Document ID: 02018R1039-20220921
Language: ENG

02018R1039 — 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) 2018/1039</p><p>of 23&#160;July 2018</p><p>concerning the authorisation of Copper(II) diacetate monohydrate, Copper(II) carbonate dihydroxy monohydrate, Copper(II) chloride dihydrate, Copper(II) oxide, Copper(II) sulphate pentahydrate, Copper(II) chelate of amino acids hydrate, Copper(II) chelate of protein hydrolysates, Copper(II) chelate of glycine hydrate (solid) and Copper(II) chelate of glycine hydrate (liquid) as feed additives for all animal species and amending Regulations (EC) No 1334/2003, (EC) No 479/2006 and (EU) No 349/2010 and Implementing Regulations (EU) No 269/2012, (EU) No 1230/2014 and (EU) 2016/2261</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 186 24.7.2018, p. 3)</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) 2022/1445&#160;of 31&#160;August 2022</a></p></td><td><p>&#160;&#160;L&#160;227</p></td><td><p>127</p></td><td><p>1.9.2022</p></td></tr></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2018/1039
of 23 July 2018
concerning the authorisation of Copper(II) diacetate monohydrate, Copper(II) carbonate dihydroxy monohydrate, Copper(II) chloride dihydrate, Copper(II) oxide, Copper(II) sulphate pentahydrate, Copper(II) chelate of amino acids hydrate, Copper(II) chelate of protein hydrolysates, Copper(II) chelate of glycine hydrate (solid) and Copper(II) chelate of glycine hydrate (liquid) as feed additives for all animal species and amending Regulations (EC) No 1334/2003, (EC) No 479/2006 and (EU) No 349/2010 and Implementing Regulations (EU) No 269/2012, (EU) No 1230/2014 and (EU) 2016/2261
(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
Special conditions of use
The authorised substances specified in the Annex as additives belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’ shall not be used in water for drinking.
Article 3
Amendment to Regulation (EC) No 1334/2003
In the Annex to Regulation (EC) No 1334/2003, the following additives are deleted from entry E4 for the element Copper-Cu: ‘cupric acetate, monohydrate, basic cupric carbonate, monohydrate, cupric chloride, dihydrate, cupric oxide, cupric sulphate, pentahydrate, copperlysine sulphate and cupric chelate of amino acids, hydrate’.
Article 4
Amendment to Regulation (EC) No 479/2006
In the Annex to Regulation (EC) No 479/2006, the entry E4 for the additive ‘Cupric chelate of glycine hydrate’ is deleted.
Article 5
Amendment to Regulation (EU) No 349/2010
In the Annex to Regulation (EU) No 349/2010, in the line 3b4.10 the text of the eighth column is replaced by the following:
‘Bovines:
— Bovines before the start of rumination: 15 (total);
— Other bovines: 30 (total).
Ovines: 15 (total).
Caprines: 35 (total)
Piglets:
— suckling and weaned up to 4 weeks after weaning: 150 (total);
— from 5-th week after weaning up to 8 weeks after weaning: 100 (total).
Crustaceans: 50 (total).
Other animals: 25 (total)’.
Article 6
Amendment to Implementing Regulation (EU) No 269/2012
In the Annex to Implementing Regulation (EU) No 269/2012, in the line 3b409 the text of the eighth column is replaced by the following:
‘Bovines:
— Bovines before the start of rumination: 15 (total);
— Other bovines: 30 (total).
Ovines: 15 (total).
Caprines: 35 (total)
Piglets:
— suckling and weaned up to 4 weeks after weaning: 150 (total);
— from 5-th week after weaning up to 8 weeks after weaning: 100 (total).
Crustaceans: 50 (total).
Other animals: 25 (total)’.
Article 7
Amendment to Implementing Regulation (EU) No 1230/2014
In the Annex to Implementing Regulation (EU) No 1230/2014, in the line 3b411 the text of the eighth column is replaced by the following:
‘Bovines:
— Bovines before the start of rumination: 15 (total);
— Other bovines: 30 (total).
Ovines: 15 (total).
Caprines: 35 (total)
Piglets:
— suckling and weaned up to 4 weeks after weaning: 150 (total);
— from 5-th week after weaning up to 8 weeks after weaning: 100 (total).
Crustaceans: 50 (total).
Other animals: 25 (total’.
Article 8
Amendment to Implementing Regulation (EU) 2016/2261
In the Annex to Implementing Regulation (EU) 2016/2261, in the line 3b412 the text of the eighth column is replaced by the following:
‘Bovines:
— Bovines before the start of rumination: 15 (total);
— Other bovines: 30 (total).
Ovines: 15 (total).
Caprines: 35 (total)
Piglets:
— suckling and weaned up to 4 weeks after weaning: 150 (total);
— from 5-th week after weaning up to 8 weeks after weaning: 100 (total).
Crustaceans: 50 (total).
Other animals: 25 (total’.
Article 9
Transitional measures
1. The substances ‘cupric acetate, monohydrate’, ‘basic cupric carbonate, monohydrate’, ‘cupric chloride, dihydrate’, ‘cupric oxide’, ‘cupric sulphate, pentahydrate’, ‘cupric chelate of amino acids, hydrate’ and ‘cupric chelate of glycine hydrate’ as authorised by Regulation (EC) No 1334/2003 and Regulation (EC) No 479/2006 and the copper compounds authorised by Regulation (EU) No 349/2010 and Implementing Regulations (EU) No 269/2012, (EU) No 1230/2014 and (EU) 2016/2261, and premixtures containing those substances, which are produced and labelled before 13 February 2019 in accordance with the rules applicable before 13 August 2018 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 13 August 2019 in accordance with the rules applicable before 13 August 2018 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 13 August 2020 in accordance with the rules applicable before 13 August 2018 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 10
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 (Cu) in mg/kg of complete feed with a moisture content of 12 %</p></td></tr><tr><td><p><span>Category of nutritional additives. Functional group: compounds of trace elements</span></p></td></tr><tr><td><p>3b401</p></td><td><p>&#8212;</p></td><td><p>Copper(II) diacetate monohydrate</p></td><td><p><span>Additive composition</span></p><p>Copper(II) diacetate monohydrate as a powder with a minimum content of 31 % copper</p><p><span>Characterisation of the active substance</span></p><p>Chemical formula: Cu(CH<span>3</span>COO)<span>2</span> &#903; H<span>2</span>O</p><p>CAS Number: 6046-93-1</p><p><span>Analytical methods</span>&#160;<a>(<span>1</span>)</a></p><p>For the identification of Copper(II) diacetate monohydrate in the feed additive:</p><div><p>&#8212;&#160;European Pharmacopoeia Monographs 2146 and 20301</p></div><p>For the crystallographic characterisation of the feed additive:</p><div><p>&#8212;&#160;X-Ray diffraction</p></div><p>For the determination of total Cu content in the feed additive and premixtures:</p><div><p>&#8212;&#160;inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or CEN/TS 15621)</p></div><p>Determination of total Cu content 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 IV-C) or</p></div><div><p>&#8212;&#160;inductively coupled plasma atomic emission, ICP-AES (EN 15510 or 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>Bovines:</p><div><p>&#8212;&#160;Bovines before the start of rumination: 15 (total);</p></div><div><p>&#8212;&#160;Other bovines: 30 (total).</p></div><p>Ovines: 15 (total).</p><p>Caprines: 35 (total)</p><p>Piglets:</p><div><p>&#8212;&#160;suckling and weaned up to 4 weeks after weaning: 150 (total).</p></div><div><p>&#8212;&#160;from 5-th week after weaning up to 8&#160;weeks after weaning: 100 (total).</p></div><p>Crustaceans: 50 (total).</p><p>Other animals: 25 (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;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><p>3.&#160;&#160;The following words shall be included in the labelling:</p><div><p>&#8212;&#160;For feed for ovines if&#160;the level of copper in&#160;the feed exceeds 10&#160;mg/kg:</p>&#8212;&#160;<p>&#8216;The level of copper in this feed may cause poisoning in certain breeds of sheep.&#8217;</p></div><div><p>&#8212;&#160;For feed for bovines after the start of rumination if the level of copper in the feed is less than 20 mg/kg:</p>&#8212;&#160;<p>&#8216;The level of copper in this feed may cause copper deficiencies in cattle grazing pastures with high contents of molybdenum or sulphur.&#8217;</p></div></td><td><p>13 August 2028</p></td></tr><tr><td><p>3b402</p></td><td><p>&#8212;</p></td><td><p>Copper(II) carbonate dihydroxy monohydrate</p></td><td><p><span>Additive composition</span></p><p>Copper(II) carbonate dihydroxy monohydrate as a powder with a minimum content of 52 % copper</p><p><span>Characterisation of the active substance</span></p><p>Chemical formula: CuCO<span>3</span> &#903; Cu(OH)<span>2</span> &#903; H<span>2</span>O</p><p>CAS Number: 100742-53-8</p><p><span>Analytical methods</span>&#160;<a>(<span>1</span>)</a></p><p>For the identification of carbonate in the feed additive:</p><div><p>&#8212;&#160;European Pharmacopoeia Monograph 20301</p></div><p>For the determination of total Cu in the feed additive and premixtures:</p><div><p>&#8212;&#160;inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or CEN/TS 15621)</p></div><p>For the determination of total Cu 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;inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or 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>Bovines:</p><div><p>&#8212;&#160;Bovines before the start of rumination: 15 (total);</p></div><div><p>&#8212;&#160;Other bovines: 30 (total).</p></div><p>Ovines: 15 (total).</p><p>Caprines: 35 (total)</p><p>Piglets:</p><div><p>&#8212;&#160;suckling and weaned up to 4 weeks after weaning: 150 (total).</p></div><div><p>&#8212;&#160;from 5-th week after weaning up to 8&#160;weeks after weaning: 100 (total).</p></div><p>Crustaceans: 50 (total).</p><p>Other animals: 25 (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;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><p>3.&#160;&#160;The following words shall be included in the labelling:</p><div><p>&#8212;&#160;For feed for ovines if the level of copper in the feed exceeds 10&#160;mg/kg:</p>&#8212;&#160;<p>&#8216;The level of copper in this feed may cause poisoning in certain breeds of sheep.&#8217;</p></div><div><p>&#8212;&#160;For feed for bovines after the start of rumination if the level of copper in the feed is less than 20 mg/kg:</p>&#8212;&#160;<p>&#8216;The level of copper in this feed may cause copper deficiencies in cattle grazing pastures with high contents of molybdenum or sulphur.&#8217;</p></div></td><td><p>13 August 2028</p></td></tr><tr><td><p>3b403</p></td><td><p>&#8212;</p></td><td><p>Copper(II) chloride dihydrate</p></td><td><p><span>Additive composition</span></p><p>Copper(II) chloride dihydrate as a powder with a minimum content of 36 % copper</p><p><span>Characterisation of the active substance</span></p><p>Chemical formula: CuCl<span>2</span> &#903; 2H<span>2</span>O</p><p>CAS Number: 10125-13-0</p><p><span>Analytical methods</span>&#160;<a>(<span>1</span>)</a></p><p>For the identification of chloride in the feed additive:</p><div><p>&#8212;&#160;European Pharmacopoeia Monograph 20301</p></div><p>For the crystallographic characterisation of the feed additive:</p><div><p>&#8212;&#160;X-Ray diffraction</p></div><p>For the determination of total Cu in the feed additive and premixtures:</p><div><p>&#8212;&#160;inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or CEN/TS 15621)</p></div><p>For the determination of total Cu 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;inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or 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>Bovines:</p><div><p>&#8212;&#160;Bovines before the start of rumination: 15 (total);</p></div><div><p>&#8212;&#160;Other bovines: 30 (total).</p></div><p>Ovines: 15 (total).</p><p>Caprines: 35 (total)</p><p>Piglets:</p><div><p>&#8212;&#160;suckling and weaned up to 4 weeks after weaning: 150 (total).</p></div><div><p>&#8212;&#160;from 5-th week after weaning up to 8&#160;weeks after weaning: 100 (total).</p></div><p>Crustaceans: 50 (total).</p><p>Other animals: 25 (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;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><p>3.&#160;&#160;The following words shall be included in the labelling:</p><div><p>&#8212;&#160;For feed for ovines if the level of copper in the feed exceeds 10&#160;mg/kg:</p>&#8212;&#160;<p>&#8216;The level of copper in this feed may cause poisoning in certain breeds of sheep.&#8217;</p></div><div><p>&#8212;&#160;For feed for bovines after the start of rumination if the level of copper in the feed is less than 20 mg/kg:</p>&#8212;&#160;<p>&#8216;The level of copper in this feed may cause copper deficiencies in cattle grazing pastures with high contents of molybdenum or sulphur.&#8217;</p></div></td><td><p>13 August 2028</p></td></tr><tr><td><p>3b404</p></td><td><p>&#8212;</p></td><td><p>Copper(II) oxide</p></td><td><p><span>Additive composition</span></p><p>Copper(II) oxide as a powder with a minimum content of 77 % copper</p><p><span>Characterisation of the active substance</span></p><p>Chemical formula: CuO</p><p>CAS Number: 1317-38-0</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 determination of total Cu in the feed additive and premixtures:</p><div><p>&#8212;&#160;inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or CEN/TS 15621)</p></div><p>For the determination of total Cu 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;inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or 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>Bovines:</p><div><p>&#8212;&#160;Bovines before the start of rumination: 15 (total);</p></div><div><p>&#8212;&#160;Other bovines: 30 (total).</p></div><p>Ovines: 15 (total).</p><p>Caprines: 35 (total)</p><p>Piglets:</p><div><p>&#8212;&#160;suckling and weaned up to 4 weeks after weaning: 150 (total).</p></div><div><p>&#8212;&#160;from 5-th week after weaning up to 8&#160;weeks after weaning: 100 (total).</p></div><p>Crustaceans: 50 (total).</p><p>Other animals: 25 (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;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><p>3.&#160;&#160;The following words shall be included in the labelling:</p><div><p>&#8212;&#160;For feed for ovines if the level of copper in the feed exceeds 10&#160;mg/kg:</p>&#8212;&#160;<p>&#8216;The level of copper in this feed may cause poisoning in certain breeds of sheep.&#8217;</p></div><div><p>&#8212;&#160;For feed for bovines after the start of rumination if the level of copper in the feed is less than 20 mg/kg:</p>&#8212;&#160;<p>&#8216;The level of copper in this feed may cause copper deficiencies in cattle grazing pastures with high contents of molybdenum or sulphur.&#8217;</p></div></td><td><p>13 August 2028</p></td></tr><tr><td><p>3b405</p></td><td><p>&#8212;</p></td><td><p>Copper(II) sulphate pentahydrate</p></td><td><p><span>Additive composition</span></p><p>Copper(II) sulphate pentahydrate as a powder with a minimum content of 24 % copper</p><p><span>Characterisation of the active substance</span></p><p>Chemical formula: CuSO<span>4</span> &#903; 5H<span>2</span>O</p><p>CAS Number: 7758-99-8</p><p><span>Analytical methods</span>&#160;<a>(<span>1</span>)</a></p><p>For the identification of Copper(II) sulphate pentahydrate in the feed additive:</p><div><p>&#8212;&#160;European Pharmacopoeia Monographs 0894 and 20301</p></div><p>For the crystallographic characterisation of the feed additive:</p><div><p>&#8212;&#160;X-Ray diffraction</p></div><p>For the determination of total Cu in the feed additive and premixtures:</p><div><p>&#8212;&#160;inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or CEN/TS 15621)</p></div><p>For the determination of total Cu 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;inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or 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>Bovines:</p><div><p>&#8212;&#160;Bovines before the start of rumination: 15 (total);</p></div><div><p>&#8212;&#160;Other bovines: 30 (total).</p></div><p>Ovines: 15 (total).</p><p>Caprines: 35 (total)</p><p>Piglets:</p><div><p>&#8212;&#160;suckling and weaned up to 4 weeks after weaning: 150 (total).</p></div><div><p>&#8212;&#160;from 5-th week after weaning up to 8&#160;weeks after weaning: 100 (total).</p></div><p>Crustaceans: 50 (total).</p><p>Other animals: 25 (total).</p></td><td><p>1.&#160;&#160;Copper(II) sulphate pentahydrate may be placed on the market and used as an additive consisting of a preparation.</p><p>2.&#160;&#160;The additive shall be incorporated into feed in the form of a premixture.</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><p>4.&#160;&#160;The following words shall be included in the labelling:</p><div><p>&#8212;&#160;For feed for ovines if the level of copper in the feed exceeds 10&#160;mg/kg:</p>&#8212;&#160;<p>&#8216;The level of copper in this feed may cause poisoning in certain breeds of sheep.&#8217;</p></div><div><p>&#8212;&#160;For feed for bovines after the start of rumination if the level of copper in the feed is less than 20 mg/kg:</p>&#8212;&#160;<p>&#8216;The level of copper in this feed may cause copper deficiencies in cattle grazing pastures with high contents of molybdenum or sulphur.&#8217;</p></div></td><td><p>13 August 2028</p></td></tr><tr><td><p><a>&#9660;M1</a></p></td></tr><tr><td><p>3b406</p></td><td><p>&#8212;</p></td><td><p>Copper (II) chelate of amino acids hydrate</p></td><td><p><span>Additive composition</span></p><p>Preparation of copper(II) amino acid complex where the copper and the amino acids derived from soya protein are chelated via coordinate covalent bonds, as a powder with a minimum content of 10&#160;% copper</p></td><td><p>All animal species</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>Bovines before the start of rumination: 15 (total);</p><p>Other bovines: 30 (total).</p><p>Ovines: 15 (total).</p><p>Caprines: 35 (total)</p><p>Piglets:</p><div><p>&#8212;&#160;suckling and weaned up to 4 weeks after weaning: 150 (total).</p></div><div><p>&#8212;&#160;from 5<span>th</span> week after weaning up to 8 weeks after weaning: 100 (total).</p></div><p>Crustaceans: 50 (total).</p><p>Other animals: 25 (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;The following words shall be included in the labelling:</p><div><p>&#8212;&#160;For feed for ovines, if the level of copper in the feed exceeds 10 mg/kg: &#8216;The level of copper in this feed may cause poisoning in certain breeds of sheep.&#8217;</p></div><div><p>&#8212;&#160;For feed for bovines after the start of rumination, if the level of copper in the feed is less than 20 mg/kg: &#8216;The level of copper in this feed may cause copper deficiencies in cattle grazing pastures with high contents of molybdenum or sulphur.&#8217;</p></div><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. 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>13&#160;August 2028</p></td></tr><tr><td><p><span>Characterisation of the active substance</span></p><p>Chemical formula: Cu(x)<span>1&#8211;3</span> &#903; nH<span>2</span>O, x = anion of any amino acid from soya protein hydrolysate.</p><p>Maximum 10&#160;% of molecules exceeding 1&#160;500  Da.</p></td></tr><tr><td><p><span>Analytical methods</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 copper 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>atomic absorption spectrometry, AAS</p><p>For the quantification of total copper 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 copper 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>3b406i</p></td><td><p>&#8212;</p></td><td><p>Copper (II) chelate of amino acids hydrate</p></td><td><p><span>Additive composition</span></p><p>Preparation of copper (II) amino acid complex, where the copper and the amino acids are chelated via coordinate covalent bonds, as a powder with a content of 10-11&#160;% copper and a minimum of 18&#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>Bovines before the start of rumination: 15 (total);</p><p>Other bovines: 30 (total).</p><p>Ovines: 15 (total).</p><p>Caprines: 35 (total)</p><p>Piglets:</p><p>suckling and weaned up to 4 weeks after weaning: 150 (total).</p><p>from 5th week after weaning up to 8 weeks after weaning: 100 (total).</p><p>Crustaceans: 50 (total).</p><p>Other animals: 25 (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;The following words shall be included in the labelling:</p><div><p>&#8212;&#160;For feed for ovines, if the level of copper in the feed exceeds 10 mg/kg: &#8216;The level of copper in this feed may cause poisoning in certain breeds of sheep.&#8217;</p></div><div><p>&#8212;&#160;For feed for bovines after the start of rumination, if the level of copper in the feed is less than 20 mg/kg: &#8216;The level of copper in this feed may cause copper deficiencies in cattle grazing pastures with high contents of molybdenum or sulphur.&#8217;</p></div><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. 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>4.&#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>13&#160;August 2028</p></td></tr><tr><td><p><span>Characterisation of the active substance</span></p><p>Chemical formula: Cu(x)<span>1-3</span>&#8226;nH<span>2</span>O, 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 methods</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 copper 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 copper 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 copper 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>3b407</p></td><td><p>&#8212;</p></td><td><p>Copper(II) chelate of protein hydrolysates</p></td><td><p><span>Additive composition</span></p><p>Copper(II) chelate of protein hydrolysates as a powder with a minimum content of 10 % copper and a minimum of 50 % copper chelated</p><p><span>Characterisation of the active substance</span></p><p>Chemical formula: Cu(x)<span>1&#8211;3</span> &#903; nH<span>2</span>O, x = anion of 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 qualitative verification of the chelation of the copper in the feed additive:</p><div><p>&#8212;&#160;Fourier Transformed Infrared (FTIR) spectroscopy followed by multivariate regression methods</p></div><p>For the determination of total Cu in the feed additive and premixtures:</p><div><p>&#8212;&#160;inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or CEN/TS 15621)</p></div><p>For the determination of total Cu 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;inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or 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>Bovines:</p><div><p>&#8212;&#160;Bovines before the start of rumination: 15 (total);</p></div><div><p>&#8212;&#160;Other bovines: 30 (total).</p></div><p>Ovines: 15 (total).</p><p>Caprines: 35 (total)</p><p>Piglets:</p><div><p>&#8212;&#160;suckling and weaned up to 4 weeks after weaning: 150 (total).</p></div><div><p>&#8212;&#160;from 5-th week after weaning up to 8&#160;weeks after weaning: 100 (total).</p></div><p>Crustaceans: 50 (total).</p><p>Other animals: 25 (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;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><p>3.&#160;&#160;The following words shall be included in the labelling:</p><div><p>&#8212;&#160;For feed for ovines if the level of copper in the feed exceeds 10&#160;mg/kg:</p>&#8212;&#160;<p>&#8216;The level of copper in this feed may cause poisoning in certain breeds of sheep.&#8217;</p></div><div><p>&#8212;&#160;For feed for bovines after the start of rumination if the level of copper in the feed is less than 20 mg/kg:</p>&#8212;&#160;<p>&#8216;The level of copper in this feed may cause copper deficiencies in cattle grazing pastures with high contents of molybdenum or sulphur.&#8217;</p></div></td><td><p>13 August 2028</p></td></tr><tr><td><p>3b413</p></td><td><p>&#8212;</p></td><td><p>Copper(II) chelate of glycine hydrate (solid)</p></td><td><p><span>Additive composition</span></p><p>Copper(II) chelate of glycine, hydrate, as a powder with a minimum content of 15 % copper and a maximum of 13 % moisture</p><p><span>Characterisation of the active substance</span></p><p>Chemical formula: Cu(x)<span>1-3</span> &#903; nH<span>2</span>O, x = 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 determination of total Cu in the feed additive and premixtures:</p><div><p>&#8212;&#160;inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or CEN/TS 15621)</p></div><p>For the determination of total Cu 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;inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or 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>Bovines:</p><div><p>&#8212;&#160;Bovines before the start of rumination: 15 (total);</p></div><div><p>&#8212;&#160;Other bovines: 30 (total).</p></div><p>Ovines: 15 (total).</p><p>Caprines: 35 (total)</p><p>Piglets:</p><div><p>&#8212;&#160;suckling and weaned up to 4 weeks after weaning: 150 (total).</p></div><div><p>&#8212;&#160;from 5-th week after weaning up to 8&#160;weeks after weaning: 100 (total).</p></div><p>Crustaceans: 50 (total).</p><p>Other animals: 25 (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;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><p>3.&#160;&#160;The following words shall be included in the labelling:</p><div><p>&#8212;&#160;For feed for ovines if the level of copper in the feed exceeds 10&#160;mg/kg:</p>&#8212;&#160;<p>&#8216;The level of copper in this feed may cause poisoning in certain breeds of sheep.&#8217;</p></div><div><p>&#8212;&#160;For feed for bovines after the start of rumination if the level of copper in the feed is less than 20 mg/kg:</p>&#8212;&#160;<p>&#8216;The level of copper in this feed may cause copper deficiencies in cattle grazing pastures with high contents of molybdenum or sulphur.&#8217;</p></div></td><td><p>13 August 2028</p></td></tr><tr><td><p>3b414</p></td><td><p>&#8212;</p></td><td><p>Copper(II) chelate of glycine hydrate (liquid)</p></td><td><p><span>Additive composition</span></p><p>Copper(II) chelate of glycine, hydrate, as a liquid with a minimum content of 6 % copper</p><p><span>Characterisation of the active substance</span></p><p>Chemical formula: Cu(x)<span>1-3</span> &#903; nH<span>2</span>O, x = 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 determination of total Cu in the feed additive and premixtures:</p><div><p>&#8212;&#160;inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or CEN/TS 15621)</p></div><p>For the determination of total Cu 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;inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or CEN/TS 15621)</p></div></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>Bovines:</p><div><p>&#8212;&#160;Bovines before the start of rumination: 15 (total);</p></div><div><p>&#8212;&#160;Other bovines: 30 (total).</p></div><p>Ovines: 15 (total).</p><p>Caprines: 35 (total)</p><p>Piglets:</p><div><p>&#8212;&#160;suckling and weaned up to 4 weeks after weaning: 150 (total).</p></div><div><p>&#8212;&#160;from 5-th week after weaning up to 8&#160;weeks after weaning: 100 (total).</p></div><p>Crustaceans: 50 (total).</p><p>Other animals: 25 (total).</p></td><td><p>1.&#160;&#160;Copper(II) chelate of glycine hydrate (liquid) may be placed on the market and used as an additive consisting of a preparation.</p><p>2.&#160;&#160;The additive shall be incorporated into feed in the form of a premixture.</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><p>4.&#160;&#160;The following words shall be included in the labelling:</p><div><p>&#8212;&#160;For feed for ovines if the level of copper in the feed exceeds 10&#160;mg/kg:</p>&#8212;&#160;<p>&#8216;The level of copper in this feed may cause poisoning in certain breeds of sheep.&#8217;</p></div><div><p>&#8212;&#160;For feed for bovines after the start of rumination if the level of copper in the feed is less than 20 mg/kg:</p>&#8212;&#160;<p>&#8216;The level of copper in this feed may cause copper deficiencies in cattle grazing pastures with high contents of molybdenum or sulphur.&#8217;</p></div></td><td><p>13 August 2028</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&#160;January 2009 laying down the methods of sampling and analysis for the official control of feed (OJ&#160;L&#160;54, 26.2.2009, p.&#160;1).</p></div></td></tr></tbody></table>