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					<dc:identifier>http://www.legislation.gov.uk/eur/2018/456/article/9</dc:identifier><dc:title>Commission Implementing Regulation (EU) 2018/456 of 19 March 2018 on the procedural steps of the consultation process for determination of novel food status in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (Text with EEA relevance)</dc:title><dct:alternative>Commission Implementing Regulation (EU) 2018/456</dct:alternative><dc:description>Commission Implementing Regulation (EU) 2018/456 of 19 March 2018 on the procedural steps of the consultation process for determination of novel food status in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (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:32018R0456</dc:source><dc:type>text</dc:type><dc:format>text/xml</dc:format><dc:language>en</dc:language><dc:modified>2024-09-25</dc:modified><dc:contributor>Expert Participation</dc:contributor><dct:valid>2020-12-31</dct:valid>
					
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               </RESOURCE_LEGAL_IS_ABOUT_CONCEPT_DIRECTORY-CODE>
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                        <IDENTIFIER>100157</IDENTIFIER>
                        <TYPE>EUROVOC</TYPE>
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                     <URI>
                        <VALUE>http://eurovoc.europa.eu/100257</VALUE>
                        <IDENTIFIER>100257</IDENTIFIER>
                        <TYPE>EUROVOC</TYPE>
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                     <PREFLABEL>6026 foodstuff</PREFLABEL>
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               </WORK_IS_ABOUT_CONCEPT_EUROVOC>
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                        <TYPE>EUROVOC</TYPE>
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                     <ALTLABEL>Community market</ALTLABEL>
                     <ALTLABEL>European Union market</ALTLABEL>
                  </WORK_IS_ABOUT_CONCEPT_EUROVOC_CONCEPT>
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                        <VALUE>http://eurovoc.europa.eu/1786</VALUE>
                        <IDENTIFIER>1786</IDENTIFIER>
                        <TYPE>EUROVOC</TYPE>
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                     <IDENTIFIER>1786</IDENTIFIER>
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                     <ALTLABEL>market State</ALTLABEL>
                     <ALTLABEL>market situation</ALTLABEL>
                     <ALTLABEL>market operation</ALTLABEL>
                     <ALTLABEL>market structure</ALTLABEL>
                  </WORK_IS_ABOUT_CONCEPT_EUROVOC_TT>
                  <WORK_IS_ABOUT_CONCEPT_EUROVOC_DOM type="concept">
                     <URI>
                        <VALUE>http://eurovoc.europa.eu/100147</VALUE>
                        <IDENTIFIER>100147</IDENTIFIER>
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                     <IDENTIFIER>20</IDENTIFIER>
                     <PREFLABEL>20 TRADE</PREFLABEL>
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                  <WORK_IS_ABOUT_CONCEPT_EUROVOC_MTH type="concept">
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                        <VALUE>http://eurovoc.europa.eu/100191</VALUE>
                        <IDENTIFIER>100191</IDENTIFIER>
                        <TYPE>EUROVOC</TYPE>
                     </URI>
                     <IDENTIFIER>2006</IDENTIFIER>
                     <PREFLABEL>2006 trade policy</PREFLABEL>
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               </WORK_IS_ABOUT_CONCEPT_EUROVOC>
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                     <IDENTIFIER>2081</IDENTIFIER>
                     <TYPE>EUROVOC</TYPE>
                  </URI>
                  <IDENTIFIER>2081</IDENTIFIER>
                  <PREFLABEL>marketing standard</PREFLABEL>
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               <IS_ABOUT type="concept">
                  <URI>
                     <VALUE>http://eurovoc.europa.eu/2300</VALUE>
                     <IDENTIFIER>2300</IDENTIFIER>
                     <TYPE>EUROVOC</TYPE>
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                  <IDENTIFIER>2300</IDENTIFIER>
                  <PREFLABEL>third country</PREFLABEL>
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               <DATE_DOCUMENT type="date">
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                  <DAY>19</DAY>
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                  <OP-CODE>SANTE</OP-CODE>
                  <IDENTIFIER>SANTE</IDENTIFIER>
                  <PREFLABEL>Directorate-General for Health and Food Safety</PREFLABEL>
                  <ALTLABEL>SANTE</ALTLABEL>
                  <ALTLABEL>DG Health and Food Safety</ALTLABEL>
               </CREATED_BY>
               <CREATED_BY type="concept">
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                  <OP-CODE>COM</OP-CODE>
                  <IDENTIFIER>COM</IDENTIFIER>
                  <PREFLABEL>European Commission</PREFLABEL>
                  <ALTLABEL>Commission of the European Communities</ALTLABEL>
                  <ALTLABEL>European Commission</ALTLABEL>
                  <ALTLABEL>Commission</ALTLABEL>
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               <ID_CELEX type="data">
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                  <IDENTIFIER>133014</IDENTIFIER>
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                     <IDENTIFIER>1520</IDENTIFIER>
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               </RESOURCE_LEGAL_IS_ABOUT_CONCEPT_DIRECTORY-CODE>
               <RESOURCE_LEGAL_IS_ABOUT_SUBJECT-MATTER type="concept_level">
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               </RESOURCE_LEGAL_IS_ABOUT_SUBJECT-MATTER>
               <RESOURCE_LEGAL_COMMENT_INTERNAL type="data">
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                        <VALUE>http://eurovoc.europa.eu/100143</VALUE>
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                        <TYPE>EUROVOC</TYPE>
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               <DATE type="date">
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                  <DAY>09</DAY>
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                  <DAY>01</DAY>
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               <DATE type="date">
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                  <YEAR>2018</YEAR>
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                  <DAY>19</DAY>
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                  <DAY>20</DAY>
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					<ukm:Alternatives><ukm:Alternative URI="http://www.legislation.gov.uk/eur/2018/456/pdfs/eur_20180456_adopted_en.pdf" Date="2018-03-20" Size="405115"/> </ukm:Alternatives>
					
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				</ukm:Metadata><EURetained><EUBody DocumentURI="http://www.legislation.gov.uk/eur/2018/456/body" IdURI="http://www.legislation.gov.uk/id/eur/2018/456/body" NumberOfProvisions="10" RestrictExtent="E+W+S+N.I." RestrictStartDate="2020-12-31"><P1group RestrictExtent="E+W+S+N.I." RestrictStartDate="2020-12-31"><Title>Confidentiality</Title><P1 DocumentURI="http://www.legislation.gov.uk/eur/2018/456/article/9" IdURI="http://www.legislation.gov.uk/id/eur/2018/456/article/9" id="article-9"><Pnumber>Article 9</Pnumber><P1para><P2 DocumentURI="http://www.legislation.gov.uk/eur/2018/456/article/9/1" IdURI="http://www.legislation.gov.uk/id/eur/2018/456/article/9/1" id="article-9-1"><Pnumber PuncBefore="" PuncAfter=".">1</Pnumber><P2para><Text>Food business operators may request the  <Substitution ChangeId="key-071c2d14389daba3e2b1ffa95e6fcc86-1727254992774" CommentaryRef="key-071c2d14389daba3e2b1ffa95e6fcc86">Food Safety Authority</Substitution>  to agree that the disclosure of certain information submitted as part of the consultation request needs to benefit from confidential treatment where disclosure of such information may harm their competitive position.</Text></P2para></P2><P2 DocumentURI="http://www.legislation.gov.uk/eur/2018/456/article/9/2" IdURI="http://www.legislation.gov.uk/id/eur/2018/456/article/9/2" id="article-9-2"><Pnumber PuncBefore="" PuncAfter=".">2</Pnumber><P2para><Text>For the purpose of paragraph 1, food business operators shall indicate to the  <Substitution ChangeId="key-071c2d14389daba3e2b1ffa95e6fcc86-1727255003413" CommentaryRef="key-071c2d14389daba3e2b1ffa95e6fcc86">Food Safety Authority</Substitution>  the parts of the information provided that they wish to be treated as confidential and provide all the necessary details to substantiate their request for confidentiality.</Text></P2para></P2><P2 DocumentURI="http://www.legislation.gov.uk/eur/2018/456/article/9/3" IdURI="http://www.legislation.gov.uk/id/eur/2018/456/article/9/3" id="article-9-3"><Pnumber PuncBefore="" PuncAfter=".">3</Pnumber><P2para><Text>The  <Substitution ChangeId="key-071c2d14389daba3e2b1ffa95e6fcc86-1727255052136" CommentaryRef="key-071c2d14389daba3e2b1ffa95e6fcc86">Food Safety Authority</Substitution>  shall inform the food business operator of its views on which parts of the information are to remain confidential.</Text></P2para><P2para><Text>However, confidentiality shall not apply to the following information:</Text><P3 DocumentURI="http://www.legislation.gov.uk/eur/2018/456/article/9/3/a" IdURI="http://www.legislation.gov.uk/id/eur/2018/456/article/9/3/a" id="article-9-3-a"><Pnumber PuncBefore="(" PuncAfter=")">a</Pnumber><P3para><Text>the name and address of the applicant;</Text></P3para></P3><P3 DocumentURI="http://www.legislation.gov.uk/eur/2018/456/article/9/3/b" IdURI="http://www.legislation.gov.uk/id/eur/2018/456/article/9/3/b" id="article-9-3-b"><Pnumber PuncBefore="(" PuncAfter=")">b</Pnumber><P3para><Text>the name and description of the food;</Text></P3para></P3><P3 DocumentURI="http://www.legislation.gov.uk/eur/2018/456/article/9/3/c" IdURI="http://www.legislation.gov.uk/id/eur/2018/456/article/9/3/c" id="article-9-3-c"><Pnumber PuncBefore="(" PuncAfter=")">c</Pnumber><P3para><Text>a summary of the studies submitted by the applicant;</Text></P3para></P3><P3 DocumentURI="http://www.legislation.gov.uk/eur/2018/456/article/9/3/d" IdURI="http://www.legislation.gov.uk/id/eur/2018/456/article/9/3/d" id="article-9-3-d"><Pnumber PuncBefore="(" PuncAfter=")">d</Pnumber><P3para><Text>where appropriate, the analysis method(s).</Text></P3para></P3></P2para></P2><P2 DocumentURI="http://www.legislation.gov.uk/eur/2018/456/article/9/4" IdURI="http://www.legislation.gov.uk/id/eur/2018/456/article/9/4" id="article-9-4"><Pnumber PuncBefore="" PuncAfter="."><CommentaryRef Ref="key-8e8a632322e9da4732faee60b3d981b3"/>4</Pnumber><P2para><Text>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Text></P2para></P2><P2 DocumentURI="http://www.legislation.gov.uk/eur/2018/456/article/9/5" IdURI="http://www.legislation.gov.uk/id/eur/2018/456/article/9/5" id="article-9-5"><Pnumber PuncBefore="" PuncAfter=".">5</Pnumber><P2para><Text>After being informed pursuant to paragraph 3, the food business operator may withdraw its consultation request within 3 weeks during which the confidentiality of the information provided shall be observed.</Text></P2para></P2><P2 DocumentURI="http://www.legislation.gov.uk/eur/2018/456/article/9/6" IdURI="http://www.legislation.gov.uk/id/eur/2018/456/article/9/6" id="article-9-6"><Pnumber PuncBefore="" PuncAfter=".">6</Pnumber><P2para><Text>The  <Substitution ChangeId="key-a27bd822ea51160773bc6f4b0b6ff8fd-1727255102243" CommentaryRef="key-a27bd822ea51160773bc6f4b0b6ff8fd">Food Safety Authority
                    </Substitution>  shall take necessary measures to ensure appropriate confidentiality of the information referred to in paragraphs 3 and received by  <Substitution ChangeId="key-1887bb0421e7f9812dcaa13e7aa74f2f-1727255116130" CommentaryRef="key-1887bb0421e7f9812dcaa13e7aa74f2f">it</Substitution>  under this Regulation, except for information which is required to be made public in order to protect human health.</Text></P2para></P2><P2 DocumentURI="http://www.legislation.gov.uk/eur/2018/456/article/9/7" IdURI="http://www.legislation.gov.uk/id/eur/2018/456/article/9/7" id="article-9-7"><Pnumber PuncBefore="" PuncAfter=".">7</Pnumber><P2para><Text>Where a food business operator withdraws or has withdrawn its consultation request in accordance with paragraph 5,  <Substitution ChangeId="key-2369093ff3e3178e085498dd6bb680e3-1727255133472" CommentaryRef="key-2369093ff3e3178e085498dd6bb680e3">the Food Safety Authority must not</Substitution> disclose information for which confidentiality was requested by the food business operator pursuant to paragraph 1.</Text></P2para></P2><P2 DocumentURI="http://www.legislation.gov.uk/eur/2018/456/article/9/8" IdURI="http://www.legislation.gov.uk/id/eur/2018/456/article/9/8" id="article-9-8"><Pnumber PuncBefore="" PuncAfter=".">8</Pnumber><P2para><Text>The application of paragraphs 1 to 7 shall not affect the exchange of information between the  <Substitution ChangeId="key-5a2b4f42024f86b142d8f57f328a1c99-1727255150657" CommentaryRef="key-5a2b4f42024f86b142d8f57f328a1c99">Food Safety Authority and the appropriate authority</Substitution>  necessary to consider the consultation requests submitted under this Regulation.</Text></P2para></P2></P1para></P1></P1group></EUBody></EURetained><Commentaries><Commentary id="key-071c2d14389daba3e2b1ffa95e6fcc86" Type="F"><Para><Text>Words in <CitationSubRef id="cj3y83jm5-00006" SectionRef="article-9" URI="http://www.legislation.gov.uk/id/eur/2018/456/article/9">Art. 9</CitationSubRef> substituted (31.12.2020) by <Citation URI="http://www.legislation.gov.uk/id/uksi/2019/702" id="cj3y83jm5-00007" Class="UnitedKingdomStatutoryInstrument" Year="2019" Number="702" Title="The Novel Food (Amendment) (EU Exit) Regulations 2019">The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702)</Citation>, <CitationSubRef CitationRef="cj3y83jm5-00007" id="cj3y83jm5-00008" SectionRef="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/702/regulation/1">regs. 1</CitationSubRef>, <CitationSubRef CitationRef="cj3y83jm5-00007" id="cj3y83jm5-00009" SectionRef="regulation-73-a" URI="http://www.legislation.gov.uk/id/uksi/2019/702/regulation/73/a" Operative="true">73(a)</CitationSubRef>; <Citation URI="http://www.legislation.gov.uk/id/ukpga/2020/1" id="cj3y83jm5-00010" Year="2020" Class="UnitedKingdomPublicGeneralAct" Number="1">2020 c. 1</Citation>, <CitationSubRef CitationRef="cj3y83jm5-00010" id="cj3y83jm5-00011" SectionRef="schedule-5-paragraph-1-1" URI="http://www.legislation.gov.uk/id/ukpga/2020/1/schedule/5/paragraph/1/1">Sch. 5 para. 1(1)</CitationSubRef></Text></Para></Commentary><Commentary id="key-8e8a632322e9da4732faee60b3d981b3" Type="F"><Para><Text><CitationSubRef id="cj3y83jm5-00015" SectionRef="article-9-4" URI="http://www.legislation.gov.uk/id/eur/2018/456/article/9/4">Art. 9(4)</CitationSubRef> omitted (31.12.2020) by virtue of <Citation URI="http://www.legislation.gov.uk/id/uksi/2019/702" id="cj3y83jm5-00016" Class="UnitedKingdomStatutoryInstrument" Year="2019" Number="702" Title="The Novel Food (Amendment) (EU Exit) Regulations 2019">The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702)</Citation>, <CitationSubRef CitationRef="cj3y83jm5-00016" id="cj3y83jm5-00017" SectionRef="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/702/regulation/1">regs. 1</CitationSubRef>, <CitationSubRef CitationRef="cj3y83jm5-00016" id="cj3y83jm5-00018" SectionRef="regulation-73-b" URI="http://www.legislation.gov.uk/id/uksi/2019/702/regulation/73/b" Operative="true">73(b)</CitationSubRef>; <Citation URI="http://www.legislation.gov.uk/id/ukpga/2020/1" id="cj3y83jm5-00019" Year="2020" Class="UnitedKingdomPublicGeneralAct" Number="1">2020 c. 1</Citation>, <CitationSubRef CitationRef="cj3y83jm5-00019" id="cj3y83jm5-00020" SectionRef="schedule-5-paragraph-1-1" URI="http://www.legislation.gov.uk/id/ukpga/2020/1/schedule/5/paragraph/1/1">Sch. 5 para. 1(1)</CitationSubRef></Text></Para></Commentary><Commentary id="key-a27bd822ea51160773bc6f4b0b6ff8fd" Type="F"><Para><Text>Words in <CitationSubRef id="cj3y83jm5-00026" SectionRef="article-9-6" URI="http://www.legislation.gov.uk/id/eur/2018/456/article/9/6">Art. 9(6)</CitationSubRef> substituted (31.12.2020) by <Citation URI="http://www.legislation.gov.uk/id/uksi/2019/702" id="cj3y83jm5-00027" Class="UnitedKingdomStatutoryInstrument" Year="2019" Number="702" Title="The Novel Food (Amendment) (EU Exit) Regulations 2019">The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702)</Citation>, <CitationSubRef CitationRef="cj3y83jm5-00027" id="cj3y83jm5-00028" SectionRef="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/702/regulation/1">regs. 1</CitationSubRef>, <CitationSubRef CitationRef="cj3y83jm5-00027" id="cj3y83jm5-00029" SectionRef="regulation-73-c-i" URI="http://www.legislation.gov.uk/id/uksi/2019/702/regulation/73/c/i" Operative="true">73(c)(i)</CitationSubRef>; <Citation URI="http://www.legislation.gov.uk/id/ukpga/2020/1" id="cj3y83jm5-00030" Year="2020" Class="UnitedKingdomPublicGeneralAct" Number="1">2020 c. 1</Citation>, <CitationSubRef CitationRef="cj3y83jm5-00030" id="cj3y83jm5-00031" SectionRef="schedule-5-paragraph-1-1" URI="http://www.legislation.gov.uk/id/ukpga/2020/1/schedule/5/paragraph/1/1">Sch. 5 para. 1(1)</CitationSubRef></Text></Para></Commentary><Commentary id="key-1887bb0421e7f9812dcaa13e7aa74f2f" Type="F"><Para><Text>Word in <CitationSubRef id="cj3y83jm5-00037" SectionRef="article-9-6" URI="http://www.legislation.gov.uk/id/eur/2018/456/article/9/6">Art. 9(6)</CitationSubRef> substituted (31.12.2020) by <Citation URI="http://www.legislation.gov.uk/id/uksi/2019/702" id="cj3y83jm5-00038" Class="UnitedKingdomStatutoryInstrument" Year="2019" Number="702" Title="The Novel Food (Amendment) (EU Exit) Regulations 2019">The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702)</Citation>, <CitationSubRef CitationRef="cj3y83jm5-00038" id="cj3y83jm5-00039" SectionRef="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/702/regulation/1">regs. 1</CitationSubRef>, <CitationSubRef CitationRef="cj3y83jm5-00038" id="cj3y83jm5-00040" SectionRef="regulation-73-c-ii" URI="http://www.legislation.gov.uk/id/uksi/2019/702/regulation/73/c/ii" Operative="true">73(c)(ii)</CitationSubRef>; <Citation URI="http://www.legislation.gov.uk/id/ukpga/2020/1" id="cj3y83jm5-00041" Year="2020" Class="UnitedKingdomPublicGeneralAct" Number="1">2020 c. 1</Citation>, <CitationSubRef CitationRef="cj3y83jm5-00041" id="cj3y83jm5-00042" SectionRef="schedule-5-paragraph-1-1" URI="http://www.legislation.gov.uk/id/ukpga/2020/1/schedule/5/paragraph/1/1">Sch. 5 para. 1(1)</CitationSubRef></Text></Para></Commentary><Commentary id="key-2369093ff3e3178e085498dd6bb680e3" Type="F"><Para><Text>Words in <CitationSubRef id="cj3y83jm5-00048" SectionRef="article-9-7" URI="http://www.legislation.gov.uk/id/eur/2018/456/article/9/7">Art. 9(7)</CitationSubRef> substituted (31.12.2020) by <Citation URI="http://www.legislation.gov.uk/id/uksi/2019/702" id="cj3y83jm5-00049" Class="UnitedKingdomStatutoryInstrument" Year="2019" Number="702" Title="The Novel Food (Amendment) (EU Exit) Regulations 2019">The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702)</Citation>, <CitationSubRef CitationRef="cj3y83jm5-00049" id="cj3y83jm5-00050" SectionRef="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/702/regulation/1">regs. 1</CitationSubRef>, <CitationSubRef CitationRef="cj3y83jm5-00049" id="cj3y83jm5-00051" SectionRef="regulation-73-d" URI="http://www.legislation.gov.uk/id/uksi/2019/702/regulation/73/d" Operative="true">73(d)</CitationSubRef>; <Citation URI="http://www.legislation.gov.uk/id/ukpga/2020/1" id="cj3y83jm5-00052" Year="2020" Class="UnitedKingdomPublicGeneralAct" Number="1">2020 c. 1</Citation>, <CitationSubRef CitationRef="cj3y83jm5-00052" id="cj3y83jm5-00053" SectionRef="schedule-5-paragraph-1-1" URI="http://www.legislation.gov.uk/id/ukpga/2020/1/schedule/5/paragraph/1/1">Sch. 5 para. 1(1)</CitationSubRef></Text></Para></Commentary><Commentary id="key-5a2b4f42024f86b142d8f57f328a1c99" Type="F"><Para><Text>Words in <CitationSubRef id="cj3y83jm5-00059" SectionRef="article-9-8" URI="http://www.legislation.gov.uk/id/eur/2018/456/article/9/8">Art. 9(8)</CitationSubRef> substituted (31.12.2020) by <Citation URI="http://www.legislation.gov.uk/id/uksi/2019/702" id="cj3y83jm5-00060" Class="UnitedKingdomStatutoryInstrument" Year="2019" Number="702" Title="The Novel Food (Amendment) (EU Exit) Regulations 2019">The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702)</Citation>, <CitationSubRef CitationRef="cj3y83jm5-00060" id="cj3y83jm5-00061" SectionRef="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/702/regulation/1">regs. 1</CitationSubRef>, <CitationSubRef CitationRef="cj3y83jm5-00060" id="cj3y83jm5-00062" SectionRef="regulation-73-e" URI="http://www.legislation.gov.uk/id/uksi/2019/702/regulation/73/e" Operative="true">73(e)</CitationSubRef>; <Citation URI="http://www.legislation.gov.uk/id/ukpga/2020/1" id="cj3y83jm5-00063" Year="2020" Class="UnitedKingdomPublicGeneralAct" Number="1">2020 c. 1</Citation>, <CitationSubRef CitationRef="cj3y83jm5-00063" id="cj3y83jm5-00064" SectionRef="schedule-5-paragraph-1-1" URI="http://www.legislation.gov.uk/id/ukpga/2020/1/schedule/5/paragraph/1/1">Sch. 5 para. 1(1)</CitationSubRef></Text></Para></Commentary></Commentaries></Legislation>