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					<dc:identifier>http://www.legislation.gov.uk/eur/2017/2001</dc:identifier><dc:title>Commission Implementing Regulation (EU) 2017/2001 of 8 November 2017 approving propan-1-ol as an existing active substance for use in biocidal products of product-type 1, 2 and 4 (Text with EEA relevance)</dc:title><dct:alternative>Commission Implementing Regulation (EU) 2017/2001</dct:alternative><dc:description>Commission Implementing Regulation (EU) 2017/2001 of 8 November 2017 approving propan-1-ol as an existing active substance for use in biocidal products of product-type 1, 2 and 4 (Text with EEA relevance)</dc:description><dc:modified>2020-12-12</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:32017R2001</dc:source><dc:type>text</dc:type><dc:format>text/xml</dc:format><dc:language>en</dc:language><dct:valid>2017-11-08</dct:valid>
					
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      <EUPrelims DocumentURI="http://www.legislation.gov.uk/eur/2017/2001/introduction" IdURI="http://www.legislation.gov.uk/id/eur/2017/2001/introduction" RestrictStartDate="2017-11-08" RestrictExtent="E+W+S+N.I.">
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               <Uppercase>Commission Implementing Regulation</Uppercase> (EU) 2017/2001</Text>
            <Text>of 8 November 2017</Text>
            <Text>approving propan-1-ol as an existing active substance for use in biocidal products of product-type 1, 2 and 4</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 the third subparagraph of Article 89(1) thereof,</Text>
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               <Text>Whereas:</Text>
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            <Division>
               <Number>(1)</Number>
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                  <Text>Commission Delegated Regulation (EU) No 1062/2014<FootnoteRef Ref="f00002"/> establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes propan-1-ol.</Text>
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               <Number>(2)</Number>
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                  <Text>Propan-1-ol has been evaluated for use in products of product-type 1, human hygiene, product-type 2, disinfectants and algaecides not intended for direct application to humans or animals, and product-type 4, food and feed area, as described in Annex V to Regulation (EU) No 528/2012.</Text>
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               <Number>(3)</Number>
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                  <Text>Germany was designated as evaluating competent authority and submitted the assessment reports together with its recommendations on 18 July 2016.</Text>
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               <Number>(4)</Number>
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                  <Text>In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinions of the European Chemicals Agency were formulated on 27 April 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.</Text>
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                  <Text>According to those opinions, biocidal products of product-types 1, 2 and 4 and containing propan-1-ol may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.</Text>
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               <Number>(6)</Number>
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                  <Text>It is therefore appropriate to approve propan-1-ol for use in biocidal products of product-types 1, 2 and 4, subject to compliance with certain specifications and conditions.</Text>
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            </Division>
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               <Number>(7)</Number>
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                  <Text>A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.</Text>
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            </Division>
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               <Number>(8)</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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            <Pnumber>Article 1</Pnumber>
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               <Text>Propan-1-ol is approved as an active substance for use in biocidal products of product-types 1, 2 and 4, subject to the specifications and conditions 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>
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         <SignedSection DocumentURI="http://www.legislation.gov.uk/eur/2017/2001/signature" IdURI="http://www.legislation.gov.uk/id/eur/2017/2001/signature" RestrictStartDate="2017-11-08" 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, 8 November 2017.</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="2017-11-08" RestrictExtent="E+W+S+N.I.">
         <Schedule DocumentURI="http://www.legislation.gov.uk/eur/2017/2001/annex" IdURI="http://www.legislation.gov.uk/id/eur/2017/2001/annex" id="annex" RestrictStartDate="2017-11-08" RestrictExtent="E+W+S+N.I.">
            <Number>ANNEX</Number>
            <ScheduleBody>
               <Tabular Orientation="landscape">
                  <table xmlns="http://www.w3.org/1999/xhtml" cols="7">
                     <tfoot><tr><td colspan="7">
                              <Footnote xmlns="http://www.legislation.gov.uk/namespaces/legislation" id="f00003">
                                 <FootnoteText>
                                    <Para>
                                       <Text>The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.</Text>
                                    </Para>
                                 </FootnoteText>
                              </Footnote>
                           </td></tr><tr><td colspan="7">
                              <Footnote xmlns="http://www.legislation.gov.uk/namespaces/legislation" id="f00004">
                                 <FootnoteText>
                                    <Para>
                                       <Text>Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (<Citation id="c00003" Class="EuropeanUnionOfficialJournal" Year="2009" URI="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2009.152.01.0011.01.ENG" Date="2009-06-16">OJ L 152, 16.6.2009, p. 11</Citation>).</Text>
                                    </Para>
                                 </FootnoteText>
                              </Footnote>
                           </td></tr><tr><td colspan="7">
                              <Footnote xmlns="http://www.legislation.gov.uk/namespaces/legislation" id="f00005">
                                 <FootnoteText>
                                    <Para>
                                       <Text>Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (<Citation id="c00004" Class="EuropeanUnionOfficialJournal" Year="2005" URI="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2005.070.01.0001.01.ENG" Date="2005-03-16">OJ L 70, 16.3.2005, p. 1</Citation>).</Text>
                                    </Para>
                                 </FootnoteText>
                              </Footnote>
                           </td></tr></tfoot>
                     <tbody><tr><th>Common Name</th><th>IUPAC NameIdentification Numbers</th><th>Minimum degree of purity of the active substance<FootnoteRef xmlns="http://www.legislation.gov.uk/namespaces/legislation" Ref="f00003"/>
                           </th><th>Date of approval</th><th>Expiry date of approval</th><th>Product type</th><th>Specific conditions</th></tr><tr><td rowspan="3">Propan-1-ol</td><td rowspan="3">
                              <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Text>IUPAC Name:</Text>
                              </Para>
                              <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Text>Propan-1-ol</Text>
                              </Para>
                              <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Text>EC No: 200-746-9</Text>
                              </Para>
                              <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Text>CAS No: 71-23-8</Text>
                              </Para>
                           </td><td rowspan="3">≥ 995 g/kg</td><td rowspan="3">1 May 2019</td><td rowspan="3">30 April 2029</td><td>1</td><td>
                              <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Text>The authorisations of biocidal products are subject to the following conditions:</Text>
                              </Para>
                              <OrderedList xmlns="http://www.legislation.gov.uk/namespaces/legislation" Type="arabic" Decoration="parens">
                                 <ListItem NumberOverride="(1)">
                                    <Para>
                                       <Text>the product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance;</Text>
                                    </Para>
                                 </ListItem>
                                 <ListItem NumberOverride="(2)">
                                    <Para>
                                       <Text>in view of the risks identified for the uses assessed, the product assessment shall pay particular attention to professional users.</Text>
                                    </Para>
                                 </ListItem>
                              </OrderedList>
                           </td></tr><tr><td>2</td><td>
                              <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Text>The authorisations of biocidal products are subject to the following condition:</Text>
                              </Para>
                              <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Text>the product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.</Text>
                              </Para>
                           </td></tr><tr><td>4</td><td>
                              <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Text>The authorisations of biocidal products are subject to the following conditions:</Text>
                              </Para>
                              <OrderedList xmlns="http://www.legislation.gov.uk/namespaces/legislation" Type="arabic" Decoration="parens">
                                 <ListItem NumberOverride="(1)">
                                    <Para>
                                       <Text>the product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance;</Text>
                                    </Para>
                                 </ListItem>
                                 <ListItem NumberOverride="(2)">
                                    <Para>
                                       <Text>in view of the risks identified for the uses assessed, the product assessment shall pay particular attention to professional users;</Text>
                                    </Para>
                                 </ListItem>
                                 <ListItem NumberOverride="(3)">
                                    <Para>
                                       <Text>for products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council<FootnoteRef Ref="f00004"/> or Regulation (EC) No 396/2005 of the European Parliament and of the Council<FootnoteRef Ref="f00005"/> shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.</Text>
                                    </Para>
                                 </ListItem>
                              </OrderedList>
                           </td></tr></tbody>
                  </table>
               </Tabular>
            </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) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (<Citation id="c00002" Class="EuropeanUnionOfficialJournal" Year="2014" URI="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2014.294.01.0001.01.ENG" Date="2014-10-10">OJ L 294, 10.10.2014, p. 1</Citation>).</Text>
            </Para>
         </FootnoteText>
      </Footnote></Footnotes></Legislation>