EU reviews iron (II) betaine complex as new animal feed additive

An application has been submitted to authorise iron (II) betaine complex as a nutritional additive for all animal species and categories. The request falls under Article 4 and seeks approval for its use in premixtures and compound feed. The feed additive contains at least 14% iron and 36% betaine by weight. It is designed for incorporation into feed with total iron levels between 450 and 750 mg/kg.

The applicant proposed using the XRD method to confirm the formation of the iron (II) betaine complex. For quantifying total iron, they suggested the EN 15621 method with ICP-AES for feed additives, premixtures, and compound feed.

The EURL, however, recommended alternative methods. For betaine content, they proposed the ICUMSA method based on HPLC-RI. For total iron in premixtures and compound feed, the EN 17053 method using ICP-MS was advised. Additionally, the EU method based on AAS, validated by the UK FSA, was recommended for quantifying iron in compound feed.

Previously, the EURL had endorsed the EN 15510 and ISO 6869 methods for iron quantification in feed additives, premixtures, and compound feed. No further testing or validation of these methods is deemed necessary. The proposed additive meets specified composition requirements. Recommended analytical methods have been identified for verifying its iron and betaine content. Authorisation now depends on the assessment of these submissions.