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES), orEN 15621: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES) after pressure digestion.For the quantification of total zinc in feed materials and compound feed:Commission Regulation (EC) No 152/2009 — Atomic Absorption Spectrometry (AAS); orEN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES); orEN 15621: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES) after pressure digestion. | All animal species | — | — | Dogs and cats: 200 (total)Salmonids and milk replacers for calves: 180 (total)Piglets, sows, rabbits and all fish other than salmonids: 150 (total)Other species and categories: 120 (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. 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. | 27 July 2026 |
| 3b602 | — | Zinc chloride anhydrous | Additive compositionZinc chloride anhydrous, as a powder with a minimum content of 46,1 % zinc.Characterisation of the active substanceChemical formula: ZnCl2CAS Number: 7646-85-7Analytical methodsnoteFor the quantification of the zinc chloride anhydrous in the feed additive:titration with sodium edetate (European Pharmacopoeia Monograph 0110).For the quantification of total zinc in the feed additive and premixtures:EN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES), orEN 15621: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES) after pressure digestion;ICP-AES CEN method (EN ISO 11885); not for premixtures.For the quantification of total zinc in feed materials and compound feed:Regulation (EC) No 152/2009 — Atomic Absorption Spectrometry (AAS); orEN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES); orEN 15621: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES) after pressure digestion. | All animal species | — | — | Dogs and cats: 200 (total)Salmonids and milk replacers for calves: 180 (total)Piglets, sows, rabbits and all fish other than salmonids: 150 (total)Other species and categories: 120 (total) | 1. The additive shall be incorporated into feed in the form of a liquid 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. 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. | 27 July 2026 |
| 3b603 | — | Zinc oxide | Additive compositionZinc oxide, as a powder with a minimum content of 72 % zincCharacterisation of the active substanceChemical formula: ZnOCAS Number: 1314-13-2Analytical methodsnoteFor the quantification of the zinc oxide in the feed additive:titration with sodium edetate (European Pharmacopoeia Monograph 0252).For the quantification of total zinc in the feed additive and premixtures:EN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES), orEN 15621: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES) after pressure digestion.For the quantification of total zinc in feed materials and compound feed:Regulation (EC) No 152/2009 — Atomic Absorption Spectrometry (AAS); orEN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES); orEN 15621: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES) after pressure digestion. | All animal species | — | — | Dogs and cats: 200 (total)Salmonids and milk replacers for calves: 180 (total)Piglets, sows, rabbits and all fish other than salmonids: 150 (total)Other species and categories: 120 (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. 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. | 27 July 2026 |
| 3b604 | — | Zinc sulphate heptahydrate | Additive compositionZinc sulphate heptahydrate, as a powder with a minimum content of 22 % zinc.Characterisation of the active substanceChemical formula: ZnSO4 · 7H2OCAS Number: 7446-20-0Analytical methodsnoteFor the quantification of the zinc sulphate heptahydrate in the feed additive:titration with sodium edetate (European Pharmacopoeia Monograph 0111).For the quantification of total zinc in the feed additive and premixtures:EN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES), orEN 15621: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES) after pressure digestion.For the quantification of total zinc in feed materials and compound feed:Regulation (EC) No 152/2009 — Atomic Absorption Spectrometry (AAS); orEN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES); orEN 15621: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES) after pressure digestion. | All animal species | — | — | Dogs and cats: 200 (total)Salmonids and milk replacers for calves: 180 (total)Piglets, sows, rabbits and all fish other than salmonids: 150 (total)Other species and categories: 120 (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. 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. | 27 July 2026 |
| 3b605 | — | Zinc sulphate monohydrate | Additive compositionZinc sulphate monohydrate, as a powder with a minimum content of 34 % zinc.Characterisation of the active substanceChemical formula: ZnSO4 · H2OCAS Number: 7446-19-7Analytical methodsnoteFor the quantification of the zinc sulphate monohydrate in the feed additive:titration with sodium edetate (European Pharmacopoeia Monograph 2159).For the quantification of total zinc in the feed additive and premixtures:EN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES), orEN 15621: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES) after pressure digestion.For the quantification of total zinc in feed materials and compound feed:Regulation (EC) No 152/2009 — Atomic Absorption Spectrometry (AAS); orEN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES); orEN 15621: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES) after pressure digestion. | All animal species | — | — | Dogs and cats: 200 (total)Salmonids and milk replacers for calves: 180 (total)Piglets, sows, rabbits and all fish other than salmonids: 150 (total)Other species and categories: 120 (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. 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. | 27 July 2026 |
| 3b606 | — | Zinc chelate of amino acids hydrate | Characterisation of the additivePreparation of zinc amino acid complex where the zinc and the amino acids derived from soya protein are chelated via coordinate covalent bonds, as a powder with a minimum content of 10 % zinc. | All animal species | — | — | Dogs and cats: 200 (total)Salmonids and milk replacers for calves: 180 (total)Piglets, sows, rabbits and all fish other than salmonids: 150 (total)Other species and categories: 120 (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. | 27 July 2026 |
| Characterisation of the active substanceChemical formula: Zn(x)1–3 · nH2O, x = anion of any amino acid from soya protein hydrolysate.Maximum of 10 % of the molecules exceeding 1500 Da. | |||||||||
| Analytical methodnote: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 zinc in the feed additive:inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) oratomic absorption spectrometry, AAS (ISO 6869)For the quantification of total zinc in premixtures:inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) oratomic absorption spectrometry, AAS (ISO 6869) orinductively coupled plasma-mass spectrometry, ICP-MS (EN 17053)For the quantification of total zinc in feed materials and compound feed:inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) oratomic absorption spectrometry, AAS (Commission Regulation (EC) No 152/2009 (Annex IV-C) or ISO 6869) orinductively coupled plasma-mass spectrometry, ICP-MS (EN 17053) | |||||||||
| 3b606i | — | Zinc chelate of amino acids hydrate | Characterisation of the additivePreparation of zinc amino acid complex, where the zinc and the amino acids are chelated via coordinate covalent bonds, as a powder with a content of 10-11 % zinc and a minimum of 17 % free amino acids. | All animal species | — | — | Dogs and cats: 200 (total)Salmonids and milk replacers for calves: 180 (total)Piglets, sows, rabbits and all fish other than salmonids: 150 (total)Other species and categories: 120 (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 including skin, and eye and breathing protections.3. For additives produced from hydrolysis of animal protein, the animal origin (avian species) shall be indicated on the label of the additive and premixtures | 27 July 2026 |
| Characterisation of the active substanceChemical formula: Zn(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 methodnote: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 17180For the quantification of total zinc in the feed additive:inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) oratomic absorption spectrometry, AAS (ISO 6869)For the quantification of total zinc in premixtures:inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) oratomic absorption spectrometry, AAS (ISO 6869) orinductively coupled plasma-mass spectrometry, ICP-MS (EN 17053)For the quantification of total zinc in feed materials and compound feed:inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) oratomic absorption spectrometry, AAS (Commission Regulation (EC) No 152/2009 (Annex IV-C) or ISO 6869) orinductively coupled plasma-mass spectrometry, ICP-MS (EN 17053) | |||||||||
| 3b612 | — | Zinc chelate of protein hydrolysates | Additive compositionZinc chelate of protein hydrolysates as a powder with a minimum content of 10 % zinc.Minimum of 85 % zinc chelated.Characterisation of the active substanceChemical formula: Zn(x)1–3 · nH2O, x = anion of protein hydrolysates containing any amino acid from soya protein hydrolysate.Analytical methodsnoteFor the quantification of protein hydrolysates content in the feed additive:ion exchange chromatography method with post-column derivatisation and UV or fluorescence detection: Regulation (EC) No 152/2009 (Annex III, F).For the determination of chelated Zinc content in the feed additive:Fourier Transformed Infrared (FTIR) spectroscopy followed by multivariate regression methods.For the quantification of total zinc in the feed additive and premixtures:EN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES), orEN/TS 15621: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES) after pressure digestion.For the quantification of total zinc in feed materials and compound feed:Regulation (EC) No 152/2009 — Atomic Absorption Spectrometry (AAS); orEN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES); orEN 15621: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES) after pressure digestion. | All animal species | — | — | Dogs and cats: 200 (total)Salmonids and milk replacers for calves: 180 (total)Piglets, sows, rabbits and all fish other than salmonids: 150 (total)Other species and categories: 120 (total) | 1. The additive shall be incorporated into feed in the form of a premixture.2. Zinc chelate of protein hydrolysates may be placed on the market and used as an additive consisting of a preparation.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. 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. | 27 July 2026 |
| 3b607 | — | Zinc chelate of glycine hydrate (solid) | Additive compositionZinc chelate of glycine, hydrate, as a powder with a minimum content of 15 % zinc.Moisture: maximum 10 %.Characterisation of the active substanceChemical formula: Zn(x)1-3 · nH2O, x = anion of glycine.Analytical methodsnoteFor the quantification of the glycine content in the feed additive:ion exchange chromatography method with post-column derivatisation and UV or fluorescence detection: Regulation (EC) No 152/2009 (Annex III, F).For the quantification of total zinc in the feed additive and premixtures:EN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES), orEN 15621: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES) after pressure digestion.For the quantification of total zinc in feed materials and compound feed:Regulation (EC) No 152/2009 — Atomic Absorption Spectrometry (AAS); orEN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES); orEN 15621: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES) after pressure digestion. | All animal species | — | — | Dogs and cats: 200 (total)Salmonids and milk replacers for calves: 180 (total)Piglets, sows, rabbits and all fish other than salmonids: 150 (total)Other species and categories: 120 (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. 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. | 27 July 2026 |
| 3b608 | — | Zinc chelate of glycine hydrate (liquid) | Additive compositionLiquid zinc chelate of glycine, hydrate, with a minimum content of 7 % zinc.Characterisation of the active substanceChemical formula: Zn(x)1-3 · nH2O, x = anion of glycine.Analytical methodsnoteFor the quantification of the glycine content in the feed additive:ion exchange chromatography method with post-column derivatisation and UV or fluorescence detection: Regulation (EC) No 152/2009 (Annex III, F).For the quantification of total zinc in the feed additive and premixtures:EN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES), orEN 15621: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES) after pressure digestion.For the quantification of total zinc in feed materials and compound feed:Regulation (EC) No 152/2009 — Atomic Absorption Spectrometry (AAS); orEN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES); orEN 15621: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES) after pressure digestion. | All animal species | — | — | Dogs and cats: 200 (total)Salmonids and milk replacers for calves: 180 (total)Piglets, sows, rabbits and all fish other than salmonids: 150 (total)Other species and categories: 120 (total) | 1. The additive shall be incorporated into feed in the form of a premixture.2. Zinc chelate of glycine (liquid) may be placed on the market and used as an additive consisting of a preparation.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. 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. | 27 July 2026 |
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