
1 

(1) These Regulations may be cited as the Feed Additives (Form of Provisional Authorisations) (Cobalt(II) Compounds) (Scotland) Regulations 2023 and come into force on 30 June 2023.
(2) These Regulations extend to Scotland only.
2 

(1) In these Regulations—
 “Regulation (EC) 1831/2003” means Regulation (EC) No. 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition,
 “Regulation (EC) 767/2009” means Regulation (EC) No. 767/2009 of the European Parliament and of the Council on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No. 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC.
(2) Any expression used both in these Regulations and in Regulation (EC) 1831/2003 or Regulation (EC) 767/2009 has the same meaning as in Regulation (EC) 1831/2003 or Regulation (EC) 767/2009, respectively.
3 

(1) The prescribed form of provisional authorisation of cobalt(II) acetate tetrahydrate (identification number 3b301) is set out in schedule 1.
(2) The prescribed form of provisional authorisation of cobalt(II) carbonate (identification number 3b302) is set out in schedule 2.
(3) The prescribed form of provisional authorisation of cobalt(II) carbonate hydroxide (2:3) monohydrate (identification number 3b303) is set out in schedule 3.
(4) The prescribed form of provisional authorisation of cobalt(II) sulphate heptahydrate (identification number 3b305) is set out in schedule 4.
JENNI MINTO
Authorised to sign by the Scottish Ministers
St Andrew’s House,
Edinburgh
30th May 2023
SCHEDULE 1
Regulation 3(1)

The substance cobalt(II) acetate tetrahydrate, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is provisionally authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Column 1 Column 2
Additive Cobalt(II) acetate tetrahydrate
Identification number of the additive 3b301
Authorisation holder 
Additive category Nutritional additives
Functional group Compounds of trace elements
Additive composition Cobalt(II) acetate tetrahydrate, as crystals/granules, with a minimum content of 23% cobaltParticles < 50 μm: below 1%
Characterisation of the active substance(s) Chemical formula: Co(CH3COO)2 × 4H2OCAS number: 6147-53-1
Analytical methods 1. For the identification of acetate in the additive:

• European Pharmacopoeia monograph 01/2008:20301
2. For the crystallographic characterisation of additive:

• X-Ray diffraction
3. For the determination of total cobalt in the additive, premixtures, compound feed and feed materials:

• Inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) in accordance with BS EN 15510:2017
or

• Inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion in accordance with BS EN 15621:2017
4. For determination of particle size distribution:

• Particle size analysis — Laser diffraction methods in accordance with BS ISO 13320:2020
Species or category of animal Ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals
Maximum age No maximum
Element (Co) in mg/kg of complete feed with a moisture content of 12% Minimum content No minimum
Maximum content 1 (total)
Other provisions 1. The additive must be incorporated into compound feed in the form of a premixture.
2. The following declarations must be made on the labelling of the additive and premixture:

• The element (cobalt) content.
• “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.”.
3. The following declaration must be made on the instructions of use of the compound feed:

• “Protective measures to avoid exposure with cobalt by inhalation or by dermal route should be taken.”.
Start of period of authorisation 15 July 2023
End of period of authorisation 14 July 2026








SCHEDULE 2
Regulation 3(2)

The substance cobalt(II) carbonate, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is provisionally authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Column 1 Column 2
Additive Cobalt(II) carbonate
Identification number of the additive 3b302
Authorisation holder 
Additive category Nutritional additives
Functional group Compounds of trace elements
Additive composition Cobalt(II) carbonate, as a powder, with a minimum content of 46% cobaltCobalt carbonate: minimum 75 %Cobalt hydroxide: 3% - 15%Water: maximum 6 %Particles < 11 μm: below 90%
Characterisation of the active substance(s) Chemical formula: CoCO3CAS number: 513-79-1
Analytical methods 1. For the identification of carbonate in the additive:
 
• European Pharmacopoeia monograph 01/2008:20301
2. For the crystallographic characterisation of additive:

• X-Ray diffraction
3. For the determination of total cobalt in the additive, premixtures, compound feed and feed materials:

• Inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) in accordance with BS EN 15510:2017
or

• Inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion in accordance with BS EN 1521:2017
4. For determination of particle size distribution:

• Particle size analysis — laser diffraction methods in accordance with BS ISO 13320:2020
Species or category of animal Ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals
Maximum age No maximum
Element (Co) in mg/kg of complete feed with a moisture content of 12% Minimum content No minimum
Maximum content 1 (total)
Other provisions 1. The additive must be incorporated into compound feed in the form of a premixture. This compound feed must be placed on the market in a non-powder form.
2. The following declarations must be made on the labelling of the additive and premixture:

• The element (cobalt) content.
• “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.”.
3. The following declaration must be made on the instructions of use of the compound feed:

• “Protective measures to avoid exposure with cobalt by inhalation or by dermal route should be taken.”.
Start of period of authorisation 15 July 2023
End of period of authorisation 14 July 2026








SCHEDULE 3
Regulation 3(3)

The substance cobalt(II) carbonate hydroxide (2:3) monohydrate, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is provisionally authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Column 1 Column 2
Additive Cobalt(II) carbonate hydroxide (2:3) monohydrate
Identification number of the additive 3b303
Authorisation holder 
Additive category Nutritional additives
Functional group Compounds of trace elements
Additive composition Cobalt(II) carbonate hydroxide (2:3) monohydrate, as powder, with a minimum content of 50% cobaltParticles < 50 μm: below 98%
Characterisation of the active substance(s) Chemical formula: 2CoCO3 × 3Co(OH)2 × H2OCAS number: 51839-24-8
Analytical methods 1. For the identification of carbonate in the additive:
 
• European Pharmacopoeia monograph 01/2008:20301
 2. For the crystallographic characterisation of additive:
 
• X-Ray diffraction
 3. For the determination of total cobalt in the additive, premixtures, compound feed and feed materials:
 
• Inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) in accordance with BS EN 15510:2017
 or
 
• Inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion in accordance with BS EN 15621:2017
 4. For determination of particle size distribution:
 
• Particle size analysis — Laser diffraction methods in accordance with BS ISO 13320:2020
Species or category of animal Ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals
Maximum age No maximum
Element (Co) in mg/kg of complete feed with a moisture content of 12% Minimum content No minimum
Maximum content 1 (total)
Other provisions 1. The additive must be incorporated into compound feed in the form of a premixture. This compound feed must be placed on the market in a non-powder form.
2. The following declarations must be made on the labelling of the additive and premixture:

• The element (cobalt) content.
• “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.”.
3. The following declaration must be made on the instructions of use of the compound feed:

• “Protective measures to avoid exposure with cobalt by inhalation or by dermal route should be taken.”.
Start of period of authorisation 15 July 2023
End of period of authorisation 14 July 2026








SCHEDULE 4
Regulation 3(4)

The substance specified in the table in this schedule, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is provisionally authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Column 1 Column 2
Additive Cobalt(II) sulphate heptahydrate
Identification number of the additive 3b305
Authorisation holder 
Additive category Nutritional additives
Functional group Compounds of trace elements
Additive composition Cobalt(II) sulphate heptahydrate, as powder, with a minimum content of 20% cobaltParticles < 50μm: below 95%
Characterisation of the active substance(s) Chemical formula: CoSO4 × 7H2OCAS number: 10026-24-1
Analytical methods 1. For the identification of sulphate in the additive:
 
• European Pharmacopoeia monograph 01/2008:20301
 2. For the crystallographic characterisation of additive:
 
• X-Ray diffraction
 3. For the determination of total cobalt in the additive, premixtures, compound feed and feed materials:
 
• Inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) in accordance with BS EN 15510:2017
 or
 
• Inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion in accordance with BS EN 15621:2017
 4. For determination of particle size distribution:
 
• Particle size analysis — Laser diffraction methods in accordance with BS ISO 13320:2020
Species or category of animal Ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals
Maximum age Not applicable
Element (Co) in mg/kg of complete feed with a moisture content of 12% Minimum content No minimum
Maximum content 1 (total)
Other provisions 1. The additive must be incorporated into compound feed in the form of a premixture. This compound feed must be placed on the market in a non-powder form.
2. The following declarations must be made on the labelling of the additive and premixture:

• The element (cobalt) content.
• “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.”.
3. The following declaration must be made on the instructions of use of the compound feed:

• “Protective measures to avoid exposure with cobalt by inhalation or by dermal route should be taken.”.
Start of period of authorisation 15 July 2023
End of period of authorisation 14 July 2026







