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					<dc:identifier>http://www.legislation.gov.uk/eur/2016/1084</dc:identifier><dc:title>Commission Implementing Regulation (EU) 2016/1084 of 5 July 2016 approving biphenyl-2-ol as an existing active substance for use in biocidal products of product-type 3 (Text with EEA relevance)</dc:title><dct:alternative>Commission Implementing Regulation (EU) 2016/1084</dct:alternative><dc:description>Commission Implementing Regulation (EU) 2016/1084 of 5 July 2016 approving biphenyl-2-ol as an existing active substance for use in biocidal products of product-type 3 (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:32016R1084</dc:source><dc:type>text</dc:type><dc:format>text/xml</dc:format><dc:language>en</dc:language><dct:valid>2016-07-05</dct:valid>
					
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      <EUPrelims DocumentURI="http://www.legislation.gov.uk/eur/2016/1084/introduction" IdURI="http://www.legislation.gov.uk/id/eur/2016/1084/introduction" RestrictStartDate="2016-07-05" RestrictExtent="E+W+S+N.I.">
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            <Text>
               <Uppercase>Commission Implementing Regulation</Uppercase> (EU) 2016/1084</Text>
            <Text>of 5 July 2016</Text>
            <Text>approving biphenyl-2-ol as an existing active substance for use in biocidal products of product-type 3</Text>
            <Text>(Text with EEA relevance)</Text>
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               <Text>THE EUROPEAN COMMISSION,</Text>
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            <P>
               <Text>Having regard to the Treaty on the Functioning of the European Union,</Text>
            </P>
            <P>
               <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>
            </P>
            <P>
               <Text>Whereas:</Text>
            </P>
            <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 biphenyl-2-ol.</Text>
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            <Division>
               <Number>(2)</Number>
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                  <Text>Biphenyl-2-ol has been evaluated for use in products of product-type 3, veterinary hygiene, as described in Annex V to Regulation (EU) No 528/2012.</Text>
               </P>
            </Division>
            <Division>
               <Number>(3)</Number>
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                  <Text>Spain was designated as evaluating competent authority and submitted the assessment report together with its recommendations on 2 June 2014.</Text>
               </P>
            </Division>
            <Division>
               <Number>(4)</Number>
               <P>
                  <Text>In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 8 December 2015 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.</Text>
               </P>
            </Division>
            <Division>
               <Number>(5)</Number>
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                  <Text>According to that opinion, biocidal products of product-type 3 and containing biphenyl-2-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 biphenyl-2-ol for use in biocidal products of product-type 3, subject to compliance with certain specifications and conditions.</Text>
               </P>
            </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>
               </P>
            </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>Biphenyl-2-ol is approved as an active substance for use in biocidal products of product-type 3, 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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               <Text>This Regulation shall be binding in its entirety and directly applicable in all Member States.</Text>
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                  <Text>Done at Brussels, 5 July 2016.</Text>
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                        <Emphasis>For the Commission</Emphasis>
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                        <Emphasis>The President</Emphasis>
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                     <Text>Jean-Claude <Uppercase>Juncker</Uppercase>
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                              <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 used for the evaluation made in accordance with Article 89(1) of Regulation (EU) No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.</Text>
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                              <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>
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                              <Footnote xmlns="http://www.legislation.gov.uk/namespaces/legislation" id="f00005">
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                                       <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>
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                     <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>Biphenyl-2-ol</td><td>
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                                 <Text>IUPAC Name:</Text>
                              </Para>
                              <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Text>ortho-phenylphenol</Text>
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                              <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Text>EC No: 201-993-5</Text>
                              </Para>
                              <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                 <Text>CAS No: 90-43-7</Text>
                              </Para>
                           </td><td>995 g/kg</td><td>1 January 2018</td><td>31 December 2027</td><td>3</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="period">
                                 <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:</Text>
                                    </Para>
                                    <Para>
                                       <OrderedList Type="alpha" Decoration="parenRight">
                                          <ListItem NumberOverride="a)">
                                             <Para>
                                                <Text>professional users;</Text>
                                             </Para>
                                          </ListItem>
                                          <ListItem NumberOverride="b)">
                                             <Para>
                                                <Text>surface water, sediment and soil compartment.</Text>
                                             </Para>
                                          </ListItem>
                                       </OrderedList>
                                    </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>