Document ID: 02013R0601-20140304
Language: ENG

02013R0601 — EN — 04.03.2014 — 001.002
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION IMPLEMENTING REGULATION (EU) No 601/2013</p><p>of 24 June 2013</p><p>concerning the authorisation of cobalt(II) acetate tetrahydrate, cobalt(II) carbonate, cobalt(II) carbonate hydroxide (2:3) monohydrate, cobalt(II) sulphate heptahydrate and coated granulated cobalt(II) carbonate hydroxide (2:3) monohydrate as feed additives</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 172 25.6.2013, p. 14)</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) No 131/2014&#160;of 11 February 2014</a></p></td><td><p>&#160;&#160;L&#160;41</p></td><td><p>3</p></td><td><p>12.2.2014</p></td></tr></table>
COMMISSION IMPLEMENTING REGULATION (EU) No 601/2013
of 24 June 2013
concerning the authorisation of cobalt(II) acetate tetrahydrate, cobalt(II) carbonate, cobalt(II) carbonate hydroxide (2:3) monohydrate, cobalt(II) sulphate heptahydrate and coated granulated cobalt(II) carbonate hydroxide (2:3) monohydrate as feed additives
(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 additives in animal nutrition, subject to the conditions laid down in that Annex.
Article 1a
Amendment to Commission Regulation (EC) No 1334/2003 ( 1 )
In the Annex to Regulation (EC) No 1334/2003, the entries ‘cobaltous acetate tetrahydrate’, ‘basic cobaltous carbonate monohydrate’ and ‘cobaltous sulphate heptahydrate’, related to the element E3 Cobalt-Co, are deleted.
Article 2
Transitional measures
The substances specified in the Annex which were authorised by Directive 70/524/EEC and feed containing them, which are produced and labelled before 4 September 2014 in accordance with the rules applicable before 15 July 2013 may continue to be placed on the market and used until the existing stocks are exhausted. As regards feed intended for pet animals, the time period for production and labelling referred to in the first sentence shall end on 4 March 2016.
Article 3
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>Element (Co) 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>3b301</p></td><td><p>&#8212;</p></td><td><p>Cobalt(II) acetate tetrahydrate</p></td><td><div><p><span>Additive composition</span></p><p>Cobalt(II) acetate tetrahydrate, as crystals/granules, with a minimum content of 23&#160;% cobalt</p><p>Particles &lt;&#160;50&#160;&#956;m: below 1&#160;%</p></div><div><p><span>Characterisation of the active substance</span></p><p>Chemical formula: Co(CH<span>3</span>COO)<span>2</span>&#160;&#215;&#160;4H<span>2</span>O</p><p>CAS number: 6147-53-1</p></div><div><p><span>Analytical methods</span>&#160;<a>(<span>1</span>)</a></p><div><p>For the identification of acetate in the additive:</p><div><p>&#8212;&#160;European Pharmacopoeia monograph 01/2008:20301.</p></div></div><div><p>For the crystallographic characterisation of additive:</p><div><p>&#8212;&#160;X-Ray diffraction.</p></div></div><div><p>For the determination of total cobalt in the additive, premixtures, compound feed and feed materials:</p><div><p>&#8212;&#160;EN 15510 &#8212; inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES)</p><p>&#8212;&#160;or</p></div><div><p>&#8212;&#160;CEN/TS 15621 &#8212; inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion.</p></div></div><div><p>For determination of particle size distribution:</p><div><p>&#8212;&#160;ISO 13320:2009 &#8212; Particle size analysis &#8212; Laser diffraction methods.</p></div></div></div></td><td><p>ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>1 (total)</p></td><td><p>1.&#160;&#160;The additive shall be incorporated into compound feed in the form of a premixture.</p><p>2.&#160;&#160;Protective measures shall be taken according to national regulations implementing EU legislation on health and safety at work including Council Directives 89/391/EEC&#160;<a>(<span>2</span>)</a>, 89/656/EEC&#160;<a>(<span>3</span>)</a>, 92/85/EEC&#160;<a>(<span>4</span>)</a> and 98/24/EC&#160;<a>(<span>5</span>)</a>. Appropriate protective gloves, respiratory and eye protection according to Council Directive 89/686/EEC&#160;<a>(<span>6</span>)</a> shall be worn during handling.</p><p>3.&#160;&#160;Declarations to be made on the labelling of the additive and premixture:</p><div><p>&#8212;&#160;Cobalt content</p></div><div><p>&#8212;&#160;&#8216;It is recommended to limit the supplementation with Cobalt to 0,3&#160;mg/kg in complete feed. In this context, the risk for Cobalt deficiency due to local conditions and the specific composition of the diet should be taken into account.&#8217;</p></div><p>4.&#160;&#160;Declarations to be made on the instructions of use of the compound feed:</p><p>&#8216;Protective measures to avoid exposure with Cobalt by inhalation or by dermal route should be taken.&#8217;</p></td><td><p>15 July 2023</p></td></tr><tr><td><p>3b302</p></td><td><p>&#8212;</p></td><td><p>Cobalt(II) carbonate</p></td><td><div><p><span>Additive composition</span></p><p>Cobalt(II) carbonate, as powder, with a minimum content of 46&#160;% cobalt</p><p>Cobalt carbonate: minimum 75&#160;%</p><p>Cobalt hydroxide: 3&#160;% - 15&#160;%</p><p>Water: maximum 6&#160;%</p><p>Particles &lt;&#160;11&#160;&#956;m: below 90&#160;%</p></div><div><p><span>Characterisation of the active substances</span></p><p>Chemical formula: CoCO<span>3</span></p><p>CAS number: 513-79-1</p></div><div><p><span>Analytical methods</span>&#160;<a>(<span>1</span>)</a></p><div><p>For the identification of carbonate in the additive:</p><div><p>&#8212;&#160;European Pharmacopoeia monograph 01/2008:20301.</p></div></div><div><p>For the crystallographic characterisation of additive:</p><div><p>&#8212;&#160;X-Ray diffraction.</p></div></div><div><p>For the determination of total cobalt in the additive, premixtures, compound feed and feed materials:</p><div><p>&#8212;&#160;EN 15510 &#8212; inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES)</p><p>&#8212;&#160;or</p></div><div><p>&#8212;&#160;CEN/TS 15621 &#8212; inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion.</p></div></div><div><p>For determination of particle size distribution:</p><div><p>&#8212;&#160;ISO 13320:2009 &#8212; Particle size analysis &#8212; Laser diffraction methods.</p></div></div></div></td><td><p>ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>1 (total)</p></td><td><p>1.&#160;&#160;The additive shall be incorporated into compound feed in the form of a premixture. This compound feed shall be placed on the market in a non-powder form.</p><p>2.&#160;&#160;Appropriate measures shall be taken to avoid the cobalt emission in the air and prevent the exposure by inhalation or by dermal route. If such measures are technically not feasible or not sufficient, protective measures shall be taken according to national regulations implementing EU legislation on health and safety at work including Directives 89/391/EEC, 89/656/EEC, 92/85/EEC, 98/24/EC and 2004/37/EC of the European Parliament and of the Council&#160;<a>(<span>7</span>)</a>. Appropriate protective gloves, respiratory and eye protection according to Directive 89/686/EEC shall be worn during handling.</p><p>3.&#160;&#160;Declarations to be made on the labelling of the additive and premixture:</p><div><p>&#8212;&#160;Cobalt content</p></div><div><p>&#8212;&#160;&#8216;It is recommended to limit the supplementation with Cobalt to 0,3&#160;mg/kg in complete feed. In this context, the risk for Cobalt deficiency due to local conditions and the specific composition of the diet should be taken into account.&#8217;</p></div><p>4.&#160;&#160;Declarations to be made on the instructions of use of the compound feed:</p><p>&#8216;Protective measures to avoid exposure with Cobalt by inhalation or by dermal route should be taken.&#8217;</p></td><td><p>15 July 2023</p></td></tr><tr><td><p>3b303</p></td><td><p>&#8212;</p></td><td><p>Cobalt(II) carbonate hydroxide (2:3) monohydrate</p></td><td><div><p><span>Additive composition</span></p><p>Cobalt (II) carbonate hydroxide (2:3) monohydrate, as powder, with a minimum content of 50&#160;% cobalt</p><p>Particles &lt;&#160;50 &#956;m: below 98&#160;%</p></div><div><p><span>Characterisation of the active substance</span></p><p>Chemical formula: 2CoCO<span>3</span>&#160;&#215;&#160;3Co(OH)<span>2</span>&#160;&#215;&#160;H<span>2</span>O</p><p>CAS number: 51839-24-8</p></div><div><p><span>Analytical methods</span>&#160;<a>(<span>1</span>)</a></p><div><p>For the identification of carbonate in the additive:</p><div><p>&#8212;&#160;European Pharmacopoeia monograph 01/2008:20301.</p></div></div><div><p>For the crystallographic characterisation of additive:</p><div><p>&#8212;&#160;X-Ray diffraction.</p></div></div><div><p>For the determination of total cobalt in the additive, premixtures, compound feed and feed materials:</p><div><p>&#8212;&#160;EN 15510 &#8212; inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES)</p><p>&#8212;&#160;or</p></div><div><p>&#8212;&#160;CEN/TS 15621 &#8212; inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion.</p></div></div><div><p>For determination of particle size distribution:</p><div><p>&#8212;&#160;ISO 13320:2009 &#8212; Particle size analysis &#8212; Laser diffraction methods.</p></div></div></div></td><td><p>ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>1 (total)</p></td><td><p>1.&#160;&#160;The additive shall be incorporated into compound feed in the form of a premixture. This compound feed shall be placed on the market in a non-powder form.</p><p>2.&#160;&#160;Appropriate measures shall be taken to avoid the cobalt emission in the air and prevent the exposure by inhalation or by dermal route. If such measures are technically not feasible or not sufficient, protective measures shall be taken according to national regulations implementing EU legislation on health and safety at work including Directives 89/391/EEC, 89/656/EEC, 92/85/EEC, 98/24/EC and 2004/37/EC. Appropriate protective gloves, respiratory and eye protection according to Directive 89/686/EEC shall be worn during handling.</p><p>3.&#160;&#160;Declarations to be made on the labelling of the additive and premixture:</p><div><p>&#8212;&#160;Cobalt content</p></div><div><p>&#8212;&#160;&#8216;It is recommended to limit the supplementation with Cobalt to 0,3&#160;mg/kg in complete feed. In this context, the risk for Cobalt deficiency due to local conditions and the specific composition of the diet should be taken into account.&#8217;</p></div><p>4.&#160;&#160;Declarations to be made on the instructions of use of the compound feed:</p><p>&#8216;Protective measures to avoid exposure with Cobalt by inhalation or by dermal route should be taken.&#8217;</p></td><td><p>15 July 2023</p></td></tr><tr><td><p>3b304</p></td><td><p>&#8212;</p></td><td><p>Coated granulated cobalt(II) carbonate</p></td><td><div><p><span>Additive composition</span></p><p>Coated granulated preparation of cobalt(II) carbonate with a cobalt content of 1&#160;% - 5&#160;%</p><p>Coating agents (2,3&#160;% - 3,0&#160;%) and dispersants (choice of poly-oxy-ethylene, sorbitan monolaurate, glycerol polyethyleneglycol ricinoleate, polyethyleneglycol 300, sorbitol, and maltodextrin)</p><p>Particles &lt;&#160;50&#160;&#956;m: below 1&#160;%</p></div><div><p><span>Characterisation of the active substance</span></p><p>Chemical formula: CoCO<span>3</span></p><p>CAS number: 513-79-1</p></div><div><p><span>Analytical methods</span>&#160;<a>(<span>1</span>)</a></p><div><p>For the identification of carbonate in the additive:</p><div><p>&#8212;&#160;European Pharmacopoeia monograph 01/2008:20301.</p></div></div><div><p>For the crystallographic characterisation of additive:</p><div><p>&#8212;&#160;X-Ray diffraction.</p></div></div><div><p>For the determination of total cobalt in the additive, premixtures, compound feed and feed materials:</p><div><p>&#8212;&#160;EN 15510 &#8212; inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES)</p><p>&#8212;&#160;or</p></div><div><p>&#8212;&#160;CEN/TS 15621 &#8212; inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion.</p></div></div><div><p>For determination of particle size distribution:</p><div><p>&#8212;&#160;ISO 13320:2009 &#8212; Particle size analysis &#8212; Laser diffraction methods.</p></div></div></div></td><td><p>ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>1 (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;Protective measures shall be taken according to national regulations implementing EU legislation on health and safety at work including Directives 89/391/EEC, 89/656/EEC, 92/85/EEC and 98/24/EC. Appropriate protective gloves, respiratory and eye protection according to Directive 89/686/EEC shall be worn during handling.</p><p>3.&#160;&#160;Declarations to be made on the labelling of the additive and premixture, if applicable:</p><div><p>&#8212;&#160;Cobalt content</p></div><div><p>&#8212;&#160;&#8216;It is recommended to limit the supplementation with Cobalt to 0,3&#160;mg/kg in complete feed. In this context, the risk for Cobalt deficiency due to local conditions and the specific composition of the diet should be taken into account.&#8217;</p></div></td><td><p>15 July 2023</p></td></tr><tr><td><p>3b305</p></td><td><p>&#8212;</p></td><td><p>Cobalt(II) sulphate heptahydrate</p></td><td><div><p><span>Additive composition</span></p><p>Cobalt(II) sulphate heptahydrate, as powder, with a minimum content of 20&#160;% cobalt</p><p>Particles &lt;&#160;50&#160;&#956;m: below 95&#160;%</p></div><div><p><span>Characterisation of the active substance</span></p><p>Chemical formula: CoSO<span>4</span>&#160;&#215;&#160;7H<span>2</span>O</p><p>CAS number: 10026-24-1</p></div><div><p><span>Analytical methods</span>&#160;<a>(<span>1</span>)</a></p><div><p>For the identification of sulphate in the additive:</p><div><p>&#8212;&#160;European Pharmacopoeia monograph 01/2008:20301.</p></div></div><div><p>For the crystallographic characterisation of additive:</p><div><p>&#8212;&#160;X-Ray diffraction.</p></div></div><div><p>For the determination of total cobalt in the additive, premixtures, compound feed and feed materials:</p><div><p>&#8212;&#160;EN 15510 &#8212; inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES)</p><p>&#8212;&#160;or</p></div><div><p>&#8212;&#160;CEN/TS 15621 &#8212; inductively coupled plasma optical (atomic) emission spectrometry (ICP-AES) after pressure digestion.</p></div></div><div><p>For determination of particle size distribution:</p><div><p>&#8212;&#160;ISO 13320:2009 &#8212; Particle size analysis &#8212; Laser diffraction methods.</p></div></div></div></td><td><p>ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>1 (total)</p></td><td><p>1.&#160;&#160;The additive shall be incorporated into compound feed in the form of a premixture. This compound feed shall be placed on the market in a non-powder form.</p><p>2.&#160;&#160;Appropriate measures shall be taken to avoid the cobalt emission in the air and prevent the exposure by inhalation or by dermal route. If such measures are technically not feasible or not sufficient, protective measures shall be taken according to national regulations implementing EU legislation on health and safety at work including Directives 89/391/EEC, 89/656/EEC, 92/85/EEC, 98/24/EC and 2004/37/EC. Appropriate protective gloves, respiratory and eye protection according to Directive 89/686/EEC shall be worn during handling.</p><p>3.&#160;&#160;Declarations to be made on the labelling of the additive and premixture:</p><div><p>&#8212;&#160;Cobalt content</p></div><div><p>&#8212;&#160;&#8216;It is recommended to limit the supplementation with Cobalt to 0,3&#160;mg/kg in complete feed. In this context, the risk for Cobalt deficiency due to local conditions and the specific composition of the diet should be taken into account.&#8217;</p></div><p>4.&#160;&#160;Declarations to be made on the instructions of use of the compound feed:</p><p>&#8216;Protective measures to avoid exposure with Cobalt by inhalation or by dermal route should be taken.&#8217;</p></td><td><p>15 July 2023</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: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx</p></div><div><a>(<span>2</span>)&#160;&#160;&#160;</a><p>OJ L 183, 29.6.1989, p. 1.</p></div><div><a>(<span>3</span>)&#160;&#160;&#160;</a><p>OJ L 393, 30.12.1989, p. 18.</p></div><div><a>(<span>4</span>)&#160;&#160;&#160;</a><p>OJ L 348, 28.11.1992, p. 1.</p></div><div><a>(<span>5</span>)&#160;&#160;&#160;</a><p>OJ L 131, 5.5.1998, p. 11.</p></div><div><a>(<span>6</span>)&#160;&#160;&#160;</a><p>OJ L 399, 30.12.1989, p. 18.</p></div><div><a>(<span>7</span>)&#160;&#160;&#160;</a><p>OJ L 158, 30.4.2004, p. 50.</p></div></td></tr></tbody></table>
<note>
( 1 ) OJ L 187, 26.7.2003, p. 11.
</note>