<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="eur"><meta><identification source="#"><FRBRWork><FRBRthis value="http://www.legislation.gov.uk/id/eur/2015/2283"/><FRBRuri value="http://www.legislation.gov.uk/id/eur/2015/2283"/><FRBRdate date="2015-11-25" name="adopted"/><FRBRauthor href=""/><FRBRcountry value="EU"/><FRBRnumber value="2283"/><FRBRname value="Regulation (EU) 2015/2283"/><FRBRprescriptive value="true"/></FRBRWork><FRBRExpression><FRBRthis value="http://www.legislation.gov.uk/eur/2015/2283/2025-11-13"/><FRBRuri value="http://www.legislation.gov.uk/eur/2015/2283/2025-11-13"/><FRBRdate date="2025-11-13" 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eId="adopted" href="" showAs="AdoptedDate"/><TLCLocation eId="extent-e+w+s+ni" href="/ontology/jurisdictions/uk.EnglandWalesScotlandNorthernIreland" showAs="E+W+S+N.I."/></references><notes source="#"><note ukl:Name="Commentary" ukl:Type="F" class="commentary F" eId="key-d730e672aae438de9f620a1bd7f70055" marker="F1"><p><ref eId="csh9myfc4-00007" class="subref" href="http://www.legislation.gov.uk/id/eur/2015/2283/article/21">Art. 21</ref>  substituted (31.12.2020) by <ref eId="csh9myfc4-00008" href="http://www.legislation.gov.uk/id/uksi/2019/702">The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702)</ref>, <ref eId="csh9myfc4-00009" class="subref" href="http://www.legislation.gov.uk/id/uksi/2019/702/regulation/1">regs. 1</ref>, <ref eId="csh9myfc4-00010" class="subref operative" href="http://www.legislation.gov.uk/id/uksi/2019/702/regulation/27">27</ref>; <ref eId="csh9myfc4-00011" href="http://www.legislation.gov.uk/id/ukpga/2020/1">2020 c. 1</ref>, <ref eId="csh9myfc4-00012" class="subref" href="http://www.legislation.gov.uk/id/ukpga/2020/1/schedule/5/paragraph/1/1">Sch. 5 para. 1(1)</ref></p></note></notes><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/eur/2015/2283/article/21</dc:identifier><dc:title>Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (Text with EEA relevance)</dc:title><dct:alternative>Regulation (EU) 2015/2283 of the European Parliament and of the Council</dct:alternative><dc:description>Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (Text with EEA relevance)</dc:description><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:32015R2283</dc:source><dc:type>text</dc:type><dc:format>text/xml</dc:format><dc:language>en</dc:language><dc:modified>2025-12-08</dc:modified><dc:contributor>Expert Participation</dc:contributor><dct:valid>2025-11-13</dct:valid><ukm:EUMetadata><ukm:DocumentClassification><ukm:DocumentCategory Value="euretained"/><ukm:DocumentMainType Value="EuropeanUnionRegulation"/><ukm:DocumentStatus Value="revised"/></ukm:DocumentClassification><ukm:Year Value="2015"/><ukm:Number Value="2283"/><ukm:EURLexIdentifiers xmlns:atom="http://www.w3.org/2005/Atom" 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URI="http://publications.europa.eu/resource/authority/fd_070/D-AL"/><ukm:Subject Scheme="SubjectMatter" Label="Internal market - Principles" URI="http://publications.europa.eu/resource/authority/fd_070/MARI"/><ukm:Subject Scheme="EuroVoc" Label="food safety" URI="http://eurovoc.europa.eu/6569"/><ukm:Subject Scheme="EuroVoc" Label="human nutrition" URI="http://eurovoc.europa.eu/1284"/><ukm:Subject Scheme="EuroVoc" Label="market approval" URI="http://eurovoc.europa.eu/5451"/><ukm:Subject Scheme="EuroVoc" Label="food standard" URI="http://eurovoc.europa.eu/2078"/><ukm:Subject Scheme="EuroVoc" Label="single market" URI="http://eurovoc.europa.eu/3299"/><ukm:Subject Scheme="EuroVoc" Label="third country" URI="http://eurovoc.europa.eu/2300"/><ukm:Subject Scheme="DirectoryCode" Label="Protection of health and safety" URI="http://publications.europa.eu/resource/authority/fd_555/152030"/><ukm:Subject Scheme="DirectoryCode" Label="Consumers" 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URI="http://publications.europa.eu/resource/authority/fd_070/PROT"/><ukm:DocumentCurrentStatus><ukm:UKAmended Value="true"/></ukm:DocumentCurrentStatus><ukm:UnappliedEffects><ukm:UnappliedEffect Comments="IP completion day" AffectedURI="http://www.legislation.gov.uk/id/eur/2015/2283" Notes="This amendment not applied to legislation.gov.uk. S.I. 2019/1013 revoked immediately before IP completion day by S.I. 2020/1504, regs. 1(2), 21(e)" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/1013" AffectingNumber="1013" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" Row="134" AffectingClass="UnitedKingdomStatutoryInstrument" URI="http://www.legislation.gov.uk/id/effect/key-d088b6c21c531cdfb0d68ed58f8861e9" EffectId="key-f6c359a4a40f42d09b697b5590e377fe" AffectingProvisions="reg. 101" RequiresApplied="false" AffectedNumber="2283" Type="words substituted" AffectedYear="2015" AffectingYear="2019" AffectedProvisions="Art. 32A(4)(d)" Modified="2021-03-18T13:49:16Z" AffectedClass="EuropeanUnionRegulation" AffectingEffectsExtent="E+W+S+N.I."><ukm:AffectedTitle>Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (Text with EEA relevance)</ukm:AffectedTitle><ukm:AffectedProvisions><ukm:Section xmlns:err="http://www.legislation.gov.uk/namespaces/error" Ref="article-32A-4-d" URI="http://www.legislation.gov.uk/id/eur/2015/2283/article/32A/4/d" err:Ref="Section missing in legislation" Missing="true">Art. 32A(4)(d)</ukm:Section></ukm:AffectedProvisions><ukm:AffectingTitle>The Food and Feed Hygiene and Safety (Miscellaneous Amendments) (EU Exit) Regulations 2019</ukm:AffectingTitle><ukm:AffectingProvisions><ukm:Section Ref="regulation-101" URI="http://www.legislation.gov.uk/id/uksi/2019/1013/regulation/101">reg. 101</ukm:Section></ukm:AffectingProvisions><ukm:CommencementAuthority><ukm:Section Ref="regulation-2" URI="http://www.legislation.gov.uk/id/uksi/2019/1013/regulation/2">reg. 2</ukm:Section></ukm:CommencementAuthority><ukm:InForceDates><ukm:InForce Date="2020-12-31" Qualification="wholly in force"/></ukm:InForceDates></ukm:UnappliedEffect></ukm:UnappliedEffects></ukm:EUMetadata><ukm:Alternatives><ukm:Alternative URI="http://www.legislation.gov.uk/eur/2015/2283/pdfs/eur_20152283_adopted_en.pdf" Date="2015-11-25" Size="533374"/><ukm:Alternative URI="http://www.legislation.gov.uk/eur/2015/2283/pdfs/eur_20152283_2021-03-27_en.pdf" Date="2021-03-27" Size="317908" Revised="2021-03-27"/></ukm:Alternatives><ukm:Statistics><ukm:TotalParagraphs Value="39"/><ukm:BodyParagraphs Value="39"/><ukm:ScheduleParagraphs Value="0"/><ukm:AttachmentParagraphs Value="0"/><ukm:TotalImages Value="0"/></ukm:Statistics></proprietary></meta><body eId="body"><chapter eId="chapter-IV"><num>CHAPTER IV</num><heading><b>ADDITIONAL PROCEDURAL RULES AND OTHER REQUIREMENTS</b></heading><article eId="article-21" uk:target="true"><num><ins class="substitution first" ukl:ChangeId="key-d730e672aae438de9f620a1bd7f70055-1669290695485" ukl:CommentaryRef="key-d730e672aae438de9f620a1bd7f70055"><noteRef uk:name="commentary" href="#key-d730e672aae438de9f620a1bd7f70055" class="commentary"/>Article 21</ins></num><heading><ins class="substitution" ukl:ChangeId="key-d730e672aae438de9f620a1bd7f70055-1669290695485" ukl:CommentaryRef="key-d730e672aae438de9f620a1bd7f70055">Additional information concerning risk management</ins></heading><paragraph eId="article-21-1"><num><ins class="substitution" ukl:ChangeId="key-d730e672aae438de9f620a1bd7f70055-1669290695485" ukl:CommentaryRef="key-d730e672aae438de9f620a1bd7f70055">1.</ins></num><content><p><ins class="substitution" ukl:ChangeId="key-d730e672aae438de9f620a1bd7f70055-1669290695485" ukl:CommentaryRef="key-d730e672aae438de9f620a1bd7f70055">Where the appropriate authority requests from an applicant additional information on matters concerning risk management, the appropriate authority must determine, together with the applicant, the period within which that information is to be provided. In such cases, the period provided for in Article 12(1) or (2) or in Article 18(1) may be extended accordingly.</ins></p></content></paragraph><paragraph eId="article-21-2"><num><ins class="substitution" ukl:ChangeId="key-d730e672aae438de9f620a1bd7f70055-1669290695485" ukl:CommentaryRef="key-d730e672aae438de9f620a1bd7f70055">2.</ins></num><content><p><ins class="substitution last" ukl:ChangeId="key-d730e672aae438de9f620a1bd7f70055-1669290695485" ukl:CommentaryRef="key-d730e672aae438de9f620a1bd7f70055">Where the additional information referred to in paragraph 1 is not received within the additional period referred to in that paragraph, the appropriate authority must act on the basis of the available information.</ins></p></content></paragraph></article></chapter></body></act></akomaNtoso>