Commission Implementing Regulation (EU) 2021/1412 of 27 August 2021 concerning the authorisation of Iron(III) citrate chelate as a feed additive for piglets and minor porcine species (holder of the authorisation: Akeso Biomedical, Inc. USA, represented in the Union by Pen & Tec Consulting SLU) (Text with EEA relevance)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
The substance specified in the Annex, 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 laid down in that Annex.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
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 mg additive/kg of complete feed with a moisture content of 12 % Category of zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters). 4d22 Akeso Biomedical, Inc. USA, represented in the Union by Pen & Tec Consulting SLU Iron(III) citrate chelate Additive composition: Iron(III) citrate chelate as a powder with a minimum iron(III) content of 15 %, a maximum iron content of 20 %, a maximum nickel content of 50 ppm 5-10 % of a coloured microtracer and a maximum of 10 % moisture. Piglets and minor porcine species (suckling and weaned) - 550 825 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 potential risks by inhalation, dermal contact or eyes contact, in particular due to the content of heavy metals including nickel. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including skin, eyes and breathing protection. 3. Declaration to be made on the label of the additive and premixture: — content of iron — content of microtracer 4. The amount of iron contained in the additive shall be taken into consideration for the calculation of the total iron content in complete feed. 19.9.2031 Characterisation of the active substance: 2-hydroxy-1,2,3-propanetricarboxylic acid iron(III) Chemical formula: C 6 H 5 FeO 7 CAS number: 3522-50-7. Analytical method ( 1 ) For the quantification of total iron in the feed additive: — inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510); or — inductively coupled plasma-atomic emission spectrometry, ICP-AES with pressure digestion (EN 15621); — atomic absorption spectrometry, AAS (EN ISO 6869); For the quantification of citrate in the feed additive: — ion-exchange high performance liquid chromatography (HPLC) coupled to ultraviolet (UV) detection; For the determination of the added content of iron(III) citrate chelate in premixtures, compound feed and feed materials: — enumeration of colour coated particles of the microtracer present at fixed mass ratio in the feed additive. ( 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
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