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					<dc:identifier>http://www.legislation.gov.uk/eudn/2016/398</dc:identifier><dc:title>Commission Implementing Decision (EU) 2016/398 of 16 March 2016 authorising the placing on the market of UV-treated bread as a novel food under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2016) 1527) (Only the Swedish text is authentic)</dc:title><dct:alternative>Commission Implementing Decision (EU) 2016/398</dct:alternative><dc:description>Commission Implementing Decision (EU) 2016/398 of 16 March 2016 authorising the placing on the market of UV-treated bread as a novel food under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2016) 1527) (Only the Swedish text is authentic)</dc:description><dc:modified>2020-12-10</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:32016D0398</dc:source><dc:type>text</dc:type><dc:format>text/xml</dc:format><dc:language>en</dc:language><dct:valid>2016-03-16</dct:valid>
					
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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 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 12 February 2014, the company Viasolde AB which makes the equipment for UV-treatment made a request to the competent authorities of Finland to place ultraviolet (UV) treated bread on the market as a novel food within the meaning of point (f) of Article 1(2) of Regulation (EC) No 258/97. The aim of the UV treatment is to enhance the vitamin D content of the bread, which means that the nutritional value of the bread would significantly differ from the nutritional value of traditionally baked bread.</Text>
               </P>
            </Division>
            <Division>
               <Number>(2)</Number>
               <P>
                  <Text>On 14 March 2014, the competent food assessment body of Finland issued its initial assessment report. In that report it came to the conclusion that UV-treated bread meets the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97.</Text>
               </P>
            </Division>
            <Division>
               <Number>(3)</Number>
               <P>
                  <Text>On 19 March 2014, the Commission forwarded the initial assessment report to the other Member States.</Text>
               </P>
            </Division>
            <Division>
               <Number>(4)</Number>
               <P>
                  <Text>Reasoned objections were raised within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97.</Text>
               </P>
            </Division>
            <Division>
               <Number>(5)</Number>
               <P>
                  <Text>On 13 November 2014, the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an additional assessment for UV-treated bread as novel food in accordance with Regulation (EC) No 258/97.</Text>
               </P>
            </Division>
            <Division>
               <Number>(6)</Number>
               <P>
                  <Text>On 11 June 2015, EFSA concluded in its ‘Scientific Opinion on the safety of UV-treated bread as a novel food’<FootnoteRef Ref="f00002"/>, that bread enriched with vitamin D<Inferior>2</Inferior> through UV treatment is safe under the proposed conditions of use.</Text>
               </P>
            </Division>
            <Division>
               <Number>(7)</Number>
               <P>
                  <Text>Therefore, the opinion gives sufficient grounds to establish that UV-treated bread as a novel food complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.</Text>
               </P>
            </Division>
            <Division>
               <Number>(8)</Number>
               <P>
                  <Text>Regulation (EC) No 1925/2006 of the European Parliament and of the Council<FootnoteRef Ref="f00003"/> lays down requirements on the addition of vitamins and minerals and of certain other substances to foods. The use of UV-treated bread should be authorised without prejudice to the requirements of this legislation.</Text>
               </P>
            </Division>
            <Division>
               <Number>(9)</Number>
               <P>
                  <Text>The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,</Text>
               </P>
            </Division>
            <P>
               <Text>HAS ADOPTED THIS DECISION:</Text>
            </P>
         </EUPreamble>
      </EUPrelims>
      <EUBody DocumentURI="http://www.legislation.gov.uk/eudn/2016/398/body" IdURI="http://www.legislation.gov.uk/id/eudn/2016/398/body" NumberOfProvisions="3" RestrictStartDate="2016-03-16" RestrictExtent="E+W+S+N.I.">
         <P1 DocumentURI="http://www.legislation.gov.uk/eudn/2016/398/article/1" IdURI="http://www.legislation.gov.uk/id/eudn/2016/398/article/1" id="article-1" RestrictStartDate="2016-03-16" RestrictExtent="E+W+S+N.I.">
            <Pnumber>Article 1</Pnumber>
            <P1para>
               <Text>UV-treated bread as specified in Annex I may be placed on the market as a novel food at the maximum level of 3 μg vitamin D<Inferior>2</Inferior> per 100 g without prejudice to the specific provisions of Regulation (EC) No 1925/2006.</Text>
            </P1para>
         </P1>
         <P1 DocumentURI="http://www.legislation.gov.uk/eudn/2016/398/article/2" IdURI="http://www.legislation.gov.uk/id/eudn/2016/398/article/2" id="article-2" RestrictStartDate="2016-03-16" RestrictExtent="E+W+S+N.I.">
            <Pnumber>Article 2</Pnumber>
            <P1para>
               <Text>The following shall be added to the designation for the labelling of the foodstuffs: ‘contains vitamin D produced by UV-treatment’.</Text>
            </P1para>
         </P1>
         <P1 DocumentURI="http://www.legislation.gov.uk/eudn/2016/398/article/3" IdURI="http://www.legislation.gov.uk/id/eudn/2016/398/article/3" id="article-3" RestrictStartDate="2016-03-16" RestrictExtent="E+W+S+N.I.">
            <Pnumber>Article 3</Pnumber>
            <P1para>
               <Text>This Decision is addressed to Viasolde AB, Dalstigen 4, 262 63, Ängelholm, Sweden.</Text>
            </P1para>
         </P1>
         <SignedSection DocumentURI="http://www.legislation.gov.uk/eudn/2016/398/signature" IdURI="http://www.legislation.gov.uk/id/eudn/2016/398/signature" RestrictStartDate="2016-03-16" RestrictExtent="E+W+S+N.I.">
            <Signatory>
               <Para>
                  <Text>Done at Brussels, 16 March 2016.</Text>
               </Para>
               <Signee>
                  <Para>
                     <Text>
                        <Emphasis>For the Commission</Emphasis>
                     </Text>
                  </Para>
                  <Para>
                     <Text>Vytenis <Uppercase>Andriukaitis</Uppercase>
                     </Text>
                  </Para>
                  <Para>
                     <Text>
                        <Emphasis>Member of the Commission</Emphasis>
                     </Text>
                  </Para>
               </Signee>
            </Signatory>
         </SignedSection>
      </EUBody>
      <Schedules RestrictStartDate="2016-03-16" RestrictExtent="E+W+S+N.I.">
         <Schedule DocumentURI="http://www.legislation.gov.uk/eudn/2016/398/annex" IdURI="http://www.legislation.gov.uk/id/eudn/2016/398/annex" id="annex" RestrictStartDate="2016-03-16" RestrictExtent="E+W+S+N.I.">
            <Number>ANNEX</Number>
            <TitleBlock>
               <Title>
                  <Strong>SPECIFICATION OF UV-TREATED BREAD</Strong>
               </Title>
            </TitleBlock>
            <ScheduleBody>
               <Division DocumentURI="http://www.legislation.gov.uk/eudn/2016/398/annex/division/1" IdURI="http://www.legislation.gov.uk/id/eudn/2016/398/annex/division/1" id="annex-division-1" RestrictStartDate="2016-03-16" RestrictExtent="E+W+S+N.I.">
                  <Title>
                     <Strong>Definition:</Strong>
                  </Title>
                  <P>
                     <Text>UV-treated bread is yeast leavened bread and rolls (without toppings) to which a treatment with ultraviolet radiation is applied after baking in order to convert ergosterol to vitamin D<Inferior>2</Inferior> (ergocalciferol).</Text>
                  </P>
                  <P>
                     <Text>UV radiation: a process of radiation in ultraviolet light within the wavelength of 240-315 nm for maximum of 5 seconds with energy input of 10-50 mJ/cm<Superior>2</Superior>.</Text>
                  </P>
               </Division>
               <Division DocumentURI="http://www.legislation.gov.uk/eudn/2016/398/annex/division/2" IdURI="http://www.legislation.gov.uk/id/eudn/2016/398/annex/division/2" id="annex-division-2" RestrictStartDate="2016-03-16" RestrictExtent="E+W+S+N.I.">
                  <Title>
                     <Strong>Vitamin D<Inferior>2</Inferior>:</Strong>
                  </Title>
                  <P>
                     <Tabular Orientation="portrait">
                        <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                           <tbody><tr><th>Chemical name</th><td>(5Z,7E,22E)-3S-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol</td></tr><tr><th>Synonym</th><td>Ergocalciferol</td></tr><tr><th>CAS No</th><td>50-14-6</td></tr><tr><th>Molecular weight</th><td>396,65 g/mol</td></tr></tbody>
                        </table>
                     </Tabular>
                  </P>
               </Division>
               <Division DocumentURI="http://www.legislation.gov.uk/eudn/2016/398/annex/division/3" IdURI="http://www.legislation.gov.uk/id/eudn/2016/398/annex/division/3" id="annex-division-3" RestrictStartDate="2016-03-16" RestrictExtent="E+W+S+N.I.">
                  <Title>
                     <Strong>Contents:</Strong>
                  </Title>
                  <P>
                     <Tabular Orientation="portrait">
                        <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                           <tfoot><tr><td colspan="2">
                                    <Footnote xmlns="http://www.legislation.gov.uk/namespaces/legislation" id="f00004">
                                       <FootnoteText>
                                          <Para>
                                             <Text>EN 12821, 2009, European Standard.</Text>
                                          </Para>
                                       </FootnoteText>
                                    </Footnote>
                                 </td></tr><tr><td colspan="2">
                                    <Footnote xmlns="http://www.legislation.gov.uk/namespaces/legislation" id="f00005">
                                       <FootnoteText>
                                          <Para>
                                             <Text>Recipe calculation.</Text>
                                          </Para>
                                       </FootnoteText>
                                    </Footnote>
                                 </td></tr></tfoot>
                           <tbody><tr><th>Vitamin D<Inferior xmlns="http://www.legislation.gov.uk/namespaces/legislation">2</Inferior> (ergocalciferol) in the final product</th><td>0,75-3 μg/100 g<FootnoteRef xmlns="http://www.legislation.gov.uk/namespaces/legislation" Ref="f00004"/>
                                 </td></tr><tr><th>Yeast in dough</th><td>1-5 g/100 g<FootnoteRef xmlns="http://www.legislation.gov.uk/namespaces/legislation" Ref="f00005"/>
                                 </td></tr></tbody>
                        </table>
                     </Tabular>
                  </P>
               </Division>
            </ScheduleBody>
         </Schedule>
      </Schedules>
   </EURetained><Footnotes><Footnote id="f00001">
         <FootnoteText>
            <Para>
               <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>
         </FootnoteText>
      </Footnote><Footnote id="f00002">
         <FootnoteText>
            <Para>
               <Text>
                  <Emphasis>EFSA Journal</Emphasis> 2015; 13(7):4148.</Text>
            </Para>
         </FootnoteText>
      </Footnote><Footnote id="f00003">
         <FootnoteText>
            <Para>
               <Text>Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (<Citation id="c00002" Class="EuropeanUnionOfficialJournal" Year="2006" URI="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2006.404.01.0026.01.ENG" Date="2006-12-30">OJ L 404, 30.12.2006, p. 26</Citation>).</Text>
            </Para>
         </FootnoteText>
      </Footnote></Footnotes></Legislation>