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Statutory Instruments

2023 No. 689

Agriculture, England

The Feed Additives (Form of Provisional Authorisations) (Cobalt(II) Compounds) (England) Regulations 2023

Made

21st June 2023

Laid before Parliament

22nd June 2023

Coming into force

14th July 2023

The Secretary of State makes these Regulations in exercise of the powers conferred by Articles 15 and 18A(3) of Regulation (EC) No. 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition(1).

There has been consultation as required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(2).

Citation, commencement, extent, and applicationI1

1.—(1) These Regulations may be cited as the Feed Additives (Form of Provisional Authorisations) (Cobalt(II) Compounds) (England) Regulations 2023 and come into force on 14th July 2023.

(2) These Regulations extend to England and Wales but apply in relation to England only.

InterpretationI2

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.

(2) Any expression used both in these Regulations and in Regulation or Regulation (EC) 1831/2003 of the European Parliament and of the Council on the placing on the market and use of feed, etc((EC) No. 767/20093) has the same meaning as it has in those Regulations.

Form of provisional authorisationsI3

3. Schedules 1 to 4, which prescribe the forms of the provisional authorisations of cobalt(II) acetate tetrahydrate (identification number 3b301), cobalt(II) carbonate (identification number 3b302), cobalt(II) carbonate hydroxide (2:3) monohydrate (identification number 3b303) and cobalt(II) sulphate heptahydrate (identification number 3b305) respectively, pursuant to Article 15 of Regulation (EC) 1831/2003, have effect(4).

Neil O’Brien

Parliamentary Under Secretary of State,

Department of Health and Social Care

21st June 2023

Regulation 3

SCHEDULE 1Form of provisional authorisation of cobalt(II) acetate tetrahydrate (identification number 3b301) as a feed additive for ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammalsI4

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 in accordance with the specifications in the following table.

AdditiveCobalt(II) acetate tetrahydrate
(1)

There is no requirement to include the name of the holder of this authorisation as this authorisation does not fall within the scope of Article 9(5) of Regulation (EC) 1831/2003.

(2)

This is a reference to the CAS Registry Number® assigned to this substance by the Chemical Abstracts Service https://cas.org/cas-data/cas-registry.

(3)

Details of the analytical methods are set out in the document referenced “JRC.D.5/FSQ/CvH/PRO/ag/Ares(2012)214390” and last updated on 6th June 2016. This document is available at the following address: https://joint-research-centre.ec.europa.eu/publications/fad-cobalt-group_en.

(4)

“Monograph 20301: 2.3.1. Identification reactions of ions and functional groups”. European Pharmacopoeia, European Directorate for the Quality of Medicines and Healthcare 11th edition. Published July 2022 (ISBN 978 92 871 9105 2). Available from European Pharmacopoeia Online https://pheur.edqm.eu/home.

(5)

BS EN 15510:2017 “Animal feeding stuffs. Methods of sampling and analysis. Determination of calcium, sodium, phosphorus, magnesium, potassium, iron, zinc, copper, manganese, cobalt, molybdenum and lead by ICP-AES”. Published by the British Standards Institution on 31st August 2017 (ISBN 978 0 580 94541 0). Available from the British Standards Institution https://knowledge.bsigroup.com.

(6)

BS EN 15621:2017 “Animal feeding stuffs: Methods of sampling and analysis. Determination of calcium, sodium, phosphorus, magnesium, potassium, sulphur, iron, zinc, copper, manganese and cobalt after pressure digestion by ICP-AES”. Published by the British Standards Institution on 31st August 2017 (ISBN 978 0 580 94543 4). Available from the British Standards Institution https://knowledge.bsigroup.com.

(7)

BS ISO 13320:2020 “Particle size analysis. Laser diffraction methods”. Published by the British Standards Institution on 31st July 2020 (ISBN 978 0 580 92329 6). Available from the British Standards Institution https://knowledge.bsigroup.com.

Identification number of the additive3b301
Authorisation holder(1)
Additive categoryNutritional additives
Functional groupCompounds of trace elements
Additive composition

Cobalt(II) acetate tetrahydrate

Crystals or granules containing a minimum content of 23% cobalt

Particles < 50 μm: below 1%

Characterisation of the active substance(s)

Chemical formula: Co(CH3COO)2 × 4H2O

CAS number: 6147-53-1(2)

Analytical methods(3)

For the identification of acetate in the additive:

  • European Pharmacopoeia monograph 20301(4)

For the crystallographic characterisation of the additive:

  • X-Ray diffraction

For the determination of total cobalt in the additive, premixtures, feed materials and compound feed:

  • Inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) in accordance with BS EN 15510:2017(5); or

  • Inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion in accordance with BS EN 15621:2017(6)

For the determination of particle size distribution:

  • Particle size analysis, laser diffraction methods in accordance with BS ISO 13320:2020(7)

Species or category of animalRuminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals
Maximum ageNot applicable
Element (Co) in mg/kg of complete feed with a moisture content of 12%Minimum contentNo minimum
Maximum content1 (total)
Other provisions
1)

The additive must be incorporated into compound feed in the form of a premixture

2)

The following must be stated 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 must be stated in the instructions for use of the compound feed:

  • “Protective measures to avoid exposure with cobalt by inhalation or by dermal route should be taken”

Start of provisional authorisation period15 July 2023
End of provisional authorisation period14 July 2028

Regulation 3

SCHEDULE 2Form of provisional authorisation of cobalt(II) carbonate (identification number 3b302) as a feed additive for ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammalsI5

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 in accordance with the specifications in the following table.

AdditiveCobalt(II) carbonate
(1)

There is no requirement to include the name of the holder of this authorisation as this authorisation does not fall within the scope of Article 9(5) of Regulation (EC) 1831/2003.

(2)

This is a reference to the CAS Registry Number® assigned to this substance by the Chemical Abstracts Service https://cas.org/cas-data/cas-registry.

(3)

Details of the analytical methods are set out in the document referenced “JRC.D.5/FSQ/CvH/PRO/ag/Ares(2012)214390” and last updated on 6th June 2016. This document is available at the following address: https://joint-research-centre.ec.europa.eu/publications/fad-cobalt-group_en.

(4)

“Monograph 20301: 2.3.1. Identification reactions of ions and functional groups”. European Pharmacopoeia, European Directorate for the Quality of Medicines and Healthcare 11th edition. Published July 2022 (ISBN 978 92 871 9105 2). Available from European Pharmacopoeia Online https://pheur.edqm.eu/home.

(5)

BS EN 15510:2017 “Animal feeding stuffs. Methods of sampling and analysis. Determination of calcium, sodium, phosphorus, magnesium, potassium, iron, zinc, copper, manganese, cobalt, molybdenum and lead by ICP-AES”. Published by the British Standards Institution on 31st August 2017 (ISBN 978 0 580 94541 0). Available from the British Standards Institution https://knowledge.bsigroup.com.

(6)

BS EN 15621:2017 “Animal feeding stuffs: Methods of sampling and analysis. Determination of calcium, sodium, phosphorus, magnesium, potassium, sulphur, iron, zinc, copper, manganese and cobalt after pressure digestion by ICP-AES”. Published by the British Standards Institution on 31st August 2017 (ISBN 978 0 580 94543 4). Available from the British Standards Institution https://knowledge.bsigroup.com.

(7)

BS ISO 13320:2020 “Particle size analysis. Laser diffraction methods”. Published by the British Standards Institution on 31st July 2020 (ISBN 978 0 580 92329 6). Available from the British Standards Institution https://knowledge.bsigroup.com.

Identification number of the additive3b302
Authorisation holder(1)
Additive categoryNutritional additives
Functional groupCompounds of trace elements
Additive composition

Cobalt(II) carbonate

Powder containing 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 substance(s)

Chemical formula: CoCO3

CAS number: 513-79-1(2)

Analytical methods(3)

For the identification of carbonate in the additive:

  • European Pharmacopoeia monograph 20301(4)

For the crystallographic characterisation of the additive:

  • X-Ray diffraction

For the determination of total cobalt in the additive, premixtures, feed materials and compound feed:

  • Inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) in accordance with BS EN 15510: 2017(5); or

  • Inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion in accordance with BS EN 15621:2017(6)

For the determination of particle size distribution:

  • Particle size analysis, laser diffraction methods in accordance with BS ISO 13320:2020(7)

Species or category of animalRuminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals
Maximum ageNot applicable
Element (Co) in mg/kg of complete feed with a moisture content of 12%Minimum contentNo minimum
Maximum content1 (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-powdered form

2)

The following must be stated 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 must be stated in the instructions for use of the compound feed:

  • “Protective measures to avoid exposure with cobalt by inhalation or by dermal route should be taken”

Start of provisional authorisation period15 July 2023
End of provisional authorisation period14 July 2028

Regulation 3

SCHEDULE 3Form of provisional authorisation of cobalt(II) carbonate hydroxide (2:3) monohydrate (identification number 3b303) as a feed additive for ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammalsI6

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 in accordance with the specifications in the following table.

AdditiveCobalt(II) carbonate hydroxide (2:3) monohydrate
(1)

There is no requirement to include the name of the holder of this authorisation as this authorisation does not fall within the scope of Article 9(5) of Regulation (EC) 1831/2003.

(2)

This is a reference to the CAS Registry Number® assigned to this substance by the Chemical Abstracts Service https://cas.org/cas-data/cas-registry.

(3)

Details of the analytical methods are set out in the document referenced “JRC.D.5/FSQ/CvH/PRO/ag/Ares(2012)214390” and last updated on 6th June 2016. This document is available at the following address: https://joint-research-centre.ec.europa.eu/publications/fad-cobalt-group_en.

(4)

“Monograph 20301: 2.3.1. Identification reactions of ions and functional groups”. European Pharmacopoeia, European Directorate for the Quality of Medicines and Healthcare 11th edition. Published July 2022 (ISBN 978 92 871 9105 2). Available from European Pharmacopoeia Online https://pheur.edqm.eu/home.

(5)

BS EN 15510:2017 “Animal feeding stuffs. Methods of sampling and analysis. Determination of calcium, sodium, phosphorus, magnesium, potassium, iron, zinc, copper, manganese, cobalt, molybdenum and lead by ICP-AES”. Published by the British Standards Institution on 31st August 2017 (ISBN 978 0 580 94541 0). Available from the British Standards Institution https://knowledge.bsigroup.com.

(6)

BS EN 15621:2017 “Animal feeding stuffs: Methods of sampling and analysis. Determination of calcium, sodium, phosphorus, magnesium, potassium, sulphur, iron, zinc, copper, manganese and cobalt after pressure digestion by ICP-AES”. Published by the British Standards Institution on 31st August 2017 (ISBN 978 0 580 94543 4). Available from the British Standards Institution https://knowledge.bsigroup.com.

(7)

BS ISO 13320:2020 “Particle size analysis. Laser diffraction methods”. Published by the British Standards Institution on 31st July 2020 (ISBN 978 0 580 92329 6). Available from the British Standards Institution https://knowledge.bsigroup.com.

Identification number of the additive3b303
Authorisation holder(1)
Additive categoryNutritional additives
Functional groupCompounds of trace elements
Additive composition

Cobalt(II) carbonate hydroxide (2:3) monohydrate

Powder with a minimum content of 50% cobalt

Particles < 50 μm: below 98%

Characterisation of the active substance(s)

Chemical formula: 2CoCO3 × 3Co(OH)2 × H2O

CAS number: 51839-24-8(2)

Analytical methods(3)

For the identification of carbonate in the additive:

  • European Pharmacopoeia monograph 20301(4)

For the crystallographic characterisation of the additive:

  • X-Ray diffraction

For the determination of total cobalt in the additive, premixtures, feed materials and compound feed:

  • Inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) in accordance with BS EN 15510: 2017(5); or

  • Inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion in accordance with BS EN 15621:2017(6)

For the determination of particle size distribution:

  • Particle size analysis, laser diffraction methods in accordance with BS ISO 13320:2020(7)

Species or category of animalRuminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals
Maximum ageNot applicable
Element (Co) in mg/kg of complete feed with a moisture content of 12%Minimum contentNo minimum
Maximum content1 (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-powdered form

2)

The following must be stated 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 must be stated in the instructions for use of the compound feed:

  • “Protective measures to avoid exposure with cobalt by inhalation or by dermal route should be taken”

Start of provisional authorisation period15 July 2023
End of provisional authorisation period14 July 2028

Regulation 3

SCHEDULE 4Form of provisional authorisation of cobalt(II) sulphate heptahydrate (identification number 3b305) as a feed additive for ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammalsI7

The substance cobalt(II) sulphate heptahydrate, 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 in accordance with the specifications in the following table.

AdditiveCobalt(II) sulphate heptahydrate
(1)

There is no requirement to include the name of the holder of this authorisation as this authorisation does not fall within the scope of Article 9(5) of Regulation (EC) 1831/2003.

(2)

This is a reference to the CAS Registry Number® assigned to this substance by the Chemical Abstracts Service https://cas.org/cas-data/cas-registry.

(3)

Details of the analytical methods are set out in the document referenced “JRC.D.5/FSQ/CvH/PRO/ag/Ares(2012)214390” and last updated on 6th June 2016. This document is available at the following address: https://joint-research-centre.ec.europa.eu/publications/fad-cobalt-group_en.

(4)

“Monograph 20301: 2.3.1. Identification reactions of ions and functional groups”. European Pharmacopoeia, European Directorate for the Quality of Medicines and Healthcare 11th edition. Published July 2022 (ISBN 978 92 871 9105 2). Available from European Pharmacopoeia Online https://pheur.edqm.eu/home.

(5)

BS EN 15510:2017 “Animal feeding stuffs. Methods of sampling and analysis. Determination of calcium, sodium, phosphorus, magnesium, potassium, iron, zinc, copper, manganese, cobalt, molybdenum and lead by ICP-AES”. Published by the British Standards Institution on 31st August 2017 (ISBN 978 0 580 94541 0). Available from the British Standards Institution https://knowledge.bsigroup.com.

(6)

BS EN 15621:2017 “Animal feeding stuffs: Methods of sampling and analysis. Determination of calcium, sodium, phosphorus, magnesium, potassium, sulphur, iron, zinc, copper, manganese and cobalt after pressure digestion by ICP-AES”. Published by the British Standards Institution on 31st August 2017 (ISBN 978 0 580 94543 4). Available from the British Standards Institution https://knowledge.bsigroup.com.

(7)

BS ISO 13320:2020 “Particle size analysis. Laser diffraction methods”. Published by the British Standards Institution on 31st July 2020 (ISBN 978 0 580 92329 6). Available from the British Standards Institution https://knowledge.bsigroup.com.

Identification number of the additive3b305
Authorisation holder(1)
Additive categoryNutritional additives
Functional groupCompounds of trace elements
Additive composition

Cobalt(II) sulphate heptahydrate

Powder with a minimum content of 20% cobalt

Particles < 50 μm: below 95%

Characterisation of the active substance(s)

Chemical formula: CoSO4 × 7H2O

CAS number: 10026-24-1(2)

Analytical methods(3)

For the identification of sulphate in the additive:

  • European Pharmacopoeia monograph 20301(4)

For the crystallographic characterisation of the additive:

  • X-Ray diffraction

For the determination of total cobalt in the additive, premixtures, feed materials and compound feed:

  • Inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) in accordance with BS EN 15510: 2017(5); or

  • Inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion in accordance with BS EN 15621:2017(6)

For the determination of particle size distribution:

  • Particle size analysis, laser diffraction methods in accordance with BS ISO 13320:2020(7)

Species or category of animalRuminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals
Maximum ageNot applicable
Element (Co) in mg/kg of complete feed with a moisture content of 12%Minimum contentNo minimum
Maximum content1 (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-powdered form

2)

The following must be stated 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 must be stated in the instructions for use of the compound feed:

  • “Protective measures to avoid exposure with cobalt by inhalation or by dermal route should be taken”

Start of provisional authorisation period15 July 2023
End of provisional authorisation period14 July 2028
(1)

EUR 2003/1831, amended by S.I. 2019/654, 2022/377 and 1351. See Article 2 for the definitions of ‘appropriate authority’ and ‘prescribe’.

(2)

EUR 2002/178, amended by S.I. 2019/641 and 2022/1351.

(3)

EUR 2009/767, amended by S.I. 2019/654 and 2022/1351.

(4)

The provisional authorisation of these feed additives is an administrative decision taken by the Secretary of State. The decision was made at the time that the Secretary of State made these Regulations.

Status: There are outstanding changes not yet made by the editorial team to The Feed Additives (Form of Provisional Authorisations) (Cobalt(II) Compounds) (England) Regulations 2023. Any changes that have already been made by the team appear in the content and are referenced with annotations.
The Feed Additives (Form of Provisional Authorisations) (Cobalt(II) Compounds) (England) Regulations 2023 (2023/689)

Displaying information

Status of this instrument

footnotecommentarytransitional and savingsin force statusrelated provisionsgeo extentinsert/omitsource countin force adj
I1Reg. 1 in force at 14.7.2023, see reg. 1(1)
I2Reg. 2 in force at 14.7.2023, see reg. 1(1)
I3Reg. 3 in force at 14.7.2023, see reg. 1(1)
I4Sch. 1 in force at 14.7.2023, see reg. 1(1)
I5Sch. 2 in force at 14.7.2023, see reg. 1(1)
I6Sch. 3 in force at 14.7.2023, see reg. 1(1)
I7Sch. 4 in force at 14.7.2023, see reg. 1(1)
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Particle size analysis. Laser diffraction methodspara SCHEDULE 2Particle_s_rt6UtLO
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Regulation (EC) 1831/2003reg. 2.legTermwCcTAxqB
This instrument is derived from the version at www.legislation.gov.uk. To see a list of all amendments (including any to be made) check the resources page for this instrument on their website. Note, the status of this instrument is given above.
This instrument is derived from the version at www.legislation.gov.uk. To see original commencement information, check the resources page associated with this instrument. n.b. commencement information for marked amendments is embedded in the relevant footnote.

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