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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 e [ r e a c h | r o h s | c p s i a | r s l | p r o p 6 5 ]

REACH – New SVHCS, New AutHoriSAtioNS, New

iNterpretAtioN, New reportassent compliance

Krystal Noseworthy-BaKer phone: 613.882.1429

krystal.baker@assentcompliance.com

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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 ]

INTROduCTION TO ASSENT COMPLIANCEassent compliance

•Consulting•GlobalRequirements•ComplianceStrategies•RegulatoryInterpretationsandImpacts

•IT•CloudComputing•ApplicationDesign

•Operations•ProgramImplementation•DataManagement

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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 ]

AgENdA•Headlines

•UpdatestoREACH

•Impacts

•SVHCs

•Additions

•UpcomingAdditions

•Impacts

•Authorisations

•France’sArticleInterpretation

•FirstReportonREACH

•Enforcement

•Q&A

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Industry could face eu reacH-

style rules – just-food.com – oct 2009

reacH: a new regulatIon for cHemIcal substances – tImesofmalta.com

eu sets rules to regulate toxIc cHemIcals

– busIness – InternatIonal Herald trIbune (ny tImes)

reacH and tHe electronIcs supply cHaIn: are you ready? – eetImes – may 2008

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HEAdLINESreach in the newsOnDec13th,2006–REACHwasapprovedbytheEuropeanParliamentandhitthenews-wirethroughoutEuropeandNorthAmerica.

Betweenupdates toguidance, industry re-sponsestoREACH,updatestotheSVHCCandidateList,andotherregulatorydevel-opmentsREACHremainsinthenews.

doubts remaIn over new eu cHemIcalslaw In swItzerland – swIssInfo.org

reactIon to reacH cHemIcals law – bbc news | europe

regulatory treatment of “artIcles” under reacHdIvergence of InterpretatIons between ecHa andtHe frencH competent autHorIty – july 2011

european parlIament approves law regulatIng cHemIcals – usa today

tHe fIgHt to Know? substances of very HIgH concern

and tHe cItIzens’ rIgHt to Know under reacH – european envIronmental board – october 2010

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reach in the news (cont’d)

•China is now spending billions of dollars throughout Europe whichwill exponentially increase trade between these two countries as well asproviding a substantial influx of money not only for the economy ingeneral but for compliance enforcement.Thiswill also serve to increasethe impact of REACH as China and Europe will work together forcomplianceoptimization.

•Finally,weare seeingGMPlaboratories inIndiabeingaccreditedby theOrganisation of Economic Cooperation and Development (OECD) inordertoreducethecostofREACHcomplianceforthechemicalindustry.Indian chemical exports are expected to double in the next 3 years andREACHwillimpactmostifnotallofthoseexports.

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wHAT dOES THIS ALL MEAN?•REACHisgoingmainstream

•Themoreattentionaregulationgetsinthemedia,themoreattentionyourcustomersgivetoit

»Moreinformationrequests»Contractchanges

•Complianceismandatorytocontinuebusiness»Moredeclarationrequests» Increasedstandardsfordeclarations

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SVHC BASICSsvhc basicsArticle33–Sourceofcompliancerequirement:

Dutytocommunicateinformationonsubstancesinarticles:

1. Any supplier of an article containing a substance meeting thecriteriainArticle57andidentifiedinaccordancewithArticle59(1)inaconcentrationabove0,1%weightbyweight (w/w) shallprovide therecipientofthearticlewithsufficientinformation,availabletothesup-plier,toallowsafeuseofthearticleincluding,asaminimum,thenameofthatsubstance.

2. Onrequestbyaconsumeranysupplierofanarticlecontainingasub-stancemeeting thecriteria inArticle57and identified inaccordancewithArticle 59(1) in a concentration above0,1%weight byweight(w/w)shallprovidetheconsumerwithsufficientinformation,availabletothesupplier,toallowsafeuseofthearticleincluding,asaminimum,thenameofthatsubstance.

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Therelevantinformationshallbeprovided,freeofcharge,within45daysofreceiptoftherequest.

•Whatdoesthismean?•Once a substance has been added to the SVHC List, you mustdeclareitspresencetoyourdownstreamusersiftheconcentrationisabove0.1%ofyourproductsweight.

•Thisistobedoneuponimmediatelyforprofessionalcustomersandwithin45daysfromrequestforconsumers.

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SVHCs – CONSTANT uPdATES•CurrentCandidateListsitsat53substances

•Therearecurrently20substancesproposedforadditiontotheCandidateList(proposedAug29th,2011).Therearealso8substancesontheRegistryofIntentions.

•ThelastupdatetotheCandidateListwasJune20th,2011.

•Updateshavebeenhappeningabouttwiceayear,howeverthisisnotafirmrequirement,infact,substancescanbeaddedMOREOFTEN.

•The head of the ECHA has stated the 136 SVHCs would be listed bytheendof2012

•Currentprojectionsstatethatthereshouldbeabout74substancesbytheendof2011

•Thisleaves62substancestobeaddedin2012

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REACHcurrent svhc candidate list

substance uses/materials

Anthracene Manufactureofdyes,pyrotechnics

4,4’–Diaminodiphenylmethane(MDA)

Hardener for epoxy resins (possible use in PCBs),hardener in adhesives, intermediate in themanufac-ture of high-performance polymers, preparation ofpolyurethane

Dibutylphthalate(DBP) Plasticizer(softener)inPVC,printinginks,paperandpackagingcoatings,etc…

Benzylbutylphthalate(BBP) Plasticizer(softener)ofPVC,acrylics,sealants,adhe-sives,inks,paints,etc..

Bis(2-ethyl(hexyl)phthalate)(DEHP) Plasticiser inpolymerproducts,mainlyPVC,blisterpacking

CobaltdichlorideGasmasks,humidityindicator,dyemordantforglassindustry, drying agent in paints, lacquers, varnishesandprintinginks,etc…

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Leadhydrogenarsenate Insecticides

DiarsenicpentaoxideDying industry, printing, colored glass, insecticide,metallurgy(tohardencopper,leadorgoldinalloys),etc…

DiarsenictrioxideDecolorizing agent for glass and enamels, oxidizingagentspecialglassandleadcrystalformulations,weedkillers

Sodiumdichromate Metalfinishing,aidingcorrosionresistance,chrome-tanningofleather,coloredglassandceramicglazes

5-tert-butyl-2,4,6-trinitro-m-xylene(muskxylene) Fragrance,cosmeticsandsoapperfumes

Hexabromocyclododecane (HBCDD)andallmajordiastereoisomers

Flame retardant used in HIPS, PS insulation andtextiles

Alkanes, C10-13, chloro (Short ChainChlorinatedParaffins)

Manufactureofbulk,largescalechemicals.Manufactureofrubberproducts.Usedinadhesives,sealants,coatingsandpaints,thinners,paintremov-ers,polymerpreparationsandcompounds.

Bis(tributyltin)oxide Biocide, antimicrobial, incorporated into polymers,flooring,tilesandcarpeting

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Triethylarsenate Intermediateforsemiconductors

Anthraceneoil

Manufacture of other substances – anthracene andcarbonblack.Other:reducingagentsinblastfurnac-es, ascomponents inbunker fuel, for impregnating,sealingandcorrosionprotection.

Anthraceneoil,anthracenepaste,distn.lightAnthraceneoil,anthracene-low

Anthraceneoil,anthracenepasteAnthraceneoil,anthracenepaste,anthracenefraction

Pitch,coaltar,hightemp.

Production of electrodes – industrial applications.Other:heavydutycorrosionprotection,specialpur-posepaving,manufactureofothersubstancesandtheproductionofclaytargets.

Acrylamide

Synthesisofpolyacrylamides(usedinvariousapplica-tions,inparticularinwastewatertreatmentandpaperprocessing. Other: polyacrylamide gels for researchpurposes,groutingagentsincivilengineering.

Aluminosilicate Refractory CeramicFibres

High-temperature insulation for industrial applica-tionsandinfireprotection

Zirconia Aluminosilicate, RefractoryCeramicFibres

High-temperature insulation for industrial applica-tionsandinfireprotection

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2,4-Dinitrotoluene

Production of toluene diisocyanate – used for themanufacture of flexible polyurethane foams. Other:gelatinizing-plasticizingagentforthemanufactureofexplosivemixtures(e.g.forairbagsincars).

Diisobutylphthalate(DIBP)Plasticiser for nitrocellulose, cellulose ether, polyac-rylate,polyacetatedispersions,gellingaidinplastics,lacquers,adhesives,explosivematerialandnailpolish.

Leadchromate

Manufacturingpigmentsanddyes,pigmentorcoat-ing agent (industrial andmaritime paint products),embalming/restoringofartproducts.Otheruses:de-tergents and bleaches, photosensitive materials andforthemanufactureofpyrotechnicpowder.

Lead chromate molybdate sulphate red(C.I.PigmentRed104)

Colouring,paintingandcoatingagentinsectorssuchastherubber,plasticandpaints,coatingsandvarnish-esindustries.OtherApplications–agriculturalequip-ment,vehiclesandaircraftaswellasroadandairstrippainting.

Lead sulfochromateyellow(C.I.PigmentYellow34)

Colouring,paintingandcoatingagentinsectorssuchastherubber,plasticandpaints,coatingsandvarnish-esindustries.OtherApplications–agriculturalequip-ment,vehiclesandaircraftaswellasroadandairstrippainting,camouflageandammunitionmarkinginthedefensearea.

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Tris(2-chloroethyl)phosphate

Additiveplasticiserandviscosityregulatorwithflame-retarding properties for acrylic resins, polyurethane,polyvinylchlorideandotherpolymers.Otherappli-cations – adhesives, coatings, flame resistant paintsand varnishes. Main industries – furniture, textile,building.

2-EthoxyethanolCommonsolventusedinsurfacecoatingssuchaslac-quersandpaints.Otheruses:varnishremovers,print-inginks,duplicatingfluids,woodstains,andepoxies.

2-Methoxyethanol Additiveinairplanede-icingsolutions.Alsousedasasolventinvarnishes,dyes,andresins.

Ammoniumdichromate

Mordant in dyeing pigments, source of pure nitro-geninlaboratory,manufacturingofchromealumandalizarin.Otheruses:oilpurification, leather tanningandpyrotechnics.

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Boricacid

Antisepticagent,insecticide,flameretardant,neutronabsorberinnuclearpowerplants,productionofglassin LCD flat panel displays, ramming mass. Otheruses:manufactureofmonofilamentfiberglass,textilefiberglass,lubricantincarromboards.

ChromicacidIntermediateinchromiumplating,coloredglassandceramicglazes,oxidizingagent,cleaningagentinlab-oratoryglassware.

Oligomers of chromic acid and dichromicacid

Dichromicacid

Chromiumtrioxide

Metal finishing, manufacture of wood preservationproducts, catalyst manufacture, chromium dioxidemanufacture and pigmentmanufacture.Other uses:Chromeplating.

Cobalt(II)carbonate Pigmentsinglass,ceramicsandpaints;catalystsinthepetroleumindustryespeciallyaspaintdriersandtraceelementadditivesinagricultureandmedicine.Otheruses: electroplating, storage batteries, and animalfeeds.PETandotherplasticsforCobalt(II)diacetate.

Cobalt(II)diacetate

Cobalt(II)dinitrate

Cobalt(II)sulphate

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Disodiumtetraborate,anhydrous

Antifungalcompoundforfiberglass,fireretardant,in-secticide,fluxinmetallurgy,texturingagentincook-ing.Otheruses:componentindetergents,cosmetics,enamelglazes,micronutrientfertilizer.

Potassiumchromate Productionofsafetymatches,inks,explosives,leathertanning,woodtreatmentanddyeingtextiles.

Potassiumdichromate

Preparationofchromicacid,manufactureofcement,application in police breathalyzer tests, leather tan-ning,inPhotographyasanoxidizingagent,silvertest-ing,woodtreatment.

Sodiumchromate

Manufactureofchromiumcompounds,waterandal-cohol-basedcoolants,pigmentformulation,mordantfordyeingwool,woodpreservative, oilwell drillingfluidsandcatalysts.

Tetraborondisodiumheptaoxide,hydrate Flame retardant in wood, paper, cotton and otherplant-derivedmaterials.

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Trichloroethylene

Industrial solvent, coffee decaffeination agent, veg-etableoilextractingagent,volatilegasanesthetic,drycleaningsolvent,degreaserformetalparts,manufac-tureofarangeoffluorocarbonrefrigerants.

2-Ethoxyethylacetate

2-EEAwasusedinthepastassolventandintermedi-ateinthechemicalindustry.Itwasalsousedfortheformulationofpaints, lacquersandvarnishes for in-dustrialuse.

Based on available information, 2-EEA is still usedontheEUmarket,assolventandfortheformulationofpaints,lacquersandvarnishedforprofessionaluseexclusively, but at very low volumes.These remain-inguses areprobably very specific, as suggested, forinstance,bythefollowingusecategory:Buildingandrepairingofshipsandboats,Manufactureofaircraftandspacecraft.

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Strontiumchromate

According to the literature and data collected fromtheconsultation,strontiumchromateisusedbyfouractivitysectors:• formulationofstrontiumchromatecontainingmix-

tures(coatingssuchaspaints,varnishes,oil-colors,sealants,etc.),

• industrial use of strontium chromate containingformulations (coatings andmixtures) in the aero-nautic/aerospacesector,

• industrial use of strontium chromate containingformulations(coatings)inthecoilcoatingsectorofsteelandaluminum,

• industrial use of strontium chromate containingformulations(coatingsandmixtures)inthevehiclecoatingsector.

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1,2-Benzenedicarboxylicacid,

di-C7-11-branchedandlinearalkylesters

“Based on information from European manufac-turers of phthalates and The European Council forPlasticisers and Intermediates (ECPI), the substanceseemsnot (anymore) tobemanufactured in theEUor importedtotheEU.DHNUPinCanadaisusedprincipallyforplasticiserapplicationsandmainlyasaplasticisertoPVC.

In Canada,DHNUP is used in polyvinyl chlorides(PVC)andfoam;automotivesealant;urethane,glass,andtransmissionadhesive;roofcoatings,barriercoat-ings, exterior trim, and tarps; cement, caulk, andsealer; andhigh-end luggage.After2006, theuseofDHNUP ismainly in theplasticizationof electricalandcommunicationwireinsulation.

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Hydrazine

Initshydratedform(insolutionconcentrationsreadyforend-usebetween3%and100%):• Synthesisofhydrazinederivatives• Thesemayactasorfindusesinproductssuchaspharmaceuticals,agrochemicals,chemicalblow-

ingagents,paints,inksandorganicdyes,reagentsforthetreatmentofnuclearreactorwaste,andothers(literatureprovidesdetailsofalargerangeofdifferentapplicationsforderivatives,salts,etc.ofhydrazine);

• Use as a monomer in polymerisations (mostly for polyurethane coatings and adhesives);useasacorrosioninhibitorinwatertreatment,mainlyfortheremovalofdissolvedoxygenandtheadjustmentofpHinthefeedwaterofboilersaswellasfortheremovalofsolidsfromsteamgenera-tors.Thecriticalareasofapplicationarenuclearandthermalpowergenerationplants(includingwatersteamcirculationfordistrictheatingandcooling).However,oxygenscavengingbasedonhydrazineisrelevantforotherindustrysectorsthatutilisesteamsuchaspapermills,steelmanu-facture,productionofchemicals.

• Butnotfoodgeneration;• Useasareducingagentinthedepositionofmetals(nickel,chromium,tinandpreciousmetals)

onplasticsandglass;• Useasareducingagentinpreciousmetalandbasicmetalrecoveryfrommetallicsaltsolutionsand

effluents;–useasareducingagentinpurificationofchemicalreagents;• Useasastabilisingagentinaromaticamines(forsubsequentpaint/inkmanufacture);• Useasalaboratorychemicalreagent;·initsanhydrousform(athighpuritylevels,>90%):• Useasapropellantforaerospacevehicles(satellitepropulsionandupperstagesofsatellitelaunchers);• Useasafuelinmilitary(emergency)powerunits(fortheF-16fighterjets);• Useingasgeneratorsforsubmarinerescuesystems

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1-Methyl-2-pyrrolidone

Coatings–High temperature coating,urethanedis-persions, acrylic and styrene latexes. Industrial andconsumercleaners.Paintremovers,floorstrippers,graf-fitiremover,industrialdegreasing,injectionheadandcast-moldingequipmentcleaning.Agriculturalchem-icals–Solventforherbicide,pesticideandfungicideformulations. ElectronicsCleaning, de-fluxing, edgebead removal, photoresist stripping. Petrochemicalprocessing.Lubeoilprocessing,naturalandsyntheticgaspurification.PharmaceuticalsSolvent.

1,2,3-Trichloropropane

Today,1,2,3-TCPisusedprimarilyasabuildingblockforthesynthesisofotherproducts,suchas:• Pesticides•Chlorinatedsolvents• Polysulfideelastomers(cross-linkingagent•Hexafluoropropylene(cross-linkingagent)approxi-

mately90%isusedasanintermediateforconver-sionintoothersubstances.

1,2-Benzenedicarboxylic acid, di-C6-8-branchedalkylesters,C7-rich

ThemainreportedusesofDIHPwere:·PlasticiserinPVC;·Plasticiserinsealantsandprintinginks.

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REACHproposals for addition to the candidate list

substanceec

numbercas

numberuses/materials

N,N-dimethylacetamide(DMAC) 204-826-4 127-19-5

Usedassolvent,mainlyinthemanufac-tureofvarioussubstancesandinthepro-ductionoffibresforclothingandotherapplications. Also used as reagent, andin products such as industrial coatings,polyimidefilms,paintstrippersandinkremovers.

Leaddiazide;Leadazide 236-542-1 13424-46-9

Mainly used as initiator or booster indetonators for both civilian and mili-taryusesandasinitiatorinpyrotechnicdevices.

Leadstyphnate 239-290-0 15245-44-0

Mainlyusedasaprimerforsmallcalibreand rifle ammunition. Other commonusesareinmunitionpyrotechnics,pow-der actuateddevices anddetonators forcivilianuse.

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2,2’-dichloro-4,4’-methyl-enedianiline(MOCA) 202-918-9 101-14-4

Mainlyusedascuringagentinresinsandintheproductionofpolymerarticlesandalsoformanufactureofothersubstances.The substance may further be used inconstructionandarts.

Phenolphthalein 201-004-7 77-09-8

Mainlyusedaslaboratoryagent(inpHindicator solutions), for theproductionofpH-indicatorpaperandinmedicinalproducts.

Leaddipicrate 229-335-2 6477-64-1

No registration for this substance hasbeen submitted to ECHA. Lead dipi-crateisanexplosivelikeleaddiazideandlead styphnate. It may be used in lowamounts in detonator mixtures togeth-er with the two other mentioned leadcompounds.

AluminosilicateRefractoryCeramicFibres

Refractory ceramic fibres are used forhigh-temperature insulation, almostexclusively in industrial applications(insulation of industrial furnaces andequipment,equipment for theautomo-tiveandaircraft/aerospaceindustry)andinfireprotection (buildings and indus-trialprocessequipment).

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ASSENTCOMPLIANCE

ZirconiaAluminosilicateRefractoryCeramicFibres

Refractory ceramic fibres are used forhigh-temperature insulation, almostexclusively in industrial applications(insulation of industrial furnaces andequipment,equipment for theautomo-tiveandaircraft/aerospaceindustry)andinfireprotection (buildings and indus-trialprocessequipment).

1,2-Dichloroethane;ethylenedichloride 203-458-1 107-06-2

Mainly used for manufacture of othersubstances.Minorusesassolventinthechemicalandpharmaceuticalindustry.

Dichromiumtris(chromate) 246-356-2 24613-89-6Mainlyusedinmixturesformetalsurfacetreatment in the aeronautic/aerospace,steelandaluminiumcoatingsectors.

Potassiumhydroxyoctaox-odizincatedichromate 234-329-8 11103-86-9

Mainlyusedincoatingsintheaeronau-tic/aerospace,steelandaluminiumcoilcoatingandvehiclecoatingsectors.

Pentazincchromateoctahydroxide 256-418-0 49663-84-5

Mainly used in coatings in the vehi-cle coating and aeronautic / aerospacesectors.

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Pentazincchromateoctahydroxide

Formaldehyde,oligomericreactionproductswithaniline(technicalMDA)

500-036-1 25214-70-4

Mainly used for manufacture of othersubstances. Minor uses are as hardenerforepoxyresins,e.g.fortheproductionof rolls, pipes andmoulds, and aswellforadhesives.

Bis(2-methoxyethyl)phthalate 204-212-6 117-82-8

No registration for this phthalate com-pound has been submitted to ECHA.Hence, the substance seems not to bemanufacturedinorimportedtotheEUin quantities above 1 t/y.Main uses inthepastwereasplasticiserinpolymericmaterials and paints, lacquers and var-nishes,includingprintinginks.

Arsenicacid 231-901-9 7778-39-4

Mainlyusedtoremovegasbubblesfromceramicglassmeltandforimprovingad-hesionbetweencopperfoilandresinintheproductionoflaminatedprintedcir-cuitboards

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Calciumarsenate 231-904-5 7778-44-1

Calciumarsenate is present in complexrawmaterialsimportedformanufactureof copper, lead and a rangeofpreciousmetals. It appearsmainly tobeused inmetallurgical refinement processes toprecipitate nickel from molten copperand to manufacture diarsenic trioxide.However,mostofthesubstanceseemstobedisposedofaswaste.

Trileaddiarsenate 222-979-5 3687-31-8

Trileaddiarsenate ispresent incomplexrawmaterialsimportedformanufactureof copper, lead and a rangeofpreciousmetals.Thetrileaddiarsenatecontainedin the rawmaterials is in themetallur-gical refinementprocess transformed tocalciumarsenate anddiarsenic trioxide.Whereas most of the calcium arsenateappearstobedisposedofaswastethedi-arsenictrioxideisusedfurther.

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2-Methoxyaniline;o-Anisidine 201-963-1 90-04-0

Mainlyusedinthemanufactureofdyesfor tattooing and coloration of paper,polymersandaluminiumfoil.

4-(1,1,3,3-tetramethylbutyl)phenol,(4-tert-Octylphenol) 205-426-2 140-66-9

Mainlyusedinthemanufactureofpoly-mer preparations and of ethoxylates.Further used as a component in adhe-sives,coatings,inksandrubberarticles.

Bis(2-methoxyethyl)ether 203-924-4 111-96-6

Used primarily as a reaction solvent orprocesschemicalinawidevarietyofap-plications.Usedalso as solvent forbat-tery electrolytes, and possibly in otherproductssuchassealants,adhesives,fu-elsandautomotivecareproducts.

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REACH – COMMON SVHCSDEHP (Bis (2-ethyl(hexyl)phthalate)

•Plasticizerinpolymerproducts,mainlyPVC,blisterpacking» InAnnexXIV–SunsetDateFeb21,2015» Exemption foruses in the immediatepackagingofmedicinalproducts covered under Regulation (EC) No 726/2004,Directive2001/82/EC,and/orDirective2001/83/EC.

BBP (Benzyl butyl phthalate)•Plasticizer(softener)ofPVC,acrylics,sealants,adhesives,inks,paints,etc…

» InAnnexXIV–SunsetDateFeb21,2015» Exemption foruses in the immediatepackagingofmedicinalproducts covered under Regulation (EC) No 726/2004,Directive2001/82/EC,and/orDirective2001/83/EC.» Alternatives:

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DBP (Dibutyl phthalate)•Plasticizer (softener) in PVC, printing inks, paper andpackagingcoatings,etc…

» InAnnexXIV–SunsetDateFeb21,2015

» ExemptionforusesintheimmediatepackagingofmedicinalproductscoveredunderRegulation (EC)No726/2004,Directive2001/82/EC,and/orDirective2001/83/EC.

» Alternatives:

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Alternatives: DEHP, DBP and BBP are frequently grouped together and therefore the alternatives overlap

•Inresilientflooring(DEHP)–plasticizers(assessmentfrom2005):di(2-eth-ylhexyl) terephthalate (DEHT), di isononyl phthalate (DINP), dipropyleneglycoldibenzoate(DGD),anddi(2-ethylhexyl)adipate(DEHA).

» Allproposedalternativesmustbeassessedforvarioussocio-economicfac-tors;health,environment,technicalcriteria(aretheyaseffective,asfunc-tional?)andcost.

» 1ofthe“alternatives”–DINP-isalreadyregulatedundertheCPSIAintheUSandundertheEUToyDirectivehowevertheECHAconductedareviewofnewdatainJuly2010anddidnotmoveforwardwithanyfurtherrestrictionsonDINP

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Danish Ministry of the Environment did a fairly heavy alternativesassessmentforthethreephthalates:

abbreviation chemical name cas no.

DINCH Di(isononyl)cyclohexane-1,2-dicarboxylate 166412-78-8

Nonylphenol 25154-52-3

TXIB Trimethylpentanyldiisobutyrate 6846-50-0

TBAC Tert-butylacetate 540-88-5

ATBC Acetyltributylcitrate 77-90-7

DEHTP(sameasDEHT) Di(2-ethyl-hexyl)terephthalate 6422-86-2

DINA diisononyladipateester 33703-08-1

DEHA Bis(2-ethylhexyl)adipate 103-23-1

DEHS Dioctylsebacate 122-62-3

  Bis(2-ethylhexyl)ester

DiBA Diisobutyladipate 141-04-8

Othernon-specifiedplasticisers

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REACH – COMMON SVHCSHBCDD (Hexabromocyclododecane)•FlameretardantusedinHIPS(HighImpactPolystyrene),PS(Polystyrene)insulationandtextiles

•InAnnexXIV–SunsetDateAug21,2015•Alternatives:

»TheECHAreleased,inthe2009reportforSVHCListcandi-dacy, that therewereno suitable alternatives forHBCDDinExpandedorExtrudedPolystyrene(EPSandXPSrespectively)howevertherearealternativeformsofinsulationtobeusedinplaceofEPS/XPS.

•Mineralwools•Phenolic Foam (not hazardous in itself however themanufactureishazardoustohumans)

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»Therearecommerciallyavailablealternativefire-retardantsavail-abletotheuseofHBCDDinHIPSandtextilecoatings,includ-ingnon-halogenatedflameretardantsthatprovidethesameleveloffireprotectionandperformance.

•Fire retardants in HIPS: Antimony trioxide (ATO),Triphenyl phosphate (Chronic toxicant with effects on liver),Decabromodiphenylether/ATO(Neurotoxicant),Decabrom-odiphenylethane/ATO(Limited data, but likely to be of low toxicity)

•Alternatives to HIPS: PolyethylenewithMagnesiumHydroxide

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“From Article 36(1)12 of the REACH Regulation it follows that downstream users (article pro-ducers are considered also as downstream users under REACH, if they use a substance or mixture in the production of their articles) have to keep available all the information they require to carry out their REACH obligations. But even if it has been identified that no obligations under REACH apply, these companies should consider documenting the results of their compliance checking. This includes documenting the decision-making on whether certain products are articles, substances or mixtures as well as the checking if specific requirements apply for these. Documenting this is recommended to producers and importers of articles in general, as it facilitates demon-strating REACH compliance towards customers and (inspecting/enforcing) authorities.”

*NotethattheboldedportionaboveisactuallyboldedintheGuidanceitselftoemphasizetheimportanceofDocumentation.

•Theupdated“GuidanceinaNutshell”wasreleasedattheendofJune.

•Compactversion(17pages)ofthecompleteguidancedocument

Therewerenohugechangesfromthepreviousguidancethatwouldimpactacomplianceplan;mostoftheupdatesnowhavetodowithfurtherclaritybutnolargedeparturesinpolicy.

REACH – OTHER NOTES ON SVHCSimportant note: echa Guidance on svhc documentation

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REACHauthorisation overview

•TheAuthorisationprocess–startswiththeidentificationofsubstancesofvery high concern (SVHC) byMember StateCompetentAuthorities ortheEuropeanChemicalsAgency(onbehalfoftheEuropeanCommission)bypreparingadossierinaccordancewithAnnexXV.Decisionsonpriori-tisationoftheseSVHCsandthesubsequentreleaseofthefinallistofsub-stancessubjecttoauthorisationisdecidedbytheCommission.

•Industry has to apply to the ECHA for authorisation for uses of thesesubstances.Afteranapprovalprocess, theholderofanauthorisationcanuseandplaceonthemarketthesubstancefortheuseshewasgrantedanauthorisation.

summary Most, if not all,substancesonthecurrentSVHCListwilleventuallyre-quireanAuthorisationfortheiruseonapersubstance,percompany,perusebasis.

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REACHthe aim of authorisation•Asperarticle55oftheREACHRegulation:“thegoodfunctioningoftheinternalmarketwhileassuringthattherisksfromsubstancesofveryhighconcernareproperlycontrolledandthatthesesubstancesareprogressivelyreplacedbysuitablealternativesubstancesortechnologieswheretheseareeconomicallyandtechnicallyviable”.

•AllAuthorisationapplicantsshallanalysetheavailabilityofalternatives,con-sidertheirrisks,andthetechnicalandeconomicfeasibilityofsubstitution.

•Iftheriskisnotadequatelycontrolled,anauthorisationmaystillbegrantedifitisproventhatthesocio-economicbenefitsoutweightherisksandtherearenosuitablealternativesubstancesortechnologies.

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REACHauthorisation process – substances beinG added to the list

Authorisation Process – Annex 15 Dossiers:1. Registryofintentions–Intentiontosubmitdossier

2. SubmissionofAnnexXVdossier(SVHCDossier)toECHAforComplianceCheck

3. PublicationofAnnexXVdossier(onceithaspassedcompliancecheck)

4. AfterCommentingperiods–CandidateList(Article33Requirementskickin)

5. Prioritisationlist–OrderinwhichsubstanceswillbereviewedforAuthorisation

6. AuthorisationList–RestrictionsandAuthorisationshandedout

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An Authorisation will contain the following information:

•Substanceidentity

•Substanceintrinsicpropertiesofveryhighconcern,

•Sunset date, date by when a substance can no more be usedwithoutauthorisation

•Application date, date beforewhich an application for authorisation foreachusethatisnotexemptedfromtheauthorisationrequirementmustbemade,inordertocontinuetousethesubstanceforthespecificuse.

•Reviewperiodforuses,ifappropriate

•Exemptedusesorcategoriesofuses

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REACH – AuTHORISATIONprocess overview – application for authorisationThe ECHA published new tools for preparation and submission ofAuthorisationApplications:

http://echa.europa.eu/news/na/201104/na_11_16_authorisation_applications_20110405_en.asp

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REACH – AuTHORISATIONcurrent authorisation list

substance included in annex, sunset date

4,4’–Diaminodiphenylmethane(MDA) InAnnexXIV–SunsetDateAug21,2014

Dibutylphthalate(DBP) InAnnexXIV–SunsetDateFeb21,2015

Benzylbutylphthalate(BBP) InAnnexXIV–SunsetDateFeb21,2015

Bis(2-ethyl(hexyl)phthalate)(DEHP) InAnnexXIV–SunsetDateFeb21,2015

5-tert-butyl-2,4,6-trinitro-m-xylene(muskxylene) InAnnexXIV–SunsetDateAug21,2014

Hexabromocyclododecane(HBCDD)andallmajordiastereoisomersidentified: InAnnexXIV–SunsetDateAug21,2015

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RECOMMENdEd fOR AuTHORISATIONrecommended for inclusion dec 17, 2010

substances

Diarsenicpentaoxide Diarsenictrioxide

Alkanes,C10-13,chloro(ShortChainChlorinatedParaffins)

*RecommendationforinclusionJune1,2009

2,4-Dinitrotoluene

Diisobutylphthalate(DIBP) Leadchromate

Leadchromatemolybdatesulphatered(C.I.PigmentRed104) Leadsulfochromateyellow(C.I.PigmentYellow34)

Tris(2-chloroethyl)phosphate

*SCCPsarealreadyincludedintheConventiononLong-RangeTransboundaryAirPollutionandtriggers additionalobligationsunderRegulation (EC)No850/2004– if further information isrequired,pleasecontactAssent.

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dRAfT RECOMMENdATION fOR AuTHORISATIONcomment deadline sept 14th

substances

Cobaltdichloride Sodiumdichromate

Ammoniumdichromate Chromicacid

Oligomersofchromicacidanddichromicacid Dichromicacid

Chromiumtrioxide Cobalt(II)carbonate

Cobalt(II)diacetate Cobalt(II)dinitrate

Cobalt(II)sulphate Potassiumchromate

Potassiumdichromate Sodiumchromate

Trichloroethylene

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wHAT dOES AuTHORISATION MEAN fOR yOu?If a substance within your products is on the Authorisation list:

•Testingand/orcreationoftestingproposals•PossiblecreationofanewCSR•AnalysisofAlternatives•SubstitutionPlan•Socio-EconomicAnalysis

Time,ExpenseandExpertiseisrequiredandtheauthorisationmaynotevenbegranted.Furthermore,theauthorisationhasasettimelimit;areviewre-portmustbesubmittedatleast18monthsbeforeitsexpiry.

Is there another option?

•Redesignensuresthatnoauthorizationshavetobesubmitted.

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REACH INTERPRETATIONfrance forGes a new path•ECHA guidance hasmaintained that complex articles will be enforced upon “as

imported”or“asmanufactured”andthereforeeachcomponentofthearticleisnotassessedagainstthe0.1%w/wthresholdindividually.FrancehasdisagreedwiththisinterpretationsincethefirstguidanceonsubstancesinarticleswaspublishedbytheECHA.

•Francewillbeenforcingthe0.1%thresholdforcontentofSVHCs(SubstancesofVeryHighConcern)basedonthe“onceanarticle,alwaysanarticleapproach”.

•Each component is an article before being incorporated into another articlethusthe“onceanarticle,alwaysanarticle”approach.

•Austria,Belgium,Denmark,Germany,Sweden (andNorway,not amember statebutfollowsREACH)haveyettoofficiallypublishanenforcementpolicycontrarytotheECHAbuthavealsomadeitclearthattheydonotprescribetotheECHA’sarticleinterpretation.

•TherearemanylongandformalstepsthatneedtobetakenbytheECHAbeforeaninfringementcaseisevenbroughtagainstFrancebeforetheEUcourtthereforeitcannotbeassumedthatthiswillberesolvedsothatallMemberstatesareworkingwiththesame“ECHAinterpretation”.

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IMPACT Of fRANCE’S ENfORCEMENT POLICyCompaniesimportingtotheEUcannotweightheirSVHCcontentagainstthewholecomplexarticle.

•EachcomponentmusthaveSVHCdata–content%andweightof thecomponent

•Declarationsmustbeupdated•2versions–oneforFrance,onefortherestoftheEU•1versionthatcontainsallthenecessaryinformation

•AstronomicalincreaseintestingcostsOR•Supplierdatagatheringandengineeringassessmentsevenmorevital

•Dataexponentiallyincreases•Storageandorganizationparamount

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REACH IS wORkINg•REACHRegulationrequiresareportatleastevery5yearsontheoverallstatusoftheRegulation

•Thisreportwillprovideinformationonwhereallstakeholders(butmostlytheECHA)canimprove

•FirstreportreleasedJuly1,2011andreportsonREACHandCLP.

•Examinesthelessonsandchallengesencounteredsofar(3yearsintoREACH,2yearsintoCLP).

•DealswitheverythingfromnanomaterialstojointregistrationtoITtoolsupport

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summary:•CommunicationandfeedbacktoallREACHstakeholders–registrants,third-party contributors, helpdesk representatives – should improvewhich shouldspeedupresponsesandguidance.

•REACH processes and Comitology should improve which will speed upSVHCadditions,authorisationadditionsalongwiththeaforementionguid-anceupdates

•Enforcementguidanceandprocesseswillhopefullybefurtherspecified(jointregistrationinparticular)

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REACH IS wORkINg – REPORT dETAILS•Further clarification is required aroundnanomaterials andhowREACHandCLPwillapply

•European Commission (EC) and Member State Competent Authorities(MSCAs)shouldfocussomeenergyonenforcementsurroundingthejointregistrationrequirement

•Itwasevensuggestedthatconsiderationshouldbegiventochangingthelegaltexttoaidinenforcement

•Intermediatesregistrationdossiersneedtobebroughtintofullcompliance–two-sidedissue:regulatoryactionANDindustrypro-activelyreassessandupdatingifnecessary.

•Dormant pre-registrations should be deleted, Companies not intendingto register their pre-registered substances should deactivate themselves.Optimizetheuseofpre-SIEFs

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•ManypointsontheECHAsneedtoimprovesupportandfeedback(bothtimingandcontent)for:thirdpartycontributionsforexaminationoftest-ingproposals,useof IT tools, legal interpretationsofoutstanding issuesfromthe“Helpdesk”submissions.

•REACHprocess reviewsaswell as the efficiencyof theCommittees andForumsassociatedwithREACH.

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REACHenforcement – echa enforcement plans for the future•Swedish Chemicals Agency announced the ECHA’s intention tosubmit an enforcement plan to the Ministry of the Environmentat the end of 2011.Enforcement project will begin in 2012http://www.kemi.se/templates/News____6284.aspx

•PreviousenforcementprocesswilllikelybeappliedtoSVHCs

•European-widecoordination

•Locallevelimplementation

•REACH-IT used by local inspectors to coordinate and verifyinformation

•Informationmustbeaccurate,transparentandreadilyavailable

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i n f o @ a s s e n t s v h c . c o m w w w. a s s e n t s v h c . c o m t e l : 8 6 6 . 9 6 4 . 6 9 3 1

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ImplementyourcomplianceschemeinaccordancewithavailableGuidanceinordertoprotectyourselfinthefuture.

AnECHAREACHandCLPEnforcementandAppealsWorkshopisplannedforOctober15th,2011.Brainstorming sessionsonenforcement,discussionontherealissuessurroundingenforcementaswellaslearningabouttheap-pealsprocesswiththeECHAareallontheagendaforthisevent.Asaresult,weshouldseequiteabitofinformationandclarityonprocessesbeingreleased.

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 ]

i n f o @ a s s e n t s v h c . c o m w w w. a s s e n t s v h c . c o m t e l : 8 6 6 . 9 6 4 . 6 9 3 1

ASSENTCOMPLIANCE

REACHenforcement – danish consumer council•Danish NGO representing the interest of Danish Consumers

http://www.forbrugerraadet.dk/english/

•SentREACHrequeststoretailersacrossDenmark

•40%repliedincompliancewithREACH•60%eitherrespondedlateornotatall•AlllaterespondentswerereportedtotheDanishEPA

Keys to a quick response:

•RestrictedSubstanceControlpolicy•Availabilityofinternaldocumentation

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 ]

i n f o @ a s s e n t s v h c . c o m w w w. a s s e n t s v h c . c o m t e l : 8 6 6 . 9 6 4 . 6 9 3 1

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REACHenforcement – mobilization of etuc and emcef

•ETUC(EuropeanTradeUnionConfederation)andtheEMCEF(EuropeanChemicalWorkers’Federation)

•Alertingtheirmemberorganizationstoalertemployerstotheirresponsi-bilitiesunderREACH.

•Ensuresworkersafety

•Ensurescontinuedbusiness

•Leafletbeingprepared

•FullendorsementoftheECHA

REACHviolationsareapotentialworkerhealthandsafetyissue.

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 ]

i n f o @ a s s e n t s v h c . c o m w w w. a s s e n t s v h c . c o m t e l : 8 6 6 . 9 6 4 . 6 9 3 1

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REACH MEMBER STATE ENfORCEMENT PENALTIES

member state penalty

Belgium Finesupto$5,385,000–Imprisonmentupto3years

France Finesupto$100,000–Imprisonmentupto2years

Germany Finesupto$135,000–Imprisonmentupto5years

Ireland Fineupto$4,000,000–Imprisonmentupto2years

Netherlands Finesupto$900,000–Imprisonmentupto6years

UnitedKingdom NolimitonFines–Imprisonmentupto2years

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 ]

i n f o @ a s s e n t s v h c . c o m w w w. a s s e n t s v h c . c o m t e l : 8 6 6 . 9 6 4 . 6 9 3 1

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REACH ENfORCEMENT – IMPACTStoppage at Customs is the most likely action for SVHC issues:

•Risktobusinesscontinuity

•Lossofcustomers•Lossofexpectedproductlaunchtimelines

•Riskoffinancialpenalty

NGO involvement will increase•More media, more attention = more enforcement, more risk tonon-compliantbusinesses

Standardized enforcement across the EU•“Quotas”willbeestablishedsoallmemberstateswillbeenforcinginordertoensuresafetyisapriorityacrosstheEU

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 ]

i n f o @ a s s e n t s v h c . c o m w w w. a s s e n t s v h c . c o m t e l : 8 6 6 . 9 6 4 . 6 9 3 1

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PRACTICAL APPLICATIONideal Qualities of a declaration of conformity•A declaration should ideally be part of a process that keeps all yourinformationcurrentandyourdeclarationsconsistent.

•Uponrequest,youshouldbeabletoshowthefollowingitems:

•Whosentthedeclaration(person,notjustcompany)»Whatwastheexactresponse»Whenwasitsent»How(email,ftp,snailmail)

•WhatwasaskedofthesupplierontheDeclaration»When»How

•Howthesedeclarationsarestored

•Howtheyareverified

•How/Whentheyareupdated

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 ]

i n f o @ a s s e n t s v h c . c o m w w w. a s s e n t s v h c . c o m t e l : 8 6 6 . 9 6 4 . 6 9 3 1

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TyPICAL SERVICE OffERINgSrohs reach component enGineers

•ManagethecompliancetoROHS,REACHSVHC,andJIGLevelA/Bstandards

•Ensure compliancewith regulatory agencies and compliance regulations,includingRoHS,REACH,andWEEE.

•ReviewandevaluateRoHS/WEEErequirementsandrequirementchangesaspublishedbyregulatingbodies

•Supportingsourcingandselectionofelectronicandmechanicalcomponents

•Serveassubjectmatterexpertonregulatorymatters

•Mentoring/supportofengineeringteamoncomplianceissues

•Specificationanddrawingreviewforcompliance

•Obsolescencemanagementandpartsubstitution

•WEEEregistrationandreporting

•Workwithsuppliersoncorrectiveactions

•More experience and less cost than hiring a full time component engineering

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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ROHS ANd REACHcomponent and product enGineerinG services

•Ondemandproductandcomponentengineeringservices

•SpecializinginawiderangeofcompliancerequirementsincludingRoHS,WEEE,REACH,UL,CSA,ETL,FCC,NOM,andProposition65.

•All component engineers have a minimum of 5 years of RoHS/REACHexperience

•Oncall,parttime,andfulltimecontactsupportavailable.

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 ]

i n f o @ a s s e n t s v h c . c o m w w w. a s s e n t s v h c . c o m t e l : 8 6 6 . 9 6 4 . 6 9 3 1

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QuESTIONS?PleasesubmityourquestionsinwritingusingtheQ&Atoolalongthetopmenutoolbar.

Any questions not addressed during the Q&A portion of this webinar will be addressed in private correspondence after the webinar.