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market of methyl vinyl ether-maleic anhydride copolymer as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2014) 9333) (Only the English text is authentic) (2014/905/EU)</dc:title><dc:description>Commission Implementing Decision of 11 December 2014 authorising the placing on the market of methyl vinyl ether-maleic anhydride copolymer as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2014) 9333) (Only the English text is authentic) (2014/905/EU)</dc:description><dc:modified>2020-12-12</dc:modified><dc:publisher>King's Printer of Acts of 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               <inline name="uppercase">Commission Implementing Decision</inline>
            </p><p>of 11 December 2014</p><p>authorising the placing on the market of methyl vinyl ether-maleic anhydride copolymer as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council</p><p>
               <i>(notified under document C(2014) 9333)</i>
            </p><p>(Only the English text is authentic)</p><p>(2014/905/EU)</p></longTitle></preface><preamble><p>THE EUROPEAN COMMISSION,</p><p>Having regard to the Treaty on the Functioning of the European Union,</p><p>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<authorialNote class="footnote" eId="f00001" marker="1"><p>
                  <ref eId="c00001" href="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">OJ L 43, 14.2.1997, p. 1</ref>.</p></authorialNote>, and in particular Article 7 thereof,</p><p>Whereas:</p><blockContainer class="division" uk:name="division"><num>(1)</num><p>On 30 June 2008 the company Reading Scientific Services Ltd made a request to the competent authorities of the Netherlands to place methyl vinyl ether-maleic anhydride copolymer on the market as a novel food ingredient for the use in chewing gum base.</p></blockContainer><blockContainer class="division" uk:name="division"><num>(2)</num><p>On 14 July 2011, the competent food assessment body of the Netherlands issued its initial assessment report. In that report it came to the conclusion that methyl vinyl ether-maleic anhydride copolymer meets the criteria set out in Article 3(1) of Regulation (EC) No 258/97.</p></blockContainer><blockContainer class="division" uk:name="division"><num>(3)</num><p>On 18 August 2011, the Commission forwarded the initial assessment report to the other Member States.</p></blockContainer><blockContainer class="division" uk:name="division"><num>(4)</num><p>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.</p></blockContainer><blockContainer class="division" uk:name="division"><num>(5)</num><p>On 12 June 2012, the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an additional assessment for methyl vinyl ether-maleic anhydride copolymer as food ingredient in accordance with Regulation (EC) No 258/97.</p></blockContainer><blockContainer class="division" uk:name="division"><num>(6)</num><p>On 10 October 2013 EFSA adopted a Scientific Opinion on the safety of methyl vinyl ether-maleic anhydride copolymer (chewing gum base ingredient) as a novel food ingredient<authorialNote class="footnote" eId="f00002" marker="2"><p>
                  <i>EFSA Journal</i> 2013;11(10):3423.</p></authorialNote>, concluding that it is safe under the proposed uses and use levels.</p></blockContainer><blockContainer class="division" uk:name="division"><num>(7)</num><p>The opinion gives sufficient grounds to establish that methyl vinyl ether-maleic anhydride copolymer in the proposed use and use levels in chewing gum base complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.</p></blockContainer><blockContainer class="division" uk:name="division"><num>(8)</num><p>The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,</p></blockContainer><p>HAS ADOPTED THIS DECISION:</p></preamble><body eId="body"><article eId="article-1"><num>Article 1</num><content><p>Methyl vinyl ether-maleic anhydride copolymer as specified in the Annex may be placed on the market in the Union as a novel food ingredient to be used in chewing gum base up to a maximum of 2 % in the finished chewing gum product.</p></content></article><article eId="article-2"><num>Article 2</num><content><p>The designation of the novel chewing gum base authorised by this Decision on the labelling of the foodstuff containing it shall be ‘gum base (including methyl vinyl ether-maleic anhydride copolymer)’ or ‘gum base (including CAS No 9011-16-9)’.</p></content></article><article eId="article-3"><num>Article 3</num><content><p>This Decision is addressed to Reading Scientific Services Ltd, The Lord Zuckerman Research Centre, Whiteknights Campus, Pepper lane, Reading, RG6 6LA, United Kingdom.</p></content></article><hcontainer name="signatures"><hcontainer name="signatureBlock"><content><p>Done at Brussels, 11 December 2014.</p><p>
                        <i>For the Commission</i>
                     </p><p>Vytenis <inline name="uppercase">Andriukaitis</inline>
                     </p><p>
                        <i>Member of the Commission</i>
                     </p></content></hcontainer></hcontainer><hcontainer name="schedules" eId="schedules"><hcontainer name="schedule" eId="annex"><num>ANNEX</num><heading>SPECIFICATION OF METHYL VINYL ETHER-MALEIC ANHYDRIDE COPOLYMER</heading><hcontainer name="division" eId="annex-division-1"><heading><b>Definition:</b></heading><content><p>Methyl vinyl ether-maleic anhydride copolymer is an anhydrous copolymer of methyl vinyl ether and maleic anhydride.</p></content></hcontainer><hcontainer name="division" eId="annex-division-2"><heading><b>Structural formula:</b></heading><content><tblock class="figure"><p><img src="http://www.legislation.gov.uk/eudn/2014/905/images/eudn_20140905_2014-12-11_en_001" ukl:Width="auto" ukl:Height="auto"/></p></tblock></content></hcontainer><hcontainer name="division" eId="annex-division-3"><content><p>
                        <b>Description</b>: Free-flowing, white to white-off powder.</p></content></hcontainer><hcontainer name="division" eId="annex-division-4"><heading><b>Identification:</b></heading><content><tblock class="table" ukl:Orientation="portrait"><foreign><table xmlns="http://www.w3.org/1999/xhtml"><tbody><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">CAS No</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">9011-16-9</p></td></tr></tbody></table></foreign></tblock></content></hcontainer><hcontainer name="division" eId="annex-division-5"><heading><b>Purity:</b></heading><content><tblock class="table" ukl:Orientation="portrait"><foreign><table xmlns="http://www.w3.org/1999/xhtml"><tbody><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Assay value</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">At least 99,5 % in dry matter</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Specific viscosity (1 % MEK)</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">2-10</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Residual methyl vinyl ether</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Not more than 150 ppm</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Residual maleic anhydride</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Not more than 250 ppm</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Acetaldehyde</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Not more than 500 ppm</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Methanol</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Not more than 500 ppm</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Dilauroyl peroxide</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Not more than 15 ppm</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Total heavy metals</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Not more than 10 ppm</p></td></tr></tbody></table></foreign></tblock></content></hcontainer><hcontainer name="division" eId="annex-division-6"><heading><b>Microbiological criteria:</b></heading><content><tblock class="table" ukl:Orientation="portrait"><foreign><table xmlns="http://www.w3.org/1999/xhtml"><tbody><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Total aerobic plate count</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Not more than 500 CFU/g</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Mould/yeast</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Not more than 500 CFU/g</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Escherichia coli</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Negative to test</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0"><i>Salmonella</i> spp.</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Negative to test</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Staphylococcus aureus</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Negative to test</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Pseudomonas aeruginosa</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Negative to test</p></td></tr></tbody></table></foreign></tblock></content></hcontainer></hcontainer></hcontainer></body></act></akomaNtoso>