Document ID: 02002R2188-20170719
Language: ENG

02002R2188 — EN — 19.07.2017 — 001.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION REGULATION (EC) No 2188/2002</p><p>of 9 December 2002</p><p>concerning the provisional authorisation of new uses of additives in feedingstuffs</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 333 10.12.2002, p. 5)</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) 2017/1145&#160;of 8 June 2017</a></p></td><td><p>&#160;&#160;L&#160;166</p></td><td><p>1</p></td><td><p>29.6.2017</p></td></tr></table>
COMMISSION REGULATION (EC) No 2188/2002
of 9 December 2002
concerning the provisional authorisation of new uses of additives in feedingstuffs
(Text with EEA relevance)
Article 1
The preparations belonging to the group ‘Enzymes’ listed in Annexes I and II to this Regulation are authorised for use as additives in animal nutrition under the conditions laid down in these Annexes.
Article 2
The preparation belonging to the group ‘Enzymes’ listed in Annex III to this Regulation is authorised for use as additive in animal nutrition under the conditions laid down in this Annex.
Article 3
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Communities .
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>No (or 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 authorization</p></td></tr><tr><td><p>Units of activity/kg of complete feedingstuff</p></td></tr><tr><td><p><span>Enzymes</span></p></td></tr><tr><td><p>11</p></td><td><p>Endo-1,4-beta-glucanase</p><div><p>EC 3.2.1.4</p></div></td><td><p>Preparation of endo-1,4-beta-glucanase, endo-1,3(4)-beta-glucanase, and endo-1,4-beta-xylanase produced by<span>Trichoderma longibrachiatum</span> (ATCC 74252) having a minimum activity of:</p><div><p>Granular and liquid form:</p><div><p>Endo-1,4-beta-glucanase:</p><div><p>8&#160;000  U&#160;<a>(<span>1</span>)</a>/g or ml</p></div></div><div><p>Endo-1,3(4)-beta-glucanase:</p><div><p>18&#160;000  U&#160;<a>(<span>2</span>)</a>/g or ml</p></div></div><div><p>Endo-1,4-beta-xylanase:</p><div><p>26&#160;000  U&#160;<a>(<span>3</span>)</a>/g or ml</p></div></div></div></td><td><p><span><a><span>&#9658;M1</span></a></span>&#160;&#8212;<span>&#160;&#9668;</span></p></td><td><p><span><a><span>&#9658;M1</span></a></span>&#160;&#8212;<span>&#160;&#9668;</span></p></td><td><p><span><a><span>&#9658;M1</span></a></span>&#160;Endo-1,4-beta-glucanase:</p><div><p>400 U<span>&#160;&#9668;</span></p></div></td><td><p><span><a><span>&#9658;M1</span></a></span>&#160;&#8212;<span>&#160;&#9668;</span></p></td><td><p><span><a><span>&#9658;M1</span></a></span>&#160;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 dosages per kilogram of complete feedingstuff:</p><div><p>endo-1,4-beta-glucanase:</p><div><p>400-1&#160;280  U</p></div></div><div><p>endo-1,3(4)-beta-glucanase:</p><div><p>900-2&#160;880  U</p></div></div><div><p>endo-1,4-beta-xylanase:</p><div><p>1&#160;300 &#8211;4&#160;160  U.</p></div></div><p>3.&#160;&#160;For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans and betaglucans), e.g. containing more than 40&#160;% wheat, triticale or barley.<span>&#160;&#9668;</span></p></td><td><p><span><a><span>&#9658;M1</span></a></span>&#160;1.1.2007<span>&#160;&#9668;</span></p></td></tr><tr><td><p>Endo-1,3(4)-beta-glucanase</p><div><p>EC 3.2.1.6</p></div></td><td><p><span><a><span>&#9658;M1</span></a></span>&#160;Endo-1,3(4)-beta-gluca-nase:</p><div><p>900 U<span>&#160;&#9668;</span></p></div></td><td><p><span><a><span>&#9658;M1</span></a></span>&#160;&#8212;<span>&#160;&#9668;</span></p></td></tr><tr><td><p>Endo-1,4-beta-xylanase</p><div><p>EC 3.2.1.8</p></div></td><td><p><span><a><span>&#9658;M1</span></a></span>&#160;Endo-1,4-beta-xylanase:</p><div><p>1&#160;300  U<span>&#160;&#9668;</span></p></div></td><td><p><span><a><span>&#9658;M1</span></a></span>&#160;&#8212;<span>&#160;&#9668;</span></p></td></tr><tr><td><p>Piglets</p></td><td><p>&#8212;</p></td><td><p>Endo-1,4-beta-gluca-nase:</p><div><p>400 U</p></div></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 dosages per kilogram of complete feedingstuff:</p><div><p>endo-1,4-beta-glucanase:</p><div><p>400-1&#160;600  U</p></div></div><div><p>endo-1,3(4)-beta-glucanase:</p><div><p>900-3&#160;600  U</p></div></div><div><p>endo-1, 4-beta-xylanase:</p><div><p>1&#160;300 &#8211;5&#160;200  U.</p></div></div><p>3.&#160;&#160;For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e.g. containing more than 40&#160;% wheat, triticale or maize or wheat and 20&#160;% rye.</p></td><td><p>1.1.2007</p></td></tr><tr><td><p>Endo-1,3(4)-beta-glucanase:</p><div><p>900 U</p></div></td><td><p>&#8212;</p></td></tr><tr><td><p>Endo-1,4-beta-xylanase:</p><div><p>1&#160;300  U</p></div></td><td><p>&#8212;</p></td></tr><tr><td><div><a>(<span>1</span>)&#160;&#160;&#160;</a><p>1 U is the amount of enzyme which liberates 0,1 micromoles of glucose from carboxymethylcellulose per minute at pH 5,0 and 40&#160;&#176;C.</p></div><div><a>(<span>2</span>)&#160;&#160;&#160;</a><p>1 U is the amount of enzyme which liberates 0,1 micromoles of glucose from barley beta-glucan per minute at pH 5,0 and 40&#160;&#176;C.</p></div><div><a>(<span>3</span>)&#160;&#160;&#160;</a><p>1 U is the amount of enzyme which liberates 0,1 micromoles of glucose from oat spelt xylan per minute at pH 5,0 and 40&#160;&#176;C.</p></div></td></tr></tbody></table>
ANNEX II
<table><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>No (or 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 authorization</p></td></tr><tr><td><p>Units of activity/kg of complete feedingstuff</p></td></tr><tr><td><p><span>Enzymes</span></p></td></tr><tr><td><p>51</p></td><td><p>Endo-1,4-beta-xylanase</p><div><p>EC 3.2.1.8</p></div></td><td><p>Preparation of endo-l,4-beta-xylanase produced by<span>Bacillus subtilis</span> (LMG S-15136) having a minimum activity of:</p><div><p>Endo-l,4-beta-xylanase:</p><div><p>Solid and liquid:</p><div><p>100 IU&#160;<a>(<span>1</span>)</a>/g or ml</p></div></div></div></td><td><p>Turkeys for fattening</p></td><td><p>&#8212;</p></td><td><p>10 IU</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 dosages per kilogram of complete feedingstuff: 10 IU.</p><p>3.&#160;&#160;For use in compound feed rich in arabinoxylan, e.g. containing minimum 40&#160;% wheat or barley.</p></td><td><p>1.1.2007</p></td></tr><tr><td><div><a>(<span>1</span>)&#160;&#160;&#160;</a><p>1 IU is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from birchwood xylan per minute at pH 4,5 and 30 &#176;C.</p></div></td></tr></tbody></table>
ANNEX III
<table><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>No (or 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 authorization</p></td></tr><tr><td><p>Units of activity/kg of complete feedingstuff</p></td></tr><tr><td><p><span>Enzymes</span></p></td></tr><tr><td><p>51</p></td><td><p>Endo-1,4-beta-xylanase:</p><div><p>EC 3.2.1.8</p></div></td><td><p>Preparation of endo-1,4-beta-xyla-nase produced by<span>Bacillus subtilis</span> (LMG S-15136) having a minimum activity of:</p><div><p>Endo-1,4-beta-xylanase:</p><div><p>Liquid:</p><div><p>100 IU&#160;<a>(<span>1</span>)</a>/ml</p></div></div></div></td><td><p>Chickens for fattening</p></td><td><p>&#8212;</p></td><td><p>10 IU</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 dosages per kilogram of complete feedingstuff: 10 IU.</p><p>3.&#160;&#160;For use in compound feed rich in arabinoxylan, e.g. containing minimum 40&#160;% wheat or barley.</p></td><td><p>1.1.2007</p></td></tr><tr><td><div><a>(<span>1</span>)&#160;&#160;&#160;</a><p>1 IU is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from birchwood xylan per minute at pH 4,5 and 3 &#176;C.</p></div></td></tr></tbody></table>