Words in Art. 47(1) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 94(a); 2020 c. 1, Sch. 5 para. 1(1)

Words in Art. 47(2) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 94(b); 2020 c. 1, Sch. 5 para. 1(1)

Art. 47(3) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 94(c); 2020 c. 1, Sch. 5 para. 1(1)

http://www.legislation.gov.uk/eur/2012/528/article/47Regulation (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 (Text with EEA relevance)Regulation (EU) No 528/2012 of the European Parliament and of the CouncilRegulation (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 (Text with EEA relevance)King's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02012R0528-20191120texttext/xmlen2024-07-31Expert Participation2024-04-06CHAPTER IXCANCELLATION, REVIEW AND AMENDMENT OF AUTHORISATIONS
Article 47Obligation for notification of unexpected or adverse effects1

On becoming aware of information concerning the authorised biocidal product, or the active substance(s) it contains, that may affect the authorisation, the holder of an authorisation shall without delay notify the competent authority .... In particular, the following shall be notified:

a

new data or information on the adverse effects of the active substance or biocidal product for humans, in particular vulnerable groups, animals or the environment;

b

any data indicating the potential of the active substance for the development of resistance;

c

new data or information indicating that the biocidal product is not sufficiently effective.

2

The competent authority ..., shall examine whether the authorisation needs to be amended or cancelled in accordance with Article 48.

3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

This XML file does not appear to have any style information associated with it. The document tree is shown below.
<akomaNtoso 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">
<portion includedIn="http://www.legislation.gov.uk/id/eur/2012/528">
<meta>
<identification source="#source">
<FRBRWork>
<FRBRthis value="http://www.legislation.gov.uk/id/eur/2012/528"/>
<FRBRuri value="http://www.legislation.gov.uk/id/eur/2012/528"/>
<FRBRdate date="2012-05-22" name="adopted"/>
<FRBRauthor href="http://publications.europa.eu/resource/authority/corporate-body/OP_DATPRO"/>
<FRBRcountry value="EU"/>
<FRBRnumber value="528"/>
<FRBRname value="Regulation (EU) 2012/528"/>
<FRBRprescriptive value="true"/>
</FRBRWork>
<FRBRExpression>
<FRBRthis value="http://www.legislation.gov.uk/eur/2012/528/article/47"/>
<FRBRuri value="http://www.legislation.gov.uk/eur/2012/528"/>
<FRBRdate date="2024-04-06" name="validFrom"/>
<FRBRauthor href="#source"/>
<FRBRlanguage language="eng"/>
</FRBRExpression>
<FRBRManifestation>
<FRBRthis value="http://www.legislation.gov.uk/eur/2012/528/article/47/data.akn"/>
<FRBRuri value="http://www.legislation.gov.uk/eur/2012/528/data.akn"/>
<FRBRdate date="2024-11-04Z" name="transform"/>
<FRBRauthor href="http://www.legislation.gov.uk"/>
<FRBRformat value="application/akn+xml"/>
</FRBRManifestation>
</identification>
<lifecycle source="#source">
<eventRef date="2012-05-22" type="generation" eId="enacted-date" source="#source"/>
<eventRef date="2012-05-22" type="amendment" source="#source"/>
<eventRef date="2020-12-31" type="amendment" source="#source"/>
<eventRef date="2020-12-31" eId="effective-date-1" source="#source"/>
<eventRef date="2022-12-31" eId="effective-date-2" source="#source"/>
<eventRef date="2024-04-06" eId="effective-date-3" source="#source"/>
</lifecycle>
<analysis source="#source">
<restrictions source="#source">
<restriction refersTo="#e+w+s+ni" type="jurisdiction"/>
<restriction href="#d4e922" refersTo="#e+w+s+ni" type="jurisdiction"/>
<restriction href="#article-47" refersTo="#e+w+s+ni" type="jurisdiction"/>
<restriction href="#chapter-IX" refersTo="#e+w+s+ni" type="jurisdiction"/>
</restrictions>
</analysis>
<temporalData source="#source">
<temporalGroup eId="period1">
<timeInterval start="#effective-date-1" refersTo="#period-concept1"/>
</temporalGroup>
<temporalGroup eId="period2">
<timeInterval start="#effective-date-2" refersTo="#period-concept2"/>
</temporalGroup>
<temporalGroup eId="period3">
<timeInterval start="#effective-date-3" refersTo="#period-concept3"/>
</temporalGroup>
</temporalData>
<references source="#source">
<TLCOrganization eId="source" href="http://www.legislation.gov.uk/id/publisher/KingsOrQueensPrinterOfActsOfParliament" showAs="King's Printer of Acts of Parliament"/>
<passiveRef href="http://www.legislation.gov.uk/id/uksi/2019/720" showAs="The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019"/>
<TLCLocation eId="e+w+s+ni" href="/ontology/jurisdictions/uk.EnglandWalesScotlandNorthernIreland" showAs="England, Wales, Scotland, Northern Ireland"/>
<TLCConcept eId="period-concept1" href="/ontology/time/2020.12.31" showAs="since 2020-12-31"/>
<TLCConcept eId="period-concept2" href="/ontology/time/2022.12.31" showAs="since 2022-12-31"/>
<TLCConcept eId="period-concept3" href="/ontology/time/2024.04.06" showAs="since 2024-04-06"/>
</references>
<notes source="#source">
<note class="commentary F" eId="key-7fefba8897b17788ec560a87ec845fff">
<p>
Words in
<ref href="http://www.legislation.gov.uk/id/eur/2012/528/article/47/1">Art. 47(1)</ref>
omitted (31.12.2020) by virtue of
<ref href="http://www.legislation.gov.uk/id/uksi/2019/720">The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720)</ref>
,
<ref href="http://www.legislation.gov.uk/id/uksi/2019/720/regulation/1/2">reg. 1(2)</ref>
,
<ref href="http://www.legislation.gov.uk/id/uksi/2019/720/schedule/2/paragraph/94/a">Sch. 2 para. 94(a)</ref>
;
<ref href="http://www.legislation.gov.uk/id/ukpga/2020/1">2020 c. 1</ref>
,
<ref href="http://www.legislation.gov.uk/id/ukpga/2020/1/schedule/5/paragraph/1/1">Sch. 5 para. 1(1)</ref>
</p>
</note>
<note class="commentary F" eId="key-a4e96d6556a9a5fb7cbbdbbf94fdc5fa">
<p>
Words in
<ref href="http://www.legislation.gov.uk/id/eur/2012/528/article/47/2">Art. 47(2)</ref>
omitted (31.12.2020) by virtue of
<ref href="http://www.legislation.gov.uk/id/uksi/2019/720">The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720)</ref>
,
<ref href="http://www.legislation.gov.uk/id/uksi/2019/720/regulation/1/2">reg. 1(2)</ref>
,
<ref href="http://www.legislation.gov.uk/id/uksi/2019/720/schedule/2/paragraph/94/b">Sch. 2 para. 94(b)</ref>
;
<ref href="http://www.legislation.gov.uk/id/ukpga/2020/1">2020 c. 1</ref>
,
<ref href="http://www.legislation.gov.uk/id/ukpga/2020/1/schedule/5/paragraph/1/1">Sch. 5 para. 1(1)</ref>
</p>
</note>
<note class="commentary F" eId="key-1d7aef16c7aeff65ce5d0cd10b6e4ef0">
<p>
<ref href="http://www.legislation.gov.uk/id/eur/2012/528/article/47/3">Art. 47(3)</ref>
omitted (31.12.2020) by virtue of
<ref href="http://www.legislation.gov.uk/id/uksi/2019/720">The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720)</ref>
,
<ref href="http://www.legislation.gov.uk/id/uksi/2019/720/regulation/1/2">reg. 1(2)</ref>
,
<ref href="http://www.legislation.gov.uk/id/uksi/2019/720/schedule/2/paragraph/94/c">Sch. 2 para. 94(c)</ref>
;
<ref href="http://www.legislation.gov.uk/id/ukpga/2020/1">2020 c. 1</ref>
,
<ref href="http://www.legislation.gov.uk/id/ukpga/2020/1/schedule/5/paragraph/1/1">Sch. 5 para. 1(1)</ref>
</p>
</note>
</notes>
<proprietary xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" 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/" xmlns:atom="http://www.w3.org/2005/Atom" source="#source">
<ukl:RestrictStartDate value="2024-04-06"/>
<dc:identifier>http://www.legislation.gov.uk/eur/2012/528/article/47</dc:identifier>
<dc:title>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 (Text with EEA relevance)</dc:title>
<dct:alternative>Regulation (EU) No 528/2012 of the European Parliament and of the Council</dct:alternative>
<dc:description>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 (Text with EEA relevance)</dc:description>
<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:02012R0528-20191120</dc:source>
<dc:type>text</dc:type>
<dc:format>text/xml</dc:format>
<dc:language>en</dc:language>
<dc:modified>2024-07-31</dc:modified>
<dc:contributor>Expert Participation</dc:contributor>
<dct:valid>2024-04-06</dct:valid>
<atom:link rel="self" href="http://www.legislation.gov.uk/eur/2012/528/article/47/data.xml" type="application/xml"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/resources" href="http://www.legislation.gov.uk/eur/2012/528/resources" title="More Resources"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/act" href="http://www.legislation.gov.uk/eur/2012/528" title="whole act"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/introduction" href="http://www.legislation.gov.uk/eur/2012/528/introduction" title="introduction"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/signature" href="http://www.legislation.gov.uk/eur/2012/528/signature" title="signature"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/body" href="http://www.legislation.gov.uk/eur/2012/528/body" title="body"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/annexes" href="http://www.legislation.gov.uk/eur/2012/528/annexes" title="annexes"/>
<atom:link rel="http://www.legislation.gov.uk/def/date/euexitday" href="http://www.legislation.gov.uk/eur/2012/528/article/47/2020-01-31" title="2020-01-31"/>
<atom:link rel="http://www.legislation.gov.uk/def/date/euexitTransitionEnd" href="http://www.legislation.gov.uk/eur/2012/528/article/47/2020-12-31" title="2020-12-31"/>
<atom:link rel="http://www.legislation.gov.uk/def/legislation/EffectsApplied" href="https://www.legislation.gov.uk/changes/applied/affected/eur/2012/528" title="Amended by UK"/>
<atom:link rel="alternate" type="application/rdf+xml" href="http://www.legislation.gov.uk/eur/2012/528/article/47/data.rdf" title="RDF/XML"/>
<atom:link rel="alternate" type="application/akn+xml" href="http://www.legislation.gov.uk/eur/2012/528/article/47/data.akn" title="AKN"/>
<atom:link rel="alternate" type="application/xhtml+xml" href="http://www.legislation.gov.uk/eur/2012/528/article/47/data.xht" title="HTML snippet"/>
<atom:link rel="alternate" type="text/html" href="http://www.legislation.gov.uk/eur/2012/528/article/47/data.htm" title="Website (XHTML) Default View"/>
<atom:link rel="alternate" type="text/csv" href="http://www.legislation.gov.uk/eur/2012/528/article/47/data.csv" title="CSV"/>
<atom:link rel="alternate" type="application/pdf" href="http://www.legislation.gov.uk/eur/2012/528/article/47/data.pdf" title="PDF"/>
<atom:link rel="alternate" type="application/akn+xhtml" href="http://www.legislation.gov.uk/eur/2012/528/article/47/data.html" title="HTML5 snippet"/>
<atom:link rel="http://purl.org/dc/terms/tableOfContents" hreflang="en" href="http://www.legislation.gov.uk/eur/2012/528/contents" title="Table of Contents"/>
<atom:link rel="http://purl.org/dc/terms/replaces" href="http://www.legislation.gov.uk/eur/2012/528/article/47/2012-05-22" title="2012-05-22"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/eur/2012/528/article/47/adopted" title="adopted"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/eur/2012/528/article/47/2012-05-22" title="2012-05-22"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/eur/2012/528/article/47/2020-12-31" title="2020-12-31"/>
<atom:link rel="up" href="http://www.legislation.gov.uk/eur/2012/528" title="Entire legislation"/>
<atom:link rel="prev" href="http://www.legislation.gov.uk/eur/2012/528/article/46" title="Provision; Article 46"/>
<atom:link rel="prevInForce" href="http://www.legislation.gov.uk/eur/2012/528/article/46" title="Provision; Article 46"/>
<atom:link rel="next" href="http://www.legislation.gov.uk/eur/2012/528/article/48" title="Provision; Article 48"/>
<atom:link rel="nextInForce" href="http://www.legislation.gov.uk/eur/2012/528/article/48" title="Provision; Article 48"/>
<ukm:EUMetadata>
<ukm:DocumentClassification>
<ukm:DocumentCategory Value="euretained"/>
<ukm:DocumentMainType Value="EuropeanUnionRegulation"/>
<ukm:DocumentStatus Value="revised"/>
</ukm:DocumentClassification>
<ukm:Year Value="2012"/>
<ukm:Number Value="528"/>
<ukm:EURLexIdentifiers>
<ukm:Cellar Value="ca4a72f3-20d9-11ea-95ab-01aa75ed71a1"/>
<ukm:CELEX Value="02012R0528-20191120"/>
<ukm:ELI Value="reg:2012:528:2019-11-20"/>
</ukm:EURLexIdentifiers>
<ukm:EnactmentDate Date="2012-05-22"/>
<ukm:EURLexModified Date="2020-12-15T15:41:10Z"/>
<ukm:EURLexExtracted Date="2020-12-15T18:06:50Z"/>
<ukm:XMLGenerated Date="2020-12-15T18:07:45Z"/>
<ukm:XMLImported Date="2020-12-16T08:21:55Z"/>
<ukm:CreatedBy Label="Provisional data" URI="http://publications.europa.eu/resource/authority/corporate-body/OP_DATPRO"/>
<ukm:UnappliedEffects>
<ukm:UnappliedEffect AffectedURI="http://www.legislation.gov.uk/id/eur/2012/528" Notes="This amendment not applied to legislation.gov.uk. Sch. 2 para. 143(14) substituted immediately before IP completion day by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 39(b)" URI="http://www.legislation.gov.uk/id/effect/key-a36ec849bb6338f1edd931be0afd3122" AffectedProvisions="Annex 6 para. 77" AffectedClass="EuropeanUnionRegulation" AffectingEffectsExtent="E+W+S+N.I." AffectingClass="UnitedKingdomStatutoryInstrument" RequiresApplied="false" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" Modified="2024-07-31T13:45:54Z" AffectingNumber="720" AffectingYear="2019" Row="138" EffectId="key-a36ec849bb6338f1edd931be0afd3122" Comments="IP completion day" AffectedNumber="528" Type="words substituted" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/720" AffectingProvisions="Sch. 2 para. 143(14)" AffectedYear="2012">
<ukm:AffectedTitle>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 (Text with EEA relevance)</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-VI" URI="http://www.legislation.gov.uk/id/eur/2012/528/annex/VI">Annex 6 </ukm:Section>
<ukm:Section Ref="annex-VI-paragraph-77" URI="http://www.legislation.gov.uk/id/eur/2012/528/annex/VI/paragraph/77" FoundRef="annex-VI">para. 77</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="schedule-2" URI="http://www.legislation.gov.uk/id/uksi/2019/720/schedule/2">Sch. 2 </ukm:Section>
<ukm:Section Ref="schedule-2-paragraph-143-14" URI="http://www.legislation.gov.uk/id/uksi/2019/720/schedule/2/paragraph/143/14">para. 143(14)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1-2" URI="http://www.legislation.gov.uk/id/uksi/2019/720/regulation/1/2">reg. 1(2)</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
</ukm:UnappliedEffects>
</ukm:EUMetadata>
<ukm:Alternatives>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2012/528/pdfs/eur_20120528_adopted_en.pdf" Date="2012-05-22" Size="1954364"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2012/528/pdfs/eur_20120528_2013-09-23_en.pdf" Date="2013-09-23" Size="1258244" Revised="2013-09-23"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2012/528/pdfs/eur_20120528_2014-04-25_en.pdf" Date="2014-04-25" Size="1352978" Revised="2014-04-25"/>
<ukm:Alternative URI="http://www.legislation.gov.uk/eur/2012/528/pdfs/eur_20120528_2019-11-20_en.pdf" Date="2019-11-20" Size="1620161" Revised="2019-11-20"/>
</ukm:Alternatives>
<ukm:CorrectionSlips>
<ukm:CorrectionSlip URI="http://www.legislation.gov.uk/eur/2012/528/pdfs/eurcs_20120528_en_001.pdf" Date="2017-10-28" Size="365468"/>
</ukm:CorrectionSlips>
<ukm:Statistics>
<ukm:TotalParagraphs Value="838"/>
<ukm:BodyParagraphs Value="117"/>
<ukm:ScheduleParagraphs Value="721"/>
<ukm:AttachmentParagraphs Value="0"/>
<ukm:TotalImages Value="0"/>
</ukm:Statistics>
</proprietary>
</meta>
<portionBody eId="body" period="#period2">
<chapter eId="chapter-IX" period="#period1">
<num>CHAPTER IX</num>
<heading>
<strong>CANCELLATION, REVIEW AND AMENDMENT OF AUTHORISATIONS</strong>
</heading>
<article eId="article-47" period="#period1">
<num>Article 47</num>
<heading>Obligation for notification of unexpected or adverse effects</heading>
<paragraph eId="article-47-1">
<num>1</num>
<intro>
<p>
On becoming aware of information concerning the authorised biocidal product, or the active substance(s) it contains, that may affect the authorisation, the holder of an authorisation shall without delay notify the competent authority
<noteRef href="#key-7fefba8897b17788ec560a87ec845fff" marker="F1" class="commentary F"/>
.... In particular, the following shall be notified:
</p>
</intro>
<subparagraph eId="article-47-1-a">
<num>a</num>
<content>
<p>new data or information on the adverse effects of the active substance or biocidal product for humans, in particular vulnerable groups, animals or the environment;</p>
</content>
</subparagraph>
<subparagraph eId="article-47-1-b">
<num>b</num>
<content>
<p>any data indicating the potential of the active substance for the development of resistance;</p>
</content>
</subparagraph>
<subparagraph eId="article-47-1-c">
<num>c</num>
<content>
<p>new data or information indicating that the biocidal product is not sufficiently effective.</p>
</content>
</subparagraph>
</paragraph>
<paragraph eId="article-47-2">
<num>2</num>
<content>
<p>
The competent authority
<noteRef href="#key-a4e96d6556a9a5fb7cbbdbbf94fdc5fa" marker="F2" class="commentary F"/>
..., shall examine whether the authorisation needs to be amended or cancelled in accordance with Article 48.
</p>
</content>
</paragraph>
<paragraph eId="article-47-3">
<num>
<noteRef href="#key-1d7aef16c7aeff65ce5d0cd10b6e4ef0" marker="F3" class="commentary F"/>
3
</num>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</paragraph>
</article>
</chapter>
</portionBody>
</portion>
</akomaNtoso>