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Parliament</dc:publisher><dc:source>https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014D0424</dc:source><dc:type>text</dc:type><dc:format>text/xml</dc:format><dc:language>en</dc:language><dct:valid>2014-07-01</dct:valid><ukm:EUMetadata><ukm:DocumentClassification><ukm:DocumentCategory Value="euretained"/><ukm:DocumentMainType Value="EuropeanUnionDecision"/><ukm:DocumentStatus Value="revised"/></ukm:DocumentClassification><ukm:Year Value="2014"/><ukm:Number Value="424"/><ukm:EURLexIdentifiers xmlns:atom="http://www.w3.org/2005/Atom" xmlns="http://www.legislation.gov.uk/namespaces/legislation"><ukm:Cellar Value="9664e97c-0281-11e4-831f-01aa75ed71a1"/><ukm:CELEX Value="32014D0424"/><ukm:ELI Value="dec_impl:2014:424:oj"/><ukm:OfficialJournal Value="JOL_2014_196_R_0007"/></ukm:EURLexIdentifiers><ukm:EnactmentDate Date="2014-07-01"/><ukm:EURLexModified Date="2018-12-15T02:17:23Z"/><ukm:EURLexExtracted 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               <inline name="uppercase">Commission Implementing Decision</inline>
            </p><p>of 1 July 2014</p><p>authorising the placing on the market of rapeseed protein 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) 4256)</i>
            </p><p>(Only the German text is authentic)</p><p>(2014/424/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 25 June 2012, the company Helm AG made a request to the competent authorities of Ireland to place rapeseed protein on the market as a novel food ingredient. Rapeseed protein is intended to be used as a vegetable protein source in foods except in infant formulae and follow-on formulae. On 18 February 2014, the Commission was notified that Siebte PMI Verwaltungs GmbH had acquired the rights to the pending request.</p></blockContainer><blockContainer class="division" uk:name="division"><num>(2)</num><p>On 17 September 2012, the competent food assessment body of Ireland issued its initial assessment report. In that report it came to the conclusion that rapeseed protein meets the criteria for novel food 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 4 October 2012, 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 14 February 2013, the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an additional assessment for rapeseed protein 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, in its ‘Scientific Opinion on the safety of “rapeseed protein isolate” as the Novel Food ingredient’<authorialNote class="footnote" eId="f00002" marker="2"><p>
                  <i>EFSA Journal</i> 2013; 11(10):3420.</p></authorialNote>, EFSA concluded that rapeseed protein is safe as a protein added to food. However, it also noted that the risk of sensitisation to rapeseed cannot be excluded and that it is likely that rapeseed can trigger allergic reactions in people allergic to mustard.</p></blockContainer><blockContainer class="division" uk:name="division"><num>(7)</num><p>Therefore, the opinion gives sufficient grounds to establish that rapeseed protein as a novel food ingredient complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97, provided that the labelling of foods containing rapeseed protein as a food ingredient is such to allow people who are allergic to mustard to avoid consumption of those foods.</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 the Food Chain and Animal Health,</p></blockContainer><p>HAS ADOPTED THIS DECISION:</p></preamble><body eId="body"><article eId="article-1"><num>Article 1</num><content><p>Rapeseed protein specified in the Annex may be placed on the market in the Union as a novel food ingredient.</p></content></article><article eId="article-2"><num>Article 2</num><content><p>The designation of rapeseed protein authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘rapeseed protein’.</p></content></article><article eId="article-3"><num>Article 3</num><content><p>The labelling of any foodstuff containing rapeseed protein shall bear an easily visible and legible statement that the product containing ‘rapeseed protein’ as a food ingredient may cause allergic reaction to consumers who are allergic to mustard and products thereof. Where relevant, this statement shall appear in close proximity to the list of ingredients.</p></content></article><article eId="article-4"><num>Article 4</num><content><p>This Decision is addressed to Siebte PMI Verwaltungs GmbH, Neuer Jungfernstieg 5, 20354 Hamburg, Germany.</p></content></article><hcontainer name="signatures"><hcontainer name="signatureBlock"><content><p>Done at Brussels, 1 July 2014.</p><p>
                        <i>For the Commission</i>
                     </p><p>Tonio <inline name="uppercase">Borg</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 RAPESEED PROTEIN</heading><content><blockList ukl:Name="KeyList" ukl:Separator=":"><item><heading><b>Definition</b></heading><p>Rapeseed protein is an aqueous protein-rich extract from rapeseed press cake originating from non-genetically modified <i>Brassica napus</i> L. and <i>Brassica rapa</i> L.</p></item><item><heading><b>Description</b></heading><p>White to off-white, spray dried powder.</p><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 protein</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Not less than 90 %</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Soluble protein</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Not less than 85 %</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Moisture</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Not more than 7 %</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Carbohydrates</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Not more than 7 %</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Fat</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Not more than 2 %</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Ash</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Not more than 4 %</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Fibre</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Not more than 0,5 %</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Total glucosinolates</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Not more than 1 mmol/l</p></td></tr></tbody></table></foreign></tblock></item><item><heading><b>Purity</b></heading><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 phytate</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Not more than 1,5 %</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Lead</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Not more than 0,5 mg/kg</p></td></tr></tbody></table></foreign></tblock></item><item><heading><b>Microbiological criteria</b></heading><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">Yeast and mould count</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Not more than 100 cfu/g</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Aerobic bacteria count</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Not more than 10 000 cfu/g</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Total coliform count</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Not more than 10 cfu/g</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0"><i>Escherichia coli</i></p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Absent in 10 g</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">Absent in 25 g</p></td></tr></tbody></table></foreign></tblock></item></blockList></content></hcontainer></hcontainer></body></act></akomaNtoso>