Commission Implementing Regulation (EU) 2017/2330 of 14 December 2017 concerning the authorisation of Iron(II) carbonate, Iron(III) chloride hexahydrate, Iron(II) sulphate monohydrate, Iron(II) sulphate heptahydrate, Iron(II) fumarate, Iron(II) chelate of amino acids hydrate, Iron(II) chelate of protein hydrolysates and Iron(II) chelate of glycine hydrate as feed additives for all animal species and of Iron dextran as feed additive for piglets and amending Regulations (EC) No 1334/2003 and (EC) No 479/2006 (Text with EEA relevance)Text with EEA relevance

• Published date: 15 December 2017
• Subject Matter: Animal feedingstuffs
• Official Gazette Publication: Official Journal of the European Union, L 333, 15 December 2017

02017R2330 — EN — 25.09.2022 — 002.001

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►B ▼C1 COMMISSION IMPLEMENTING REGULATION (EU) 2017/2330 of 14 December 2017 concerning the authorisation of Iron(II) carbonate, Iron(III) chloride hexahydrate, Iron(II) sulphate monohydrate, Iron(II) sulphate heptahydrate, Iron(II) fumarate, Iron(II) chelate of amino acids hydrate, Iron(II) chelate of protein hydrolysates and Iron(II) chelate of glycine hydrate as feed additives for all animal species and of Iron dextran as feed additive for piglets and amending Regulations (EC) No 1334/2003 and (EC) No 479/2006 (Text with EEA relevance) ▼B (OJ L 333 15.12.2017, p. 41)

Amended by:

		Official Journal
		No	page	date
M1	COMMISSION IMPLEMENTING REGULATION (EU) 2019/230 of 7 February 2019	L 37	111	8.2.2019
►M2	COMMISSION IMPLEMENTING REGULATION (EU) 2022/1457 of 2 September 2022	L 229	10	5.9.2022

Corrected by:

►C1 Corrigendum, OJ L 351, 30.12.2017, p. 202 (2017/2330)

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▼B

▼C1

COMMISSION IMPLEMENTING REGULATION (EU) 2017/2330

of 14 December 2017

concerning the authorisation of Iron(II) carbonate, Iron(III) chloride hexahydrate, Iron(II) sulphate monohydrate, Iron(II) sulphate heptahydrate, Iron(II) fumarate, Iron(II) chelate of amino acids hydrate, Iron(II) chelate of protein hydrolysates and Iron(II) chelate of glycine hydrate as feed additives for all animal species and of Iron dextran as feed additive for piglets and amending Regulations (EC) No 1334/2003 and (EC) No 479/2006

(Text with EEA relevance)

Article 1

Authorisation

The substances specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, are authorised as feed additives in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

Special conditions of use

The authorised substances specified in the Annex as additives belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’ shall not be used in water for drinking.

Article 3

Denial

The authorisation for ferric oxide is hereby denied and the substance shall no longer be used as nutritional feed additive.

Article 4

Amendment to Regulation (EC) No 1334/2003

In the Annex to Regulation (EC) No 1334/2003, from the entry E1 on the element Iron-Fe the following additives, their chemical formulas and descriptions are deleted: ‘Ferric chloride hexahydrate’, ‘Ferrous carbonate’, ‘Ferrous chelate of amino acids hydrate’, ‘Ferrous fumarate’, ‘Ferrous sulphate heptahydrate’, ‘Ferrous sulphate monohydrate’ and ‘Ferric oxide’.

Article 5

Amendment to Regulation (EC) No 479/2006

In the Annex to Regulation (EC) No 479/2006, the entry E1 on the additive ‘Ferrous chelate of glycine, hydrate’ is deleted.

Article 6

Transitional measures

1.

The substances ‘Ferric chloride hexahydrate’, ‘Ferrous carbonate’, ‘Ferrous chelate of amino acids hydrate’, ‘Ferrous chelate of glycine hydrate’, ‘Ferrous fumarate’, ‘Ferrous sulphate heptahydrate’, ‘Ferric oxide’ and ‘Ferrous sulphate monohydrate’ as authorised by Commission Regulation (EC) No 1334/2003 and Commission Regulation (EC) No 479/2006, and premixtures containing those substances, which are produced and labelled before 4 July 2018 in accordance with the rules applicable before 4 January 2018 may continue to be placed on the market and used until the existing stocks are exhausted.

2.

Feed materials and compound feed containing the substances referred to in paragraph 1 which are produced and labelled before 4 January 2019 in accordance with the rules applicable before 4 January 2018 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

3.

Feed materials and compound feed containing the substances referred to in paragraph 1 which are produced and labelled before 4 January 2020 in accordance with the rules applicable before 4 January 2018 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.

Article 7

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

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ANNEX

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

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