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					<dc:identifier>http://www.legislation.gov.uk/eur/2019/913/adopted</dc:identifier><dc:title>Commission Implementing Regulation (EU) 2019/913 of 29 May 2019 concerning the renewal of the authorisation of lanthanum carbonate octahydrate as a feed additive for cats and repealing Regulation (EC) No 163/2008 (holder of authorisation Bayer HealthCare AG) (Text with EEA relevance)</dc:title><dct:alternative>Commission Implementing Regulation (EU) 2019/913</dct:alternative><dc:description>Commission Implementing Regulation (EU) 2019/913 of 29 May 2019 concerning the renewal of the authorisation of lanthanum carbonate octahydrate as a feed additive for cats and repealing Regulation (EC) No 163/2008 (holder of authorisation Bayer HealthCare AG) (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:32019R0913</dc:source><dc:type>text</dc:type><dc:format>text/xml</dc:format><dc:language>en</dc:language>
					
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					<ukm:Alternatives><ukm:Alternative URI="http://www.legislation.gov.uk/eur/2019/913/pdfs/eur_20190913_adopted_en.pdf" Date="2019-05-29" Size="380987"/> </ukm:Alternatives>
					
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            <Text>of 29 May 2019</Text>
            <Text>concerning the renewal of the authorisation of lanthanum carbonate octahydrate as a feed additive for cats and repealing Regulation (EC) No 163/2008 (holder of authorisation Bayer HealthCare AG)</Text>
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               <P>
                  <Text>Lanthanum carbonate octahydrate was authorised for 10 years as a feed additive for cats by Commission Regulation (EC) No 163/2008<FootnoteRef Ref="f00002"/>.</Text>
               </P>
            </Division>
            <Division>
               <Number>(3)</Number>
               <P>
                  <Text>In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitted by the holder of that authorisation for the renewal of the authorisation of lanthanum carbonate octahydrate as a feed additive for cats, requesting that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.</Text>
               </P>
            </Division>
            <Division>
               <Number>(4)</Number>
               <P>
                  <Text>The European Food Safety Authority (‘the Authority’) concluded in its opinion of 29 November 2018<FootnoteRef Ref="f00003"/> that the applicant has provided data demonstrating that the additive complies with the conditions of authorisation.</Text>
               </P>
            </Division>
            <Division>
               <Number>(5)</Number>
               <P>
                  <Text>The assessment of lanthanum carbonate octahydrate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of that additive should be renewed as specified in the Annex to this Regulation.</Text>
               </P>
            </Division>
            <Division>
               <Number>(6)</Number>
               <P>
                  <Text>As a consequence of the renewal of the authorisation of lanthanum carbonate octahydrate as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EC) No 163/2008 should be repealed.</Text>
               </P>
            </Division>
            <Division>
               <Number>(7)</Number>
               <P>
                  <Text>The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,</Text>
               </P>
            </Division>
            <P>
               <Text>HAS ADOPTED THIS REGULATION:</Text>
            </P>
         </EUPreamble>
      </EUPrelims>
      <EUBody DocumentURI="http://www.legislation.gov.uk/eur/2019/913/body/adopted" IdURI="http://www.legislation.gov.uk/id/eur/2019/913/body" NumberOfProvisions="3">
         <P1 DocumentURI="http://www.legislation.gov.uk/eur/2019/913/article/1/adopted" IdURI="http://www.legislation.gov.uk/id/eur/2019/913/article/1" id="article-1">
            <Pnumber>Article 1</Pnumber>
            <P1para>
               <Text>The authorisation of the additive specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is renewed subject to the conditions laid down in that Annex.</Text>
            </P1para>
         </P1>
         <P1 DocumentURI="http://www.legislation.gov.uk/eur/2019/913/article/2/adopted" IdURI="http://www.legislation.gov.uk/id/eur/2019/913/article/2" id="article-2">
            <Pnumber>Article 2</Pnumber>
            <P1para>
               <Text>Regulation (EC) No 163/2008 is repealed.</Text>
            </P1para>
         </P1>
         <P1 DocumentURI="http://www.legislation.gov.uk/eur/2019/913/article/3/adopted" IdURI="http://www.legislation.gov.uk/id/eur/2019/913/article/3" id="article-3">
            <Pnumber>Article 3</Pnumber>
            <P1para>
               <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>
            </P1para>
         </P1>
         <SignedSection DocumentURI="http://www.legislation.gov.uk/eur/2019/913/signature/adopted" IdURI="http://www.legislation.gov.uk/id/eur/2019/913/signature">
            <Para>
               <Text>This Regulation shall be binding in its entirety and directly applicable in all Member States.</Text>
            </Para>
            <Signatory>
               <Para>
                  <Text>Done at Brussels, 29 May 2019.</Text>
               </Para>
               <Signee>
                  <Para>
                     <Text>
                        <Emphasis>For the Commission</Emphasis>
                     </Text>
                  </Para>
                  <Para>
                     <Text>
                        <Emphasis>The President</Emphasis>
                     </Text>
                  </Para>
                  <Para>
                     <Text>Jean-Claude <Uppercase>Juncker</Uppercase>
                     </Text>
                  </Para>
               </Signee>
            </Signatory>
         </SignedSection>
      </EUBody>
      <Schedules>
         <Schedule DocumentURI="http://www.legislation.gov.uk/eur/2019/913/annex/adopted" IdURI="http://www.legislation.gov.uk/id/eur/2019/913/annex" id="annex">
            <Number>ANNEX</Number>
            <ScheduleBody>
               <Tabular Orientation="landscape">
                  <table xmlns="http://www.w3.org/1999/xhtml" cols="9">
                     <tfoot><tr><td colspan="9">
                              <Footnote xmlns="http://www.legislation.gov.uk/namespaces/legislation" id="f00004">
                                 <FootnoteText>
                                    <Para>
                                       <Text>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</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>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">mg of additive/kg of complete feedingstuff with a moisture content of 12 %</th></tr><tr><th colspan="9">
                              <Strong xmlns="http://www.legislation.gov.uk/namespaces/legislation">Category of zootechnical additives. Functional group: other zootechnical additives (decrease in phosphorous excretion via urine)</Strong>
                           </th></tr><tr><td>4d1</td><td>Bayer HealthCare AG</td><td>Lanthanum carbonate octahydrate</td><td>
                              <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Title>
                                    <Emphasis>Additive composition:</Emphasis>
                                 </Title>
                                 <P>
                                    <Text>Preparation of Lanthanum carbonate octahydrate</Text>
                                 </P>
                                 <P>
                                    <Text>At least 85 % Lanthanum carbonate octahydrate as active substance.</Text>
                                 </P>
                              </Division>
                              <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Title>
                                    <Emphasis>Characterisation of the active substance:</Emphasis>
                                 </Title>
                                 <P>
                                    <Text>Lanthanum carbonate octahydrate</Text>
                                 </P>
                                 <P>
                                    <Text>La<Inferior>2</Inferior>(CO<Inferior>3</Inferior>)<Inferior>3*</Inferior>8H<Inferior>2</Inferior>O</Text>
                                 </P>
                                 <P>
                                    <Text>CAS number 6487-39-4</Text>
                                 </P>
                              </Division>
                              <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Title>
                                    <Emphasis>Analytical method</Emphasis>
                                    <FootnoteRef Ref="f00004"/>
                                 </Title>
                                 <P>
                                    <Text>For the quantification of Carbonate in the feed additive:</Text>
                                 </P>
                                 <P>
                                    <Text>Community Method (Reg. (EC) No 152/2009 – Annex III-O)</Text>
                                 </P>
                                 <P>
                                    <Text>For the quantification of Lanthanum in the feed additive and feedingstuffs:</Text>
                                 </P>
                                 <P>
                                    <Text>Inductively Coupled Plasma Atomic Emission Spectrometry (ICP-AES)</Text>
                                 </P>
                              </Division>
                           </td><td>Cats</td><td>1 500</td><td>7 500</td><td>
                              <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Number>1.</Number>
                                 <P>
                                    <Text>In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.</Text>
                                 </P>
                              </Division>
                              <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Number>2.</Number>
                                 <P>
                                    <Text>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.</Text>
                                 </P>
                              </Division>
                              <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Number>3.</Number>
                                 <Title>In the directions for use of the additive, the following shall be indicated:</Title>
                                 <P>
                                    <BlockAmendment TargetClass="unknown" TargetSubClass="unknown" Context="unknown" Format="single">
                                       <Para>
                                          <Text>avoid simultaneous use of feeds with high level of phosphorus.</Text>
                                       </Para>
                                    </BlockAmendment>
                                    <AppendText>.</AppendText>
                                 </P>
                              </Division>
                           </td><td>25 June 2029</td></tr></tbody>
                  </table>
               </Tabular>
            </ScheduleBody>
         </Schedule>
      </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>Commission Regulation (EC) No 163/2008 of 22 February 2008 concerning an authorisation of the preparation Lanthanum carbonate octahydrate (Lantharenol) as a feed additive (<Citation id="c00002" Class="EuropeanUnionOfficialJournal" Year="2008" URI="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2008.050.01.0003.01.ENG" Date="2008-02-23">OJ L 50, 23.2.2008, p. 3</Citation>).</Text>
            </Para>
         </FootnoteText>
      </Footnote><Footnote id="f00003">
         <FootnoteText>
            <Para>
               <Text>
                  <Emphasis>EFSA Journal</Emphasis> 2018;16(12):5542.</Text>
            </Para>
         </FootnoteText>
      </Footnote></Footnotes></Legislation>