Document ID: 02005R0358-20170331
Language: ENG

02005R0358 — EN — 31.03.2017 — 002.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>COMMISSION REGULATION (EC) No 358/2005</p><p>of 2 March 2005</p><p>concerning the authorisations without a time limit of certain additives and the authorisation of new uses of additives already authorised in feedingstuffs</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 057 3.3.2005, 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) No 643/2013&#160;of 4 July 2013</a></p></td><td><p>&#160;&#160;L&#160;186</p></td><td><p>7</p></td><td><p>5.7.2013</p></td></tr><tr><td><p><a>&#9658;M2</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2017/429&#160;of 10 March 2017</a></p></td><td><p>&#160;&#160;L&#160;66</p></td><td><p>4</p></td><td><p>11.3.2017</p></td></tr></table>
COMMISSION REGULATION (EC) No 358/2005
of 2 March 2005
concerning the authorisations without a time limit of certain additives and the authorisation of new uses of additives already authorised in feedingstuffs
(Text with EEA relevance)
Article 1
The preparations belonging to the group ‘Enzymes’ as set out 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 substances belonging to the group ‘Colourants, including pigments, other colourants’ as set out 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 set out in Annex III are authorised provisionally for four years as additives in animal nutrition under the conditions laid down in that Annex.
Article 4
The preparation belonging to the group ‘Micro-organisms’, as set out in Annex IV is authorised provisionally for four years as additive in animal nutrition under the conditions laid down in that Annex.
Article 5
This Regulation shall enter into force on the third 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>Units of activity/kg of complete feedingstuff</p></td></tr><tr><td><p>Enzymes</p></td></tr><tr><td><p>E 1619</p></td><td><p>Alpha-amylase EC 3.2.1.1</p><p>Endo-1,3(4)-beta-glucanase EC 3.2.1.6</p></td><td><p>Preparation of alpha-amylase and endo-1,3(4)-beta-glucanase produced by<span>Bacillus amyloliquefaciens</span> (DSM 9553) having minimum activities of:</p><div><p>Coated form:</p><div><p>Alpha-amylase: 200&#160;KNU&#160;<a>(<span>1</span>)</a>/g</p></div><div><p>Endo-1,3(4)-beta-glucanase: 350&#160;FBG&#160;<a>(<span>2</span>)</a>/g</p></div></div><div><p>Liquid form:</p><div><p>Alpha-amylase: 130&#160;KNU/ml</p></div><div><p>Endo-1,3(4)-beta-glucanase: 225&#160;FBG/ml</p></div></div></td><td><p>Chickens for fattening</p></td><td><p>&#8211;&#8211;</p></td><td><p>alpha-amylase: 10&#160;KNU</p></td><td><p>&#8211;&#8211;</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>alpha-amylase: 20&#8211;40&#160;KNU</p></div><div><p>endo-1,3(4)-beta-glucanase: 35&#8211;70&#160;FBG</p></div><p>3.&#160;&#160;For use in compound feed rich in starch and beta glucans, e.g. containing more than 40&#160;% cereals (e.g. barley, oats, wheat, rye, triticale, or maize).</p></td><td><p>Without a time limit</p></td></tr><tr><td><p>endo-1,3(4)-beta &#8211;glucanase: 17&#160;FBG</p></td><td><p>&#8211;&#8211;</p></td></tr><tr><td><p>E 1620</p></td><td><p>Endo-1,3(4)-beta-glucanase EC 3.2.1.6</p><p>Endo-1,4-beta-glucanase EC 3.2.1.4</p><p>Alpha-amylase EC 3.2.1.1</p><p>Bacillolysin EC 3.4.24.28</p><p>Endo-1,4-beta-xylanase EC 3.2.1.8</p></td><td><p>Preparation of endo-1,3(4)-beta-glucanase produced by<span>Aspergillus aculeatus</span> (CBS 589.94), endo-1,4-beta-glucanase produced by<span>Trichoderma longibrachiatum</span> (CBS 592.94), alpha-amylase produced by<span>Bacillus amyloliquefaciens</span> (DSM 9553), bacillolysin produced by<span>Bacillus amyloliquefaciens</span> (DSM 9554) and endo-1,4-beta-xylanase produced by<span>Trichoderma viride</span> (NIBH FERM BP 4842) having a minimum activity of:</p><div><p>Endo-1,3(4)-beta-glucanase: 2&#160;350 &#160;U&#160;<a>(<span>3</span>)</a>/g</p></div><div><p>Endo-1,4-beta-glucanase: 4&#160;000 &#160;U&#160;<a>(<span>4</span>)</a>/g</p></div><div><p>Alpha-amylase: 400&#160;U&#160;<a>(<span>5</span>)</a>/g</p></div><div><p>Bacillolysin: 450&#160;U&#160;<a>(<span>6</span>)</a>/g</p></div><div><p>Endo-1,4-beta-xylanase: 20&#160;000 &#160;U&#160;<a>(<span>7</span>)</a>/g</p></div></td><td><p>Chickens for fattening</p></td><td><p>&#8211;&#8211;</p></td><td><p>Endo-1,3(4)-beta-glucanase: 587&#160;U</p></td><td><p>&#8211;&#8211;</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-1,3(4)-beta-glucanase: 1&#160;175 &#8211;2&#160;350 &#160;U</p></div><div><p>endo-1,4-beta-glucanase: 2&#160;000 &#8211;4&#160;000 &#160;U</p></div><div><p>alpha-amylase: 200&#8211;400&#160;U</p></div><div><p>bacillolysin: 225&#8211;450&#160;U</p></div><div><p>endo-1,4-beta-xylanase: 10&#160;000 &#8211;20&#160;000 &#160;U</p></div><p>3.&#160;&#160;For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e.g. containing more than 45&#160;% wheat.</p></td><td><p>Without a time limit</p></td></tr><tr><td><p>Endo-1,4-beta-glucanase: 1&#160;000 &#160;U</p></td><td><p>&#8211;&#8211;</p></td></tr><tr><td><p>Alpha-amylase: 100&#160;U</p></td><td><p>&#8211;&#8211;</p></td></tr><tr><td><p>Bacillolysin: 112&#160;U</p></td><td><p>&#8211;&#8211;</p></td></tr><tr><td><p>Endo-1,4-beta-xylanase: 5&#160;000 &#160;U</p></td><td><p>&#8211;&#8211;</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>E 1622</p></td><td><p>Endo-1,3(4)-beta-glucanase EC 3.2.1.6</p><p>Endo-1,4-beta-xylanase EC 3.2.1.8</p></td><td><p>Preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by<span>Trichoderma longibrachiatum</span> (CBS 357.94) having a minimum activity of:</p><div><p>Granulated form:</p><div><p>6&#160;000 &#160;BGU&#160;<a>(<span>8</span>)</a>/g</p></div><div><p>8&#160;250 &#160;EXU&#160;<a>(<span>9</span>)</a>/g</p></div></div><div><p>Liquid form:</p><div><p>2&#160;000 &#160;BGU/ml</p></div><div><p>2&#160;750 &#160;EXU/ml</p></div></div></td><td><p>Chickens for fattening</p></td><td><p>&#8211;&#8211;</p></td><td><p>endo-1,3(4)-beta-glucanase: 500&#160;BGU</p></td><td><p>&#8211;&#8211;</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-1,3(4)-beta-glucanase: 500&#160;BGU</p></div><div><p>endo-1,4-beta-xylanase: 680&#160;EXU</p></div><p>3.&#160;&#160;For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e.g. containing more than 30&#160;% wheat and 30&#160;% barley, or 20&#160;% rye.</p></td><td><p>Without a time limit</p></td></tr><tr><td><p>endo-1,4-beta-xylanase: 680 EXU</p></td><td><p>&#8211;&#8211;</p></td></tr><tr><td><p><a>(<span>1</span>)&#160;&#160;&#160;</a>1 KNU is the amount of enzyme which liberates 672 micromoles of reducing sugars (glucose equivalent) from soluble starch per minute at pH 5,6 and 37&#160;&#176;C.</p><p><a>(<span>2</span>)&#160;&#160;&#160;</a>1 FBG 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>3</span>)&#160;&#160;&#160;</a>1 U is the amount of enzyme which liberates 0,0056 micromoles of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 7,5 and 30&#160;&#176;C.</p><p><a>(<span>4</span>)&#160;&#160;&#160;</a>1 U is the amount of enzyme which liberates 0,0056 micromoles of reducing sugars (glucose equivalents) from carboxymethylcellulose per minute at pH 4,8 and 50&#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 water insoluble cross-linked starch polymer per minute at pH 7,5 and 37&#160;&#176;C.</p><p><a>(<span>6</span>)&#160;&#160;&#160;</a>1 U is the amount of enzyme which makes 1 microgram of azo-casein soluble in trichloracetic acid per minute at pH 7,5 and 37&#160;&#176;C.</p><p><a>(<span>7</span>)&#160;&#160;&#160;</a>1 U is the amount of enzyme which liberates 0,0067 micromoles of reducing sugars (xylose equivalents) from birchwood xylan per minute at pH 5,3 and 50&#160;&#176;C.</p><p><a>(<span>8</span>)&#160;&#160;&#160;</a>1 BGU is the amount of enzyme which liberates 0,278 micromoles of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 3,5 and 40&#160;&#176;C.</p><p><a>(<span>9</span>)&#160;&#160;&#160;</a>1 EXU is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from wheat arabinoxylan per minute at pH 3,5 and 55&#160;&#176;C.</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>mg/kg of complete feedingstuff</p></td></tr><tr><td><p>Colourants, including pigments</p></td></tr><tr><td><p>2.&#160;&#160;Other colourants</p></td></tr><tr><td><p>E 102</p></td><td><p>Tartrazine</p></td><td><p>C<span>16</span>H<span>9</span>N<span>4</span>O<span>9</span>S<span>2</span>Na<span>3</span></p></td><td><p>Grain-eating ornamental birds</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>150</p></td><td><p>&#8212;</p></td><td><p>Without a time limit</p></td></tr><tr><td><p>Small rodents</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>150</p></td><td><p>&#8212;</p></td><td><p>Without a time limit</p></td></tr><tr><td><p>E 110</p></td><td><p>Sunset yellow FCF</p></td><td><p>C<span>16</span>H<span>10</span>N<span>2</span>O<span>7</span>S<span>2</span>Na<span>2</span></p></td><td><p>Grain-eating ornamental birds</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>150</p></td><td><p>&#8212;</p></td><td><p>Without a time limit</p></td></tr><tr><td><p>Small rodents</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>150</p></td><td><p>&#8212;</p></td><td><p>Without a time limit</p></td></tr><tr><td><p><a>&#9660;M1</a>&#160;&#8212;&#8212;&#8212;&#8212;&#8212;</p></td></tr><tr><td><p><a>&#9660;B</a></p></td></tr><tr><td><p>E 141</p></td><td><p>Chlorophyll copper complex</p></td><td><p>&#8212;</p></td><td><p>Grain-eating ornamental birds</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>150</p></td><td><p>&#8212;</p></td><td><p>Without a time limit</p></td></tr><tr><td><p>Small rodents</p></td><td><p>&#8212;</p></td><td><p>&#8212;</p></td><td><p>150</p></td><td><p>&#8212;</p></td><td><p>Without a time limit</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>51</p></td><td><p>Endo-1,4-beta-xylanase EC 3.2.1.8</p></td><td><p>Preparation of endo-1,4-beta-xylanase produced by<span>Bacillus subtilis</span> (LMG S-15136) having a minimum activity of:</p><p>Solid and liquid form:</p><div><p>100 IU&#160;<a>(<span>1</span>)</a>/g or ml</p></div></td><td><p>Laying hens</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 dose per kg 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>6 March 2009</p></td></tr><tr><td><p>28</p></td><td><p>3-Phytase EC 3.1.3.8</p></td><td><p>Preparation of 3-phytase produced by<span>Trichoderma reesei</span> (CBS 528.94) having a minimum activity of:</p><div><p>Solid form: 5&#160;000  PPU&#160;<a>(<span>2</span>)</a>/g</p></div><div><p>Liquid form: 1&#160;000  PPU/g</p></div></td><td><p>Turkeys for fattening</p></td><td><p>&#8212;</p></td><td><p>250 PPU</p></td><td><p>&#8212;</p></td><td><p>1.&#160;&#160;In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.</p><p>2.&#160;&#160;Recommended dose per kg of complete feedingstuff: 250-1&#160;000  PPU</p><p>3.&#160;&#160;For use in compound feed containing more than 0,22&#160;% phytin bound phosphorus.</p></td><td><p>6 March 2009</p></td></tr><tr><td><p>Sows</p></td><td><p>&#8212;</p></td><td><p>250 PPU</p></td><td><p>&#8212;</p></td><td><p>1.&#160;&#160;In the directions for use of the additive and pre-mixture, indicate the storage temperature, storage life and stability to pelleting.</p><p>2.&#160;&#160;Recommended dose per kg of complete feedingstuff: 500-1&#160;000  PPU</p><p>3.&#160;&#160;For use in compound feed containing more than 0,22&#160;% phytin bound phosphorus.</p></td><td><p>6 March 2009</p></td></tr><tr><td><p><a>(<span>1</span>)&#160;&#160;&#160;</a>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&#160;&#176;C.</p><p><a>(<span>2</span>)&#160;&#160;&#160;</a>1 PPU is the amount of enzyme which liberates 1 micromole of inorganic phosphate from sodium phytate per minute at pH 5 and 37&#160;&#176;C.</p></td></tr></tbody></table>
ANNEX IV
<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>10</p></td><td><p><span>Enterococcus faecium</span> NCIMB 10415</p></td><td><p>Preparation of<span>Enterococcus faecium</span> containing a minimum of microencapsulated form: 5&#160;&#215;&#160;10<span>9</span> CFU/g</p></td><td><p>Dogs</p></td><td><p>&#8212;</p></td><td><p>4,5&#160;&#215;&#160;10<span>6</span></p></td><td><p>2&#160;&#215;&#160;10<span>9</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>6 March 2009</p></td></tr><tr><td><p>Cats</p></td><td><p>&#8212;</p></td><td><p>5&#160;&#215;&#160;10<span>6</span></p></td><td><p>8&#160;&#215;&#160;10<span>9</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>6 March 2009</p></td></tr></tbody></table>