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 — Iron (II) chelate of amino acids hydrate Additive composition: Preparation of Iron(II) amino acid complex where the iron and the amino acids derived from soya protein are chelated via coordinate covalent bonds, as a powder with a minimum content of 9 % iron. All animal species — — Ovine: 500 (total (2)) Bovines and poultry: 450 (total (2)) Piglets up to 1 week before weaning: 250 mg/day (total (2)) Pet animals: 600 (total (2)) Other species: 750 (total (2)) 1. The additive shall be incorporated into feed in the form of a premixture. 2. 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 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, including breathing, skin and eye protection. 4 January 2028

Characterisation of the active substance: Chemical formula: Fe(x)1–3·nH2O, x = anion of any amino acid from soya protein hydrolysate. Maximum 10 % of molecules exceeding 1500 Da.

Analytical methods (1): For the quantification of amino acid content in the feed additive: — ion exchange chromatography with post-column derivatisation and optical detection (IEC-VIS/FLD) — For the quantification of the free amino acid content in the feed additive: — ion exchange chromatography with post-column derivatisation and optical detection (IEC-VIS/FLD), For the quantification of total iron in the feed additive: — inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or — atomic absorption spectrometry, AAS (ISO 6869) For the quantification of total iron in premixtures: — inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or — atomic absorption spectrometry, AAS (ISO 6869) or — inductively coupled plasma-mass spectrometry, ICP-MS (EN 17053) For the quantification of total iron in feed materials and compound feed: — inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or — atomic absorption spectrometry, AAS (Commission Regulation (EC) No 152/2009 (Annex IV-C) or ISO 6869) or — inductively coupled plasma-mass spectrometry, ICP-MS (EN 17053)

3b106i — Iron (II) chelate of amino acids hydrate Additive composition: Preparation of iron (II) amino acid complex, where the iron and the amino acids are chelated via coordinate covalent bonds, as a powder with an iron content of 9 – 10 % and a minimum of 18 % free amino acids. All animal species — — Ovine: 500 (total (2)) Bovines and poultry: 450 (total (2)) Piglets up to 1 week before weaning: 250 (total (2)) Pet animals: 600 (total (2)) Other species: 750 (total (2)) 1. The additive shall be incorporated into feed in the form of a premixture. 2. 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 or eyes contact in particular due to the content of heavy metals.. 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, including breathing, skin and eye protection. 3. For additives produced from hydrolysis of animal protein, the animal origin (avian species) shall be indicated on the label of the additive and premixtures. 4 January 2028

Characterisation of the active substance: Chemical formula: Fe(x)1-3•nH2O, where x is equal to any amino acid coming from hydrolysed protein sources from feathers or plants; Maximum 10 % of molecules exceeding 1500 Da.

Analytical methods (1): For the quantification of the free amino acid content in the feed additive: — ion exchange chromatography with post-column derivatisation and optical detection (IEC-VIS/FLD), Commission Regulation (EC) No 152/2009 (Annex III,F) and EN ISO 17180 For the quantification of total iron in the feed additive: — inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or — atomic absorption spectrometry, AAS (ISO 6869) For the quantification of total iron in premixtures: — inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or — atomic absorption spectrometry, AAS (ISO 6869) or — inductively coupled plasma-mass spectrometry, ICP-MS (EN 17053) For the quantification of total iron in feed materials and compound feed: — inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or — atomic absorption spectrometry, AAS (Commission Regulation (EC) No 152/2009 (Annex IV-C) or ISO 6869) or — inductively coupled plasma-mass spectrometry, 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