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					<dc:identifier>http://www.legislation.gov.uk/eur/2016/622</dc:identifier><dc:title>Commission Regulation (EU) 2016/622 of 21 April 2016 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance)</dc:title><dct:alternative>Commission Regulation (EU) 2016/622</dct:alternative><dc:description>Commission Regulation (EU) 2016/622 of 21 April 2016 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (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:32016R0622</dc:source><dc:type>text</dc:type><dc:format>text/xml</dc:format><dc:language>en</dc:language><dct:valid>2016-04-21</dct:valid>
					
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                  <YEAR>2016</YEAR>
                  <MONTH>04</MONTH>
                  <DAY>22</DAY>
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               <EXPRESSION_SUBTITLE type="data">
                  <VALUE>C/2016/2224</VALUE>
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                  <VALUE>en</VALUE>
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               <EXPRESSION_TITLE type="data">
                  <VALUE>Commission Regulation (EU) 2016/622 of 21 April 2016 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance)</VALUE>
               </EXPRESSION_TITLE>
               <TITLE type="data">
                  <VALUE>Commission Regulation (EU) 2016/622 of 21 April 2016 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance)</VALUE>
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                  <VALUE>eng</VALUE>
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					<ukm:Alternatives><ukm:Alternative URI="http://www.legislation.gov.uk/eur/2016/622/pdfs/eur_20160622_adopted_en.pdf" Date="2016-04-22" Size="326502"/> </ukm:Alternatives>
					
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      <EUPrelims DocumentURI="http://www.legislation.gov.uk/eur/2016/622/introduction" IdURI="http://www.legislation.gov.uk/id/eur/2016/622/introduction" RestrictStartDate="2016-04-21" RestrictExtent="E+W+S+N.I.">
         <MultilineTitle>
            <Text>
               <Uppercase>Commission Regulation</Uppercase> (EU) 2016/622</Text>
            <Text>of 21 April 2016</Text>
            <Text>amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products</Text>
            <Text>(Text with EEA relevance)</Text>
         </MultilineTitle>
         <EUPreamble>
            <P>
               <Text>THE EUROPEAN COMMISSION,</Text>
            </P>
            <P>
               <Text>Having regard to the Treaty on the Functioning of the European Union,</Text>
            </P>
            <P>
               <Text>Having regard to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products<FootnoteRef Ref="f00001"/>, and in particular Article 31(2) thereof,</Text>
            </P>
            <P>
               <Text>Whereas:</Text>
            </P>
            <Division>
               <Number>(1)</Number>
               <P>
                  <Text>On 27 March 2014, the Scientific Committee on Consumer Safety (‘SCCS’) issued a scientific opinion on potassium hydroxide<FootnoteRef Ref="f00002"/>, which concluded that potassium hydroxide is safe for use as a callosity softener/remover up to a maximum concentration of 1,5 % w/w.</Text>
               </P>
            </Division>
            <Division>
               <Number>(2)</Number>
               <P>
                  <Text>The SCCS also concluded that the safe use of cosmetic products containing free potassium hydroxide in concentrations from 0,5 % w/w depends on responsible risk management, through warnings and extensive guidance for use.</Text>
               </P>
            </Division>
            <Division>
               <Number>(3)</Number>
               <P>
                  <Text>Following the scientific opinion of the SCCS, the Commission considers that potassium hydroxide should be considered safe for use as a callosity softener/remover up to a maximum use concentration of 1,5 % w/w.</Text>
               </P>
            </Division>
            <Division>
               <Number>(4)</Number>
               <P>
                  <Text>In light of the conclusion of the SCCS regarding responsible risk management with respect to products containing free potassium hydroxide in concentrations from 0,5 % w/w, the Commission considers that cosmetic products containing potassium hydroxide for use as a callosity softener/remover should bear a warning referring to the directions for use.</Text>
               </P>
            </Division>
            <Division>
               <Number>(5)</Number>
               <P>
                  <Text>Regulation (EC) No 1223/2009 should therefore be amended accordingly.</Text>
               </P>
            </Division>
            <Division>
               <Number>(6)</Number>
               <P>
                  <Text>The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products,</Text>
               </P>
            </Division>
            <P>
               <Text>HAS ADOPTED THIS REGULATION:</Text>
            </P>
         </EUPreamble>
      </EUPrelims>
      <EUBody DocumentURI="http://www.legislation.gov.uk/eur/2016/622/body" IdURI="http://www.legislation.gov.uk/id/eur/2016/622/body" NumberOfProvisions="2" RestrictStartDate="2016-04-21" RestrictExtent="E+W+S+N.I.">
         <P1 DocumentURI="http://www.legislation.gov.uk/eur/2016/622/article/1" IdURI="http://www.legislation.gov.uk/id/eur/2016/622/article/1" id="article-1" RestrictStartDate="2016-04-21" RestrictExtent="E+W+S+N.I.">
            <Pnumber>Article 1</Pnumber>
            <P1para>
               <Text>Annex III to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this Regulation.</Text>
            </P1para>
         </P1>
         <P1 DocumentURI="http://www.legislation.gov.uk/eur/2016/622/article/2" IdURI="http://www.legislation.gov.uk/id/eur/2016/622/article/2" id="article-2" RestrictStartDate="2016-04-21" RestrictExtent="E+W+S+N.I.">
            <Pnumber>Article 2</Pnumber>
            <P1para>
               <Text>This Regulation shall enter into force on the twentieth day following that of its publication in the <Emphasis>Official Journal of the European Union</Emphasis>.</Text>
            </P1para>
         </P1>
         <SignedSection DocumentURI="http://www.legislation.gov.uk/eur/2016/622/signature" IdURI="http://www.legislation.gov.uk/id/eur/2016/622/signature" RestrictStartDate="2016-04-21" 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, 21 April 2016.</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="2016-04-21" RestrictExtent="E+W+S+N.I.">
         <Schedule DocumentURI="http://www.legislation.gov.uk/eur/2016/622/annex" IdURI="http://www.legislation.gov.uk/id/eur/2016/622/annex" id="annex" RestrictStartDate="2016-04-21" RestrictExtent="E+W+S+N.I.">
            <Number>ANNEX</Number>
            <ScheduleBody>
               <P DocumentURI="http://www.legislation.gov.uk/eur/2016/622/annex/paragraph/1" IdURI="http://www.legislation.gov.uk/id/eur/2016/622/annex/paragraph/1" id="annex-paragraph-1" RestrictStartDate="2016-04-21" RestrictExtent="E+W+S+N.I.">
                  <Text>Annex III to Regulation (EC) No 1223/2009 is amended as follows:</Text>
               </P>
               <P DocumentURI="http://www.legislation.gov.uk/eur/2016/622/annex/paragraph/2" IdURI="http://www.legislation.gov.uk/id/eur/2016/622/annex/paragraph/2" id="annex-paragraph-2" RestrictStartDate="2016-04-21" RestrictExtent="E+W+S+N.I.">
                  <OrderedList Type="arabic" Decoration="parens">
                     <ListItem NumberOverride="(1)">
                        <Para>
                           <Text>entry 15a is replaced by the following entry:</Text>
                        </Para>
                        <Para>
                           <BlockAmendment TargetClass="unknown" TargetSubClass="unknown" Context="unknown" Format="none">
                              <Tabular Orientation="landscape">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="9">
                                    <tfoot><tr><td colspan="9">
                                             <Footnote xmlns="http://www.legislation.gov.uk/namespaces/legislation" id="f00003">
                                                <FootnoteText>
                                                   <Para>
                                                      <Text>For other uses of potassium hydroxide, see Annex III, No 15d.</Text>
                                                   </Para>
                                                </FootnoteText>
                                             </Footnote>
                                          </td></tr><tr><td colspan="9">
                                             <Footnote xmlns="http://www.legislation.gov.uk/namespaces/legislation" id="f00004">
                                                <FootnoteText>
                                                   <Para>
                                                      <Text>The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the sum should not exceed the limits given in column g.’;</Text>
                                                   </Para>
                                                </FootnoteText>
                                             </Footnote>
                                          </td></tr></tfoot>
                                    <tbody><tr><th rowspan="2">Ref No.</th><th colspan="4">Substance identification</th><th colspan="3">Restrictions</th><th rowspan="2">Wording of conditions of use and warnings</th></tr><tr><th>Chemical name/INN</th><th>Name of Common Ingredients Glossary</th><th>CAS number</th><th>EC number</th><th>Product type, body parts</th><th>Maximum concentration in ready for use preparation</th><th>Other</th></tr><tr><th>a</th><th>b</th><th>c</th><th>d</th><th>e</th><th>f</th><th>g</th><th>h</th><th>i</th></tr><tr><td rowspan="5">‘15a</td><td rowspan="5">Potassium or sodium hydroxide<FootnoteRef xmlns="http://www.legislation.gov.uk/namespaces/legislation" Ref="f00003"/>
                                          </td><td rowspan="5">Potassium hydroxide/sodium hydroxide</td><td rowspan="5">1310-58-3/1310-73-2</td><td rowspan="5">215-181-3/215-185-5</td><td>
                                             <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Number>(a)</Number>
                                                <P>
                                                   <Text>Nail cuticle solvent</Text>
                                                </P>
                                             </Division>
                                          </td><td>
                                             <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Number>(a)</Number>
                                                <P>
                                                   <Text>5 %<FootnoteRef Ref="f00004"/>
                                                   </Text>
                                                </P>
                                             </Division>
                                          </td><td/><td>
                                             <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Number>(a)</Number>
                                                <Title>Contains alkali</Title>
                                                <P>
                                                   <Text>Avoid contact with eyes</Text>
                                                </P>
                                                <P>
                                                   <Text>Can cause blindness</Text>
                                                </P>
                                                <P>
                                                   <Text>Keep out of reach of children</Text>
                                                </P>
                                             </Division>
                                          </td></tr><tr><td rowspan="2">
                                             <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Number>(b)</Number>
                                                <P>
                                                   <Text>Hair straightener</Text>
                                                </P>
                                             </Division>
                                          </td><td>2 %<FootnoteRef xmlns="http://www.legislation.gov.uk/namespaces/legislation" Ref="f00004"/>
                                          </td><td>General use</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Contains alkali</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Avoid contact with eyes</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Can cause blindness</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Keep out of reach of children</Text>
                                             </Para>
                                          </td></tr><tr><td>4,5 %<FootnoteRef xmlns="http://www.legislation.gov.uk/namespaces/legislation" Ref="f00004"/>
                                          </td><td>Professional use</td><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>For professional use only</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Avoid contact with eyes</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Can cause blindness</Text>
                                             </Para>
                                          </td></tr><tr><td>
                                             <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Number>(c)</Number>
                                                <P>
                                                   <Text>pH adjuster for depilatories</Text>
                                                </P>
                                             </Division>
                                          </td><td/><td>
                                             <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Number>(c)</Number>
                                                <P>
                                                   <Text>pH &lt; 12,7</Text>
                                                </P>
                                             </Division>
                                          </td><td>
                                             <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Number>(c)</Number>
                                                <Title>Keep out of reach of children</Title>
                                                <P>
                                                   <Text>Avoid contact with eyes</Text>
                                                </P>
                                             </Division>
                                          </td></tr><tr><td>
                                             <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Number>(d)</Number>
                                                <P>
                                                   <Text>Other uses as pH adjuster</Text>
                                                </P>
                                             </Division>
                                          </td><td/><td>
                                             <Division xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Number>(d)</Number>
                                                <P>
                                                   <Text>pH &lt; 11</Text>
                                                </P>
                                             </Division>
                                          </td><td/></tr></tbody>
                                 </table>
                              </Tabular>
                           </BlockAmendment>
                        </Para>
                     </ListItem>
                     <ListItem NumberOverride="(2)">
                        <Para>
                           <Text>entry 15d is inserted:</Text>
                        </Para>
                        <Para>
                           <BlockAmendment TargetClass="unknown" TargetSubClass="unknown" Context="unknown" Format="none">
                              <Tabular Orientation="landscape">
                                 <table xmlns="http://www.w3.org/1999/xhtml" cols="9">
                                    <tfoot><tr><td colspan="9">
                                             <Footnote xmlns="http://www.legislation.gov.uk/namespaces/legislation" id="f00005">
                                                <FootnoteText>
                                                   <Para>
                                                      <Text>For other uses of Potassium hydroxide, see Annex III, No 15a.</Text>
                                                   </Para>
                                                </FootnoteText>
                                             </Footnote>
                                          </td></tr><tr><td colspan="9">
                                             <Footnote xmlns="http://www.legislation.gov.uk/namespaces/legislation" id="f00006">
                                                <FootnoteText>
                                                   <Para>
                                                      <Text>The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the sum should not exceed the limits given in column g.’</Text>
                                                   </Para>
                                                </FootnoteText>
                                             </Footnote>
                                          </td></tr></tfoot>
                                    <tbody><tr><th rowspan="2">Ref No.</th><th colspan="4">Substance identification</th><th colspan="3">Restrictions</th><th rowspan="2">Wording of conditions of use and warnings</th></tr><tr><th>Chemical name/INN</th><th>Name of Common Ingredients Glossary</th><th>CAS number</th><th>EC number</th><th>Product type, body parts</th><th>Maximum concentration in ready for use preparation</th><th>Other</th></tr><tr><th>a</th><th>b</th><th>c</th><th>d</th><th>e</th><th>f</th><th>g</th><th>h</th><th>i</th></tr><tr><td>‘15d</td><td>Potassium hydroxide<FootnoteRef xmlns="http://www.legislation.gov.uk/namespaces/legislation" Ref="f00005"/>
                                          </td><td>Potassium hydroxide</td><td>1310-58-3</td><td>215-181-3</td><td>Callosity softener/remover</td><td>1,5 %<FootnoteRef xmlns="http://www.legislation.gov.uk/namespaces/legislation" Ref="f00006"/>
                                          </td><td/><td>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Contains alkali</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Avoid contact with eyes</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Keep out of reach of children</Text>
                                             </Para>
                                             <Para xmlns="http://www.legislation.gov.uk/namespaces/legislation">
                                                <Text>Read directions for use carefully</Text>
                                             </Para>
                                          </td></tr></tbody>
                                 </table>
                              </Tabular>
                           </BlockAmendment>
                        </Para>
                     </ListItem>
                  </OrderedList>
               </P>
            </ScheduleBody>
         </Schedule>
      </Schedules>
   </EURetained><Footnotes><Footnote id="f00001">
         <FootnoteText>
            <Para>
               <Text>
                  <Citation id="c00001" 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_.2009.342.01.0059.01.ENG" Date="2009-12-22">OJ L 342, 22.12.2009, p. 59</Citation>.</Text>
            </Para>
         </FootnoteText>
      </Footnote><Footnote id="f00002">
         <FootnoteText>
            <Para>
               <Text>SCCS/1527/14, http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_154.pdf</Text>
            </Para>
         </FootnoteText>
      </Footnote></Footnotes></Legislation>