Commission Implementing Regulation (EU) 2022/1472 of 5 September 2022 concerning the authorisation of manganese lysinate sulphate as a feed additive for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2022/1472
• Articles: 3

Article 1

The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Schedules & Appendices

ANNEX

ANNEX

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

Content of element (Mn) in mg/kg of complete feed with a moisture content of 12 %

Category of nutritional additives. Functional group: compounds of trace elements.

3b511

-

Manganese lysinate sulphate

Additive composition

Manganese and amino acid L-lysine: ratio of 1:1

(monohydrate) having a content of:

—

manganese 16 % – 18 %;

—

lysine 44 % – 47 %;

—

sulphate 27 % – 31 % (calculated from sulphur),

Solid form (≤ 10 % moisture)

All animal species other than fish

-

-

150 (total)

1.

The additive shall be incorporated into feed in the form of a premixture.

2.

For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including breathing, skin and eye protection.

26.9.2032

Characterisation of the active substances

Chemical formulas:

C 6 H 16 MnN 2 O 7 S

IUPAC: monoaquamonolysinatomanganese (II) sulphate

Fish

100 (total)

Analytical methods

( 1 )

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

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en