Manganese chelate of lysine and glutamic acid - 3b509

In the current application authorisation is sought under Article 4(1) for manganese chelates of lysine and glutamic acid 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. 

Manganese chelates of lysine and glutamic acid is a solid preparation with a minimum content of 15 % (w/w) of manganese, 19 % (w/w) of lysine and 19 % (w/w) of glutamic acid. 

The feed additive is intended to be incorporated into premixtures and feedingstuffs. The Applicant proposed maximum levels of total manganese in feedingstuffs ranging from 100 to 150 mg/kg – depending of the animal species/category – and thus complying with the limits set in the Regulations (EC) No 1334/2003 and (EU) 2017/1490. 

For the quantification of total manganese in the feed additive, premixtures and feedingstuffs the Applicant submitted the two internationally recognised ring-trial validated CEN methods based on inductively coupled plasma-atomic emission spectrometry (ICP-AES): EN 15510 and EN 15621. These two methods together with the Community method based on atomic absorption spectrometry, which was further ring-trial validated by the UK Food Standards Agency (FSA), were previously evaluated and recommended by the EURL in the frame of the manganese group dossier. 

In addition, the EURL is aware of two ring-trial validated methods, namely: ISO 6869 based on atomic absorption spectrometry (AAS) and EN 17053 based on inductively coupled plasma-mass spectrometry (ICP-MS). 

Based on the acceptable method performance characteristics available, the EURL recommends for official control the five ring-trial validated methods: i) EN 15621 and ISO 6869 for the quantification of total manganese in the feed additive, premixtures and feedingstuffs; ii) EN 15510 and EN 17053 for the quantification of total manganese in premixtures and feedingstuffs; and iii) the Community method (Commission Regulation (EC) No 152/2009 – Annex IV-C) for the quantification of total manganese in feedingstuffs. 

For the quantification of lysine and glutamic acid in the feed additive the Applicant submitted the ring-trial validated EN ISO 13903 method based on ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS). This standard method is equivalent to the experimental protocol described in the Community method designed for the determination of free (synthetic and natural) and of total (peptide-bound and free) amino acids including lysine and glutamic acid, using an amino acid analyser or a High Performance Liquid Chromatography (HPLC) equipment. This method does not distinguish between the salts and the amino acid enantiomers. 

The Applicant applied the above mentioned IEC-VIS method for the analysis of five batches of the feed additive with an averaged content of 20 % (w/w) for lysine and 23 % (w/w) for glutamic acid. Relative standard deviations for repeatability (RSD_r) of 2.5 % were obtained for lysine and glutamic acid. This is in agreement with the precision values reported in the frame of two ring-trial validation studies. 

Based on the performance characteristics available, the EURL recommends for official control the method based on IEC-VIS to quantify lysine and glutamic acid in the feed additive. 

In addition, upon the request from DG SANTE, the EURL evaluated the supplementary information in order to confirm the chelated structures of the feed additive. 

Upon the request from DG SANTE, the EURL evaluated the supplementary information provided in the frame of the following feed additive dossiers: 2017-0071, 2017-0072, 2018-0009 and 2018-0010, in order to confirm the chelated structures of the corresponding feed additives. 

For proving the chelated structures of the feed additives the Applicant has proposed the measurements of the chelated products by mid-infrared (IR) spectrometry and visual interpretation of the acquired spectra of the chelated products and the reference spectra of lysine and glutamic acid. 

The Applicant provided the mid-infrared (IR) spectra of the feed additives, of the individual chelated products of the trace elements and of lysine and glutamic acid. 

Based on the available data, the EURL recommends for official control the measurements by mid-IR spectrometry together with the determination of the content of the trace element (copper, zinc, manganese and iron) and lysine and glutamic acid in the products for proving the chelated structure of the feed additives.

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.

Recommended Method

as of:

- Commission Implementing Regulation (EU) 2021/1425

For the quantification of total manganese in the feed additive and premixtures:

Atomic Absorption Spectrometry, AAS (EN ISO 6869); or

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 manganese in feed materials and compound feed:

Atomic Absorption Spectrometry, AAS (Commission Regulation (EC) No 152/2009, Annex IV-C); or

Atomic Absorption Spectrometry, AAS (EN ISO 6869); or

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 the lysine and glutamic acid content in the feed additive: 

Ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)

For proving the chelated structure of the feed additive:

Mid-infrared (IR) spectrometry together with the determination of the content of the trace element and lysine and glutamic acid in the feed additive