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					<dc:identifier>http://www.legislation.gov.uk/eur/2018/1258</dc:identifier><dc:title>Commission Implementing Regulation (EU) 2018/1258 of 18 September 2018 granting a Union authorisation for the biocidal product family Ecolab Iodine PT3 Family (Text with EEA relevance)</dc:title><dct:alternative>Commission Implementing Regulation (EU) 2018/1258</dct:alternative><dc:description>Commission Implementing Regulation (EU) 2018/1258 of 18 September 2018 granting a Union authorisation for the biocidal product family Ecolab Iodine PT3 Family (Text with EEA relevance)</dc:description><dc:modified>2020-12-10</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:32018R1258</dc:source><dc:type>text</dc:type><dc:format>text/xml</dc:format><dc:language>en</dc:language><dct:valid>2018-09-18</dct:valid>
					
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               <Uppercase>Commission Implementing Regulation</Uppercase> (EU) 2018/1258</Text>
            <Text>of 18 September 2018</Text>
            <Text>granting a Union authorisation for the biocidal product family Ecolab Iodine PT3 Family</Text>
            <Text>(Text with EEA relevance)</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 (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products<FootnoteRef Ref="f00001"/>, and in particular Article 44(5) thereof,</Text>
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               <Text>Whereas:</Text>
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            <Division>
               <Number>(1)</Number>
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                  <Text>On 23 July 2015, Ecolab Deutschland GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named Ecolab Iodine PT3 Family (‘the product family’) of product-type 3, as described in Annex V to that Regulation. The Netherlands agreed that their competent authority referred to in Article 43(1) of Regulation (EU) No 528/2012 evaluate this application. The application was recorded under the case number BC-VG018734-32 in the Register for Biocidal Products (‘the Register’).</Text>
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               <Number>(2)</Number>
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                  <Text>The biocidal product family contains iodine, including polyvinylpyrrolidone iodine, as active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012. Taking into account the intrinsic properties of the active substance, once the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100<FootnoteRef Ref="f00002"/> will become applicable, the Commission will consider the need to review the approval of iodine, including polyvinylpyrrolidone iodine, in accordance with Article 15 of Regulation (EU) No 528/2012. Depending on the outcome of that review, the Commission will then consider whether the Union authorisations for products containing the active substance have to be reviewed in accordance with Article 48 of Regulation (EU) No 528/2012.</Text>
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               <Number>(3)</Number>
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                  <Text>On 6 June 2017, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, the assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).</Text>
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            </Division>
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               <Number>(4)</Number>
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                  <Text>On 12 January 2018, the Agency submitted to the Commission an opinion<FootnoteRef Ref="f00003"/>, including the draft summary of the biocidal product characteristics (‘SPC’) and the final assessment report on the product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. The opinion concluded that the product family falls within the definition of ‘biocidal product family’ laid down in Article 3(1)(s) of Regulation (EU) No 528/2012, that it was found eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, the product family meets the conditions laid down in Article 19(1) and (6) of that Regulation.</Text>
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               <Number>(5)</Number>
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                  <Text>On 26 February 2018, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.</Text>
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            </Division>
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               <Number>(6)</Number>
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                  <Text>The Commission concurs with the opinion of the Agency and considers therefore appropriate to grant a Union authorisation for the biocidal product family, and to record the SPC and the assessment report on the product family in the Register in accordance with Article 71(6) of Regulation (EU) No 528/2012.</Text>
               </P>
            </Division>
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               <Number>(7)</Number>
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                  <Text>The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,</Text>
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               <Text>HAS ADOPTED THIS REGULATION:</Text>
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      <EUBody DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/body" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/body" NumberOfProvisions="2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
         <P1 DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/article/1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/article/1" id="article-1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
            <Pnumber>Article 1</Pnumber>
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               <Text>A Union authorisation is granted to Ecolab Deutschland GmbH for the biocidal product family Ecolab Iodine PT3 Family with authorisation number EU-0018398-0000.</Text>
            </P1para>
            <P1para>
               <Text>The Union authorisation is valid from 11 October 2018 until 30 September 2028.</Text>
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               <Text>The Union authorisation is subject to compliance with the SPC set out in the Annex.</Text>
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            <Pnumber>Article 2</Pnumber>
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               <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>
         <SignedSection DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/signature" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/signature" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
            <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, 18 September 2018.</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 RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
         <Schedule DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex" id="annex" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
            <Number>ANNEX</Number>
            <TitleBlock>
               <Title>
                  <Strong>Summary of product characteristics for a biocidal product family</Strong>
               </Title>
            </TitleBlock>
            <ScheduleBody>
               <P DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/paragraph/1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/paragraph/1" id="annex-paragraph-1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                  <Text>Ecolab Iodine PT3 Family</Text>
               </P>
               <P DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/paragraph/2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/paragraph/2" id="annex-paragraph-2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                  <Text>Product type 3 — Veterinary hygiene (Disinfectants)</Text>
               </P>
               <P DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/paragraph/3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/paragraph/3" id="annex-paragraph-3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                  <Text>Authorisation number: EU-0018398-0000</Text>
               </P>
               <P DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/paragraph/4" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/paragraph/4" id="annex-paragraph-4" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                  <Text>R4BP asset number: EU-0018398-0000</Text>
               </P>
               <EUPart DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/I" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/I" id="annex-part-I" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                  <Number>PART I</Number>
                  <Title>
                     <Strong>FIRST INFORMATION LEVEL</Strong>
                  </Title>
                  <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/I/division/1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/I/division/1" id="annex-part-I-division-1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                     <Number>1.</Number>
                     <Title>
                        <Strong>ADMINISTRATIVE INFORMATION</Strong>
                     </Title>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/I/division/1/division/1.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/I/division/1/division/1.1" id="annex-part-I-division-1-division-1.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>1.1.</Number>
                        <Title>
                           <Strong>Family name</Strong>
                        </Title>
                        <P>
                           <Tabular Orientation="portrait">
                              <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                 <tbody><tr><td>Name</td><td>Ecolab Iodine PT3 Family</td></tr><tr><td/><td/></tr></tbody>
                              </table>
                           </Tabular>
                        </P>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/I/division/1/division/1.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/I/division/1/division/1.2" id="annex-part-I-division-1-division-1.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>1.2.</Number>
                        <Title>
                           <Strong>Product type(s)</Strong>
                        </Title>
                        <P>
                           <Tabular Orientation="portrait">
                              <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                 <tbody><tr><td>Product type(s)</td><td>PT03 — Veterinary hygiene (Disinfectants)</td></tr><tr><td/><td/></tr></tbody>
                              </table>
                           </Tabular>
                        </P>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/I/division/1/division/1.3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/I/division/1/division/1.3" id="annex-part-I-division-1-division-1.3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>1.3.</Number>
                        <Title>
                           <Strong>Authorisation holder</Strong>
                        </Title>
                        <P>
                           <Tabular Orientation="portrait">
                              <table xmlns="http://www.w3.org/1999/xhtml" cols="3">
                                 <tbody><tr><td rowspan="2">Name and address of the authorisation holder</td><td>Name</td><td>Ecolab Deutschland GmbH</td></tr><tr><td>Address</td><td>Ecolab-Allee 1, 40789 Monheim, Germany</td></tr><tr><td>Authorisation number</td><td colspan="2">EU-0018398-0000</td></tr><tr><td>
                                          <Emphasis xmlns="http://www.legislation.gov.uk/namespaces/legislation">R4BP asset number</Emphasis>
                                       </td><td colspan="2">EU-0018398-0000</td></tr><tr><td>Date of the authorisation</td><td colspan="2">11 October 2018</td></tr><tr><td>Expiry date of the authorisation</td><td colspan="2">30 September 2028</td></tr></tbody>
                              </table>
                           </Tabular>
                        </P>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/I/division/1/division/1.4" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/I/division/1/division/1.4" id="annex-part-I-division-1-division-1.4" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>1.4.</Number>
                        <Title>
                           <Strong>Manufacturer(s) of the biocidal products</Strong>
                        </Title>
                        <P>
                           <Tabular Orientation="portrait">
                              <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                 <tbody><tr><td>Name of manufacturer</td><td>Ecolab Europe GmbH</td></tr><tr><td>Address of manufacturer</td><td>Richtistrasse 7, 8304 Walliselen Switzerland</td></tr><tr><td>Location of manufacturing sites</td><td>
                                          <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                             <Text>Ecolab Baglan, ECOLAB CONTAMINATION CONTROL BRUNEL WAY, BAGLAN ENERGY PARK, NEATH, SA11 2GA South Wales United Kingdom</Text>
                                          </Para>
                                          <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                             <Text>Ecolab Leeds, LOTHERTON WAY, GARFORTH, LEEDS LS25 2JY Leeds United Kingdom</Text>
                                          </Para>
                                          <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                             <Text>Ecolab Rovigo, Viale del Lavoro 10, 45100 Rovigo Italy</Text>
                                          </Para>
                                          <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                             <Text>Ecolab Biebesheim Nalco Deutschland Manufacturing GmbH und Co.KG, Justus-von-Liebig-Str. 11 D-64584 Biebesheim Germany</Text>
                                          </Para>
                                          <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                             <Text>Ecolab NETHERLANDS BV, NL01ECOLAB, BRUGWAL 11 3432NZ NIEUWEGEIN Netherlands</Text>
                                          </Para>
                                          <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                             <Text>Ecolab Weavergate, ECOLAB WEAVERGATE PLANT WINNINGTON AVENUE, NORTHWICH CHESHIRE CW8 3AA NORTHWICH United Kingdom</Text>
                                          </Para>
                                          <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                             <Text>Ecolab Mullingar, Forest Park, Mullingar Ind. Estate, Mullingar, Co. Zone C Westmeath Ireland</Text>
                                          </Para>
                                          <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                             <Text>Ecolab Maribor, Ecolab d.o.o.,Vajngerlova 4 2000 Maribor Slovenia</Text>
                                          </Para>
                                          <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                             <Text>Ecolab Rozzano, VIA GRANDI 9/11 20089 ROZZANO Italy</Text>
                                          </Para>
                                          <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                             <Text>Ecolab B.V.B.A, Havenlaan: 4 3980 Tessenderlo Belgium</Text>
                                          </Para>
                                          <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                             <Text>Ecolab CELRA, Nalco Española Manufacturing, SLU C/Tramuntana s/n, Polígono Industrial de Celrà 17460 CELRÀ Spain</Text>
                                          </Para>
                                          <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                             <Text>Ecolab Chalons Ecolab production France SAS, BP509 Avenue de Général Patton 51006 Châlons-en-Champagne France</Text>
                                          </Para>
                                          <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                             <Text>Ecolab Mandra, 25km Old National Road Athens Mandra, oo Attica Greece</Text>
                                          </Para>
                                          <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                             <Text>NALCO FINLAND MANUFACTURING OY, Kivikummuntie 1 FIN-07955 Tesjoki Finland</Text>
                                          </Para>
                                       </td></tr></tbody>
                              </table>
                           </Tabular>
                        </P>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/I/division/1/division/1.5" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/I/division/1/division/1.5" id="annex-part-I-division-1-division-1.5" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>1.5.</Number>
                        <Title>
                           <Strong>Manufacturer(s) of the active substance(s)</Strong>
                        </Title>
                        <P>
                           <Tabular Orientation="portrait">
                              <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                 <tbody><tr><td>Active substance</td><td>Polyvinylpyrrolidone iodine</td></tr><tr><td>Name of manufacturer</td><td>ISP Chemicals LLC, Affiliate of Ashland Inc.</td></tr><tr><td>Address of manufacturer</td><td>455 N. MAIN ST. (HWY 95) KY 42029 CALVERT CITY United States</td></tr><tr><td>Location of manufacturing sites</td><td>455 N. MAIN ST. (HWY 95) KY 42029 CALVERT CITY United States</td></tr></tbody>
                              </table>
                           </Tabular>
                        </P>
                        <P>
                           <Tabular Orientation="portrait">
                              <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                 <tbody><tr><td>Active substance</td><td>Iodine</td></tr><tr><td>Name of manufacturer</td><td>ACF Minera S.A.</td></tr><tr><td>Address of manufacturer</td><td>San Martín No 499 00 Iquique Chile</td></tr><tr><td>Location of manufacturing sites</td><td>Lagunas mine 00 Pozo Almonte Chile</td></tr></tbody>
                              </table>
                           </Tabular>
                        </P>
                        <P>
                           <Tabular Orientation="portrait">
                              <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                 <tbody><tr><td>Active substance</td><td>Iodine</td></tr><tr><td>Name of manufacturer</td><td>SQM S.A.</td></tr><tr><td>Address of manufacturer</td><td>Los Militares 4290 Piso 4 Santiago Chile</td></tr><tr><td>Location of manufacturing sites</td><td>Nueva Victoria plant 00 Pedro de Valdivia Chile</td></tr></tbody>
                              </table>
                           </Tabular>
                        </P>
                        <P>
                           <Tabular Orientation="portrait">
                              <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                 <tbody><tr><td>Active substance</td><td>Iodine</td></tr><tr><td>Name of manufacturer</td><td>Cosayach Nitratos S.A.</td></tr><tr><td>Address of manufacturer</td><td>Amunategui 178 00 Santiago Chile</td></tr><tr><td>Location of manufacturing sites</td><td>S.C.M. Cosayach Cala Cala 00 Pozo Almonte Chile</td></tr></tbody>
                              </table>
                           </Tabular>
                        </P>
                        <P>
                           <Tabular Orientation="portrait">
                              <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                 <tbody><tr><td>Active substance</td><td>Iodine</td></tr><tr><td>Name of manufacturer</td><td>Nihon Tennen Gas Development Co., Ltd/ Kanto Natural Gas Development Co., Ltd</td></tr><tr><td>Address of manufacturer</td><td>661 Mobara Chiba 297-8550 Mobara City Japan</td></tr><tr><td>Location of manufacturing sites</td><td>Chiba Plant, 2508 Minami-Hinata, Shirako-Machi, Chosei-Gun 299-4205 Chiba Japan</td></tr></tbody>
                              </table>
                           </Tabular>
                        </P>
                     </Division>
                  </Division>
                  <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/I/division/2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/I/division/2" id="annex-part-I-division-2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                     <Number>2.</Number>
                     <Title>
                        <Strong>PRODUCT FAMILY COMPOSITION AND FORMULATION</Strong>
                     </Title>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/I/division/2/division/2.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/I/division/2/division/2.1" id="annex-part-I-division-2-division-2.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>2.1.</Number>
                        <Title>
                           <Strong>Qualitative and quantitative information on the composition of the family</Strong>
                        </Title>
                        <P>
                           <Tabular Orientation="portrait">
                              <table xmlns="http://www.w3.org/1999/xhtml" cols="7">
                                 <tbody><tr><th rowspan="2">Common name</th><th rowspan="2">IUPAC name</th><th rowspan="2">Function</th><th rowspan="2">CAS number</th><th rowspan="2">EC number</th><th colspan="2">Content (%)</th></tr><tr><th>Min</th><th>Max</th></tr><tr><td>Polyvinylpyrrolidone iodine</td><td/><td>Active substance</td><td>25655-41-8</td><td/><td>1</td><td>3</td></tr><tr><td>Iodine</td><td/><td>Active substance</td><td>7553-56-2</td><td>231-442-4</td><td>0,11</td><td>0,33</td></tr></tbody>
                              </table>
                           </Tabular>
                        </P>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/I/division/2/division/2.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/I/division/2/division/2.2" id="annex-part-I-division-2-division-2.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>2.2.</Number>
                        <Title>
                           <Strong>Type(s) of formulation</Strong>
                        </Title>
                        <P>
                           <Tabular Orientation="portrait">
                              <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                 <tbody><tr><td>Formulation(s)</td><td>AL — Any other liquid</td></tr><tr><td/><td/></tr></tbody>
                              </table>
                           </Tabular>
                        </P>
                     </Division>
                  </Division>
               </EUPart>
               <EUPart DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II" id="annex-part-II" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                  <Number>PART II</Number>
                  <Title>
                     <Strong>SECOND INFORMATION LEVEL — META SPC(S)</Strong>
                  </Title>
                  <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1" id="annex-part-II-division-1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                     <Title>
                        <Strong>META SPC 1</Strong>
                     </Title>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1/division/1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1/division/1" id="annex-part-II-division-1-division-1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>1.</Number>
                        <Title>META SPC 1 ADMINISTRATIVE INFORMATION</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1/division/1/division/1.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1/division/1/division/1.1" id="annex-part-II-division-1-division-1-division-1.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>1.1.</Number>
                           <Title>
                              <Strong>Meta SPC 1 identifier</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Identifier</td><td>meta SPC 1</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1/division/1/division/1.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1/division/1/division/1.2" id="annex-part-II-division-1-division-1-division-1.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>1.2.</Number>
                           <Title>
                              <Strong>Suffix to the authorisation number</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Number</td><td>1-1</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1/division/1/division/1.3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1/division/1/division/1.3" id="annex-part-II-division-1-division-1-division-1.3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>1.3.</Number>
                           <Title>
                              <Strong>Product type(s)</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Product type(s)</td><td>PT03 — Veterinary hygiene (Disinfectants)</td></tr><tr><td/><td/></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1/division/2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1/division/2" id="annex-part-II-division-1-division-2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>2.</Number>
                        <Title>META SPC 1 COMPOSITION</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1/division/2/division/2.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1/division/2/division/2.1" id="annex-part-II-division-1-division-2-division-2.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>2.1.</Number>
                           <Title>
                              <Strong>Qualitative and quantitative information on the composition of the meta SPC 1</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="7">
                                    <tbody><tr><th rowspan="2">Common name</th><th rowspan="2">IUPAC name</th><th rowspan="2">Function</th><th rowspan="2">CAS number</th><th rowspan="2">EC number</th><th colspan="2">Content (%)</th></tr><tr><th>Min</th><th>Max</th></tr><tr><td>Polyvinylpyrrolidone iodine</td><td/><td>Active substance</td><td>25655-41-8</td><td/><td>1</td><td>1</td></tr><tr><td>Iodine</td><td/><td>Active substance</td><td>7553-56-2</td><td>231-442-4</td><td>0,11</td><td>0,11</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1/division/2/division/2.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1/division/2/division/2.2" id="annex-part-II-division-1-division-2-division-2.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>2.2.</Number>
                           <Title>
                              <Strong>Type(s) of formulation of the meta SPC 1</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Formulation</td><td>AL — Any other liquid</td></tr><tr><td/><td/></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1/division/3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1/division/3" id="annex-part-II-division-1-division-3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>3.</Number>
                        <Title>HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1</Title>
                        <P>
                           <Tabular Orientation="portrait">
                              <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                 <tbody><tr><td>Hazard statements</td><td/></tr><tr><td>Precautionary statements</td><td/></tr></tbody>
                              </table>
                           </Tabular>
                        </P>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1/division/4" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1/division/4" id="annex-part-II-division-1-division-4" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>4.</Number>
                        <Title>AUTHORISED USE(S) OF THE META SPC 1</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1/division/4/division/4.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1/division/4/division/4.1" id="annex-part-II-division-1-division-4-division-4.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>4.1.</Number>
                           <Title>
                              <Strong>Use description</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <Title>
                                    <Strong>Table 1. Use # 1 – Teat dips for post-milking disinfection</Strong>
                                 </Title>
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Product Type</td><td>PT03 — Veterinary hygiene (Disinfectants)</td></tr><tr><td>Where relevant, an exact description of the authorised use</td><td>—</td></tr><tr><td>Target organism(s) (including development stage)</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Bacteria</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Yeasts</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Enveloped viruses</Text>
                                             </Para>
                                          </td></tr><tr><td>Field(s) of use</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Indoor</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)</Text>
                                             </Para>
                                          </td></tr><tr><td>Application method(s)</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Manual dipping using a dip cup -</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>3-10 ml (dipping)</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>1-3 post-milking disinfections per day</Text>
                                             </Para>
                                          </td></tr><tr><td>Application rate(s) and frequency</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>3-10 ml (dipping)</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Post-milking application 1x - 3x per day (apply after every milking).</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Per milking event 3-10 ml of product are needed (animals with four teats).</Text>
                                             </Para>
                                          </td></tr><tr><td>Category(ies) of users</td><td>Professional</td></tr><tr><td>Pack sizes and packaging material</td><td>container, Plastic: HDPE, 0,5-1 000 l</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1/division/4/division/4.1/division/4.1.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1/division/4/division/4.1/division/4.1.1" id="annex-part-II-division-1-division-4-division-4.1-division-4.1.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.1.</Number>
                              <Title>
                                 <Emphasis>Use-specific instructions for use</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 1</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1/division/4/division/4.1/division/4.1.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1/division/4/division/4.1/division/4.1.2" id="annex-part-II-division-1-division-4-division-4.1-division-4.1.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.2.</Number>
                              <Title>
                                 <Emphasis>Use-specific risk mitigation measures</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 1</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1/division/4/division/4.1/division/4.1.3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1/division/4/division/4.1/division/4.1.3" id="annex-part-II-division-1-division-4-division-4.1-division-4.1.3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.3.</Number>
                              <Title>
                                 <Emphasis>Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 1</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1/division/4/division/4.1/division/4.1.4" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1/division/4/division/4.1/division/4.1.4" id="annex-part-II-division-1-division-4-division-4.1-division-4.1.4" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.4.</Number>
                              <Title>
                                 <Emphasis>Where specific to the use, the instructions for safe disposal of the product and its packaging</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 1</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1/division/4/division/4.1/division/4.1.5" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1/division/4/division/4.1/division/4.1.5" id="annex-part-II-division-1-division-4-division-4.1-division-4.1.5" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.5.</Number>
                              <Title>
                                 <Emphasis>Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 1</Text>
                              </P>
                           </Division>
                        </Division>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1/division/5" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1/division/5" id="annex-part-II-division-1-division-5" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>5.</Number>
                        <Title>GENERAL DIRECTIONS FOR USE<FootnoteRef Ref="f00004"/> OF THE META SPC 1</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1/division/5/division/5.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1/division/5/division/5.1" id="annex-part-II-division-1-division-5-division-5.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.1.</Number>
                           <Title>
                              <Strong>Instructions for use</Strong>
                           </Title>
                           <P>
                              <Text>Always read the label or leaflet before use and follow all the instructions provided.</Text>
                           </P>
                           <P>
                              <Text>Product to be applied post-milking by use of a dipping cup.</Text>
                           </P>
                           <P>
                              <Text>The products must be brought to temperatures above 20 °C before use.</Text>
                           </P>
                           <P>
                              <Text>Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.</Text>
                           </P>
                           <P>
                              <Text>The use of a dosing pump for filling the product into the application equipment is recommended.</Text>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1/division/5/division/5.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1/division/5/division/5.2" id="annex-part-II-division-1-division-5-division-5.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.2.</Number>
                           <Title>
                              <Strong>Risk mitigation measures</Strong>
                           </Title>
                           <P>
                              <Text>In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.</Text>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1/division/5/division/5.3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1/division/5/division/5.3" id="annex-part-II-division-1-division-5-division-5.3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.3.</Number>
                           <Title>
                              <Strong>Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment</Strong>
                           </Title>
                           <P>
                              <Text>Potential Health Effects</Text>
                           </P>
                           <P>
                              <Text>Eyes: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>Skin: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>Ingestion: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>Inhalation: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>Chronic Exposure: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>First Aid Measures:</Text>
                           </P>
                           <P>
                              <Text>Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.</Text>
                           </P>
                           <P>
                              <Text>Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.</Text>
                           </P>
                           <P>
                              <Text>Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.</Text>
                           </P>
                           <P>
                              <Text>Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.</Text>
                           </P>
                           <P>
                              <Text>Environmental emergency measures: Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer If legally allowed.</Text>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1/division/5/division/5.4" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1/division/5/division/5.4" id="annex-part-II-division-1-division-5-division-5.4" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.4.</Number>
                           <Title>
                              <Strong>Instructions for safe disposal of the product and its packaging</Strong>
                           </Title>
                           <P>
                              <Text>At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.</Text>
                           </P>
                           <P>
                              <Text>European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.</Text>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1/division/5/division/5.5" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1/division/5/division/5.5" id="annex-part-II-division-1-division-5-division-5.5" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.5.</Number>
                           <Title>
                              <Strong>Conditions of storage and shelf-life of the product under normal conditions of storage</Strong>
                           </Title>
                           <P>
                              <Text>Store between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.</Text>
                           </P>
                           <P>
                              <Text>Shelf life: 24 months</Text>
                           </P>
                        </Division>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1/division/6" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1/division/6" id="annex-part-II-division-1-division-6" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>6.</Number>
                        <Title>OTHER INFORMATION</Title>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1/division/7" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1/division/7" id="annex-part-II-division-1-division-7" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>7.</Number>
                        <Title>THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1/division/7/division/7.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1/division/7/division/7.1" id="annex-part-II-division-1-division-7-division-7.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>7.1.</Number>
                           <Title>
                              <Strong>Trade name(s), authorisation number and specific composition of each individual product</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="6">
                                    <tbody><tr><td>Trade name(s)</td><td colspan="5">Ioklar Super Dip D</td></tr><tr><td>Authorisation number</td><td colspan="5">EU-0018398-0001 1-1</td></tr><tr><th>Common name</th><th>IUPAC name</th><th>Function</th><th>CAS number</th><th>EC number</th><th>Content (%)</th></tr><tr><td>Polyvinylpyrrolidone iodine</td><td/><td>Active substance</td><td>25655-41-8</td><td/><td>1</td></tr><tr><td>Iodine</td><td/><td>Active substance</td><td>7553-56-2</td><td>231-442-4</td><td>0,11</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/1/division/7/division/7.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/1/division/7/division/7.2" id="annex-part-II-division-1-division-7-division-7.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>7.2.</Number>
                           <Title>
                              <Strong>Trade name(s), authorisation number and specific composition of each individual product</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="6">
                                    <tbody><tr><td>Trade name(s)</td><td colspan="5">IoKlar Superdip</td></tr><tr><td>Authorisation number</td><td colspan="5">EU-0018398-0002 1-1</td></tr><tr><th>Common name</th><th>IUPAC name</th><th>Function</th><th>CAS number</th><th>EC number</th><th>Content (%)</th></tr><tr><td>Polyvinylpyrrolidone iodine</td><td/><td>Active substance</td><td>25655-41-8</td><td/><td>1</td></tr><tr><td>Iodine</td><td/><td>Active substance</td><td>7553-56-2</td><td>231-442-4</td><td>0,11</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                     </Division>
                  </Division>
                  <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2" id="annex-part-II-division-2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                     <Title>
                        <Strong>META SPC 2</Strong>
                     </Title>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2/division/1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2/division/1" id="annex-part-II-division-2-division-1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>1.</Number>
                        <Title>META SPC 2 ADMINISTRATIVE INFORMATION</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2/division/1/division/1.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2/division/1/division/1.1" id="annex-part-II-division-2-division-1-division-1.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>1.1.</Number>
                           <Title>
                              <Strong>Meta SPC 2 identifier</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Identifier</td><td>meta SPC 2</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2/division/1/division/1.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2/division/1/division/1.2" id="annex-part-II-division-2-division-1-division-1.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>1.2.</Number>
                           <Title>
                              <Strong>Suffix to the authorisation number</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Number</td><td>1-2</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2/division/1/division/1.3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2/division/1/division/1.3" id="annex-part-II-division-2-division-1-division-1.3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>1.3.</Number>
                           <Title>
                              <Strong>Product type(s)</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Product type(s)</td><td>PT03 — Veterinary hygiene (Disinfectants)</td></tr><tr><td/><td/></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2/division/2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2/division/2" id="annex-part-II-division-2-division-2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>2.</Number>
                        <Title>META SPC 2 COMPOSITION</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2/division/2/division/2.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2/division/2/division/2.1" id="annex-part-II-division-2-division-2-division-2.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>2.1.</Number>
                           <Title>
                              <Strong>Qualitative and quantitative information on the composition of the meta SPC 2</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="7">
                                    <tbody><tr><th rowspan="2">Common name</th><th rowspan="2">IUPAC name</th><th rowspan="2">Function</th><th rowspan="2">CAS number</th><th rowspan="2">EC number</th><th colspan="2">Content (%)</th></tr><tr><th>Min</th><th>Max</th></tr><tr><td>Polyvinylpyrrolidone iodine</td><td/><td>Active substance</td><td>25655-41-8</td><td/><td>1,35</td><td>1,35</td></tr><tr><td>Iodine</td><td/><td>Active substance</td><td>7553-56-2</td><td>231-442-4</td><td>0,15</td><td>0,15</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2/division/2/division/2.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2/division/2/division/2.2" id="annex-part-II-division-2-division-2-division-2.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>2.2.</Number>
                           <Title>
                              <Strong>Type(s) of formulation of the meta SPC 2</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Formulation</td><td>AL — Any other liquid</td></tr><tr><td/><td/></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2/division/3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2/division/3" id="annex-part-II-division-2-division-3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>3.</Number>
                        <Title>HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2</Title>
                        <P>
                           <Tabular Orientation="portrait">
                              <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                 <tbody><tr><td>Hazard statements</td><td/></tr><tr><td>Precautionary statements</td><td/></tr></tbody>
                              </table>
                           </Tabular>
                        </P>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2/division/4" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2/division/4" id="annex-part-II-division-2-division-4" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>4.</Number>
                        <Title>AUTHORISED USE(S) OF THE META SPC 2</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2/division/4/division/4.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2/division/4/division/4.1" id="annex-part-II-division-2-division-4-division-4.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>4.1.</Number>
                           <Title>
                              <Strong>Use description</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <Title>
                                    <Strong>Table 2. Use # 1 – Teat dips for post-milking disinfection</Strong>
                                 </Title>
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Product Type</td><td>PT03 — Veterinary hygiene (Disinfectants)</td></tr><tr><td>Where relevant, an exact description of the authorised use</td><td>—</td></tr><tr><td>Target organism(s) (including development stage)</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Bacteria</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Yeasts</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Enveloped viruses</Text>
                                             </Para>
                                          </td></tr><tr><td>Field(s) of use</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Indoor</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)</Text>
                                             </Para>
                                          </td></tr><tr><td>Application method(s)</td><td>Manual dipping using a dip cup</td></tr><tr><td>Application rate(s) and frequency</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Post-milking application 1x - 3x per day (apply after every milking).</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Per milking event 3-10 ml of product are needed (animals with four teats).</Text>
                                             </Para>
                                          </td></tr><tr><td>Category(ies) of users</td><td>Professional</td></tr><tr><td>Pack sizes and packaging material</td><td>0,5 l – 1 000 l HDPE container</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2/division/4/division/4.1/division/4.1.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2/division/4/division/4.1/division/4.1.1" id="annex-part-II-division-2-division-4-division-4.1-division-4.1.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.1.</Number>
                              <Title>
                                 <Emphasis>Use-specific instructions for use</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 2</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2/division/4/division/4.1/division/4.1.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2/division/4/division/4.1/division/4.1.2" id="annex-part-II-division-2-division-4-division-4.1-division-4.1.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.2.</Number>
                              <Title>
                                 <Emphasis>Use-specific risk mitigation measures</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 2</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2/division/4/division/4.1/division/4.1.3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2/division/4/division/4.1/division/4.1.3" id="annex-part-II-division-2-division-4-division-4.1-division-4.1.3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.3.</Number>
                              <Title>
                                 <Emphasis>Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 2</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2/division/4/division/4.1/division/4.1.4" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2/division/4/division/4.1/division/4.1.4" id="annex-part-II-division-2-division-4-division-4.1-division-4.1.4" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.4.</Number>
                              <Title>
                                 <Emphasis>Where specific to the use, the instructions for safe disposal of the product and its packaging</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 2</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2/division/4/division/4.1/division/4.1.5" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2/division/4/division/4.1/division/4.1.5" id="annex-part-II-division-2-division-4-division-4.1-division-4.1.5" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.5.</Number>
                              <Title>
                                 <Emphasis>Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 2</Text>
                              </P>
                           </Division>
                        </Division>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2/division/5" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2/division/5" id="annex-part-II-division-2-division-5" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>5.</Number>
                        <Title>GENERAL DIRECTIONS FOR USE<FootnoteRef Ref="f00005"/> OF THE META SPC 2</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2/division/5/division/5.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2/division/5/division/5.1" id="annex-part-II-division-2-division-5-division-5.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.1.</Number>
                           <Title>
                              <Strong>Instructions for use</Strong>
                           </Title>
                           <P>
                              <Text>Always read the label or leaflet before use and follow all the instructions provided.</Text>
                           </P>
                           <P>
                              <Text>The products must be brought to temperatures above 20 °C before use.</Text>
                           </P>
                           <P>
                              <Text>Product to be applied post-milking by use of a dipping cup.</Text>
                           </P>
                           <P>
                              <Text>Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.</Text>
                           </P>
                           <P>
                              <Text>The use of a dosing pump for filling the product into the application equipment is recommended.</Text>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2/division/5/division/5.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2/division/5/division/5.2" id="annex-part-II-division-2-division-5-division-5.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.2.</Number>
                           <Title>
                              <Strong>Risk mitigation measures</Strong>
                           </Title>
                           <P>
                              <Text>In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.</Text>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2/division/5/division/5.3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2/division/5/division/5.3" id="annex-part-II-division-2-division-5-division-5.3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.3.</Number>
                           <Title>
                              <Strong>Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment</Strong>
                           </Title>
                           <P>
                              <Text>Potential Health Effects</Text>
                           </P>
                           <P>
                              <Text>Eyes: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>Skin: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>Ingestion: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>Inhalation: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>Chronic Exposure: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>First Aid Measures:</Text>
                           </P>
                           <P>
                              <Text>Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.</Text>
                           </P>
                           <P>
                              <Text>Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.</Text>
                           </P>
                           <P>
                              <Text>Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.</Text>
                           </P>
                           <P>
                              <Text>Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.</Text>
                           </P>
                           <P>
                              <Text>Environmental emergency measures: Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer If legally allowed.</Text>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2/division/5/division/5.4" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2/division/5/division/5.4" id="annex-part-II-division-2-division-5-division-5.4" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.4.</Number>
                           <Title>
                              <Strong>Instructions for safe disposal of the product and its packaging</Strong>
                           </Title>
                           <P>
                              <Text>At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.</Text>
                           </P>
                           <P>
                              <Text>European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.</Text>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2/division/5/division/5.5" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2/division/5/division/5.5" id="annex-part-II-division-2-division-5-division-5.5" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.5.</Number>
                           <Title>
                              <Strong>Conditions of storage and shelf-life of the product under normal conditions of storage</Strong>
                           </Title>
                           <P>
                              <Text>Store between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.</Text>
                           </P>
                           <P>
                              <Text>Shelf life: 24 months</Text>
                           </P>
                        </Division>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2/division/6" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2/division/6" id="annex-part-II-division-2-division-6" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>6.</Number>
                        <Title>OTHER INFORMATION</Title>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2/division/7" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2/division/7" id="annex-part-II-division-2-division-7" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>7.</Number>
                        <Title>THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2/division/7/division/7.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2/division/7/division/7.1" id="annex-part-II-division-2-division-7-division-7.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>7.1.</Number>
                           <Title>
                              <Strong>Trade name(s), authorisation number and specific composition of each individual product</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="6">
                                    <tbody><tr><td>Trade name(s)</td><td colspan="5">
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Io-Shield D</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>IoShield</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>MEPA Barrier D</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>BARIOPROTECT</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>MS Cow Udder BLOCK</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Iodocop EXTRA</Text>
                                             </Para>
                                          </td></tr><tr><td>Authorisation number</td><td colspan="5">EU-0018398-0003 1-2</td></tr><tr><th>Common name</th><th>IUPAC name</th><th>Function</th><th>CAS number</th><th>EC number</th><th>Content (%)</th></tr><tr><td>Polyvinylpyrrolidone iodine</td><td/><td>Active substance</td><td>25655-41-8</td><td/><td>1,35</td></tr><tr><td>Iodine</td><td/><td>Active substance</td><td>7553-56-2</td><td>231-442-4</td><td>0,15</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/2/division/7/division/7.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/2/division/7/division/7.2" id="annex-part-II-division-2-division-7-division-7.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>7.2.</Number>
                           <Title>
                              <Strong>Trade name(s), authorisation number and specific composition of each individual product</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="6">
                                    <tbody><tr><td>Trade name(s)</td><td colspan="5">
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>IoDark</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Iodocop EXTRA GREEN</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Mammizan Protect</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>MS Cow Udder BLACK</Text>
                                             </Para>
                                          </td></tr><tr><td>Authorisation number</td><td colspan="5">EU-0018398-0004 1-2</td></tr><tr><th>Common name</th><th>IUPAC name</th><th>Function</th><th>CAS number</th><th>EC number</th><th>Content (%)</th></tr><tr><td>Polyvinylpyrrolidone iodine</td><td/><td>Active substance</td><td>25655-41-8</td><td/><td>1,35</td></tr><tr><td>Iodine</td><td/><td>Active substance</td><td>7553-56-2</td><td>231-442-4</td><td>0,15</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                     </Division>
                  </Division>
                  <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3" id="annex-part-II-division-3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                     <Title>
                        <Strong>META SPC 3</Strong>
                     </Title>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/1" id="annex-part-II-division-3-division-1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>1.</Number>
                        <Title>META SPC 3 ADMINISTRATIVE INFORMATION</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/1/division/1.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/1/division/1.1" id="annex-part-II-division-3-division-1-division-1.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>1.1.</Number>
                           <Title>
                              <Strong>Meta SPC 3 identifier</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Identifier</td><td>meta SPC 3</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/1/division/1.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/1/division/1.2" id="annex-part-II-division-3-division-1-division-1.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>1.2.</Number>
                           <Title>
                              <Strong>Suffix to the authorisation number</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Number</td><td>1-3</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/1/division/1.3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/1/division/1.3" id="annex-part-II-division-3-division-1-division-1.3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>1.3.</Number>
                           <Title>
                              <Strong>Product type(s)</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Product type(s)</td><td>PT03 — Veterinary hygiene (Disinfectants)</td></tr><tr><td/><td/></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/2" id="annex-part-II-division-3-division-2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>2.</Number>
                        <Title>META SPC 3 COMPOSITION</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/2/division/2.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/2/division/2.1" id="annex-part-II-division-3-division-2-division-2.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>2.1.</Number>
                           <Title>
                              <Strong>Qualitative and quantitative information on the composition of the meta SPC 3</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="7">
                                    <tbody><tr><th rowspan="2">Common name</th><th rowspan="2">IUPAC name</th><th rowspan="2">Function</th><th rowspan="2">CAS number</th><th rowspan="2">EC number</th><th colspan="2">Content (%)</th></tr><tr><th>Min</th><th>Max</th></tr><tr><td>Polyvinylpyrrolidone iodine</td><td/><td>Active substance</td><td>25655-41-8</td><td/><td>2,45</td><td>2,45</td></tr><tr><td>Iodine</td><td/><td>Active substance</td><td>7553-56-2</td><td>231-442-4</td><td>0,27</td><td>0,27</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/2/division/2.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/2/division/2.2" id="annex-part-II-division-3-division-2-division-2.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>2.2.</Number>
                           <Title>
                              <Strong>Type(s) of formulation of the meta SPC 3</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Formulation</td><td>AL — Any other liquid</td></tr><tr><td/><td/></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/3" id="annex-part-II-division-3-division-3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>3.</Number>
                        <Title>HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3</Title>
                        <P>
                           <Tabular Orientation="portrait">
                              <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                 <tbody><tr><td>Hazard statements</td><td>Harmful to aquatic life with long lasting effects.</td></tr><tr><td>Precautionary statements</td><td>Avoid release to the environment.</td></tr></tbody>
                              </table>
                           </Tabular>
                        </P>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/4" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/4" id="annex-part-II-division-3-division-4" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>4.</Number>
                        <Title>AUTHORISED USE(S) OF THE META SPC 3</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/4/division/4.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/4/division/4.1" id="annex-part-II-division-3-division-4-division-4.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>4.1.</Number>
                           <Title>
                              <Strong>Use description</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <Title>
                                    <Strong>Table 3. Use # 1 – Teat dips or sprays for post-milking disinfection</Strong>
                                 </Title>
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Product Type</td><td>PT03 — Veterinary hygiene (Disinfectants)</td></tr><tr><td>Where relevant, an exact description of the authorised use</td><td>—</td></tr><tr><td>Target organism(s) (including development stage)</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Bacteria</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Yeasts</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Enveloped viruses</Text>
                                             </Para>
                                          </td></tr><tr><td>Field(s) of use</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Indoor</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)</Text>
                                             </Para>
                                          </td></tr><tr><td>Application method(s)</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Dipping or spraying:</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Manual dipping using a dip cup or</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Manual spraying using a trigger sprayer or</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Manual spraying using an electronic sprayer or</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Automated spraying by robot.</Text>
                                             </Para>
                                          </td></tr><tr><td>Application rate(s) and frequency</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Post-milking application 1x – 3x per day</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Per milking event 3-10 ml (dipping) to 10-15 ml (spraying) of product are needed (animals with four teats).</Text>
                                             </Para>
                                          </td></tr><tr><td>Category(ies) of users</td><td>Professional</td></tr><tr><td>Pack sizes and packaging material</td><td>0,5 l – 1 000 l HDPE container</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/4/division/4.1/division/4.1.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/4/division/4.1/division/4.1.1" id="annex-part-II-division-3-division-4-division-4.1-division-4.1.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.1.</Number>
                              <Title>
                                 <Emphasis>Use-specific instructions for use</Emphasis>
                              </Title>
                              <P>
                                 <Text>Product to be applied by dipping or spraying on teats of milk-producing animals post-milking, using manual or automatic equipment. Post-milking: Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.</Text>
                              </P>
                              <P>
                                 <Text>See also general instructions for use of meta SPC 3.</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/4/division/4.1/division/4.1.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/4/division/4.1/division/4.1.2" id="annex-part-II-division-3-division-4-division-4.1-division-4.1.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.2.</Number>
                              <Title>
                                 <Emphasis>Use-specific risk mitigation measures</Emphasis>
                              </Title>
                              <P>
                                 <Text>In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.</Text>
                              </P>
                              <P>
                                 <Text>See also general risk mitigation measures of meta SPC 3.</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/4/division/4.1/division/4.1.3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/4/division/4.1/division/4.1.3" id="annex-part-II-division-3-division-4-division-4.1-division-4.1.3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.3.</Number>
                              <Title>
                                 <Emphasis>Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 3</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/4/division/4.1/division/4.1.4" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/4/division/4.1/division/4.1.4" id="annex-part-II-division-3-division-4-division-4.1-division-4.1.4" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.4.</Number>
                              <Title>
                                 <Emphasis>Where specific to the use, the instructions for safe disposal of the product and its packaging</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 3</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/4/division/4.1/division/4.1.5" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/4/division/4.1/division/4.1.5" id="annex-part-II-division-3-division-4-division-4.1-division-4.1.5" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.5.</Number>
                              <Title>
                                 <Emphasis>Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 3</Text>
                              </P>
                           </Division>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/4/division/4.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/4/division/4.2" id="annex-part-II-division-3-division-4-division-4.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>4.2.</Number>
                           <Title>
                              <Strong>Use description</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <Title>
                                    <Strong>Table 4. Use # 2 – Teat dips or sprays for pre-milking disinfection</Strong>
                                 </Title>
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Product Type</td><td>PT03 — Veterinary hygiene (Disinfectants)</td></tr><tr><td>Where relevant, an exact description of the authorised use</td><td>—</td></tr><tr><td>Target organism(s) (including development stage)</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Bacteria</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Yeasts</Text>
                                             </Para>
                                          </td></tr><tr><td>Field(s) of use</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Indoor</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Pre-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)</Text>
                                             </Para>
                                          </td></tr><tr><td>Application method(s)</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Dipping or spraying:</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Manual dipping using a dip cup or</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Manual spraying using a trigger sprayer or</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Manual spraying using an electronic sprayer.</Text>
                                             </Para>
                                          </td></tr><tr><td>Application rate(s) and frequency</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Pre-milking application 1x – 3x per day</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Per milking event 3-10 ml (dipping) to 10-15 ml (spraying) of product are needed (animals with four teats).</Text>
                                             </Para>
                                          </td></tr><tr><td>Category(ies) of users</td><td>Professional</td></tr><tr><td>Pack sizes and packaging material</td><td>0,5 l – 1 000 l HDPE container</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/4/division/4.2/division/4.2.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/4/division/4.2/division/4.2.1" id="annex-part-II-division-3-division-4-division-4.2-division-4.2.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.2.1.</Number>
                              <Title>
                                 <Emphasis>Use-specific instructions for use</Emphasis>
                              </Title>
                              <P>
                                 <Text>Product to be applied by dipping or spraying on teats of milk-producing animals pre-milking, using manual equipment.</Text>
                              </P>
                              <P>
                                 <Text>Pre-milking: Clean teats by wiping with cloth before disinfection. Apply product on the whole teats and leave it for 1 min. Then wipe with a single use paper or a towel.</Text>
                              </P>
                              <P>
                                 <Text>See also general instructions for use of meta SPC3.</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/4/division/4.2/division/4.2.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/4/division/4.2/division/4.2.2" id="annex-part-II-division-3-division-4-division-4.2-division-4.2.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.2.2.</Number>
                              <Title>
                                 <Emphasis>Use-specific risk mitigation measures</Emphasis>
                              </Title>
                              <P>
                                 <Text>In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection.</Text>
                              </P>
                              <P>
                                 <Text>See also general risk mitigation measures of meta SPC3.</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/4/division/4.2/division/4.2.3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/4/division/4.2/division/4.2.3" id="annex-part-II-division-3-division-4-division-4.2-division-4.2.3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.2.3.</Number>
                              <Title>
                                 <Emphasis>Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 3</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/4/division/4.2/division/4.2.4" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/4/division/4.2/division/4.2.4" id="annex-part-II-division-3-division-4-division-4.2-division-4.2.4" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.2.4.</Number>
                              <Title>
                                 <Emphasis>Where specific to the use, the instructions for safe disposal of the product and its packaging</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 3</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/4/division/4.2/division/4.2.5" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/4/division/4.2/division/4.2.5" id="annex-part-II-division-3-division-4-division-4.2-division-4.2.5" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.2.5.</Number>
                              <Title>
                                 <Emphasis>Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 3</Text>
                              </P>
                           </Division>
                        </Division>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/5" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/5" id="annex-part-II-division-3-division-5" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>5.</Number>
                        <Title>GENERAL DIRECTIONS FOR USE<FootnoteRef Ref="f00006"/> OF THE META SPC 3</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/5/division/5.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/5/division/5.1" id="annex-part-II-division-3-division-5-division-5.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.1.</Number>
                           <Title>
                              <Strong>Instructions for use</Strong>
                           </Title>
                           <P>
                              <Text>See use-specific instructions for each use.</Text>
                           </P>
                           <P>
                              <Text>Always read the label or leaflet before use and follow all the instructions provided.</Text>
                           </P>
                           <P>
                              <Text>The products must be brought to temperatures above 20 °C before use.</Text>
                           </P>
                           <P>
                              <Text>The use of a dosing pump for filling the product into the application equipment is recommended</Text>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/5/division/5.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/5/division/5.2" id="annex-part-II-division-3-division-5-division-5.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.2.</Number>
                           <Title>
                              <Strong>Risk mitigation measures</Strong>
                           </Title>
                           <P>
                              <Text>See use-specific risk mitigation measures for each use.</Text>
                           </P>
                           <P>
                              <Text>Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) for spraying application.</Text>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/5/division/5.3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/5/division/5.3" id="annex-part-II-division-3-division-5-division-5.3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.3.</Number>
                           <Title>
                              <Strong>Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment</Strong>
                           </Title>
                           <P>
                              <Text>Potential Health Effects</Text>
                           </P>
                           <P>
                              <Text>Eyes: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>Skin: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>Ingestion: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>Inhalation: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>Chronic Exposure: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>First Aid Measures:</Text>
                           </P>
                           <P>
                              <Text>Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.</Text>
                           </P>
                           <P>
                              <Text>Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.</Text>
                           </P>
                           <P>
                              <Text>Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.</Text>
                           </P>
                           <P>
                              <Text>Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.</Text>
                           </P>
                           <P>
                              <Text>Environmental emergency measures: Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer If legally allowed.</Text>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/5/division/5.4" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/5/division/5.4" id="annex-part-II-division-3-division-5-division-5.4" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.4.</Number>
                           <Title>
                              <Strong>Instructions for safe disposal of the product and its packaging</Strong>
                           </Title>
                           <P>
                              <Text>At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.</Text>
                           </P>
                           <P>
                              <Text>European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.</Text>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/5/division/5.5" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/5/division/5.5" id="annex-part-II-division-3-division-5-division-5.5" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.5.</Number>
                           <Title>
                              <Strong>Conditions of storage and shelf-life of the product under normal conditions of storage</Strong>
                           </Title>
                           <P>
                              <Text>Store between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.</Text>
                           </P>
                           <P>
                              <Text>Shelf life: 24 months</Text>
                           </P>
                        </Division>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/6" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/6" id="annex-part-II-division-3-division-6" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>6.</Number>
                        <Title>OTHER INFORMATION</Title>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/7" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/7" id="annex-part-II-division-3-division-7" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>7.</Number>
                        <Title>THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/3/division/7/division/7.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/3/division/7/division/7.1" id="annex-part-II-division-3-division-7-division-7.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>7.1.</Number>
                           <Title>
                              <Strong>Trade name(s), authorisation number and specific composition of each individual product</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="6">
                                    <tbody><tr><td>Trade name(s)</td><td colspan="5">
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>IoKlar Multi</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>MEPA Iospray Plus D</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>ASTRI-IO</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>DESINTEC MH-Iodine S</Text>
                                             </Para>
                                          </td></tr><tr><td>Authorisation number</td><td colspan="5">EU-0018398-0005 1-3</td></tr><tr><th>Common name</th><th>IUPAC name</th><th>Function</th><th>CAS number</th><th>EC number</th><th>Content (%)</th></tr><tr><td>Polyvinylpyrrolidone iodine</td><td/><td>Active substance</td><td>25655-41-8</td><td/><td>2,45</td></tr><tr><td>Iodine</td><td/><td>Active substance</td><td>7553-56-2</td><td>231-442-4</td><td>0,27</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                     </Division>
                  </Division>
                  <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/4" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/4" id="annex-part-II-division-4" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                     <Title>
                        <Strong>META SPC 4</Strong>
                     </Title>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/4/division/1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/4/division/1" id="annex-part-II-division-4-division-1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>1.</Number>
                        <Title>META SPC 4 ADMINISTRATIVE INFORMATION</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/4/division/1/division/1.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/4/division/1/division/1.1" id="annex-part-II-division-4-division-1-division-1.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>1.1.</Number>
                           <Title>
                              <Strong>Meta SPC 4 identifier</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Identifier</td><td>meta SPC 4</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/4/division/1/division/1.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/4/division/1/division/1.2" id="annex-part-II-division-4-division-1-division-1.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>1.2.</Number>
                           <Title>
                              <Strong>Suffix to the authorisation number</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Number</td><td>1-4</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/4/division/1/division/1.3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/4/division/1/division/1.3" id="annex-part-II-division-4-division-1-division-1.3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>1.3.</Number>
                           <Title>
                              <Strong>Product type(s)</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Product type(s)</td><td>PT03 — Veterinary hygiene (Disinfectants)</td></tr><tr><td/><td/></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/4/division/2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/4/division/2" id="annex-part-II-division-4-division-2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>2.</Number>
                        <Title>META SPC 4 COMPOSITION</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/4/division/2/division/2.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/4/division/2/division/2.1" id="annex-part-II-division-4-division-2-division-2.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>2.1.</Number>
                           <Title>
                              <Strong>Qualitative and quantitative information on the composition of the meta SPC 4</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="7">
                                    <tbody><tr><th rowspan="2">Common name</th><th rowspan="2">IUPAC name</th><th rowspan="2">Function</th><th rowspan="2">CAS number</th><th rowspan="2">EC number</th><th colspan="2">Content (%)</th></tr><tr><th>Min</th><th>Max</th></tr><tr><td>Polyvinylpyrrolidone iodine</td><td/><td>Active substance</td><td>25655-41-8</td><td/><td>1</td><td>1</td></tr><tr><td>Iodine</td><td/><td>Active substance</td><td>7553-56-2</td><td>231-442-4</td><td>0,11</td><td>0,11</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/4/division/2/division/2.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/4/division/2/division/2.2" id="annex-part-II-division-4-division-2-division-2.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>2.2.</Number>
                           <Title>
                              <Strong>Type(s) of formulation of the meta SPC 4</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Formulation</td><td>AL — Any other liquid</td></tr><tr><td/><td/></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/4/division/3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/4/division/3" id="annex-part-II-division-4-division-3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>3.</Number>
                        <Title>HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4</Title>
                        <P>
                           <Tabular Orientation="portrait">
                              <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                 <tbody><tr><td>Hazard statements</td><td/></tr><tr><td>Precautionary statements</td><td/></tr></tbody>
                              </table>
                           </Tabular>
                        </P>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/4/division/4" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/4/division/4" id="annex-part-II-division-4-division-4" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>4.</Number>
                        <Title>AUTHORISED USE(S) OF THE META SPC 4</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/4/division/4/division/4.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/4/division/4/division/4.1" id="annex-part-II-division-4-division-4-division-4.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>4.1.</Number>
                           <Title>
                              <Strong>Use description</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <Title>
                                    <Strong>Table 5. Use # 1 – Teat dips or sprays for post-milking disinfection</Strong>
                                 </Title>
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Product Type</td><td>PT03 — Veterinary hygiene (Disinfectants)</td></tr><tr><td>Where relevant, an exact description of the authorised use</td><td>—</td></tr><tr><td>Target organism(s) (including development stage)</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Bacteria</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Yeasts</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Enveloped viruses</Text>
                                             </Para>
                                          </td></tr><tr><td>Field(s) of use</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Indoor</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)</Text>
                                             </Para>
                                          </td></tr><tr><td>Application method(s)</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Dipping or spraying:</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Manual dipping using a dip cup or</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Manual spraying using a trigger sprayer or</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Manual spraying using an electronic sprayer or</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Automated spraying by robot.</Text>
                                             </Para>
                                          </td></tr><tr><td>Application rate(s) and frequency</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Post-milking application 1x - 3x per day.</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Per milking event 3-10 ml (dipping) to 10-15 ml (spraying) of product are needed (animals with four teats).</Text>
                                             </Para>
                                          </td></tr><tr><td>Category(ies) of users</td><td>Professional</td></tr><tr><td>Pack sizes and packaging material</td><td>0,5 l – 1 000 l HDPE container</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/4/division/4/division/4.1/division/4.1.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/4/division/4/division/4.1/division/4.1.1" id="annex-part-II-division-4-division-4-division-4.1-division-4.1.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.1.</Number>
                              <Title>
                                 <Emphasis>Use-specific instructions for use</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 4</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/4/division/4/division/4.1/division/4.1.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/4/division/4/division/4.1/division/4.1.2" id="annex-part-II-division-4-division-4-division-4.1-division-4.1.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.2.</Number>
                              <Title>
                                 <Emphasis>Use-specific risk mitigation measures</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 4</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/4/division/4/division/4.1/division/4.1.3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/4/division/4/division/4.1/division/4.1.3" id="annex-part-II-division-4-division-4-division-4.1-division-4.1.3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.3.</Number>
                              <Title>
                                 <Emphasis>Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 4</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/4/division/4/division/4.1/division/4.1.4" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/4/division/4/division/4.1/division/4.1.4" id="annex-part-II-division-4-division-4-division-4.1-division-4.1.4" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.4.</Number>
                              <Title>
                                 <Emphasis>Where specific to the use, the instructions for safe disposal of the product and its packaging</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 4</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/4/division/4/division/4.1/division/4.1.5" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/4/division/4/division/4.1/division/4.1.5" id="annex-part-II-division-4-division-4-division-4.1-division-4.1.5" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.5.</Number>
                              <Title>
                                 <Emphasis>Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 4</Text>
                              </P>
                           </Division>
                        </Division>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/4/division/5" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/4/division/5" id="annex-part-II-division-4-division-5" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>5.</Number>
                        <Title>GENERAL DIRECTIONS FOR USE<FootnoteRef Ref="f00007"/> OF THE META SPC 4</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/4/division/5/division/5.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/4/division/5/division/5.1" id="annex-part-II-division-4-division-5-division-5.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.1.</Number>
                           <Title>
                              <Strong>Instructions for use</Strong>
                           </Title>
                           <P>
                              <Text>Always read the label or leaflet before use and follow all the instructions provided.</Text>
                           </P>
                           <P>
                              <Text>The products must be brought to temperatures above 20 °C before use.</Text>
                           </P>
                           <P>
                              <Text>Product to be applied by dipping or spraying on teats of milk-producing animals post-milking using manual or automatic equipment.</Text>
                           </P>
                           <P>
                              <Text>Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.</Text>
                           </P>
                           <P>
                              <Text>The use of a dosing pump for filling the product into the application equipment is recommended.</Text>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/4/division/5/division/5.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/4/division/5/division/5.2" id="annex-part-II-division-4-division-5-division-5.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.2.</Number>
                           <Title>
                              <Strong>Risk mitigation measures</Strong>
                           </Title>
                           <P>
                              <Text>Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) for spraying application.</Text>
                           </P>
                           <P>
                              <Text>In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.</Text>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/4/division/5/division/5.3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/4/division/5/division/5.3" id="annex-part-II-division-4-division-5-division-5.3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.3.</Number>
                           <Title>
                              <Strong>Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment</Strong>
                           </Title>
                           <P>
                              <Text>Potential Health Effects</Text>
                           </P>
                           <P>
                              <Text>Eyes: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>Skin: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>Ingestion: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>Inhalation: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>Chronic Exposure: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>First Aid Measures:</Text>
                           </P>
                           <P>
                              <Text>Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.</Text>
                           </P>
                           <P>
                              <Text>Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.</Text>
                           </P>
                           <P>
                              <Text>Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.</Text>
                           </P>
                           <P>
                              <Text>Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.</Text>
                           </P>
                           <P>
                              <Text>Environmental emergency measures: Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer If legally allowed.</Text>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/4/division/5/division/5.4" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/4/division/5/division/5.4" id="annex-part-II-division-4-division-5-division-5.4" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.4.</Number>
                           <Title>
                              <Strong>Instructions for safe disposal of the product and its packaging</Strong>
                           </Title>
                           <P>
                              <Text>At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.</Text>
                           </P>
                           <P>
                              <Text>European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.</Text>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/4/division/5/division/5.5" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/4/division/5/division/5.5" id="annex-part-II-division-4-division-5-division-5.5" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.5.</Number>
                           <Title>
                              <Strong>Conditions of storage and shelf-life of the product under normal conditions of storage</Strong>
                           </Title>
                           <P>
                              <Text>Store between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.</Text>
                           </P>
                           <P>
                              <Text>Shelf life: 24 months</Text>
                           </P>
                        </Division>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/4/division/6" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/4/division/6" id="annex-part-II-division-4-division-6" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>6.</Number>
                        <Title>OTHER INFORMATION</Title>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/4/division/7" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/4/division/7" id="annex-part-II-division-4-division-7" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>7.</Number>
                        <Title>THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/4/division/7/division/7.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/4/division/7/division/7.1" id="annex-part-II-division-4-division-7-division-7.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>7.1.</Number>
                           <Title>
                              <Strong>Trade name(s), authorisation number and specific composition of each individual product</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="6">
                                    <tbody><tr><td>Trade name(s)</td><td colspan="5">
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Veloucid Spray D</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>VelouCid Spray</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>MEPA Soft Spray D</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>ASTRI-UC</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>SAC WINTERSPRAY</Text>
                                             </Para>
                                          </td></tr><tr><td>Authorisation number</td><td colspan="5">EU-0018398-0006 1-4</td></tr><tr><th>Common name</th><th>IUPAC name</th><th>Function</th><th>CAS number</th><th>EC number</th><th>Content (%)</th></tr><tr><td>Polyvinylpyrrolidone iodine</td><td/><td>Active substance</td><td>25655-41-8</td><td/><td>1</td></tr><tr><td>Iodine</td><td/><td>Active substance</td><td>7553-56-2</td><td>231-442-4</td><td>0,11</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                     </Division>
                  </Division>
                  <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/5" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/5" id="annex-part-II-division-5" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                     <Title>
                        <Strong>META SPC 5</Strong>
                     </Title>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/5/division/1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/5/division/1" id="annex-part-II-division-5-division-1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>1.</Number>
                        <Title>META SPC 5 ADMINISTRATIVE INFORMATION</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/5/division/1/division/1.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/5/division/1/division/1.1" id="annex-part-II-division-5-division-1-division-1.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>1.1.</Number>
                           <Title>
                              <Strong>Meta SPC 5 identifier</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Identifier</td><td>meta SPC 5</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/5/division/1/division/1.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/5/division/1/division/1.2" id="annex-part-II-division-5-division-1-division-1.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>1.2.</Number>
                           <Title>
                              <Strong>Suffix to the authorisation number</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Number</td><td>1-5</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/5/division/1/division/1.3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/5/division/1/division/1.3" id="annex-part-II-division-5-division-1-division-1.3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>1.3.</Number>
                           <Title>
                              <Strong>Product type(s)</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Product type(s)</td><td>PT03 — Veterinary hygiene (Disinfectants)</td></tr><tr><td/><td/></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/5/division/2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/5/division/2" id="annex-part-II-division-5-division-2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>2.</Number>
                        <Title>META SPC 5 COMPOSITION</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/5/division/2/division/2.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/5/division/2/division/2.1" id="annex-part-II-division-5-division-2-division-2.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>2.1.</Number>
                           <Title>
                              <Strong>Qualitative and quantitative information on the composition of the meta SPC 5</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="7">
                                    <tbody><tr><th rowspan="2">Common name</th><th rowspan="2">IUPAC name</th><th rowspan="2">Function</th><th rowspan="2">CAS number</th><th rowspan="2">EC number</th><th colspan="2">Content (%)</th></tr><tr><th>Min</th><th>Max</th></tr><tr><td>Polyvinylpyrrolidone iodine</td><td/><td>Active substance</td><td>25655-41-8</td><td/><td>1</td><td>1</td></tr><tr><td>Iodine</td><td/><td>Active substance</td><td>7553-56-2</td><td>231-442-4</td><td>0,11</td><td>0,11</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/5/division/2/division/2.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/5/division/2/division/2.2" id="annex-part-II-division-5-division-2-division-2.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>2.2.</Number>
                           <Title>
                              <Strong>Type(s) of formulation of the meta SPC 5</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Formulation</td><td>AL — Any other liquid</td></tr><tr><td/><td/></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/5/division/3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/5/division/3" id="annex-part-II-division-5-division-3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>3.</Number>
                        <Title>HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5</Title>
                        <P>
                           <Tabular Orientation="portrait">
                              <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                 <tbody><tr><td>Hazard statements</td><td/></tr><tr><td>Precautionary statements</td><td/></tr></tbody>
                              </table>
                           </Tabular>
                        </P>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/5/division/4" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/5/division/4" id="annex-part-II-division-5-division-4" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>4.</Number>
                        <Title>AUTHORISED USE(S) OF THE META SPC 5</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/5/division/4/division/4.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/5/division/4/division/4.1" id="annex-part-II-division-5-division-4-division-4.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>4.1.</Number>
                           <Title>
                              <Strong>Use description</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <Title>
                                    <Strong>Table 6. Use # 1 – Teat dips for post-milking disinfection</Strong>
                                 </Title>
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Product Type</td><td>PT03 — Veterinary hygiene (Disinfectants)</td></tr><tr><td>Where relevant, an exact description of the authorised use</td><td>—</td></tr><tr><td>Target organism(s) (including development stage)</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Bacteria</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Yeasts</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Enveloped viruses</Text>
                                             </Para>
                                          </td></tr><tr><td>Field(s) of use</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Indoor</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)</Text>
                                             </Para>
                                          </td></tr><tr><td>Application method(s)</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Dipping</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Manual dipping using a dip cup.</Text>
                                             </Para>
                                          </td></tr><tr><td>Application rate(s) and frequency</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Post-milking application 1x – 3x per day</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Per milking event 3-10 ml of product are needed (animals with four teats).</Text>
                                             </Para>
                                          </td></tr><tr><td>Category(ies) of users</td><td>Professional</td></tr><tr><td>Pack sizes and packaging material</td><td>0,5 l – 1 000 l HDPE container</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/5/division/4/division/4.1/division/4.1.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/5/division/4/division/4.1/division/4.1.1" id="annex-part-II-division-5-division-4-division-4.1-division-4.1.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.1.</Number>
                              <Title>
                                 <Emphasis>Use-specific instructions for use</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 5</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/5/division/4/division/4.1/division/4.1.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/5/division/4/division/4.1/division/4.1.2" id="annex-part-II-division-5-division-4-division-4.1-division-4.1.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.2.</Number>
                              <Title>
                                 <Emphasis>Use-specific risk mitigation measures</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 5</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/5/division/4/division/4.1/division/4.1.3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/5/division/4/division/4.1/division/4.1.3" id="annex-part-II-division-5-division-4-division-4.1-division-4.1.3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.3.</Number>
                              <Title>
                                 <Emphasis>Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 5</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/5/division/4/division/4.1/division/4.1.4" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/5/division/4/division/4.1/division/4.1.4" id="annex-part-II-division-5-division-4-division-4.1-division-4.1.4" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.4.</Number>
                              <Title>
                                 <Emphasis>Where specific to the use, the instructions for safe disposal of the product and its packaging</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 5</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/5/division/4/division/4.1/division/4.1.5" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/5/division/4/division/4.1/division/4.1.5" id="annex-part-II-division-5-division-4-division-4.1-division-4.1.5" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.5.</Number>
                              <Title>
                                 <Emphasis>Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 5</Text>
                              </P>
                           </Division>
                        </Division>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/5/division/5" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/5/division/5" id="annex-part-II-division-5-division-5" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>5.</Number>
                        <Title>GENERAL DIRECTIONS FOR USE<FootnoteRef Ref="f00008"/> OF THE META SPC 5</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/5/division/5/division/5.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/5/division/5/division/5.1" id="annex-part-II-division-5-division-5-division-5.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.1.</Number>
                           <Title>
                              <Strong>Instructions for use</Strong>
                           </Title>
                           <P>
                              <Text>Always read the label or leaflet before use and follow all the instructions provided.</Text>
                           </P>
                           <P>
                              <Text>The products must be brought to temperatures above 20 °C before use.</Text>
                           </P>
                           <P>
                              <Text>Product to be applied post-milking by use of a dipping cup.</Text>
                           </P>
                           <P>
                              <Text>Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.</Text>
                           </P>
                           <P>
                              <Text>The use of a dosing pump for filling the product into the application equipment is recommended.</Text>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/5/division/5/division/5.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/5/division/5/division/5.2" id="annex-part-II-division-5-division-5-division-5.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.2.</Number>
                           <Title>
                              <Strong>Risk mitigation measures</Strong>
                           </Title>
                           <P>
                              <Text>In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.</Text>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/5/division/5/division/5.3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/5/division/5/division/5.3" id="annex-part-II-division-5-division-5-division-5.3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.3.</Number>
                           <Title>
                              <Strong>Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment</Strong>
                           </Title>
                           <P>
                              <Text>Potential Health Effects</Text>
                           </P>
                           <P>
                              <Text>Eyes: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>Skin: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>Ingestion: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>Inhalation: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>Chronic Exposure: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>First Aid Measures:</Text>
                           </P>
                           <P>
                              <Text>Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.</Text>
                           </P>
                           <P>
                              <Text>Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.</Text>
                           </P>
                           <P>
                              <Text>Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.</Text>
                           </P>
                           <P>
                              <Text>Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.</Text>
                           </P>
                           <P>
                              <Text>Environmental emergency measures: Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer If legally allowed.</Text>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/5/division/5/division/5.4" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/5/division/5/division/5.4" id="annex-part-II-division-5-division-5-division-5.4" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.4.</Number>
                           <Title>
                              <Strong>Instructions for safe disposal of the product and its packaging</Strong>
                           </Title>
                           <P>
                              <Text>At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.</Text>
                           </P>
                           <P>
                              <Text>European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.</Text>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/5/division/5/division/5.5" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/5/division/5/division/5.5" id="annex-part-II-division-5-division-5-division-5.5" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.5.</Number>
                           <Title>
                              <Strong>Conditions of storage and shelf-life of the product under normal conditions of storage</Strong>
                           </Title>
                           <P>
                              <Text>Store between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.</Text>
                           </P>
                           <P>
                              <Text>Shelf life: 18 months</Text>
                           </P>
                        </Division>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/5/division/6" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/5/division/6" id="annex-part-II-division-5-division-6" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>6.</Number>
                        <Title>OTHER INFORMATION</Title>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/5/division/7" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/5/division/7" id="annex-part-II-division-5-division-7" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>7.</Number>
                        <Title>THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/5/division/7/division/7.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/5/division/7/division/7.1" id="annex-part-II-division-5-division-7-division-7.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>7.1.</Number>
                           <Title>
                              <Strong>Trade name(s), authorisation number and specific composition of each individual product</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="6">
                                    <tbody><tr><td>Trade name(s)</td><td colspan="5">
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Veloucid D</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>VelouCid</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>MEPA Care D</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Cremadip</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>MS Cow Udder SEPIA</Text>
                                             </Para>
                                          </td></tr><tr><td>Authorisation number</td><td colspan="5">EU-0018398-0007 1-5</td></tr><tr><th>Common name</th><th>IUPAC name</th><th>Function</th><th>CAS number</th><th>EC number</th><th>Content (%)</th></tr><tr><td>Polyvinylpyrrolidone iodine</td><td/><td>Active substance</td><td>25655-41-8</td><td/><td>1</td></tr><tr><td>Iodine</td><td/><td>Active substance</td><td>7553-56-2</td><td>231-442-4</td><td>0,11</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                     </Division>
                  </Division>
                  <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/6" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/6" id="annex-part-II-division-6" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                     <Title>
                        <Strong>META SPC 6</Strong>
                     </Title>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/6/division/1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/6/division/1" id="annex-part-II-division-6-division-1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>1.</Number>
                        <Title>META SPC 6 ADMINISTRATIVE INFORMATION</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/6/division/1/division/1.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/6/division/1/division/1.1" id="annex-part-II-division-6-division-1-division-1.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>1.1.</Number>
                           <Title>
                              <Strong>Meta SPC 6 identifier</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Identifier</td><td>meta SPC 6</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/6/division/1/division/1.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/6/division/1/division/1.2" id="annex-part-II-division-6-division-1-division-1.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>1.2.</Number>
                           <Title>
                              <Strong>Suffix to the authorisation number</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Number</td><td>1-6</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/6/division/1/division/1.3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/6/division/1/division/1.3" id="annex-part-II-division-6-division-1-division-1.3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>1.3.</Number>
                           <Title>
                              <Strong>Product type(s)</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Product type(s)</td><td>PT03 — Veterinary hygiene (Disinfectants)</td></tr><tr><td/><td/></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/6/division/2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/6/division/2" id="annex-part-II-division-6-division-2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>2.</Number>
                        <Title>META SPC 6 COMPOSITION</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/6/division/2/division/2.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/6/division/2/division/2.1" id="annex-part-II-division-6-division-2-division-2.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>2.1.</Number>
                           <Title>
                              <Strong>Qualitative and quantitative information on the composition of the meta SPC 6</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="7">
                                    <tbody><tr><th rowspan="2">Common name</th><th rowspan="2">IUPAC name</th><th rowspan="2">Function</th><th rowspan="2">CAS number</th><th rowspan="2">EC number</th><th colspan="2">Content (%)</th></tr><tr><th>Min</th><th>Max</th></tr><tr><td>Polyvinylpyrrolidone iodine</td><td/><td>Active substance</td><td>25655-41-8</td><td/><td>1,35</td><td>1,35</td></tr><tr><td>Iodine</td><td/><td>Active substance</td><td>7553-56-2</td><td>231-442-4</td><td>0,15</td><td>0,15</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/6/division/2/division/2.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/6/division/2/division/2.2" id="annex-part-II-division-6-division-2-division-2.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>2.2.</Number>
                           <Title>
                              <Strong>Type(s) of formulation of the meta SPC 6</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Formulation</td><td>AL — Any other liquid</td></tr><tr><td/><td/></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/6/division/3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/6/division/3" id="annex-part-II-division-6-division-3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>3.</Number>
                        <Title>HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6</Title>
                        <P>
                           <Tabular Orientation="portrait">
                              <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                 <tbody><tr><td>Hazard statements</td><td/></tr><tr><td>Precautionary statements</td><td/></tr></tbody>
                              </table>
                           </Tabular>
                        </P>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/6/division/4" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/6/division/4" id="annex-part-II-division-6-division-4" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>4.</Number>
                        <Title>AUTHORISED USE(S) OF THE META SPC 6</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/6/division/4/division/4.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/6/division/4/division/4.1" id="annex-part-II-division-6-division-4-division-4.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>4.1.</Number>
                           <Title>
                              <Strong>Use description</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <Title>
                                    <Strong>Table 7. Use # 1 – Teat dips or sprays for post-milking disinfection</Strong>
                                 </Title>
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="2">
                                    <tbody><tr><td>Product Type</td><td>PT03 — Veterinary hygiene (Disinfectants)</td></tr><tr><td>Where relevant, an exact description of the authorised use</td><td>—</td></tr><tr><td>Target organism(s) (including development stage)</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Bacteria</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Yeasts</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Enveloped viruses</Text>
                                             </Para>
                                          </td></tr><tr><td>Field(s) of use</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Indoor</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)</Text>
                                             </Para>
                                          </td></tr><tr><td>Application method(s)</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Dipping or spraying:</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Manual dipping using a dip cup or</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Manual spraying using a trigger sprayer or</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Manual spraying using an electronic sprayer or</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Automated spraying by robot.</Text>
                                             </Para>
                                          </td></tr><tr><td>Application rate(s) and frequency</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Post-milking application 1x – 3x per day</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Per milking event 3-10 ml (dipping) to 10-15 ml (spraying) of product are needed (animals with four teats).</Text>
                                             </Para>
                                          </td></tr><tr><td>Category(ies) of users</td><td>Professional</td></tr><tr><td>Pack sizes and packaging material</td><td>0,5 l – 1 000 l HDPE container</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/6/division/4/division/4.1/division/4.1.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/6/division/4/division/4.1/division/4.1.1" id="annex-part-II-division-6-division-4-division-4.1-division-4.1.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.1.</Number>
                              <Title>
                                 <Emphasis>Use-specific instructions for use</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 6</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/6/division/4/division/4.1/division/4.1.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/6/division/4/division/4.1/division/4.1.2" id="annex-part-II-division-6-division-4-division-4.1-division-4.1.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.2.</Number>
                              <Title>
                                 <Emphasis>Use-specific risk mitigation measures</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 6</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/6/division/4/division/4.1/division/4.1.3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/6/division/4/division/4.1/division/4.1.3" id="annex-part-II-division-6-division-4-division-4.1-division-4.1.3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.3.</Number>
                              <Title>
                                 <Emphasis>Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 6</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/6/division/4/division/4.1/division/4.1.4" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/6/division/4/division/4.1/division/4.1.4" id="annex-part-II-division-6-division-4-division-4.1-division-4.1.4" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.4.</Number>
                              <Title>
                                 <Emphasis>Where specific to the use, the instructions for safe disposal of the product and its packaging</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 6</Text>
                              </P>
                           </Division>
                           <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/6/division/4/division/4.1/division/4.1.5" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/6/division/4/division/4.1/division/4.1.5" id="annex-part-II-division-6-division-4-division-4.1-division-4.1.5" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                              <Number>4.1.5.</Number>
                              <Title>
                                 <Emphasis>Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage</Emphasis>
                              </Title>
                              <P>
                                 <Text>See general directions for use of meta SPC 6</Text>
                              </P>
                           </Division>
                        </Division>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/6/division/5" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/6/division/5" id="annex-part-II-division-6-division-5" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>5.</Number>
                        <Title>GENERAL DIRECTIONS FOR USE<FootnoteRef Ref="f00009"/> OF THE META SPC 6</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/6/division/5/division/5.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/6/division/5/division/5.1" id="annex-part-II-division-6-division-5-division-5.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.1.</Number>
                           <Title>
                              <Strong>Instructions for use</Strong>
                           </Title>
                           <P>
                              <Text>Always read the label or leaflet before use and follow all the instructions provided.</Text>
                           </P>
                           <P>
                              <Text>The products must be brought to temperatures above 20 °C before use.</Text>
                           </P>
                           <P>
                              <Text>Product to be applied by dipping or spraying post-milking using manual or automatic equipment.</Text>
                           </P>
                           <P>
                              <Text>Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.</Text>
                           </P>
                           <P>
                              <Text>The use of a dosing pump for filling the product into the application equipment is recommended.</Text>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/6/division/5/division/5.2" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/6/division/5/division/5.2" id="annex-part-II-division-6-division-5-division-5.2" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.2.</Number>
                           <Title>
                              <Strong>Risk mitigation measures</Strong>
                           </Title>
                           <P>
                              <Text>Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) for spraying application</Text>
                           </P>
                           <P>
                              <Text>In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.</Text>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/6/division/5/division/5.3" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/6/division/5/division/5.3" id="annex-part-II-division-6-division-5-division-5.3" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.3.</Number>
                           <Title>
                              <Strong>Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment</Strong>
                           </Title>
                           <P>
                              <Text>Potential Health Effects</Text>
                           </P>
                           <P>
                              <Text>Eyes: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>Skin: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>Ingestion: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>Inhalation: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>Chronic Exposure: Health injuries are not known or expected under normal use.</Text>
                           </P>
                           <P>
                              <Text>First Aid Measures:</Text>
                           </P>
                           <P>
                              <Text>Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.</Text>
                           </P>
                           <P>
                              <Text>Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.</Text>
                           </P>
                           <P>
                              <Text>Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.</Text>
                           </P>
                           <P>
                              <Text>Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.</Text>
                           </P>
                           <P>
                              <Text>Environmental emergency measures: Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer If legally allowed.</Text>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/6/division/5/division/5.4" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/6/division/5/division/5.4" id="annex-part-II-division-6-division-5-division-5.4" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.4.</Number>
                           <Title>
                              <Strong>Instructions for safe disposal of the product and its packaging</Strong>
                           </Title>
                           <P>
                              <Text>At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.</Text>
                           </P>
                           <P>
                              <Text>European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.</Text>
                           </P>
                        </Division>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/6/division/5/division/5.5" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/6/division/5/division/5.5" id="annex-part-II-division-6-division-5-division-5.5" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>5.5.</Number>
                           <Title>
                              <Strong>Conditions of storage and shelf-life of the product under normal conditions of storage</Strong>
                           </Title>
                           <P>
                              <Text>Store between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.</Text>
                           </P>
                           <P>
                              <Text>Shelf life: 24 months</Text>
                           </P>
                        </Division>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/6/division/6" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/6/division/6" id="annex-part-II-division-6-division-6" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>6.</Number>
                        <Title>OTHER INFORMATION</Title>
                     </Division>
                     <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/6/division/7" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/6/division/7" id="annex-part-II-division-6-division-7" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                        <Number>7.</Number>
                        <Title>THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6</Title>
                        <Division DocumentURI="http://www.legislation.gov.uk/eur/2018/1258/annex/part/II/division/6/division/7/division/7.1" IdURI="http://www.legislation.gov.uk/id/eur/2018/1258/annex/part/II/division/6/division/7/division/7.1" id="annex-part-II-division-6-division-7-division-7.1" RestrictStartDate="2018-09-18" RestrictExtent="E+W+S+N.I.">
                           <Number>7.1.</Number>
                           <Title>
                              <Strong>Trade name(s), authorisation number and specific composition of each individual product</Strong>
                           </Title>
                           <P>
                              <Tabular Orientation="portrait">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="6">
                                    <tbody><tr><td>Trade name(s)</td><td colspan="5">
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>MEPA Barrier Spray D</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>IoShield Spray</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>QUARESS-Barrier</Text>
                                             </Para>
                                          </td></tr><tr><td>Authorisation number</td><td colspan="5">EU-0018398-0008 1-6</td></tr><tr><th>Common name</th><th>IUPAC name</th><th>Function</th><th>CAS number</th><th>EC number</th><th>Content (%)</th></tr><tr><td>Polyvinylpyrrolidone iodine</td><td/><td>Active substance</td><td>25655-41-8</td><td/><td>1,35</td></tr><tr><td>Iodine</td><td/><td>Active substance</td><td>7553-56-2</td><td>231-442-4</td><td>0,15</td></tr></tbody>
                                 </table>
                              </Tabular>
                           </P>
                        </Division>
                     </Division>
                  </Division>
               </EUPart>
            </ScheduleBody>
         </Schedule>
      </Schedules>
   </EURetained><Footnotes><Footnote id="f00001">
         <FootnoteText>
            <Para>
               <Text>
                  <Citation id="c00001" Class="EuropeanUnionOfficialJournal" Year="2012" URI="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2012.167.01.0001.01.ENG" Date="2012-06-27">OJ L 167, 27.6.2012, p. 1</Citation>.</Text>
            </Para>
         </FootnoteText>
      </Footnote><Footnote id="f00002">
         <FootnoteText>
            <Para>
               <Text>Commission delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (<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_.2017.301.01.0001.01.ENG" Date="2017-11-17">OJ L 301, 17.11.2017, p. 1</Citation>).</Text>
            </Para>
         </FootnoteText>
      </Footnote><Footnote id="f00003">
         <FootnoteText>
            <Para>
               <Text>ECHA opinion of 12 December 2017 on the Union authorisation of Ecolab Iodine PT3 Family (ECHA/BPC/177/2017).</Text>
            </Para>
         </FootnoteText>
      </Footnote><Footnote id="f00004">
         <FootnoteText>
            <Para>
               <Text>Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC1.</Text>
            </Para>
         </FootnoteText>
      </Footnote><Footnote id="f00005">
         <FootnoteText>
            <Para>
               <Text>Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC2.</Text>
            </Para>
         </FootnoteText>
      </Footnote><Footnote id="f00006">
         <FootnoteText>
            <Para>
               <Text>Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC3.</Text>
            </Para>
         </FootnoteText>
      </Footnote><Footnote id="f00007">
         <FootnoteText>
            <Para>
               <Text>Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC4.</Text>
            </Para>
         </FootnoteText>
      </Footnote><Footnote id="f00008">
         <FootnoteText>
            <Para>
               <Text>Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC5.</Text>
            </Para>
         </FootnoteText>
      </Footnote><Footnote id="f00009">
         <FootnoteText>
            <Para>
               <Text>Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC6.</Text>
            </Para>
         </FootnoteText>
      </Footnote></Footnotes></Legislation>