Commission Implementing Regulation (EU) 2024/1055 of 10 April 2024 concerning the authorisation of iron(II) – betaine complex as a feed additive for all animal species

Authorisation

Article 1

The substance specified in the Annex, 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 laid down in that Annex.

Entry into force

Article 2

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

ANNEXSupplementary provisions

ANNEX Identification number of the feed additive 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 the element (Fe) in mg/kg of complete feed with a moisture content of 12 % or in mg element (Fe)/day Category: nutritional additives. Functional group: compounds of trace elements 3b112 Iron(II) – betaine complex Additive composition Iron betaine complex with a minimum of 14 % of iron and a minimum of 36 % of betaine. Nickel: maximum 58 mg/kg. Solid form. Characterisation of the active substances Name: catena-[diaqua sulfato-μ2-(trimethylammonio)acetato-iron(II)] Chemical formula: [Fe (H 2 O)2((CH 3 )3NCH 2 COO)(SO 4 )]n Specifications Minimum of 14 % of iron, Minimum 36 % betaine, Sulphur: 9 %–12 %. Maximum 5 % moisture. Analytical methods  ( 1 ) For the quantification of total iron in the feed additive: — Inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15621 or EN 15510) or — Atomic absorption spectrometry, AAS (ISO 6869). For the quantification of total iron in premixtures: — Inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15621 or EN 15510) or — Atomic absorption spectrometry, AAS (ISO 6869) or — Inductively coupled plasma-mass spectrometry, ICP-MS (EN 17053). For the quantification of total iron in compound feed: — Inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15621 or EN 15510) 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). For the quantification of betaine in the feed additive: — High performance liquid chromatography with refraction index detection (HPLC-RI). For the quantification of sulphur and sulphate in the feed additive: — Inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15621). Proof of complex formation between iron, betaine and sulphate  ( 2 ) : Powder X-ray diffraction (XRD). Ovines — — 500 mg/kg 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 organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment. 1 May 2034 Bovines — — 450 mg/kg Piglets Until one week before weaning — 250 mg/day Poultry — — 450 mg/kg Pets — — 600 mg/kg Other animal species — — 750 mg/kg ( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports ( 2 )   Stoe Stadi P diffractometer in Guinier geometry using Cu-Κα1 radiation (Johann Gemonochromator) and a Stoe imageplate detector IP-PSD.