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					<dc:identifier>http://www.legislation.gov.uk/eur/2015/2283/article/12</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>
					
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				</ukm:Metadata><EURetained><EUBody DocumentURI="http://www.legislation.gov.uk/eur/2015/2283/body" IdURI="http://www.legislation.gov.uk/id/eur/2015/2283/body" NumberOfProvisions="39" RestrictExtent="E+W+S+N.I." RestrictStartDate="2025-11-13"><EUChapter DocumentURI="http://www.legislation.gov.uk/eur/2015/2283/chapter/III" IdURI="http://www.legislation.gov.uk/id/eur/2015/2283/chapter/III" NumberOfProvisions="11" id="chapter-III" RestrictExtent="E+W+S+N.I." RestrictStartDate="2025-04-01"><Number>CHAPTER III</Number><Title><Strong>AUTHORISATION PROCEDURES FOR A NOVEL FOOD</Strong></Title><EUSection DocumentURI="http://www.legislation.gov.uk/eur/2015/2283/chapter/III/section/I" IdURI="http://www.legislation.gov.uk/id/eur/2015/2283/chapter/III/section/I" NumberOfProvisions="4" id="chapter-III-section-I" RestrictExtent="E+W+S+N.I." RestrictStartDate="2025-04-01"><Number><Emphasis>SECTION I</Emphasis></Number><Title><Strong><Emphasis>General rules</Emphasis></Strong></Title><P1group RestrictExtent="E+W+S+N.I." RestrictStartDate="2025-04-01"><Title><Substitution ChangeId="key-639166f5e69ef0d706991afa4ff94bf9-1669284936646" CommentaryRef="key-639166f5e69ef0d706991afa4ff94bf9">Authorisation of a novel food </Substitution><CommentaryRef Ref="key-1f47d78136900b28dd96e799811ef685"/><Substitution ChangeId="key-639166f5e69ef0d706991afa4ff94bf9-1669284936646" CommentaryRef="key-639166f5e69ef0d706991afa4ff94bf9">...</Substitution></Title><P1 DocumentURI="http://www.legislation.gov.uk/eur/2015/2283/article/12" IdURI="http://www.legislation.gov.uk/id/eur/2015/2283/article/12" id="article-12"><Pnumber><Substitution ChangeId="key-639166f5e69ef0d706991afa4ff94bf9-1669284936646" CommentaryRef="key-639166f5e69ef0d706991afa4ff94bf9">Article 12</Substitution></Pnumber><P1para><P2 DocumentURI="http://www.legislation.gov.uk/eur/2015/2283/article/12/1" IdURI="http://www.legislation.gov.uk/id/eur/2015/2283/article/12/1" id="article-12-1"><Pnumber PuncBefore="" PuncAfter="."><Substitution ChangeId="key-639166f5e69ef0d706991afa4ff94bf9-1669284936646" CommentaryRef="key-639166f5e69ef0d706991afa4ff94bf9">1</Substitution></Pnumber><P2para><Text><Substitution ChangeId="key-639166f5e69ef0d706991afa4ff94bf9-1669284936646" CommentaryRef="key-639166f5e69ef0d706991afa4ff94bf9">Within seven months from the date of publication of the Food Safety Authority's opinion, the appropriate authority must </Substitution><Substitution ChangeId="key-639166f5e69ef0d706991afa4ff94bf9-1669284936646" CommentaryRef="key-639166f5e69ef0d706991afa4ff94bf9"><Substitution ChangeId="key-a658d61ef1b484e533e8d2a1087a85fd-1747386250483" CommentaryRef="key-a658d61ef1b484e533e8d2a1087a85fd">determine the authorisation status</Substitution></Substitution><Substitution ChangeId="key-639166f5e69ef0d706991afa4ff94bf9-1669284936646" CommentaryRef="key-639166f5e69ef0d706991afa4ff94bf9">   of a novel food, taking into account the following—</Substitution></Text><P3 DocumentURI="http://www.legislation.gov.uk/eur/2015/2283/article/12/1/a" IdURI="http://www.legislation.gov.uk/id/eur/2015/2283/article/12/1/a" id="article-12-1-a"><Pnumber PuncBefore="(" PuncAfter=")"><Substitution ChangeId="key-639166f5e69ef0d706991afa4ff94bf9-1669284936646" CommentaryRef="key-639166f5e69ef0d706991afa4ff94bf9">a</Substitution></Pnumber><P3para><Text><Substitution ChangeId="key-639166f5e69ef0d706991afa4ff94bf9-1669284936646" CommentaryRef="key-639166f5e69ef0d706991afa4ff94bf9">the conditions provided for in points (a) and (b) of Article 7 and, where applicable, in point (c) of that Article;</Substitution></Text></P3para></P3><P3 DocumentURI="http://www.legislation.gov.uk/eur/2015/2283/article/12/1/b" IdURI="http://www.legislation.gov.uk/id/eur/2015/2283/article/12/1/b" id="article-12-1-b"><Pnumber PuncBefore="(" PuncAfter=")"><Substitution ChangeId="key-639166f5e69ef0d706991afa4ff94bf9-1669284936646" CommentaryRef="key-639166f5e69ef0d706991afa4ff94bf9">b</Substitution></Pnumber><P3para><Text><Substitution ChangeId="key-639166f5e69ef0d706991afa4ff94bf9-1669284936646" CommentaryRef="key-639166f5e69ef0d706991afa4ff94bf9">any relevant provision of </Substitution><Substitution ChangeId="key-639166f5e69ef0d706991afa4ff94bf9-1669284936646" CommentaryRef="key-639166f5e69ef0d706991afa4ff94bf9"><Substitution ChangeId="key-f12b5a27fd24bb754e6ed39b14cc2e2d-1742476270000" CommentaryRef="key-f12b5a27fd24bb754e6ed39b14cc2e2d">assimilated direct</Substitution></Substitution><Substitution ChangeId="key-639166f5e69ef0d706991afa4ff94bf9-1669284936646" CommentaryRef="key-639166f5e69ef0d706991afa4ff94bf9"> legislation, including the precautionary principle as referred to in Article 7 of Regulation </Substitution><Citation URI="http://www.legislation.gov.uk/id/eur/2002/178" id="c00004" Class="EuropeanUnionRegulation" Year="2002" Number="178"><Substitution ChangeId="key-639166f5e69ef0d706991afa4ff94bf9-1669284936646" CommentaryRef="key-639166f5e69ef0d706991afa4ff94bf9">(EC) No. 178/2002</Substitution></Citation><Substitution ChangeId="key-639166f5e69ef0d706991afa4ff94bf9-1669284936646" CommentaryRef="key-639166f5e69ef0d706991afa4ff94bf9">;</Substitution></Text></P3para></P3><P3 DocumentURI="http://www.legislation.gov.uk/eur/2015/2283/article/12/1/c" IdURI="http://www.legislation.gov.uk/id/eur/2015/2283/article/12/1/c" id="article-12-1-c"><Pnumber PuncBefore="(" PuncAfter=")"><Substitution ChangeId="key-639166f5e69ef0d706991afa4ff94bf9-1669284936646" CommentaryRef="key-639166f5e69ef0d706991afa4ff94bf9">c</Substitution></Pnumber><P3para><Text><Substitution ChangeId="key-639166f5e69ef0d706991afa4ff94bf9-1669284936646" CommentaryRef="key-639166f5e69ef0d706991afa4ff94bf9">the Food Safety Authority's opinion;</Substitution></Text></P3para></P3><P3 DocumentURI="http://www.legislation.gov.uk/eur/2015/2283/article/12/1/d" IdURI="http://www.legislation.gov.uk/id/eur/2015/2283/article/12/1/d" id="article-12-1-d"><Pnumber PuncBefore="(" PuncAfter=")"><Substitution ChangeId="key-639166f5e69ef0d706991afa4ff94bf9-1669284936646" CommentaryRef="key-639166f5e69ef0d706991afa4ff94bf9">d</Substitution></Pnumber><P3para><Text><Substitution ChangeId="key-639166f5e69ef0d706991afa4ff94bf9-1669284936646" CommentaryRef="key-639166f5e69ef0d706991afa4ff94bf9">any other legitimate factors relevant to the application under consideration.</Substitution></Text></P3para></P3></P2para></P2><P2 DocumentURI="http://www.legislation.gov.uk/eur/2015/2283/article/12/2" IdURI="http://www.legislation.gov.uk/id/eur/2015/2283/article/12/2" id="article-12-2"><Pnumber PuncBefore="" PuncAfter="."><Substitution ChangeId="key-639166f5e69ef0d706991afa4ff94bf9-1669284936646" CommentaryRef="key-639166f5e69ef0d706991afa4ff94bf9">2</Substitution></Pnumber><P2para><Text><Substitution ChangeId="key-639166f5e69ef0d706991afa4ff94bf9-1669284936646" CommentaryRef="key-639166f5e69ef0d706991afa4ff94bf9">Where the appropriate authority has not requested an opinion from the Food Safety Authority in accordance with Article 10(3), the seven month period provided for in paragraph 1 of this Article starts from the date on which the valid application is received by the appropriate authority in accordance with Article 10(1).</Substitution></Text></P2para></P2><P2 DocumentURI="http://www.legislation.gov.uk/eur/2015/2283/article/12/2A" IdURI="http://www.legislation.gov.uk/id/eur/2015/2283/article/12/2A" id="article-12-2A"><Pnumber><Substitution ChangeId="key-639166f5e69ef0d706991afa4ff94bf9-1669284936646" CommentaryRef="key-639166f5e69ef0d706991afa4ff94bf9"><Addition ChangeId="key-c46973c68708ee697f88115584dfbca1-1747386183435" CommentaryRef="key-c46973c68708ee697f88115584dfbca1">2A.</Addition></Substitution></Pnumber><P2para><Text><Substitution ChangeId="key-639166f5e69ef0d706991afa4ff94bf9-1669284936646" CommentaryRef="key-639166f5e69ef0d706991afa4ff94bf9"><Addition ChangeId="key-c46973c68708ee697f88115584dfbca1-1747386183435" CommentaryRef="key-c46973c68708ee697f88115584dfbca1">Where the appropriate authority determines the authorisation status of a novel food, the appropriate authority must specify the date on which the authorisation, modification, suspension or revocation is to have effect and communicate the determination to the Food Safety Authority, and the Food Safety Authority must update the domestic list referred to in Article 3B accordingly.</Addition></Substitution></Text></P2para></P2></P1para></P1></P1group></EUSection></EUChapter></EUBody></EURetained><Commentaries><Commentary id="key-639166f5e69ef0d706991afa4ff94bf9" Type="F"><Para><Text>Art. 12 substituted (31.12.2020) by <Citation URI="http://www.legislation.gov.uk/id/uksi/2019/702" id="d10e4" 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="d10e4" id="ccd8e720221124102013434Z" URI="http://www.legislation.gov.uk/id/uksi/2019/702/regulation/1" SectionRef="regulation-1">regs. 1</CitationSubRef>, <CitationSubRef CitationRef="d10e4" id="ccd8e1020221124102013434Z" URI="http://www.legislation.gov.uk/id/uksi/2019/702/regulation/18" Operative="true" SectionRef="regulation-18">18</CitationSubRef> (as amended by <Citation URI="http://www.legislation.gov.uk/id/uksi/2020/1504" id="d10e13" Class="UnitedKingdomStatutoryInstrument" Year="2020" Number="1504">S.I. 2020/1504</Citation>, <CitationSubRef CitationRef="d10e13" id="ccd8e1620221124102013434Z" URI="http://www.legislation.gov.uk/id/uksi/2020/1504/regulation/1/2" SectionRef="regulation-1-2">regs. 1(2)</CitationSubRef>, <CitationSubRef CitationRef="d10e13" id="ccd8e2020221124102013434Z" URI="http://www.legislation.gov.uk/id/uksi/2020/1504/regulation/15/5" Operative="true" SectionRef="regulation-15-5">15(5)</CitationSubRef>); <Citation URI="http://www.legislation.gov.uk/id/ukpga/2020/1" id="d10e23" Year="2020" Class="UnitedKingdomPublicGeneralAct" Number="1">2020 c. 1</Citation>, <CitationSubRef CitationRef="d10e23" id="ccd8e2620221124102013434Z" URI="http://www.legislation.gov.uk/id/ukpga/2020/1/schedule/5/paragraph/1/1" Operative="true" SectionRef="schedule-5-paragraph-1-1">Sch. 5 para. 1(1)</CitationSubRef></Text></Para></Commentary><Commentary id="key-f12b5a27fd24bb754e6ed39b14cc2e2d" Type="F"><Para><Text>Words in Art. 12(1)(b) substituted (27.2.2025) by <Citation URI="http://www.legislation.gov.uk/id/uksi/2025/82" id="cq3mg0pd5-00007" Class="UnitedKingdomStatutoryInstrument" Year="2025" Number="82" Title="The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025">The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82)</Citation>, <CitationSubRef CitationRef="cq3mg0pd5-00007" id="cq3mg0pd5-00008" SectionRef="regulation-1-2" URI="http://www.legislation.gov.uk/id/uksi/2025/82/regulation/1/2">reg. 1(2)</CitationSubRef>, <CitationSubRef CitationRef="cq3mg0pd5-00007" id="cq3mg0pd5-00009" SectionRef="schedule-11-paragraph-22" URI="http://www.legislation.gov.uk/id/uksi/2025/82/schedule/11/paragraph/22" Operative="true">Sch. 11 para. 22</CitationSubRef></Text></Para></Commentary><Commentary id="key-1f47d78136900b28dd96e799811ef685" Type="F"><Para><Text>Words in Art. 12 heading omitted (1.4.2025) by virtue of <Citation URI="http://www.legislation.gov.uk/id/uksi/2025/361" id="cscvsy615-00007" Class="UnitedKingdomStatutoryInstrument" Year="2025" Number="361" Title="The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025">The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361)</Citation>, <CitationSubRef CitationRef="cscvsy615-00007" id="cscvsy615-00008" SectionRef="regulation-1-2" URI="http://www.legislation.gov.uk/id/uksi/2025/361/regulation/1/2">regs. 1(2)</CitationSubRef>, <CitationSubRef CitationRef="cscvsy615-00007" id="cscvsy615-00009" SectionRef="regulation-17-8-a" URI="http://www.legislation.gov.uk/id/uksi/2025/361/regulation/17/8/a" Operative="true">17(8)(a)</CitationSubRef> (with <CitationSubRef CitationRef="cscvsy615-00007" id="cscvsy615-00010" SectionRef="regulation-23" URI="http://www.legislation.gov.uk/id/uksi/2025/361/regulation/23">reg. 23</CitationSubRef>)</Text></Para></Commentary><Commentary id="key-c46973c68708ee697f88115584dfbca1" Type="F"><Para><Text>Art. 12(2A) inserted (1.4.2025) by <Citation URI="http://www.legislation.gov.uk/id/uksi/2025/361" id="cscvsy615-00017" Class="UnitedKingdomStatutoryInstrument" Year="2025" Number="361" Title="The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025">The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361)</Citation>, <CitationSubRef CitationRef="cscvsy615-00017" id="cscvsy615-00018" SectionRef="regulation-1-2" URI="http://www.legislation.gov.uk/id/uksi/2025/361/regulation/1/2">regs. 1(2)</CitationSubRef>, <CitationSubRef CitationRef="cscvsy615-00017" id="cscvsy615-00019" SectionRef="regulation-17-8-c" URI="http://www.legislation.gov.uk/id/uksi/2025/361/regulation/17/8/c" Operative="true">17(8)(c)</CitationSubRef> (with <CitationSubRef CitationRef="cscvsy615-00017" id="cscvsy615-00020" SectionRef="regulation-23" URI="http://www.legislation.gov.uk/id/uksi/2025/361/regulation/23">reg. 23</CitationSubRef>)</Text></Para></Commentary><Commentary id="key-a658d61ef1b484e533e8d2a1087a85fd" Type="F"><Para><Text>Words in Art. 12(1) substituted (1.4.2025) by <Citation URI="http://www.legislation.gov.uk/id/uksi/2025/361" id="cscvsy615-00027" Class="UnitedKingdomStatutoryInstrument" Year="2025" Number="361" Title="The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025">The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361)</Citation>, <CitationSubRef CitationRef="cscvsy615-00027" id="cscvsy615-00028" SectionRef="regulation-1-2" URI="http://www.legislation.gov.uk/id/uksi/2025/361/regulation/1/2">regs. 1(2)</CitationSubRef>, <CitationSubRef CitationRef="cscvsy615-00027" id="cscvsy615-00029" SectionRef="regulation-17-8-b" URI="http://www.legislation.gov.uk/id/uksi/2025/361/regulation/17/8/b" Operative="true">17(8)(b)</CitationSubRef> (with <CitationSubRef CitationRef="cscvsy615-00027" id="cscvsy615-00030" SectionRef="regulation-23" URI="http://www.legislation.gov.uk/id/uksi/2025/361/regulation/23">reg. 23</CitationSubRef>)</Text></Para></Commentary></Commentaries></Legislation>