LegalizeThe Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission Regulation (EU) 2020/354) (Wales) Regulations 2024
| (1) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry. | (1) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry. |
|---|---|
| (2) European Inventory of Existing Commercial Substances, as published in OJ No C146A, 15.6.90, p.1. | (2) European Inventory of Existing Commercial Substances, as published in OJ No C146A, 15.6.90, p.1. |
| (3) Details of the analytical methods are set out in the document referenced “Ares(2021)145311 – 07/01/2021” and “JRC F.5/CvH/SB/AS/Ares”, and last updated on 17 February 2021. Available at https://joint-research-centre.ec.europa.eu/publications/fad-2020-0006_en. | (3) Details of the analytical methods are set out in the document referenced “Ares(2021)145311 – 07/01/2021” and “JRC F.5/CvH/SB/AS/Ares”, and last updated on 17 February 2021. Available at https://joint-research-centre.ec.europa.eu/publications/fad-2020-0006_en. |
| (4) European Pharmacopoeia monograph - Ph. Eur. 8.0, 01/2014:1036. Published online by the European Directorate for the Quality of Medicines and Healthcare on 1 January 2024. Available at: https://pheur.edqm.eu/home. | (4) European Pharmacopoeia monograph - Ph. Eur. 8.0, 01/2014:1036. Published online by the European Directorate for the Quality of Medicines and Healthcare on 1 January 2024. Available at: https://pheur.edqm.eu/home. |
| (5) Under reference BS EN 14148:2003 “Foodstuffs. Determination of vitamin K1 by HPLC”. Published by the British Standards Institution on 25 July 2003 (ISBN 0 580 42317 4). Available at: https://knowledge.bsigroup.com. | (5) Under reference BS EN 14148:2003 “Foodstuffs. Determination of vitamin K1 by HPLC”. Published by the British Standards Institution on 25 July 2003 (ISBN 0 580 42317 4). Available at: https://knowledge.bsigroup.com. |
| (6) Content of phytomenadione (vitamin K₁) (mg/kg of complete feed with a moisture content of 12%). | (6) Content of phytomenadione (vitamin K₁) (mg/kg of complete feed with a moisture content of 12%). |
| Additive | Phytomenadione or vitamin K₁ |
| Identification number | 3a712 |
| Authorisation holder | None |
| Additive category | Nutritional additives |
| Functional group | Vitamins, pro-vitamins and chemically well-defined substances having similar effect |
| Additive composition | Produced by chemical synthesis Solid preparation containing a minimum of 4.2% of phytomenadione (vitamin K₁) |
| Characterisation of the active substance(s) | 2-methyl-3-[(E-7R,11R)-3,7,11,15-tetramethylhexadec-2- enyl] naphthalene-1,4-dione (phytomenadione) (C₃₁H₄₆O₂) CAS number: 84-80-0[^f01069] EINECS number: 201-564-2[^f01070] with the following components: E-phytomenadione: 75% minimum E-epoxyphytomenadione: 4% maximum Total purity of E-phytomenadione, E-epoxyphytomenadione and Z-phytomenadione isomers: 97% minimum |
| Analytical methods[^f01071] | For the determination of phytomenadione (vitamin K₁) in the feed additive: High performance liquid chromatography (HPLC) (European Pharmacopoeia monograph 1036[^f01072]) |
| Analytical methods[^f01071] | For the determination of phytomenadione in the additive preparation and in complimentary feed: High performance liquid chromatography with fluorescence detection (HPLC-FLD) (BS EN 14148:2003[^f01073]) |
| Species or category of animal | Horses |
| Maximum age | None |
| Minimum content[^f01074] | None |
| Maximum content[^f01074] | None |
| Other provisions | The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture. |
SCHEDULE 17 — ...
The preparation of copper chelate of hydroxy analogue of methionine specified in the table, belonging to the additive category “nutritional additives” and to the functional group “compounds of trace elements”, is authorised as an additive in animal nutrition subject to the conditions set out in the table[^f00038].
| (1) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry. | (1) CAS Registry Number® assigned to this preparation 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 “D08-FSQ(2007)D/29104”, and last updated on 6 June 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2007-0012_en. | (2) Details of the analytical methods are set out in the document referenced “D08-FSQ(2007)D/29104”, and last updated on 6 June 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2007-0012_en. |
| (3) 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 at: https://knowledge.bsigroup.com. | (3) 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 at: https://knowledge.bsigroup.com. |
| (4) 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 at: https://knowledge.bsigroup.com. | (4) 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 at: https://knowledge.bsigroup.com. |
| (5) Under reference BS EN ISO 6869:2001 “Animal feeding stuffs. Determination of the contents of calcium, copper, iron, magnesium, manganese, potassium, sodium and zinc. Method using atomic absorption spectrometry”. Published by the British Standards Institution on 15 March 2001 (ISBN 0 580 36933 1). Available at: https://knowledge.bsigroup.com. | (5) Under reference BS EN ISO 6869:2001 “Animal feeding stuffs. Determination of the contents of calcium, copper, iron, magnesium, manganese, potassium, sodium and zinc. Method using atomic absorption spectrometry”. Published by the British Standards Institution on 15 March 2001 (ISBN 0 580 36933 1). Available at: https://knowledge.bsigroup.com. |
| (6) Under reference BS EN 17053:2018 “Animal feeding stuffs: Methods of sampling and analysis. Determination of trace elements, heavy metals and other elements in feed by ICP-MS (multi-method)”. Published by the British Standards Institution on 28 February 2018 (ISBN 978 0 580 94471 0). Available at: https://knowledge.bsigroup.com. | (6) Under reference BS EN 17053:2018 “Animal feeding stuffs: Methods of sampling and analysis. Determination of trace elements, heavy metals and other elements in feed by ICP-MS (multi-method)”. Published by the British Standards Institution on 28 February 2018 (ISBN 978 0 580 94471 0). Available at: https://knowledge.bsigroup.com. |
| (7) Content of copper (Cu) (mg/kg of complete feed with a moisture content of 12%). | (7) Content of copper (Cu) (mg/kg of complete feed with a moisture content of 12%). |
| Additive | Copper chelate of hydroxy analogue of methionine |
| Identification number | 3b410i |
| Authorisation holder | None |
| Additive category | Nutritional additives |
| Functional group | Compounds of trace elements |
| Additive composition | Copper chelate of hydroxy analogue of methionine in solid form containing a minimum of 16% copper and the following components: (2-hydroxy-4-methylthio) butanoic acid: 78% minimum Nickel: 20 ppm maximum |
| Characterisation of the active substance(s) | Copper chelate of hydroxy analogue of methionine (Cu(CH₃S(CH₂)₂-CH(OH)-COO)₂) CAS number[^f01075]: 292140-30-8 |
| Analytical methods[^f01076] | For the quantification of the hydroxy analogue of methionine content in the feed additive: Titrimetry, potentiometric titration after oxidation reduction reaction |
| Analytical methods[^f01076] | For the quantification of total copper in the feed additive: Inductively coupled plasma atomic emission spectrometry (ICP-AES) (BS EN 15510:2017[^f01077] or BS EN 15621:2017[^f01078]); or Atomic absorption spectrometry (AAS) (BS EN ISO 6869:2001)[^f01079] |
| Analytical methods[^f01076] | For the quantification of total copper in premixtures: Inductively coupled plasma atomic emission spectrometry (ICP-AES) (BS EN 15510:2017[^f01077] or BS EN 15621:2017[^f01078]); or Atomic absorption spectrometry (AAS) (BS EN ISO 6869:2001[^f01079]); or Inductively coupled plasma mass spectrometry (ICP-MS) (BS EN 17053:2018[^f01080]) |
| Analytical methods[^f01076] | For the quantification of total copper in feed materials and compound feed: Inductively coupled plasma atomic emission spectrometry (ICP-AES) (BS EN 15510:2017[^f01077] or BS EN 15621:2017[^f01078]); or Atomic absorption spectrometry (AAS) (Commission Regulation (EC) No 152/2009 laying down the methods of sampling and analysis for official control of feed - Annex 4, C or BS EN ISO 6869:2001[^f01079]); or Inductively coupled plasma mass spectrometry (ICP-MS) (BS EN 17053:2018[^f01080]) |
| Species or category of animal | All animal species |
| Maximum age | None |
| Minimum content[^f01081] | None |
| Maximum content[^f01081] | For bovines: Before the start of rumination: 15 mg/kg (total) Other: 30 mg/kg (total) |
| Maximum content[^f01081] | For ovines: 15 mg/kg (total) |
| Maximum content[^f01081] | For caprines: 35 mg/kg (total) |
| Maximum content[^f01081] | For piglets: Suckling and weaned up 4 weeks after weaning:150 mg/kg (total) From 5th week up to 8 weeks after weaning: 100 mg/kg (total) |
| Maximum content[^f01081] | For crustaceans: 50 mg/kg (total) |
| Maximum content[^f01081] | For all other animal species: 25 mg/kg (total) |
| Other provisions | 1. The additive must be incorporated into feed in the form of a premixture. |
| Other provisions | 2. For feed for sheep, where the level of copper in the feed exceeds 10 mg/kg, the following must be stated, in English or in English and Welsh, on the labelling of the feed: In English: “The level of copper in this feed may cause poisoning in certain breeds of sheep”. In Welsh: “Gall lefel y copr yn y bwyd anifeiliaid hwn achosi gwenwyno mewn rhai bridiau o ddefaid”. |
| Other provisions | 3. For feed for bovines after the start of rumination, where the level of copper in the feed is less than 20 mg/kg, the following must be stated, in English or in English and Welsh, on the labelling of the feed: In English: “The level of copper in this feed may cause copper deficiencies in cattle grazing pastures with high contents of molybdenum or sulphur”. In Welsh: “Gall lefel y copr yn y bwyd anifeiliaid hwn achosi diffygion copr mewn gwartheg syn pori tir sydd â chynnwys uchel o folybdenwm neu sylffwr”. |
SCHEDULE 18 — ...
The preparation of manganese chelate of hydroxy analogue of methionine specified in the table, belonging to the additive category “nutritional additives” and to the functional group “compounds of trace elements”, is authorised as an additive in animal nutrition subject to the conditions set out in the table[^f00039].
| (1) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry. | (1) CAS Registry Number® assigned to this preparation 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 “D08-FSQ(2007)D/29224”, and last updated on 6 June 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2007-0011_en. | (2) Details of the analytical methods are set out in the document referenced “D08-FSQ(2007)D/29224”, and last updated on 6 June 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2007-0011_en. |
| (3) Under reference BS EN ISO 6869:2001 “Animal feeding stuffs. Determination of the contents of calcium, copper, iron, magnesium, manganese, potassium, sodium and zinc. Method using atomic absorption spectrometry”. Published by the British Standards Institution on 15 March 2001 (ISBN 0 580 36933 1). Available at: https://knowledge.bsigroup.com. | (3) Under reference BS EN ISO 6869:2001 “Animal feeding stuffs. Determination of the contents of calcium, copper, iron, magnesium, manganese, potassium, sodium and zinc. Method using atomic absorption spectrometry”. Published by the British Standards Institution on 15 March 2001 (ISBN 0 580 36933 1). Available at: https://knowledge.bsigroup.com. |
| (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 at: https://knowledge.bsigroup.com. | (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 at: 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 at: 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 at: https://knowledge.bsigroup.com. |
| (6) Content of manganese (Mn) (mg/kg of complete feed with a moisture content of 12%). | (6) Content of manganese (Mn) (mg/kg of complete feed with a moisture content of 12%). |
| Additive | Manganese chelate of hydroxy analogue of methionine |
| Identification number | 3b510 |
| Authorisation holder | None |
| Additive category | Nutritional additives |
| Functional group | Compounds of trace elements |
| Additive composition | Manganese chelate of hydroxy analogue of methionine in solid form containing a minimum of 14% manganese and the following components: (2-hydroxy-4-methylthio) butanoic acid: 76% minimum Nickel: 170 ppm maximum |
| Characterisation of the active substance(s) | Manganese chelate of hydroxy analogue of methionine (Mn(CH₃S(CH₂)₂-CH(OH)-COO)₂) CAS number[^f01082]: 292140-29-5 |
| Analytical methods[^f01083] | For the quantification of the hydroxy analogue of methionine content in the feed additive: Titrimetry, potentiometric titration after oxidation reduction reaction |
| Analytical methods[^f01083] | For the quantification of total manganese in the feed additive and premixtures Atomic absorption spectrometry (AAS) (BS EN ISO 6869:2001[^f01084]), or Inductively coupled plasma atomic emission spectrometry (ICP-AES) (BS EN 15510:2017[^f01085]), or Inductively coupled plasma atomic emission spectrometry after pressure digestion (ICP-AES) (BS EN 15621:2017[^f01086]) |
| Analytical methods[^f01083] | For the quantification of total manganese in feed materials and compound feed: Atomic absorption spectrometry (AAS) (Commission Regulation (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed - Annex 4, C or BS EN ISO 6869:2001[^f01084]), or Inductively coupled plasma atomic emission spectrometry, ICP-AES (BS EN 15510:2017[^f01085]), or Inductively coupled plasma atomic emission spectrometry after pressure digestion (ICP-AES) (BS EN 15621:2017[^f01086]) |
| Species or category of animal | All animal species |
| Maximum age | None |
| Minimum content[^f01087] | None |
| Maximum content[^f01087] | For fish: 100 mg/kg (total) |
| Maximum content[^f01087] | For all other animal species: 150 mg/kg (total) |
| Other provisions | 1. The additive must be incorporated into feed in the form of a premixture. |
| Other provisions | 2. Manganese chelate of hydroxy analogue of methionine may be placed on the market and used as an additive consisting of a preparation. |
SCHEDULE 19 — ...
The preparation of zinc chelate of hydroxy analogue of methionine specified in the table, belonging to the additive category “nutritional additives” and to the functional group “compounds of trace elements”, is authorised as an additive in animal nutrition subject to the conditions set out in the table[^f00040].
| (1) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry. | (1) CAS Registry Number® assigned to this preparation 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 “D08-FSQ(2007)D/29110”, and last updated on 6 June 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2007-0010_en. | (2) Details of the analytical methods are set out in the document referenced “D08-FSQ(2007)D/29110”, and last updated on 6 June 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2007-0010_en. |
| (3) 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 at: https://knowledge.bsigroup.com. | (3) 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 at: https://knowledge.bsigroup.com. |
| (4) 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 at: https://knowledge.bsigroup.com. | (4) 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 at: https://knowledge.bsigroup.com. |
| (5) Under reference BS EN ISO 6869:2001 “Animal feeding stuffs. Determination of the contents of calcium, copper, iron, magnesium, manganese, potassium, sodium and zinc. Method using atomic absorption spectrometry”. Published by the British Standards Institution on 15 March 2001 (ISBN 0 580 36933 1). Available at: https://knowledge.bsigroup.com. | (5) Under reference BS EN ISO 6869:2001 “Animal feeding stuffs. Determination of the contents of calcium, copper, iron, magnesium, manganese, potassium, sodium and zinc. Method using atomic absorption spectrometry”. Published by the British Standards Institution on 15 March 2001 (ISBN 0 580 36933 1). Available at: https://knowledge.bsigroup.com. |
| (6) Under reference BS EN 17053:2018 “Animal feeding stuffs: Methods of sampling and analysis. Determination of trace elements, heavy metals and other elements in feed by ICP-MS (multi-method)”. Published by the British Standards Institution on 28 February 2018 (ISBN 978 0 580 94471 0). Available at: https://knowledge.bsigroup.com. | (6) Under reference BS EN 17053:2018 “Animal feeding stuffs: Methods of sampling and analysis. Determination of trace elements, heavy metals and other elements in feed by ICP-MS (multi-method)”. Published by the British Standards Institution on 28 February 2018 (ISBN 978 0 580 94471 0). Available at: https://knowledge.bsigroup.com. |
| (7) Content of zinc (Zn) (mg/kg of complete feed with a moisture content of 12%). | (7) Content of zinc (Zn) (mg/kg of complete feed with a moisture content of 12%). |
| Additive | Zinc chelate of hydroxy analogue of methionine |
| Identification number | 3b610 |
| Authorisation holder | None |
| Additive category | Nutritional additives |
| Functional group | Compounds of trace elements |
| Additive composition | Zinc chelate of hydroxy analogue of methionine in solid form containing a minimum of 17% zinc and the following components. (2-hydroxy-4-methylthio) butanoic acid: 79% minimum Nickel: 1.7 ppm maximum |
| Characterisation of the active substance(s) | Zinc chelate of hydroxy analogue of methionine (Zn(CH₃S(CH₂)₂-CH(OH)-COO)₂) CAS number[^f01088]: 292140-29-5 |
| Analytical methods[^f01089] | For the quantification of the hydroxy analogue of methionine content in the feed additive: Titrimetry, potentiometric titration after oxidation reduction reaction |
| Analytical methods[^f01089] | For the quantification of total zinc in the feed additive: Inductively coupled plasma atomic emission spectrometry (ICP-AES) (BS EN 15510:2017[^f01090] or BS EN 15621:2017[^f01091]), or Atomic absorption spectrometry (AAS) (BS EN ISO 6869:2001[^f01092]) |
| Analytical methods[^f01089] | For the quantification of total zinc in premixtures: Inductively coupled plasma atomic emission spectrometry (ICP-AES) (BS EN 15510:2017[^f01090] or BS EN 15621:2017[^f01091]), or Atomic absorption spectrometry (AAS) (BS EN ISO 6869:2001[^f01092]), or Inductively coupled plasma mass spectrometry (ICP-MS) (BS EN 17053:2018[^f01093]) |
| Analytical methods[^f01089] | For the quantification of total zinc in feed materials and compound feed: Inductively coupled plasma atomic emission spectrometry (ICP-AES) (BS EN 15510:2017[^f01090] or BS EN 15621:2017[^f01091]), or Atomic absorption spectrometry (AAS) (Commission Regulation (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed - Annex 4, C or BS EN ISO 6869:2001[^f01092]), or Inductively coupled plasma mass spectrometry ICP-MS (BS EN 17053:2018[^f01093]) |
| Species or category of animal | All animal species |
| Maximum age | None |
| Minimum content[^f01094] | None |
| Maximum content[^f01094] | For cats: 200 mg/kg (total) |
| Maximum content[^f01094] | For dogs: 200mg/kg (total) |
| Maximum content[^f01094] | For fish: Salmonids: 180 mg/kg (total) Other: 150 mg/kg (total) |
| Maximum content[^f01094] | For milk replacers for calves: 180 mg/kg (total) |
| Maximum content[^f01094] | For rabbits: 150 mg/kg (total) |
| Maximum content[^f01094] | For Suidae: Piglets, sows: 150 mg/kg (total) Other: 120 mg/kg (total) |
| Maximum content[^f01094] | For all other animal species: 120 mg/kg (total) |
| Other provisions | 1. The additive must be incorporated into feed in the form of a premixture. |
| Other provisions | 2. Zinc chelate of hydroxy analogue of methionine may be placed on the market and used as an additive consisting of a preparation. |
SCHEDULE 20 — ...
The preparation of fumonisin esterase (EC 3.1.1.87) produced by fermentation with Komagataella phaffii (DSM 32159) specified in the table, belonging to the additive category “technological additives” and to the functional group “substances for reduction of the contamination of feed by mycotoxins”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
| (1) 1 U is the enzymatic activity that releases 1 µmol tricarballylic acid per minute from 100 µM fumonisin B1 in 20 mM Tris-Cl buffer pH 8.0 with 0.1 mg/ml bovine serum albumin at 30 ºC. | (1) 1 U is the enzymatic activity that releases 1 µmol tricarballylic acid per minute from 100 µM fumonisin B1 in 20 mM Tris-Cl buffer pH 8.0 with 0.1 mg/ml bovine serum albumin at 30 ºC. |
|---|---|
| (2) Identification number allocated by the International Union of Biochemistry and Molecular Biology (IUBMB) https://iubmb.org. | (2) Identification number allocated by the International Union of Biochemistry and Molecular Biology (IUBMB) https://iubmb.org. |
| (3) Details of the analytical methods are set out in the document referenced “Ares(2017)2516958 - 17/05/2017” and “JRC F.5/CvH/MGH /mds/Ares”, and last updated on 18 May 2017. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2017-0005_en. | (3) Details of the analytical methods are set out in the document referenced “Ares(2017)2516958 - 17/05/2017” and “JRC F.5/CvH/MGH /mds/Ares”, and last updated on 18 May 2017. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2017-0005_en. |
| (4) Units of activity/kg of fresh material. | (4) Units of activity/kg of fresh material. |
| Additive | Fumonisin esterase (EC 3.1.1.87) |
| Identification number | 1m03i |
| Authorisation holder | None |
| Additive category | Technological additives |
| Functional group | Substances for reduction of the contamination of feed by mycotoxins |
| Additive composition | Preparation of fumonisin esterase (EC 3.1.1.87) produced by fermentation with Komagataella phaffii (DSM 32159) having a minimum enzyme activity of 3000 U/g[^f01095] |
| Characterisation of the active substance(s) | Fumonisin esterase (EC 3.1.1.87) produced by Komagataella phaffii (DSM 32159) EC (IUBMB) Number[^f01096]: 3.1.1.87 |
| Analytical methods[^f01097] | For the determination of fumonisin esterase activity: High performance liquid chromatography coupled with a tandem mass spectrometry (HPLC-MS/MS) method based on the quantification of the tricarballylic acid released from the action of the enzyme on fumonisin B₁ at pH 8.0 and 30 ºC. |
| Species or category of animal | All animal species |
| Maximum age | None |
| Minimum content[^f01098] | 40 U/kg |
| Maximum content[^f01098] | None |
| Other provisions | 1. The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture. |
| Other provisions | 2. The additive is authorised for use only in maize-based silages. |
SCHEDULE 21 — ...
Commission Regulation (EC) No 109/2007 concerning the authorisation of monensin sodium (Coxidin) as a feed additive[^f00041]
Commission Regulation (EU) No 333/2010 concerning the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.)[^f00042]
Commission Regulation (EU) No 335/2010 concerning the authorisation of zinc chelate of hydroxy analogue of methionine as a feed additive for all animal species[^f00043]
Commission Regulation (EU) No 349/2010 concerning the authorisation of copper chelate of hydroxy analogue of methionine as a feed additive for all animal species[^f00044]
Commission Regulation (EU) No 350/2010 concerning the authorisation of manganese chelate of hydroxy analogue of methionine as a feed additive for all animal species[^f00045]
Commission Regulation (EU) No 170/2011 concerning the authorisation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for piglets (weaned) and amending Regulation (EC) No 1200/2005 (holder of authorisation Prosol SpA)[^f00046]
Commission Regulation (EU) No 184/2011 concerning the authorisation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for chickens reared for laying, turkeys, minor avian species and other ornamental and game birds (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.)[^f00047]
Commission Implementing Regulation (EU) No98/2012 concerning the authorisation of 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036) as a feed additive for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, laying hens, other avian species for fattening and laying, weaned piglets, pigs for fattening and sows (holder of authorisation Huvepharma AD)[^f00048]
Commission Implementing Regulation (EU) No140/2012 concerning the authorisation of monensin sodium as a feed additive for chickens reared for laying (holder of authorisation Huvepharma NV Belgium)[^f00049]
Commission Implementing Regulation (EU) 2019/893 concerning the renewal of the authorisation of Bacillus subtilis DSM 15544 as a feed additive for chickens for fattening and repealing Regulation (EC) No 1444/2006 (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.)[^f00050]
Commission Implementing Regulation (EU) 2020/146 amending Regulation (EU) No333/2010, Implementing Regulation (EU) 2017/2312, Implementing Regulation (EU) 2018/1081, Implementing Regulation (EU) 2016/897, Implementing Regulation (EU) 2019/893 and Regulation (EU) No184/2011 concerning the authorisations of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive[^f00051]
Signed
Sarah Murphy — Minister for Mental Health and Wellbeing, under the authority of the Cabinet Secretary for Health and Social Care, one of the Welsh Ministers — 27 November 2024
Explanatory note
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Footnotes
[^f00004]: EUR 2009/767, amended by S.I. 2019/654, 2022/1351. S.I. 2019/654 was amended by S.I. 2020/1504.
[^f00005]: EUR 2008/429, to which there are amendments not relevant to these Regulations.
[^f00010]: But see regulation 15 of these Regulations for transitional provision. See Schedule 11 to these Regulations for the new authorisation of butylated hydroxyanisole as a feed additive for cats.
[^f00014]: See Schedule 6 to these Regulations for relevant renewed authorisation of this feed additive.
[^f00015]: EUR 2012/98, amended prior to implementation period completion day by Commission Implementing Regulation (EU) 2016/348 (EUR 2016/348). EUR 2012/98 is revoked by regulation 20 of, and Schedule 21 to, these Regulations.
[^f00016]: See Schedule 7 to these Regulations for relevant renewed and consolidated authorisation of this feed additive.
[^f00017]: EUR 2010/333, amended prior to implementation period completion day by Commission Implementing Regulation (EU) 2020/146 (EUR 2020/146). EUR 2010/333 and 2020/146 are revoked by regulation 20 of, and Schedule 21 to, these Regulations
[^f00018]: EUR 2011/184, amended prior to implementation period completion day by Commission Implementing Regulation (EU) 2020/146 (EUR 2020/146). EUR 2011/184 and 2020/146 are revoked by regulation 20 of, and Schedule 21 to, these Regulations
[^f00019]: See regulation 4 of these Regulations for amendments to EUR 2016/897.
[^f00020]: EUR 2019/893, amended prior to implementation period completion day by Commission Implementing Regulation (EU) 2020/146 (EUR 2020/146). EUR 2019/893 and 2020/146 are revoked by regulation 20 of, and Schedule 21 to, these Regulations.
[^f00021]: See regulation 7 of these Regulations for amendments to EUR 2019/804.
[^f00022]: See Schedule 17 to these Regulations for the renewed authorisation of this feed additive.
[^f00023]: EUR 2010/349, amended prior to implementation period completion day by Commission Implementing Regulation (EU) 2018/1039 (EUR 2018/1039). EUR 2010/349 is revoked by regulation 20 of, and Schedule 21 to, these Regulations.
[^f00024]: See Schedule 18 to these Regulations for the renewed authorisation of this feed additive.
[^f00025]: EUR 2010/350. EUR 2010/350 is revoked by regulation 20 of, and Schedule 21 to, these Regulations.
[^f00026]: See Schedule 19 to these Regulations for the renewed authorisation of this feed additive.
[^f00027]: EUR 2010/335, amended prior to implementation period completion day by Commission Implementing Regulation (EU) 2016/1095 (EUR 2016/1095). EUR 2010/335 is revoked by regulation 20 of, and Schedule 21 to, these Regulations.
[^f00028]: EUR 2020/354, to which there are amendments not relevant to these Regulations.
Editorial notes
[^key-cd49bc782d9eb23d8e2d32a4b7ccc0b2]: Reg. 1 in force at 20.12.2024, see reg. 1(2)(c)
[^key-a69db0cd3531eb8bb4a3c9c9e1065b55]: Reg. 2 in force at 20.12.2024, see reg. 1(2)(c)
[^key-6ae1092a2592473117c574c2e5e90576]: Reg. 8 in force at 20.12.2024, see reg. 1(2)(c)
[^key-ed4d71fd507b5b94282c1e5ed0cc4099]: Reg. 12 in force at 20.12.2024, see reg. 1(2)(c)
[^key-a75b664b28e04a00895aad684ed15f2a]: Reg. 13 in force at 20.12.2024, see reg. 1(2)(c)
[^key-95a6a4ef493016909faa03dfc6bc7d62]: Reg. 14 in force at 20.12.2024, see reg. 1(2)(c)
[^key-3928c4b44484c71e033d0a340c06aa81]: Reg. 15 in force at 20.12.2024, see reg. 1(2)(c)
[^key-0444e826542923f71f679607171df51c]: Reg. 16 in force at 20.12.2024, see reg. 1(2)(c)
[^key-2a7ecd99c02f469d76de7cfba944b316]: Reg. 17 in force at 20.12.2024, see reg. 1(2)(c)
[^key-013299e554e691ab49e94e04b73e0889]: Words in reg. 2(1) substituted (31.3.2025) by The Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission Regulation (EU) 2020/354) (Wales) (Amendment) Regulations 2025 (S.I. 2025/384), regs. 1, 2(2)
Enwi, rhychwant, cymhwyso a dod i rym
Dehongli
Awdurdodiadau
Addasu awdurdodiadau: paratoad o Bacillus velezensis (DSM 15544) (rhif adnabod 4b1820)
Addasu awdurdodiad: burum wedi ei seleneiddio a gynhyrchir drwy eplesu â Saccharomyces cerevisiae CNCM I-3060, anactifedig (rhif adnabod 3b810)
Dileu awdurdodiad hydrocsianisol bwtyleiddiedig fel cynnyrch presennol at ddibenion Erthygl 10 o Reoliad (EC) Rhif 1831/2003
Newidiadau o ran deiliad awdurdodiad: diwygio Rheoliad Gweithredu’r Comisiwn (EU) Rhif 887/2011 a Rheoliadau Gweithredu’r Comisiwn (EU) 2017/961 a 2020/1395
Darpariaeth drosiannol: 6-ffytas (EC 3.1.3.26) a gynhyrchir drwy eplesu â Komagataella phaffii (Komagataella pastoris yn flaenorol) (DSM 23036) (rhif adnabod 4a16)
Darpariaeth drosiannol: Bacillus velezensis (Bacillus subtilis C-3102 yn flaenorol) (DSM 15544) (rhif adnabod 4b1820)
Darpariaeth drosiannol: Burum wedi ei seleneiddio a gynhyrchir drwy eplesu â Saccharomyces cerevisiae CNCM I-3060, anactifedig (rhif adnabod 3b810)
Darpariaeth drosiannol: Hydrocsianisol bwtyleiddiedig fel ychwanegyn bwyd anifeiliaid ar gyfer cathod
Darpariaethau trosiannol: Celadau copor, manganîs, a zincoanaloghydrocsio fethionin (rhifau adnabod 3b410i, 3b510 a 3b610 yn y drefn honno)
Addasu nodwedd faethol hanfodol ar gyfer bwyd anifeiliaid a fwriedir i leihau’r risg o dwymyn llaeth a chlwy’r llaeth is-glinigol
Diwygio Rheoliad Gweithredu’r Comisiwn (EU) 2016/1095
Diwygio Rheoliad Gweithredu’r Comisiwn (EU) 2018/1039
Dirymiadau
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