Document ID: 02005R2036-20170628
Language: ENG

02005R2036 — EN — 28.06.2017 — 003.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>COMMISSION REGULATION (EC) No 2036/2005</p><p>of 14 December 2005</p><p>concerning the permanent authorisations of certain additives in feedingstuffs and the provisional authorisation of a new use of certain additives already authorised in feedingstuffs</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 328 15.12.2005, p. 13)</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 1018/2012&#160;of 5 November 2012</a></p></td><td><p>&#160;&#160;L&#160;307</p></td><td><p>56</p></td><td><p>7.11.2012</p></td></tr><tr><td><p><a>&#9658;M2</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) No 1206/2012&#160;of 14 December 2012</a></p></td><td><p>&#160;&#160;L&#160;347</p></td><td><p>12</p></td><td><p>15.12.2012</p></td></tr><tr><td><p><a>&#9658;M3</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2017/961&#160;of 7 June 2017</a></p></td><td><p>&#160;&#160;L&#160;145</p></td><td><p>7</p></td><td><p>8.6.2017</p></td></tr></table>
COMMISSION REGULATION (EC) No 2036/2005
of 14 December 2005
concerning the permanent authorisations of certain additives in feedingstuffs and the provisional authorisation of a new use of certain additives already authorised in feedingstuffs
(Text with EEA relevance)
Article 1
The preparations belonging to the group ‘Micro-organisms’, as specified in Annex I, are authorised for use without a time limit as additives in animal nutrition under the conditions laid down in that Annex.
Article 2
The preparations belonging to the group ‘Enzymes’, as specified in Annex II, are authorised for use without a time limit as additives in animal nutrition under the conditions laid down in that Annex.
Article 3
The preparations belonging to the group ‘Enzymes’, as specified in Annex III, are authorised for use for four years as additives in animal nutrition under the conditions laid down in that Annex.
Article 4
This Regulation shall enter into force on the 20th day following 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>EC No</p></td><td><p>Additive</p></td><td><p>Chemical formula, description</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>CFU/kg of complete feedingstuff</p></td></tr><tr><td><p>Micro-organisms</p></td></tr><tr><td><p>E 1703</p></td><td><p><span>Saccharomyces cerevisiae</span></p><p>CNCM I-1079</p></td><td><p>Preparation of<span>Saccharomyces cerevisiae</span> containing a minimum of:</p><p>2 &#215; 10<span>10</span>&#160;CFU/g additive</p></td><td><p>Sows</p></td><td><p>&#8212;</p></td><td><p>1 &#215; 10<span>9</span></p></td><td><p><span><a><span>&#9658;M1</span></a></span>&#160;6 &#215; 10<span>9</span><span>&#160;&#9668;</span></p></td><td><p>In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.</p></td><td><p>Without a time limit</p></td></tr><tr><td><p>E 1712</p></td><td><p><span>Pediococcus acidilactici</span></p><p>CNCM MA 18/5M</p></td><td><p>Preparation of<span>Pediococcus acidilactici</span> containing a minimum of:</p><p>1 &#215; 10<span>10</span> CFU/g additive</p></td><td><p>Pigs for fattening</p></td><td><p>&#8212;</p></td><td><p>1 &#215; 10<span>9</span></p></td><td><p><span><a><span>&#9658;M1</span></a></span>&#160;1 &#215; 10<span>9</span><span>&#160;&#9668;</span></p></td><td><p>In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.</p></td><td><p>Without a time limit</p></td></tr><tr><td><p><a>&#9660;M3</a>&#160;&#8212;&#8212;&#8212;&#8212;&#8212;</p></td></tr><tr><td><p><a>&#9660;B</a></p></td></tr></tbody></table>
ANNEX II
<table><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>EC No</p></td><td><p>Additive</p></td><td><p>Chemical formula, description</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>Units of activity/kg of complete feedingstuff</p></td></tr><tr><td><p>Enzymes</p></td></tr><tr><td><p>E 1636</p></td><td><p>Endo-1,3(4)-beta-glucanase</p><p>EC 3.2.1.6</p></td><td><p>Preparation of endo-1,3(4)-beta-glucanase produced by<span>Trichoderma reesei</span> (CBS 526.94) having a minimum activity of:</p><div><p>Solid form: 700&#160;000  BU&#160;<a>(<span>1</span>)</a>/g</p></div><div><p>Liquid form: 300&#160;000  BU/g</p></div></td><td><p>Chickens for fattening</p></td><td><p>&#8212;</p></td><td><p>17&#160;500  BU</p></td><td><p>&#8212;</p></td><td><p>1.&#160;&#160;In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.</p><p>2.&#160;&#160;Recommended dose per kg of complete feedingstuff: 17&#160;500 -50&#160;000  BU.</p><p>3.&#160;&#160;For use in compound feed rich in non-starch polysaccharides (mainly glucans), e.g. containing more than 20&#160;% barley or 30&#160;% rye.</p></td><td><p>Without a time limit</p></td></tr><tr><td><p>E 1637</p></td><td><div><p>Endo-1,4-beta-xylanase</p><p>EC 3.2.1.8</p></div><div><p>Endo-1,3(4)-beta-glucanase</p><p>EC 3.2.1.6</p></div><div><p>Subtilisin</p><p>EC 3.4.21.62</p></div><div><p>Alpha-amylase</p><p>EC 3.2.1.1</p></div><div><p>Polygalacturonase</p><p>EC 3.2.1.15</p></div></td><td><p>Preparation of endo-1,4-beta-xylanase produced by<span>Trichoderma longibrachiatum</span> (ATCC 2105), endo-1,3(4)-beta-glucanase and alpha-amylase produced by<span>Bacillus amyloliquefaciens</span> (DSM 9553), subtilisin produced by<span>Bacillus subtilis</span> (ATCC 2107), polygalacturonase produced by<span>Aspergillus aculeatus</span> (CBS 589.94) having a mimimum activity of:</p><div><p>Endo-1,4-beta-xylanase: 300 U&#160;<a>(<span>2</span>)</a>/g</p></div><div><p>Endo-1,3(4)-beta-glucanase: 150 U&#160;<a>(<span>3</span>)</a>/g</p></div><div><p>Subtilisin: 4&#160;000  U&#160;<a>(<span>4</span>)</a>/g</p></div><div><p>Alpha-amylase: 400 U&#160;<a>(<span>5</span>)</a>/g</p></div><div><p>Polygalacturonase: 25 U&#160;<a>(<span>6</span>)</a>/g</p></div></td><td><p>Chickens for fattening</p></td><td><p>&#8212;</p></td><td><p>endo-1,4-beta-xylanase:</p><p>300 U</p></td><td><p>&#8212;</p></td><td><p>1.&#160;&#160;In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.</p><p>2.&#160;&#160;Recommended dose per kg of complete feedingstuff:</p><div><p>endo-1,4-beta-xylanase: 300 U</p></div><div><p>endo-1,3(4)-beta-glucanase: 150 U</p></div><div><p>subtilisin: 4&#160;000  U</p></div><div><p>alpha-amylase: 400 U</p></div><div><p>polygalacturonase: 25 U.</p></div><p>3.&#160;&#160;For use in compound feed rich in starch and non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e.g. containing more than 40&#160;% maize or 60&#160;% wheat.</p></td><td><p>Without a time limit</p></td></tr><tr><td><p>endo-1,3(4)-beta-glucanase:</p><p>150 U</p></td><td><p>&#8212;</p></td></tr><tr><td><p>subtilisin:</p><p>4&#160;000  U</p></td><td><p>&#8212;</p></td></tr><tr><td><p>alpha-amylase:</p><p>400 U</p></td><td><p>&#8212;</p></td></tr><tr><td><p>polygalacturonase:</p><p>25 U</p></td><td><p>&#8212;</p></td></tr><tr><td><p><a>(<span>1</span>)&#160;&#160;&#160;</a>1 BU is the amount of enzyme which liberates 0,06 micromoles of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 4,8 and 50&#160;&#176;C.</p><p><a>(<span>2</span>)&#160;&#160;&#160;</a>1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from oat spelt xylan per minute at pH 5,3 and 50&#160;&#176;C.</p><p><a>(<span>3</span>)&#160;&#160;&#160;</a>1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 5,0 and 30&#160;&#176;C.</p><p><a>(<span>4</span>)&#160;&#160;&#160;</a>1 U is the amount of enzyme which liberates 1 microgram of phenolic compound (tyrosine equivalents) from a casein substrate per minute at pH 7,5 and 40&#160;&#176;C.</p><p><a>(<span>5</span>)&#160;&#160;&#160;</a>1 U is the amount of enzyme which hydrolyses 1 micromole of glucosidic linkages from a water insoluble cross-linked starch polymer substrate per minute at pH 6,5 and 37&#160;&#176;C.</p><p><a>(<span>6</span>)&#160;&#160;&#160;</a>1 U is the amount of enzyme which liberates 1 micromole of reducing material (galacturonic acid equivalents) from a poly D-galacturonic substrate per minute at pH 5,0 and 40&#160;&#176;C.</p></td></tr></tbody></table>
ANNEX III
<table><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>EC No or No</p></td><td><p>Additive</p></td><td><p>Chemical formula, description</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>Units of activity/kg of complete feedingstuff</p></td></tr><tr><td><p>Enzymes</p></td></tr><tr><td><p><a>&#9660;M2</a>&#160;&#8212;&#8212;&#8212;&#8212;&#8212;</p></td></tr><tr><td><p><a>&#9660;B</a></p></td></tr><tr><td><p>37</p></td><td><div><p>Endo-1,4-beta-xylanase</p><p>EC 3.2.1.8</p></div><div><p>Subtilisin</p><p>EC 3.4.21.62</p></div></td><td><p>Preparation of endo-1,4-beta-xylanase produced by<span>Trichoderma longibrachiatum</span> (ATCC 2105) and subtilisin produced by<span>Bacillus subtilis</span> (ATCC 2107) having a minimum activity of:</p><div><p>Endo-1,4-beta-xylanase: 5&#160;000  U&#160;<a>(<span>1</span>)</a>/g</p></div><div><p>Subtilisin: 1&#160;600  U&#160;<a>(<span>2</span>)</a>/g</p></div></td><td><p>Ducks</p></td><td><p>&#8212;</p></td><td><p>endo-1,4-beta-xylanase:</p><p>2&#160;500  U</p></td><td><p>&#8212;</p></td><td><p>1.&#160;&#160;In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.</p><p>2.&#160;&#160;Recommended dose per kg of complete feedingstuff:</p><div><p>endo-1,4-beta-xylanase: 2&#160;500  U</p></div><div><p>subtilisin: 800 U.</p></div><p>3.&#160;&#160;For use in compound feed e.g. containing more than 65&#160;% wheat.</p></td><td><p>4.1.2010</p></td></tr><tr><td><p>subtilisin:</p><p>800 U</p></td><td><p>&#8212;</p></td></tr><tr><td><p>59</p></td><td><div><p>Endo-1,4-beta-xylanase</p><p>EC 3.2.1.8</p></div><div><p>Endo-1,3(4)-beta-glucanase</p><p>EC 3.2.1.6</p></div><div><p>Subtilisin</p><p>EC 3.4.21.62</p></div><div><p>Alpha-amylase</p><p>EC 3.2.1.1</p></div><div><p>Polygalacturonase</p><p>EC 3.2.1.15</p></div></td><td><p>Preparation of endo-1,4-beta-xylanase produced by<span>Trichoderma longibrachiatum</span> (ATCC 2105), endo-1,3(4)-beta-glucanase and alpha-amylase produced by<span>Bacillus amyloliquefaciens</span> (DSM 9553), subtilisin produced by<span>Bacillus subtilis</span> (ATCC 2107), polygalacturonase produced by<span>Aspergillus aculeatus</span> (CBS 589.94) having a mimimum activity of:</p><div><p>Endo-1,4-beta-xylanase: 300 U&#160;<a>(<span>1</span>)</a>/g</p></div><div><p>Endo-1,3(4)-beta-glucanase: 150 U&#160;<a>(<span>3</span>)</a>/g</p></div><div><p>Subtilisin: 4&#160;000  U&#160;<a>(<span>2</span>)</a>/g</p></div><div><p>Alpha-amylase: 400 U&#160;<a>(<span>4</span>)</a>/g</p></div><div><p>Polygalacturonase: 25 U&#160;<a>(<span>5</span>)</a>/g</p></div></td><td><p>Ducks</p></td><td><p>&#8212;</p></td><td><p>endo-1,4-beta-xylanase:</p><p>300 U</p></td><td><p>&#8212;</p></td><td><p>1.&#160;&#160;In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.</p><p>2.&#160;&#160;Recommended dose per kg of complete feedingstuff:</p><div><p>endo-1,4-beta-xylanase: 300 U</p></div><div><p>endo-1,3(4)-beta-glucanase: 150 U</p></div><div><p>subtilisin: 4&#160;000  U</p></div><div><p>alpha-amylase: 400 U</p></div><div><p>polygalacturonase: 25 U.</p></div><p>3.&#160;&#160;For use in compound feed rich in starch and non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e.g. containing more than 40&#160;% maize.</p></td><td><p>4.1.2010</p></td></tr><tr><td><p>endo-1,3(4)-beta-glucanase:</p><p>150 U</p></td><td><p>&#8212;</p></td></tr><tr><td><p>subtilisin:</p><p>4&#160;000  U</p></td><td><p>&#8212;</p></td></tr><tr><td><p>alpha-amylase:</p><p>400 U</p></td><td><p>&#8212;</p></td></tr><tr><td><p>polygalacturonase:</p><p>25 U</p></td><td><p>&#8212;</p></td></tr><tr><td><p>Laying hens</p></td><td><p>&#8212;</p></td><td><p>endo-1,4-beta-xylanase:</p><p>225 U</p></td><td><p>&#8212;</p></td><td><p>1.&#160;&#160;In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.</p><p>2.&#160;&#160;Recommended dose per kg of complete feedingstuff:</p><div><p>endo-1,4-beta-xylanase: 225 U</p></div><div><p>endo-1,3(4)-beta-glucanase: 112 U</p></div><div><p>subtilisin: 3&#160;000  U</p></div><div><p>alpha-amylase: 300 U</p></div><div><p>polygalacturonase: 18 U.</p></div><p>3.&#160;&#160;For use in compound feed rich in starch and non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e.g. containing more than 40&#160;% maize.</p></td><td><p>4.1.2010</p></td></tr><tr><td><p>endo-1,3(4)-beta-glucanase:</p><p>112 U</p></td><td><p>&#8212;</p></td></tr><tr><td><p>subtilisin:</p><p>3&#160;000  U</p></td><td><p>&#8212;</p></td></tr><tr><td><p>alpha-amylase:</p><p>300 U</p></td><td><p>&#8212;</p></td></tr><tr><td><p>polygalac-turonase:</p><p>18 U</p></td><td><p>&#8212;</p></td></tr><tr><td><p><a>(<span>1</span>)&#160;&#160;&#160;</a>1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from oat spelt xylan per minute at pH 5,3 and 50&#160;&#176;C.</p><p><a>(<span>2</span>)&#160;&#160;&#160;</a>1 U is the amount of enzyme which liberates 1 microgram of phenolic compound (tyrosine equivalents) from a casein substrate per minute at pH 7,5 and 40&#160;&#176;C.</p><p><a>(<span>3</span>)&#160;&#160;&#160;</a>1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 5,0 and 30&#160;&#176;C.</p><p><a>(<span>4</span>)&#160;&#160;&#160;</a>1 U is the amount of enzyme which hydrolyses 1 micromole of glucosidic linkages from a water insoluble cross-linked starch polymer substrate per minute at pH 6,5 and 37&#160;&#176;C.</p><p><a>(<span>5</span>)&#160;&#160;&#160;</a>1 U is the amount of enzyme which liberates 1 micromole of reducing material (galacturonic acid equivalents) from a poly D-galacturonic substrate per minute at pH 5,0 and 40 &#176;C.</p></td></tr></tbody></table>