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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
[email protected]
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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
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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
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i n f o @ a s s e n t s v h c . c o m w w w. a s s e n t s v h c . c o m t e l : 8 6 6 . 9 6 4 . 6 9 3 1
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)
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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
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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
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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)
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i n f o @ a s s e n t s v h c . c o m w w w. a s s e n t s v h c . c o m t e l : 8 6 6 . 9 6 4 . 6 9 3 1
ASSENTCOMPLIANCE
REACH – REgISTRATION 2013overview•AppliestosubstancesproducedorimportedintotheEUat≥100tonnesperyearpermanufacturerorimporter.
•Greaternumberofsubstancesisexpectedtoberegisteredin2013thanin2010.
•Thetotaldatarequirementsfor≥100tonnesubstancesarelessthanthoseforthe≥1000tonnesubstances.
•Unfortunately because these substances have smaller tonnages, they are lesswidelyusedwhichmeansitismorethanpossiblethatlessdatawillbeavailabletofulfilltheREACHdossierinformationrequirements.
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ASSENTCOMPLIANCE
•Thismaymeanthereisincreaseduseofalternativemethodsforfillingdatagaps,(read-across,QuantitativeStructureActivityRelationships(QSARs),newtestingorthecreationoftestingplans.)
•ThebiggesthelptodossiercompletionareSIEFs(SubstanceInformationExchangeForums)andConsortiums–Lettersofaccesstothedossiersandinformationtheyhavealreadygatheredareessentialforpropercompletionofdatarequirements.Thecostoflettersofaccessisdeterminedbythenum-berofregistrantssoitisimportanttoinvestigatethisassoonaspossible.
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ASSENTCOMPLIANCE
REACH – REgISTRATION 2013requirements
•InformationRequirementsareestablishedinAnnexVII,VIIIandIXoftheREACHRegulation: Standard InformationRequirements forSubstancesManufacturedorImportedinQuantitiesof1TonneorMore,10TonnesorMoreand100TonnesorMore
•Sections4-7oftheIUCLIDDossierarewheretheinformationalincreaseisconcentrated
•Asyoumovefromonetonnageleveltoanother,theregistrationdossierin-formationrequirementsincreasehoweverthesesannexesalsoestablishtherulesforanyadaptationfromtheinformationrequirement
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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
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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
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ASSENTCOMPLIANCE
REACH – REgISTRATIONfaqs
•Whatifthereisnoleadregistrant?
•WhatifIalreadyhaveanOnlyRepresentative?
•Whathappensifwedonotmeetthe2013Deadline?
•Oncewehaveregisteredisthereanythingelsewewillneedtoworryabout?
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ASSENTCOMPLIANCE
IMPACTS – REgISTRATION 2013 REACH COMPLIANCE•CustomsStoppages
•DeliveryDelaysorRejections•NewProductLaunchdelays
•Fines
•Imprisonment
•Lossofbusiness•REACHcomplianceisquicklybecomingacontractualobligationandiftheobligationcannotbemetthenpotentialcustomersmoveon
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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
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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
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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
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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)
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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
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ASSENTCOMPLIANCE
CLPfaqs•Myproductsareallmixtures,domySDSshavetohaveCLPclassificationinformationonthem?
•Iregisteredmysubstancesbeforethe2010deadlinebutIamnotsureiftheCLPinformationwasincluded?
•My substance is under the 1 tonne threshold for REACH so I did notnotifyforCLP,shouldIhaveanyconcerns?
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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...
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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
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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 %
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ASSENTCOMPLIANCE
PICTOgRAMS
Skull&Crossbones HealthHazard Corrossion
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i n f o @ a s s e n t s v h c . c o m w w w. a s s e n t s v h c . c o m t e l : 8 6 6 . 9 6 4 . 6 9 3 1
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
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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
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i n f o @ a s s e n t s v h c . c o m w w w. a s s e n t s v h c . c o m t e l : 8 6 6 . 9 6 4 . 6 9 3 1
ASSENTCOMPLIANCE
AuTHORISATION REVIEw•The Authorisation process – startswiththeidentificationofsubstancesofveryhighconcern(SVHC)byMemberStateCompetentAuthoritiesortheEuropeanChemicalsAgency(onbehalfoftheEuropeanCommission)bypreparingadossierinaccordancewithAnnexXV.
•DecisionsonprioritisationoftheseSVHCsandthesubsequentreleaseofthefinallistofsubstancessubjecttoauthorisationisdecidedbytheCommission.
•Each Authorisation:•identifiesthesubstance,•providesit’s“propertiesofveryhighconcern”,•makesclearboththeSunsetDateandtheApplicationDate•includesthereviewperiodandtheexemptedusesorcategoriesofuses,ifapplicable
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ASSENTCOMPLIANCE
•SVHCCandidateListsubstanceswillmostlikelyALLeventuallybeontheauthorisationlist
•Applicabletoimportedsubstancesontheirownorinpreparations.•Substances being an integral part of articles are NOT subject toauthorisation
•ApplicabletoallsubstancesmanufacturedintheEuropeanUnion
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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
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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
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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 ]
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
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
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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 ]
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
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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 ]
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
QuESTIONS?PleasesubmityourquestionsinwritingusingtheQ&Atoolalongthetopmenutoolbar.
AnyquestionsnotaddressedduringtheQ&Aportionofthiswebinarwillbeaddressedinprivatecorrespondenceafterthewebinar.