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					<dc:identifier>http://www.legislation.gov.uk/eudn/2008/985</dc:identifier><dc:title>Commission Decision of 15 December 2008 authorising the placing on the market of leaves of Morinda citrifolia as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2008) 8108) (Only the English text is authentic) (2008/985/EC)</dc:title><dc:description>Commission Decision of 15 December 2008 authorising the placing on the market of leaves of Morinda citrifolia as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2008) 8108) (Only the English text is authentic) (2008/985/EC)</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:32008D0985</dc:source><dc:type>text</dc:type><dc:format>text/xml</dc:format><dc:language>en</dc:language><dct:valid>2008-12-15</dct:valid>
					
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                  <VALUE>2008/985/EC: Commission Decision of 15 December 2008 authorising the placing on the market of leaves of Morinda citrifolia as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2008) 8108)</VALUE>
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      <EUPrelims DocumentURI="http://www.legislation.gov.uk/eudn/2008/985/introduction" IdURI="http://www.legislation.gov.uk/id/eudn/2008/985/introduction" RestrictStartDate="2008-12-15" RestrictExtent="E+W+S+N.I.">
         <MultilineTitle>
            <Text>
               <Uppercase>Commission Decision</Uppercase>
            </Text>
            <Text>of 15 December 2008</Text>
            <Text>authorising the placing on the market of leaves of <Emphasis>Morinda citrifolia</Emphasis> as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council</Text>
            <Text>(notified under document number C(2008) 8108)</Text>
            <Text>(Only the English text is authentic)</Text>
            <Text>(2008/985/EC)</Text>
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         <EUPreamble>
            <P>
               <Text>THE COMMISSION OF THE EUROPEAN COMMUNITIES,</Text>
            </P>
            <P>
               <Text>Having regard to the Treaty establishing the European Community,</Text>
            </P>
            <P>
               <Text>Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients<FootnoteRef Ref="f00001"/>, and in particular Article 7 thereof,</Text>
            </P>
            <P>
               <Text>Whereas:</Text>
            </P>
            <Division>
               <Number>(1)</Number>
               <P>
                  <Text>On 10 November 2004 Baker &amp; McKenzie on behalf of Morinda Inc., made a request to the competent authorities of Belgium to place the leaves of <Emphasis>Morinda citrifolia</Emphasis> on the market as a novel food ingredient.</Text>
               </P>
            </Division>
            <Division>
               <Number>(2)</Number>
               <P>
                  <Text>On 30 November 2005 the competent food assessment body of Belgium issued its initial assessment report. In that report it came to the conclusion that an additional assessment was required.</Text>
               </P>
            </Division>
            <Division>
               <Number>(3)</Number>
               <P>
                  <Text>The Commission forwarded the initial assessment report to all Member States on 21 March 2006.</Text>
               </P>
            </Division>
            <Division>
               <Number>(4)</Number>
               <P>
                  <Text>Some Member States raised additional questions about the safety of the leaves of <Emphasis>Morinda citrifolia</Emphasis>.</Text>
               </P>
            </Division>
            <Division>
               <Number>(5)</Number>
               <P>
                  <Text>Therefore the European Food Safety Authority (EFSA) was consulted on 14 November 2006.</Text>
               </P>
            </Division>
            <Division>
               <Number>(6)</Number>
               <P>
                  <Text>On 10 July 2008 EFSA adopted the ‘Opinion of the Scientific Panel on dietetic Products, Nutrition and Allergies on a request from the Commission related to the safety of leaves from <Emphasis>Morinda citrifolia</Emphasis> L.’.</Text>
               </P>
            </Division>
            <Division>
               <Number>(7)</Number>
               <P>
                  <Text>In the opinion the panel came to the conclusion that the use of dried and roasted <Emphasis>M. citrifolia</Emphasis> leaves for the preparation of infusions at the anticipated levels of intake is safe.</Text>
               </P>
            </Division>
            <Division>
               <Number>(8)</Number>
               <P>
                  <Text>On the basis of the scientific assessment, it is established that dried and roasted leaves of <Emphasis>Morinda citrifolia</Emphasis> comply with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.</Text>
               </P>
            </Division>
            <Division>
               <Number>(9)</Number>
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                  <Text>The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,</Text>
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               <Text>HAS ADOPTED THIS DECISION:</Text>
            </P>
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      <EUBody DocumentURI="http://www.legislation.gov.uk/eudn/2008/985/body" IdURI="http://www.legislation.gov.uk/id/eudn/2008/985/body" NumberOfProvisions="4" RestrictStartDate="2008-12-15" RestrictExtent="E+W+S+N.I.">
         <P1 DocumentURI="http://www.legislation.gov.uk/eudn/2008/985/article/1" IdURI="http://www.legislation.gov.uk/id/eudn/2008/985/article/1" id="article-1" RestrictStartDate="2008-12-15" RestrictExtent="E+W+S+N.I.">
            <Pnumber>Article 1</Pnumber>
            <P1para>
               <Text>Dried and roasted leaves of <Emphasis>Morinda citrifolia</Emphasis> as specified in the Annex may be placed on the market in the Community as a novel food ingredient for the preparation of infusions.</Text>
            </P1para>
         </P1>
         <P1 DocumentURI="http://www.legislation.gov.uk/eudn/2008/985/article/2" IdURI="http://www.legislation.gov.uk/id/eudn/2008/985/article/2" id="article-2" RestrictStartDate="2008-12-15" RestrictExtent="E+W+S+N.I.">
            <Pnumber>Article 2</Pnumber>
            <P1para>
               <Text>The designation of the novel food ingredient authorised by this Decision on the labelling of the foodstuff containing it shall be ‘Noni leaves’ or ‘leaves of <Emphasis>Morinda citrifolia</Emphasis>’.</Text>
            </P1para>
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            <Pnumber>Article 3</Pnumber>
            <P1para>
               <Text>Dried and roasted leaves of <Emphasis>Morinda citrifolia</Emphasis> shall be exclusively used for the preparation of infusions. They shall be presented in such a manner that a cup of infusion to be consumed would not be prepared with more than 1 g of dried and roasted leaves of <Emphasis>Morinda citrifolia</Emphasis>.</Text>
            </P1para>
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            <Pnumber>Article 4</Pnumber>
            <P1para>
               <Text>This Decision is addressed to Morinda Inc., 333 West River Park Drive, Provo, Utah 84604, USA.</Text>
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                  <Text>Done at Brussels, 15 December 2008.</Text>
               </Para>
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                     <Text>
                        <Emphasis>For the Commission</Emphasis>
                     </Text>
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                  <Para>
                     <Text>Androulla <Uppercase>Vassiliou</Uppercase>
                     </Text>
                  </Para>
                  <Para>
                     <Text>
                        <Emphasis>Member of the Commission</Emphasis>
                     </Text>
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         <Schedule DocumentURI="http://www.legislation.gov.uk/eudn/2008/985/annex" IdURI="http://www.legislation.gov.uk/id/eudn/2008/985/annex" id="annex" RestrictStartDate="2008-12-15" RestrictExtent="E+W+S+N.I.">
            <Number>ANNEX</Number>
            <TitleBlock>
               <Title>SPECIFICATIONS OF DRIED AND ROASTED LEAVES OF <Emphasis>MORINDA CITRIFOLIA</Emphasis>
               </Title>
            </TitleBlock>
            <ScheduleBody>
               <Division DocumentURI="http://www.legislation.gov.uk/eudn/2008/985/annex/division/1" IdURI="http://www.legislation.gov.uk/id/eudn/2008/985/annex/division/1" id="annex-division-1" RestrictStartDate="2008-12-15" RestrictExtent="E+W+S+N.I.">
                  <Title>Description</Title>
                  <P>
                     <Text>After cutting, the leaves of <Emphasis>Morinda citrifolia</Emphasis> are subject to drying and roasting steps. The product has a particle size ranging from broken leaves to coarse powder with fines. It is of greenish brown to brown colour.</Text>
                  </P>
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                  <Title>Composition of dried and roasted leaves of <Emphasis>M. citrifolia</Emphasis>
                  </Title>
                  <P>
                     <Tabular Orientation="portrait">
                        <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                           <tbody><tr><td>Moisture</td><td>&lt; 5,2 %</td></tr><tr><td>Protein</td><td>17 to 20 %</td></tr><tr><td>Carbohydrate</td><td>55 to 65 %</td></tr><tr><td>Ash</td><td>10 to 13 %</td></tr><tr><td>Fat</td><td>4-9 %</td></tr><tr><td>Oxalic acid</td><td>&lt; 0,14 %</td></tr><tr><td>Tannic acid</td><td>&lt; 2,7 %</td></tr><tr><td>5,15-dimethylmorindol</td><td>less than 47 mg/kg</td></tr><tr><td>Rubiadin</td><td>non detectable</td></tr><tr><td>Lucidin</td><td>non detectable</td></tr></tbody>
                        </table>
                     </Tabular>
                  </P>
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   </EURetained><Footnotes><Footnote id="f00001">
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               <Text>
                  <Citation id="c00001" Class="EuropeanUnionOfficialJournal" Year="1997" URI="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.1997.043.01.0001.01.ENG" Date="1997-02-14">OJ L 43, 14.2.1997, p. 1</Citation>.</Text>
            </Para>
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