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Welsh Statutory Instruments
Agriculture, Wales
Made
20 June 2023
Laid before Senedd Cymru
22 June 2023
Coming into force
14 July 2023
The Welsh Ministers make these Regulations in exercise of the powers conferred by Articles 15 and 18A(3)(b) of Regulation (EC) No 1831/2003of 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 178/2002of 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).
1.—(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.
2.—(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 1831/2003of the European Parliament and of the Council on additives for use in animal nutrition;
“ Regulation 767/2009” (“Rheoliad 767/2009”) means Regulation (EC) No 767/2009of the European Parliament and of the Council on the placing on the market and use of feed( 3).
3.—(1) Paragraphs (2) to (5) prescribe the forms of provisional authorisations for certain feed additives( 4).
(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.
Lynne Neagle
Deputy Minister for Mental Health and Wellbeing, under the authority of the Minister for Health and Social Services, one of the Welsh Ministers
20 June 2023
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.
(1)
CAS Registry Number® assigned to this substance by the Chemical Abstracts Servicehttps://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%. | |
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
|
Characterisation of the active substance(s) |
Cobalt(II) acetate tetrahydrate
|
Analytical methods (2) |
For the identification of acetate in the additive:
|
For the crystallographic characterisation of the additive:
| |
For the determination of total cobalt in the additive, premixtures, compound feed and feed materials: | |
For determination of particle size distribution:
| |
Species or category of animal |
|
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:
| |
4. The following must be stated, in English or in English and Welsh, on the instructions of use of the compound feed:
| |
Start of provisional authorisation period | 15 July 2023 |
End of provisional authorisation period | End of 14 July 2028 |
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.
(1)
CAS Registry Number® assigned to this substance by the Chemical Abstracts Servicehttps://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 Onlinehttps://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%. | |
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
|
Characterisation of the active substance(s) |
Cobalt(II) carbonate
|
Analytical methods (2) |
For the identification of carbonate in the additive:
|
For the crystallographic characterisation of the additive:
| |
For the determination of total cobalt in the additive, premixtures, compound feed and feed materials: | |
For determination of particle size distribution:
| |
Species or category of animal |
|
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:
| |
4. The following must be stated, in English or in English and Welsh, on the instructions of use of the compound feed:
| |
Start of provisional authorisation period | 15 July 2023 |
End of provisional authorisation period | End of 14 July 2028 |
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.
(1)
CAS Registry Number® assigned to this substance by the Chemical Abstracts Servicehttps://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 Onlinehttps://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%. | |
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
|
Characterisation of the active substance(s) |
Cobalt(II) carbonate hydroxide (2:3) monohydrate
|
Analytical methods (2) |
For the identification of carbonate in the additive:
|
For the crystallographic characterisation of the additive:
| |
For the determination of total cobalt in the additive, premixtures, compound feed and feed materials: | |
For determination of particle size distribution:
| |
Species or category of animal |
|
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:
| |
4. The following must be stated, in English or in English and Welsh, on the instructions of use of the compound feed:
| |
Start of provisional authorisation period | 15 July 2023 |
End of provisional authorisation period | End of 14 July 2028 |
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.
(1)
CAS Registry Number® assigned to this substance by the Chemical Abstracts Servicehttps://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 Onlinehttps://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%. | |
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
|
Characterisation of the active substance(s) |
Cobalt(II) sulphate heptahydrate
|
Analytical methods (2) |
For the identification of sulphate in the additive:
|
For the crystallographic characterisation of the additive:
| |
For the determination of total cobalt in the additive, premixtures, compound feed and feed materials: | |
For determination of particle size distribution:
| |
Species or category of animal |
|
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:
| |
4. The following must be stated, in English or in English and Welsh, on the instructions of use of the compound feed:
| |
Start of provisional authorisation period | 15 July 2023 |
End of provisional authorisation period | End of 14 July 2028 |
(This note is not part of the Regulations)
These Regulations make provision as regards the provisional authorisation, in relation to Wales, of certain feed additives under Regulation (EC) No 1831/2003of the European Parliament and of the Council on additives for use in animal nutrition.
Regulation 3, and Schedules 1 to 4, prescribe the forms of the provisional authorisations, in relation to Wales, of four feed additives.
Schedule 1 contains the prescribed form of provisional authorisation for cobalt(II) acetate tetrahydrate (identification number 3b301).
Schedule 2 contains the prescribed form of provisional authorisation for cobalt(II) carbonate (identification number 3b302).
Schedule 3 contains the prescribed form of provisional authorisation for cobalt(II) carbonate hydroxide (2:3) monohydrate (identification number 3b303).
Schedule 4 contains the prescribed form of provisional authorisation for cobalt(II) sulphate heptahydrate (identification number 3b305).
Further information, including in relation to any documentation referenced in the Schedules, can be obtained from the Food Standards Agency, 11th Floor, Southgate House, Wood Street, Cardiff, CF10 1EW or by writing to regulated.products.wales@food.gov.uk.
The Welsh Ministers’ Code of Practice on the carrying out of Regulatory Impact Assessments was considered in relation to these Regulations. As a result, it was not considered necessary to carry out a regulatory impact assessment as to the likely costs and benefits of complying with these Regulations.
EUR 2003/1831, amended by S.I. 2019/654, 2022/377and 2022/1351. S.I. 2019/654was amended by S.I. 2020/1504. The terms “ prescribe” and “ appropriate authority” are defined in Article 2 of EUR 2003/1831.
EUR 2002/178, amended by S.I. 2019/641; there are other amending instruments but none is relevant. S.I. 2019/641was amended by S.I. 2020/1504.
EUR 2009/767, amended by S.I. 2019/654; there is another amending instrument not relevant to these Regulations. S.I. 2019/654was amended by S.I. 2020/1504.
The feed additives were provisionally authorised, in relation to Wales, by administrative decision of the Welsh Ministers dated 20 June 2023, pursuant to Article 15 of EUR 2003/1831.