EU Review Underway for Manganese-Betaine Feed Additive Approval

An application has been submitted for the authorisation of manganese (II) betaine complex as a nutritional feed additive. The request falls under Article 4 of Regulation (EC) No 1831/2003, covering all animal species and categories. The additive contains at least 17% manganese and 42% betaine by weight. The applicant proposes the use of the additive in premixtures and compound feed. For fish, the maximum manganese content would be 100 mg/kg, while for other species, it would be 150 mg/kg. The additive’s main components are manganese and betaine, with strict minimum concentrations defined.

For manganese quantification, the applicant recommends the EN 15621 method using ICP-AES. Other previously recommended methods include EN 15510 and ISO 6869, which use ICP-AES and AAS respectively. The EU method with AAS and EN 17053 with ICP-MS are also suggested for premixtures and compound feed. The applicant has proposed the ICUMSA method using HPLC-RI for betaine quantification. To confirm the formation of the manganese (II) betaine complex, the EURL recommends the XRD method.

The authorisation seeks approval for a new feed additive with defined manganese and betaine levels. Multiple analytical methods have been proposed for verifying its composition. If approved, the additive will be used in animal feed with specified maximum manganese concentrations.