Document ID: 02016R1964-20210106
Language: ENG

02016R1964 — EN — 06.01.2021 — 001.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION IMPLEMENTING REGULATION (EU) 2016/1964</p><p>of 9 November 2016</p><p>concerning the authorisations of a preparation of dolomite-magnesite for dairy cows and other ruminants for dairy production, weaned piglets and pigs for fattening and a preparation of montmorillonite-illite for all animal species as feed additives</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 303 10.11.2016, p. 7)</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) 2020/2120&#160;of 16 December 2020</a></p></td><td><p>&#160;&#160;L&#160;426</p></td><td><p>22</p></td><td><p>17.12.2020</p></td></tr></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2016/1964
of 9 November 2016
concerning the authorisations of a preparation of dolomite-magnesite for dairy cows and other ruminants for dairy production, weaned piglets and pigs for fattening and a preparation of montmorillonite-illite for all animal species as feed additives
(Text with EEA relevance)
Article 1
The preparation specified in the Annex I, belonging to the additive category ‘technological additives’ and to the functional group ‘anti-caking agents’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2
The preparation specified in the Annex II, belonging to the additive category ‘technological additives’ and to the functional groups ‘anti-caking agents’ and ‘binders’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 3
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 I
<table><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Identification number of the additive</p></td><td><p>Additive</p></td><td><p>Chemical formula, description, methods of analysis</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>mg of additive/kg of complete feedingstuff with a moisture content of 12 %</p></td></tr><tr><td><p><span>Technological additives: anti-caking agents</span></p></td></tr><tr><td><p>1g598</p></td><td><p>Dolomite-Magnesite</p></td><td><p><span>Additive composition</span></p><p>Preparation of natural mixture of:</p><p>dolomite and magnesite &#8805; 40 % (having a minimum content of: carbonates 24 %).</p><p><span>Characterisation of the active substance</span></p><p>Dolomite:</p><div><p>CAS number 16389-88-1</p></div><div><p>(CaMg)(CO<span>3</span>)<span>2</span></p></div><p>Magnesite:</p><div><p>CAS number 546-93-0</p></div><div><p>MgCO<span>3</span></p></div><p>Talc (hydrated silicates of magnesium):</p><div><p>CAS number 14807-96-6</p></div><div><p>Mg<span>3</span>Si<span>4</span>O<span>10</span>(OH)<span>2</span></p></div><div><p>Talc &#8805; 35 %</p></div><p>Chlorite (aluminium&#8211;magnesium):</p><div><p>CAS number 1318-59-8</p></div><div><p>(Mg,Fe,Al)<span>6</span>(Si, Al)4O<span>10</span>(OH)<span>8</span></p></div><div><p>Iron (structural) 6 % (average)</p></div><div><p>Chlorite &#8805; 16 %</p></div><div><p>Free of quartz and asbestos</p></div><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>Characterisation of the feed additive:</p><div><p>&#8212;&#160;X-ray diffraction (XRD), together with</p></div><div><p>&#8212;&#160;atomic absorption spectrophotometry (AAS).</p></div></td><td><p>Dairy cows and other ruminants for dairy production</p><p>Weaned piglets</p><p>Pigs for fattening</p></td><td><p>&#8212;</p></td><td><p>5&#160;000</p></td><td><p>20&#160;000</p></td><td><p>1.&#160;&#160;For use in weaned piglets until 35&#160;kg.</p><p>2.&#160;&#160;In the labelling of the additive and premixtures containing it, the following shall be indicated: &#8216;The additive dolomite-magnesite is rich in (inert) iron&#8217;.</p><p>3.&#160;&#160;For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.</p></td><td><p>30 November 2026</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 for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports</p></div></td></tr></tbody></table>
ANNEX II
<table><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Identification number of the additive</p></td><td><p>Additive</p></td><td><p>Chemical formula, description, methods of analysis</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>mg of additive/kg of complete feedingstuff with a moisture content of 12 %</p></td></tr><tr><td><p><a>&#9660;M1</a></p></td></tr><tr><td><p><span>Category of technological additives. Functional group: binders</span></p></td></tr><tr><td><p>1g557</p></td><td><p>Montmorillonite-Illite</p></td><td><p><span>Additive composition</span></p><p>Preparation of montmorillonite-illite mixed layer clay mineral: phyllosilicates &#8805; 75 %</p><p><span>Characterisation of active substance</span></p><p>Phyllosilicates &#8805; 75 %:</p><p>&#8805; 35 % montmorillonite-illite (swellable)</p><p>&#8805; 30 % illite/muscovite</p><p>&#8804; 15 % kaolinite (non-swellable)</p><p>Quartz &#8804; 20 %</p><p>Iron (structural) 3,6 % (average)</p><p>Free of asbestos</p></td><td><p>All animal species</p></td><td><p>-</p></td><td><p>10&#160;000</p></td><td><p>20&#160;000</p></td><td><p>1.&#160;&#160;The instructions for use shall indicate the following:</p><div><p>&#8212;&#160;&#8216;The simultaneous oral use with macrolides shall be avoided&#8217;,</p></div><div><p>&#8212;&#160;&#8216;In addition, for poultry, the simultaneous use with robenidine shall be avoided&#8217;.</p></div><p>2.&#160;&#160;For poultry: the simultaneous oral use with coccidiostats other than robenidine is contraindicated with level of montmorillonite-illite above 10&#160;000  mg/kg of complete feed.</p><p>3.&#160;&#160;In the labelling of feed additive and premixtures containing it, the following shall be indicated: &#8216;The additive, montmorillonite-illite, is rich in (inert) iron&#8217;.</p><p>4.&#160;&#160;For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection</p><p>5.&#160;&#160;total amount of different sources of montmorillonite-illite in complete feedingstuff shall not exceeded the permitted maximum level of 20&#160;000  mg/kg of complete feedingstuff.</p></td><td><p>30 November 2026</p></td></tr><tr><td><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>For the determination in feed additive:</p><div><p>&#8212;&#160;X-ray diffraction (XRD)</p></div><div><p>&#8212;&#160;Inductively coupled plasma atomic emission spectroscopy (ICP-AES)</p></div></td></tr><tr><td><p><span>Category of technological additives. Functional group: anti-caking agent</span></p></td></tr><tr><td><p>1g557</p></td><td><p>Montmorillonite-Illite</p></td><td><p><span>Additive composition</span></p><p>Preparation of montmorillonite-illite mixed layer clay mineral: phyllosilicates &#8805; 75 %</p><p><span>Characterisation of active substance</span></p><p>Phyllosilicates &#8805; 75 %:</p><p>&#8805; 35 % montmorillonite-illite (swellable)</p><p>&#8805; 30 % illite/muscovite</p><p>&#8804; 15 % kaolinite (non-swellable)</p><p>Quartz &#8804; 20 %</p><p>Iron (structural) 3,6 % (average)</p><p>Free of asbestos</p></td><td><p>All animal species</p></td><td><p>-</p></td><td><p>-</p></td><td><p>20&#160;000</p></td><td><p>1.&#160;&#160;The instructions for use shall indicate the following:</p><div><p>&#8212;&#160;&#8216;The simultaneous oral use with macrolides shall be avoided&#8217;,</p></div><div><p>&#8212;&#160;&#8216;In addition, for poultry, the simultaneous use with robenidine shall be avoided&#8217;.</p></div><p>2.&#160;&#160;The additive shall be used at a minimum level of:</p><div><p>&#8212;&#160;10&#160;000  mg/kg when it is used as anti-caking agent directly in complementary feedingstuffs,</p></div><div><p>&#8212;&#160;20&#160;000  mg/kg when it is used as anti-caking agent in complete feedingstuffs.</p></div><p>3.&#160;&#160;For poultry: the simultaneous oral use with coccidiostats other than robenidine is contraindicated.</p><p>4.&#160;&#160;In the labelling of feed additive and premixtures containing it, the following shall be indicated: &#8216;The additive, montmorillonite-illite, is rich in (inert) iron&#8217;.</p><p>5.&#160;&#160;For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection</p><p>6.&#160;&#160;The total amount of different sources of montmorillonite-illite in complete feedingstuff shall not exceeded the permitted maximum level of 20&#160;000  mg/kg of complete feedingstuff.</p></td><td><p>30 November 2026</p></td></tr><tr><td><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>For the determination in feed additive:</p><div><p>&#8212;&#160;X-ray diffraction (XRD)</p></div><div><p>&#8212;&#160;Inductively coupled plasma atomic emission spectroscopy (ICP-AES)</p></div></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></td></tr></tbody></table>