<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/2005/608"/><FRBRuri value="http://www.legislation.gov.uk/id/eudn/2005/608"/><FRBRdate date="2005-08-08" name="adopted"/><FRBRauthor href=""/><FRBRcountry value="EU"/><FRBRnumber value="608"/><FRBRname value="Decision (EU) 2005/608"/><FRBRprescriptive value="true"/></FRBRWork><FRBRExpression><FRBRthis value="http://www.legislation.gov.uk/eudn/2005/608/2005-08-08"/><FRBRuri value="http://www.legislation.gov.uk/eudn/2005/608/2005-08-08"/><FRBRdate date="2005-08-08" 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refersTo="#period-from-2005-08-08" type="jurisdiction"/><restriction href="#article-4" refersTo="#period-from-2005-08-08" type="jurisdiction"/></restrictions><otherAnalysis source=""/></analysis><temporalData source="#"><temporalGroup eId="period-from-2005-08-08"><timeInterval start="#date-2005-08-08" 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/2005/608/article/4</dc:identifier><dc:title>Commission Decision of 8 August 2005 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., line MON 863) genetically modified for resistance to corn rootworm (notified under document number C(2005) 2950) (Only the German text is authentic) (Text with EEA relevance) (2005/608/EC)</dc:title><dc:description>Commission Decision of 8 August 2005 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., line MON 863) genetically modified for resistance to corn rootworm (notified under document number C(2005) 2950) (Only the German text is authentic) (Text with EEA relevance) (2005/608/EC)</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:32005D0608</dc:source><dc:type>text</dc:type><dc:format>text/xml</dc:format><dc:language>en</dc:language><dct:valid>2005-08-08</dct:valid><ukm:EUMetadata><ukm:DocumentClassification><ukm:DocumentCategory Value="euretained"/><ukm:DocumentMainType Value="EuropeanUnionDecision"/><ukm:DocumentStatus Value="revised"/></ukm:DocumentClassification><ukm:Year Value="2005"/><ukm:Number Value="608"/><ukm:EURLexIdentifiers xmlns:atom="http://www.w3.org/2005/Atom" xmlns="http://www.legislation.gov.uk/namespaces/legislation"><ukm:Cellar Value="1181d3fa-4fb1-4f59-ac74-980a668b76dd"/><ukm:OfficialJournal Value="JOL_2005_207_R_0017_01"/><ukm:CELEX Value="32005D0608"/><ukm:ELI Value="dec:2005:608:oj"/></ukm:EURLexIdentifiers><ukm:EnactmentDate Date="2005-08-08"/><ukm:EURLexModified Date="2019-09-13T20:24:56Z"/><ukm:EURLexExtracted Date="2019-09-13T23:15:06Z"/><ukm:XMLGenerated Date="2020-12-11T18:43:32Z"/><ukm:XMLImported Date="2020-12-11T19:52:24Z"/><ukm:Treaty Title="Treaty establishing the European Community (consolidated version 1992)" Code="TEC_1992"/><ukm:CreatedBy Label="European Commission" URI="http://publications.europa.eu/resource/authority/corporate-body/COM"/><ukm:Subject Scheme="EuroVoc" Label="labelling" URI="http://eurovoc.europa.eu/893"/><ukm:Subject Scheme="SubjectMatter" Label="Consumer protection" URI="http://publications.europa.eu/resource/authority/fd_070/PROT"/><ukm:Subject Scheme="EuroVoc" Label="genetically modified organism" URI="http://eurovoc.europa.eu/5768"/><ukm:Subject Scheme="SubjectMatter" Label="Foodstuffs" URI="http://publications.europa.eu/resource/authority/fd_070/D-AL"/><ukm:Subject Scheme="EuroVoc" Label="Germany" URI="http://eurovoc.europa.eu/1318"/><ukm:Subject Scheme="SubjectMatter" Label="Environment" URI="http://publications.europa.eu/resource/authority/fd_070/ENV"/><ukm:Subject Scheme="EuroVoc" Label="cereal product" URI="http://eurovoc.europa.eu/2729"/><ukm:Subject Scheme="EuroVoc" Label="food safety" URI="http://eurovoc.europa.eu/6569"/><ukm:Subject Scheme="EuroVoc" Label="market approval" URI="http://eurovoc.europa.eu/5451"/><ukm:Subject Scheme="DirectoryCode" Label="Chemicals, industrial risk and biotechnology" URI="http://publications.europa.eu/resource/authority/fd_555/15102050"/><ukm:Subject Scheme="DirectoryCode" Label="Pollution and nuisances" URI="http://publications.europa.eu/resource/authority/fd_555/151020"/><ukm:Subject Scheme="DirectoryCode" Label="Environment, consumers and health protection" URI="http://publications.europa.eu/resource/authority/fd_555/15"/><ukm:Subject Scheme="DirectoryCode" Label="Environment" URI="http://publications.europa.eu/resource/authority/fd_555/1510"/><ukm:Subject Scheme="EuroVoc" Label="maize" URI="http://eurovoc.europa.eu/1744"/><ukm:DocumentCurrentStatus><ukm:UKAmended Value="false"/></ukm:DocumentCurrentStatus></ukm:EUMetadata><ukm:Alternatives><ukm:Alternative URI="http://www.legislation.gov.uk/eudn/2005/608/pdfs/eudn_20050608_adopted_en.pdf" Date="2005-08-08" Size="50624"/></ukm:Alternatives><ukm:Statistics><ukm:TotalParagraphs Value="6"/><ukm:BodyParagraphs Value="6"/><ukm:ScheduleParagraphs Value="0"/><ukm:AttachmentParagraphs Value="0"/><ukm:TotalImages Value="0"/></ukm:Statistics></proprietary></meta><body eId="body"><article eId="article-4" uk:target="true"><num>Article 4</num><heading>Monitoring</heading><paragraph eId="article-4-1"><num>1.</num><content><p>Throughout the period of validity of the consent, the consent holder shall ensure that the monitoring plan, contained in the notification, to check for any adverse effects on human and animal health or the environment arising from handling or use of the product, is put in place and implemented.</p></content></paragraph><paragraph eId="article-4-2"><num>2.</num><content><p>The consent holder shall directly inform the operators and users concerning the safety and general characteristics of the product and of the conditions as to monitoring, including the appropriate management measures to be taken in case of accidental grain spillage.</p></content></paragraph><paragraph eId="article-4-3"><num>3.</num><content><p>The consent holder shall submit to the Commission and to the competent authorities of the Member States annual reports on the results of the monitoring activities.</p></content></paragraph><paragraph eId="article-4-4"><num>4.</num><content><p>Without prejudice to Article 20 of Directive 2001/18/EC the monitoring plan as notified shall, where appropriate and subject to the agreement of the Commission and the competent authority of the Member State which received the original notification, be revised by the consent holder, and/or by the competent authority of the Member State which received the original notification, in the light of the results of the monitoring activities.</p></content></paragraph><paragraph eId="article-4-5"><num>5.</num><intro><p>The consent holder shall be in the position to give evidence to the Commission and the competent authorities of the Member States:</p></intro><level class="para1"><num>(a)</num><content><p>that the monitoring networks as specified in the monitoring plan contained in the notification collect the information relevant for the monitoring of the product and</p></content></level><level class="para1"><num>(b)</num><content><p>that the members of these networks have agreed to make available that information to the consent holder before the date of the submission of the monitoring reports to the Commission and competent authorities of the Member States in accordance with paragraph 3.</p></content></level></paragraph></article></body></act></akomaNtoso>