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					<dc:identifier>http://www.legislation.gov.uk/eur/2016/1412/introduction</dc:identifier><dc:title>Commission Regulation (EU) 2016/1412 of 24 August 2016 refusing to authorise a health claim made on foods and referring to the reduction of disease risk (Text with EEA relevance)</dc:title><dct:alternative>Commission Regulation (EU) 2016/1412</dct:alternative><dc:description>Commission Regulation (EU) 2016/1412 of 24 August 2016 refusing to authorise a health claim made on foods and referring to the reduction of disease risk (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:32016R1412</dc:source><dc:type>text</dc:type><dc:format>text/xml</dc:format><dc:language>en</dc:language><dc:modified>2024-07-12</dc:modified><dc:contributor>Expert Participation</dc:contributor><dct:valid>2020-12-31</dct:valid>
					
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                  <VALUE>Commission Regulation (EU) 2016/1412 of 24 August 2016 refusing to authorise a health claim made on foods and referring to the reduction of disease risk (Text with EEA relevance)</VALUE>
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					<ukm:Alternatives><ukm:Alternative URI="http://www.legislation.gov.uk/eur/2016/1412/pdfs/eur_20161412_adopted_en.pdf" Date="2016-08-25" Size="522296"/> </ukm:Alternatives>
					
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				</ukm:Metadata><EURetained><EUPrelims DocumentURI="http://www.legislation.gov.uk/eur/2016/1412/introduction" IdURI="http://www.legislation.gov.uk/id/eur/2016/1412/introduction" RestrictExtent="E+W+S+N.I." RestrictStartDate="2016-08-24">
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            <Text>
               <Uppercase>Commission Regulation</Uppercase> (EU) 2016/1412</Text>
            <Text>of 24 August 2016</Text>
            <Text>refusing to authorise a health claim made on foods and referring to the reduction of disease risk</Text>
            <Text>(Text with EEA relevance)</Text>
         </MultilineTitle>
         <EUPreamble>
            <P>
               <Text>THE EUROPEAN COMMISSION,</Text>
            </P>
            <P>
               <Text>Having regard to the Treaty on the Functioning of the European Union,</Text>
            </P>
            <P>
               <Text>Having regard to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods<FootnoteRef Ref="f00001"/>, and in particular Article 17(3) thereof,</Text>
            </P>
            <P>
               <Text>Whereas:</Text>
            </P>
            <Division>
               <Number>(1)</Number>
               <P>
                  <Text>Pursuant to Regulation (EC) No 1924/2006 health claims made on foods are prohibited unless they are authorised by the Commission in accordance with that Regulation and included in a list of permitted claims.</Text>
               </P>
            </Division>
            <Division>
               <Number>(2)</Number>
               <P>
                  <Text>Regulation (EC) No 1924/2006 also provides that applications for authorisations of health claims may be submitted by food business operators to the national competent authority of a Member State. The national competent authority is to forward valid applications to the European Food Safety Authority (EFSA), hereinafter referred to as ‘the Authority’.</Text>
               </P>
            </Division>
            <Division>
               <Number>(3)</Number>
               <P>
                  <Text>Following receipt of an application the Authority is to inform without delay the other Member States and the Commission thereof, and to deliver an opinion on the health claim concerned.</Text>
               </P>
            </Division>
            <Division>
               <Number>(4)</Number>
               <P>
                  <Text>The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority.</Text>
               </P>
            </Division>
            <Division>
               <Number>(5)</Number>
               <P>
                  <Text>Following an application from Han-Asiabiotech GmbH, submitted pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to Symbiosal<Superior>®</Superior> and lowering of blood pressure and reduced risk of hypertension (Question No EFSA-Q-2014-00366<FootnoteRef Ref="f00002"/>). The claim proposed by the applicant was worded as follows: ‘Symbiosal has been shown to lower the rising of blood pressure when used as a replacement of traditional table salt. The rising of blood pressure is a risk factor for high blood pressure (hypertension)’.</Text>
               </P>
            </Division>
            <Division>
               <Number>(6)</Number>
               <P>
                  <Text>On 1 July 2015, the Commission and the Member States received the scientific opinion from the Authority, which concluded that on the basis of the data presented a cause and effect relationship had not been established between the consumption of Symbiosal<Superior>®</Superior> instead of table salt and lowering of blood pressure. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.</Text>
               </P>
            </Division>
            <Division>
               <Number>(7)</Number>
               <P>
                  <Text>The measure provided for in this Regulation is in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,</Text>
               </P>
            </Division>
            <P>
               <Text>HAS ADOPTED THIS REGULATION:</Text>
            </P>
         </EUPreamble>
      </EUPrelims></EURetained><Footnotes><Footnote id="f00001">
         <FootnoteText>
            <Para>
               <Text>
                  <Citation id="c00001" Class="EuropeanUnionOfficialJournal" Year="2006" URI="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2006.404.01.0009.01.ENG" Date="2006-12-30">OJ L 404, 30.12.2006, p. 9</Citation>.</Text>
            </Para>
         </FootnoteText>
      </Footnote><Footnote id="f00002">
         <FootnoteText>
            <Para>
               <Text>
                  <Emphasis>EFSA Journal</Emphasis> 2015;13(7):4147.</Text>
            </Para>
         </FootnoteText>
      </Footnote></Footnotes></Legislation>