Commission Implementing Regulation (EU) 2017/1490 of 21 August 2017 concerning the authorisation of manganous chloride tetrahydrate, manganese (II) oxide, manganous sulphate monohydrate, manganese chelate of amino acids hydrate, manganese chelate of protein hydrolysates, manganese chelate of glycine hydrate and dimanganese chloride trihydroxide as feed additives for all animal species (Text with EEA relevance. )
Modified by
  • Commission Implementing Regulation (EU) 2022/1442of 31 August 2022amending 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), 32022R1442, September 1, 2022
Commission Implementing Regulation (EU) 2017/1490of 21 August 2017concerning the authorisation of manganous chloride tetrahydrate, manganese (II) oxide, manganous sulphate monohydrate, manganese chelate of amino acids hydrate, manganese chelate of protein hydrolysates, manganese chelate of glycine hydrate and dimanganese chloride trihydroxide as feed additives for all animal species(Text with EEA relevance)
Article 1AuthorisationThe 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 2DenialAuthorisation 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 3Transitional measures1.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 4Entry into forceThis 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.ANNEX
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-reportsCommission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for official control of feed (OJ L 54, 26.2.2009, p. 1).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).Category of nutritional additives. Functional group: compounds of trace elements
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
Content of element (Mn) in mg/kg of complete feed with a moisture content of 12 %
3b501—Manganous chloride tetrahydrateAdditive compositionManganous chloride tetrahydrate, as a powder, with a minimum content of 27 % manganese.Characterisation of the active substanceManganous chloride tetrahydrateChemical formula: MnCl2 · 4H2OCAS Number: 13446-34-9Analytical methodsFor 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); orInductively Coupled Plasma — Atomic Emission Spectrometry, ICP-AES (EN 15510); orInductively 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); orAtomic Absorption Spectrometry, AAS (EN ISO 6869); orInductively Coupled Plasma — Atomic Emission Spectrometry, ICP-AES (EN 15510); orInductively 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) oxideAdditive compositionManganous oxide, as a powder, with a minimum content of 60 % manganese;Minimum content of 77,5 % MnO and a maximum content of 2 % MnO2Characterisation of the active substanceManganous oxideChemical formula: MnOCAS Number: 1344-43-0Analytical methodsFor 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); orInductively Coupled Plasma — Atomic Emission Spectrometry, ICP-AES (EN 15510); orInductively 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); orAtomic Absorption Spectrometry, AAS (EN ISO 6869); orInductively Coupled Plasma — Atomic Emission Spectrometry, ICP-AES (EN 15510); orInductively 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 monohydrateAdditive compositionManganous sulphate monohydrate, as a powder, with a minimum content of 95 % manganous sulphate monohydrate and of 31 % manganese.Characterisation of the active substanceManganous sulphate monohydrateChemical formula: MnSO4 · H2OCAS Number: 10034-96-5Analytical methodsFor 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); orInductively Coupled Plasma — Atomic Emission Spectrometry, ICP-AES (EN 15510); orInductively 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); orAtomic Absorption Spectrometry, AAS (EN ISO 6869); orInductively Coupled Plasma — Atomic Emission Spectrometry, ICP-AES (EN 15510); orInductively 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 hydrateAdditive compositionPreparation 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)Other species: 150 (total)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 substanceChemical formula: Mn(x)1–3 nH2O, x = anion of any amino acid derived from acid hydrolysed soya protein;Maximum 10 % of molecules exceeding 1500 Da.
Analytical methodFor 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) oratomic 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) oratomic absorption spectrometry, AAS (ISO 6869) orinductively 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) oratomic absorption spectrometry, AAS (Commission Regulation (EC) No 152/2009 (Annex IV-C) or ISO 6869) orinductively coupled plasma-mass spectrometry, ICP-MS (EN 17053)
3b504i—Manganese chelate of amino acids hydrateAdditive compositionPreparation 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)Other species: 150 (total)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 premixtures11 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 1500 Da.
Analytical methodFor 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 17180For the quantification of total manganese in the feed additive:inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) oratomic 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) oratomic absorption spectrometry, AAS (ISO 6869) orinductively 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) oratomic absorption spectrometry, AAS (Commission Regulation (EC) No 152/2009 (Annex IV-C) or ISO 6869) orinductively coupled plasma-mass spectrometry, ICP-MS (EN 17053)
3b505—Manganese chelate of protein hydrolysatesAdditive compositionManganese chelate of protein hydrolysates as a powder with a minimum content of 10 % manganese.Minimum of 50 % manganese chelated.Characterisation of the active substanceChemical formula: Mn(x)1–3 · nH2O, x = anion of protein hydrolysates containing any amino acid from soya protein hydrolysate.Analytical methodsFor 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); orInductively Coupled Plasma — Atomic Emission Spectrometry, ICP-AES (EN 15510); orInductively 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); orAtomic Absorption Spectrometry, AAS (EN ISO 6869); orInductively Coupled Plasma — Atomic Emission Spectrometry, ICP-AES (EN 15510); orInductively 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 hydrateAdditive compositionManganese chelate of glycine, hydrate, as a powder with a minimum content of 15 % manganese.Moisture: maximum 10 %.Characterisation of the active substanceChemical formula: Mn(x)1-3 · nH2O, x = anion of glycine.Analytical methodsFor 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); orInductively Coupled Plasma — Atomic Emission Spectrometry, ICP-AES (EN 15510); orInductively 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); orAtomic Absorption Spectrometry, AAS (EN ISO 6869); orInductively Coupled Plasma — Atomic Emission Spectrometry, ICP-AES (EN 15510); orInductively 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 trihydroxideAdditive compositionGranulate powder with a minimum content of 44 % manganese and a maximum content of 7 % manganese oxideCharacterisation of the active substanceDimanganese chloride trihydroxideChemical formula: Mn2(OH)3ClCAS Number: 39438-40-9Analytical methodsFor 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); orInductively Coupled Plasma — Atomic Emission Spectrometry, ICP-AES (EN 15510); orInductively 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); orAtomic Absorption Spectrometry, AAS (EN ISO 6869); orInductively Coupled Plasma — Atomic Emission Spectrometry, ICP-AES (EN 15510); orInductively 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
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