The 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. |
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| (2) Details of the analytical methods are set out in the document referenced “Ares(2019)7003671 - 12/11/2019” and “JRC F.5/CvH/SB/AS/Ares”, and last updated on 27 January 2020. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2019-00160028_en. | (2) Details of the analytical methods are set out in the document referenced “Ares(2019)7003671 - 12/11/2019” and “JRC F.5/CvH/SB/AS/Ares”, and last updated on 27 January 2020. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2019-00160028_en. |
| (3) Food Chemicals Codex (FCC), 13th edition (Method: FCC L-lysine monohydrochloride monograph published). Published by the United States Pharmacopeial Convention on 1 March 2022 (ISSN 2153-1455). Available at: https://www.foodchemicalscodex.org/. | (3) Food Chemicals Codex (FCC), 13th edition (Method: FCC L-lysine monohydrochloride monograph published). Published by the United States Pharmacopeial Convention on 1 March 2022 (ISSN 2153-1455). Available at: https://www.foodchemicalscodex.org/. |
| (4) Under reference BS EN ISO 17180:2013 “Animal feeding stuffs. Determination of lysine, methionine and threonine in commercial amino acid products and premixtures”. Published by the British Standards Institution on 30 April 2013 (ISBN 978 0 580 76077 8). Available at: https://knowledge.bsigroup.com. | (4) Under reference BS EN ISO 17180:2013 “Animal feeding stuffs. Determination of lysine, methionine and threonine in commercial amino acid products and premixtures”. Published by the British Standards Institution on 30 April 2013 (ISBN 978 0 580 76077 8). Available at: https://knowledge.bsigroup.com. |
| (5) Content of L-lysine monohydrochloride (mg/kg of complete feed with a moisture content of 12%). | (5) Content of L-lysine monohydrochloride (mg/kg of complete feed with a moisture content of 12%). |
| Additive | L-lysine monohydrochloride (technically pure) |
| Identification number | 3c322ii |
| Authorisation holder | None |
| Additive category | Nutritional additives |
| Functional group | Amino acids, their salts and analogues |
| Additive composition | Powder of L-lysine monohydrochloride with a minimum of 78% L-lysine and a maximum moisture content of 1.5% |
| Characterisation of the active substance(s) | L-lysine monohydrochloride (technically pure) (NH₂(CH₂)₄CH(NH₂)COOH) produced by fermentation with Corynebacterium glutamicum (KCCM 80183) CAS number[^f01053]: 657-27-2 |
| Analytical method[^f01054] | For the identification of L-lysine monohydrochloride in the feed additive: Food Chemicals Codex[^f01055] “L-lysine monohydrochloride monograph” |
| Analytical method[^f01054] | For the quantification of lysine in the feed additive and premixtures containing more than 10% lysine: Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) (BS EN ISO 17180:2013[^f01056]) |
| Analytical method[^f01054] | For the quantification of lysine in premixtures, feed materials and compound feed: Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) (Commission Regulation (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed - Annex 3, F) |
| Analytical method[^f01054] | For the quantification of lysine in water: Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) (BS EN ISO 17180:2013[^f01056]), or Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) (Commission Regulation (EC) No 152/2009 - Annex 3, F) |
| Species or category of animal | All animal species |
| Maximum age | None |
| Minimum content[^f01057] | None |
| Maximum content | None |
| Other provisions | 1. The L-lysine content must be stated on the labelling of the additive. |
| Other provisions | 2. The additive may be used via water for drinking. |
| Other provisions | 3. The following must be stated, in English or in English and Welsh, on the labelling of the additive and premixture: In English: “The supplementation with L-lysine, in particular via water for drinking, should take into account all essential and conditionally essential amino acids in order to avoid imbalances”. In Welsh: “Dylai’r atchwanegiad ag L-lysin, yn arbennig drwy ddŵr i’w yfed, ystyried yr holl asidau amino hanfodol ac amodol hanfodol er mwyn osgoi anghydbwysedd”. |
SCHEDULE 14 — ...
The substance disodium 5’-guanylate (GMP) produced by fermentation with Corynebacterium stationis (KCCM 10530) and Escherichia coli K-12 (KFCC 11067) specified in the table, belonging to the additive category “sensory additives” and to the functional group “flavouring compounds”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
| (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. |
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| (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(2020)4619276 – 04/09/2020” and “JRC F.5/CvH/ZE/AS/Ares”, and last updated on 16 October 2020. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2019-0085_en. | (3) Details of the analytical methods are set out in the document referenced “Ares(2020)4619276 – 04/09/2020” and “JRC F.5/CvH/ZE/AS/Ares”, and last updated on 16 October 2020. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2019-0085_en. |
| (4) Food and Agriculture Organisation of the United Nations (FAO) Joint FAO/WHO Expert Committee on Food Additives (JECFA) - Combined Compendium of Food Additive Specifications, “Disodium 5’-guanylate” Monograph 1 (2006). Published by the FAO and last updated (Web version) August 2011 (ISBN 92-5-105569-6). Available at:https://www.fao.org/food/food-safety-quality/scientific-advice/jecfa/jecfa-additives/detail/en/c/255 | (4) Food and Agriculture Organisation of the United Nations (FAO) Joint FAO/WHO Expert Committee on Food Additives (JECFA) - Combined Compendium of Food Additive Specifications, “Disodium 5’-guanylate” Monograph 1 (2006). Published by the FAO and last updated (Web version) August 2011 (ISBN 92-5-105569-6). Available at:https://www.fao.org/food/food-safety-quality/scientific-advice/jecfa/jecfa-additives/detail/en/c/255 |
| (5) Content of disodium 5’-guanylate (mg/kg of complete feed with a moisture content of 12%). | (5) Content of disodium 5’-guanylate (mg/kg of complete feed with a moisture content of 12%). |
| Additive | Disodium 5’-guanylate |
| Identification number | 2b627i |
| Authorisation holder | None |
| Additive category | Sensory additives |
| Functional group | Flavouring compounds |
| Additive composition | Powder of disodium 5’-guanylate with a minimum purity criteria of 97%. |
| Characterisation of the active substance(s) | Hydrated form of disodium 5’-guanylate (GMP) produced by fermentation with Corynebacterium stationis(KCCM 10530) andEscherichia coliK-12 (KFCC 11067)(C₁₀H₁₂N₅Na₂O₈P) CAS number: 5550-12-9[^f01058] EINECS number[^f01059]: 226-914-1 |
| Analytical methods[^f01060] | For the identification of disodium 5’-guanylate (GMP) in the feed additive: FAO JECFA monograph[^f01061] “disodium 5’-guanylate” |
| Analytical methods[^f01060] | For the determination of disodium 5’-guanylate (GMP) in the feed additive, flavouring premixtures and water: High performance liquid chromatography coupled to UV detection (HPLC-UV) |
| Species or category of animal | All animal species |
| Maximum age | None |
| Minimum content[^f01062] | None |
| Maximum content[^f01062] | None |
| Other provisions | 1. The storage condition-s and stability to heat treatment must be stated in the directions for use of the feed additive and premixture. |
| Other provisions | 2. The additive must be incorporated into the feed in the form of a premixture. |
| Other provisions | 3. The following must be stated, in English or in English and Welsh, on the labelling of the additive: In English: “Recommended maximum content of the active substance when used alone or in combination with other ribonucleotides up to the same level per kg of complete feedingstuff with a moisture content of 12%: 50 mg”. In Welsh: “Yr uchafswm cynnwys a argymhellir o’r sylwedd actif pan y’i defnyddir ar ei ben ei hun neu mewn cyfuniad â riboniwcleotidau eraill hyd at yr un lefel fesul kg o fwyd anifeiliaid â chynnwys lleithder o 12%: 50 mg”. |
| Other provisions | 4. The functional group, identification number, name and added amount of the active substance must be indicated on the label of the premixture where the use level on the label of the premixture would result in the level of active substance (alone or in combination with other ribonucleotides) in complete feed exceeding 50 mg/kg. |
SCHEDULE 15 — ...
The preparation of muramidase (EC 3.2.1.17) produced by fermentation with Trichoderma reesei (DSM 32338) specified in the table, belonging to the additive category “zootechnical additives” and to the functional group “other zootechnical additives”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
| (1) 1 LSU(F) is defined as the amount of enzyme that increases the fluorescence of 12.5 µg/ml fluorescein-labelled peptidoglycan per minute at pH 6.0 and 30 ºC by a value that corresponds to the fluorescence of approximately 0.06 nmol fluorescein isothiocyanate isomer. | (1) 1 LSU(F) is defined as the amount of enzyme that increases the fluorescence of 12.5 µg/ml fluorescein-labelled peptidoglycan per minute at pH 6.0 and 30 ºC by a value that corresponds to the fluorescence of approximately 0.06 nmol fluorescein isothiocyanate isomer. |
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| (2) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry. | (2) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry. |
| (3) European Inventory of Existing Commercial Substances, as published in OJ No C146A, 15.6.90, p.1. | (3) European Inventory of Existing Commercial Substances, as published in OJ No C146A, 15.6.90, p.1. |
| (4) Identification number allocated by the International Union of Biochemistry and Molecular Biology (IUBMB) https://iubmb.org. | (4) Identification number allocated by the International Union of Biochemistry and Molecular Biology (IUBMB) https://iubmb.org. |
| (5) Details of the analytical methods are set out in the document referenced “Ares(2018)811287 - 12/02/2018” and “JRC F.5/CvH/SB/AS/Ares”, and last updated on 2 March 2018. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2017-0046_en. | (5) Details of the analytical methods are set out in the document referenced “Ares(2018)811287 - 12/02/2018” and “JRC F.5/CvH/SB/AS/Ares”, and last updated on 2 March 2018. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2017-0046_en. |
| (6) Content of muramidase (LSU(F)/kg of complete feed with a moisture content of 12%) | (6) Content of muramidase (LSU(F)/kg of complete feed with a moisture content of 12%) |
| Additive | Muramidase (EC 3.2.1.17) |
| Identification number | 4d16 |
| Authorisation holder | DSM Nutritional Products Ltd |
| Additive category | Zootechnical additives |
| Functional group | Other zootechnical additives |
| Additive composition | Solid and liquid preparationsofmuramidase (EC 3.2.1.17) produced by fermentation with Trichoderma reesei (DSM 32338) having a minimum enzyme activity of 60,000 LSU(F)/g[^f01063] |
| Characterisation of the active substance(s) | Muramidase (EC 3.2.1.17) produced by fermentation with Trichoderma reesei (DSM 32338) CAS number: 9001-63-2[^f01064] EINECS number: 232-620-4[^f01065] EC (IUBMB) number[^f01066]: 3.2.1.17 |
| Analytical methods[^f01067] | For the quantification of muramidase in the feed additive, premixtures and compound feed: Fluorescence-based enzyme assay method that determines the enzyme-catalysed depolymerisation of a fluorescein-labelled peptidoglycan preparation at pH 6.0 and 30 °C. |
| Species or category of animal | Weaned piglets |
| Maximum age | None |
| Minimum content[^f01068] | 50,000 LSU(F)/kg |
| Maximum content[^f01068] | 65,000 LSU(F)/kg |
| 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 16 — ...
The preparation of phytomenadione (vitamin K₁) specified in the table, belonging to the additive category “nutritional additives” and to the functional group “vitamins, pro-vitamins and chemically well-defined substances having a similar effect”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
| (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. |
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| (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. |
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| (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. |
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| (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
EUR 2009/767, amended by S.I. 2019/654, 2022/1351. S.I. 2019/654 was amended by S.I. 2020/1504.
EUR 2008/429, to which there are amendments not relevant to these Regulations.
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.
See Schedule 6 to these Regulations for relevant renewed authorisation of this feed additive.
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.
See Schedule 7 to these Regulations for relevant renewed and consolidated authorisation of this feed additive.
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
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
See regulation 4 of these Regulations for amendments to EUR 2016/897.
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.
See regulation 7 of these Regulations for amendments to EUR 2019/804.
See Schedule 17 to these Regulations for the renewed authorisation of this feed additive.
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.
See Schedule 18 to these Regulations for the renewed authorisation of this feed additive.
EUR 2010/350. EUR 2010/350 is revoked by regulation 20 of, and Schedule 21 to, these Regulations.
See Schedule 19 to these Regulations for the renewed authorisation of this feed additive.
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.
EUR 2020/354, to which there are amendments not relevant to these Regulations.
Editorial notes
Reg. 1 in force at 20.12.2024, see reg. 1(2)(c)
Reg. 2 in force at 20.12.2024, see reg. 1(2)(c)
Reg. 8 in force at 20.12.2024, see reg. 1(2)(c)
Reg. 12 in force at 20.12.2024, see reg. 1(2)(c)
Reg. 13 in force at 20.12.2024, see reg. 1(2)(c)
Reg. 14 in force at 20.12.2024, see reg. 1(2)(c)
Reg. 15 in force at 20.12.2024, see reg. 1(2)(c)
Reg. 16 in force at 20.12.2024, see reg. 1(2)(c)
Reg. 17 in force at 20.12.2024, see reg. 1(2)(c)
Regulations revoked (except for regs. 8, 12-17 and regs. 1, 2 so far as they relate to regs. 8, 12-17) (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 2 (i) (with reg. 23)
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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