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i n f o @ a s s e n T c o m p l i a n c e . c o m w w w. a s s e n T c o m p l i a n c e . c o m T e l : 6 1 3 . 2 9 0 . 8 0 4 4
ASSENTCOMPLIANCE
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 – 20 New SVHCS – How are you affeCted?
assenT compliance
Krystal Noseworthy-BaKer pHone: 613.882.1429
i n f o @ a s s e n T c o m p l i a n c e . c o m w w w. a s s e n T c o m p l i a n c e . c o m T e l : 6 1 3 . 2 9 0 . 8 0 4 4
ASSENTCOMPLIANCE
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
i n f o @ a s s e n T c o m p l i a n c e . c o m w w w. a s s e n T c o m p l i a n c e . c o m T e l : 6 1 3 . 2 9 0 . 8 0 4 4
ASSENTCOMPLIANCE
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•AdditionstotheSVHCCandidateList
•IndustriesaffectedbythenewSVHCs
•RequirementsforthenewSVHCs
•REACHuptonow
•AssentServices
•Q&A
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 ]
i n f o @ a s s e n T c o m p l i a n c e . c o m w w w. a s s e n T c o m p l i a n c e . c o m T e l : 6 1 3 . 2 9 0 . 8 0 4 4
ASSENTCOMPLIANCE
REACHnewesT aDDiTions To THe sVHc canDiDaTe lisT
20added,73intotalAddedDec19th,2011
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.
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 ]
i n f o @ a s s e n T c o m p l i a n c e . c o m w w w. a s s e n T c o m p l i a n c e . c o m T e l : 6 1 3 . 2 9 0 . 8 0 4 4
ASSENTCOMPLIANCE
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.
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 ]
i n f o @ a s s e n T c o m p l i a n c e . c o m w w w. a s s e n T c o m p l i a n c e . c o m T e l : 6 1 3 . 2 9 0 . 8 0 4 4
ASSENTCOMPLIANCE
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).
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.
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 ]
i n f o @ a s s e n T c o m p l i a n c e . c o m w w w. a s s e n T c o m p l i a n c e . c o m T e l : 6 1 3 . 2 9 0 . 8 0 4 4
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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.
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.
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 ]
i n f o @ a s s e n T c o m p l i a n c e . c o m w w w. a s s e n T c o m p l i a n c e . c o m T e l : 6 1 3 . 2 9 0 . 8 0 4 4
ASSENTCOMPLIANCE
Arsenicacid 231-901-9 7778-39-4
Mainlyusedtoremovegasbubblesfromceramicglassmeltandforimprovingad-hesionbetweencopperfoilandresinintheproductionoflaminatedprintedcir-cuitboards
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.
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 ]
i n f o @ a s s e n T c o m p l i a n c e . c o m w w w. a s s e n T c o m p l i a n c e . c o m T e l : 6 1 3 . 2 9 0 . 8 0 4 4
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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.
Important Note: Amongst these substances, the first “equivalent level of concern”substance has been approved; 4-tert-octyl phenol (4-(1,1,3,3-tetramethylbutyl)phenol)wasidentifiedasanSVHCbecauseofitsendocrinedisruptingpropertiescausingprobableseriouseffectstotheenvironment.
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 ]
i n f o @ a s s e n T c o m p l i a n c e . c o m w w w. a s s e n T c o m p l i a n c e . c o m T e l : 6 1 3 . 2 9 0 . 8 0 4 4
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INduSTRIES AffECTEdmosT common uses for THe new sVHcsThemorecommonly-usedsubstancesinclude:
•DMAC;acommonsolventusedinman-madefibreandpolyurethaneproduction;•ClothingIndustry•Polyurethanesareusedinthemanufactureofflexible,high-resiliencefoam seating; rigid foam insulation panels;microcellular foam sealsandgaskets;durableelastomericwheelsandtires;automotivesuspen-sion bushings; electrical potting compounds; high performance ad-hesives; surface coatings and surface sealants; synthetic fibers (e.g.Spandex); carpetunderlay; andhard-plastic parts (i.e. for electronicinstruments).Polyurethaneisalsousedforthemanufactureofhoseasitcombinesthebestpropertiesofbothrubberandplastic.1
•Also a reagent used in industrial coatings, polyimide films, paintstrippersandinkremovers
1 Wikipedia – http://en.wikipedia.org/wiki/Polyurethane#Applications
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 ]
i n f o @ a s s e n T c o m p l i a n c e . c o m w w w. a s s e n T c o m p l i a n c e . c o m T e l : 6 1 3 . 2 9 0 . 8 0 4 4
ASSENTCOMPLIANCE
•MOCA,which is alsoused tomakepolyurethaneproducts (MOCAhasbeenfoundingears,gaskets,shoesoles,rollsandbeltdrivesincameras)aswellasacoatingtohelpsetglues,plasticsandadhesives;
•ManufacturingIndustry•VariousConsumerGoods
•4,4-methylenedianiline(MDA)andit’sassociatedpolymericMDA(PMDA)whichincludesTechnicalorOligomeric.MDAisusedinpolyurethanes,forthemanufactureofspandexfibers,thermoplasticresins,andcoatingsaswellasrigidandsemiflexiblefoaminsulationandparticleboardmanufacture.
•ClothingIndustry•VariousConsumerGoods
INduSTRIES AffECTEd (CONTINuEd)
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 ]
i n f o @ a s s e n T c o m p l i a n c e . c o m w w w. a s s e n T c o m p l i a n c e . c o m T e l : 6 1 3 . 2 9 0 . 8 0 4 4
ASSENTCOMPLIANCE
INduSTRIES AffECTEd (CONTINuEd)mosT common uses for THe new sVHcsAnotherphthalatehasbeenaddedtotheCandidateList–Bis(2-methoxyethyl)phthalate–howeverthisonedoesnotappeartobenearlyasprevalentastherestofthephthalateSVHCs.Itisaplasticizer,likeallphthalates,andisusedinpaints,lacquers,varnishesandprintinginks.
Calcium arsenate was originally used as a pesticide and germicide andnow,withinthedossiersubmittedtotheECHA,is listedasbeingusedinmetallurgicalprocesses.
Trilead diarsenate is very similar in that it originated as a pesticide andherbicidebutisalsonowusedinmetallurgy.
•MetallurgicalIndustry
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 ]
i n f o @ a s s e n T c o m p l i a n c e . c o m w w w. a s s e n T c o m p l i a n c e . c o m T e l : 6 1 3 . 2 9 0 . 8 0 4 4
ASSENTCOMPLIANCE
A group of lead explosive substances (Lead diazide, Lead styphnate, Leaddipicrate)are also included and are likely to impact only a very particularsectionofindustry.
Arsenic Acid is another example of a specifically used substancehoweverthereisonehugedifference;thatspecificuseisintheproductionoflaminated printed circuit boards (PCBs) which are practically a universalproductvitaltoawidevarietyofindustries.
•ElectronicsIndustryistheprimaryaffectee
INduSTRIES AffECTEd (CONTINuEd)
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 ]
i n f o @ a s s e n T c o m p l i a n c e . c o m w w w. a s s e n T c o m p l i a n c e . c o m T e l : 6 1 3 . 2 9 0 . 8 0 4 4
ASSENTCOMPLIANCE
INduSTRIES AffECTEd (CONTINuEd)mosT common uses for THe new sVHcsTheaeronauticandaerospaceindustryisheavilyimpactedbythislistas3sub-stancesarealmostexclusivelyusedinthatsector;Dichromiumtris(chromate),Potassium hydroxyoctaoxodizincatedi-chromate and Pentazinc chromateoctahydroxide.
•Vehicle industry also affected (these 3 substances are used as vehiclecoatingsaswell)
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 ]
i n f o @ a s s e n T c o m p l i a n c e . c o m w w w. a s s e n T c o m p l i a n c e . c o m T e l : 6 1 3 . 2 9 0 . 8 0 4 4
ASSENTCOMPLIANCE
INduSTRIES AffECTEd (CONTINuEd)mosT common uses for THe new sVHcsTherefractoryceramicfibresareusedexclusivelyashigh-temperatureinsu-lation for industrial applications.These fibreswere already on the SVHCCandidateListbutidentificationissueshavearisensincetheirfirstinclusionandthereforetheyarebeingclarifiedand“re-added”.
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 ]
i n f o @ a s s e n T c o m p l i a n c e . c o m w w w. a s s e n T c o m p l i a n c e . c o m T e l : 6 1 3 . 2 9 0 . 8 0 4 4
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SVHCS – MORE TO COME•CurrentCandidateListsitsat73substances
•Updateshavebeenhappeningabouttwiceayear,howeverthisisnotafirmrequirement,infact,substancescanbeaddedMOREOFTEN.
•TheheadoftheECHAhasstatedthe136SVHCswouldbelistedbytheendof2012
•Thismeans63moresubstanceswillneedtobeaddedin2012tomeetthequotasetbytheECHA
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 ]
i n f o @ a s s e n T c o m p l i a n c e . c o m w w w. a s s e n T c o m p l i a n c e . c o m T e l : 6 1 3 . 2 9 0 . 8 0 4 4
ASSENTCOMPLIANCE
REquIREMENTSwHaT Do new sVHcs mean for your company?CompaniesnowneedtoassesswhethertheyhavelegalobligationsresultingfromtheinclusionofsubstancesintheCandidateList.
ThelegalobligationsrelatedtoSVHCsincludeCommunicationandNotification.
communicaTion
Anyproducersorimportersofarticlesplacedonthemarket2intheEUmustnowdeclarethepresenceofanyofthesesubstances(inadditiontotheexist-ing53substances)inanarticleinaconcentrationexceeding0.1%w/w.
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 concentration 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.
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 ]
i n f o @ a s s e n T c o m p l i a n c e . c o m w w w. a s s e n T c o m p l i a n c e . c o m T e l : 6 1 3 . 2 9 0 . 8 0 4 4
ASSENTCOMPLIANCE
2. On request by a consumer any supplier of an article containing a substance 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.
The relevant information shall be provided, free of charge, within 45 days of receipt of the request.
What does this mean?•OnceasubstancehasbeenaddedtotheSVHCList,youmustde-clareitspresencetoyourdownstreamusersiftheconcentrationisabove0.1%ofyourproductsweight.
•Thisistobedoneuponimmediatelyforprofessionalcustomersandwithin45daysfromrequestforconsumers.
2 Article 3.12 of the REACH Regulation specifies:Placingonthemarket:meanssupplyingormakingavailable,whetherinreturnforpaymentorfreeofcharge,toathirdparty.Importshallbedeemedtobeplacingonthemarket;
• Thisistobedoneuponimmediatelyforprofessionalcustomersandwithin45daysfromrequestforconsumers.
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 ]
i n f o @ a s s e n T c o m p l i a n c e . c o m w w w. a s s e n T c o m p l i a n c e . c o m T e l : 6 1 3 . 2 9 0 . 8 0 4 4
ASSENTCOMPLIANCE
REquIREMENTS (CONTINuEd)wHaT Do new sVHcs mean for your company?Practical Application – Ideal 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 e [ 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 c o m p l i a n c e . c o m w w w. a s s e n T c o m p l i a n c e . c o m T e l : 6 1 3 . 2 9 0 . 8 0 4 4
ASSENTCOMPLIANCE
REquIREMENTS (CONTINuEd)wHaT Do new sVHcs mean for your company?
noTificaTion
Furthermore,thesesameproducersandimportershavesixmonthsfromthedatethenewSVHCswereincluded(19June2012)tonotifytheECHAif
A. The (SVHC) is present in those articles in quantities totalling over 1 tonne per producer or importer per year
and
B. The (SVHC) is present in those articles above a concentration of 0,1 % weight by weight (w/w)
•AnotificationiscreatedusingthesamesoftwareasaREACHregistration–IUCLID.•Itisamuchlessintensedossierthanaregistrationdossier.
•facilitatethetaskofnotification,ECHAhasmadeavailablepre-filledsubstancedatasetsinIUCLID5.3format.
•EachCandidateList substance has its ownpre-filled dataset,whichcanbedownloadedfromtheCandidateListwebpage.
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 ]
i n f o @ a s s e n T c o m p l i a n c e . c o m w w w. a s s e n T c o m p l i a n c e . c o m T e l : 6 1 3 . 2 9 0 . 8 0 4 4
ASSENTCOMPLIANCE
•These datasets contain:»Theidentity(substancename,ECand/orCASnumber)»Theclassificationandlabellingofthesubstance.
•The following information must be entered by the notifier:» Identityandcontactdetails,»Registrationnumber(ifavailable),»Thetonnagerangeofthesubstance,» Abriefdescriptionof theuses of the substance in the articleitselfandtheusesofthearticle.
•REACH-ITisthesubmissiontoolthatmustbeused.
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 ]
i n f o @ a s s e n T c o m p l i a n c e . c o m w w w. a s s e n T c o m p l i a n c e . c o m T e l : 6 1 3 . 2 9 0 . 8 0 4 4
ASSENTCOMPLIANCE
REquIREMENTS (CONTINuEd)wHaT Do new sVHcs mean for your company?
auTHorisaTion
AnychemicalsplacedontheCandidateListcanalsoeventuallybeapprovedforanauthorizationlistwheretheywillthenbebannedfromuseunlessanauthorizationissubmittedandapprovedbeforetheapplicablesunsetdate
•Most, ifnotall, substancesonthecurrentSVHCListwilleventuallymoveontotheAuthorisationlistandthereforerequireanAuthorisationfortheiruse.
•Authorisations are required on a per substance, per use, per supplychain(youoranactorupyoursupplychainmusthavebeengrantedanauthorisation)basis.
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 ]
i n f o @ a s s e n T c o m p l i a n c e . c o m w w w. a s s e n T c o m p l i a n c e . c o m T e l : 6 1 3 . 2 9 0 . 8 0 4 4
ASSENTCOMPLIANCE
REquIREMENTS (CONTINuEd)wHaT Do new sVHcs mean for your company?
Authorisation Process – Annex 15 Dossiers:1. Registry of intentions –Intentiontosubmitdossier
2. Submission of Annex XV dossier(SVHCDossier)toECHAforComplianceCheck
3. Publication of Annex XV dossier(onceithaspassedcompliancecheck)
4. After Commenting periods –CandidateList(Article33Requirementskickin)•20NewSVHCsjustcompletedSTEP4
5. Prioritisation list –OrderinwhichsubstanceswillbereviewedforAuthorisation
6. Authorisation List – RestrictionsandAuthorisationshandedout
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 ]
i n f o @ a s s e n T c o m p l i a n c e . c o m w w w. a s s e n T c o m p l i a n c e . c o m T e l : 6 1 3 . 2 9 0 . 8 0 4 4
ASSENTCOMPLIANCE
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
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 ]
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ASSENTCOMPLIANCE
REquIREMENTS (CONTINuEd)wHaT Do new sVHcs mean for your company?
Guidance on SVHC Documentation
From Article 36(1)12 of the REACH Regulation it follows that downstream us-ers (article producers 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 demonstrating REACH compliance towards customers and (inspecting/enforcing) authorities.
*Note:TheboldedportionaboveisactuallyboldedintheGuidanceitselftoemphasizetheimportanceofDocumentation.
“
”
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 ]
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ASSENTCOMPLIANCE
REACH uP TO NOwinDusTry inpuT on THe impacT of reacH•Majorindustryplayers,specificallythosethatwereaffectedbyregistration,begandealingwithREACHfromthemomentitwasofficiallypublished(2007)andsomeevenfromitsinception(over8yearsago)
•Even larger companieswho dealt onlywith “articles” started tryingtounderstandtheirresponsibilitiesforSVHCsayearbeforethefirstSVHClistwaspublished.
•Ofcourse,wehavealsoheardthosecompanieswhoonlybegantack-lingREACHoncetheircustomersstartedasking
•REACH compliance is handled many different ways:•Manualdatagathering•Software,whetherexternalorinternal
»MajorenhancementforSupplierDataGathering•Externalconsultingorinternaltrainingandemployeedevelopment•E-learningprogrammesforvendors
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•Majorsupplierengagement»WorkingtounderstandREACHandstayaheadofthecurve»Restrictorremovesubstancesaspermitted
•Difficulties encountered so far in the process:•LackofawarenessinSupplyChain•LackofknowledgeinSupplyChain
» In fact, it has been experienced that European Suppliers aremorepoorlyinformedthanNAsuppliers
•Refusaltorespond•Commercialchallengesasalternativesubstancescostmore
» Increaseinproductdevelopmentdifficulties
•Sustainingtheremovalofasubstance» Especiallyifavendorbuysfrommultiplesuppliers
•Theever-changingSVHClist•Lack of adoption across industries of a standardized format forcollectinginformation
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REACH uP TO NOw (CONTINuEd)inDusTry inpuT on THe impacT of reacH
Kingfisherplc,Europe’s leadinghomeimprovementretailerwithover900storesin8countriesinEuropeandAsia.
PaulEllis–QualityRegulationManagerprovidedsomeoftheinsightgainedduringhis8yearsofexperiencewithREACH.TheKingfisherREACHpro-gramisrobustandindustry-leading,thereforeprovidinganinvaluablepointofview.
•WeviewREACHasimportantbecauseofthegrowingconsumerconcernson chemical content inproduct, andbecauseof our long standingCSRcredentialsonchemicals.
•TheissuesforthevendorsareknowingwhichSVHCtolookfor,andthen,wheretofindthemintheproduct.Thisisthemostcommonchallengefac-ingvendorsandretailers!
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•Thedifficultieshehasencounteredwerepointedinthepreviousslidehow-everitisreassuringtoknowthatevenalargecompanyencountersthesamedifficultiesassmallerbusinessesstrugglingtodealwithREACH:
•VendorsarenotawareofREACH•Internalcommercialchallenges,becausealternativesubstancestendtocostmore
•Sustainingtheremovalofthesubstance,especiallyifthevendorbuysincomponentsfromvarioussuppliers
•LackofknowledgeaboutREACHinthesupplychain
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•KingfisherhastheirowninternaldatagatheringsystemwhichtheybuilttodealwithREACHaswellastheirothercomplianceneeds.
•Wedon’tlimitourmethodstojustthesystemdatacapture,wehaveengagedwithanumberofvendorstoencouragethemtoadoptafasterpacetoREAChthantheywouldnormallyhavedone,thismeantweworkedwithkeyvendorsto“remove”substancesfromtheirproducts,whichenabledustolearnhowtodoremovethesubstanceandhowtosustainthesubstancesabsencefromtheproduct.
•Wealsoprovidean“elearning”programmeonourcompliancemeth-ods and seminars to educate the vendors,which even now, some 2yearsafterREACHcameintoforce,wearefindingthevendorsarenotpreparedorhavetheirowncompliancemethodsinplace.
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REACH uP TO NOw (CONTINuEd)inDusTry inpuT on THe impacT of reacH
Kimberly-ClarkhasbeendealingwithREACHsince2005.BarryPodd,theAssociateDirectorforGlobalRegulatoryAffairs,providesinterestinginsight:
•The size of KC has helped as suppliers tend to respond to informationrequests as long as they are based in Europe and are aware of therequirements laid down in the REACh Regulation. The quality of theinformationvarieswiththesizeofthecompanyand,broadlyspeaking,thebest informationhasbeen received fromthosecompanieswith resourcesdedicated to implementing the REAChRegulation as opposed to thosewheretheresponsibilityissplit.
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•ThesituationisoftenmorechallengingwhenthesupplierisbasedoutsideEurope,andthishappensalotwithglobalcompanies,becausethelevelofknowledgetheyhaveofREAChisnotalwaysataconsistentlyhighlevel.Somecompaniesrequiretrainingbeforetheycananswerourrequestsforinformationontherawmaterialstheysupplyand,inthemain,althoughtheywanttocooperatetheyarenotalwaysinapostiontodosowhentheinitialrequestisreceived.
•Weareinthefortunateposition,becauseofourproductrange,ofnotus-ingSvHCsinourproducts.That isgoodbutwestillneedtocollect theinformationrequiredtohelpusrespondtoenquiriesfromourcustomersinthewaysprescribedintheREAChRegulation.ThisinvolvesmonitoringdevelopmentstotheCandidateListofSVHCsandcheckingeachtimethatitisupdatedtoensurethatthesubstanceslistedarenotusedinanyofourproductsorrawmaterials.Foracompanylikeoursthisisnotdifficulttodobut,giventheCandidateListisupdatedtwiceperyear,itisaresourceintensiveexercise.
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HOw CAN ASSENT HELP?consulTing serVices
•Manage the compliance to ROHS, REACH, CLP and otherEnvironmentalstandards
•Ensurecompliancewithregulatoryagenciesandcomplianceregulations•Reviewandevaluateenvironmentalrequirementsandchangesaspublishedbyregulatingbodies
•Supportsourcingandselectionofelectronicandmechanicalcomponents•Serveassubjectmatterexpertonregulatorymatters•Specificationanddrawingreviewforcompliance•Obsolescencemanagementandpartsubstitution•Workwithsuppliersoncorrectiveactions
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HOw CAN ASSENT HELP?sofTware serVices•Automatically gather environmental compliance data from yoursupplychain(Declarations,COC’s,DOC’s,etc.)
•Platformforsupplierstoenterenvironmentalcomplianceinformation•Generatecustomreportsbasedongatheredcompliancedata:
•Allowsforatoplevelviewofcomplianceprogressoradrilldowntoproductorpartlevelcompliance
•Instantlyisolateproblemareasbasedonproducts,partsormaterials.
•GeneratecompliancedocumentsforEnforcementagenciesanddownstreamusers.•Acts as aplatform for internal teams tomanageenvironmentaldataandmakeinternaldeclarationsbasedonobtainedinformation:
•EngineeringOverride
•Automaticcommunicationtooltoinformsuppliersofchangestoenviron-mentalregulations
•Free model for large cap companies looking to implement a software platform with their supply chain
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quESTIONS?PleasesubmityourquestionsinwritingusingtheQ&Atoolalongthetopmenutoolbar.
Any questions not addressed during the Q&A portion of thiswebinarwillbeaddressedinprivatecorrespondenceafterthewebinar.