
Article 1 
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 
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 
In the Annex to Regulation (EC) No 479/2006, the entry E6 on the additive ‘Zinc chelate of glycine hydrate’ is deleted.
Article 4 
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 
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 
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 

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 8 
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.Done at Brussels, 6 July 2016.
For the Commission
The President
Jean-Claude JUNCKER
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 
Zinc acetate dihydrate, as a powder with a minimum content of 29,6 % zinc.

Chemical formula: Zn(CH3COO)2 · 2H2O

CAS Number: 5970-45-6

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 — 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 
Zinc chloride anhydrous, as a powder with a minimum content of 46,1 % zinc.

Chemical formula: ZnCl2

CAS Number: 7646-85-7

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 
Zinc oxide, as a powder with a minimum content of 72 % zinc

Chemical formula: ZnO

CAS Number: 1314-13-2

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 
Zinc sulphate heptahydrate, as a powder with a minimum content of 22 % zinc.

Chemical formula: ZnSO4 · 7H2O

CAS Number: 7446-20-0

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 
Zinc sulphate monohydrate, as a powder with a minimum content of 34 % zinc.

Chemical formula: ZnSO4 · H2O

CAS Number: 7446-19-7

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 
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.

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.

For the quantification of amino acid content in the feed additive:


— ion exchange chromatography method with post-column derivatisation and UV or fluorescence detection: Commission 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 amino acids 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
3b612 — Zinc chelate of protein hydrolysates 
Zinc chelate of protein hydrolysates as a powder with a minimum content of 10 % zinc.

Minimum of 85 % zinc chelated.

Chemical formula: Zn(x)1–3 · nH2O, x = anion of protein hydrolysates containing any amino acid from soya protein hydrolysate.

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) 
Zinc chelate of glycine, hydrate, as a powder with a minimum content of 15 % zinc.

Moisture: maximum 10 %.

Chemical formula: Zn(x)1-3 · nH2O, x = anion of glycine.

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) 
Liquid zinc chelate of glycine, hydrate, with a minimum content of 7 % zinc.

Chemical formula: Zn(x)1-3 · nH2O, x = anion of glycine.

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

