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

3b501

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Manganous chloride tetrahydrate

Additive composition

Manganous chloride tetrahydrate, as a powder, with a minimum content of 27 % manganese.

Characterisation of the active substance

Manganous chloride tetrahydrate

Chemical formula: MnCl2 · 4H2O

CAS Number: 13446-34-9

Analytical methods (1)

For the identification reactions of chloride in the feed additive:

For the crystallographic characterisation of the feed additive:

For the quantification of total manganese in the feed additive and premixtures:

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

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.  Manganous chloride tetrahydrate 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 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.

11 September 2027

3b502

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Manganese (II) oxide

Additive composition

Manganous oxide, as a powder, with a minimum content of 60 % manganese;

Minimum content of 77,5 % MnO and a maximum content of 2 % MnO2

Characterisation of the active substance

Manganous oxide

Chemical formula: MnO

CAS Number: 1344-43-0

Analytical methods (1)

For the crystallographic characterisation of the feed additive:

For the quantification of total manganese in the feed additive and premixtures:

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

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.  Manganese (II) oxide 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 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.

11 September 2027

3b503

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Manganous sulphate monohydrate

Additive composition

Manganous sulphate monohydrate, as a powder, with a minimum content of 95 % manganous sulphate monohydrate and of 31 % manganese.

Characterisation of the active substance

Manganous sulphate monohydrate

Chemical formula: MnSO4 · H2O

CAS Number: 10034-96-5

Analytical methods (1)

For the quantification of the manganous sulphate monohydrate in the feed additive:

For the identification reactions of sulphates in the feed additive:

For the crystallographic characterisation of the feed additive:

For the quantification of total manganese in the feed additive and premixtures:

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

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.  Manganous sulphate monohydrate 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 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.

11 September 2027

▼M1

3b504

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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 (3))

Other species: 150 (total (3))

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:

For the quantification of total manganese in the feed additive:

For the quantification of total manganese in premixtures:

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

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 (3))

Other species: 150 (total (3))

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:

For the quantification of total manganese in the feed additive:

For the quantification of total manganese in premixtures:

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

▼B

3b505

—

Manganese chelate of protein hydrolysates

Additive composition

Manganese chelate of protein hydrolysates as a powder with a minimum content of 10 % manganese.

Minimum of 50 % manganese chelated.

Characterisation of the active substance

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

Analytical methods (1)

For the quantification of protein hydrolysates content in the feed additive:

For the determination of chelated manganese content in the feed additive:

For the quantification of total manganese in the feed additive and premixtures:

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

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.  Manganese chelate of protein hydrolysates 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 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.

11 September 2027

3b506

—

Manganese chelate of glycine hydrate

Additive composition

Manganese chelate of glycine, hydrate, as a powder with a minimum content of 15 % manganese.

Moisture: maximum 10 %.

Characterisation of the active substance

Chemical formula: Mn(x)1-3 · nH2O, x = anion of glycine.

Analytical methods (1)

For the quantification of the glycine content in the feed additive:

For the quantification of total manganese in the feed additive and premixtures:

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

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.  Manganese chelate of glycine hydrate 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 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.

11 September 2027

3b507

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Dimanganese chloride trihydroxide

Additive composition

Granulate powder with a minimum content of 44 % manganese and a maximum content of 7 % manganese oxide

Characterisation of the active substance

Dimanganese chloride trihydroxide

Chemical formula: Mn2(OH)3Cl

CAS Number: 39438-40-9

Analytical methods (1)

For the identification of the crystallographic characterisation of the feed additive:

For the quantification of chlorine in the feed additive:

For the quantification of total manganese in the feed additive and premixtures:

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

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.  Dimanganese chloride trihydroxide 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 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.

11 September 2027