Commission Implementing Regulation (EU) 2016/1095 of 6 July 2016 concerning the authorisation of Zinc acetate dihydrate, Zinc chloride anhydrous, Zinc oxide, Zinc sulphate heptahydrate, Zinc sulphate monohydrate, Zinc chelate of amino acids hydrate, Zinc chelate of protein hydrolysates, Zinc chelate of glycine hydrate (solid) and Zinc chelate of glycine hydrate (liquid) as feed additives for all animal species and amending Regulations (EC) No 1334/2003, (EC) No 479/2006, (EU) No 335/2010 and Implementing Regulations (EU) No 991/2012 and (EU) No 636/2013 (Text with EEA relevance)

Current text a fecha 2022-09-25

COMMISSION IMPLEMENTING REGULATION (EU) 2016/1095

of 6 July 2016

concerning the authorisation of Zinc acetate dihydrate, Zinc chloride anhydrous, Zinc oxide, Zinc sulphate heptahydrate, Zinc sulphate monohydrate, Zinc chelate of amino acids hydrate, Zinc chelate of protein hydrolysates, Zinc chelate of glycine hydrate (solid) and Zinc chelate of glycine hydrate (liquid) as feed additives for all animal species and amending Regulations (EC) No 1334/2003, (EC) No 479/2006, (EU) No 335/2010 and Implementing Regulations (EU) No 991/2012 and (EU) No 636/2013

(Text with EEA relevance)

Article 1

Authorisation

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 2

Amendment 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 3

Amendment 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 4

Amendment 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 5

Amendment 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 6

Amendment 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 7

Transitional measures

Article 8

Entry 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

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 (Zn) in mg/kg of complete feed with a moisture content of 12 %
Category of nutritional additives. Functional group: compounds of trace elements
3b601	—	Zinc acetate dihydrate	Additive composition Zinc acetate dihydrate, as a powder with a minimum content of 29,6 % zinc. Characterisation of the active substance Chemical formula: Zn(CH3COO)2 · 2H2O CAS Number: 5970-45-6 Analytical methods (¹) For 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), or — EN 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 (²) — Atomic Absorption Spectrometry (AAS); or — EN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES); or — EN 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 composition Zinc chloride anhydrous, as a powder with a minimum content of 46,1 % zinc. Characterisation of the active substance Chemical formula: ZnCl2 CAS Number: 7646-85-7 Analytical methods (¹) For 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), or — EN 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); or — EN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES); or — EN 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 composition Zinc oxide, as a powder with a minimum content of 72 % zinc Characterisation of the active substance Chemical formula: ZnO CAS Number: 1314-13-2 Analytical methods (¹) For 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), or — EN 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); or — EN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES); or — EN 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 composition Zinc sulphate heptahydrate, as a powder with a minimum content of 22 % zinc. Characterisation of the active substance Chemical formula: ZnSO4 · 7H2O CAS Number: 7446-20-0 Analytical methods (¹) For 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), or — EN 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); or — EN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES); or — EN 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 composition Zinc sulphate monohydrate, as a powder with a minimum content of 34 % zinc. Characterisation of the active substance Chemical formula: ZnSO4 · H2O CAS Number: 7446-19-7 Analytical methods (¹) For 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), or — EN 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); or — EN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES); or — EN 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 additive Preparation 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 substance Chemical formula: Zn(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 method (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 zinc 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 zinc 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 zinc 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)
3b606i	—	Zinc chelate of amino acids hydrate	Characterisation of the additive Preparation 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 substance Chemical 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 method (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 zinc 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 zinc 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 zinc 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)

3b612	—	Zinc chelate of protein hydrolysates	Additive composition Zinc chelate of protein hydrolysates as a powder with a minimum content of 10 % zinc. Minimum of 85 % zinc chelated. Characterisation of the active substance Chemical formula: Zn(x)1–3 · nH2O, x = anion of protein hydrolysates containing any amino acid from soya protein hydrolysate. Analytical methods (¹) For 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), or — EN/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); or — EN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES); or — EN 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 composition Zinc chelate of glycine, hydrate, as a powder with a minimum content of 15 % zinc. Moisture: maximum 10 %. Characterisation of the active substance Chemical formula: Zn(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 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), or — EN 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); or — EN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES); or — EN 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 composition Liquid zinc chelate of glycine, hydrate, with a minimum content of 7 % zinc. Characterisation of the active substance Chemical formula: Zn(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 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), or — EN 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); or — EN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES); or — EN 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
(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 (²) Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1).