Commission Implementing Regulation (EU) 2021/1425 of 31 August 2021 concerning the authorisation of manganese chelate of lysine and glutamic acid as feed additive for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/1425
• Articles: 3

Article 1

The preparation 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: nutritional additives

Functional group: compounds of trace elements

3b509

-

Manganese chelate of lysine and glutamic acid

Additive composition:

Preparation of chelates of manganese with lysine and chelates of manganese with glutamic acid in a ratio of 1:1 as a powder with

a manganese content between 15 and 17 %,

a lysine content between 20 and 21,5 %,

a glutamic acid content between 22 and 24 %,

a maximum of 3,5 % moisture and

a maximum of 4 ppm nickel.

All animal species

-

-

Fish: 100 (total)

Other species: 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 by inhalation, dermal contact or eyes contact, in particular due to the content of heavy metals including nickel. 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 eyes, skin and breathing.

21 September 2031

Characterisation of the active substances:

Chemical formulas:

Manganese-2,6- diaminohexanoic acid, chloride and hydrogen sulfate salt:

C 6 H 19 ClN 2 O 8 SMn

Manganese-2-aminopentanedioic acid, sodium and hydrogen sulfate salt:

C 5 H 10 NNaO 9 SMn

Analytical methods

( *1 ) :

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

( *1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports