Iron (II) betaine complex

In the current application an authorisation is sought under Article 4 for iron (II) betaine complex under the category/ functional group (3b) "nutritional additives"/"compounds of trace elements", according to the classification system of Annex I of Regulation (EC) No 1831/2003. Specifically, the authorisation is sought for the use of the feed additive for all animal species and categories.
According to the Applicant, the feed additive is a solid preparation of iron (II) betaine complex containing minimum of 14 % (w/w) of iron and minimum of 36 % (w/w) of betaine as main components.
The feed additive is intended to be incorporated into premixtures and compound feed with the proposed levels of total iron are ranging from 450 to 750 mg/kg in compound feed.
For the quantification of total iron in the feed additive, premixtures and compound feed the Applicant proposed the internationally recognised ring-trial validated EN 15621 method based on inductively coupled plasma-atomic emission spectrometry (ICP-AES).
In addition, the EN 15510 method based on ICP-AES and ISO 6869 method based on AAS have been previously evaluated and recommended by the EURL for the quantification of total iron in feed additives, premixtures and compound feed in the frame of several iron dossiers.
Furthermore, the European Union (EU) method based on atomic absorption spectrometry (AAS), which was further ring-trial validated by the UK Food Standards Agency (FSA) has been previously recommended by the EURL for the quantification of total iron in compound feed.
The EURL is also aware of the ring-trial validated EN 17053 method based on inductively coupled plasma-mass spectrometry (ICP-MS), which has been recommended for the quantification of total iron in premixtures and compound feed in the frame of some former iron dossiers.
Based on the acceptable method performance characteristics, the EURL recommends for official control the five ring-trial validated methods: (i) EN 15621, EN 15510 and ISO 6869 for the quantification of total iron in the feed additive; (ii) EN 15621, EN 15510, ISO 6869 and EN 17053 for the quantification of total iron in premixtures; and iii) EN 15621, EN 15510, ISO 6869, EN 17053 and EU method for the quantification of total iron in compound feed.
For the quantification of betaine in the feed additive the Applicant proposed the official method of International Commission for Uniform Methods of Sugar Analysis (ICUMSA) based on high performance liquid chromatography with refraction index detection (HPLC-RI), which is dedicated for the determination of betaine in beet molasses.
Based on the available data, the EURL recommends for official control the above mentioned method based on HPLC-RI for the quantification of betaine content in the feed additive.
In addition, for proving the formation of iron (II) betaine complex, the Applicant proposed the qualitative X-ray powder diffraction (XRD) method, where the diffraction patterns are compared to those of the starting materials. The EURL considers the X-ray powder diffraction (XRD) method suitable for proving the complex formation between iron and betaine.
Further testing or validation of the methods to be performed through the consortium of National Reference Laboratories as specified by Article 10 (Commission Regulation (EC) No 378/2005, as last amended by Regulation (EU) 2015/1761) is not considered necessary.