the eu biocidal products regulation (no. 528/2012) for... · regulation (no. 528/2012) guidance...

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Contact:AnneliWeinholt

AboutASDTheAeroSpaceandDefence IndustriesAssociationofEuroperepresents theaeronautics, space,defenceandsecurity industries inEuropeinallmattersofcommoninterestwiththeobjectiveofpromotingandsupportingthecompetitivedevelopmentofthesector.ItsmembershipcomprisesmajorEuropeanaerospaceanddefencecompaniesaswellasnationalassociations.

ASD|RueMontoyer10I1000Brussels,BelgiumIT:[email protected]

TheEUBiocidalProductsRegulation(No.528/2012)GuidancedocumentforASDindustries

January2016

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EUBiocidalProdcutsRegulation(528/2012)

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DisclaimerTheAeroSpaceandDefence IndustriesAssociationofEurope(ASD)represents theaeronautics,space,defence and security industries in Europe in all matters of common interest with the objective ofpromotingandsupportingthecompetitivedevelopmentofthesector.ASD'smembershipiscomposedof major European aerospace and defence companies and 27 member associations in 19 countries(Austria,Belgium,Bulgaria, theCzechRepublic,Denmark,Finland,France,Germany,Greece, Italy, theNetherlands,Norway,Poland,Portugal,Spain,Sweden,Switzerland,TurkeyandtheUK). In2014over3000aeronautics,spaceanddefencecompaniesinthesecountriesemployedmorethan795,000peopleandgeneratedaturnoverof€199.4billion.

ThisguidancedocumentistheproductoftheASDREACHImplementationWorkingGroup(RIWG);Sub-WorkingGroupfortheBiocidalProductRegulation(BPR).

ThisdocumentcontainsinformationandrecommendationswhichhavebeenprovidedingoodfaithbytheASDRIWGBPRSub-WorkingGroup, reflecting thebest knowledgeavailable fromexperts in theirfield,andinaccordancewiththecurrentconsolidatedamendedversionsoftheregulatorytextsattimeofwriting:November2015.

Guidance is provided in good faith anddoes not substitute the original legal text or official guidancedocuments.ASDacceptsno liability regarding thecontentof thisguidance,nor issuesarising from itsuse.ASDisnotresponsibleforthecontentoftheincludedhyperlinks.

Alwaysrefertotheoriginallegaltext.

AcknowledgementTheASDREACH ImplementationWorkingGroup (RIWG); Sub-WorkingGroup for theBiocidal ProductRegulation very much appreciates the exchange of comments, suggestions and questions with theAutomotiveIndustryTaskForce-Biocidesduringthedevelopmentofthisguidance.

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AbbreviationsA&D AerospaceandDefence

AS ActiveSubstance;biocidalActiveSubstance

ASD AeroSpaceandDefenceIndustriesAssociationofEurope

AS+PT ActiveSubstance+ProductType

BP BiocidalProduct

BPD BiocidalProductsDirective(98/8/EC)

BPR BiocidalProductsRegulation(EUNo.528/2012)

CLP Classification,LabellingandPackaging(ECNo.1272/2008)

EC EuropeanCommission

ECHA EuropeanChemicalsAgency

EEA EuropeanEconomicArea

EU EuropeanUnion

MoD MinistryofDefence

PT ProductType

REACH Registration,Evaluation,AuthorisationandRestrictionofChemicals(ECNo.1907/2006)

SDS SafetyDataSheet

TA TreatedArticle

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TableofContents

DISCLAIMER..........................................................................................................................................I

ACKNOWLEDGEMENT...........................................................................................................................I

ABBREVIATIONS...................................................................................................................................II

FOREWORD..........................................................................................................................................1

EXECUTIVESUMMARY..........................................................................................................................2

1.0WHATISTHEEUBIOCIDALPRODUCTSREGULATION(BPR)?...........................................................31.1WHICHCOUNTRIESAREINCLUDED?............................................................................................................31.2KEYDEFINITIONS....................................................................................................................................31.3WHATARETHEEXCLUSIONSFROMSCOPE?..................................................................................................71.4ARETHEREANYDEFENCEEXEMPTIONS?......................................................................................................71.5COMPLIANCEENFORCEMENT....................................................................................................................7

2.0WHICHTYPESOFPRODUCTSTHATIUSEORMANUFACTUREMIGHTBEAFFECTED?.......................82.1WHENISASUBSTANCEREGULATEDBYTHEBPR?.........................................................................................8

3.0HOWDOESTHEBPR2012DIFFERFROMTHEBIOCIDALPRODUCTSDIRECTIVE1998(BPD)?..........103.1TREATEDARTICLECOMPLIANCEOBLIGATIONS.............................................................................................103.2ARTICLE95LISTFORACTIVESUBSTANCESUPPLIERSANDBIOCIDALPRODUCTIMPORTERS..................................11

4.0WHENMIGHTIHAVEOBLIGATIONSUNDERTHEBPR?..................................................................144.1IFYOUIMPORTORMANUFACTUREBIOCIDALPRODUCTSINTHEEU..........................................................144.2IFYOUIMPORTORMANUFACTURETREATEDARTICLESINTHEEU.............................................................14

5.0HOWCANICHECKIFIHAVEAPRODUCTTHATISWITHINSCOPEOFTHEREGULATION?..............16

6.0I’VEIDENTIFIEDTHATIMANUFACTURE,IMPORTORUSEPRODUCTSTHATFALLWITHINSCOPEOFTHEREGULATION.HOWCANICHECKIFTHOSEPRODUCTSARECOMPLIANTWITHTHEBPR?............17

6.1IFYOUHAVEABIOCIDALPRODUCT..........................................................................................................176.2IFYOUHAVEATREATEDARTICLE.............................................................................................................19

6.2.1COMMUNICATIONOFINFORMATIONONTREATEDARTICLES(LABELLING)................................20

7.0WHATABOUTCOMPLEX(TREATED)ARTICLES?.............................................................................21

8.0IMPLICATIONSOFWORKPROGRAMMEDECISIONSFORACTIVESUBSTANCES..............................228.1WHATARETHEPOTENTIALIMPLICATIONSFORBIOCIDALPRODUCTAVAILABILITY?............................................238.2WHATARETHEPOTENTIALIMPLICATIONSFORTREATEDARTICLEAVAILABILITY?...............................................23

9.0DURATIONSOFAPPROVALSANDAUTHORISATIONS....................................................................259.1ACTIVESUBSTANCEAPPROVALS...............................................................................................................259.2BIOCIDALPRODUCTAUTHORISATIONS.......................................................................................................25

9.2.1Cancellationofbiocidalproductauthorisations........................................................................25

10.0WHATARETHEUPCOMINGDEADLINES?....................................................................................26

11.0WHERECANIFINDOUTMORE?..................................................................................................27

APPENDICES.......................................................................................................................................28

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ForewordThisguidancedocumentaims togiveanoverviewof the2012EUBiocidalProductsRegulation (BPR),highlighting themain changesbetween thenew regulationand itspredecessor; the1998EUBiocidalProductsDirective(BPD).

This overview provided gives a practical interpretation from an Aerospace and Defence perspective;aimingtohelpreadersidentifyiftheymaybeaffectedbytheregulation,wherecomplianceissuesandobsolescencerisksmayariseandwhatthemaincomplianceobligationslooklike.

For the previously uninitiated, the BPR is a complex regulation requiring much interpretation tounderstandwhichsubstances,mixtures(formulations)andarticlesareregulated.Practicalguidanceand‘howto’informationispresentedinordertoaidthisunderstandingandtohelphighlightpotentialareasofnon-complianceandobsolescenceriskintheAerospaceandDefencesector.

The guidance focuses on ensuring compliance of current products and inventories (in use pre-BPR)rather than how development of new biocidal active substances and related products would bemanaged.

This guidance is not a comprehensive overview of the regulation and intentionally focuses on theaspectsconsideredtobeofmostinterestandimpacttoAerospaceandDefencecompanies.Assuch,thedetailofmanytopicsisexcludedfromscope,includingbutnotlimitedto;biocidalproductauthorisationprocesses, product families, biocidal product advertising, nanomaterial and in-situ active substances,candidates for substitution. This guidance also focuses only on the BPR and does not discuss otherregulatoryobligationsthatmayapplyinparallele.g.REACH,CLP.

Thisguidanceisdesignedtohelpidentifypotentialcomplianceissuesbeforereferringtothelegaltextsandseekingregulatorysupportincaseswhereactionmaybewarranted.

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ExecutivesummaryTheEuropeanBiocidalProductsRegulationEU528/2012alsoknownastheBPR,cameintoforceon1September2013with thepurposeof regulatingall biocidalproducts (thoseproductsdesigned to kill,repelor inhibitundesirableorganismsbyanymeansotherthanmerelyphysicalormechanicalaction)andtheactiveingredientsusedtogivesuchproductstheirbiocidalefficacy.

The regulationofbiocidalproducts in theEUensures thatallbiocidesare riskassessed for toxicity tohumansandtheenvironmentbeforetheyarepermittedtobeplacedonthemarket,andthattheyaresufficientlyactiveagainsttheharmfulorganismstheyaredesignedtotarget.Thisisdoneviaprocessesof approval for biocidal active substances (the active ingredients) and via authorisation of biocidalproducts(substances,formulationsorarticlesthatcontaintheactivesubstancesandareintendedtobeusedasbiocides).

Superseding an existing EU Biocidal Products Directive (98/8/EC), the BPR aims to improve freemovement of biocidal products in Europe, protect health and the environment, harmoniseimplementation between Member States, regulate imported products that contain biocidal activesubstances (treated articles) and ensure fair sharing of the costs associated with approval dossiersrequiredforbiocidalactivesubstances.

This widened scope and tightened provisions of the BPR, compared to the rescinded directive, havehighlighted potential compliance obligations and associated supply risk concerns to the attention ofAerospaceandDefencecompanies.

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1.0WhatistheEUBiocidalProductsRegulation(BPR)?

TheBPR1isanEUregulationconcerningtheregulationofbiocidalproducts;thoseproductsdesignedtokill, repel or inhibit undesirable organisms by any means other than merely physical or mechanicalaction.

Theregulationaimsto improvefreemovementofbiocidalproducts inEurope,protecthealthandtheenvironmentandtoharmoniseimplementationbetweenMemberStates.

The regulationofbiocidalproducts in theEUensures thatallbiocidesare riskassessed for toxicity tohumansandtheenvironmentbeforetheyarepermittedtobeplacedonthemarketandthattheyaresufficientlyactiveagainsttheharmfulorganismstheyaredesignedtotarget.Thisisdoneviaprocessesof approval for biocidal active substances (the active ingredients) and via authorisation of biocidalproducts(substances,formulationsorarticlesthatcontaintheactivesubstancesandareintendedtobeusedasbiocides).

Until September 2013, Biocidal products were regulated under the EU Biocidal Products Directive of1998.ThiswassupersededonSeptember1st2013bythe2012BiocidalProductsRegulation.Itswidenedscope and tightened provisions highlighted compliance concerns to the attention of Aerospace andDefencecompanies.

1.1Whichcountriesareincluded?TheBPRapplieswithintheEEAandassuchIceland,LiechtensteinandNorwayareincludedinadditiontotheEUMemberStates.

CountrieswishingtoapplyforaccessiontotheEUwillalsobealigningtheirnationalregulationstothatoftheEU.Forexample,Turkey,whosenationalregulationforbiocidalproductsisstillalignedtotheEUBPD,areanticipatedtoadoptafutureregulationthatmimicstheBPR.

1.2KeyDefinitionsTable1 references thekeydefinitions thatare important forunderstandingand interpretationof theBPR. Where appropriate, examples are given and the related compliance obligations detailed.Definitionsarenotpreciselyreproducedaccordingtotheoriginalregulatorytextasperarticle3andthismaybeconsultedinconjunction.

1http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1438609476193&uri=CELEX:02012R0528-20140425

Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22May 2012concerningthemakingavailableonthemarketanduseofbiocidalproducts.

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Term BPRDefinition Example/Explanation ObligationsHarmfulOrganism

An organism, including pathogenicagents, which has an unwantedpresence or detrimental effect onhumans, their activities or theproducts they use or produce, onanimalsortheenvironment

Includesinsects,microbes,bacteria,rodents,algaeetc.

(Biocidal)ActiveSubstance(AS)

Asubstanceoramicro-organismthathas an action on or against harmfulorganisms.

These are substance levelingredients – the actualchemical or micro-organismthat is responsible for actingagainst harmful organisms e.g.IPBC (Iodopropynylbutylcarbamate) used as apreservative for formulationssuchaspaintsorcuttingfluids.

Any product containing a biocidalactive substance (that has beenincorporated with the intention ofexploitingitsbiocidalproperty)thatisbeing placed on the EU market mayonly contain existing biocidal activesubstances that have an approval (orcontain existing biocidal activesubstances that are pending reviewvia the work programme) for use intherelevantproducttype.Productswishing to usenewbiocidalactive substances may not bemarketed until an approval, or aninterim authorisation, has beenobtained.Product obligations will varydependent on if the product isconsideredtobeabiocidalproductoratreatedarticle.

Existing(Biocidal)ActiveSubstance

An active substance which wasalready available on the market inbiocidalproductson14May2000andwhichisunderevaluationintheworkprogramme for existing activesubstances used in biocidal products.An active substance is regarded as'existing' only for the product-type(s)forwhich it is being evaluated in theworkprogramme.

New(Biocidal)ActiveSubstance

An active substance which is not'existing' according to the abovedefinition, i.e. an active substancewhich was made available on themarketinbiocidalproductsonlyafter14 May 2000 or which was notincluded in the work programme forevaluation. An active substance is'existing' only for the product-typesforwhich it is being evaluated in thereview programme, but will beregarded as ‘new’ for the product-types which are not included in theworkprogramme.

ProductType(PT)

There are 22 product types (PT) thatare established under the BPR andlisted in annex V (see appendix 1).Each biocidal active substancerequiring approval for use in the EUhas tobeapprovedagainst a specificproducttype.Thisenablesapprovalofsomeusesbutnotothers,dependingontherisksassociatedwithuseoftheactivesubstance.

Product types cover a widevariety of uses. Of particularrelevance may be: PT6 –preservatives for productsduring storage, PT13 –workingor cutting fluid preservatives,PT21–antifoulingproducts.

Biocidal active substances must onlybeusedinproducttypesforwhichanapproval has been granted (or isidentifiedundertheworkprogrambutisstillpendingreview).

Annex IList

Listofactivesubstancespermittedforsimplified biocidal productauthorisation.

These active substances areconsideredtobelowriskandassuch are permitted for use inbiocidalproductsofanyproducttype provided that they areused in accordance with anyconditions stipulated in theannex.

Therearemuchsimplifiedinformationrequirements for thebiocidalproductauthorisationwhenonlyusingAnnexIactive substances. These activesubstances are also consideredapproved.

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Term BPRDefinition Example/Explanation ObligationsWorkProgramme(EU) No1062/20142

&

Union Listofapprovedactivesubstances

A rolling work programme that hasbeenrunningsince2000.Concernedwith evaluating and approving ALLexisting biocidal active substances;those which have been identifiedagainst a PT use as of interest forcontinueduse(approvals).This isanexhaustivelist.An article 95 list is established thatlists all suppliers/importers whohave sought approval for a biocidalactivesubstance-producttype.A Union List is established, whichcontainsallapprovedbiocidalactivesubstances against their PTapprovals.

Manufacturersandimportersofbiocidal active substancesmustsubmit an approval dossier inorder to market (or continuemarketing for existing activesubstances)biocidalproductsinthe EU. They are required toseek approval for each biocidalactive substance-product typecombination that they wish tomarket.The work plan will assess eachapproval application anddetermine if the ‘activesubstance + product type’- isapprovedforuseornot.

It may take several years before anapprovalandproductsusingexistingactivescancontinue tobemarketeduntiladecisionismadeprovidedthatan approval dossier has beensubmitted.Forapprovaldecisions;theAS+PTwillbeaddedtotheUnionList.Biocidal products using the ASmustapply for product authorisationbefore the approval decision of thelastASintheproductispublished.For non-approval decisions; reliantbiocidalproductsmustbewithdrawnfrom themarket within 180 days ofthe decision. Up to 365 days arepermitted for use or disposal ofexisting stocks of affected biocidalproducts.

Article 95List

A list of approved suppliers forbiocidalactivesubstanceswithintheEU.

Inordertoplacebiocidalactivesubstances on the EU market(for their use in biocidalproducts); all suppliers of suchactivesubstanceswithintheEUmust be named on the article95 list. In the case of importedbiocidal products; the activesubstance supplier will be thebiocidal product importer andmust appear on the article 95list for the relevant AS+PT.Suppliers can only be enteredonto the list when they havesubmitted a dossier forapproval of a biocidal activesubstance (thishappensvia theWorkProgramme)orpaidforaletter of access to an existingdossier.Active substance suppliers arelisted against each AS+PT forwhich they are an approvedsupplier.

As of September 2015, biocidalproducts may not be placed on theEU market unless the manufactureror importer of the active substance(or the importer of the biocidalproduct in cases where they aremanufactured outside of the EU)appearsonthearticle95list.In some cases biocidal productsuppliersmaychoosetobe listedonarticle95inordertoguaranteetheirsourcesofactivesubstances (incaseall their active substance suppliersare not listed).The obligation forarticle 95 listing of active substancesuppliers does not apply directly totreatedarticles,whichdonothavetobe sourced via an EU approvedbiocidalactivesupplychain,althoughthey must still only contain activesubstances that are on the UnionList, Annex I or have been notifiedandarependingreviewontheworkplan.

Makingavailableon themarket

Any supply of a biocidal product ortreatedarticlefordistributionorusein the course of a commercialactivity, whether in return forpaymentorfreeofcharge.

Makingavailableonthemarketofabiocidalproductortreatedarticleinthe EU includes ANY SUPPLY. This applies regardless of whether theproducts have been purchased or supplied free of charge. It includesdistributionanduseofbiocidalproductsandtreatedarticlesinadditiontomakingthemavailableforpurchase.

Placing onthemarket

The first making available on themarket of a biocidal product ortreatedarticle.

Refers to the first time that a particular biocidal product or treatedarticleismadeavailableontheEUmarket.

2http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32014R1062

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Table1:ExplanationofKeytermsanddefinitions

Term BPRDefinition Example/Explanation ObligationsBiocidalProduct(BP)

(a)Anysubstanceormixture,intheforminwhich it is supplied to the user, consistingof, containing or generating one or moreactive substances, with the intention ofdestroying, deterring, rendering harmless,preventing the action of, or otherwiseexertingacontrollingeffecton,anyharmfulorganism by any means other than merephysicalormechanicalaction,(b) Any substance or mixture, generatedfrom substances or mixtures which do notthemselves fall under (a), to be used withthe intention of destroying, deterring,rendering harmless, preventing the actionof,orotherwiseexertingacontrollingeffecton, any harmful organism by any meansother than mere physical or mechanicalaction(c) A treated article that has a primaryBiocidal function shall be considered aBiocidal product (A 'treated article with aprimary biocidal function' is thus a treatedarticle that has one or more functions, ofwhich one is a biocidal function that is offirstrank,importance,orvaluecomparedtotheotherfunctionsofthetreatedarticle).

In the case of formulationsthese would be products thathave a primary function as abiocide; are required tokill/repel/inhibit unwantedorganisms e.g. disinfectants,fumigants, insecticides, anti-foulingpaints.Articles can also fall under thedefinition of biocidal products.Where they contain or aretreated with an activesubstance whose presencecontributes to one of themainintendedpurposesofthearticlee.g. insecticide impregnatedmosquito nets, antibacterialwipes, antimicrobial trunking.These are all articles designedwith a primary functionalrequirement for propertiesderived from use of a biocidalactivesubstance.

Biocidal products must onlycontain biocidal activesubstances that have anapproval for thatproduct type(or have been identified andare still pending review underthe work program). They mayonly contain biocidal activesubstances purchased via amanufacturerorimporterwhois registered on the article 95list.Whenanarticlehasaprimarybiocidal function then it willalso be classed as a biocidalproduct.Anauthorisation forabiocidalproduct is needed beforebeingplacedon themarket inan EU Member State.Authorisations can be appliedforatnationalleveloratUnionlevel if the product is to bedistributedthroughouttheEU.Maximumauthorisationperiodis10yearsandtherecouldbeconditions attached to theauthorisatione.g. for labelling,restrictiontoindustrialuse.Authorisation numbers areissued.

TreatedArticle(TA)

Anysubstance,mixtureorarticlewhichhasbeen treated with, or intentionallyincorporates,oneormorebiocidalproducts.

In the case of formulations;treated articles are those thathave been treated with orincorporate a biocidal productbutwhere this does not confera primary biocidal function e.g.metal-working fluids andpaintsthat contain biocidalpreservatives to protect theproduct from microbialdegradation.In the case of objects such asArticles as defined by REACH;treated articles are those thathave been treated with orincorporate a biocidal productbutwhere this does not confera primary biocidal function e.g.anti-microbial preservatives inPVC components, woodenobjects treated with biocidalpreservativestopreventdecay.

For treated articlesmanufactured in the EU – thebiocidal product that they aretreated with or incorporateMUSThaveanauthorisation.Imports into the EU offormulations or articles thatare classed as treated articlesMUST contain only activesubstances that are approvedfor the relevant product typeintheEU(AS+PTapproval).

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1.3Whataretheexclusionsfromscope?Article 2 sets out the scope of the regulation. It applies to all substances, formulations and articles(definitionaccordingtoREACH)thatmeetthedefinitionsofbiocidalproductsandtreatedarticlesANDfallintoscopeofoneoftheproducttypeslistedinannexVoftheBPR.

Exclusions from scope of the BPR are listed in article 2(2) and include items that are regulatedelsewhere, such asmedical devices, cosmetic products, food and feeding stuffs, veterinarymedicinalproducts,humanmedicinalproducts,foodadditives,plantprotectionproductsandtoys.

1.4Arethereanydefenceexemptions?Article2(8)doesallowforMemberStatestopermitexemptionsfromtheregulationintheinterestsofdefence:

“Member States may allow for exemptions from this Regulation in specific cases for certain biocidalproducts,ontheirownorinatreatedarticle,wherenecessaryintheinterestsofdefence.”

ThereisnouniversalexclusionoftheBPRdutiesfordefenceproducts;ratherindustryneedstoapplyforanexemptiononacasebycasebasis.Applicationsforexemptionare,inmostcases,consideredbytherespectiveMinistryofDefence(MoD).

It is recommended toseekguidance fromthe relevantMemberState forcaseswhere it isbelievedadefenceexemptionwouldbewarrantedortocheckthatadefenceexemptionissuedbyoneMemberStatewillberecognisedbyanother.

1.5ComplianceenforcementArticle65placestheresponsibilityforsurveyingthemarketforproductcomplianceandanysubsequentenforcement with each Member State Competent Authority. As such monitoring and enforcementactivities,penaltiesandsanctionsmaydifferbetweencountries.Itisrecommendedtoseekadvicefromtheappropriatecompetentauthoritywheretheremaybeconcernsregardingcompliance.

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2.0 Which types of products that I use or manufacture might beaffected?Examplesofbiocidalproductandtreatedarticleproductsthatmaybeused,importedormanufacturedby A&D companies or their suppliers are given in table 2. Examples given represent a selection ofproducttypes(PT)consideredtobeofmostrelevancetoA&Dcompanies.

Table2:ExamplesofitemsthatfallintoscopeofBPRproducttypesrelevanttoA&Dcompanies

2.1WhenisasubstanceregulatedbytheBPR?ItisimportanttounderstandthatsubstancesareonlyregulatedbytheBPRwhentheyarepresentinaproductwith the intention of performing a biocidal function that is integral to that product.When asubstanceispresentinaproductwiththeintentionofperformingabiocidalfunction,itwillfallundertheBPRdefinitionofanactivesubstance.

Thereisnotadirectlistofprohibitedsubstances,ratherlistsofsubstances(activesubstances)thatareeither‘notapproved’or‘approved’foruseasabiocideinaparticularproducttype.Thereisalsoalistofsubstancesawaitingevaluation (for anapprovaldecision) via theworkprogramme;active substancesnotyetapprovedbutneverthelesspermittedtoremainincommerceuntiladecisionistaken.Theworkprogrammeisdiscussedinfurtherdetailinsection9.1.

Substancespresentinproducts,thatarenotonalistofapprovedactivesubstances,arenotsubstancesnotifiedtotheworkprogramme(awaitingevaluationforapprovaldecisions)orarenon-approvedactivesubstances for that product type, could still fall into scope of the regulation. If such substances arepresentasbiocidalactivesubstances(includedintheproductfortheirbiocidalfunction)thentheywillbe classed as new active substances under the BPR. Theymust gain approval for use in the affectedproducttypebeforebeingplacedonthemarket.

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Substances canhavea ‘nonapproval’decisionagainst them foruse inoneproduct typeandyetalsohavean ‘approval’decision thatpermits theiruse inanotherproduct type. Forexample,boricacid isapprovedforuseasabiocidalactivesubstanceinPT83;woodpreservatives,andyetisnotapprovedforuseinPT134;workingandcuttingfluids.

Anon-approvaldecisionfortheuseofasubstanceinaparticularproducttypedoesnotexcludetheuseof that substance from such products. Itmerely excludes the use of that substance in such productswhenpresentasabiocidalactivesubstance.

To use the previous example; although not approved as a biocidal active substance for use in PT13workingandcuttingfluids;boricacidmaystillbefoundinmetalworkingfluidswhenit is includedforpropertiesotherthanitsbiocidalfunction.Boricacid istypicallyusedinsuchformulationsfor itsanti-corrosiveproperties; itmaynotbepresentatasufficient level inorder tobeefficaciousasabiocidalactive substance inanycase,andother substances in the formulationmaybepresentas thebiocidalactivesubstances.

This question of when a substance is present as a biocidal active substance makes it difficult foroperators other than thebiocidal productmanufacturer to knowwhich substances are includedwiththeintentofexploitingtheirbiocidalfunction.Thismakesidentificationofsupplychainnon-complianceand BPR driven obsolescence risks very challenging for A&D manufacturers who have a reliance onbiocidalproductsandtreatedarticles.

*orawaitingapprovaldecisionintheworkprogrammewhilstthisisstillanongoingconcern3Approvaldecision:http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32009L0094:EN:NOT4Nonapprovaldecision:http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32008D0809

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3.0HowdoestheBPR2012differfromtheBiocidalProductsDirective1998(BPD)?UnderDirective98/8/ECoftheEuropeanParliamentandoftheCouncilof16February1998concerningthe placing of biocidal products on themarket (BPD), biocidal products used byA&D companies andtheirupstreamsuppliers(e.g.formulatorsusingbiocidalproductsaspreservativesinwater-basedpaintsorcuttingfluids)werealreadybeingregulatedwithintheEU.Theworkprogrammeforactivesubstanceapprovalswasalsowellestablished.

ThepostBPDyearswillhavealreadyaffectedrationalisationoftheactivesubstancespermittedforusein biocidal products in the EU. The authorisation requirements for such biocidal products will haveaffectedtheselectionofbiocidalproductsavailableonthemarketwithintheEU.Itfollowsthatmuchregulatorydrivenobsolescenceoftheactivesubstancesavailableforuseinbiocidalproducts,andoftherelated biocidal products, on the EUmarket is expected to have already happened as a result of theBPD.Thereisaresidualobsolescenceriskthatbiocidalproductsusingactivesubstancesthatarestilltobeevaluated(whichforsomemaynothappenuntil2024)couldbewithdrawnfromsaleonceadecisionismadeastotheirapprovalstatus.

Newobsolescence risksmayarise resulting fromtheadditionsand tighteningof the regulatory scopethatisintroducedwiththe2012BPR.

Increasedfocusonensuringcost-sharingofactivesubstanceapprovaldossiersandincreasedvigilancearound importedproducts (treatedarticles) containingbiocidal active substanceshas resulted innewmeasures,toaddresstheseissues,beingadoptedintothelegaltextoftheBPR.

UndertheBPR,it isnowpossibletogainauthorisationofbiocidalproductsatUnionlevel,sothatoneauthorisationwillallowtheproducttobeplacedonthemarketEUwide.NationallevelauthorisationsforindividualMemberStatesarealsostillavailable.

Additionally,thescopeoftheBPR(comparedtotheproceedingBPD)isexpandedsuchthatbiocidesforuse incuttingfluids,asvermicides(againstworms)and in-situgeneratedbiocidesarenowspecificallyregulated.

3.1TreatedarticlecomplianceobligationsUnder the BPD, products within the EU were regulated at 2 levels – the biocidal active substance(ingredient)levelandthebiocidalproductlevel.ThescopeiswidenedintheBPRtoincludecomplianceobligationsforproductsfallingunderthedefinitionof‘treatedarticles’.Theseareproducts(substances,mixtures and articles) that contain a biocidal product (such as biocidal preservatives in water-basedpaints)butwhichdonothaveaprimarybiocidalfunctionthemselves(theprimaryfunctionofthepaintistoprotectasurfaceratherthantokillorrepelundesiredorganisms).

OwingtothefactthatEUmanufacturedtreatedarticleswillbeproducedusingEUauthorisedprecursorbiocidal products, the likelihood of compliance issues is expected to be low. It follows that importedtreatedarticlesaremostatriskofnon-complianceandrelatedobsolescence.

For treated article formulations in particular, there is a higher likelihood that upstream distributorimport and direct import bymember companies could evidence caseswhere compliance obligations

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maybeoverlookedifitisnotrecognisedthatsuchproductsfallintoscopeoftreatedarticlesaccordingtotheBPR.

Figure1:SchematicofmaincomplianceobligationsfortreatedarticlesundertheEUBPR

Figure1showsaschematicofthecomplianceobligationsfortreatedarticles.TheyellowboxeshighlighttheobligationsthatarenewlyintroducedundertheBPR.

Thearticle95approvedsupplier listobligationdoesnotdirectlyapply toactivesubstances in treatedarticles.Bydefinition,anunformulatedactivesubstanceusedtodirectlyproduceatreatedarticlewillalsobe classedas abiocidal product and thus (if used in theEU for treatedarticlemanufacture)willrequireabiocidalproductauthorisation inaddition to itsAS+PTapproval for the sameuse. It followsthatforimportedtreatedarticlestherewillbenoarticle95listingrequiredinregardofthesourcefortheactivesubstancescontainedthereinbutforimportedbiocidalproductsthisobligationisvalid.

3.2Article95ListforactivesubstancesuppliersandbiocidalproductimportersTheBPRhas increasedobligations foractive substances inorder toprevent ‘free-riding’andpromotecost-sharing of the financial outlay associated with getting an active substance approved for use inbiocidalproducts. Thearticle95 list of approvedactive substance supplierswas introduced such thatonlysuppliersofactivesubstanceswhohavecontributedtotheapprovaldossiercostsarepermittedtosupplythoseactivesubstancesforuseinbiocidalproductsintheEU.

InpractisetherewillbenoeffectonEUactivesubstancesupplierswhoalreadyeitherholdanapprovalorhavesubmittedanactivesubstanceapprovaldossier(theywillgainautomaticinclusiontothearticle

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95list).Othersuppliers(‘alternativesuppliers’)willberequiredtoputtogetherandsubmittherequiredactivesubstanceapprovaldossierortonegotiatewithcurrentdossierholdersinordertogainlettersofaccessforthecontentsandthussatisfythecriteriafortheirinclusiononthearticle95list.

Importersofbiocidalproductswillbeclassedastheactivesubstancesuppliersforthoseingredientsintheir imported biocidal products and will therefore also have to be registered on the article 95 list.Imported biocidal products are therefore most at risk of non-compliance and related obsolescence.Figure2showshowthenewrequirementsoftheBPR(yellowbox)affectbiocidalproducts.

Figure2:SchematicofmaincomplianceobligationsforbiocidalproductsunderEUBPR

Althoughitistypicallyexpectedthatitwillbethemanufacturersandsuppliersofactivesubstancesthatwillberegisteredonthearticle95list,itispossibleforanyactortotakeoverthisresponsibilityfortheactive substances in thebiocidalproducts theyareplacingon themarket in theEU (so ineffect theybecome the registered active substance supplier). Users of active substances, such as formulators ofbiocidal products, may wish to become registered on the article 95 list in order to guarantee theirupstreamactivesubstancesupplyortokeepflexibilityinchoiceofactivesubstancesupplier.

Forimportedbiocidalproducts,theimportermustberegisteredonthearticle95listagainsttheactivesubstancesthereini.e.thebiocidalproductimporteristheEUactivesubstancesupplierinthisscenario.

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Allsuppliersofthoseactivesubstancesthatareeitherapprovedornotifiedtotheworkprogrammeby01 September 2015must also be registered on the article 95 list by this deadline. After this date allactive substances sourced in the EU for biocidal product manufacture must be purchased from asupplieronthislist.

For the purposes of enforcement and compliance demonstrationwith article 95(2), EU producers orimportersofbiocidalproductsmayneedtobeable toevidencethat thesourceof thebiocidalactivesubstances contained, are article 95 compliant5. For biocidal product importers or some EU biocidalproduct formulators who appear on the article 95 list for the relevant AS+PT, then this is easilydemonstrated. If the producer or importer itself is not listed on article 95 for the biocidal activesubstances, then this could be a letter from the active substance supplier or invoices for the activesubstancecomingfromanarticle95listedsource,forexample.

Foractivesubstancesthatwerenotrequiredtobenotifiedtotheworkprogrammeby01September2015(suchasAS+PTcombinationsthatarenewtothescopeoftheBPR,andhaduntil30October2015forworkprogrammenotification)thentheirsupplierswillbeautomaticallyaddedtothearticle95listwhensuchnotificationismade.

5CA-May15-Doc.4.13-Final–NotefordiscussionwithCompetentAuthorities.Subject:CompliancewithandenforcementofArticle95:https://circabc.europa.eu/sd/a/f3f9d952-94a1-4c31-b34a-cb7a6016b134/CA-May15-Doc.4.13%20-%20Final%20-%20Article%2095%20implementation%20and%20enforcement.doc

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4.0WhenmightIhaveobligationsundertheBPR?There are compliance obligations for substances, mixtures (formulations) and articles (per REACHdefinition)thatareclassedasbiocidalproductsandtreatedarticlesaccordingtotheBPR.

If you are an importer (into EU and between EEA states) or manufacturer of products that class asbiocidalproductsortreatedarticles,thenyouwillbedirectlyaffectedbyobligationstocomplywiththeBPRinordertokeepthoseproductsonthemarket.

Ifyouareauserofproductsthatareclassedasbiocidalproductsortreatedarticles,thenyoumaybeindirectlyaffectedbytheBPRduetoriskofupstreamreformulationorobsolescence.

4.1IfyouimportormanufactureBIOCIDALPRODUCTSintheEUIftheBiocidalProductisaFormulation…

1) Importerswillneed toobtain the relevant ‘ActiveSubstance+ProductType’approval for theactivesubstances inanyformulationsthattheyimport intotheEUthatareclassedasbiocidalproducts.Manufacturerswillneedtoensurethattheiractivesubstancesuppliersarelistedonthearticle95listfortheproducttypeandbeabletoevidencethis.

2) Youwillalsohavetoobtainauthorisationsforthebiocidalproduct.ThismaybeatnationallevelifonlyimportingormanufacturinginoneMemberState,orUnionleveltocoverthewholeEU.

3) Youwillhavetocomplywithanylabellingrequirementsforthebiocidalproducts.

IftheBiocidalProductisanArticle(accordingtoREACH)…1) Importerswillneedtoobtaintherelevant‘ActiveSubstance+ProductType’approvalforthe

activesubstancesinanyarticlesthattheyimportormanufactureintheEUthatareclassedasbiocidalproducts.Manufacturerswillneedtoensurethattheiractivesubstancesuppliersarelistedonthearticle95listfortheproducttypeandbeabletoevidencethis.

2) Youwillhavetoobtainauthorisationsforthebiocidalproduct.ThismaybeatnationallevelifonlyimportingormanufacturinginoneMemberState,orUnionleveltocoverthewholeEU.

3) Youwillhavetocomplywithanylabellingrequirementsforthebiocidalproducts(refertoarticle69).

4.2IfyouimportormanufactureTREATEDARTICLESintheEUIftheTreatedArticleisaFormulation…

It is important to recognise that substances, formulationsorarticles(perREACHdefinition)canbe classed as biocidal products and that both formulations and articles (perREACH definition)canbeclassedastreatedarticles.

NOTE: For EU sourced formulations, in the case that you import biocidal products from oneMemberState toanother,youwouldneed toensurethat thebiocidalproducthas the relevantauthorisationsforuseineachcountry

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1) YouhavetoensurethatthebiocidalactivesubstancethatispresentintheformulationisapprovedfortherelevantuseintheEUi.e.hastherelevant‘ActiveSubstance+ProductTypeapproval’(itissufficientthattheactivesubstancehasbeenapprovedforuseintheproducttype;youarenotrequiredtobetheapprovalholder).

IftheTreatedArticleisanArticle(accordingtoREACH)…1) Youhavetoensurethatthebiocidalactivesubstancethatispresentinoronthearticleis

approvedfortherelevantuseintheEUi.e.hastherelevant‘ActiveSubstance+ProductTypeapproval’(itissufficientthattheactivesubstancehasbeenapprovedforuseintheproducttype;youarenotrequiredtobetheapprovalholder).Complexarticlesarealsoinscopeifthetreatedarticlecomponentstillconfersabiocidalbenefittothefinishedarticle.

NOTE: It is important todeterminewhichconstituentsofanybiocidalproductor treatedarticleare the ones responsible for conferring the biocidal properties (the Active Substances). This isbecause some constituents that can perform as biocidal active substancesmay be present butmaynotbeincorporatedforthatpurpose.

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5.0 How can I check if I have a product that is within scope of theregulation?TofallwithinscopeoftheBPR,yourproductwillneedtofallunderthedefinitionofatreatedarticleorabiocidalproduct.Ifitisneither,thenitwillnotfallwithinscopeoftheBPRandisnotrequiredtomeetcomplianceobligations.

Flowchart1.1givesguidanceonhowtodetermine ifyourproduct (item) fallswithinthescopeof theBPRaseitherabiocidalproductortreatedarticle.

Flowchart1.1:IdentificationofobligationsundertheBPR

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6.0 I’ve identified that Imanufacture, importoruseproducts that fallwithin scopeof the regulation.Howcan I check if thoseproductsarecompliantwiththeBPR?As it isnotalwaysobviouswhichsubstancespresent inaformulationorarticlearethebiocidalactivesubstances,inmanycasesadialoguewithsupplierswillberequiredtoprovideassuranceofcompliance.

6.1IfyouhaveaBiocidalProductFlowchart 2.1 canbeused tohelp identifywhether your biocidal product is currently compliantwithobligationsoftheBPR.Wheretheremaybeacomplianceissue,suggestedremedialactionsaregiven.Insomecases,non-compliancewillmeanthattheproductcannolongerbemarketedinitscurrentform.

Flowchart2.1:Checkforbiocidalproductcompliance

Inconjunctionwithflowchart2.1,table3providespracticalguidanceregardingthespecificsofhowtocheckwhetherthebiocidalproductmeetstherequirementsnecessarytoassurecompliance.

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Parameter HowtocheckDoes Biocidal Product have BPRauthorisations in Member Stateswheredistributed?

CheckforUnionauthorisations(coversallMemberStates)onECHAwebsite:ThelistofbiocidalproductswithUnionauthorisationwillbepublishedontheECHAwebsitehttp://echa.europa.eu/regulations/biocidal-products-regulation/authorisation-of-biocidal-products/union-authorisationCheckECHAwebsiteforauthorisationsunderBPR=thoseissuedAFTER01/09/2013(detailswhichcountriesproductshavebeenauthorisedfor):http://echa.europa.eu/web/guest/information-on-chemicals/biocidal-products?approval_id=0013-14NOTE:Thesearenotupdatedin‘realtime’.Ifproductisnotlisteditmaystillbeawaitingadditiontothelistatthenextupdateormaynotbeonthepubliclists.InwhichcaseacheckshouldbemadewiththeproductsupplierfirstandrelevantMemberStateCompetentAuthoritysecond.

Does Biocidal Product haveAuthorisationexemptionsinrelevantMemberStates?Article 2 (8) states that MemberStates may allow for exemptionsfrom this Regulation in specificcases for certain biocidal products,ontheirownor inatreatedarticle,where necessary in the interests ofdefence.

CheckwithrelevantsuppliersandcompetentauthoritiesfordefenceexemptionCountry ExemptionsdetailUK TheBiocidalProductsandChemicals(Appointmentof

AuthoritiesandEnforcement)Regulations2013No.1506Chapter4(30)–personsareexemptfromBPRandCLPIF(a)holdingadefenceexemptioncertificatemadebytheSecretaryofStateinrespectofthatprovision;or(b)candemonstratethattheappropriateauthoritiesofanotherMemberStatehaveexemptedthatpersonfromcomplianceintheinterestsofdefence.

IsBiocidalProductstillcoveredinMemberStatesofsupplybyauthorisationsgrantedundertheBPD?

CheckECHAwebsiteforauthorisationsunderBPD=thoseissuedBEFORE01/09/2013(detailswhichcountriesbiocidalproductshaveauthorisationsfor):http://echa.europa.eu/web/guest/information-on-chemicals/biocidal-products?approval_id=0013-14

Does biocidal product comply withrelevantMember States transitionalarrangements? i.e. Is BiocidalProductauthorised/licensed/registered/notified etc. under national legislationwhere still required undertransitionalmeasures?

Country LegislationListofMemberStateCompetentAuthoritiesandhelpdesks:http://echa.europa.eu/web/guest/support/helpdesks/national-helpdesks/list-of-national-helpdesksUK ControlofPesticidesRegulation.COPRdatabase:

http://webcommunities.hse.gov.uk/connect.ti/pesticides/view?objectId=2308

Netherlands

CTGBListofauthorisedproductsbydownloadhttp://www.ctgb.nl/en/biocidal-products/assessment-framework-biocidal-products/transitional-legislation

France SIMMBADdatabasehttps://simmbad.fr/public/servlet/accueilGrandPublic.html

Germany BAUAdatabasehttps://www.biozid-meldeverordnung.de/offen/

Areactivesubstancesupplier(s)listedonarticle95listforproducttype?

Thearticle95listofactivesubstancesupplierscanbedownloadedfromtheECHAwebsite:http://echa.europa.eu/information-on-chemicals/active-substance-suppliersIsbiocidalproductimporteron

article95listforactivesubstance(s)inbiocidalproduct?Table3:‘Howto’informationchecksforbiocidalproductcompliance

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6.2IfyouhaveaTreatedArticleFlowchart 3.1 can be used to help identify whether your treated article is currently compliant withobligationsoftheBPR.Wheretheremaybeacomplianceissue,suggestedremedialactionsaregiven.Insomecases,non-compliancewillmeanthattheproductcannolongerbemadeavailableinitscurrentform.

Flowchart3.1:Checkfortreatedarticlecompliance

Inconjunctionwithflowchart3.1,table4providespracticalguidanceregardingthespecificsofhowtocheckwhetherthebiocidalproductmeetstherequirementsnecessarytoassurecompliance.

Parameter HowtocheckAreActiveSubstance(s)presentlistedonUnionListforrelevantPT?

EuropeanCommissionincludesapprovedactivesubstancesintheUnionListofapprovedactivesubstances(formerlyAnnexIofDirective98/8/EC).EC website for Union List links to ECHA website search:http://echa.europa.eu/web/guest/information-on-chemicals/biocidal-active-substances

AreActiveSubstance(s)presentlistedonAnnexIforrelevantPT?

Checkmostcurrenttext,includingamendments,forannexIlistintheregulation.LinkavailableonECHAwebsite:http://echa.europa.eu/regulations/biocidal-products-regulation/legislation

AreActiveSubstance(s)notifiedtoWorkProgrammependingreviewforPT?

Tocheckwhichsubstance/producttypecombinationsareincludedintheReviewProgramme,pleaserefertoAnnexII,partIofCommissionDelegatedRegulation(EU)No1062/2014(WorkProgramme)orECHAwebsitesearch:http://echa.europa.eu/web/guest/information-on-chemicals/biocidal-active-

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substancesDoActiveSubstanceshaveanon-approvaldecisionfortheProductType?

Checkcommissionwebsitefornon-approvals(consolidatedlistalsoavailable):https://circabc.europa.eu/d/a/workspace/SpacesStore/491962c1-8f3e-4adb-9e0c-cf1a782895d9/Consolidated%20list%20of%20non-inclusion%20decisions.pdf

Table4:‘Howto’checkinformationfortreatedarticlecompliance

6.2.1Communicationofinformationontreatedarticles(labelling)Ifyouareplacingatreatedarticleontothemarket, thenyouwillneedtocheckwhetheryouhavetocomplywithrequirementstocommunicatecertaininformation.Therequiredinformationwilltypicallybeprovidedon theproduct labellingbutarticle58(6)of the regulationpermits for information tobeprovidedinotherlocationswherethisismoreappropriate.

Flowchart3.2canbeusedtodetermineinformationcommunicationrequirementsfortreatedarticles.

Flowchart3.2:Guidancefortreatedarticleinformationcommunicationrequirements

Article58(5)alsomandatesthatatreatedarticlesuppliermust,within45daysofreceiptofaconsumerrequest, provide that consumer, free of charge, with information on the biocidal treatment of thetreated article. Typically, A&D companies would not be expected to supply to consumers but theprovisionmaybenoted.

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7.0Whataboutcomplex(treated)articles?BPRprovisionswillapply togoodswhereoneorseveral individualcomponents incorporateabiocidalproduct,whichconfersabiocidalpropertytothefinishedarticle,suchas increasing itsdurability.Theprovisions will not apply where goods are treated with or incorporate biocides in the course ofmanufacturingtoperformaspecificbiocidalfunctionatthatstageoftheprocess,butthendonotgiverisetoanintendedbiocidalpropertyinthefinishedgoods.

Interpretationonacasebycasebasismayberequiredinordertoascertainwhencomplexarticlesaredefinedastreatedarticlesaccordingtotheregulation.Itisimportanttorememberthatitisthefinishedgood(atthecomponentlevelandfinalassemblylevel)thatistobeassessedastowhetheritisclassedasatreatedarticlewhenplacedonthemarket.Anassemblycontainingtreatedarticleswillnotalwaysbeclassedasatreatedarticleinitsownright.

Ifabiocidalclaim isattributedtobiocide-containinggoodswhenmarketede.g.durability,anti-odour,thenthiswouldevidencethattheincorporationofabiocideinthegoodswasintentionalandthuscausethemtobeclassedastreatedarticles.

The European Commission issued a note for guidance in November 20146 that addresses frequentlyaskedquestionsontreatedarticles.Withinthedocumenttherearenotesconcernedwithclarifyingthesituationfortreatedarticlesandtwoexamplesaregiven:

1) Compositewoodmadeusingglue(treatedarticle)thatcontainsapreservative(biocidalproduct)Becausethepreservativeinthegluedoesnotconferanybiocidalbenefitstotheoverallcompositewood,thiswouldnotcausethewoodtobeclassedasatreatedarticle.

2) Televisionthatcontainsacomponent(treatedarticle)thathasbeentreatedwithafungicide(biocidalproduct)topreventfungalgrowthBecausetheentiretelevisionrequiresthecomponenttobetreatedwithafungicideinordertoincreasethedurabilityofthewholeunit,thiswouldcausethetelevisiontobeclassedasatreatedarticle.

6https://circabc.europa.eu/d/a/workspace/SpacesStore/15baa078-162c-4186-aaa2-6293a80e1561/CA-Nov14-Doc.6.1%20-%20Treated%20articles%20guidance%20note.doc

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8.0ImplicationsofWorkProgrammedecisionsforactivesubstancesAstheworkprogrammeisasubstantialexercisestretchingseveralyearsinduration(thefirst10yearsweremanagedinalignmenttotheBPD),biocidalproductsandtreatedarticleswhoseactivesubstanceshavebeennotifiedtotheprogrammeandarestillawaitingevaluationarepermittedtoremainonthemarket(albeitincompliancetoanyMemberStatetransitionalmeasures)untiladecisionistaken.

Onlyoncealloftheactivesubstancesinabiocidalproducthavebeenapproved(someproductswillrelyon multiple active substances), can the biocidal product gain authorisation under the BPR. Biocidalproductauthorisationapplicationsaretobemadenolaterthanthedateoftheapprovaldecisionofthelast active substance. Such biocidal products may then remain on the market whilst awaitingauthorisation decisions. Competent authorities must reach a decision regarding a biocidal productauthorisationwithin3yearsof thedateofapprovalof the lastactive substance (article89(3)). In themeantime,forsomeproducttypes(insecticides,rodenticides,disinfectants inparticular);therewillbeauthorisationsrequiredunderrespectiveMemberStatelegislationthatprecededtheBPD&BPRandisstillinplaceduringtransition.

Table 5 provides a summary of active substance notification status in the work programme and theimplicationsforactivesubstances,biocidalproductsandtreatedarticles.

Table5:Workprogramme-activesubstancenotificationstages

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8.1Whatarethepotentialimplicationsforbiocidalproductavailability?There is apossibility thatactive substances receiveanon-approvaldecision, inwhich caseassociatedbiocidalproductsandtreatedarticlesarerequiredtoberemovedfromthemarketwithin180dayspostdecision.Thisisaveryshortwindowforperformingsubstitutionactivitiesshouldaerospaceordefencecompaniesrelyonproductswhoseactivesubstancesreceivea‘notapproved’decision.

Thecriteriathatanactivesubstanceneedstomeetforanapprovalareclearlycommunicatedinarticle4. Owing to the costs associated with putting together active substance approval dossiers, it is notexpectedthatthoseAS+PTnotifiedtotheworkprogrammewouldhavebeensupportedtothisend,iftherewascausetoexpectanon-approvaldecision.

Approval decisions for active substances may also trigger a point of withdrawal from market forproducts that were in compliance whilst the active substances were under review, but for which abiocidal product authorisation cannot be commercially justified beyond this trigger for obtainingbiocidalproductauthorisations.AnyaffectedproductsarelikelytobefromproducttypesnotsubjecttoMemberState transitionalmeasuresandas suchnotpreviously required tohaveany typeofbiocidalproductauthorisationormarketingpermit.Forexample,thesecouldbeproductsfallingundersomeofthe following BPR product types: PT6 preservatives for products during storage, PT9 fibre, leather,rubberandpolymerisedmaterialspreservatives,PT13workingorcuttingfluids.

For biocidal products whose active substances are all approved, they should be removed from themarket180daysaftertheapprovaldecisionforthelastactivesubstanceIFauthorisationisnotappliedfor.Thereisaperiodof365dayspermittedforuseofexistingstocks(article89(3)).

Also at risk are niche products thatmay not fit into a biocidal product authorisation portfolio whenrationalised by the supplier as part of their commercial strategy. Biocidal productsmanufactured bySMEsarealsomorelikelytosufferfromasimilarlackofbusinesscasetosupportthebiocidalproductauthorisation required to keep a product on themarket after the active substance approval decisiontriggersthisobligation.

8.2Whatarethepotentialimplicationsfortreatedarticleavailability?Treatedarticlesareused throughout theA&D industry.Theywill include formulations suchaspaints,lubricants, fuels, adhesives; and articles such as textile and plastic products; that contain a biocidalproduct (which comprises or contains the active substance). The presence of such a biocidal product(=active substance) in the treated article could be to preserve the shelf life of a formulation, protectmarineequipmentfromfoulingortopreventmouldgrowthonasurface.

Ifsuchtreatedarticleswerereformulatedbecausetheprecursorbiocidalproduct/activesubstancehadto be changed, then it may affect the shelf life/longevity of such a product, where protection fromharmfulorganismsisdesirabletopreservetheproduct.However,thepreservativesystemusedwouldnot typicallybeanticipatedtootherwiseaffect the technical specificationof the treatedarticle. If thedurationof protectionagainst productdegradation/damage/interferenceowing toharmful organismswerereduced,thenmoreregularreplacementofaffectedproductsandmorefrequentmaintenanceorcleaningcouldbenecessary.

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In cases where either the biocidal product required to manufacture a treated article is no longeravailable and cannot be substituted, or where the treated article relies on an active substance thatreceives a non-approval decision (i.e. is thus BPR non-compliant) and similarly cannot not besubstituted,thensuchtreatedarticleswillnolongerbeabletobeimportedormanufacturedintheEU.

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9.0DurationsofapprovalsandauthorisationsBoth biocidal active substance approvals and biocidal product authorisations are time limited.Regulatory compliance, regulatory fees and obsolescence risk owing to the BPR remain an ongoingconcern.

9.1ActivesubstanceapprovalsDepending on certain criteria, including hazard profile and efficacy; a biocidal active substanceauthorisation pertaining to use in a particular product typewill typically be granted for a period notexceedingof10years(article4).

In some cases,where the active substancemeets one ormore criteria laid out in article 10.1 of theregulation (related to specific intrinsic hazard properties, exposure levels and purities of the activesubstances), then the biocidal active substancemay be given a reduced approval validity period, notexceeding7yearsandbeclassedasa‘candidateforsubstitution’.

9.2BiocidalproductauthorisationsInaccordancewitharticle17,biocidalproductauthorisationscanbegrantedforamaximumof10years.Authorisations can be granted for single products or for a product family (products used for similarpurposes, with similar efficacies and risks and containing active substances with the samespecifications).AuthorisationscanbegrantedforoneMemberStateorattheUnionlevel(tocoverthewholeEUwithoneauthorisation).Applicationstorenewbiocidalproductauthorisationsmustbemadeatleast550daysbeforetheauthorisationexpires(articles31&45).

9.2.1CancellationofbiocidalproductauthorisationsArticle 47 provides for biocidal product authorisation holders to notify, without delay, the issuingcompetent authority should they become aware of information concerning the biocidal activesubstancesorthebiocidalproductthatmayaffecttheauthorisation.Thisincludesnewdataonadverseeffects,developmentofresistanceorinsufficientefficacy.

The competent authority will review the granted authorisation and examine if there is a need foramendmentorcancellation.

Cancellations of biocidal product authorisations will impose a need to remove products from themarket.Inthecaseofcancellations,wherethereisnotconsideredanunacceptablerisktohumanandanimalhealthor theenvironment,aperiodofgracenotexceeding180days,maybegranted for themakingavailableonthemarket.Thereisthepossibilityofanadditionalgraceperiod,notexceeding180days,foruseofexistingstocks.

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10.0Whataretheupcomingdeadlines?SinceSeptember2015,allsuppliersofbiocidalactivesubstanceshavehadtoberegistered(i.e.boughtintothecostofapprovaldossier)onthearticle95listinordertocontinuesupplyingactivesubstancesfor use in biocidal products. This requirement has a knock-on effect for both biocidal products andtreated articles produced in the EU. Themain compliance deadlines to be aware of are depicted infigure3withinformationregardingtheobligationsforbiocidalproductsortreatedarticles.

Figure3:SchematicofkeydeadlinesforcompliancewiththeBPR

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11.0WherecanIfindoutmore?The original regulatory texts are recommended in conjunction with guidance material published byECHAandtheEC.Nationalbiocideshelpdesksareagoodsourceforaskingspecificquestionsregardingcompliance.Table6listslinkstosomeoftheseusefulresources.

Source Description LinkRegulatorytextsandassociatedlists

EU Journal – Regulation fulltext; Biocidal ProductsRegulation

Full text (consolidated) of the 2012 BiocidalProductsRegulation

http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1438609476193&uri=CELEX:02012R0528-20140425

EU Journal – Regulation fulltext;WorkProgramme

Full text (consolidated) of the 2014 WorkProgrammeRegulation

http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32014R1062

Article95List List of approved suppliers for biocidal activesubstances(AS+PT)intheEU

http://echa.europa.eu/information-on-chemicals/active-substance-suppliers

Union List of approved activesubstances

List of approved AS+PT for use in biocidalproductsintheEU

http://echa.europa.eu/web/guest/information-on-chemicals/biocidal-active-substances

GuidanceresourcesECHAwebsite Providesmuch guidance on the regulatory text

andhowtocomplywithobligationshttp://echa.europa.eu/en/regulations/biocidal-products-regulation

ECHA Practical Guide onBiocidalProductsRegulation

OriginalguidancedocumentissuedbyECHA http://echa.europa.eu/web/guest/practical-guides/bpr-practical-guides

Nationalbiocideshelpdesks Member State competent authority websitesand helpdesks are a good starting point foradviceandclarificationsonBRPobligationsandtransitionalarrangementsineachcountry.

ECHA list of National helpdesks:http://echa.europa.eu/web/guest/support/helpdesks/national-helpdesks/list-of-national-helpdesks

CIRCABC–biocidesgroup Commission website for informationmanagement; biocides interest group. Publicspace contains documents from competentauthoritymeetingsetc.

Link directly to biocides group:https://circabc.europa.eu/faces/jsp/extension/wai/navigation/container.jsp?FormPrincipal:_idcl=FormPrincipal:_idJsp28&FormPrincipal_SUBMIT=1&id=e947a950-8032-4df9-a3f0-f61eefd3d81b&javax.faces.ViewState=rO0ABXVyABNbTGphdmEubGFuZy5PYmplY3Q7kM5YnxBzKWwCAAB4cAAAAAN0AAExcHQAKy9qc3AvZXh0ZW5zaW9uL3dhaS9uYXZpZ2F0aW9uL2NvbnRhaW5lci5qc3A

Table6:Linktoresourcesforfurtherinformation

Theappendicestothisguidanceincludeareproductionoftheproducttype(PT)listtakenfromannexVof theregulation (appendix1)andhighlightedsections (articles)of theregulationtoaidnavigationtotherelevantpoints(appendix2).

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AppendicesA1:ListofProductTypesandtheirdescriptions(fromAnnexVoftheBPR)

MAINGROUP1:DisinfectantsTheseproduct-typesexcludecleaningproductsthatarenotintendedtohaveabiocidaleffect,includingwashingliquids,powdersandsimilarproducts.

PT1

Humanhygiene Productsinthisgrouparebiocidalproductsusedforhumanhygienepurposes,appliedonorincontactwithhumanskinorscalpsfortheprimarypurposeofdisinfectingtheskinorscalp.

PT2 Disinfectantsandalgaecidesnotintendedfordirectapplicationtohumansoranimals

Productsusedforthedisinfectionofsurfaces,materials,equipmentandfurniturewhicharenotusedfordirectcontactwithfoodorfeedingstuffs.Usageareasinclude,interalia,swimmingpools,aquariums,bathingandotherwaters;airconditioningsystems;andwallsandfloorsinprivate,public,andindustrialareasandinotherareasforprofessionalactivities.Productsusedfordisinfectionofair,waternotusedforhumanoranimalconsumption,chemicaltoilets,wastewater,hospitalwasteandsoil.Productsusedasalgaecidesfortreatmentofswimmingpools,aquariumsandotherwatersandforremedialtreatmentofconstructionmaterials.Productsusedtobeincorporatedintextiles,tissues,masks,paintsandotherarticlesormaterialswiththepurposeofproducingtreatedarticleswithdisinfectingproperties.

PT3 Veterinaryhygiene Productsusedforveterinaryhygienepurposessuchasdisinfectants,disinfectingsoaps,oralorcorporalhygieneproductsorwithanti-microbialfunction.Productsusedtodisinfectthematerialsandsurfacesassociatedwiththehousingortransportationofanimals

PT4 Foodandfeedarea Productsusedforthedisinfectionofequipment,containers,consumptionutensils,surfacesorpipeworkassociatedwiththeproduction,transport,storageorconsumptionoffoodorfeed(includingdrinkingwater)forhumansandanimals.Productsusedtobeincorporatedintomaterialswhichmayenterintocontactwithfood

PT5 Drinkingwater Productsusedforthedisinfectionofdrinkingwaterforbothhumansandanimals.

MAINGROUP2:PreservativesUnlessotherwisestatedtheseproduct-typesincludeonlyproductstopreventmicrobialandalgaldevelopment.

PT6 Preservativesforproductsduringstorage

Products used for the preservation of manufactured products, other than foodstuffs,feeding stuffs, cosmetics or medicinal products or medical devices by the control ofmicrobialdeteriorationtoensuretheirshelflife.Productsusedaspreservativesforthestorageoruseofrodenticide,insecticideorotherbaits.

PT7 Filmpreservatives Productsusedforthepreservationoffilmsorcoatingsbythecontrolofmicrobialdeteriorationoralgalgrowthinordertoprotecttheinitialpropertiesofthesurfaceofmaterialsorobjectssuchaspaints,plastics,sealants,walladhesives,binders,papers,artworks.

PT8 Woodpreservatives

Productsusedforthepreservationofwood,fromandincludingthesaw-millstage,orwoodproductsbythecontrolofwood-destroyingorwood-disfiguringorganisms,includinginsects.Thisproduct-typeincludesbothpreventiveandcurativeproducts.

PT9 Fibre,leather,rubberandpolymerisedmaterials

Productsusedforthepreservationoffibrousorpolymerisedmaterials,suchasleather,rubberorpaperortextileproductsbythecontrolofmicrobiologicaldeterioration.Thisproduct-typeincludesbiocidalproductswhichantagonisethesettlementofmicro-organismsonthesurfaceofmaterialsandthereforehamperorpreventthedevelopment

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preservatives ofodourand/orofferotherkindsofbenefits.

PT10 Constructionmaterialpreservatives

Productsusedforthepreservationofmasonry,compositematerials,orotherconstructionmaterialsotherthanwoodbythecontrolofmicrobiological,andalgalattack.

PT11 Preservativesforliquid-coolingandprocessingsystems

Productsusedforthepreservationofwaterorotherliquidsusedincoolingandprocessingsystemsbythecontrolofharmfulorganismssuchasmicrobes,algaeandmussels.Productsusedforthedisinfectionofdrinkingwaterorofwaterforswimmingpoolsarenotincludedinthisproduct-type.

PT12 Slimicides Productsusedforthepreventionorcontrolofslimegrowthonmaterials,equipmentandstructures,usedinindustrialprocesses,e.g.onwoodandpaperpulp,poroussandstratainoilextraction.

PT13 Workingorcuttingfluidpreservatives

Productstocontrolmicrobialdeteriorationinfluidsusedforworkingorcuttingmetal,glassorothermaterials.

MAINGROUP3:Pestcontrol

PT14 Rodenticides Productsusedforthecontrolofmice,ratsorotherrodents,bymeansotherthanrepulsionorattraction.

PT15 Avicides Productsusedforthecontrolofbirds,bymeansotherthanrepulsionorattraction.

PT16 Molluscicides,vermicidesandproductstocontrolotherinvertebrates

Productsusedforthecontrolofmolluscs,wormsandinvertebratesnotcoveredbyotherproduct-types,bymeansotherthanrepulsionorattraction.

PT17 Piscicides Productsusedforthecontroloffish,bymeansotherthanrepulsionorattraction.

PT18 Insecticides,acaricidesandproductstocontrolotherarthropods

Productsusedforthecontrolofarthropods(e.g.insects,arachnidsandcrustaceans),bymeansotherthanrepulsionorattraction.

PT19 Repellentsandattractants

Productsusedtocontrolharmfulorganisms(invertebratessuchasfleas,vertebratessuchasbirds,fish,rodents),byrepellingorattracting,includingthosethatareusedforhumanorveterinaryhygieneeitherdirectlyontheskinorindirectlyintheenvironmentofhumansoranimals.

PT20 Controlofothervertebrates

Productsusedforthecontrolofvertebratesotherthanthosealreadycoveredbytheotherproduct-typesofthismaingroup,bymeansotherthanrepulsionorattraction.

MAINGROUP4:Otherbiocidalproducts

PT21 Antifoulingproducts

Productsusedtocontrolthegrowthandsettlementoffoulingorganisms(microbesandhigherformsofplantoranimalspecies)onvessels,aquacultureequipmentorotherstructuresusedinwater.

PT22 Embalmingandtaxidermistfluids

Productsusedforthedisinfectionandpreservationofhumanoranimalcorpses,orpartsthereof.

the eu biocidal products regulation (no. 528/2012) for... · regulation (no. 528/2012) guidance...

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