Copper lysinate sulfate

In the current application an authorisation is sought under Article 4(1) for copper lysinate sulfate under the category 3 “nutritional additives”, functional group (b) ”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.
According to the Applicant, the feed additive is a complex of copper with L-lysine at a ratio of 1:1 (equimolar); sulfate is also present in the additive. The feed additive is marketed under the name Plexomin® L-Cu. According to the Applicant, copper lysinate sulfate has a minimum content of copper of 18 % (w/w) (active substance) and a minimum content of lysine of 40 % (w/w). It is intended to be incorporated into compound feed through premixtures. The Applicant for the various target species proposed different values of maximum doses of copper (i.e. from 15 mg/kg to 150 mg/kg complete feed).
For the quantification of total copper in the feed additive, premixtures and compound feed the Applicant proposed several internationally recognised ring-trial validated methods, namely (i) ISO 6869 based on atomic absorption spectrometry (AAS), (ii) EN 15621 and (iii) EN 15510 based on inductively coupled plasma-atomic emission spectrometry (ICP-AES). Moreover, for the quantification of total copper in premixtures and compound feed the Applicant has proposed (ⅳ) the internationally recognised ring-trial validated method EN 17053 based on inductively coupled plasma-mass spectrometry (ICP-MS) and for the quantification in compound feed only (v) the European Union method based on AAS. The above mentioned methods were previously evaluated and recommended by the EURL in the frame of several copper based feed additive dossiers and are all listed or described in Commission Regulation (EC) No 152/2009, as last amended by Commission Implementing Regulation (EU) 2024/771. Based on the available performance characteristics of the methods, the EURL recommends for official control the five ring-trial validated methods: (i) ISO 6869, EN 15621 and EN 15510 for the quantification of total copper in the feed additive, premixtures and compound feed; (ii) EN 17053 for the quantification of total copper in premixtures and compound feed; and (iii) the European Union method for the quantification of total copper in compound feed.
For the determination of lysine in the feed additive the Applicant proposed the ring-trial validated method EN ISO 17180 based on ion-exchange chromatography (IEC) coupled to post-column derivatisation and optical (VIS or FLD) detection dedicated for the determination of free lysine, methionine and threonine in commercial amino acid products and premixtures containing more than 10 % of the amino acid. The above mentioned method was previously evaluated and recommended by the EURL in the frame of several lysine based feed additive dossiers and is listed in Commission Regulation (EC) No 152/2009, as last amended by Commission Implementing Regulation (EU) 2024/771. Based on the performance characteristics available, the EURL recommends for official control the EN ISO 17180 method for the determination of free lysine in the feed additive.
For the identification of the sulfate in the relevant feed additives the EURL has recommended in former evaluations the generic European Pharmacopoeia monograph (Ph. Eur. 20301) on identification of ions and functional groups. The EURL recommends for official control the above-mentioned European Pharmacopoeia monograph for the identification of sulfate in the feed additive in the frame of the current application.
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.