Zinc bislysinate (3b613)

Recommended Method

as of:

• Commission Implementing Regulation (EU) 2016/973

For the quantification of Lysine content in the feed additive and premixtures:

• Ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-UV/FD) - VDLUFA 4.11.6 or EN ISO 17180

For the quantification of total zinc content in the feed additive and premixtures:

• Inductively Coupled Plasma Atomic Emission Spectrometry (ICP-AES) - EN 15510, or
• Inductively Coupled Plasma Atomic Emission Spectrometry after pressure digestion, (ICP-AES) – EN 15621

For the quantification of total zinc in the feed materials and compound feed:

• Inductively Coupled Plasma Atomic Emission Spectrometry (ICP-AES) - EN 15510, or
• Inductively Coupled Plasma Atomic Emission Spectrometry after pressure digestion, (ICP-AES) – EN 15621, or
• Atomic Absorption Spectrometry (AAS) - Commission Regulation (EC) No 152/2009

Executive Summary

In the current application authorisation is sought under article 4(1) for Zinc Chelate of L-Lysinate HCl 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, authorisation is sought for the use of the feed additive for all categories and species. Zinc Chelate of L-Lysinate HCl is a white-grey free flowing powder or granules with a minimum content of 13.7 % total zinc and a maximum content of 86.3 % L-Lysine HCl. The feed additive is intended to be incorporated into premixtures and feedingstuffs. The Applicant suggested maximum levels of total zinc in the feedingstuffs complying to the limits set in Regulation (EC) No 1334/2003, ranging from 150 to 250 mg/kg - depending of the animal species/category. For the quantification of Lysine content in the feed additive and premixtures the Applicant submitted the ring-trial validated method by the “Association of German Agricultural Analytical and Research Institutes” (VDLUFA, Germany – Method 4.11.6), based on ion-exchange chromatography coupled with post-column derivatisation and colourimetric or fluorescence detection. Furthermore, the EURL identified the recently published ring-trial validated method EN ISO 17180:2013 for the "determination of Lysine […] in commercial amino acid products and premixtures", based on ion-exchange chromatography coupled with post-column derivatisation and colourimetric or fluorescence detection. The method does not distinguish between the salts and the amino acid enantiomers and applies for the products/premixtures containing more than 10 % of amino acid content. Based on acceptable performance characteristics available, the EURL recommends for official control the two ring-trial validated methods (VDLUFA 4.11.6 and EN ISO 17180:2013) to quantify Lysine in the feed additive and premixtures. For the quantification of total Lysine in feedingstuffs the EURL already evaluated and recommended in the frame of the Lysine group dossier FAD-2010-0067 the the ring-trial validated Community method. This method applies for the determination of free (synthetic and natural) and of total (peptide-bound and free) amino acids, using an amino acid analyzer or High Performance Liquid Chromatography (HPLC) equipment. The method does not distinguish between the salts and the amino acid enantiomers. This method was further ring-trial validated, resulting in the EN ISO 13903:2005 method. For the determination of total zinc in the feed additive, premixtures and feedingstuffs the Applicant submitted the internationally recognised ring-trial validated method EN 15510 based on inductively coupled plasma atomic emission spectroscopy (ICP-AES). Two additional methods were previously evaluated and recommended by the EURL in the frame of the Zinc group dossier: the ring-trial validated EN 15621 method based on ICP-AES after pressure digestion and the Community method based on atomic absorption spectroscopy. The Community method was further ring-trial validated by the UK Food Standards Agency (FSA). Based on the acceptable method performance characteristics available, the EURL recommends for official control the two CEN methods (EN 15510 or EN 15621) for the quantification of total zinc in the feed additive, premixtures and feedingstuffs, together with the Community method (Com Reg (EC) No 152/2009 – Annex IV-C) for the determination of total zinc in feedingstuffs. 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) is not considered necessary.