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

Title, extent, application and coming into force1.

(1)

The title of these Regulations is the Feed Additives (Form of Provisional Authorisations) (Cobalt(II) Compounds) (Wales) Regulations 2023.

(2)

These Regulations—

(a)

extend to England and Wales;

(b)

apply in relation to Wales;

(c)

come into force on 14 July 2023.

Interpretation2.

(1)

Expressions used in these Regulations and in Regulation 1831/2003 or Regulation 767/2009 have the same meaning as in Regulation 1831/2003 or Regulation 767/2009, respectively.

(2)

In paragraph (1)—

“Regulation 1831/2003” (“Rheoliad 1831/2003”) means Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition;

“Regulation 767/2009” (“Rheoliad 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 feed3.

Form of provisional authorisations3.

(1)

Paragraphs (2) to (5) prescribe the forms of provisional authorisations for certain feed additives4.

(2)

The prescribed form of provisional authorisation of cobalt(II) acetate tetrahydrate (identification number 3b301) is set out in Schedule 1.

(3)

The prescribed form of provisional authorisation of cobalt(II) carbonate (identification number 3b302) is set out in Schedule 2.

(4)

The prescribed form of provisional authorisation of cobalt(II) carbonate hydroxide (2:3) monohydrate (identification number 3b303) is set out in Schedule 3.

(5)

The prescribed form of provisional authorisation of cobalt(II) sulphate heptahydrate (identification number 3b305) is set out in Schedule 4.

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 mammals

Regulation 3(2)

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.

Additive	Cobalt(II) acetate tetrahydrate
Identification number of the additive	3b301
Authorisation holder	None specified
Additive category	Nutritional additives
Functional group	Compounds of trace elements
Additive composition	Cobalt(II) acetate tetrahydrate Crystals/granules, containing a minimum of 23% cobalt Particles < 50 μm: below 1%
Characterisation of the active substance(s)	Cobalt(II) acetate tetrahydrate Co(CH₃COO)₂ × 4H₂O CAS number(1): 6147-53-1
Analytical methods(2)	For the identification of acetate in the additive: European Pharmacopoeia monograph 20301(3)
	For the crystallographic characterisation of the additive: X-ray diffraction
	For the determination of total cobalt in the additive, premixtures, compound feed and feed materials: Inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) (BS EN 15510:2017(4)), or Inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion (BS EN 15621:2017(5))
	For determination of particle size distribution: Particle size analysis — Laser diffraction methods (BS ISO 13320:2020(6))
Species or category of animal	Ruminants with a functional rumen Equidae Lagomorphs Rodents Herbivore reptiles Zoo mammals
Maximum age	None
Minimum content(7)	None
Maximum content(7)	1 (total)
Other provisions	1. The additive must be incorporated into compound feed in the form of a premixture.
	2. The total element (cobalt) content must be stated on the labelling of the additive and premixture.
	3. The following must be stated, in English or in English and Welsh, on the labelling of the additive and premixture: In English: “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.” In Welsh: “Argymhellir cyfyngu ar atchwanegu â chobalt i 0.3 mg/kg mewn bwyd anifeiliaid cyflawn. Yn y cyd-destun hwn, dylid ystyried y risg o ddiffyg cobalt oherwydd amodau lleol a chyfansoddiad penodol y deiet.”
	4. The following must be stated, in English or in English and Welsh, on the instructions of use of the compound feed: In English: “Protective measures to avoid exposure with cobalt by inhalation or by dermal route should be taken.” In Welsh: “Dylid cymryd mesurau diogelu i osgoi dod i gysylltiad â chobalt drwy fewnanadlu neu drwy lwybr croenol.”
Start of provisional authorisation period	15 July 2023
End of provisional authorisation period	End of 14 July 2028

(1)

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

(2)

Details of the analytical methods are set out in the document referenced “JRC.D.5/FSQ/CvH/PRO/ag/ARES(2012)214390” dated 24 February 2012, and last updated on 6 June 2016. This document is available at the following address: https://joint-research-centre.ec.europa.eu/publications/fad-cobalt-group_en.

(3)

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.

(4)

Under reference 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 31 August 2017 (ISBN 978 0 580 94541 0). Available from the British Standards Institution https://knowledge.bsigroup.com.

(5)

Under reference 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 31 August 2017 (ISBN 978 0 580 94543 4). Available from the British Standards Institution https://knowledge.bsigroup.com.

(6)

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

(7)

Content of element (cobalt) in mg/kg of complete feed with a moisture content of 12%.

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 mammals

Regulation 3(3)

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.

Additive	Cobalt(II) carbonate
Identification number of the additive	3b302
Authorisation holder	None specified
Additive category	Nutritional additives
Functional group	Compounds of trace elements
Additive composition	Cobalt(II) carbonate Powder, containing a minimum 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)	Cobalt(II) carbonate CoCO₃ CAS number(1): 513-79-1
Analytical methods(2)	For the identification of carbonate in the additive: European Pharmacopoeia monograph 20301(3)
	For the crystallographic characterisation of the additive: X-ray diffraction
	For the determination of total cobalt in the additive, premixtures, compound feed and feed materials: Inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) (BS EN 15510:2017(4)), or Inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion (BS EN 15621:2017(5))
	For determination of particle size distribution: Particle size analysis — Laser diffraction methods (BS ISO 13320:2020(6))
Species or category of animal	Ruminants with a functional rumen Equidae Lagomorphs Rodents Herbivore reptiles Zoo mammals
Maximum age	None
Minimum content(7)	None
Maximum content(7)	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 total element (cobalt) content must be stated on the labelling of the additive and premixture.
	3. The following must be stated, in English or in English and Welsh, on the labelling of the additive and premixture: In English: “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.” In Welsh: “Argymhellir cyfyngu ar atchwanegu â chobalt i 0.3 mg/kg mewn bwyd anifeiliaid cyflawn. Yn y cyd-destun hwn, dylid ystyried y risg o ddiffyg cobalt oherwydd amodau lleol a chyfansoddiad penodol y deiet.”
	4. The following must be stated, in English or in English and Welsh, on the instructions of use of the compound feed: In English: “Protective measures to avoid exposure with cobalt by inhalation or by dermal route should be taken.” In Welsh: “Dylid cymryd mesurau diogelu i osgoi dod i gysylltiad â chobalt drwy fewnanadlu neu drwy lwybr croenol.”
Start of provisional authorisation period	15 July 2023
End of provisional authorisation period	End of 14 July 2028

(1)

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

(2)

Details of the analytical methods are set out in the document referenced “JRC.D.5/FSQ/CvH/PRO/ag/ARES(2012)214390” dated 24 February 2012, and last updated on 6 June 2016. This document is available at the following address: https://joint-research-centre.ec.europa.eu/publications/fad-cobalt-group_en.

(3)

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.

(4)

Under reference 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 31 August 2017 (ISBN 978 0 580 94541 0). Available from the British Standards Institution https://knowledge.bsigroup.com.

(5)

Under reference 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 31 August 2017 (ISBN 978 0 580 94543 4). Available from the British Standards Institution https://knowledge.bsigroup.com.

(6)

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

(7)

Content of element (cobalt) in mg/kg of complete feed with a moisture content of 12%.

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 mammals

Regulation 3(4)

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.

Additive	Cobalt(II) carbonate hydroxide (2:3) monohydrate
Identification number of the additive	3b303
Authorisation holder	None specified
Additive category	Nutritional additives
Functional group	Compounds of trace elements
Additive composition	Cobalt(II) carbonate hydroxide (2:3) monohydrate Powder, containing a minimum of 50% cobalt Particles < 50 μm: below 98%
Characterisation of the active substance(s)	Cobalt(II) carbonate hydroxide (2:3) monohydrate 2CoCO₃ × 3Co(OH)₂ × H₂O CAS number(1): 51839-24-8
Analytical methods(2)	For the identification of carbonate in the additive: European Pharmacopoeia monograph 20301(3)
	For the crystallographic characterisation of the additive: X-ray diffraction
	For the determination of total cobalt in the additive, premixtures, compound feed and feed materials: Inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) (BS EN 15510:2017(4)), or Inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion (BS EN 15621:2017(5))
	For determination of particle size distribution: Particle size analysis — Laser diffraction methods (BS ISO 13320:2020(6))
Species or category of animal	Ruminants with a functional rumen Equidae Lagomorphs Rodents Herbivore reptiles Zoo mammals
Maximum age	None
Minimum content(7)	None
Maximum content(7)	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 total element (cobalt) content must be stated on the labelling of the additive and premixture.
	3. The following must be stated, in English or in English and Welsh, on the labelling of the additive and premixture: In English: “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.” In Welsh: “Argymhellir cyfyngu ar atchwanegu â chobalt i 0.3 mg/kg mewn bwyd anifeiliaid cyflawn. Yn y cyd-destun hwn, dylid ystyried y risg o ddiffyg cobalt oherwydd amodau lleol a chyfansoddiad penodol y deiet.”
	4. The following must be stated, in English or in English and Welsh, on the instructions of use of the compound feed: In English: “Protective measures to avoid exposure with cobalt by inhalation or by dermal route should be taken.” In Welsh: “Dylid cymryd mesurau diogelu i osgoi dod i gysylltiad â chobalt drwy fewnanadlu neu drwy lwybr croenol.”
Start of provisional authorisation period	15 July 2023
End of provisional authorisation period	End of 14 July 2028

(1)

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

(2)

Details of the analytical methods are set out in the document referenced “JRC.D.5/FSQ/CvH/PRO/ag/ARES(2012)214390” dated 24 February 2012, and last updated on 6 June 2016. This document is available at the following address: https://joint-research-centre.ec.europa.eu/publications/fad-cobalt-group_en.

(3)

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.

(4)

Under reference 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 31 August 2017 (ISBN 978 0 580 94541 0). Available from the British Standards Institution https://knowledge.bsigroup.com.

(5)

Under reference 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 31 August 2017 (ISBN 978 0 580 94543 4). Available from the British Standards Institution https://knowledge.bsigroup.com.

(6)

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

(7)

Content of element (cobalt) in mg/kg of complete feed with a moisture content of 12%.

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 mammals

Regulation 3(5)

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, subject to the conditions set out in the table.

Additive	Cobalt(II) sulphate heptahydrate
Identification number of the additive	3b305
Authorisation holder	None specified
Additive category	Nutritional additives
Functional group	Compounds of trace elements
Additive composition	Cobalt(II) sulphate heptahydrate Powder, containing a minimum of 20% cobalt Particles < 50 μm: below 95%
Characterisation of the active substance(s)	Cobalt(II) sulphate heptahydrate CoSO₄ × 7H₂O CAS number(1): 10026-24-1
Analytical methods(2)	For the identification of sulphate in the additive: European Pharmacopoeia monograph 20301(3)
	For the crystallographic characterisation of the additive: X-ray diffraction
	For the determination of total cobalt in the additive, premixtures, compound feed and feed materials: Inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) (BS EN 15510:2017(4)), or Inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion (BS EN 15621:2017(5))
	For determination of particle size distribution: Particle size analysis — Laser diffraction methods (BS ISO 13320:2020(6))
Species or category of animal	Ruminants with a functional rumen Equidae Lagomorphs Rodents Herbivore reptiles Zoo mammals
Maximum age	None
Minimum content(7)	None
Maximum content(7)	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 total element (cobalt) content must be stated on the labelling of the additive and premixture.
	3. The following must be stated, in English or in English and Welsh, on the labelling of the additive and premixture: In English: “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.” In Welsh: “Argymhellir cyfyngu ar atchwanegu â chobalt i 0.3 mg/kg mewn bwyd anifeiliaid cyflawn. Yn y cyd-destun hwn, dylid ystyried y risg o ddiffyg cobalt oherwydd amodau lleol a chyfansoddiad penodol y deiet.”
	4. The following must be stated, in English or in English and Welsh, on the instructions of use of the compound feed: In English: “Protective measures to avoid exposure with cobalt by inhalation or by dermal route should be taken.” In Welsh: “Dylid cymryd mesurau diogelu i osgoi dod i gysylltiad â chobalt drwy fewnanadlu neu drwy lwybr croenol.”
Start of provisional authorisation period	15 July 2023
End of provisional authorisation period	End of 14 July 2028

(1)

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

(2)

Details of the analytical methods are set out in the document referenced “JRC.D.5/FSQ/CvH/PRO/ag/ARES(2012)214390” dated 24 February 2012, and last updated on 6 June 2016. This document is available at the following address: https://joint-research-centre.ec.europa.eu/publications/fad-cobalt-group_en.

(3)

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.

(4)

Under reference 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 31 August 2017 (ISBN 978 0 580 94541 0). Available from the British Standards Institution https://knowledge.bsigroup.com.

(5)

Under reference 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 31 August 2017 (ISBN 978 0 580 94543 4). Available from the British Standards Institution https://knowledge.bsigroup.com.

(6)

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

(7)

Content of element (cobalt) in mg/kg of complete feed with a moisture content of 12%.