<akomaNtoso xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xsi:schemaLocation="http://docs.oasis-open.org/legaldocml/ns/akn/3.0 http://docs.oasis-open.org/legaldocml/akn-core/v1.0/cos01/part2-specs/schemas/akomantoso30.xsd"><act name="eur"><meta><identification source="#"><FRBRWork><FRBRthis value="http://www.legislation.gov.uk/id/eur/2019/4"/><FRBRuri value="http://www.legislation.gov.uk/id/eur/2019/4"/><FRBRdate date="2018-12-11" name="adopted"/><FRBRauthor href=""/><FRBRcountry value="EU"/><FRBRnumber value="4"/><FRBRname value="Regulation (EU) 2019/4"/><FRBRprescriptive value="true"/></FRBRWork><FRBRExpression><FRBRthis value="http://www.legislation.gov.uk/eur/2019/4/2018-12-11"/><FRBRuri value="http://www.legislation.gov.uk/eur/2019/4/2018-12-11"/><FRBRdate date="2018-12-11" 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href="/ontology/jurisdictions/uk.EnglandWalesScotlandNorthernIreland" showAs="E+W+S+N.I."/></references><proprietary xmlns:ukm="http://www.legislation.gov.uk/namespaces/metadata" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:dct="http://purl.org/dc/terms/" source="#"><dc:identifier>http://www.legislation.gov.uk/eur/2019/4/chapter/I</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><ukm:EUMetadata><ukm:DocumentClassification><ukm:DocumentCategory Value="euretained"/><ukm:DocumentMainType Value="EuropeanUnionRegulation"/><ukm:DocumentStatus Value="revised"/></ukm:DocumentClassification><ukm:Year Value="2019"/><ukm:Number Value="4"/><ukm:EURLexIdentifiers xmlns:atom="http://www.w3.org/2005/Atom" xmlns="http://www.legislation.gov.uk/namespaces/legislation"><ukm:Cellar Value="ff765aa0-120a-11e9-81b4-01aa75ed71a1"/><ukm:OfficialJournal Value="JOL_2019_004_R_0001"/><ukm:ELI 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Scheme="EuroVoc" Label="health control" URI="http://eurovoc.europa.eu/192"/><ukm:Subject Scheme="EuroVoc" Label="veterinary medicinal product" URI="http://eurovoc.europa.eu/2785"/><ukm:Subject Scheme="EuroVoc" Label="drug surveillance" URI="http://eurovoc.europa.eu/5916"/><ukm:Subject Scheme="SubjectMatter" Label="Animal feedingstuffs" URI="http://publications.europa.eu/resource/authority/fd_070/AL-A"/><ukm:Subject Scheme="SubjectMatter" Label="Veterinary legislation" URI="http://publications.europa.eu/resource/authority/fd_070/VETE"/><ukm:Subject Scheme="EuroVoc" Label="labelling" URI="http://eurovoc.europa.eu/893"/><ukm:Subject Scheme="EuroVoc" Label="animal health" URI="http://eurovoc.europa.eu/5877"/><ukm:DocumentCurrentStatus><ukm:UKAmended Value="false"/></ukm:DocumentCurrentStatus></ukm:EUMetadata><ukm:Alternatives><ukm:Alternative URI="http://www.legislation.gov.uk/eur/2019/4/pdfs/eur_20190004_adopted_en.pdf" Date="2018-12-11" Size="866627"/></ukm:Alternatives><ukm:Statistics><ukm:TotalParagraphs Value="94"/><ukm:BodyParagraphs Value="26"/><ukm:ScheduleParagraphs Value="68"/><ukm:AttachmentParagraphs Value="0"/><ukm:TotalImages Value="0"/></ukm:Statistics></proprietary></meta><body eId="body"><chapter eId="chapter-I" uk:target="true"><num>CHAPTER I</num><heading><b>SUBJECT MATTER, SCOPE AND DEFINITIONS</b></heading><article eId="article-1"><num>Article 1</num><heading>Subject matter</heading><content><p>This Regulation lays down specific provisions regarding medicated feed and intermediate products, which are additional to Union legislation on feed and apply without prejudice in particular to Regulations (EC) No 1831/2003, (EC) No 183/2005 and (EC) No 767/2009 and Directive 2002/32/EC.</p></content></article><article eId="article-2"><num>Article 2</num><heading>Scope</heading><paragraph eId="article-2-1"><num>1.</num><intro><p>This Regulation applies to:</p></intro><level class="para1"><num>(a)</num><content><p>the manufacture, storage and transport of medicated feed and intermediate products;</p></content></level><level class="para1"><num>(b)</num><content><p>the placing on the market, including import from third countries, and use of medicated feed and intermediate products;</p></content></level><level class="para1"><num>(c)</num><content><p>the export to third countries of medicated feed and intermediate products. However, Articles 9, 16, 17 and 18 shall not apply to medicated feed and intermediate products whose label indicates that they are intended for export to third countries.</p></content></level></paragraph><paragraph eId="article-2-2"><num>2.</num><content><p>This Regulation does not apply to veterinary medicinal products as defined in Regulation (EU) 2019/6 except where such products are included in a medicated feed or an intermediate product.</p></content></paragraph></article><article eId="article-3"><num>Article 3</num><heading>Definitions</heading><paragraph eId="article-3-1"><num>1.</num><intro><p>For the purposes of this Regulation, the following definitions apply:</p></intro><level class="para1"><num>(a)</num><content><p>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;</p></content></level><level class="para1"><num>(b)</num><content><p>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;</p></content></level><level class="para1"><num>(c)</num><content><p>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;</p></content></level><level class="para1"><num>(d)</num><content><p>the definition of ‘establishment’ as laid down in point (d) of Article 3 of Regulation (EC) No 183/2005;</p></content></level><level class="para1"><num>(e)</num><content><p>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;</p></content></level><level class="para1"><num>(f)</num><content><p>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.</p></content></level></paragraph><paragraph eId="article-3-2"><num>2.</num><intro><p>The following definitions also apply:</p></intro><level class="para1"><num>(a)</num><content><p>‘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;</p></content></level><level class="para1"><num>(b)</num><content><p>‘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;</p></content></level><level class="para1"><num>(c)</num><content><p>‘non-target feed’ means feed, whether medicated or not, which is not intended to contain a specific active substance;</p></content></level><level class="para1"><num>(d)</num><content><p>‘cross-contamination’ means contamination of a non-target feed with an active substance originating from the previous use of the facilities or equipment;</p></content></level><level class="para1"><num>(e)</num><content><p>‘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;</p></content></level><level class="para1"><num>(f)</num><content><p>‘mobile mixer’ means a feed business operator with a feed establishment consisting of a specifically equipped vehicle for the manufacture of medicated feed;</p></content></level><level class="para1"><num>(g)</num><content><p>‘on-farm mixer’ means a feed business operator manufacturing medicated feed for the exclusive use on its farm;</p></content></level><level class="para1"><num>(h)</num><content><p>‘veterinary prescription for medicated feed’ means a document issued by a veterinarian for a medicated feed;</p></content></level><level class="para1"><num>(i)</num><content><p>‘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;</p></content></level><level class="para1"><num>(j)</num><content><p>‘animal keeper’ means any natural or legal person responsible for animals, whether on a permanent or on a temporary basis.</p></content></level></paragraph></article></chapter></body></act></akomaNtoso>