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					<dc:identifier>http://www.legislation.gov.uk/eur/2017/2469/article/7</dc:identifier><dc:title>Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements for applications referred to in Article 10 of 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) 2017/2469</dct:alternative><dc:description>Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements for applications referred to in Article 10 of 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:32017R2469</dc:source><dc:type>text</dc:type><dc:format>text/xml</dc:format><dc:language>en</dc:language><dc:modified>2025-05-23</dc:modified><dc:contributor>Expert Participation</dc:contributor><dct:valid>2025-04-01</dct:valid>
					
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					<ukm:Alternatives><ukm:Alternative URI="http://www.legislation.gov.uk/eur/2017/2469/pdfs/eur_20172469_adopted_en.pdf" Date="2017-12-30" Size="407910"/> </ukm:Alternatives>
					
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				</ukm:Metadata><EURetained><EUBody DocumentURI="http://www.legislation.gov.uk/eur/2017/2469/body" IdURI="http://www.legislation.gov.uk/id/eur/2017/2469/body" NumberOfProvisions="9" RestrictExtent="E+W+S+N.I." RestrictStartDate="2020-12-31"><P1group RestrictExtent="E+W+S+N.I." RestrictStartDate="2020-12-31"><Title>Information to be included in the opinion of the Authority</Title><P1 DocumentURI="http://www.legislation.gov.uk/eur/2017/2469/article/7" IdURI="http://www.legislation.gov.uk/id/eur/2017/2469/article/7" id="article-7"><Pnumber>Article 7</Pnumber><P1para><P2 DocumentURI="http://www.legislation.gov.uk/eur/2017/2469/article/7/1" IdURI="http://www.legislation.gov.uk/id/eur/2017/2469/article/7/1" id="article-7-1"><Pnumber PuncBefore="" PuncAfter=".">1</Pnumber><P2para><Text>The opinion of the Authority shall include the following information:</Text><P3 DocumentURI="http://www.legislation.gov.uk/eur/2017/2469/article/7/1/a" IdURI="http://www.legislation.gov.uk/id/eur/2017/2469/article/7/1/a" id="article-7-1-a"><Pnumber PuncBefore="(" PuncAfter=")">a</Pnumber><P3para><Text>the identity of the novel food;</Text></P3para></P3><P3 DocumentURI="http://www.legislation.gov.uk/eur/2017/2469/article/7/1/b" IdURI="http://www.legislation.gov.uk/id/eur/2017/2469/article/7/1/b" id="article-7-1-b"><Pnumber PuncBefore="(" PuncAfter=")">b</Pnumber><P3para><Text>the assessment of the production process;</Text></P3para></P3><P3 DocumentURI="http://www.legislation.gov.uk/eur/2017/2469/article/7/1/c" IdURI="http://www.legislation.gov.uk/id/eur/2017/2469/article/7/1/c" id="article-7-1-c"><Pnumber PuncBefore="(" PuncAfter=")">c</Pnumber><P3para><Text>compositional data;</Text></P3para></P3><P3 DocumentURI="http://www.legislation.gov.uk/eur/2017/2469/article/7/1/d" IdURI="http://www.legislation.gov.uk/id/eur/2017/2469/article/7/1/d" id="article-7-1-d"><Pnumber PuncBefore="(" PuncAfter=")">d</Pnumber><P3para><Text>specifications;</Text></P3para></P3><P3 DocumentURI="http://www.legislation.gov.uk/eur/2017/2469/article/7/1/e" IdURI="http://www.legislation.gov.uk/id/eur/2017/2469/article/7/1/e" id="article-7-1-e"><Pnumber PuncBefore="(" PuncAfter=")">e</Pnumber><P3para><Text>the history of use of the novel food and/or its source;</Text></P3para></P3><P3 DocumentURI="http://www.legislation.gov.uk/eur/2017/2469/article/7/1/f" IdURI="http://www.legislation.gov.uk/id/eur/2017/2469/article/7/1/f" id="article-7-1-f"><Pnumber PuncBefore="(" PuncAfter=")">f</Pnumber><P3para><Text>the proposed uses and use levels and anticipated intake;</Text></P3para></P3><P3 DocumentURI="http://www.legislation.gov.uk/eur/2017/2469/article/7/1/g" IdURI="http://www.legislation.gov.uk/id/eur/2017/2469/article/7/1/g" id="article-7-1-g"><Pnumber PuncBefore="(" PuncAfter=")">g</Pnumber><P3para><Text>absorption, distribution, metabolism and excretion (ADME);</Text></P3para></P3><P3 DocumentURI="http://www.legislation.gov.uk/eur/2017/2469/article/7/1/h" IdURI="http://www.legislation.gov.uk/id/eur/2017/2469/article/7/1/h" id="article-7-1-h"><Pnumber PuncBefore="(" PuncAfter=")">h</Pnumber><P3para><Text>nutritional information;</Text></P3para></P3><P3 DocumentURI="http://www.legislation.gov.uk/eur/2017/2469/article/7/1/i" IdURI="http://www.legislation.gov.uk/id/eur/2017/2469/article/7/1/i" id="article-7-1-i"><Pnumber PuncBefore="(" PuncAfter=")">i</Pnumber><P3para><Text>toxicological information;</Text></P3para></P3><P3 DocumentURI="http://www.legislation.gov.uk/eur/2017/2469/article/7/1/j" IdURI="http://www.legislation.gov.uk/id/eur/2017/2469/article/7/1/j" id="article-7-1-j"><Pnumber PuncBefore="(" PuncAfter=")">j</Pnumber><P3para><Text>allergenicity;</Text></P3para></P3><P3 DocumentURI="http://www.legislation.gov.uk/eur/2017/2469/article/7/1/k" IdURI="http://www.legislation.gov.uk/id/eur/2017/2469/article/7/1/k" id="article-7-1-k"><Pnumber PuncBefore="(" PuncAfter=")">k</Pnumber><P3para><Text>an overall risk assessment for the novel food under the proposed uses and use levels and highlighting uncertainties and limitations where relevant;</Text></P3para></P3><P3 DocumentURI="http://www.legislation.gov.uk/eur/2017/2469/article/7/1/l" IdURI="http://www.legislation.gov.uk/id/eur/2017/2469/article/7/1/l" id="article-7-1-l"><Pnumber PuncBefore="(" PuncAfter=")">l</Pnumber><P3para><Text>when the dietary exposure exceeds the health-based guidance value identified in the overall risk assessment, the dietary exposure assessment of the novel food shall be detailed, providing the contribution to the total exposure of each food category or foodstuff for which the use is authorised or has been requested;</Text></P3para></P3><P3 DocumentURI="http://www.legislation.gov.uk/eur/2017/2469/article/7/1/m" IdURI="http://www.legislation.gov.uk/id/eur/2017/2469/article/7/1/m" id="article-7-1-m"><Pnumber PuncBefore="(" PuncAfter=")">m</Pnumber><P3para><Text>conclusions.</Text></P3para></P3></P2para></P2><P2 DocumentURI="http://www.legislation.gov.uk/eur/2017/2469/article/7/2" IdURI="http://www.legislation.gov.uk/id/eur/2017/2469/article/7/2" id="article-7-2"><Pnumber PuncBefore="" PuncAfter=".">2</Pnumber><P2para><Text>The  <Substitution ChangeId="key-93c0da43becff8b000121d4e3ad38310-1721980908007" CommentaryRef="key-93c0da43becff8b000121d4e3ad38310">appropriate authority</Substitution>  may ask for additional information in its request for an opinion of the Authority.</Text></P2para></P2></P1para></P1></P1group></EUBody></EURetained><Commentaries><Commentary id="key-93c0da43becff8b000121d4e3ad38310" Type="F"><Para><Text>Words in <CitationSubRef id="cgoq4h095-00006" SectionRef="article-7-2" URI="http://www.legislation.gov.uk/id/eur/2017/2469/article/7/2">Art. 7(2)</CitationSubRef> substituted (31.12.2020) by <Citation URI="http://www.legislation.gov.uk/id/uksi/2019/702" id="cgoq4h095-00007" 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="cgoq4h095-00007" id="cgoq4h095-00008" SectionRef="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/702/regulation/1">regs. 1</CitationSubRef>, <CitationSubRef CitationRef="cgoq4h095-00007" id="cgoq4h095-00009" SectionRef="regulation-57" URI="http://www.legislation.gov.uk/id/uksi/2019/702/regulation/57" Operative="true">57</CitationSubRef>; <Citation URI="http://www.legislation.gov.uk/id/ukpga/2020/1" id="cgoq4h095-00010" Year="2020" Class="UnitedKingdomPublicGeneralAct" Number="1">2020 c. 1</Citation>, <CitationSubRef CitationRef="cgoq4h095-00010" id="cgoq4h095-00011" 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></Commentaries></Legislation>