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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 ]
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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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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.
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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•Whatdoesthismean?•Once a substance has been added to the SVHC List, you mustdeclareitspresencetoyourdownstreamusersiftheconcentrationisabove0.1%ofyourproductsweight.
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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
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.
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.
Mordant in dyeing pigments, source of pure nitro-geninlaboratory,manufacturingofchromealumandalizarin.Otheruses:oilpurification, leather tanningandpyrotechnics.
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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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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-
• 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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• Use as a monomer in polymerisations (mostly for polyurethane coatings and adhesives);useasacorrosioninhibitorinwatertreatment,mainlyfortheremovalofdissolvedoxygenandtheadjustmentofpHinthefeedwaterofboilersaswellasfortheremovalofsolidsfromsteamgenera-tors.Thecriticalareasofapplicationarenuclearandthermalpowergenerationplants(includingwatersteamcirculationfordistrictheatingandcooling).However,oxygenscavengingbasedonhydrazineisrelevantforotherindustrysectorsthatutilisesteamsuchaspapermills,steelmanu-facture,productionofchemicals.
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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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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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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).
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.
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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.
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.
» 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…
•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.”
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”.
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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:
*SCCPsarealreadyincludedintheConventiononLong-RangeTransboundaryAirPollutionandtriggers additionalobligationsunderRegulation (EC)No850/2004– if further information isrequired,pleasecontactAssent.
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dRAfT RECOMMENdATION fOR AuTHORISATIONcomment deadline sept 14th
•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
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
ASSENTCOMPLIANCE
PRACTICAL APPLICATIONideal Qualities of a declaration of conformity•A declaration should ideally be part of a process that keeps all yourinformationcurrentandyourdeclarationsconsistent.