
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 
The substances specified in the Annex which were authorised by Directive 70/524/EEC and feed containing them, which are produced and labelled before 15 January 2014 in accordance with the rules applicable before 15 July 2013 may continue to be placed on the market and used until the existing stocks are exhausted.
Article 3 
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, 24 June 2013.
For the Commission
The President
José Manuel BARROSO
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 (Co) in mg/kg of complete feedingstuff with a moisture content of 12 %
Category of nutritional additives. Functional group: compounds of trace elements
3b801 — Cobalt(II) acetate tetrahydrate 
 Additive composition
Cobalt(II) acetate tetrahydrate, as crystals/granules, with a minimum content of 23 % cobalt
Particles < 50 μm: below 1 %
 Characterisation of the active substance
Chemical formula: Co(CH3COO)2 × 4H2O
CAS number: 6147-53-1
 Analytical methods
 For the identification of acetate in the additive:
— European Pharmacopoeia monograph 01/2008:20301.
 For the crystallographic characterisation of additive:
— X-Ray diffraction.
 For the determination of total cobalt in the additive, premixtures, compound feed and feed materials:
— EN 15510 — inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES)
or
— CEN/TS 15621 — inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion.
 For determination of particle size distribution:
— ISO 13320:2009 — Particle size analysis — Laser diffraction methods ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals — — 1 (total) 
1.. The additive shall be incorporated into feed in the form of a premixture.
2.. Protective measures shall be taken according to national regulations implementing EU legislation on health and safety at work including Council Directives 89/391/EEC, 89/656/EEC, 92/85/EEC and 98/24/EC. Appropriate protective gloves, respiratory and eye protection according to Council Directive 89/686/EEC shall be worn during handling.
3.. Declarations to be made on the labelling of the additive and premixture:

— 'It is recommended to limit the supplementation with Cobalt to 0,3 mg/kg in complete feed. In this context, the risk for Cobalt deficiency due to local conditions and the specific composition of the diet should be taken into account.' 15 July 2023
3b802 — Cobalt(II) carbonate 
 Additive composition
Cobalt(II) carbonate, as powder, with a minimum content of 46 % cobalt
Cobalt carbonate: minimum 75 %
Cobalt hydroxide: 3 % - 15 %
Water: maximum 6 %
Particles < 11 μm: below 90 %
 Characterisation of the active substances
Chemical formula: CoCO3
CAS number: 513-79-1
Chemical formula Co(OH)2
CAS number: 21041-93-0
 Analytical methods
 For the identification of carbonate in the additive:
— European Pharmacopoeia monograph 01/2008:20301.
 For the crystallographic characterisation of additive:
— X-Ray diffraction.
 For the determination of total cobalt in the additive, premixtures, compound feed and feed materials:
— EN 15510 — inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES)
or
— CEN/TS 15621 — inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion.
 For determination of particle size distribution:
— ISO 13320:2009 — Particle size analysis — Laser diffraction methods ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals — — 1 (total) 
1.. The additive shall be incorporated into feed in the form of a premixture. This feed shall be placed on the market in a pelleted form.
2.. Protective measures shall be taken according to national regulations implementing EU legislation on health and safety at work including Directives 89/391/EEC, 89/656/EEC, 92/85/EEC, 98/24/EC and 2004/37/EC of the European Parliament and of the Council. Appropriate protective gloves, respiratory and eye protection according to Directive 89/686/EEC shall be worn during handling.
3.. Declarations to be made on the labelling of the additive and premixture:

— 'It is recommended to limit the supplementation with Cobalt to 0,3 mg/kg in complete feed. In this context, the risk for Cobalt deficiency due to local conditions and the specific composition of the diet should be taken into account.' 15 July 2023
3b803 — Cobalt(II) carbonate hydroxide (2:3) monohydrate 
 Additive composition
Cobalt(II) carbonate hydroxide (2:3) monohydrate, as powder, with a minimum content of 50 % cobalt
Particles < 50 μm: below 98 %
 Characterisation of the active substance
Chemical formula: 2CoCO3 × 3Co(OH)2 × H2O
CAS number: 51839-24-8
 Analytical methods
 For the identification of carbonate in the additive:
— European Pharmacopoeia monograph 01/2008:20301.
 For the crystallographic characterisation of additive:
— X-Ray diffraction.
 For the determination of total cobalt in the additive, premixtures, compound feed and feed materials:
— EN 15510 — inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES)
or
— CEN/TS 15621 — inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion.
 For determination of particle size distribution:
— ISO 13320:2009 — Particle size analysis — Laser diffraction methods ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals — — 1 (total) 
1.. The additive shall be incorporated into feed in the form of a premixture. This feed shall be placed on the market in a pelleted form.
2.. Protective measures shall be taken according to national regulations implementing EU legislation on health and safety at work including Directives 89/391/EEC, 89/656/EEC, 92/85/EEC, 98/24/EC and 2004/37/EC. Appropriate protective gloves, respiratory and eye protection according to Directive 89/686/EEC shall be worn during handling.
3.. Declarations to be made on the labelling of the additive and premixture:

— 'It is recommended to limit the supplementation with Cobalt to 0,3 mg/kg in complete feed. In this context, the risk for Cobalt deficiency due to local conditions and the specific composition of the diet should be taken into account.' 15 July 2023
3b804 — Coated granulated cobalt(II) carbonate hydroxide (2:3) monohydrate 
 Additive composition
Coated granulated cobalt(II) carbonate hydroxide (2:3) monohydrate with a cobalt content of 1 % - 5 %
Coating agents (2,3 % - 3,0 %) and dispersants (choice of poly-oxy-ethylene, sorbitan monolaurate, glycerol polyethyleneglycol ricinoleate, polyethyleneglycol 300, sorbitol, and maltodextrin)
Particles < 50 μm: below 1 %
 Characterisation of the active substance
Chemical formula: 2CoCO3 × 3Co(OH)2 × H2O
CAS number: 51839-24-8
 Analytical methods
 For the identification of carbonate in the additive:
— European Pharmacopoeia monograph 01/2008:20301.
 For the crystallographic characterisation of additive:
— X-Ray diffraction.
 For the determination of total cobalt in the additive, premixtures, compound feed and feed materials:
— EN 15510 — inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES)
or
— CEN/TS 15621 — inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion.
 For determination of particle size distribution:
— ISO 13320:2009 — Particle size analysis — Laser diffraction methods ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals — — 1 (total) 
1.. Protective measures shall be taken according to national regulations implementing EU legislation on health and safety at work including Directives 89/391/EEC, 89/656/EEC, 92/85/EEC and 98/24/EC. Appropriate protective gloves, respiratory and eye protection according to Directive 89/686/EEC shall be worn during handling.
2.. Declarations to be made on the labelling of the additive and premixture, if applicable:

— 'It is recommended to limit the supplementation with Cobalt to 0,3 mg/kg in complete feed. In this context, the risk for Cobalt deficiency due to local conditions and the specific composition of the diet should be taken into account.' 15 July 2023
3b805 — Cobalt(II) sulphate, heptahydrate 
 Additive composition
Cobalt(II) sulphate, heptahydrate, as powder, with a minimum content of 20 % cobalt
Particles < 50 μm: below 95 %
 Characterisation of the active substance
Chemical formula: CoSO4 × 7H2O
CAS number: 10026-24-1
 Analytical methods
 For the identification of sulphate in the additive:
— European Pharmacopoeia monograph 01/2008:20301.
 For the crystallographic characterisation of additive:
— X-Ray diffraction.
 For the determination of total cobalt in the additive, premixtures, compound feed and feed materials:
— EN 15510 — inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES)
or
— CEN/TS 15621 — inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion.
 For determination of particle size distribution:
— ISO 13320:2009 — Particle size analysis — Laser diffraction methods ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals — — 1 (total) 
1.. The additive shall be incorporated into feed in the form of a premixture. This feed shall be placed on the market in a pelleted form.
2.. Protective measures shall be taken according to national regulations implementing EU legislation on health and safety at work including Directives 89/391/EEC, 89/656/EEC, 92/85/EEC, 98/24/EC and 2004/37/EC. Appropriate protective gloves, respiratory and eye protection according to Directive 89/686/EEC shall be worn during handling.
3.. Declarations to be made on the labelling of the additive and premixture:

— 'It is recommended to limit the supplementation with Cobalt to 0,3 mg/kg in complete feed. In this context, the risk for Cobalt deficiency due to local conditions and the specific composition of the diet should be taken into account.' 15 July 2023






