Manganese lysinate sulphate - 3b511

In the current application an authorisation is sought under Article 4(1) for Manganese lysinate sulfate (Plexomin® L-Mn) 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. 

Manganese lysinate sulfate is a complex of manganese with L-lysine with a content ranging from 15 to 18 % (w/w) for manganese as an active substance, 44 to 47 % (w/w) for lysine and 27 to 31 % (w/w) for sulfate. 

The feed additive is intended to be incorporated into feedingstuffs through premixtures. The Applicant proposed maximum levels of total manganese in feedingstuffs complying with the limits set in Regulations (EC) No 1334/2003 and (EU) 2017/1490: 100 mg/kg for fish; and 150 mg/kg for other species. 

For the quantification of total manganese in the feed additive, premixtures and feedingstuffs the Applicant proposed several internationally recognised ring-trial validated methods, namely ISO 6869 based on atomic absorption spectrometry (AAS), EN 15621 and EN 15510 based on inductively coupled plasma-atomic emission spectrometry (ICP-AES). 

Moreover, the internationally recognised ring-trial validated method EN 17053 based on inductively coupled plasma-mass spectrometry (ICP-MS) and the European Union method based on AAS (Commission Regulation (EC) No 152/2009 – Annex IV-C), which has been further ring-trial validated by the UK Food Standards Agency (FSA), have been proposed by the Applicant for the quantification of total manganese in premixtures and feedingstuffs and feedingstuffs only, respectively. The above mentioned methods were previously evaluated and recommended by the EURL in the frame of several manganese based feed additive dossiers. 

Recommended method

as of:

- Commission Implementing Regulation (EU) 2022/1472

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

Atomic Absorption Spectrometry (AAS) – ISO 6869; or

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

Inductively Coupled Plasma- Atomic Emission Spectrometry (ICP-AES) – EN 15510; or

Inductively Coupled Plasma- Mass Spectrometry (ICP-MS) – EN 17053 (for premixtures and feedingstuffs only); or

Atomic Absorption Spectrometry (AAS) – Commission Regulation (EC) No 152/2009 (for feedingstuffs only)

For the quantification of lysine in the feed additive:

ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS/FLD) – EN ISO 17180

For the identification of sulphate in the feed additive:

European Pharmacopoeia monograph 20301