Commission Implementing Regulation (EU) 2020/1795 of 30 November 2020 concerning the authorisation of iron chelate of lysine and glutamic acid as a feed additive for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/1795
• 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 (Fe) in mg/kg of complete feed with a moisture content of 12 %

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

3b111

-

Iron chelate of lysine and glutamic acid

Additive composition

Mixture of chelates of iron with lysine and chelates of iron with glutamic acid in a ratio of 1:1 as a powder with

an iron content between 15 and 16 %,

a lysine content between 19 and 21 %,

a glutamic acid content between 18,5 and 21,5 % and

a maximum of 3 % moisture

All animal species

-

-

Ovine: 500 (total  ( 2 ) )

Bovines and poultry: 450 (total  ( 2 ) )

Piglets up to one week before weaning: 250 mg/day (total  ( 2 ) )

Pet animals: 600 (total  ( 2 ) )

Other species: 750 (total  ( 2 ) )

1.

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

2.

Iron chelate of lysine and glutamic acid may be placed on the market and used as an additive consisting of a preparation.

3.

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 or eyes contact. 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 protection.

21.12.2030

Characterisation of the active substances

Chemical formulas:

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

C 6 H 17 ClFeN 2 O 7 S

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

C 5 H 12 FeNNaO 10 S

Analytical methods

( 1 )

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

For the quantification of total iron in the feed additive:

—

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 iron in 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); or

—

Inductively Coupled Plasma – Mass Spectrometry, ICP-MS (EN 17053).

For the quantification of total iron 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) or

—

Inductively Coupled Plasma – Mass Spectrometry, ICP-MS (EN 17053).

( 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

( 2 )   The amount of inert iron is not to be taken into consideration for the calculation of the total iron content of the feed.