Document ID: 02017R1490-20220921
Language: ENG

02017R1490 — EN — 21.09.2022 — 001.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION IMPLEMENTING REGULATION (EU) 2017/1490</p><p>of 21 August 2017</p><p>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</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 216 22.8.2017, p. 1)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p>&#160;</p></td><td><p>&#160;</p></td><td><p>Official Journal</p></td></tr><tr><td><p>&#160;&#160;No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>&#9658;M1</a></p></td><td><p><a>                              COMMISSION IMPLEMENTING REGULATION (EU) 2022/1442&#160;of 31&#160;August 2022</a></p></td><td><p>&#160;&#160;L&#160;227</p></td><td><p>117</p></td><td><p>1.9.2022</p></td></tr></table>
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)
Article 1
Authorisation
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
Denial
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
Transitional measures
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
Entry into force
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.
ANNEX
<table><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Identification number of the additive</p></td><td><p>Name of the holder of authorisation</p></td><td><p>Additive</p></td><td><p>Composition, chemical formula, description, analytical method</p></td><td><p>Species or category of animal</p></td><td><p>Maximum age</p></td><td><p>Minimum content</p></td><td><p>Maximum content</p></td><td><p>Other provisions</p></td><td><p>End of period of authorisation</p></td></tr><tr><td><p>Content of element (Mn) in mg/kg of complete feed with a moisture content of 12&#160;%</p></td></tr><tr><td><p><span>Category of nutritional additives. Functional group: compounds of trace elements</span></p></td></tr><tr><td><p>3b501</p></td><td><p>&#8212;</p></td><td><p>Manganous chloride tetrahydrate</p></td><td><p><span>Additive composition</span></p><p>Manganous chloride tetrahydrate, as a powder, with a minimum content of 27&#160;% manganese.</p><p><span>Characterisation of the active substance</span></p><p>Manganous chloride tetrahydrate</p><p>Chemical formula: MnCl<span>2</span>&#160;&#903;&#160;4H<span>2</span>O</p><p>CAS Number: 13446-34-9</p><p><span>Analytical methods</span>&#160;<a>(<span>1</span>)</a></p><p>For the identification reactions of chloride in the feed additive:</p><div><p>&#8212;&#160;European Pharmacopoeia Monograph 2.3.1;</p></div><p>For the crystallographic characterisation of the feed additive:</p><div><p>&#8212;&#160;X-Ray diffraction;</p></div><p>For the quantification of total manganese in the feed additive and premixtures:</p><div><p>&#8212;&#160;Atomic Absorption Spectrometry,AAS (EN ISO 6869); or</p></div><div><p>&#8212;&#160;Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry, ICP-AES (EN 15510); or</p></div><div><p>&#8212;&#160;Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621);</p></div><p>For the quantification of total manganese in feed materials and compound feed:</p><div><p>&#8212;&#160;Atomic Absorption Spectrometry, AAS (Commission Regulation (EC) No 152/2009&#160;<a>(<span>2</span>)</a>, Annex&#160;IV-C); or</p></div><div><p>&#8212;&#160;Atomic Absorption Spectrometry, AAS (EN ISO 6869); or</p></div><div><p>&#8212;&#160;Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry, ICP-AES (EN 15510); or</p></div><div><p>&#8212;&#160;Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621).</p></div></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>Fish: 100 (total)</p><p>Other species: 150 (total)</p></td><td><p>1.&#160;&#160;The additive shall be incorporated into feed in the form of a premixture.</p><p>2.&#160;&#160;Manganous chloride tetrahydrate may be placed on the market and used as an additive consisting of a preparation.</p><p>3.&#160;&#160;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.</p></td><td><p>11 September 2027</p></td></tr><tr><td><p>3b502</p></td><td><p>&#8212;</p></td><td><p>Manganese (II) oxide</p></td><td><p><span>Additive composition</span></p><p>Manganous oxide, as a powder, with a minimum content of 60&#160;% manganese;</p><p>Minimum content of 77,5&#160;% MnO and a maximum content of 2&#160;% MnO<span>2</span></p><p><span>Characterisation of the active substance</span></p><p>Manganous oxide</p><p>Chemical formula: MnO</p><p>CAS Number: 1344-43-0</p><p><span>Analytical methods</span>&#160;<a>(<span>1</span>)</a></p><p>For the crystallographic characterisation of the feed additive:</p><div><p>&#8212;&#160;X-Ray diffraction;</p></div><p>For the quantification of total manganese in the feed additive and premixtures:</p><div><p>&#8212;&#160;Atomic Absorption Spectrometry,AAS (EN ISO 6869); or</p></div><div><p>&#8212;&#160;Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry, ICP-AES (EN 15510); or</p></div><div><p>&#8212;&#160;Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621);</p></div><p>For the quantification of total manganese in feed materials and compound feed:</p><div><p>&#8212;&#160;Atomic Absorption Spectrometry, AAS (Regulation (EC) No 152/2009, Annex IV-C); or</p></div><div><p>&#8212;&#160;Atomic Absorption Spectrometry, AAS (EN ISO 6869); or</p></div><div><p>&#8212;&#160;Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry, ICP-AES (EN 15510); or</p></div><div><p>&#8212;&#160;Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621).</p></div></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>Fish: 100 (total)</p><p>Other species: 150 (total)</p></td><td><p>1.&#160;&#160;The additive shall be incorporated into feed in the form of a premixture.</p><p>2.&#160;&#160;Manganese (II) oxide may be placed on the market and used as an additive consisting of a preparation.</p><p>3.&#160;&#160;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.</p></td><td><p>11 September 2027</p></td></tr><tr><td><p>3b503</p></td><td><p>&#8212;</p></td><td><p>Manganous sulphate monohydrate</p></td><td><p><span>Additive composition</span></p><p>Manganous sulphate monohydrate, as a powder, with a minimum content of 95&#160;% manganous sulphate monohydrate and of 31&#160;% manganese.</p><p><span>Characterisation of the active substance</span></p><p>Manganous sulphate monohydrate</p><p>Chemical formula: MnSO<span>4</span>&#160;&#903;&#160;H<span>2</span>O</p><p>CAS Number: 10034-96-5</p><p><span>Analytical methods</span>&#160;<a>(<span>1</span>)</a></p><p>For the quantification of the manganous sulphate monohydrate in the feed additive:</p><div><p>&#8212;&#160;titration with ammonium and cerium nitrate (Ph. Eur Monograph 1543);</p></div><p>For the identification reactions of sulphates in the feed additive:</p><div><p>&#8212;&#160;European Pharmacopoeia Monograph 2.3.1;</p></div><p>For the crystallographic characterisation of the feed additive:</p><div><p>&#8212;&#160;X-Ray diffraction;</p></div><p>For the quantification of total manganese in the feed additive and premixtures:</p><div><p>&#8212;&#160;Atomic Absorption Spectrometry,AAS (EN ISO 6869); or</p></div><div><p>&#8212;&#160;Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry, ICP-AES (EN 15510); or</p></div><div><p>&#8212;&#160;Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621);</p></div><p>For the quantification of total manganese in feed materials and compound feed:</p><div><p>&#8212;&#160;Atomic Absorption Spectrometry, AAS (Regulation (EC) No 152/2009, Annex IV-C); or</p></div><div><p>&#8212;&#160;Atomic Absorption Spectrometry, AAS (EN ISO 6869); or</p></div><div><p>&#8212;&#160;Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry, ICP-AES (EN 15510); or</p></div><div><p>&#8212;&#160;Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621).</p></div></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>Fish: 100 (total)</p><p>Other species: 150 (total)</p></td><td><p>1.&#160;&#160;The additive shall be incorporated into feed in the form of a premixture.</p><p>2.&#160;&#160;Manganous sulphate monohydrate may be placed on the market and used as an additive consisting of a preparation.</p><p>3.&#160;&#160;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.</p></td><td><p>11 September 2027</p></td></tr><tr><td><p><a>&#9660;M1</a></p></td></tr><tr><td><p>3b504</p></td><td><p>&#8212;</p></td><td><p>Manganese chelate of amino acids hydrate</p></td><td><p><span>Additive composition</span></p><p>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&#160;% manganese.</p></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>Fish: 100 (total&#160;<a>(<span>3</span>)</a>)</p><p>Other species: 150 (total&#160;<a>(<span>3</span>)</a>)</p></td><td><p>1.&#160;&#160;The additive shall be incorporated into feed in the form of a premixture.</p><p>2.&#160;&#160;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.</p></td><td><p>11&#160;September 2027</p></td></tr><tr><td><p><span>Characterisation of the active substance</span></p><p>Chemical formula: Mn(x)<span>1&#8211;3</span> nH2O,<span>x</span> = anion of any amino acid derived from acid hydrolysed soya protein;</p><p>Maximum 10&#160;% of molecules exceeding 1&#160;500  Da.</p></td></tr><tr><td><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>For the quantification of amino acid content in the feed additive:</p><div><p>&#8212;&#160;ion exchange chromatography with post-column derivatisation and optical detection (IEC-VIS/FLD)</p></div><p>For the quantification of total manganese in the feed additive:</p><div><p>&#8212;&#160;inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or</p></div><div><p>&#8212;&#160;atomic absorption spectrometry, AAS (ISO 6869)</p></div><p>For the quantification of total manganese in premixtures:</p><div><p>&#8212;&#160;inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or</p></div><div><p>&#8212;&#160;atomic absorption spectrometry, AAS (ISO 6869) or</p></div><div><p>&#8212;&#160;inductively coupled plasma-mass spectrometry, ICP-MS (EN 17053)</p></div><p>For the quantification of total manganese in feed materials and compound feed:</p><div><p>&#8212;&#160;inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or</p></div><div><p>&#8212;&#160;atomic absorption spectrometry, AAS (Commission Regulation (EC) No&#160;152/2009 (Annex IV-C) or ISO 6869) or</p></div><div><p>&#8212;&#160;inductively coupled plasma-mass spectrometry, ICP-MS (EN 17053)</p></div></td></tr><tr><td><p>3b504i</p></td><td><p>&#8212;</p></td><td><p>Manganese chelate of amino acids hydrate</p></td><td><p><span>Additive composition</span></p><p>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 &#8211; 9&#160;% manganese and a minimum of 17&#160;% free amino acids.</p></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>Fish: 100 (total&#160;<a>(<span>3</span>)</a>)</p><p>Other species: 150 (total&#160;<a>(<span>3</span>)</a>)</p></td><td><p>1.&#160;&#160;The additive shall be incorporated into feed in the form of a premixture.</p><p>2.&#160;&#160;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.</p><p>3.&#160;&#160;For additives produced from hydrolysis of animal protein, the animal origin (<span>avian species</span>) shall be indicated on the label of the additive and premixtures</p></td><td><p>11&#160;September 2027</p></td></tr><tr><td><p>Characterisation of the active substance:</p><p>Chemical formula: Mn(x)<span>1-3</span>&#8226;nH2O, where x is equal to any amino acid coming from hydrolysed protein sources from feathers or plants;</p><p>Maximum 10&#160;% of molecules exceeding 1&#160;500  Da.</p></td></tr><tr><td><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>For the quantification of amino acid content in the feed additive:</p><div><p>&#8212;&#160;ion exchange chromatography with post-column derivatisation and optical detection (IEC-VIS/FLD), Commission Regulation 152/2009 (Annex III,F) and EN ISO 17180</p></div><p>For the quantification of total manganese in the feed additive:</p><div><p>&#8212;&#160;inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or</p></div><div><p>&#8212;&#160;atomic absorption spectrometry, AAS (ISO 6869)</p></div><p>For the quantification of total manganese in premixtures:</p><div><p>&#8212;&#160;inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or</p></div><div><p>&#8212;&#160;atomic absorption spectrometry, AAS (ISO 6869) or</p></div><div><p>&#8212;&#160;inductively coupled plasma-mass spectrometry, ICP-MS (EN 17053)</p></div><p>For the quantification of total manganese in feed materials and compound feed:</p><div><p>&#8212;&#160;inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or</p></div><div><p>&#8212;&#160;atomic absorption spectrometry, AAS (Commission Regulation (EC) No&#160;152/2009 (Annex IV-C) or ISO 6869) or</p></div><div><p>&#8212;&#160;inductively coupled plasma-mass spectrometry, ICP-MS (EN 17053)</p></div></td></tr><tr><td><p><a>&#9660;B</a></p></td></tr><tr><td><p>3b505</p></td><td><p>&#8212;</p></td><td><p>Manganese chelate of protein hydrolysates</p></td><td><p><span>Additive composition</span></p><p>Manganese chelate of protein hydrolysates as a powder with a minimum content of 10&#160;% manganese.</p><p>Minimum of 50&#160;% manganese chelated.</p><p><span>Characterisation of the active substance</span></p><p>Chemical formula: Mn(x)<span>1&#8211;3</span>&#160;&#903;&#160;nH<span>2</span>O, x&#160;=&#160;anion of protein hydrolysates containing any amino acid from soya protein hydrolysate.</p><p><span>Analytical methods</span>&#160;<a>(<span>1</span>)</a></p><p>For the quantification of protein hydrolysates content in the feed additive:</p><div><p>&#8212;&#160;ion exchange chromatography combined with post-column ninhydrin derivatisation and photometric detection (Regulation (EC) No 152/2009, Annex III, F);</p></div><p>For the determination of chelated manganese content in the feed additive:</p><div><p>&#8212;&#160;Fourier Transformed Infrared (FTIR) spectroscopy followed by multivariate regression methods.</p></div><p>For the quantification of total manganese in the feed additive and premixtures:</p><div><p>&#8212;&#160;Atomic Absorption Spectrometry,AAS (EN ISO 6869); or</p></div><div><p>&#8212;&#160;Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry, ICP-AES (EN 15510); or</p></div><div><p>&#8212;&#160;Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621);</p></div><p>For the quantification of total manganese in feed materials and compound feed:</p><div><p>&#8212;&#160;Atomic Absorption Spectrometry, AAS (Regulation (EC) No 152/2009, Annex IV-C); or</p></div><div><p>&#8212;&#160;Atomic Absorption Spectrometry, AAS (EN ISO 6869); or</p></div><div><p>&#8212;&#160;Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry, ICP-AES (EN 15510); or</p></div><div><p>&#8212;&#160;Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621).</p></div></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>Fish: 100 (total)</p><p>Other species: 150 (total)</p></td><td><p>1.&#160;&#160;The additive shall be incorporated into feed in the form of a premixture.</p><p>2.&#160;&#160;Manganese chelate of protein hydrolysates may be placed on the market and used as an additive consisting of a preparation.</p><p>3.&#160;&#160;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.</p></td><td><p>11 September 2027</p></td></tr><tr><td><p>3b506</p></td><td><p>&#8212;</p></td><td><p>Manganese chelate of glycine hydrate</p></td><td><p><span>Additive composition</span></p><p>Manganese chelate of glycine, hydrate, as a powder with a minimum content of 15&#160;% manganese.</p><p>Moisture: maximum 10&#160;%.</p><p><span>Characterisation of the active substance</span></p><p>Chemical formula: Mn(x)<span>1-3</span>&#160;&#903;&#160;nH<span>2</span>O, x&#160;=&#160;anion of glycine.</p><p><span>Analytical methods</span>&#160;<a>(<span>1</span>)</a></p><p>For the quantification of the glycine content in the feed additive:</p><div><p>&#8212;&#160;ion exchange chromatography combined with post-column ninhydrin derivatisation and photometric detection (Regulation (EC) No 152/2009, Annex III, F);</p></div><p>For the quantification of total manganese in the feed additive and premixtures:</p><div><p>&#8212;&#160;Atomic Absorption Spectrometry,AAS (EN ISO 6869); or</p></div><div><p>&#8212;&#160;Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry, ICP-AES (EN 15510); or</p></div><div><p>&#8212;&#160;Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621);</p></div><p>For the quantification of total manganese in feed materials and compound feed:</p><div><p>&#8212;&#160;Atomic Absorption Spectrometry, AAS (Regulation (EC) No 152/2009, Annex IV-C); or</p></div><div><p>&#8212;&#160;Atomic Absorption Spectrometry, AAS (EN ISO 6869); or</p></div><div><p>&#8212;&#160;Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry, ICP-AES (EN 15510); or</p></div><div><p>&#8212;&#160;Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621).</p></div></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>Fish: 100 (total)</p><p>Other species: 150 (total)</p></td><td><p>1.&#160;&#160;The additive shall be incorporated into feed in the form of a premixture.</p><p>2.&#160;&#160;Manganese chelate of glycine hydrate may be placed on the market and used as an additive consisting of a preparation.</p><p>3.&#160;&#160;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.</p></td><td><p>11 September 2027</p></td></tr><tr><td><p>3b507</p></td><td><p>&#8212;</p></td><td><p>Dimanganese chloride trihydroxide</p></td><td><p><span>Additive composition</span></p><p>Granulate powder with a minimum content of 44&#160;% manganese and a maximum content of 7&#160;% manganese oxide</p><p><span>Characterisation of the active substance</span></p><p>Dimanganese chloride trihydroxide</p><p>Chemical formula: Mn<span>2</span>(OH)<span>3</span>Cl</p><p>CAS Number: 39438-40-9</p><p><span>Analytical methods</span>&#160;<a>(<span>1</span>)</a></p><p>For the identification of the crystallographic characterisation of the feed additive:</p><div><p>&#8212;&#160;X-Ray diffraction;</p></div><p>For the quantification of chlorine in the feed additive:</p><div><p>&#8212;&#160;Titration &#8212; Regulation (EC) No 152/2009;</p></div><p>For the quantification of total manganese in the feed additive and premixtures:</p><div><p>&#8212;&#160;Atomic Absorption Spectrometry, AAS (EN ISO 6869); or</p></div><div><p>&#8212;&#160;Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry, ICP-AES (EN 15510); or</p></div><div><p>&#8212;&#160;Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621);</p></div><p>For the quantification of total manganese in feed materials and compound feed:</p><div><p>&#8212;&#160;Atomic Absorption Spectrometry, AAS (Regulation (EC) No 152/2009, Annex IV-C); or</p></div><div><p>&#8212;&#160;Atomic Absorption Spectrometry, AAS (EN ISO 6869); or</p></div><div><p>&#8212;&#160;Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry, ICP-AES (EN 15510); or</p></div><div><p>&#8212;&#160;Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry after pressure digestion, ICP-AES (CEN/TS 15621).</p></div></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>Fish: 100 (total)</p><p>Other species: 150 (total)</p></td><td><p>1.&#160;&#160;The additive shall be incorporated into feed in the form of a premixture.</p><p>2.&#160;&#160;Dimanganese chloride trihydroxide may be placed on the market and used as an additive consisting of a preparation.</p><p>3.&#160;&#160;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.</p></td><td><p>11 September 2027</p></td></tr><tr><td><div><a>(<span>1</span>)&#160;&#160;&#160;</a><p>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</p></div><div><a>(<span>2</span>)&#160;&#160;&#160;</a><p>Commission 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).</p></div><div><a>(<span>3</span>)&#160;&#160;&#160;</a><p>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).</p></div></td></tr></tbody></table>