EU reviews manganese-betaine complex as new nutritional feed additive

An application has been submitted under Article 4 for the authorisation of manganese (II) betaine complex as a nutritional additive. The additive is intended for use in feed for all animal species and categories. It is a solid preparation containing at least 17% manganese and 42% betaine by weight. The feed additive is designed for incorporation into premixtures and compound feed. For fish, the maximum manganese content is set at 100 mg/kg, while for other species, it is capped at 150 mg/kg.

To verify the formation of the manganese (II) betaine complex, the EURL recommends using X-ray powder diffraction (XRD). For betaine quantification in the additive, the applicant has proposed the ICUMSA method with HPLC-RI.

For total manganese quantification, several methods have been recommended. In the feed additive, EN 15621, EN 15510, and ISO 6869 are suggested. The applicant also proposed EN 15621 using ICP-AES for manganese analysis in the additive, premixtures, and compound feed.

For premixtures and compound feed, the recommended methods for total manganese quantification include EN 15621, EN 15510, ISO 6869, and EN 17053. Additionally, EN 17053 using ICP-MS has been specifically recommended for these matrices. Previously, EN 15510 (ICP-AES) and ISO 6869 (AAS) were also advised for manganese quantification in additives, premixtures, and compound feed. The proposed additive must meet strict composition and usage limits. Approved analytical methods will ensure accurate quantification of manganese and betaine in all applications. The authorisation process will determine its suitability for widespread use in animal feed.