<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/2012/307"/><FRBRuri value="http://www.legislation.gov.uk/id/eur/2012/307"/><FRBRdate date="2012-04-11" name="adopted"/><FRBRauthor href=""/><FRBRcountry value="EU"/><FRBRnumber value="307"/><FRBRname value="Regulation (EU) 2012/307"/><FRBRprescriptive value="true"/></FRBRWork><FRBRExpression><FRBRthis value="http://www.legislation.gov.uk/eur/2012/307/2020-12-31"/><FRBRuri value="http://www.legislation.gov.uk/eur/2012/307/2020-12-31"/><FRBRdate date="2020-12-31" 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refersTo="#period-from-2020-12-31" type="jurisdiction"/><restriction href="#article-3" refersTo="#period-from-2020-12-31" type="jurisdiction"/></restrictions><otherAnalysis source=""><uk:commentary href="#article-3" refersTo="#key-29387bda30bfd1d4dee0cb38fb700605"/><uk:commentary href="#article-3" refersTo="#key-a8d0868e961f16e0d874b1fce514062a"/><uk:commentary href="#article-3" refersTo="#key-57f3e91e7a61820b66e0cf66f6b88a73"/><uk:commentary href="#article-3" refersTo="#key-4b031dd60358f7af056337a277dcbd28"/></otherAnalysis></analysis><temporalData source="#"><temporalGroup eId="period-from-2020-12-31"><timeInterval start="#date-2020-12-31" 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><notes source="#"><note ukl:Name="Commentary" ukl:Type="F" class="commentary F" eId="key-29387bda30bfd1d4dee0cb38fb700605" marker="F1"><p>Word in <ref eId="cj2l77kh5-00015" class="subref" href="http://www.legislation.gov.uk/id/eur/2012/307/article/3/1">Art. 3(1)</ref> substituted (31.12.2020) by <ref eId="cj2l77kh5-00016" href="http://www.legislation.gov.uk/id/uksi/2019/651">The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651)</ref>, <ref eId="cj2l77kh5-00017" class="subref" href="http://www.legislation.gov.uk/id/uksi/2019/651/regulation/1/1">regs. 1(1)</ref>, <ref eId="cj2l77kh5-00018" class="subref operative" href="http://www.legislation.gov.uk/id/uksi/2019/651/regulation/43/3/a/i">43(3)(a)(i)</ref>; <ref eId="cj2l77kh5-00019" href="http://www.legislation.gov.uk/id/ukpga/2020/1">2020 c. 1</ref>, <ref eId="cj2l77kh5-00020" 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><note ukl:Name="Commentary" ukl:Type="F" class="commentary F" eId="key-a8d0868e961f16e0d874b1fce514062a" marker="F2"><p>Words in <ref eId="cj2l77kh5-00026" class="subref" href="http://www.legislation.gov.uk/id/eur/2012/307/article/3/1">Art. 3(1)</ref> substituted (31.12.2020) by <ref eId="cj2l77kh5-00027" href="http://www.legislation.gov.uk/id/uksi/2019/651">The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651)</ref>, <ref eId="cj2l77kh5-00028" class="subref" href="http://www.legislation.gov.uk/id/uksi/2019/651/regulation/1/1">regs. 1(1)</ref>, <ref eId="cj2l77kh5-00029" class="subref operative" href="http://www.legislation.gov.uk/id/uksi/2019/651/regulation/43/3/a/ii">43(3)(a)(ii)</ref> (as amended by <ref eId="cj2l77kh5-00007" href="http://www.legislation.gov.uk/id/uksi/2020/1476">S.I. 2020/1476</ref>, <ref eId="cj2l77kh5-00008" class="subref" href="http://www.legislation.gov.uk/id/uksi/2020/1476/regulation/1/2">regs. 1(2)</ref>, <ref eId="cj2l77kh5-00009" class="subref operative" href="http://www.legislation.gov.uk/id/uksi/2020/1476/regulation/6/5">6(5)</ref>); <ref eId="cj2l77kh5-00030" href="http://www.legislation.gov.uk/id/ukpga/2020/1">2020 c. 1</ref>, <ref eId="cj2l77kh5-00031" 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><note ukl:Name="Commentary" ukl:Type="F" class="commentary F" eId="key-57f3e91e7a61820b66e0cf66f6b88a73" marker="F3"><p>Words in <ref eId="cj2l77kh5-00037" class="subref" href="http://www.legislation.gov.uk/id/eur/2012/307/article/3/2">Art. 3(2)</ref> substituted (31.12.2020) by <ref eId="cj2l77kh5-00038" href="http://www.legislation.gov.uk/id/uksi/2019/651">The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651)</ref>, <ref eId="cj2l77kh5-00039" class="subref" href="http://www.legislation.gov.uk/id/uksi/2019/651/regulation/1/1">regs. 1(1)</ref>, <ref eId="cj2l77kh5-00040" class="subref operative" href="http://www.legislation.gov.uk/id/uksi/2019/651/regulation/43/3/b">43(3)(b)</ref>; <ref eId="cj2l77kh5-00041" href="http://www.legislation.gov.uk/id/ukpga/2020/1">2020 c. 1</ref>, <ref eId="cj2l77kh5-00042" 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><note ukl:Name="Commentary" ukl:Type="F" class="commentary F" eId="key-4b031dd60358f7af056337a277dcbd28" marker="F4"><p><ref eId="cj2l77kh5-00046" class="subref" href="http://www.legislation.gov.uk/id/eur/2012/307/article/3/4">Art. 3(4)</ref> omitted (31.12.2020) by virtue of <ref eId="cj2l77kh5-00047" href="http://www.legislation.gov.uk/id/uksi/2019/651">The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651)</ref>, <ref eId="cj2l77kh5-00048" class="subref" href="http://www.legislation.gov.uk/id/uksi/2019/651/regulation/1/1">regs. 1(1)</ref>, <ref eId="cj2l77kh5-00049" class="subref operative" href="http://www.legislation.gov.uk/id/uksi/2019/651/regulation/43/3/c">43(3)(c)</ref>; <ref eId="cj2l77kh5-00050" href="http://www.legislation.gov.uk/id/ukpga/2020/1">2020 c. 1</ref>, <ref eId="cj2l77kh5-00051" 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/2012/307/article/3</dc:identifier><dc:title>Commission Implementing Regulation (EU) No 307/2012 of 11 April 2012 establishing implementing rules for the application of Article 8 of Regulation (EC) No 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods</dc:title><dct:alternative>Commission Implementing Regulation (EU) No 307/2012</dct:alternative><dc:description>Commission Implementing Regulation (EU) No 307/2012 of 11 April 2012 establishing implementing rules for the application of Article 8 of Regulation (EC) No 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods</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:32012R0307</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><ukm:EUMetadata><ukm:DocumentClassification><ukm:DocumentCategory Value="euretained"/><ukm:DocumentMainType Value="EuropeanUnionRegulation"/><ukm:DocumentStatus Value="revised"/></ukm:DocumentClassification><ukm:Year 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Size="734226"/></ukm:Alternatives><ukm:Statistics><ukm:TotalParagraphs Value="7"/><ukm:BodyParagraphs Value="7"/><ukm:ScheduleParagraphs Value="0"/><ukm:AttachmentParagraphs Value="0"/><ukm:TotalImages Value="0"/></ukm:Statistics></proprietary></meta><body eId="body"><article eId="article-3" uk:target="true"><num>Article 3</num><heading>Conditions to be met for the request</heading><paragraph eId="article-3-1"><num>1.</num><content><p>In  <ins class="substitution first last" ukl:ChangeId="key-29387bda30bfd1d4dee0cb38fb700605-1727172665119" ukl:CommentaryRef="key-29387bda30bfd1d4dee0cb38fb700605"><noteRef uk:name="commentary" href="#key-29387bda30bfd1d4dee0cb38fb700605" class="commentary"/>assessing</ins>  the conditions under which the concerned substance is added to foods or used in the manufacture of foods, as laid down in paragraph 1 of Article 8 of Regulation (EC) No 1925/2006, the placing on the market in one or more  <ins class="substitution first last" ukl:ChangeId="key-a8d0868e961f16e0d874b1fce514062a-1727172710539" ukl:CommentaryRef="key-a8d0868e961f16e0d874b1fce514062a"><noteRef uk:name="commentary" href="#key-a8d0868e961f16e0d874b1fce514062a" class="commentary"/>parts of Great Britain</ins>  of the food product to which the substance has been added shall be taken into account.</p></content></paragraph><paragraph eId="article-3-2"><num>2.</num><intro><p> <ins class="substitution first" ukl:ChangeId="key-57f3e91e7a61820b66e0cf66f6b88a73-1727172819617" ukl:CommentaryRef="key-57f3e91e7a61820b66e0cf66f6b88a73"><noteRef uk:name="commentary" href="#key-57f3e91e7a61820b66e0cf66f6b88a73" class="commentary"/>The power to make regulations under Article 8 of Regulation </ins><ref eId="c00067" href="http://www.legislation.gov.uk/id/eur/2006/1925"><ins class="substitution" ukl:ChangeId="key-57f3e91e7a61820b66e0cf66f6b88a73-1727172819617" ukl:CommentaryRef="key-57f3e91e7a61820b66e0cf66f6b88a73">(EC) No 1925/2006</ins></ref><ins class="substitution last" ukl:ChangeId="key-57f3e91e7a61820b66e0cf66f6b88a73-1727172819617" ukl:CommentaryRef="key-57f3e91e7a61820b66e0cf66f6b88a73"> may be exercised where the assessment referred to in paragraph 1</ins>  shows at least one of the following:</p></intro><level class="para1" eId="article-3-2-a"><num>(a)</num><content><p>a potential risk to consumers is associated with the ingestion of amounts of the substance that greatly exceed those reasonably expected under normal conditions of consumption of a balanced and varied diet, due to the conditions under which the substance is added to food or used in the manufacture of food;</p></content></level><level class="para1" eId="article-3-2-b"><num>(b)</num><content><p>a potential risk to consumers is associated with the consumption of this substance by the general adult population or other specified population group for which a potential risk has been identified.</p></content></level></paragraph><paragraph eId="article-3-3"><num>3.</num><content><p>For the purposes of this Regulation those conditions that would result in the ingestion of amounts of a substance greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet shall occur under actual circumstances and shall be assessed on a case-by-case basis in comparison with the average intake of the concerned substance by the general adult population or other specified population group for which health concerns have been raised.</p></content></paragraph><paragraph eId="article-3-4"><num><noteRef href="#key-4b031dd60358f7af056337a277dcbd28" uk:name="commentary" ukl:Name="CommentaryRef" class="commentary"/>4.</num><content><p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p></content></paragraph></article></body></act></akomaNtoso>