C u s t o m s o l u t i o n s f o r C o m p l i a n C e [ r e a C H | r o H s | C p s i a | r s l | p r o p 6 5 ]

RoHS II, CLP & REACH A Guide for 2011

assent ComplianCe

Jonathan hughes pHone: 613.290.8044

Jon.HugHes@assentComplianCe.Com

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ASSENTCoMPLIANCE

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ASSENTCoMPLIANCE

INTRoduCTIoN To ASSENT CoMPLIANCEassent ComplianCe

•Consulting•GlobalRequirements•ComplianceStrategies•RegulatoryInterpretationsandImpacts

•IT•CloudComputing•ApplicationDesign

•Operations•ProgramImplementation•DataManagement

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ASSENTCoMPLIANCE

AgENdA•RoHSII•CLP•REACH•2011timeline•Q&A

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ASSENTCoMPLIANCE

RoHS IIlegislation overview

•TherecastoftheRoHSDirective(RoHSII)wasapprovedinNovemberof2010.

•NonewsubstanceshavebeenimmediatelyaddedtothescopeoftheRoHSDirective.

•Thereisaprocessforaddingnewsubstances.4substancesareupforreviewforadditiontoRoHSwithinamaximumof3years:

•HBCDD•DEHP•BBP•DBP

•Additionalsubstancescanbeaddedinthefuture

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ASSENTCoMPLIANCE

RoHS II (CoNT’d)legislation overview

•AllcurrentexemptionsareincludedintheRecast

•RoHSwillnowbeapartoftheCEMarkingDirective•ThiswillcreateauniformapproachtoTechnicalDocumentationandDeclarationsofConformity.

•ProductsinscopeofCEmaynotnecessarilybeinscopeofRoHS

•RoHSDeclarationofConformityformatisnowoutlinedintheRoHSRecast.

•Productnumber•Manufacturername•Productinfo•Declarationstatement•Etc•Mustbetranslatedintolanguageofmemberstatewhereproductisplacedonmarketormadeavailable

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RoHS II (CoNT’d)legislation overview

•AllactorsinasupplyhavethelegalresponsibilitytoinformtheMemberstateNationalAuthorityiftheydiscoveranon-compliantproduct.

•Productsmustthenbewithdrawnfromthemarket,recalledorhavecorrectivemeasuresimplementedtoensurecompliance.

•InformationanddocumentationmustbeprovidedtoaNationalAuthorityuponrequest.

•Manufacturersanddistributorsmustkeeparegisterofallnon-compliantproductsandproductrecalls.

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RoHS II (CoNT’d)legislation overview

•ThereareSpecificrequirementsforwithdrawalfrommarket:

“Manufacturers who consider or have reason to believe that a EEE which they have placed on the market is not in conformity with this Directive immediately take the necessary corrective measures to bring that EEE into conformity, to withdraw it or recall it, if appropriate and immedi-ately inform the competent national authorities of the Member States in which they made the EEE available to that effect, giving details, in par-ticular, of the non-compliance and of any corrective measures taken;”

•Recallmeansanymeasureaimedatachievingthereturnofaproductthathasalreadybeenmadeavailabletotheenduser

•Withdrawalmeansanymeasureaimedatpreventingaproductinthesupplychainfrombeingmadeavailableonthemarket.

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RoHS II—SCoPEsCope CHanges

•Appliestoallelectricalequipment•MostexemptionsfromRoHSIarestillinplace(military,auto,largescalestationaryandfixed,etc)

•MedicalDevicesareinscope3yearsfromentryintoforce•In-vitroMedicalDeviceswillbeinscope5yearsfromentryintoforce•Monitoringandcontrolinstruments–3yearsfromentryintoforce•IndustrialMonitoringandcontrolinstruments–5yearsfromentryintoforce

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RoHS IItimeline

•RoHSIItakesaffectonthe20thdayafterpublicationintheEUJournal.

•Shouldbepublishwithinthenext2months.Couldbeasearlyasthismonth

•RoHSisaDirectivenotaRegulation—IndividualMemberstatesmustpassNationalLegislationatleast18monthsafterthatdate.

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RoHS IIBusiness impaCts•Enforcement ismuchmore formal andRoHSmustbe addressedbymanufacturersandtheirdownstreamusers:

•Legal responsibility to notify national authority means no moreinternalizedorprivatecorrectiveaction

•Mandatoryproductwithdrawal•Registryofproductrecalls

•4newsubstanceshavebeendelayedandmustfollowasimilarprocesstoSVHCsforinclusiontoRoHSII.

•Substances will very likely pass through this process (they did forREACH)andwillbeonRoHSIIwithin3yearsatthemost.

•IncorporationofRoHSIIintotheCEmarkmeansafailureonRoHSwillinvalidateyourCEmark—thisisastop shipment issue.

•Manufacturer’smustmakesuretheirRoHSprogramisaccurateandnotmerelyapaperworkexercise.

•Downstreamuser’smust establish the importance ofRoHS IIwiththeirsuppliersandwriteitintoT&Cs(iftheyhavenotalready).

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CLPlegislation overview

•CLPalignsexistingEUlegislationtotheUnitedNationsGloballyHarmonisedSystem(GHS).

•CLPcontributes to theGHSaim that the samehazardswillbedescribedandlabeledinthesamewayallaroundtheworld.

•UndertheCLPregulation,acompanymustnotifytheEuropeanChemicalAgency(ECHA)ofhazardoussubstancesitimportsontheirownorinmixturesabove0.1%byweight.

•ThedeadlinewasJanuary3rd,2011forproductscurrentlyplacedonthemarket.

•1monthafterproductisplacedonthemarketforproductsplacedonthemarketafterDecember2010.

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CLPsCope

•Who this applies to:

•Importersormanufacturersof substancesoverone (1) tonperannumintotheEU

•Importersormanufacturersofsubstancesclassifiedashazardousunder CLP and placed on the market—irrespective of thetonnage(noone(1)tonlimit).

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CLPBusiness impaCts

•How will this affect my company?•YoumusteithernotifyyoursubstancesinscopewiththeECHAormakesuresomeoneinyoursupplyhascoveredyouintheirnotification

•Coverssubstancesthatwerepre-registeredforREACHbuthaveadeadlineof2013or2018.

•Includessubstancesimportedatavolumelessthan1metrictonperannum

•What if I missed the deadline?•Contactyoursupplychain—hasanyonealreadycoveredyouwiththeirCLPnotification?

•Contactaserviceprovidertoseewhatyouroptionsare.

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REACHsvHC BasiCs

artiCle 33 – sourCe of ComplianCe requirement:

Duty to communicate information on substances in articles:

1. Any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concen-tration above 0,1 % weight by weight (w/w) shall provide the recipient of the article with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance.

2. On request by a consumer any supplier of an article containing a sub-stance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall provide the consumer with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance.

Therelevantinformationshallbeprovided,freeofcharge,within45daysofreceiptoftherequest.

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What Does this mean?

•OnceasubstancehasbeenaddedtotheSVHCList,youmustdeclareitspresencetoyourdownstreamusersiftheconcentrationisabove0.1%ofyourproductsweight.

•Thisistobedoneuponimmediatelyforprofessionalcustomersandwithin45daysfromrequestforconsumers.Contactaserviceprovidertoseewhatyouroptionsare.

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REACHCurrent svHC Candidate list

Link to the SVHC Candidate List: ht tp : / / e cha . europa . eu / chem_data /au thor i s a t i on_pro c e s s /candidate_list_table_en.asp

•Currentlyat46substances•Newadditionsplannedevery6months•Anysubstancescontainedinproductsatalevelgreaterthan0.1%w/wmustbecommunicatedtodownstreamusersimme-diatelyforB2Brelationshipsandtheinformationneedstobemadeavailablewithin45daysforconsumers(thepublic).

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REACHmost reCent additions to tHe Candidate list

suBstanCe Cas # eC # Common uses

2-Ethoxyethanol 110-80-5 203-804-1 Solventandchemicalintermediate

2-Methoxyethanol 109-86-4 203-713-7 Solvent,chemicalintermediateandadditiveforfuels

Cobaltdi(acetate) 71-48-7 200-755-8Usedinthemanufactureofcatalysts,productionofotherchemicals,surfacetreatment,alloys,pigments,dyes,rubberadhesion,andfeedadditive.

Cobalt(II)carbonate 513-79-1 208-169-4

Usedinthemanufactureofcatalysts,productionofotherchemicals,surfacetreatment,alloys,pigments,dyes,rubberadhesion,andfeedadditive.coatfrit)andotherchemicalsandusedasafeedadditive.

Cobaltdinitrate 10141-05-6 233-402-1 Usedtomanufacturecatalystsandotherchemicals,usedinsurfacetreatmentsandbatteries.

Cobalt(II)sulphate 10124-43-3 233-334-2

Manufactureofcatalystsanddriers,surfacetreat-ments(suchaselectroplating),corrosionpreven-tion,productionofpigments,decolourizing(inglass,pottery),batteries,animalfoodsupplement,soilfertilizer,andotherchemicals

Chromiumtrioxide 215-607-8 1333-82-0 Usedformetalfinishingandasfixingagentinwaterbornewoodpreservatives.

Acidsgeneratedfromchromiumtrioxideandtheiroligomers:1)Chromicacid2)Dichromicacid

1)231-801-52)236-881-5

1)7738-94-52)13530-68-2

Substancesaregeneratedwhenchromiumtrioxideisdissolvedinwater.Consequently,theusesofthesesubstancesarethesameasindicatedforchromium.

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REACHfuture additions to tHe svHC list

Here is an excerpt from ECHA’s press release on March 25, 2010regardingREACH:

“Accelerating addition of substances to the Candidate List: Both Commissioners expressed disappointment at their con-firmation hearings at the low number of SVHCs that had been placed on the REACH Candidate List for authorisation. They revealed that they had discussed the matter at length with ECHA and had secured the agency’s commitment to a “roadmap” that would allow another 106 “top priority” substances to be added to the Candidate List by 2012. ECHA indicated that this was the maximum number of substances it felt it could administer without compromising on the quality of assessment.”

Link: http://europa.eu/rapid/pressReleasesAction.do?reference=IP/10/360&format=HTML&aged=0&language=EN&guiLanguage=en

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REACHautHorisation overview

•The Authorisation process

•StartswiththeidentificationofSVHC’sbyMemberStateCompetentAuthoritiesortheECHA

•Preparation&SubmissionofAnnex15dossiers.

•DecisionsonprioritisationoftheseSVHCsandthesub-sequentreleaseofthefinallistofsubstancessubjecttoau-thorisationisdecidedbytheCommission.

•IndustryhastoapplytotheECHAforauthorisationforusesofthesesubstances.

•Afteranapprovalprocess,theholderofanauthorisationcanuseandplaceonthemarketthesubstancefortheuseshewasgrant-edanauthorisation.

SummarySubstances on the current SVHC List will eventually require anAuthorisationfortheiruseonapersubstance,percompany,perusebasis.

ASSENTCoMPLIANCE

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REACHtHe aim of autHorisation

•Asperarticle55oftheREACHRegulation: “…the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable”.

•AllAuthorisationapplicantsshallanalysetheavailabilityofalterna-tives,considertheirrisks,andthetechnicalandeconomicfeasibilityofsubstitution.

•Iftheriskisnotadequatelycontrolled,anauthorisationmaystillbegrantedifitisproventhatthesocio-economicbenefitsoutweightherisksandtherearenosuitablealternativesubstancesortechnologies.

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REACHautHorisation proCess

1. Registryofintentions–Intentiontosubmitdossier

2. SubmissionofAnnexXVdossier(SVHCDossier)toECHAforComplianceCheck

3. PublicationofAnnexXVdossier(onceithaspassedcompliancecheck)

4. AfterCommentingperiods–CandidateList(Article33Requirementskickin)

5. Prioritisationlist–OrderinwhichsubstanceswillbereviewedforAuthorisation

6. AuthorisationList–RestrictionsandAuthorisationshandedout

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REACHsvHC Candidate list addition timeline

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REACHstandard ComplianCe metHodologies

•Testingmethod•WetchemicaltestingforsubstancesontheSVHClist

•Declarationmethod•BusinessesasksuppliersiftheirmaterialscontainSVHCs.

•UseresponsesasproofofREACHcompliance

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REACH

advantages

•Testingmethod•Direct•Conclusive

•Declarationmethod•Lowercost•Cancoverentireproductline

disadvantages

•Testingmethod•Highcostpertest•Mustberedoneeveryrevision

•Declarationmethod•Significanthumanresourcetimeisexpended

•Updates&supplierresponsesmustbeconstantlytracked

•InfoneedstobemergedwithexistingPLM/ERPsystems

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REACHBusiness impaCts

•BusinessisthecurrentdriverofSVHCcompliancethroughProductSpecificationsandRFP’s.

•Eventually,anycompanywhoseproductsendupintheEUwillhavetocompletelydisclosetheSVHCstatusofalltheirproducts.

•ECHAguidancestatesthatsupplychaincommunicationmustbedocumentedinordertodemonstrateREACHcompliance.

•Notificationsaretobeginthisyear—youmustobtainyourSVHCinformationinordertocompleteanynecessaryNotifications

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PRACTICAL APPLICATIoNSideal qualities of a deClaration of Conformity•Adeclarationshouldideallybepartofaprocessthatkeepsallyourinformationcurrentandyourdeclarationsconsistent.

•Uponrequest,youshouldbeabletoshowthefollowingitems:

•Who sent the declaration (person, not just company)?•Whatwastheexactresponse?•Whenwasitsent?•How(email,ftp,snailmail)?

•What was asked of the supplier on the Declaration?•When?•How?

•How these declarations are stored?•How they are verified?•How/when they are updated?

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C u s t o m s o l u t i o n s f o r C o m p l i a n C y [ r e a C H | r o H s | C p s i a | r s l | p r o p 6 5 ]

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SERvICE offERINgSConsulting serviCes

•ManagethecompliancetoROHS,REACH,CLPandotherEnvironmentalstandards

•Ensurecompliancewithregulatoryagenciesandcomplianceregulations•Reviewandevaluateenvironmentalrequirementsandchangesaspublishedbyregulatingbodies

•Supportsourcingandselectionofelectronicandmechanicalcomponents•Serveassubjectmatterexpertonregulatorymatters•Specificationanddrawingreviewforcompliance•Obsolescencemanagementandpartsubstitution•Workwithsuppliersoncorrectiveactions

More experience and less cost than hiring a full time component engineer.

ASSENTCoMPLIANCE

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C u s t o m s o l u t i o n s f o r C o m p l i a n C y [ r e a C H | r o H s | C p s i a | r s l | p r o p 6 5 ]

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SERvICE offERINgSsoftware•Automaticallygatherdataenvironmentalcompliancedatafromyoursupplychain(Declarations,COC’s,DOC’s,etc.)

•Platformforsupplierstoenterenvironmentalcomplianceinformation

•Generatecustomreportsbasedongatheredcompliancedata:•Allowsforatoplevelviewofcomplianceprogressoradrilldowntoproductorpartlevelcompliance

•Instantlyisolateproblemareasbasedonproducts,partsormaterials.

•GeneratecompliancedocumentsforEnforcementagenciesanddownstreamusers.

•Actsasaplatformforinternalteamstomanageenvironmentaldataandmakeinternaldeclarationsbasedonobtainedinformation:

•EngineeringOverride

•Automaticcommunicationtooltoinformsuppliersofchangestoenvi-ronmentalregulations

•Free model for large cap companies looking to implement a software platform with their supply chain

ASSENTCoMPLIANCE

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C u s t o m s o l u t i o n s f o r C o m p l i a n C y [ r e a C H | r o H s | C p s i a | r s l | p r o p 6 5 ]

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QuESTIoNS?PleasesubmityourquestionsinwritingusingtheQ&Atoolalongthetopmenutoolbar.AnyquestionsnotaddressedduringtheQ&Aportionofthiswebinarwillbeaddressedinprivatecorrespondenceafterthewebinar.

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