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REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and...

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[email protected] WWW.ASSENTCOMPLIANCE.COM TEL: 613.290.8044 ASSENT COMPLIANCE CUSTOM SOLUTIONS FOR COMPLIANCE [ REACH | RoHS | CPSIA | RSL | PROP 65 ] REACH – 20 NEW SVHCS – HOW ARE YOU AFFECTED? ASSENT COMPLIANCE KRYSTAL NOSEWORTHY-BAKER PHONE: 613.882.1429 [email protected]
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Page 1: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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

[email protected]

Page 2: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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

Page 3: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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

Page 4: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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.

Page 5: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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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2,2’-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.

Page 6: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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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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.

Page 7: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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

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.

Page 8: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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.

Page 9: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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-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.

Page 10: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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 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

Page 11: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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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•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)

Page 12: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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

Page 13: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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)

Page 14: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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)

Page 15: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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”.

Page 16: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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

Page 17: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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.

Page 18: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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.

Page 19: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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?

Page 20: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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.

Page 21: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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.

Page 22: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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.

Page 23: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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

Page 24: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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

Page 25: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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?

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.

Page 26: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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

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

Page 27: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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

•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

REACH uP TO NOw (CONTINuEd)

Page 28: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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

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!

Page 29: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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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•Thedifficultieshehasencounteredwerepointedinthepreviousslidehow-everitisreassuringtoknowthatevenalargecompanyencountersthesamedifficultiesassmallerbusinessesstrugglingtodealwithREACH:

•VendorsarenotawareofREACH•Internalcommercialchallenges,becausealternativesubstancestendtocostmore

•Sustainingtheremovalofthesubstance,especiallyifthevendorbuysincomponentsfromvarioussuppliers

•LackofknowledgeaboutREACHinthesupplychain

REACH uP TO NOw (CONTINuEd)

Page 30: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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

•KingfisherhastheirowninternaldatagatheringsystemwhichtheybuilttodealwithREACHaswellastheirothercomplianceneeds.

•Wedon’tlimitourmethodstojustthesystemdatacapture,wehaveengagedwithanumberofvendorstoencouragethemtoadoptafasterpacetoREAChthantheywouldnormallyhavedone,thismeantweworkedwithkeyvendorsto“remove”substancesfromtheirproducts,whichenabledustolearnhowtodoremovethesubstanceandhowtosustainthesubstancesabsencefromtheproduct.

•Wealsoprovidean“elearning”programmeonourcompliancemeth-ods and seminars to educate the vendors,which even now, some 2yearsafterREACHcameintoforce,wearefindingthevendorsarenotpreparedorhavetheirowncompliancemethodsinplace.

REACH uP TO NOw (CONTINuEd)

Page 31: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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

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.

Page 32: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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

•ThesituationisoftenmorechallengingwhenthesupplierisbasedoutsideEurope,andthishappensalotwithglobalcompanies,becausethelevelofknowledgetheyhaveofREAChisnotalwaysataconsistentlyhighlevel.Somecompaniesrequiretrainingbeforetheycananswerourrequestsforinformationontherawmaterialstheysupplyand,inthemain,althoughtheywanttocooperatetheyarenotalwaysinapostiontodosowhentheinitialrequestisreceived.

•Weareinthefortunateposition,becauseofourproductrange,ofnotus-ingSvHCsinourproducts.That isgoodbutwestillneedtocollect theinformationrequiredtohelpusrespondtoenquiriesfromourcustomersinthewaysprescribedintheREAChRegulation.ThisinvolvesmonitoringdevelopmentstotheCandidateListofSVHCsandcheckingeachtimethatitisupdatedtoensurethatthesubstanceslistedarenotusedinanyofourproductsorrawmaterials.Foracompanylikeoursthisisnotdifficulttodobut,giventheCandidateListisupdatedtwiceperyear,itisaresourceintensiveexercise.

REACH uP TO NOw (CONTINuEd)

Page 33: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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

HOw CAN ASSENT HELP?consulTing serVices

•Manage the compliance to ROHS, REACH, CLP and otherEnvironmentalstandards

•Ensurecompliancewithregulatoryagenciesandcomplianceregulations•Reviewandevaluateenvironmentalrequirementsandchangesaspublishedbyregulatingbodies

•Supportsourcingandselectionofelectronicandmechanicalcomponents•Serveassubjectmatterexpertonregulatorymatters•Specificationanddrawingreviewforcompliance•Obsolescencemanagementandpartsubstitution•Workwithsuppliersoncorrectiveactions

Page 34: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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

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

Page 35: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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

Page 36: REACH – 20 New SVHCS – How are you affeCted?€¦ · tive and aircraft/aerospace industry) and in fireprotection (buildings and indus-trial process equipment). 1,2-Dichloroethane;

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

quESTIONS?PleasesubmityourquestionsinwritingusingtheQ&Atoolalongthetopmenutoolbar.

Any questions not addressed during the Q&A portion of thiswebinarwillbeaddressedinprivatecorrespondenceafterthewebinar.


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