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					<dc:identifier>http://www.legislation.gov.uk/eur/2019/849/adopted</dc:identifier><dc:title>Commission Implementing Regulation (EU) 2019/849 of 24 May 2019 amending Implementing Regulation (EU) 2017/1492 as regards the maximum content of cholecalciferol (vitamin D3) in feed for salmonids (Text with EEA relevance)</dc:title><dct:alternative>Commission Implementing Regulation (EU) 2019/849</dct:alternative><dc:description>Commission Implementing Regulation (EU) 2019/849 of 24 May 2019 amending Implementing Regulation (EU) 2017/1492 as regards the maximum content of cholecalciferol (vitamin D3) in feed for salmonids (Text with EEA relevance)</dc:description><dc:modified>2020-12-11</dc:modified><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:32019R0849</dc:source><dc:type>text</dc:type><dc:format>text/xml</dc:format><dc:language>en</dc:language>
					
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					<ukm:Alternatives><ukm:Alternative URI="http://www.legislation.gov.uk/eur/2019/849/pdfs/eur_20190849_adopted_en.pdf" Date="2019-05-24" Size="391841"/> </ukm:Alternatives>
					
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               <Uppercase>Commission Implementing Regulation</Uppercase> (EU) 2019/849</Text>
            <Text>of 24 May 2019</Text>
            <Text>amending Implementing Regulation (EU) 2017/1492 as regards the maximum content of cholecalciferol (vitamin D3) in feed for salmonids</Text>
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               <Text>THE EUROPEAN COMMISSION,</Text>
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               <Text>Having regard to the Treaty on the Functioning of the European Union,</Text>
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               <Text>Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition<FootnoteRef Ref="f00001"/>, and in particular Article 13(2) thereof,</Text>
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               <Text>Whereas:</Text>
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               <Number>(1)</Number>
               <P>
                  <Text>Commission Implementing Regulation (EU) 2017/1492<FootnoteRef Ref="f00002"/> authorises cholecalciferol (vitamin D<Inferior>3</Inferior>) as nutritional additive for all animal species. In that Regulation, the maximum authorised content of vitamin D<Inferior>3</Inferior> for fish is 3 000 IU/kg of complete feedingstuff.</Text>
               </P>
            </Division>
            <Division>
               <Number>(2)</Number>
               <P>
                  <Text>The Norwegian Food Safety Authority (NFSA) submitted studies on the safety of vitamin D<Inferior>3</Inferior> for fish and consumers at substantially higher levels (60 000 IU/kg of complete feedingstuff) than the maximum authorised content.</Text>
               </P>
            </Division>
            <Division>
               <Number>(3)</Number>
               <P>
                  <Text>For control purposes the results of calculation of tolerance levels can lead to a discrepancy in values between the two units (mg or IU). For this reason, the levels in the authorisation should be established only in International Units.</Text>
               </P>
            </Division>
            <Division>
               <Number>(4)</Number>
               <P>
                  <Text>On the basis of the data submitted by the NFSA, the European Food Safety Authority concluded in its opinions of 25 January 2017<FootnoteRef Ref="f00003"/> and 29 November 2018<FootnoteRef Ref="f00004"/> that a total level of 60 000 IU of vitamin D<Inferior>3</Inferior> per kg of complete feedingstuff is safe for consumers and the environment. The European Food Safety Authority also concluded that the levels proposed were safe for salmonids. For other fish, no sufficient data were available to conclude on the safety for a total level of 60 000 IU vitamin D<Inferior>3</Inferior>/kg of complete feedingstuff. Consequently, the authorisation should be restricted to salmonids. It also concluded in the opinion of 13 November 2012<FootnoteRef Ref="f00005"/> that vitamin D<Inferior>3</Inferior> is not an irritant to skin and eyes and is not a skin sensitiser. For some formulations of vitamin D<Inferior>3</Inferior> there is a potential for workers to be exposed to high levels of vitamin D<Inferior>3</Inferior> by inhalation. Inhaled vitamin D<Inferior>3</Inferior> is highly toxic. Exposure to dust is harmful to persons handling the additive. As the levels of vitamin D<Inferior>3</Inferior> have been increased this may have implications for user safety, therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive.</Text>
               </P>
            </Division>
            <Division>
               <Number>(5)</Number>
               <P>
                  <Text>The Annex to Implementing Regulation (EU) 2017/1492 should therefore be amended accordingly.</Text>
               </P>
            </Division>
            <Division>
               <Number>(6)</Number>
               <P>
                  <Text>The measures provided for in this Regulation are 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>
      <EUBody DocumentURI="http://www.legislation.gov.uk/eur/2019/849/body/adopted" IdURI="http://www.legislation.gov.uk/id/eur/2019/849/body" NumberOfProvisions="2">
         <P1 DocumentURI="http://www.legislation.gov.uk/eur/2019/849/article/1/adopted" IdURI="http://www.legislation.gov.uk/id/eur/2019/849/article/1" id="article-1">
            <Pnumber>Article 1</Pnumber>
            <P1para>
               <Text>The Annex to Implementing Regulation (EU) 2017/1492 is replaced by the text set out in the Annex to this Regulation.</Text>
            </P1para>
         </P1>
         <P1group>
            <Title>Entry into force</Title>
            <P1 DocumentURI="http://www.legislation.gov.uk/eur/2019/849/article/2/adopted" IdURI="http://www.legislation.gov.uk/id/eur/2019/849/article/2" id="article-2">
               <Pnumber>Article 2</Pnumber>
               <P1para>
                  <Text>This Regulation shall enter into force on the twentieth day following that of its publication in the <Emphasis>Official Journal of the European Union</Emphasis>.</Text>
               </P1para>
            </P1>
         </P1group>
         <SignedSection DocumentURI="http://www.legislation.gov.uk/eur/2019/849/signature/adopted" IdURI="http://www.legislation.gov.uk/id/eur/2019/849/signature">
            <Para>
               <Text>This Regulation shall be binding in its entirety and directly applicable in all Member States.</Text>
            </Para>
            <Signatory>
               <Para>
                  <Text>Done at Brussels, 24 May 2019.</Text>
               </Para>
               <Signee>
                  <Para>
                     <Text>
                        <Emphasis>For the Commission</Emphasis>
                     </Text>
                  </Para>
                  <Para>
                     <Text>
                        <Emphasis>The President</Emphasis>
                     </Text>
                  </Para>
                  <Para>
                     <Text>Jean-Claude <Uppercase>Juncker</Uppercase>
                     </Text>
                  </Para>
               </Signee>
            </Signatory>
         </SignedSection>
      </EUBody>
      <Schedules>
         <Schedule DocumentURI="http://www.legislation.gov.uk/eur/2019/849/annex/adopted" IdURI="http://www.legislation.gov.uk/id/eur/2019/849/annex" id="annex">
            <Number>ANNEX</Number>
            <ScheduleBody>
               <Tabular Orientation="landscape">
                  <table xmlns="http://www.w3.org/1999/xhtml" cols="10">
                     <tfoot><tr><td colspan="10">
                              <Footnote xmlns="http://www.legislation.gov.uk/namespaces/legislation" id="f00006">
                                 <FootnoteText>
                                    <Para>
                                       <Text>40 IU cholecalciferol = 0,001 mg cholecalciferol</Text>
                                    </Para>
                                 </FootnoteText>
                              </Footnote>
                           </td></tr><tr><td colspan="10">
                              <Footnote xmlns="http://www.legislation.gov.uk/namespaces/legislation" id="f00007">
                                 <FootnoteText>
                                    <Para>
                                       <Text>Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports</Text>
                                    </Para>
                                 </FootnoteText>
                              </Footnote>
                           </td></tr></tfoot>
                     <tbody><tr><th rowspan="2">Identification number of the additive</th><th rowspan="2">Name of the holder of authorisation</th><th rowspan="2">Additive</th><th rowspan="2">Composition, chemical formula, description, analytical method</th><th rowspan="2">Species or category of animal</th><th rowspan="2">Maximum age</th><th>Minimum content</th><th>Maximum content</th><th rowspan="2">Other provisions</th><th rowspan="2">End of period of authorisation</th></tr><tr><th colspan="2">IU of cholecalciferol<FootnoteRef xmlns="http://www.legislation.gov.uk/namespaces/legislation" Ref="f00006"/>/kg of complete feedingstuff with a moisture content of 12 %.</th></tr><tr><th colspan="10">
                              <Strong xmlns="http://www.legislation.gov.uk/namespaces/legislation">Category of nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect.</Strong>
                           </th></tr><tr><td rowspan="12">3a671</td><td rowspan="12">—</td><td rowspan="12">‘Cholecalciferol’ or ‘Vitamin D<Inferior xmlns="http://www.legislation.gov.uk/namespaces/legislation">3</Inferior>’</td><td rowspan="12">
                              <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Title>
                                    <Emphasis>Additive composition</Emphasis>
                                 </Title>
                                 <P>
                                    <Text>Cholecalciferol.</Text>
                                 </P>
                              </Division>
                              <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Title>
                                    <Emphasis>Characterisation of the active substance</Emphasis>
                                 </Title>
                                 <P>
                                    <Text>Cholecalciferol</Text>
                                 </P>
                                 <P>
                                    <Text>C<Inferior>27</Inferior>H<Inferior>44</Inferior>O</Text>
                                 </P>
                                 <P>
                                    <Text>CAS number: 67-97-0</Text>
                                 </P>
                                 <P>
                                    <Text>Cholecalciferol solid and resin form, produced by chemical synthesis.</Text>
                                 </P>
                                 <P>
                                    <Text>Purity criteria:</Text>
                                 </P>
                                 <P>
                                    <Text>Min. 80 % (cholecalciferol and precholecalciferol) and max. 7 % tachysterol.</Text>
                                 </P>
                              </Division>
                              <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Title>
                                    <Emphasis>Method of analysis</Emphasis>
                                    <FootnoteRef Ref="f00007"/>
                                 </Title>
                                 <P>
                                    <UnorderedList Decoration="dash">
                                       <ListItem>
                                          <Para>
                                             <Text>For the determination of Vitamin D<Inferior>3</Inferior> in the feed additive: High Performance Liquid Chromatography coupled to UV detection (HPLC-UV, 254 nm) - European Pharmacopoeia method 01/2008:0574,0575,0598.</Text>
                                          </Para>
                                       </ListItem>
                                       <ListItem>
                                          <Para>
                                             <Text>For the determination of Vitamin D<Inferior>3</Inferior> in premixtures: High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV) - VDLUFA 1997, Methodenbuch, Method 13.8.1.</Text>
                                          </Para>
                                       </ListItem>
                                       <ListItem>
                                          <Para>
                                             <Text>For the determination of vitamin D<Inferior>3</Inferior> in feedingstuffs:</Text>
                                          </Para>
                                          <UnorderedList Decoration="dash">
                                             <ListItem>
                                                <Para>
                                                   <Text>High Performance Liquid Chromatography coupled to UV detection at 265 nm (HPLC-UV)-VDLUFA 1997, Methodenbuch, Method 13.8.1; or</Text>
                                                </Para>
                                             </ListItem>
                                             <ListItem>
                                                <Para>
                                                   <Text>Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821.</Text>
                                                </Para>
                                             </ListItem>
                                          </UnorderedList>
                                       </ListItem>
                                       <ListItem>
                                          <Para>
                                             <Text>For the determination of vitamin D<Inferior>3</Inferior> in water: Reverse-Phase High Performance Liquid Chromatography coupled to UV detection at 265 nm (RP-HPLC-UV), EN 12821.</Text>
                                          </Para>
                                       </ListItem>
                                    </UnorderedList>
                                 </P>
                              </Division>
                           </td><td>Pigs</td><td>—</td><td>—</td><td>2 000 IU</td><td rowspan="12">
                              <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Number>1.</Number>
                                 <P>
                                    <Text>Vitamin D<Inferior>3</Inferior> may be placed on the market and used as an additive consisting of a preparation.</Text>
                                 </P>
                              </Division>
                              <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Number>2.</Number>
                                 <P>
                                    <Text>The additive shall be incorporated into the feed in the form of a premixture.</Text>
                                 </P>
                              </Division>
                              <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Number>3.</Number>
                                 <P>
                                    <Text>In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.</Text>
                                 </P>
                              </Division>
                              <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Number>4.</Number>
                                 <Title>Maximum content of the combination of 25-hydroxycholecalciferol with cholecalciferol per kg of complete feedingstuff:</Title>
                                 <P>
                                    <UnorderedList Decoration="dash">
                                       <ListItem>
                                          <Para>
                                             <Text>≤ 5 000 IU of vitamin D<Inferior>3</Inferior> for chickens for fattening and turkeys for fattening,</Text>
                                          </Para>
                                       </ListItem>
                                       <ListItem>
                                          <Para>
                                             <Text>≤ 3 200 IU for other poultry,</Text>
                                          </Para>
                                       </ListItem>
                                       <ListItem>
                                          <Para>
                                             <Text>≤ 2 000 IU for pigs.</Text>
                                          </Para>
                                       </ListItem>
                                    </UnorderedList>
                                 </P>
                              </Division>
                              <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Number>5.</Number>
                                 <P>
                                    <Text>Simultaneous use with Vitamin D<Inferior>2</Inferior> is not allowed.</Text>
                                 </P>
                              </Division>
                              <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Number>6.</Number>
                                 <P>
                                    <Text>For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the very hazardous effects of vitamin D<Inferior>3</Inferior> by inhalation. Where the risks associated to those very hazardous effects cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.</Text>
                                 </P>
                              </Division>
                           </td><td rowspan="12">11 September 2027</td></tr><tr><td>Milk replacers for piglets</td><td>—</td><td>—</td><td>10 000 IU</td></tr><tr><td>Bovines</td><td>—</td><td>—</td><td>4 000 IU</td></tr><tr><td>Milk replacers for calves</td><td>—</td><td>—</td><td>10 000 IU</td></tr><tr><td>Ovines</td><td>—</td><td>—</td><td>4 000 IU</td></tr><tr><td>Chickens for fattening</td><td>—</td><td>—</td><td>5 000 IU</td></tr><tr><td>Turkeys</td><td>—</td><td>—</td><td>5 000 IU</td></tr><tr><td>Other poultry</td><td>—</td><td>—</td><td>3 200 IU</td></tr><tr><td>Equines</td><td>—</td><td>—</td><td>4 000 IU</td></tr><tr><td>Salmonids</td><td>—</td><td>—</td><td>60 000 IU</td></tr><tr><td>Other fish species</td><td>—</td><td>—</td><td>3 000 IU</td></tr><tr><td>Other animal species</td><td>—</td><td>—</td><td>2 000 IU</td></tr></tbody>
                  </table>
               </Tabular>
            </ScheduleBody>
         </Schedule>
      </Schedules>
   </EURetained><Footnotes><Footnote id="f00001">
         <FootnoteText>
            <Para>
               <Text>
                  <Citation id="c00001" Class="EuropeanUnionOfficialJournal" Year="2003" URI="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2003.268.01.0029.01.ENG" Date="2003-10-18">OJ L 268, 18.10.2003, p. 29</Citation>.</Text>
            </Para>
         </FootnoteText>
      </Footnote><Footnote id="f00002">
         <FootnoteText>
            <Para>
               <Text>Commission Implementing Regulation (EU) 2017/1492 of 21 August 2017 concerning the authorisation of cholecalciferol as a feed additive for all animal species (<Citation id="c00002" Class="EuropeanUnionOfficialJournal" Year="2017" URI="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2017.216.01.0019.01.ENG" Date="2017-08-22">OJ L 216, 22.8.2017, p. 19</Citation>).</Text>
            </Para>
         </FootnoteText>
      </Footnote><Footnote id="f00003">
         <FootnoteText>
            <Para>
               <Text>
                  <Emphasis>EFSA Journal</Emphasis> 2017;15(3):4713.</Text>
            </Para>
         </FootnoteText>
      </Footnote><Footnote id="f00004">
         <FootnoteText>
            <Para>
               <Text>
                  <Emphasis>EFSA Journal</Emphasis> 2019;17(1):5540.</Text>
            </Para>
         </FootnoteText>
      </Footnote><Footnote id="f00005">
         <FootnoteText>
            <Para>
               <Text>
                  <Emphasis>EFSA Journal</Emphasis> 2012;10(12):2968</Text>
            </Para>
         </FootnoteText>
      </Footnote></Footnotes></Legislation>