<akomaNtoso xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xsi:schemaLocation="http://docs.oasis-open.org/legaldocml/ns/akn/3.0 http://docs.oasis-open.org/legaldocml/akn-core/v1.0/cos01/part2-specs/schemas/akomantoso30.xsd"><act name="eudn"><meta><identification source="#"><FRBRWork><FRBRthis value="http://www.legislation.gov.uk/id/eudn/2012/461"/><FRBRuri value="http://www.legislation.gov.uk/id/eudn/2012/461"/><FRBRdate date="2012-08-03" name="adopted"/><FRBRauthor href=""/><FRBRcountry value="EU"/><FRBRnumber value="461"/><FRBRname value="Decision (EU) 2012/461"/><FRBRprescriptive value="true"/></FRBRWork><FRBRExpression><FRBRthis value="http://www.legislation.gov.uk/eudn/2012/461/2012-08-03"/><FRBRuri value="http://www.legislation.gov.uk/eudn/2012/461/2012-08-03"/><FRBRdate date="2012-08-03" name="validFrom"/><FRBRauthor href="#"/><FRBRlanguage language="eng"/></FRBRExpression><FRBRManifestation><FRBRthis value="http://www.legislation.gov.uk/eudn/2012/461/2012-08-03/data.akn"/><FRBRuri value="http://www.legislation.gov.uk/eudn/2012/461/2012-08-03/data.akn"/><FRBRdate date="2026-08-11+01:00" name="transform"/><FRBRauthor href="http://www.legislation.gov.uk"/><FRBRformat value="application/akn+xml"/></FRBRManifestation></identification><lifecycle source="#"><eventRef refersTo="#adopted" date="2012-08-03" eId="date-adopted" source="#"/><eventRef date="2012-08-03" eId="date-2012-08-03" source="#"/></lifecycle><analysis source="#"><restrictions source="#"><restriction refersTo="#extent-e+w+s+ni" type="jurisdiction"/><restriction href="#preface" refersTo="#extent-e+w+s+ni" type="jurisdiction"/><restriction href="#body" refersTo="#extent-e+w+s+ni" type="jurisdiction"/><restriction href="#article-1" refersTo="#extent-e+w+s+ni" type="jurisdiction"/><restriction href="#article-2" refersTo="#extent-e+w+s+ni" type="jurisdiction"/><restriction href="#article-3" refersTo="#extent-e+w+s+ni" type="jurisdiction"/><restriction href="#article-4" refersTo="#extent-e+w+s+ni" type="jurisdiction"/><restriction href="#body-signatures" refersTo="#extent-e+w+s+ni" type="jurisdiction"/><restriction href="#schedules" refersTo="#extent-e+w+s+ni" type="jurisdiction"/><restriction href="#annex" refersTo="#extent-e+w+s+ni" type="jurisdiction"/><restriction href="#annex-division-1" refersTo="#extent-e+w+s+ni" type="jurisdiction"/><restriction href="#annex-division-2" refersTo="#extent-e+w+s+ni" type="jurisdiction"/><restriction refersTo="#period-from-2012-08-03" type="jurisdiction"/><restriction href="#preface" refersTo="#period-from-2012-08-03" type="jurisdiction"/><restriction href="#body" refersTo="#period-from-2012-08-03" type="jurisdiction"/><restriction href="#article-1" refersTo="#period-from-2012-08-03" type="jurisdiction"/><restriction href="#article-2" refersTo="#period-from-2012-08-03" type="jurisdiction"/><restriction href="#article-3" refersTo="#period-from-2012-08-03" type="jurisdiction"/><restriction href="#article-4" refersTo="#period-from-2012-08-03" type="jurisdiction"/><restriction href="#body-signatures" refersTo="#period-from-2012-08-03" type="jurisdiction"/><restriction href="#schedules" refersTo="#period-from-2012-08-03" type="jurisdiction"/><restriction href="#annex" refersTo="#period-from-2012-08-03" type="jurisdiction"/><restriction href="#annex-division-1" refersTo="#period-from-2012-08-03" type="jurisdiction"/><restriction href="#annex-division-2" refersTo="#period-from-2012-08-03" type="jurisdiction"/></restrictions><otherAnalysis source=""/></analysis><temporalData source="#"><temporalGroup eId="period-from-2012-08-03"><timeInterval start="#date-2012-08-03" refersTo="#"/></temporalGroup></temporalData><references source="#"><TLCEvent eId="adopted" href="" showAs="AdoptedDate"/><TLCLocation eId="extent-e+w+s+ni" href="/ontology/jurisdictions/uk.EnglandWalesScotlandNorthernIreland" showAs="E+W+S+N.I."/></references><proprietary xmlns:ukm="http://www.legislation.gov.uk/namespaces/metadata" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:dct="http://purl.org/dc/terms/" source="#"><dc:identifier>http://www.legislation.gov.uk/eudn/2012/461</dc:identifier><dc:title>Commission Implementing Decision of 3 August 2012 authorising the placing on the market of a novel chewing gum base as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council and repealing Commission Implementing Decision 2011/882/EU (notified under document C(2012) 5406) (Only the English text is authentic) (2012/461/EU)</dc:title><dc:description>Commission Implementing Decision of 3 August 2012 authorising the placing on the market of a novel chewing gum base as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council and repealing Commission Implementing Decision 2011/882/EU (notified under document C(2012) 5406) (Only the English text is authentic) (2012/461/EU)</dc:description><dc:modified>2020-12-11</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:32012D0461</dc:source><dc:type>text</dc:type><dc:format>text/xml</dc:format><dc:language>en</dc:language><dct:valid>2012-08-03</dct:valid><ukm:EUMetadata><ukm:DocumentClassification><ukm:DocumentCategory Value="euretained"/><ukm:DocumentMainType Value="EuropeanUnionDecision"/><ukm:DocumentStatus Value="revised"/></ukm:DocumentClassification><ukm:Year Value="2012"/><ukm:Number Value="461"/><ukm:EURLexIdentifiers xmlns:atom="http://www.w3.org/2005/Atom" xmlns="http://www.legislation.gov.uk/namespaces/legislation"><ukm:Cellar Value="ab546740-e07b-11e1-905c-01aa75ed71a1"/><ukm:OfficialJournal Value="JOL_2012_210_R_0014_01"/><ukm:ELI Value="dec_impl:2012:461:oj"/><ukm:CELEX Value="32012D0461"/></ukm:EURLexIdentifiers><ukm:EnactmentDate Date="2012-08-03"/><ukm:EURLexModified Date="2018-12-15T02:13:55Z"/><ukm:EURLexExtracted Date="2018-12-15T18:37:35Z"/><ukm:XMLGenerated Date="2020-12-11T19:02:50Z"/><ukm:XMLImported Date="2020-12-11T19:04:54Z"/><ukm:Treaty Title="Treaty on the Functioning of the European Union (consolidated version 2008)" Code="TFEU_2008"/><ukm:CreatedBy Label="European Commission" URI="http://publications.europa.eu/resource/authority/corporate-body/COM"/><ukm:Subject Scheme="SubjectMatter" Label="Foodstuffs" URI="http://publications.europa.eu/resource/authority/fd_070/D-AL"/><ukm:Subject Scheme="DirectoryCode" Label="Foodstuffs" URI="http://publications.europa.eu/resource/authority/fd_555/133014"/><ukm:Subject Scheme="DirectoryCode" Label="Internal market: approximation of laws" URI="http://publications.europa.eu/resource/authority/fd_555/1330"/><ukm:Subject Scheme="DirectoryCode" Label="Industrial policy and internal market" URI="http://publications.europa.eu/resource/authority/fd_555/13"/><ukm:Subject Scheme="EuroVoc" Label="labelling" URI="http://eurovoc.europa.eu/893"/><ukm:Subject Scheme="EuroVoc" Label="chemical product" URI="http://eurovoc.europa.eu/2739"/><ukm:Subject Scheme="EuroVoc" Label="market approval" URI="http://eurovoc.europa.eu/5451"/><ukm:Subject Scheme="EuroVoc" Label="food safety" URI="http://eurovoc.europa.eu/6569"/><ukm:Subject Scheme="EuroVoc" Label="food inspection" URI="http://eurovoc.europa.eu/1442"/><ukm:DocumentCurrentStatus><ukm:UKAmended Value="false"/></ukm:DocumentCurrentStatus></ukm:EUMetadata><ukm:Alternatives><ukm:Alternative URI="http://www.legislation.gov.uk/eudn/2012/461/pdfs/eudn_20120461_adopted_en.pdf" Date="2012-08-03" Size="794899"/></ukm:Alternatives><ukm:Statistics><ukm:TotalParagraphs Value="8"/><ukm:BodyParagraphs Value="4"/><ukm:ScheduleParagraphs Value="4"/><ukm:AttachmentParagraphs Value="0"/><ukm:TotalImages Value="2"/></ukm:Statistics></proprietary></meta><preface eId="preface"><longTitle><p>
               <inline name="uppercase">Commission Implementing Decision</inline>
            </p><p>of 3 August 2012</p><p>authorising the placing on the market of a novel chewing gum base as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council and repealing Commission Implementing Decision 2011/882/EU</p><p>(notified under document C(2012) 5406)</p><p>(Only the English text is authentic)</p><p>(2012/461/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 10 October 2007 the company Revolymer Ltd made a request to the competent authorities of the Netherlands to place a novel chewing gum base on the market as a novel food ingredient.</p></blockContainer><blockContainer class="division" uk:name="division"><num>(2)</num><p>On 23 April 2009 the competent food assessment body of the Netherlands issued its initial assessment report. In that report it came to the conclusion that the novel chewing gum base can safely be used as a food ingredient.</p></blockContainer><blockContainer class="division" uk:name="division"><num>(3)</num><p>The Commission forwarded the initial assessment report to all Member States on 30 April 2009.</p></blockContainer><blockContainer class="division" uk:name="division"><num>(4)</num><p>Within the 60 days period laid down in Article 6(4) of Regulation (EC) No 258/97 reasoned objections to the marketing of the product were raised in accordance with that provision.</p></blockContainer><blockContainer class="division" uk:name="division"><num>(5)</num><p>Therefore the European Food Safety Authority (EFSA) was consulted on 2 July 2010.</p></blockContainer><blockContainer class="division" uk:name="division"><num>(6)</num><p>On 25 March 2011, EFSA in the ‘Scientific Opinion on the safety of a “novel chewing gum base (REV-7)” as a novel food ingredient’<authorialNote class="footnote" eId="f00002" marker="2"><p>
                  <i>EFSA Journal</i> 2011; 9(4):2127.</p></authorialNote> came to the conclusion that the novel chewing gum base was safe at the proposed conditions of use and the proposed levels of intake.</p></blockContainer><blockContainer class="division" uk:name="division"><num>(7)</num><p>The novel chewing gum base complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97 and therefore Commission Implementing Decision 2011/882/EU of 21 December 2011 authorising the placing on the market of a novel chewing gum base as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council<authorialNote class="footnote" eId="f00003" marker="3"><p>
                  <ref eId="c00002" href="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2011.343.01.0121.01.ENG">OJ L 343, 23.12.2011, p. 121</ref>.</p></authorialNote> was adopted.</p></blockContainer><blockContainer class="division" uk:name="division"><num>(8)</num><p>Article 2 of Implementing Decision 2011/882/EU provided that the designation of the novel chewing gum base authorised thereby on the labelling of the foodstuff containing it shall be ‘gum base (1,3-butadiene, 2-methyl-homopolymer, maleated, esters with polyethylene glycol mono-Me ether)’.</p></blockContainer><blockContainer class="division" uk:name="division"><num>(9)</num><p>However, while the full chemical name provides for a clear and unambiguous designation of the substance, its length might dominate the labelling of the foodstuff containing it. As chewing gum is frequently sold in packages with limited space on the surface for labelling, it would be appropriate to provide a shorter alternative for the labelling.</p></blockContainer><blockContainer class="division" uk:name="division"><num>(10)</num><p>The Chemical Abstract Service (CAS) registry numbers (CAS No) are an international standard for the designation of chemicals, which provides equivalent information to that of the chemical name as regards the nature of the substance.</p></blockContainer><blockContainer class="division" uk:name="division"><num>(11)</num><p>It is therefore appropriate to allow the use of the CAS registry number for the designation of the novel chewing gum base authorised by Implementing Decision 2011/882/EU on the labelling of the foodstuff containing it as an alternative to the full chemical name.</p></blockContainer><blockContainer class="division" uk:name="division"><num>(12)</num><p>The Annex could have caused misunderstandings as in its title it provided only a part of the chemical name. Furthermore the CAS No should be given in the Annex.</p></blockContainer><blockContainer class="division" uk:name="division"><num>(13)</num><p>Therefore, it appears appropriate to repeal and replace Implementing Decision 2011/882/EU by a new Decision with the abovementioned modifications.</p></blockContainer><blockContainer class="division" uk:name="division"><num>(14)</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>The novel chewing gum base as specified in the Annex may be placed on the market in the Union as a novel food ingredient for the use in chewing gum up to a maximum of 8 %.</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 1,3-butadiene, 2-methyl-homopolymer, maleated, esters with polyethylene glycol mono-Me ether)’ or ‘gum base (including CAS No: 1246080-53-4)’.</p></content></article><article eId="article-3"><num>Article 3</num><content><p>Implementing Decision 2011/882/EU is hereby repealed.</p></content></article><article eId="article-4"><num>Article 4</num><content><p>This Decision is addressed to Revolymer Ltd, 1, NewTech Square, Deeside Industrial Park, Deeside, Flintshire, CH5 2NT, United Kingdom.</p></content></article><hcontainer name="signatures"><hcontainer name="signatureBlock"><content><p>Done at Brussels, 3 August 2012.</p><p>
                        <i>For the Commission</i>
                     </p><p>John <inline name="uppercase">Dalli</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><b>Specifications of the novel chewing gum base</b></heading><hcontainer name="division" eId="annex-division-1"><heading><i>Description</i></heading><content><p>The novel food ingredient is a synthetic polymer (Patent number WO2006016179). It has a white to off-white colour.</p><p>It consists of branched polymers of monomethoxypolyethylene glycol (MPEG) grafted onto polyisoprene-graft-maleic anhydride (PIP-g-MA), and unreacted MPEG (less than 35 % by weight).</p><p>
                        <i>CAS No 1246080-53-4</i>
                     </p></content></hcontainer><hcontainer name="division" eId="annex-division-2"><heading><i>Molecular structure of MPEG grafted PIP-g-MA</i></heading><content><tblock class="figure"><p><img src="http://www.legislation.gov.uk/eudn/2012/461/images/eudn_20120461_2012-08-03_en_001" ukl:Width="auto" ukl:Height="auto"/></p></tblock><tblock class="figure"><p><img src="http://www.legislation.gov.uk/eudn/2012/461/images/eudn_20120461_2012-08-03_en_002" ukl:Width="auto" ukl:Height="auto"/></p></tblock><tblock class="table" ukl:Orientation="portrait"><foreign><table xmlns="http://www.w3.org/1999/xhtml"><tbody><tr><th colspan="2"><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Characterisitics of 1,3-butadiene, 2-methyl-homopolymer, maleated, esters with polyethylene glycol mono-Me ether/CAS No 1246080-53-4</p></th></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">less than 5 %</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Aluminium</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">less than 3 mg/kg</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Lithium</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">less than 0,5 mg/kg</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Nickel</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">less than 0,5 mg/kg</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Residual anhydride</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">less than 15 μmol/g</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Polydispersity index</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">less than 1,4</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Isoprene</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">less than 0,05 mg/kg</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Ethylene oxide</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">less than 0,2 mg/kg</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Free maleic anhydride</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">less than 0,1 %</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Total oligomeres (less than 1 000 Dalton)</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">not more than 50 mg/kg</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Ethylene glycol</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">less than 200 mg/kg</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Diethylene glycol</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">less than 30 mg/kg</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Monoethylene glycol methyl ether</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">less than 3 mg/kg</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Diethylene glycol methyl ether</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">less than 4 mg/kg</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Triethylene glycol methyl ether</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">less than 7 mg/kg</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">1,4-Dioxane</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">less than 2 mg/kg</p></td></tr><tr><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">Formaldehyde</p></td><td><p xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0">less than 10 mg/kg</p></td></tr></tbody></table></foreign></tblock></content></hcontainer></hcontainer></hcontainer></body></act></akomaNtoso>