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					<dc:identifier>http://www.legislation.gov.uk/eur/2019/4/article/3</dc:identifier><dc:title>Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (Text with EEA relevance)</dc:title><dct:alternative>Regulation (EU) 2019/4 of the European Parliament and of the Council</dct:alternative><dc:description>Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (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:32019R0004</dc:source><dc:type>text</dc:type><dc:format>text/xml</dc:format><dc:language>en</dc:language><dct:valid>2018-12-11</dct:valid>
					
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                  <VALUE>Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (Text with EEA relevance)</VALUE>
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               <Strong>SUBJECT MATTER, SCOPE AND DEFINITIONS</Strong>
            </Title><P1group RestrictStartDate="2018-12-11" RestrictExtent="E+W+S+N.I."><Title>Definitions</Title><P1 DocumentURI="http://www.legislation.gov.uk/eur/2019/4/article/3" IdURI="http://www.legislation.gov.uk/id/eur/2019/4/article/3" id="article-3">
                  <Pnumber>Article 3</Pnumber>
                  <P1para>
                     <P2 DocumentURI="http://www.legislation.gov.uk/eur/2019/4/article/3/1" IdURI="http://www.legislation.gov.uk/id/eur/2019/4/article/3/1" id="article-3-1">
                        <Pnumber PuncBefore="" PuncAfter=".">1</Pnumber>
                        <P2para>
                           <Text>For the purposes of this Regulation, the following definitions apply:</Text>
                           <P3>
                              <Pnumber PuncBefore="(" PuncAfter=")">a</Pnumber>
                              <P3para>
                                 <Text>the definitions of ‘feed’, ‘feed business’ and ‘placing on the market’ as laid down, respectively, in points 4, 5 and 8 of Article 3 of Regulation (EC) No 178/2002;</Text>
                              </P3para>
                           </P3>
                           <P3>
                              <Pnumber PuncBefore="(" PuncAfter=")">b</Pnumber>
                              <P3para>
                                 <Text>the definitions of ‘feed additives’ and ‘daily ration’ as laid down, respectively, in points (a) and (f) of Article 2(2) of Regulation (EC) No 1831/2003;</Text>
                              </P3para>
                           </P3>
                           <P3>
                              <Pnumber PuncBefore="(" PuncAfter=")">c</Pnumber>
                              <P3para>
                                 <Text>the definitions of ‘food-producing animal’, ‘non-food-producing animals’, ‘fur animals’, ‘feed materials’, ‘compound feed’, ‘complete feed’, ‘complementary feed’, ‘mineral feed’, ‘minimum storage life’, ‘batch’, ‘labelling’ and ‘label’ as laid down, respectively, in points (c), (d), (e), (g), (h), (i), (j), (k), (q), (r), (s) and (t) of Article 3(2) of Regulation (EC) No 767/2009;</Text>
                              </P3para>
                           </P3>
                           <P3>
                              <Pnumber PuncBefore="(" PuncAfter=")">d</Pnumber>
                              <P3para>
                                 <Text>the definition of ‘establishment’ as laid down in point (d) of Article 3 of Regulation (EC) No 183/2005;</Text>
                              </P3para>
                           </P3>
                           <P3>
                              <Pnumber PuncBefore="(" PuncAfter=")">e</Pnumber>
                              <P3para>
                                 <Text>the definitions of ‘official controls’ and ‘competent authorities’ as laid down, respectively, in Article 2(1) and in point 3 of Article 3, of Regulation (EU) 2017/625;</Text>
                              </P3para>
                           </P3>
                           <P3>
                              <Pnumber PuncBefore="(" PuncAfter=")">f</Pnumber>
                              <P3para>
                                 <Text>the definitions of ‘veterinary medicinal product’, ‘active substance’, ‘immunological veterinary medicinal product’, ‘antimicrobial’, ‘antiparasitic’, ‘antibiotic’, ‘metaphylaxis’, ‘prophylaxis’, and ‘withdrawal period’, as laid down, respectively, in points 1, 3, 5, 12, 13, 14, 15, 16 and 34 of Article 4 of Regulation (EU) 2019/6, and ‘summary of the product characteristics’ referred to in Article 35 of that Regulation.</Text>
                              </P3para>
                           </P3>
                        </P2para>
                     </P2>
                     <P2 DocumentURI="http://www.legislation.gov.uk/eur/2019/4/article/3/2" IdURI="http://www.legislation.gov.uk/id/eur/2019/4/article/3/2" id="article-3-2">
                        <Pnumber PuncBefore="" PuncAfter=".">2</Pnumber>
                        <P2para>
                           <Text>The following definitions also apply:</Text>
                           <P3>
                              <Pnumber PuncBefore="(" PuncAfter=")">a</Pnumber>
                              <P3para>
                                 <Text>‘medicated feed’ means a feed, which is ready to be directly fed to animals without further processing, consisting of a homogenous mixture of one or more veterinary medicinal products or intermediate products with feed materials or compound feed;</Text>
                              </P3para>
                           </P3>
                           <P3>
                              <Pnumber PuncBefore="(" PuncAfter=")">b</Pnumber>
                              <P3para>
                                 <Text>‘intermediate product’ means a feed, which is not ready to be directly fed to animals without further processing, consisting of a homogenous mixture of one or more veterinary medicinal products with feed materials or compound feed, exclusively intended to be used for the manufacture of medicated feed;</Text>
                              </P3para>
                           </P3>
                           <P3>
                              <Pnumber PuncBefore="(" PuncAfter=")">c</Pnumber>
                              <P3para>
                                 <Text>‘non-target feed’ means feed, whether medicated or not, which is not intended to contain a specific active substance;</Text>
                              </P3para>
                           </P3>
                           <P3>
                              <Pnumber PuncBefore="(" PuncAfter=")">d</Pnumber>
                              <P3para>
                                 <Text>‘cross-contamination’ means contamination of a non-target feed with an active substance originating from the previous use of the facilities or equipment;</Text>
                              </P3para>
                           </P3>
                           <P3>
                              <Pnumber PuncBefore="(" PuncAfter=")">e</Pnumber>
                              <P3para>
                                 <Text>‘feed business operator’ means any natural or legal person responsible for ensuring that the requirements of this Regulation are met within the feed business under that person’s control;</Text>
                              </P3para>
                           </P3>
                           <P3>
                              <Pnumber PuncBefore="(" PuncAfter=")">f</Pnumber>
                              <P3para>
                                 <Text>‘mobile mixer’ means a feed business operator with a feed establishment consisting of a specifically equipped vehicle for the manufacture of medicated feed;</Text>
                              </P3para>
                           </P3>
                           <P3>
                              <Pnumber PuncBefore="(" PuncAfter=")">g</Pnumber>
                              <P3para>
                                 <Text>‘on-farm mixer’ means a feed business operator manufacturing medicated feed for the exclusive use on its farm;</Text>
                              </P3para>
                           </P3>
                           <P3>
                              <Pnumber PuncBefore="(" PuncAfter=")">h</Pnumber>
                              <P3para>
                                 <Text>‘veterinary prescription for medicated feed’ means a document issued by a veterinarian for a medicated feed;</Text>
                              </P3para>
                           </P3>
                           <P3>
                              <Pnumber PuncBefore="(" PuncAfter=")">i</Pnumber>
                              <P3para>
                                 <Text>‘advertising’ means the making of a representation in any form in connection with medicated feed and intermediate products in order to promote prescription or use of medicated feed comprising also the supply of samples and sponsorships;</Text>
                              </P3para>
                           </P3>
                           <P3>
                              <Pnumber PuncBefore="(" PuncAfter=")">j</Pnumber>
                              <P3para>
                                 <Text>‘animal keeper’ means any natural or legal person responsible for animals, whether on a permanent or on a temporary basis.</Text>
                              </P3para>
                           </P3>
                        </P2para>
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