The authorisation may take blood,sweat and tears, but if AshtonEaton can make it, so can you.REACHThe Commission pushes to <strong>in</strong>tensify<strong>the</strong> SVHC identification process and haspublished to this end its Roadmap onSVHC for 2020.When should Istart to worry?The company’s alarm bells forauthorisation should r<strong>in</strong>g, when Echarecommends <strong>the</strong> substance from <strong>the</strong>candidate list for <strong>in</strong>clusion <strong>in</strong> AnnexXIV.Accord<strong>in</strong>g to its current practice, Echascreens <strong>the</strong> candidate list <strong>in</strong> its latestversion once per year and prioritises5–10 substances from it based on its<strong>in</strong>tr<strong>in</strong>sic properties, <strong>the</strong> number ofsites, release pattern, volume on <strong>the</strong>EU market <strong>in</strong> <strong>the</strong> scope of authorisationand appropriateness of <strong>the</strong> authorisationprocedure as compared to o<strong>the</strong>r regulatory<strong>in</strong>struments such as restrictions.Prioritised substances become public,when Echa starts <strong>the</strong> 3-month publicconsultation on its draft recommendation,usually dur<strong>in</strong>g <strong>the</strong> summer time.So far, four recommendation roundshave been completed by Echa, andwith <strong>the</strong> exception of cobalt salts lastyear <strong>the</strong> Commission has acceptedEcha’s <strong>in</strong>clusion proposals. Currently,22 substances are <strong>in</strong>cluded <strong>in</strong> AnnexXIV. The m<strong>in</strong>imum timeframe from <strong>the</strong>publication of <strong>the</strong> draft recommendationto <strong>the</strong> latest application date isapproximately 3 years.Do I need to applyfor authorisation?A major challenge under Reachauthorisation is <strong>the</strong> uncerta<strong>in</strong>ty, whoshould apply for authorisation. Accord<strong>in</strong>gto <strong>the</strong> legal text it can be <strong>the</strong> substancemanufacturer, importer or downstreamuser, and applications can be made<strong>in</strong>dividually or jo<strong>in</strong>tly.Fur<strong>the</strong>rmore, authorisation is notrequired, if an exemption applies (e.g. for<strong>in</strong>termediate uses <strong>in</strong> terms of Reach). Theproblem is that nei<strong>the</strong>r <strong>the</strong> decision whoThe company’s alarmbells for authorisationshould r<strong>in</strong>g, when Echarecommends <strong>the</strong> substancefrom <strong>the</strong> candidate list for<strong>in</strong>clusion <strong>in</strong> Annex XIV.30 KEMIA 5/2013
should apply for authorisation nor <strong>the</strong>establishment of an exemption based on<strong>the</strong> Reach legal text is formalised <strong>in</strong> <strong>the</strong>Regulation. These are bus<strong>in</strong>ess decisionsor fall <strong>in</strong> <strong>the</strong> area of risk management.Exemptions should only be relied upon,if <strong>the</strong> conditions for its application havebeen carefully verified. A written analysisand justification is highly recommendedfor compliance purposes, as well asconsultation with <strong>the</strong> competent nationalauthority, Echa and—depend<strong>in</strong>g on <strong>the</strong>case—<strong>the</strong> European Commission.As regards <strong>the</strong> applicant, Reach allows<strong>the</strong> “top-down” coverage of all or selecteddownstream uses <strong>in</strong> <strong>the</strong> application of<strong>the</strong> upstream manufacturer, importeror downstream user (e.g. formulator),whereas <strong>the</strong> f<strong>in</strong>al user may only applyfor authorisation for his own use.Thus <strong>the</strong> f<strong>in</strong>al user is at <strong>the</strong> EUformulator’s mercy with regards to<strong>the</strong> authorisation for <strong>the</strong> formulationstage, unless he decides to import <strong>the</strong>mixture from outside EU. Therefore, anagreement on <strong>the</strong> application strategywith<strong>in</strong> each supply cha<strong>in</strong> needs to befound and <strong>the</strong> actors should engage <strong>in</strong>communication to this end, as well as for<strong>the</strong> preparation of suitable authorisationdossiers.How to prepare<strong>the</strong> dossier?Applications are to be made for a specificuse of <strong>the</strong> Annex XIV substance. Theproper def<strong>in</strong>ition and description of <strong>the</strong>use is critical for <strong>the</strong> chances to get <strong>the</strong>desired authorisation. Ideally, it needsto be tailored to <strong>the</strong> specific exposureconditions and risk managementmeasures, requirements for substitutionand socio-economic factors.The authorisation dossier normallycomprises three major assessment reports:<strong>the</strong> Chemical Safety Report (CSR) todocument use under adequate control orwith “acceptable” risk, <strong>the</strong> Analysis ofAlternatives (AoA) to document (non-)availability and/or (non-)suitability ofalternative substances or technologies,and <strong>the</strong> Socio-Economic Analysis (SEA)to document <strong>the</strong> socio-economic benefitsof <strong>the</strong> use versus its adverse effects onhuman health and <strong>the</strong> environment.The assessment reports need to bewritten accord<strong>in</strong>g to <strong>the</strong> applicableauthorisation route: For so-called“threshold substances”—represent<strong>in</strong>ga m<strong>in</strong>ority of cases of Annex XIVsubstances—<strong>the</strong> “adequate controlroute” is viable, i.e. <strong>the</strong> authorisationmust be granted based on evidence ofadequate control of <strong>the</strong> risk from <strong>the</strong> use<strong>in</strong> <strong>the</strong> applicant’s CSR. AoA and SEAare mostly relevant to determ<strong>in</strong>e anyauthorisation conditions, especially <strong>the</strong>length of <strong>the</strong> review period.By contrast, no safe use can bedemonstrated by def<strong>in</strong>ition for “nonthresholdsubstances”. In this case, anauthorisation may only be granted on <strong>the</strong>“socio-economic route”, if <strong>the</strong> applicantshows that <strong>the</strong> socio-economic benefitsfrom <strong>the</strong> use outweigh <strong>the</strong> risks, andsuitable alternatives are not available.Hence, under <strong>the</strong> latter route AoA andSEA become crucial for <strong>the</strong> grant<strong>in</strong>g ofan authorisation.A long anddemand<strong>in</strong>g processThe authorisation process takes manyyears from <strong>the</strong> candidate list proposalto <strong>the</strong> Commission decision on<strong>in</strong>dividual applications. In between,affected companies need to make anumber of strategic decisions—applyor not? alone or with o<strong>the</strong>rs? applicationcontent?—and do highly demand<strong>in</strong>gtechnical work which require bus<strong>in</strong>ess,<strong>chemical</strong>, communication, legal, projectmanagement, R&D, toxicological ando<strong>the</strong>r skills.Granted authorisations are subject toperiodical review, until safer alternativesare implemented. Authorisation can<strong>the</strong>refore well be seen as <strong>the</strong> “decathlon”amongst <strong>the</strong> Reach processes.So be prepared, if you wish to defendyour SVHC. The process is still new.Echa just received its first application <strong>in</strong>May.Tim BeckerThe author is chief EU complianceofficer at REACHLaw Oy.tim.becker@reachlaw.fiExplor<strong>in</strong>gpossibilities...Borealis is a lead<strong>in</strong>g provider of <strong>chemical</strong> and <strong>in</strong>novative plastics solutions thatcreate value for society. From simple everyday products that make life easier tostep-chang<strong>in</strong>g technological developments, Borealis is lead<strong>in</strong>g <strong>the</strong> way.Borealis provides <strong>in</strong>novative, value creat<strong>in</strong>g plastics solutions for <strong>the</strong> <strong>in</strong>frastructure,automotive and advanced packag<strong>in</strong>g markets.Innovations are <strong>in</strong> key position <strong>in</strong> Borealis strategy. The company <strong>in</strong>vests strongly<strong>in</strong> technology and development <strong>in</strong> its Innovations Centres <strong>in</strong> Porvoo, F<strong>in</strong>land,Stenungsund, Sweden and L<strong>in</strong>z, Austria.www.borealisgroup.com
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