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

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 – RegistRation 2013 is not the only RequiRement,

aRe you Ready foR the next 2 yeaRs?

assent compliance

Krystal Noseworthy-BaKer phone: 613.882.1429

krystal.baker@assentcompliance.com

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

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

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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ASSENTCOMPLIANCE

AgENdA•RecentECHAReleases

•DataSharing–RulingsandReports

•RegistrationOverview•Requirements

•Timelines

•Process

•FAQs

•Impacts

•CLPOverview•Requirements

•Timelines

•Process

•FAQs

•Impacts

•ImplementationTimelines

•CommonIndustryPractices

•AuthorisationReview

•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 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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ASSENTCOMPLIANCE

REgISTRATION – RECENT ECHA RELEASESFirstReportCardwasreleasedJuly1,2011

•Examinedthelessonsandchallengesencounteredsofar(3yearsintoREACH,2yearsintoCLP).Dealtwitheverythingfromnanomateri-alstojointregistrationtoITtoolsupport

•Communication, feedback,process, comitology all need to improveresponsetime,therearenoissueswiththequalityofresponsesimplyhowquicklytheinformationisgettingupanddownthechain

•Enforcementguidanceandprocesseswillhopefullybeclarifiedandreleased

Green MEP Satu Hassi (European Parliament Environment Committeeliaison)andtheECHA

•DiscussiononSVHCs

•Discussiononcompliancechecksandmakingdossiersbetter(=moretime-consuming)

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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ASSENTCOMPLIANCE

Therearecurrently4416registrationswith20175registrationnumbershavingbeengranted(therewereover143000pre-registrations)

Registrationdossiersforintermediatesarenotuptothenecessarystandardshttp://echa.europa.eu/news/na/201105/na_11_21_intermidiates_en.asp

•TheECHAscreenedover400dossiersandfoundthemajoritydonotmeettheconditionsnecessarytobenefitfromthereducedinformationrequirementsforintermediates

•The ECHA is placing onus on the registrants to reassess andupdateasrequired

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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ASSENTCOMPLIANCE

07 Mar 2011 – Completeness checks completed by ECHA as requiredhttp://echa.europa.eu/news/na/201103/na_11_08_echa_meets_completeness_check_deadline_en.asp

•15366dossiersrelevanttothe2010deadlineweresubmittedinthe2monthsleadinguptothedeadline

•ItisECHA’sdutytoundertakeacompletenesscheckonthesewithinathreemonthperiodwhichendedonFebruary28th,2011–ThedeadlinewasmetbytheECHA.

On a separate REACH note:SDSGuidancewasofficiallypublishedSeptember7th,2011

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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ASSENTCOMPLIANCE

dATA SHARINg – RuLINgS ANd REPORTSMultipleRegistrants,SameSubstance

•August10th,2011http://echa.europa.eu/news/na/201108/na_11_33_same_substance_reg-istrants_20110810.asp

•CompanieshavesubmittedregistrationswithouttakingpartinasingleSubstanceInformationExchangeForum(SIEF)

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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ASSENTCOMPLIANCE

REACH – REgISTRATION 2013overview•AppliestosubstancesproducedorimportedintotheEUat≥100tonnesperyearpermanufacturerorimporter.

•Greaternumberofsubstancesisexpectedtoberegisteredin2013thanin2010.

•Thetotaldatarequirementsfor≥100tonnesubstancesarelessthanthoseforthe≥1000tonnesubstances.

•Unfortunately because these substances have smaller tonnages, they are lesswidelyusedwhichmeansitismorethanpossiblethatlessdatawillbeavailabletofulfilltheREACHdossierinformationrequirements.

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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ASSENTCOMPLIANCE

•Thismaymeanthereisincreaseduseofalternativemethodsforfillingdatagaps,(read-across,QuantitativeStructureActivityRelationships(QSARs),newtestingorthecreationoftestingplans.)

•ThebiggesthelptodossiercompletionareSIEFs(SubstanceInformationExchangeForums)andConsortiums–Lettersofaccesstothedossiersandinformationtheyhavealreadygatheredareessentialforpropercompletionofdatarequirements.Thecostoflettersofaccessisdeterminedbythenum-berofregistrantssoitisimportanttoinvestigatethisassoonaspossible.

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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ASSENTCOMPLIANCE

REACH – REgISTRATION 2013requirements

•InformationRequirementsareestablishedinAnnexVII,VIIIandIXoftheREACHRegulation: Standard InformationRequirements forSubstancesManufacturedorImportedinQuantitiesof1TonneorMore,10TonnesorMoreand100TonnesorMore

•Sections4-7oftheIUCLIDDossierarewheretheinformationalincreaseisconcentrated

•Asyoumovefromonetonnageleveltoanother,theregistrationdossierin-formationrequirementsincreasehoweverthesesannexesalsoestablishtherulesforanyadaptationfromtheinformationrequirement

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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ASSENTCOMPLIANCE

REACH – REgISTRATIONtimeline

Collection,verificationandentry

ofallnecessaryexisting

dossierdata.

LocateandappointOnlyRepresentativeifrequired.

CompletionofSection1.4

TestingUVIR

NMRMS

HPLCGC

Entryofremainingdataintodossier.

TCCDossierSubmission

Registration>1000tonnes,OMRs,R50-53

Dec1,2010

Registration>=100tonnes

JunE 1, 2013

Registration>1tonne

Registration<100tonnes

JunE 1, 2018

LOAAccessLetterand

ReceptionofLeadDossier

TODAYSEptEmbER

21, 2011JunE 1, 2012

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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ASSENTCOMPLIANCE

REACH – REgISTRATIONprocess

Gathermembershipdata

andcosts

ActiveSIEFandConsortiumInvestigation

DataGathering

Gatherdataasnecessary

CompleteDossier

CompleteDossier

TCC

TCC

SubmitDossier

SubmitDossier

IdentifyDataGaps

Sections1–13

Gathermembership

process.GatherLoA.

GatherDossierInstructions

andSubstanceDataset

IdentifyDataGaps

Sections1&3

GatherDataasnecessary

YES

nO

IsthereanactiveSEForCorsortium?

SubstanceReview

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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ASSENTCOMPLIANCE

REACH – REgISTRATIONfaqs

•Whatifthereisnoleadregistrant?

•WhatifIalreadyhaveanOnlyRepresentative?

•Whathappensifwedonotmeetthe2013Deadline?

•Oncewehaveregisteredisthereanythingelsewewillneedtoworryabout?

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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ASSENTCOMPLIANCE

IMPACTS – REgISTRATION 2013 REACH COMPLIANCE•CustomsStoppages

•DeliveryDelaysorRejections•NewProductLaunchdelays

•Fines

•Imprisonment

•Lossofbusiness•REACHcomplianceisquicklybecomingacontractualobligationandiftheobligationcannotbemetthenpotentialcustomersmoveon

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

CLASSIfICATION, LAbELINg + PACkAgINg (CLP)overview – classification•Regulation(EC)No1272/2008•GHS(GlobalHarmonisedSystem)Based•Impactstheclassificationofsubstances,mixtures,including:

•SafetyDataSheets•Packaging•Labelling

•CLp Classification Deadlines:•Substances: 1December2010

» Ifalreadyonthemarketbefore1December2010 1December2012

•mixtures: 1June2015» Ifalreadyonthemarketbefore1June2015 1June2017

•CLPSDSs•DeadlinesforSDSs(ANDLABELS),sameasclassificationdeadlines

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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ASSENTCOMPLIANCE

CLASSIfICATION, LAbELINg + PACkAgINg (CLP)overview – notification•CLp notification Scope:

•SubstancessubjecttoregistrationunderREACH»Unlessalreadyregistered(during2010registration)withtheCLPclassificationincluded

•SubstancesclassifiedashazardousunderCLPandplacedonmarket» IRRESPECTIVEOFTONNAGE

•Substances classified as hazardous underCLP and in amixture aboveconcentrationlimits(AnnexICLP,orinDPD)whichresultsinmixturebeingclassifiedashazardousandthemixtureisplacedonthemarket

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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ASSENTCOMPLIANCE

•CLp notification Deadlines:•Substancesonmarket1December2010:January3rd,2011

•Substancesonmarketafter1December2010:1monthfromdateofplacementonmarket

•ORshavenoroleunderCLP

•NotificationtomatchRegistration

•Harmonisedclassificationpublished–Notificationtobeupdated

•14 mar 2011 – http://echa.europa.eu/news/na/201103/a_11_10_rac_opinions_clh_20110314_en.asp

•15 June 2011 – http://echa.europa.eu/news/na/201106/a_11_27_rac_adopts_ten_scientific_opinions_en.asp

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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ASSENTCOMPLIANCE

CLPnotification process

DecideonNotificationSubmitter

(EUEntity)

Collection,verficationand

entryofallnecessaryexisting

dossierdata

OptImAL:Completionof

Section1.4TestingUVIR

NMRMS

HPLCGC

ConfirmSubstanceIdentityalready

entered

CompletionTCCandSubmission

ofdossier

Haveyoucompletednotificationsfor

hazardoussubstancesandallsubstancesunderthescopeofREACH?

Withouttestingtimeincluded,normally

takes2-4weeks(VeryDataDependent)

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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ASSENTCOMPLIANCE

CLPtimeline

CLPClassification(Substances)Dec1,2010

CLPNotificationJanuary3,2011

TODAYSEptEmbER

21, 2011

CLPClassificationTransition

(Substances)December1,2012

CLPClassification(Mixtures)

June1,2015

CLPClassificationTransition(Mixtures)

June1,2017

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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ASSENTCOMPLIANCE

CLPfaqs•Myproductsareallmixtures,domySDSshavetohaveCLPclassificationinformationonthem?

•Iregisteredmysubstancesbeforethe2010deadlinebutIamnotsureiftheCLPinformationwasincluded?

•My substance is under the 1 tonne threshold for REACH so I did notnotifyforCLP,shouldIhaveanyconcerns?

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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ASSENTCOMPLIANCE

CLPimpacts•Atthistime,theprimaryimpactiscustomsstoppages.

•ItisveryobviouswhensubstancesdonotmeettheCLPrequirements

Example: FormaldehydeDSDClassification :Carc.Cat.3;R40–T;R23/24/25–C;R34–R43Risk Phrases :+ R23/24/25:Toxicbyinhalation,incontactwithskinandifswallowed.

:+ R34:Causesburns.:+ R40:Limitedevidenceofacarcinogeniceffect.:+ R43:Maycausesensitizationbyskincontact.

Safety Phrases :+ S1/2:Keeplockedupandoutofthereachofchildren.:+ S26:Incaseofcontactwitheyes,rinseimmediatelywithplentyofwaterandseekmedicaladvice.:+ S36/37/39:Wearsuitableprotectiveclothing,glovesandeye/faceprotection.:+ S45 : In caseof accidentor if you feelunwell, seekmedical advice immediately(showthelabelwherepossible).:+ S51:Useonlyinwell-ventilatedareas.

Symbol(s) andIndication(s) of Danger

+ T:

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 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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ASSENTCOMPLIANCE

SpecificConcentrationLimit(s)Concentration Classification

C≥25 % T;R23/24/25

5 %≤C<25 % Xn;R20/21/22

C≥25 % C;R34

5 %≤C<25 % Xi;R36/37/38

C≥0,2 % R43

(cont’d)Example: FormaldehydeDSD

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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ASSENTCOMPLIANCE

CLPimpacts (cont’d)CLp

REguLATION (EC) NO 1272/2008 ANNEx VI TAbLE 3.1

classification labelling

Hazard Class and Category Code(s)

Hazard Statement Code(s)

pictogram Signal Word Code(s)

Hazard Statement Code(s)

Carc.2AcuteTox.3*AcuteTox.3*AcuteTox.3*SkinCorr.1BSkinSens.1

H351H331H311H301H314H317

GHS06GHS08GHS05Dgr

H351H331H311H301H314H317

SPECIfIC CONCENTRATION LIMITS ANd M fACTORS

concentration

C≥25 %5 %≤C<25 %5 %≤C<25 %C≥5 %C≥0,2 %

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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ASSENTCOMPLIANCE

PICTOgRAMS

Skull&Crossbones HealthHazard Corrossion

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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ASSENTCOMPLIANCE

REACH ANd CLPtimeline reviewQuestions&AnswersonRegulation(EC)No1272/2008onclassification,labelingandpackagingofsubstancesandmixtures:

REACHentryinto

force

June1,2007

reachtimeline

clptimeline

substances

mixtures

year 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019onwards

all new substances

and mixtures

substances and mixtures ≥ 1000

tonnes per year or of very high concern

substances and mixtures ≥ 100 tonnes

per yearsubstances and mixtures ≥ 1 tonne per year

classified, labelled and packaged under clp.classified under both dsd and clp; labelled and packaged under clp.

classified, labelled and packaged under dsd. if clp is applied in full as well, no dsd labelling and

packaging.

classified, labelled and packaged under dpd. if clp is applied in full as well, no dpd labelling and packaging.

Firstphaseindeadline

December1,2010

Secondphaseindeadline

June1,2013

Thirdphaseindeadline

June1,2018

ObligationtoapplyCLPtomixtures.Pleasenotethatforcertainsubstances/mixturesinthe2012/2017deadlineforre-labellingand

re-packagingapplies

June1,2015

CLPentryintoforce;repealof

AnnexItoDSD

January20,2009

ObligationtoapplyCLPtosubstances

December1,2010

Pre-registrationperiod

June1toDecember1,2008

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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ASSENTCOMPLIANCE

COMMON INduSTRy PRACTICES – REACH & CLP•Registration:OnlyRepresentativeNomination

•Registration – Joint Dossier:REACHCentrumisacommonlyusedSIEFandConsortiumadministrativefirmwithestablishedprocesses,contracts,andLoAs

•CLp Classification:In-housechemicalassessmentbasedondefinedCLPthresh-olds(withinregulation)ORThirdPartyassessmentbasedontestingresults

•CLp notification:Importerofrecord/manufacturerprovidesinformationtoThirdpartyforcompletionandsubmissionofdossierontheirbehalf

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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ASSENTCOMPLIANCE

AuTHORISATION REVIEw•The Authorisation process – startswiththeidentificationofsubstancesofveryhighconcern(SVHC)byMemberStateCompetentAuthoritiesortheEuropeanChemicalsAgency(onbehalfoftheEuropeanCommission)bypreparingadossierinaccordancewithAnnexXV.

•DecisionsonprioritisationoftheseSVHCsandthesubsequentreleaseofthefinallistofsubstancessubjecttoauthorisationisdecidedbytheCommission.

•Each Authorisation:•identifiesthesubstance,•providesit’s“propertiesofveryhighconcern”,•makesclearboththeSunsetDateandtheApplicationDate•includesthereviewperiodandtheexemptedusesorcategoriesofuses,ifapplicable

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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ASSENTCOMPLIANCE

•SVHCCandidateListsubstanceswillmostlikelyALLeventuallybeontheauthorisationlist

•Applicabletoimportedsubstancesontheirownorinpreparations.•Substances being an integral part of articles are NOT subject toauthorisation

•ApplicabletoallsubstancesmanufacturedintheEuropeanUnion

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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ASSENTCOMPLIANCE

AuTHORISATION REVIEw (CONT’d)•Authorisation Applications (dossiers) are created in IUCLID (same asREACHRegistrationdossiersandCLPnotificationdossiers)

•TheyareNOTsubmittedinREACH-IT,theyuseawebformviatheECHAwebsite

•TheyincludeaCSR,analternativesanalysis,asocio-economicanaly-sisandasubstitutionplan

•Applicationsmustbesubmitted18MONTHSbeforethesunsetdate

•Applicationcreationshouldstartatleast30MONTHS(2.5YEARS)beforethesunsetdate

•Youwillseeonthenextslidethatthesunsetdatesarein2014and2015:

» ApplicationdeadlinesstartingFebruary2013–February2014» Application creation process should start February 2012 –February2013

•Whatisthealternative?•REDESIGN

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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ASSENTCOMPLIANCE

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

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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ASSENTCOMPLIANCE

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

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

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

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

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