Identification number of the additive Name of the holder of authorisation Additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation

Content of element (Fe) in mg/kg of complete feed with a moisture content of 12 % or in mg element (Fe)/day or week

Category of nutritional additives. Functional group: compounds of trace elements

3b101 Iron(II) carbonate (siderite) Additive composition: Powder sourced from mined ore, containing siderite, with a minimum content of 70 % FeCO3 and of 39 % total iron Characterisation of the active substance: Chemical formula: FeCO3 CAS Number: 563–71–3 Analytical methods (1): For the identification of iron and carbonate in the feed additive: — European Pharmacopoeia Monograph 2.3.1. For the crystallographic characterisation of the feed additive: — X-Ray diffraction. For the quantification of total iron in the feed additive and premixtures: — Atomic Absorption Spectrometry, AAS (EN ISO 6869); or — Inductively Coupled Plasma – Atomic Emission Spectrometry, ICP-AES (EN 15510); or — Inductively Coupled Plasma – Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621). For the quantification of total iron in feed materials and compound feed: — Atomic Absorption Spectrometry, AAS (Commission Regulation (EC) No 152/2009, Annex IV-C); or — Atomic Absorption Spectrometry, AAS (EN ISO 6869); or — Inductively Coupled Plasma – Atomic Emission Spectrometry, ICP-AES (EN 15510) or — Inductively Coupled Plasma – Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621). All animal species except piglets, calves, chicken up to 14 days and turkey up to 28 days — — Ovine: 500 (total (2)) Bovines and poultry: 450 (total (2)) Pet animals: 600 (total (2)) Other species: 750 (total (2)) 1. Iron(II) carbonate may be placed on the market and used as an additive consisting of a preparation. 2. The additive shall be incorporated into feed in the form of a premixture. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment. 4. In the labelling of the additive and premixtures containing it, the following shall be indicated: ‘Iron(II) carbonate should not be used as iron source for young animals due to its limited bioavailability.’ 4 January 2028

3b102 — Iron(III) chloride hexahydrate Additive composition: Iron(III) chloride hexahydrate, as a powder with a minimum content of 19 % iron. Characterisation of the active substance: Chemical formula: FeCl3 · 6H2O CAS Number: 10025–77–1 Analytical methods (1): For the identification of iron and chloride in the feed additive: — European Pharmacopoeia Monograph 2.3.1. For the crystallographic characterisation of the feed additive: — X-Ray diffraction. For the quantification of the ferric chloride hexahydrate in the feed additive: — titration with sodium thiosulfate (Ph. Eur Monograph 1515). For the quantification of total iron in the feed additive and premixtures: — Atomic Absorption Spectrometry, AAS (EN ISO 6869); or — Inductively Coupled Plasma – Atomic Emission Spectrometry, ICP-AES (EN 15510); or — Inductively Coupled Plasma – Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621). For the quantification of total iron in feed materials and compound feed: — Atomic Absorption Spectrometry, AAS (Commission Regulation (EC) No 152/2009, Annex IV-C); or — Atomic Absorption Spectrometry, AAS (EN ISO 6869); or — Inductively Coupled Plasma – Atomic Emission Spectrometry, ICP-AES (EN 15510) or — Inductively Coupled Plasma – Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621). All animal species — — Ovine: 500 (total (2)) Bovines and poultry: 450 (total (2)) Piglets up to one week before weaning: 250 mg/day (total (2)) Pet animals: 600 (total (2)) Other species: 750 (total (2)) 1. Iron(III) chloride hexahydrate may be placed on the market and used as an additive consisting of a preparation. 2. The additive shall be incorporated into feed in the form of a liquid premixture. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment. 4 January 2028

3b103 — Iron(II) sulphate monohydrate Additive composition: Iron(II) sulphate monohydrate, as powder or granules with a minimum content of 29 % iron. Characterisation of the active substance: Chemical formula: FeSO4 · H2O CAS Number: 17375–41–6 Analytical methods (1): For the identification of iron and sulphate in the feed additive: — European Pharmacopoeia Monograph 2.3.1. For the crystallographic characterisation of the feed additive: — X-Ray diffraction. For the quantification of the iron(II) sulphate monohydrate in the feed additive: — titration with ammonium and cerium nitrate (Ph. Eur Monograph 0083); or — titration with potassium dichromate (EN 889). For the quantification of total iron in the feed additive and premixtures: — Atomic Absorption Spectrometry, AAS (EN ISO 6869); or — Inductively Coupled Plasma – Atomic Emission Spectrometry, ICP-AES (EN 15510); or — Inductively Coupled Plasma – Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621). For the quantification of total iron in feed materials and compound feed: — Atomic Absorption Spectrometry, AAS (Commission Regulation (EC) No 152/2009, Annex IV-C); or — Atomic Absorption Spectrometry, AAS (EN ISO 6869); or — Inductively Coupled Plasma – Atomic Emission Spectrometry, ICP-AES (EN 15510) or — Inductively Coupled Plasma – Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621). All animal species — — Ovine: 500 (total (2)) Bovines and poultry: 450 (total (2)) Piglets up to one week before weaning: 250 mg/day (total (2)) Pet animals: 600 (total (2)) Other species: 750 (total (2)) 1. Iron(II) sulphate monohydrate may be placed on the market and used as an additive consisting of a preparation. 2. The additive shall be incorporated into feed in the form of a premixture. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment. 4 January 2028

3b104 — Iron(II) sulphate heptahydrate Additive composition: Iron(II) sulphate heptahydrate, as a powder with a minimum content of 18 % iron. Characterisation of the active substance: Chemical formula: FeSO4 · 7H2O CAS Number: 7782–63–0 Analytical methods (1): For the identification of iron and sulphate in the feed additive: — European Pharmacopoeia Monograph 2.3.1. For the crystallographic characterisation of the feed additive: X-Ray diffraction. For the quantification of the iron(II) sulphate heptahydrate in the feed additive: — titration with ammonium and cerium nitrate (Ph. Eur Monograph 0083); or — titration with potassium dichromate (EN 889). For the quantification of total iron in the feed additive and premixtures: — Atomic Absorption Spectrometry, AAS (EN ISO 6869); or — Inductively Coupled Plasma – Atomic Emission Spectrometry, ICP-AES (EN 15510); or — Inductively Coupled Plasma – Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621). For the quantification of total iron in feed materials and compound feed: — Atomic Absorption Spectrometry, AAS (Commission Regulation (EC) No 152/2009, Annex IV-C); or — Atomic Absorption Spectrometry, AAS (EN ISO 6869); or — Inductively Coupled Plasma – Atomic Emission Spectrometry, ICP-AES (EN 15510) or — Inductively Coupled Plasma – Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621). All animal species — — Ovine: 500 (total (2)) Bovines and poultry: 450 (total (2)) Piglets up to one week before weaning: 250 mg/day (total (2)) Pet animals: 600 (total (2)) Other species: 750 (total (2)) 1. Iron(II) sulphate heptahydrate may be placed on the market and used as an additive consisting of a preparation. 2. The additive shall be incorporated into feed in the form of a premixture. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment. 4 January 2028

3b105 Iron(II) fumarate Additive composition: Iron(II) fumarate, as a powder with a minimum content of 30 % iron. Characterisation of the active substance: Chemical formula: C4H2FeO4 CAS Number: 141–01–5 Analytical methods (1): For the quantification of the Iron(II) fumarate in the feed additive: — titration with cerium sulphate (Ph. Eur Monograph 0902). For the quantification of total iron in the feed additive and premixtures: — Atomic Absorption Spectrometry, AAS (EN ISO 6869); or — Inductively Coupled Plasma – Atomic Emission Spectrometry, ICP-AES (EN 15510); or — Inductively Coupled Plasma – Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621). For the quantification of total iron in feed materials and compound feed: — Atomic Absorption Spectrometry, AAS (Commission Regulation (EC) No 152/2009, Annex IV-C); or — Atomic Absorption Spectrometry, AAS (EN ISO 6869); or — Inductively Coupled Plasma – Atomic Emission Spectrometry, ICP-AES (EN 15510) or — Inductively Coupled Plasma – Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621). All animal species — — Ovine: 500 (total (2)) Bovines and poultry: 450 (total (2)) Piglets up to one week before weaning: 250 mg/day (total (2)) Pet animals: 600 (total (2)) Other species: 750 (total (2)) 1. Iron(II) fumarate may be placed on the market and used as an additive consisting of a preparation. 2. The additive shall be incorporated into feed in the form of a premixture. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

3b106 - Crágach iarainn (II) de híodráit aimíonaigéad Comhdhéanamh an bhreiseáin Ullmhóid coimpléasc aimíonaigéid iarainn (II) ina ndéantar an t-iarann agus na haimíonaigéid a dhíorthaítear ó phróitéin soighe a chrágadh trí naisc chomhfhiúsacha chomhordanáideacha, mar phúdar le cion íosta de 9 % iarainn. Gach speiceas ainmhíoch - - Ainmhithe de chineál caorach: 500 (iomlán (5)) Bó-ainmhithe agus éanlaith chlóis: 450 (iomlán (5)) Bainbh suas le seachtain amháin sula mbaintear de dhiúl iad: 250 mg/lá (iomlán (5)) Peataí: 600 (iomlán (5)) Speicis eile: 750 (iomlán (5)) 1. Déanfar an breiseán a ionchorprú sa bheatha i bhfoirm réamh-mheascáin. 2. I gcás úsáideoirí an bhreiseáin agus na réamh-mheascán, bunóidh oibreoirí gnólachtaí beathaithe nósanna imeachta oibríochtúla agus bearta eagraíochtúla iomchuí chun aghaidh a thabhairt ar rioscaí a d’fhéadfadh eascairt as ionanálú, as teagmháil dheirmeach nó as teagmháil leis na súile. I gcás nach féidir na rioscaí a laghdú go leibhéal inghlactha leis na nósanna imeachta agus na bearta sin, is le trealamh cosanta pearsanta, lena n-áirítear cosaint don análú, don chraiceann agus do na súile a úsáidfear an breiseán agus na réamh-mheascáin. 4 Eanáir 2028

Tréithriú na substainte gníomhaí Foirmle cheimiceach: Fe(x) 1–3·nH2O, x = ainian d’aimíonaigéad ar bith ó hidrealasáit phróitéin soighe. Uasmhéid 10 % de mhóilíní ar mó iad ná 1500 Da.

Modhanna anailíse (4) Maidir le cion iomlán an aimíonaigéid atá sa bhreiseán beathaithe a chainníochtú: — crómatagrafaíocht malartaithe ian cúpláilte le díorthúchán iarcholúin agus brath optúil (IEC-VIS/FLD) — Maidir le cion iomlán an saoraimíonaigéid atá sa bhreiseán beathaithe a chainníochtú: — crómatagrafaíocht malartaithe ian cúpláilte le díorthúchán iarcholúin agus brath optúil (IEC-VIS/FLD), Maidir le cion iomlán an iarainn atá sa bhreiseán beathaithe a chainníochtú: — speictriméadracht astaíochta adamhaí le plasma cúpláilte go hionduchtach, ICP-AES (EN 15510 nó EN 15621) nó — speictriméadracht ionsú adamhaigh, AAS (ISO 6869) Maidir le cion iomlán an iarainn atá sna réamh-mheascáin a chainníochtú: — speictriméadracht astaíochta adamhaí le plasma cúpláilte go hionduchtach, ICP-AES (EN 15510 nó EN 15621) nó — speictriméadracht ionsú adamhaigh, AAS (ISO 6869) nó — speictriméadracht astaíochta adamhaí le plasma cúpláilte go hionduchtach, ICP-MS (EN 17053) Maidir le cion iomlán an iarainn in ábhair bheatha agus i mbeatha chumaisc a chainníochtú: — speictriméadracht astaíochta adamhaí le plasma cúpláilte go hionduchtach, ICP-AES (EN 15510 nó EN 15621) nó — speictriméadracht ionsú adamhaigh, AAS (Rialachán (CE) Uimh. 152/2009 ón gCoimisiún, (Iarscríbhinn IV-C) nó ISO 6869) nó — speictriméadracht astaíochta adamhaí le plasma cúpláilte go hionduchtach, ICP-MS (EN 17053)

3b106i - Crágach iarainn (II) de híodráit aimíonaigéad Comhdhéanamh an bhreiseáin Ullmhóid coimpléasc aimíonaigéid iarainn (II) ina ndéantar an t-iarann agus na haimíonaigéid a chrágadh trí naisc chomhfhiúsacha chomhordanáideacha, mar phúdar le cion iarainn 9-10 % agus cion íosta saoraimíonaigéad 18 %. Gach speiceas ainmhíoch - - Ainmhithe de chineál caorach: 500 (iomlán (5)) Bó-ainmhithe agus éanlaith chlóis: 450 (iomlán (5)) Bainbh suas le seachtain amháin sula mbaintear de dhiúl iad: 250 (iomlán (5)) Peataí: 600 (iomlán (5)) Speicis eile: 750 (iomlán (5)) 1. Déanfar an breiseán a ionchorprú sa bheatha i bhfoirm réamh-mheascáin. 2. Maidir le húsáideoirí na mbreiseán agus na réamh-mheascán, bunóidh oibreoirí gnólachtaí beathaithe nósanna imeachta oibríochtúla agus bearta eagraíochtúla iomchuí chun aghaidh a thabhairt ar rioscaí a d’fhéadfadh eascairt as ionanálú, as teagmháil dheirmeach nó as teagmháil leis na súile, go háirithe i ngeall ar chion na miotal trom. I gcás nach féidir na rioscaí a laghdú go leibhéal inghlactha leis na nósanna imeachta agus na bearta sin, is le trealamh cosanta pearsanta, lena n-áirítear cosaint don análú, don chraiceann agus do na súile a úsáidfear an breiseán agus na réamh-mheascáin. 3. I gcás breiseán a tháirgtear ó hidrealú ar phróitéin ainmhíoch, sonrófar an tionscnamh ainmhíoch (speicis éanúla) ar lipéad an bhreiseáin agus na réamh-mheascán. 4 Eanáir 2028

Tréithriú na substainte gníomhaí Foirmle cheimiceach: Fe(x)1-3•nH2O, nuair is ionann x agus aimíonaigéad ar bith ó fhoinsí próitéine hidrealaithe ó chleití nó ó phlandaí; Uasmhéid 10 % de mhóilíní ar mó iad ná 1500 Da.

Modhanna anailíse (4) Maidir le cion iomlán an saoraimíonaigéid atá sa bhreiseán beathaithe a chainníochtú: — crómatagrafaíocht malartaithe ian le díorthúchán iarcholúin agus brath optúil (IEC-VIS/FLD), Rialachán (CE) Uimh. 152/2009 ón gCoimisiún (Iarscríbhinn III, F) agus EN ISO 17180 Maidir le cion iomlán an iarainn atá sa bhreiseán beathaithe a chainníochtú: — speictriméadracht astaíochta adamhaí le plasma cúpláilte go hionduchtach, ICP-AES (EN 15510 nó EN 15621) nó — speictriméadracht ionsú adamhaigh, AAS (ISO 6869) Maidir le cion iomlán an iarainn sna réamh-mheascáin a chainníochtú: — speictriméadracht astaíochta adamhaí le plasma cúpláilte go hionduchtach, ICP-AES (EN 15510 nó EN 15621) nó — speictriméadracht ionsú adamhaigh, AAS (ISO 6869) nó — speictriméadracht astaíochta adamhaí le plasma cúpláilte go hionduchtach, ICP-MS (EN 17053) Maidir le cion iomlán an iarainn in ábhair bheatha agus i mbeatha chumaisc a chainníochtú: — speictriméadracht astaíochta adamhaí le plasma cúpláilte go hionduchtach, ICP-AES (EN 15510 nó EN 15621) nó — speictriméadracht ionsú adamhaigh, AAS (Rialachán (CE) Uimh. 152/2009 ón gCoimisiún, (Iarscríbhinn IV-C) nó ISO 6869) nó — speictriméadracht astaíochta adamhaí le plasma cúpláilte go hionduchtach, ICP-MS (EN 17053)

3b107 — Iron(II) chelate of protein hydrolysates Additive composition: Iron(II) chelate of protein hydrolysates as a powder with a minimum content of 10 % iron. Minimum of 50 % iron chelated. Characterisation of the active substance: Chemical formula: Fe(x)1–3 · nH2O, x = anion of any amino acid from soya protein hydrolysate. Analytical methods (1): For the quantification of protein hydrolysates content in the feed additive: — ion exchange chromatography combined with post-column ninhydrin derivatisation and photometric detection (Commission Regulation (EC) No 152/2009, Annex III, F). For the qualitative verification of the chelation of the iron in the feed additive: — Fourier Transformed Infrared (FTIR) spectroscopy followed by multivariate regression methods (to be updated by EURL) (3). For the quantification of total iron in the feed additive and premixtures: — Atomic Absorption Spectrometry, AAS (EN ISO 6869); or — Inductively Coupled Plasma – Atomic Emission Spectrometry, ICP-AES (EN 15510); or — Inductively Coupled Plasma – Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621). For the quantification of total iron in feed materials and compound feed: — Atomic Absorption Spectrometry, AAS (Commission Regulation (EC) No 152/2009, Annex IV-C); or — Atomic Absorption Spectrometry, AAS (EN ISO 6869); or — Inductively Coupled Plasma – Atomic Emission Spectrometry, ICP-AES (EN 15510) or — Inductively Coupled Plasma – Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621). All animal species — — Ovine: 500 (total (2)) Bovines and poultry: 450 (total (2)) Piglets up to one week before weaning: 250 mg/day (total (2)) Pet animals: 600 (total (2)) Other species: 750 (total (2)) 1. Iron(II) chelate of protein hydrolysates may be placed on the market and used as an additive consisting of a preparation. 2. The additive shall be incorporated into feed in the form of a premixture. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment. 4 January 2028

3b108 — Iron(II) chelate of glycine hydrate Additive composition: Iron(II) chelate of glycine, hydrate, as a powder with a minimum content of 15 % iron. Moisture: maximum 10 %. Characterisation of the active substance: Chemical formula: Fe(x)1-3 · nH2O, x = anion of glycine. Analytical methods (1): For the quantification of the glycine content in the feed additive: — ion exchange chromatography combined with post-column ninhydrin derivatisation and photometric detection (Commission Regulation (EC) No 152/2009, Annex III, F). For the quantification of total iron in the feed additive and premixtures: — Atomic Absorption Spectrometry, AAS (EN ISO 6869); or — Inductively Coupled Plasma – Atomic Emission Spectrometry, ICP-AES (EN 15510); or — Inductively Coupled Plasma – Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621). For the quantification of total iron in feed materials and compound feed: — Atomic Absorption Spectrometry, AAS (Commission Regulation (EC) No 152/2009, Annex IV-C); or — Atomic Absorption Spectrometry, AAS (EN ISO 6869); or — Inductively Coupled Plasma – Atomic Emission Spectrometry, ICP-AES (EN 15510) or — Inductively Coupled Plasma – Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621). All animal species — — Ovine: 500 (total (2)) Bovines and poultry: 450 (total (2)) Piglets up to one week before weaning: 250 mg/day (total (2)) Pet animals: 600 (total (2)) Other species: 750 (total (2)) 1. Iron(II) chelate of glycine hydrate may be placed on the market and used as an additive consisting of a preparation. 2. The additive shall be incorporated into feed in the form of a premixture. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment. 4 January 2028

3b110 Iron dextran 10 % Additive composition: Colloidal, aqueous solution of iron dextran with 25 % iron dextran (10 % total iron, 15 % dextran), 1,5 % sodium chloride, 0,4 % phenol and 73,1 % water Characterisation of the active substance: Iron dextran Chemical formula: (C6H10O5)n · [Fe(OH)3]m IUPAC name: ferric hydroxide dextran (α,3-α1,6 glucan) complex CAS Number: 9004-66-4 Analytical methods (1): For the characterisation of the feed additive: — British and US Pharmacopeia Iron Dextran monographs. For the quantification of total iron in the feed additive and premixtures: — Atomic Absorption Spectrometry, AAS (EN ISO 6869); or — Inductively Coupled Plasma – Atomic Emission Spectrometry, ICP-AES (EN 15510); or — Inductively Coupled Plasma – Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621). For the quantification of total iron in feed materials and compound feed: — Atomic Absorption Spectrometry, AAS (Commission Regulation (EC) No 152/2009, Annex IV-C); or — Atomic Absorption Spectrometry, AAS (EN ISO 6869); or — Inductively Coupled Plasma – Atomic Emission Spectrometry, ICP-AES (EN 15510) or — Inductively Coupled Plasma – Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621). Suckling piglets — — 200 mg/day once in the first week of life and 300 mg/day once in the second week of life 1. For users of the additive, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive shall be used with appropriate personal protective equipment. 2. Indicate in the instructions of use: — ‘The additive shall be fed only individually directly via a complementary feed.’ — ‘The additive shall not be administered to piglets deficient in vitamin E and/or selenium.’ — ‘The simultaneous use of other iron compounds shall be avoided during the administration period (first 2 weeks of life) of iron dextran 10 %.’ 4 January 2028