
Article 1 
The substances specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, are authorised as feed additives in animal nutrition, subject to the conditions laid down in that Annex.
Article 2 
Authorisation of the substances specified in the Annex as additives belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’ is denied for use in water for drinking.
Article 3 

1. The substances manganous chloride tetrahydrate, manganous oxide, manganous sulphate monohydrate, manganese chelate of amino acids hydrate and manganese chelate of glycine hydrate as authorised by Regulations (EC) No 1334/2003 and (EC) No 479/2006, and premixtures containing those substances, which are produced and labelled before 11 March 2018 in accordance with the rules applicable before 11 September 2017 may continue to be placed on the market and used until the existing stocks are exhausted.
2. Feed materials and compound feed containing the substances referred to in paragraph 1 which are produced and labelled before 11 September 2018 in accordance with the rules applicable before 11 September 2017 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
3. Feed materials and compound feed containing the substances referred to in paragraph 1 which are produced and labelled before 11 September 2019 in accordance with the rules applicable before 11 September 2017 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
Article 4 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 21 August 2017.
For the Commission
The President
Jean-Claude JUNCKER
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 of nutritional additives. Functional group: compounds of trace elements
3b501 — Manganous chloride tetrahydrate 
Manganous chloride tetrahydrate, as a powder, with a minimum content of 27 % manganese.

Manganous chloride tetrahydrate

Chemical formula: MnCl2 · 4H2O

CAS Number: 13446-34-9

For the identification reactions of chloride in the feed additive:


— European Pharmacopoeia Monograph 2.3.1;

For the crystallographic characterisation of the feed additive:


— X-Ray diffraction;

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 (CEN/TS 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 (CEN/TS 15621).
 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 — Manganese (II) oxide 
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

Manganous oxide

Chemical formula: MnO

CAS Number: 1344-43-0

For the crystallographic characterisation of the feed additive:


— X-Ray diffraction;

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 (CEN/TS 15621);

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


— Atomic Absorption Spectrometry, AAS (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 (CEN/TS 15621).
 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 — Manganous sulphate monohydrate 
Manganous sulphate monohydrate, as a powder, with a minimum content of 95 % manganous sulphate monohydrate and of 31 % manganese.

Manganous sulphate monohydrate

Chemical formula: MnSO4 · H2O

CAS Number: 10034-96-5

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


— titration with ammonium and cerium nitrate (Ph. Eur Monograph 1543);

For the identification reactions of sulphates in the feed additive:


— European Pharmacopoeia Monograph 2.3.1;

For the crystallographic characterisation of the feed additive:


— X-Ray diffraction;

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 (CEN/TS 15621);

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


— Atomic Absorption Spectrometry, AAS (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 (CEN/TS 15621).
 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
3b504 — Manganese chelate of amino acids hydrate 
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.

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

Maximum of 10 % of the molecules exceeding 1 500 Da.

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


— ion exchange chromatography combined with post-column ninhydrin derivatisation and photometric detection (Regulation (EC) No 152/2009, Annex III, F);

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 (CEN/TS 15621);

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


— Atomic Absorption Spectrometry, AAS (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 (CEN/TS 15621).
 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 amino acids 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
3b505 — Manganese chelate of protein hydrolysates 
Manganese chelate of protein hydrolysates as a powder with a minimum content of 10 % manganese.

Minimum of 50 % manganese chelated.

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

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


— ion exchange chromatography combined with post-column ninhydrin derivatisation and photometric detection (Regulation (EC) No 152/2009, Annex III, F);

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


— Fourier Transformed Infrared (FTIR) spectroscopy followed by multivariate regression methods.

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 (CEN/TS 15621);

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


— Atomic Absorption Spectrometry, AAS (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 (CEN/TS 15621).
 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 
Manganese chelate of glycine, hydrate, as a powder with a minimum content of 15 % manganese.

Moisture: maximum 10 %.

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

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


— ion exchange chromatography combined with post-column ninhydrin derivatisation and photometric detection (Regulation (EC) No 152/2009, Annex III, F);

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 (CEN/TS 15621);

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


— Atomic Absorption Spectrometry, AAS (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 (CEN/TS 15621).
 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 — Dimanganese chloride trihydroxide 
Granulate powder with a minimum content of 44 % manganese and a maximum content of 7 % manganese oxide

Dimanganese chloride trihydroxide

Chemical formula: Mn2(OH)3Cl

CAS Number: 39438-40-9

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


— X-Ray diffraction;

For the quantification of chlorine in the feed additive:


— Titration — Regulation (EC) No 152/2009;

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 (CEN/TS 15621);

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


— Atomic Absorption Spectrometry, AAS (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 (CEN/TS 15621).
 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

