Commission Implementing Regulation (EU) 2022/1442 of 31 August 2022 amending Implementing Regulation (EU) 2017/1490 as regards the terms of authorisation of manganese chelate of amino acids hydrate as a feed additive for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2022/1442
• Articles: 3

Article 1

In the Annex to Implementing Regulation (EU) 2017/1490, the entry for manganese 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 (Mn) mg/kg of complete feed with a moisture content of 12 %

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

‘3b504

-

Manganese chelate of amino acids hydrate

Additive composition

Preparation of manganese amino acid complex where the manganese and the amino acids derived from soya protein are chelated via coordinate covalent bonds, as a powder with a minimum content of 8 % manganese.

All animal species

-

-

Fish: 100 (total  ( 2 ) )

Other species: 150 (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 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 skin, eye and breathing protection.

11 September 2027

Characterisation of the active substance

Chemical formula: Mn(x) 1–3 nH2O, x = anion of any amino acid derived from acid hydrolysed soya protein;

Maximum 10 % of molecules exceeding 1 500 Da.

Analytical method

( 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 total manganese 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 manganese 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 manganese 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)

3b504i

-

Manganese chelate of amino acids hydrate

Additive composition

Preparation of manganese amino acid complex, where the manganese and the amino acids are chelated via coordinate covalent bonds, as a powder with a content of 8 – 9 % manganese and a minimum of 17 % free amino acids.

All animal species

-

-

Fish: 100 (total  ( 2 ) )

Other species: 150 (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 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 skin, eye and breathing 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

11 September 2027’

Characterisation of the active substance:

Chemical formula: Mn(x) 1-3 •nH2O, where x is equal to any amino acid coming from hydrolysed protein sources from feathers or plants;

Maximum 10 % of molecules exceeding 1 500 Da.

Analytical method

( 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), Commission Regulation 152/2009 (Annex III,F) and EN ISO 17180

For the quantification of total manganese 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 manganese 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 manganese 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 manganese is not to be taken into consideration for the calculation of the total manganese content of the feed (manganese/kg complete feed).