Zinc-L-selenomethionine (3b818)

In the current application a modification of the current authorisation (3b818) is sought under article 13 for Zinc-L-selenomethionine 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 current authorisation, the feed additive contains a minimum of 62 % (w/w) of L-selenomethionine, 24.5 % (w/w) of selenium and 19 % (w/w) of zinc. The modified authorisation is sought for a solid preparation (Availa® Se 4%, w/w) with a selenium content ranging from 1 to 46 g/kg of the preparation. The feed additive is intended to be incorporated into feed through premixtures with a proposed maximum total selenium content of 0.5 mg/kg complete feed or 0.2 mg/kg organic selenium supplemented via complete feed.
For the quantification of selenomethionine in the feed additive the Applicant submitted a single-laboratory validated and further verified method based on high performance liquid chromatography with fluorescence detection (HPLC-FLD) after pre-column derivatisation with ortho-phthalaldehyde (OPA). Based on the acceptable performance characteristics presented the EURL recommends for official control this HPLC-FLD method to quantify selenomethionine in the feed additive.
For the quantification of total selenium in the feed additive the Applicant submitted the official AOAC 2006.03 method designed for the analysis of elements in fertilisers, based on inductively coupled plasma-atomic emission spectrometry (ICP-AES). Furthermore, in the frame of former dossiers related to feed additives containing selenium, the EURL evaluated several alternative single-laboratory validated and further verified methods recommending for official control either inductively coupled plasma-atomic emission spectrometry (ICP-AES), or inductively coupled plasma-mass spectrometry (ICP-MS) for the quantification of total selenium in the feed additive. Based on the performance characteristics available the EURL recommends for the official control the method of AOAC International (AOAC, 2006.03) and three single-laboratory validated and further verified methods (based on ICP coupled with AES or MS) mentioned above for the quantification of total selenium in the feed additive.
For the quantification of total selenium in premixtures and compound feed the Applicant did not propose any method for official control. Nevertheless, for the quantification of total selenium in premixtures and compound feed, the EURL found the ring-trial validated EN 17053 based on ICP-MS and designed for the “Determination of trace elements, heavy metals and other elements in feed”. Furthermore, the EURL previously evaluated and recommended the CEN method EN 16159 based on hydride generation atomic absorption spectrometry (HGAAS). Based on the performance characteristics available the EURL recommends for official control for the quantification of total selenium in premixtures and compound feed the ring-trial validated methods EN 17053 based on ICP-MS and the EN 16159 based on HGAAS.
For the quantification of total zinc in the feed additive, premixtures and compound feed the Applicant submitted the internationally recognised ring-trial validated method EN 15510 based on ICP-AES. Furthermore, additional methods, formerly evaluated by the EURL in the frame of zinc-related dossiers, are considered fit-for-purpose for the current dossier. Therefore, based on the acceptable method performance characteristics, the EURL recommends for official control for the quantification of total zinc in the feed additive the ring-trial validated methods EN 15510 and EN 15621 based on ICP-AES or the ISO 6869 based on AAS. Furthermore, for the possible quantification of total zinc in premixtures and compound feed, the EURL considers these methods, together with the ring-trial validated method EN 17053 based on ICP-MS and the European Union method based on AAS (for compound feed only), fit-for-purpose
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.