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					<dc:identifier>http://www.legislation.gov.uk/eur/2012/1019</dc:identifier><dc:title>Commission Implementing Regulation (EU) No 1019/2012 of 6 November 2012 amending Commission Regulation (EC) No 1096/2009 as regards the minimum content of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) as a feed additive in feed for chickens for fattening and for ducks (holder of authorisation BASF SE) (Text with EEA relevance)</dc:title><dct:alternative>Commission Implementing Regulation (EU) No 1019/2012</dct:alternative><dc:description>Commission Implementing Regulation (EU) No 1019/2012 of 6 November 2012 amending Commission Regulation (EC) No 1096/2009 as regards the minimum content of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) as a feed additive in feed for chickens for fattening and for ducks (holder of authorisation BASF SE) (Text with EEA relevance)</dc:description><dc:modified>2020-12-12</dc:modified><dc:publisher>King's Printer of Acts of Parliament</dc:publisher><dc:source>https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32012R1019</dc:source><dc:type>text</dc:type><dc:format>text/xml</dc:format><dc:language>en</dc:language><dct:valid>2012-11-06</dct:valid>
					
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					<ukm:Alternatives><ukm:Alternative URI="http://www.legislation.gov.uk/eur/2012/1019/pdfs/eur_20121019_adopted_en.pdf" Date="2012-11-06" Size="825690"/> </ukm:Alternatives>
					
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            <Text>
               <Uppercase>Commission Implementing Regulation</Uppercase> (EU) No 1019/2012</Text>
            <Text>of 6 November 2012</Text>
            <Text>amending Commission Regulation (EC) No 1096/2009 as regards the minimum content of endo-1,4-beta-xylanase produced by <Emphasis>Aspergillus niger</Emphasis> (CBS 109.713) as a feed additive in feed for chickens for fattening and for ducks (holder of authorisation BASF SE)</Text>
            <Text>(Text with EEA relevance)</Text>
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         <EUPreamble>
            <P>
               <Text>THE EUROPEAN COMMISSION,</Text>
            </P>
            <P>
               <Text>Having regard to the Treaty on the Functioning of the European Union,</Text>
            </P>
            <P>
               <Text>Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition<FootnoteRef Ref="f00001"/>, and in particular Article 13(3) thereof,</Text>
            </P>
            <P>
               <Text>Whereas:</Text>
            </P>
            <Division>
               <Number>(1)</Number>
               <P>
                  <Text>The enzyme endo-1,4-beta-xylanase produced by <Emphasis>Aspergillus niger</Emphasis> (CBS 109.713), belonging to the additive category of ‘zootechnical additives’ was authorised for 10 years as a feed additive for use on chickens for fattening and for ducks by Commission Regulation (EC) No 1096/2009<FootnoteRef Ref="f00002"/> and for use on turkeys for fattening by Commission Regulation (EC) No 1380/2007<FootnoteRef Ref="f00003"/>.</Text>
               </P>
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               <Number>(2)</Number>
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                  <Text>In accordance with Article 13(3) of Regulation (EC) No 1831/2003, the holder of the authorisation has proposed changing the terms of the authorisation of the enzyme concerned by reducing its minimum content from 560 TXU/kg to 280 TXU/kg as regards use on chickens for fattening and ducks. The application was accompanied by the relevant supporting data.</Text>
               </P>
            </Division>
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               <Number>(3)</Number>
               <P>
                  <Text>The European Food Safety Authority (hereinafter ‘the Authority’) concluded in its opinion of 2 February 2012<FootnoteRef Ref="f00004"/> that, under the new proposed conditions of use, the enzyme concerned is efficacious at the requested minimum dose of 280 TXU/kg. The Authority does not consider that there is a need for specific requirements of post-market monitoring.</Text>
               </P>
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               <Number>(4)</Number>
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                  <Text>The conditions provided for in Article 5 of Regulation (EC) No 1831/2003 are satisfied.</Text>
               </P>
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               <Number>(5)</Number>
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                  <Text>Commission Regulation (EC) No 1096/2009 should therefore be amended accordingly.</Text>
               </P>
            </Division>
            <Division>
               <Number>(6)</Number>
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                  <Text>The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,</Text>
               </P>
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               <Text>HAS ADOPTED THIS REGULATION:</Text>
            </P>
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            <Pnumber>Article 1</Pnumber>
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               <Text>Regulation (EC) No 1096/2009 is amended in accordance with the Annex to this Regulation.</Text>
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            <Pnumber>Article 2</Pnumber>
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               <Text>This Regulation shall enter into force on the twentieth day following that of its publication in the <Emphasis>Official Journal of the European Union</Emphasis>.</Text>
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               <Text>This Regulation shall be binding in its entirety and directly applicable in all Member States.</Text>
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                  <Text>Done at Brussels, 6 November 2012.</Text>
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                        <Emphasis>For the Commission</Emphasis>
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                     <Text>
                        <Emphasis>The President</Emphasis>
                     </Text>
                  </Para>
                  <Para>
                     <Text>José Manuel <Uppercase>Barroso</Uppercase>
                     </Text>
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            <Number>ANNEX</Number>
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                  <Text>The Annex to Regulation (EC) No 1096/2009 is replaced by the following:</Text>
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                        <Number>‘ANNEX</Number>
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                                       <Footnote xmlns="http://www.legislation.gov.uk/namespaces/legislation" id="f00005">
                                          <FootnoteText>
                                             <Para>
                                                <Text>1 TXU is the amount of enzyme which liberates 5 micromole of reducing sugars (xylose equivalents) from wheat arabinoxylan per minute at pH 3,5 and 55 °C.</Text>
                                             </Para>
                                          </FootnoteText>
                                       </Footnote>
                                    </td></tr><tr><td colspan="10">
                                       <Footnote xmlns="http://www.legislation.gov.uk/namespaces/legislation" id="f00006">
                                          <FootnoteText>
                                             <Para>
                                                <Text>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’</Text>
                                             </Para>
                                          </FootnoteText>
                                       </Footnote>
                                    </td></tr></tfoot>
                              <tbody><tr><th rowspan="2">Identification number of the additive</th><th rowspan="2">Name of the holder of authorisation</th><th rowspan="2">Additive</th><th rowspan="2">Composition, chemical formula, description, analytical method</th><th rowspan="2">Species or category of animal</th><th rowspan="2">Maximum age</th><th>Minimum content</th><th>Maximum content</th><th rowspan="2">Other provisions</th><th rowspan="2">End of period of authorisation</th></tr><tr><th colspan="2">Units of activity/kg of complete feedingstuff with a moisture content of 12 %</th></tr><tr><th colspan="10">
                                       <Strong xmlns="http://www.legislation.gov.uk/namespaces/legislation">Category of zootechnical additives. Functional group: digestibility enhancers.</Strong>
                                    </th></tr><tr><td rowspan="2">4a62</td><td rowspan="2">BASF SE</td><td rowspan="2">
                                       <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                          <Text>Endo-1,4-beta-xylanase</Text>
                                       </Para>
                                       <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                          <Text>EC 3.2.1.8</Text>
                                       </Para>
                                    </td><td rowspan="2">
                                       <UnorderedList xmlns="http://www.legislation.gov.uk/namespaces/legislation" Decoration="none">
                                          <ListItem>
                                             <Para>
                                                <Text>
                                                   <Emphasis>Additive composition</Emphasis>
                                                </Text>
                                             </Para>
                                             <Para>
                                                <Text>Preparation of endo-1,4-beta-xylanase produced by <Emphasis>Aspergillus niger</Emphasis> (CBS 109.713) having a minimum activity of:</Text>
                                             </Para>
                                             <UnorderedList Decoration="none">
                                                <ListItem>
                                                   <Para>
                                                      <Text>solid form: 5 600 TXU<FootnoteRef Ref="f00005"/>/g</Text>
                                                   </Para>
                                                </ListItem>
                                                <ListItem>
                                                   <Para>
                                                      <Text>liquid form: 5 600 TXU/ml</Text>
                                                   </Para>
                                                </ListItem>
                                             </UnorderedList>
                                          </ListItem>
                                          <ListItem>
                                             <Para>
                                                <Text>
                                                   <Emphasis>Characterisation of the active substance</Emphasis>
                                                </Text>
                                             </Para>
                                             <Para>
                                                <Text>Endo-1,4-beta-xylanase produced by <Emphasis>Aspergillus niger</Emphasis> (CBS 109.713)</Text>
                                             </Para>
                                          </ListItem>
                                          <ListItem>
                                             <Para>
                                                <Text>
                                                   <Emphasis>Analytical method</Emphasis>
                                                   <FootnoteRef Ref="f00006"/>
                                                </Text>
                                             </Para>
                                             <Para>
                                                <Text>Viscosimetric method based on decrease of viscosity produced by action of endo-1,4-beta-xylanase on the xylan-containing substrate (wheat arabinoxylan) at pH 3,5 and 55 °C</Text>
                                             </Para>
                                          </ListItem>
                                       </UnorderedList>
                                    </td><td>Chickens for fattening</td><td rowspan="2">—</td><td>280 TXU</td><td rowspan="2">—</td><td rowspan="2">
                                       <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                          <Number>1.</Number>
                                          <P>
                                             <Text>In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.</Text>
                                          </P>
                                       </Division>
                                       <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                          <Number>2.</Number>
                                          <P>
                                             <Text>Recommended maximum dose per kilogram of complete feedingstuff for chickens for fattening and ducks: 800 TXU.</Text>
                                          </P>
                                       </Division>
                                       <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                          <Number>3.</Number>
                                          <P>
                                             <Text>For use in feed rich in starch and non-starch polysaccharides (mainly beta-glucans and arabinoxylans).</Text>
                                          </P>
                                       </Division>
                                    </td><td rowspan="2">7.12.2019</td></tr><tr><td>Ducks</td><td>280 TXU</td></tr></tbody>
                           </table>
                        </Tabular>
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      </Schedules>
   </EURetained><Footnotes><Footnote id="f00001">
         <FootnoteText>
            <Para>
               <Text>
                  <Citation id="c00001" Class="EuropeanUnionOfficialJournal" Year="2003" URI="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2003.268.01.0029.01.ENG" Date="2003-10-18">OJ L 268, 18.10.2003, p. 29</Citation>.</Text>
            </Para>
         </FootnoteText>
      </Footnote><Footnote id="f00002">
         <FootnoteText>
            <Para>
               <Text>
                  <Citation id="c00002" Class="EuropeanUnionOfficialJournal" Year="2009" URI="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2009.301.01.0003.01.ENG" Date="2009-11-17">OJ L 301, 17.11.2009, p. 3</Citation>.</Text>
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      </Footnote><Footnote id="f00003">
         <FootnoteText>
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                  <Citation id="c00003" Class="EuropeanUnionOfficialJournal" Year="2007" URI="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2007.309.01.0021.01.ENG" Date="2007-11-27">OJ L 309, 27.11.2007, p. 21</Citation>.</Text>
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      </Footnote><Footnote id="f00004">
         <FootnoteText>
            <Para>
               <Text>
                  <Emphasis>EFSA Journal</Emphasis> 2012; 10(2):2575.</Text>
            </Para>
         </FootnoteText>
      </Footnote></Footnotes></Legislation>