Commission Implementing Regulation (EU) 2022/1457 of 2 September 2022 amending Implementing Regulation (EU) 2017/2330 as regards the terms of authorisation of iron (II) chelate of amino acids hydrate as a feed additive for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2022/1457
• Articles: 3

Article 1

In the Annex to Implementing Regulation (EU) 2017/2330, the entry for iron (II) chelate of amino acids hydrate is amended in accordance with the Annex to this Regulation.

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

‘3b106

-

Iron (II) chelate of amino acids hydrate

Additive composition:

Preparation of Iron(II) amino acid complex where the iron and the amino acids derived from soya protein are chelated via coordinate covalent bonds, as a powder with a minimum content of 9 % iron.

All animal species

-

-

Ovine: 500 (total  ( 2 ) )

Bovines and poultry: 450 (total  ( 2 ) )

Piglets up to 1 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.

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, skin and eye protection.

4 January 2028

Characterisation of the active substance:

Chemical formula: Fe(x) 1–3 ·nH2O, x = anion of any amino acid from soya protein hydrolysate.

Maximum 10 % of molecules exceeding 1500 Da.

Analytical methods

( 1 ) :

For the quantification of amino acid content in the feed additive:

—

ion exchange chromatography with post-column derivatisation and optical detection (IEC-VIS/FLD)

—

For the quantification of the free amino acid content in the feed additive:

—

ion exchange chromatography with post-column derivatisation and optical detection (IEC-VIS/FLD),

For the quantification of total iron in the feed additive:

—

inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or

—

atomic absorption spectrometry, AAS (ISO 6869)

For the quantification of total iron in premixtures:

—

inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or

—

atomic absorption spectrometry, AAS (ISO 6869) or

—

inductively coupled plasma-mass spectrometry, ICP-MS (EN 17053)

For the quantification of total iron in feed materials and compound feed:

—

inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or

—

atomic absorption spectrometry, AAS (Commission Regulation (EC) No 152/2009 (Annex IV-C) or ISO 6869) or

—

inductively coupled plasma-mass spectrometry, ICP-MS (EN 17053)

3b106i

-

Iron (II) chelate of amino acids hydrate

Additive composition:

Preparation of iron (II) amino acid complex, where the iron and the amino acids are chelated via coordinate covalent bonds, as a powder with an iron content of 9 – 10 % and a minimum of 18 % free amino acids.

All animal species

-

-

Ovine: 500 (total   ( 2 ) )

Bovines and poultry: 450 (total  ( 2 ) )

Piglets up to 1 week before weaning: 250 (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.

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 in particular due to the content of heavy metals.. 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.

3.

For additives produced from hydrolysis of animal protein, the animal origin ( avian species ) shall be indicated on the label of the additive and premixtures.

4 January 2028

Characterisation of the active substance:

Chemical formula: Fe(x) 1-3 •nH 2 O, where x is equal to any amino acid coming from hydrolysed protein sources from feathers or plants;

Maximum 10 % of molecules exceeding 1500 Da.

Analytical methods

( 1 ) :

For the quantification of the free amino acid content in the feed additive:

—

ion exchange chromatography with post-column derivatisation and optical detection (IEC-VIS/FLD), Commission Regulation (EC) No 152/2009 (Annex III,F) and EN ISO 17180

For the quantification of total iron in the feed additive:

—

inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or

—

atomic absorption spectrometry, AAS (ISO 6869)

For the quantification of total iron in premixtures:

—

inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or

—

atomic absorption spectrometry, AAS (ISO 6869) or

—

inductively coupled plasma-mass spectrometry, ICP-MS (EN 17053)

For the quantification of total iron in feed materials and compound feed:

—

inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or

—

atomic absorption spectrometry, AAS (Commission Regulation (EC) No 152/2009 (Annex IV-C) or ISO 6869) 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 (iron/kg complete feed)’