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Ca n Mo re Be L e ss? Asse ssing Da ta Ava ila b le fro m the C&L I nve nto ry a nd RE ACH We b site s SOCIE T Y F OR CHE MICAL HAZARD COMMUNI CAT I ON CHARL E ST ON, SC MARCH 25, 2014 T o da y s Disc ussio n 2 u

  1. Ca n Mo re Be L e ss? Asse ssing Da ta Ava ila b le fro m the C&L I nve nto ry a nd RE ACH We b site s SOCIE T Y F OR CHE MICAL HAZARD COMMUNI CAT I ON CHARL E ST ON, SC MARCH 25, 2014

  2. T o da y’ s Disc ussio n 2 u Using the C & L I nve nto ry da ta b a se u Wha t is “re lia b le ” da ta ? Ca n we a sse ss q ua lity e a sily? u Re vie wing the RE ACH da ta se ts u I mplic a tio ns to GHS c la ssific a tio ns

  3. Using the C&L I nve nto ry Da ta b a se 3 u F irst: Wha t is the C & L I nve nto ry? u Cla ssific a tio n a nd la b e ling info rma tio n u No tifie d unde r RE ACH Re g ula tio n, a nd u No tifie d unde r CL P Re g ula tio n, a nd u Anne x VI o f CL P (le g a lly b inding ha rmo nize d c la ssific a tio ns) u T o o l fo r ha za rd c o mmunic a tio n u Re ve a ls the diffe re nc e s in the c la ssific a tio n a nd la b e lling o f the sa me sub sta nc e a pplie d b y diffe re nt supplie rs u http:/ / e c ha .e uro pa .e u/ we b / g ue st/ info rma tio n-o n- c he mic a ls/ c l-inve nto ry-da ta b a se

  4. Using the C&L I nve nto ry Da ta b a se 4 u Se c o nd: Who a re the no tifie rs? u Cla ssific a tio ns in RE ACH re g istra tio n do ssie rs a re a uto ma tic a lly pla c e d in the da ta b a se a nd ma rke d with a g re e n c he c k ma rk u Any ma nufa c ture r o r impo rte r who pla c e s o n the ma rke t a sub sta nc e tha t me e ts the ha za rd c rite ria in the CL P sha ll no tify the Ag e nc y (E CHA). u Sub sta nc e s pla c e d o n the ma rke t o n o r a fte r 1 De c . 2010 within 1 mo nth u I nc lude s sub sta nc e s in mixture s

  5. Using the C&L I nve nto ry Da ta b a se 5 u T hird: Wha t is NOT in the pub lic da ta b a se ? u Co nta c t de ta ils o f no tifie r o r re g istra nt u No info rma tio n o n impuritie s o r a dditive s u Sub sta nc e s c la ime d c o nfide ntia l b y the sub mitte r/ no tifie r

  6. Using the C&L I nve nto ry Da ta b a se 6 Information submitte d to Information available in E CHA database I de ntity o f the no tifie r X I de ntity o f the sub sta nc e , E I NE CS na me , E C# , CAS# inc luding impuritie s o r o the r info rma tio n Cla ssific a tio n o f the (a s de te rmine d b y the sub sta nc e sub mitte r) I ndic a tio n o f re a so n fo r L a c k o f da ta o r do e s no t e mpty c la ss me e t c rite ria Spe c ific c o nc e ntra tio n limits (re c o mme nda tio ns b y o r M-fa c to rs sub mitte r) L a b e l e le me nts

  7. Using the C&L I nve nto ry Da ta b a se 7 u F o urth: Who ve rifie s the c la ssific a tio ns sub mitte d? u No o ne . T he info rma tio n pub lishe d in the C&L I nve nto ry is no t re vie we d o r ve rifie d b y E CHA o r a ny o the r a utho rity. u E CHA do e s no t g ua ra nte e the c o rre c tne ss o f the info rma tio n. u E CHA c a nno t ma ke a c ha ng e to a ny e le me nt in the da ta b a se witho ut a prio r no tic e .

  8. Using the C&L I nve nto ry Da ta b a se 8 u F ifth. Why a re the re diffe ring c la ssific a tio ns fo r the “sa me ” sub sta nc e ? u So me ma y b e due to te c hnic a l e rro rs ma de during the no tific a tio n pro c e ss u No t a ssig ning a ll la b e ling e le me nts c o rre c tly u Slig ht diffe re nc e s in c la ssific a tio n suc h a s ro ute o f e ntry o r no ro ute indic a te d u Diffe re nt inte rpre ta tio ns o f sc ie ntific studie s use d fo r c la ssific a tio n u Diffe re nt a c c e ss to da ta u Diffe re nt ide ntifie d pro pe rtie s a nd/ o r impuritie s J

  9. Using the C&L I nve nto ry Da ta b a se 9 u Sixth. Will the diffe re nt c la ssific a tio ns fo r “sing le ” sub sta nc e s b e “ha rmo nize d”? u T ha t is the inte nt o f the inve nto ry u I t is e sse ntia lly the re spo nsib ility o f the re g istra nt(s) a nd no tifie r(s) to ma ke e ve ry e ffo rt to c o me to a n a g re e d e ntry u No t muc h mo ve me nt o r inc e ntive to ta ke this o n, so it ma y b e a ve ry lo ng time u T he re a re mo re tha n 6 millio n no tific a tio ns fo r mo re tha n 110,000 sub sta nc e s

  10. Using the C&L I nve nto ry Da ta b a se 10 u Se ve nth: Ca n I do wnlo a d the re sults o f a se a rc h? u No . Vie wing is the o nly o ptio n. u E ig hth: Ca n I use the se a rc h re sults fro m the C&L I nve nto ry da ta b a se ? u Re pro duc tio n o r furthe r distrib utio n o f se a rc h re sults ma y b e sub je c t to c o pyrig ht pro te c tio ns.

  11. Using the C&L I nve nto ry Da ta b a se 11 u Ninth: Ho w c a n this info rma tio n b e use ful? u Che c k re sults a g a inst yo ur o wn c la ssific a tio n. Yo u ma y wa nt to se e wha t the ma jo rity o f no tifie rs ha ve c o nc lude d (ma jo rity ma y no t a lwa ys b e rig ht). u Co nfirm ma nda to ry ha rmo nize d c la ssific a tio n a nd la b e ling e le me nts fro m Anne x VI . u I f the re is a ha za rd c la ss no t inc lud e d fo r whic h yo u ha ve info rma tio n o r da ta , o b lig e d to a dd to yo ur c la ssific a tio n b ut c a n’ t c ha ng e the ha za rds pre se nte d. u Mig ht use to xic ity c a te g o ry to a ssig n a n AT E va lue o r in the a b se nc e o f a c a te g o ry, lo o k to se e if due to “la c k o f da ta ” o r “c o nc lusive b ut do e s no t me e t c rite ria ”

  12. Using the C&L I nve nto ry Da ta b a se 12 u T e nth: Wha t sho uld I b e a wa re o f a s I re vie w the info rma tio n in the da ta b a se ? u E ve ry sub sta nc e o n the ma rke t o n 1 De c 2010 ha d to b e no tifie d within 30 da ys u No t a ll no tifie rs we re / a re skille d in the “a rt” o f GHS u I mpuritie s a nd a dditive s ma y a c c o unt fo r diffe re nt c la ssific a tio ns b ut no info rma tio n pro vide d u Ag g re g a tio n o f no tifie rs is do ne b y c o mpute r P c rite ria ha s b e e n upda te d to GHS 4 th e ditio n in the u CL inte rim sinc e first no tific a tio ns u Mo re ma y b e le ss….

  13. Wha t is Re lia b le Da ta ? 13 u T o xic o lo g ists ha ve de ve lo pe d so me b e st pra c tic e s fo r e va lua ting da ta q ua lity a nd re lia b ility. u Sta nda rds o f q ua lity o fte n drive n b y pro g ra ms like RE ACH, T SCA, pha rma c e utic a l a nd pe stic ide pro g ra ms. u E sta b lishe d te st pro to c o ls, a nd g o o d la b o ra to ry pra c tic e s (GL P) u Da ta se ts fo r “e xisting ” c he mic a ls ma y ha ve b e e n de ve lo pe d o ve r de c a de s b y a wide ra ng e o f me tho ds u E PA-HPV, OE CD-HPV a nd RE ACH ha ve a do pte d K limish sc o ring syste m

  14. Wha t is Re lia b le Da ta ? 14 u K limish e sta b lishe d syste m fo r e va lua tio n o f da ta q ua lity fo r ha za rd a nd risk a sse ssme nts u Re lia b ility – e va lua ting inhe re nt q ua lity o f a te st re po rt/ pub lic a tio n u Re le va nc e – e xte nt to whic h da ta / te sts a re a ppro pria te fo r a pa rtic ula r ha za rd u Ade q ua c y – use fulne ss o f the da ta

  15. Wha t is Re lia b le Da ta ? 15 u Re lia b ility sc o re s u 1= re lia b le witho ut re stric tio n u 2= re lia b le with re stric tio ns u 3= no t re lia b le u 4= no t a ssig na b le u A sho rt justific a tio n is inc lude d with the sc o re u Sc o ring do e s no t e xc lude a ll unre lia b le da ta sinc e it ma y b e use d a s suppo rting o the r re sults

  16. Re vie wing the RE ACH Da ta se ts 16 u F irst: Wha t do e s the RE ACH re g istra tio n info rma tio n re pre se nt? u As pa rt o f re g istra tio n, c o mpa nie s must c o mpile a ll a va ila b le da ta a nd info rma tio n o n the sub sta nc e , e va lua te it a nd pro vide a c la ssific a tio n a nd la b e l. u 2010 re g istra tio n de a dline wa s fo r c o mpa nie s ma nufa c turing / impo rting ≥ 1000 to ns/ ye a r u 2013 re g istra tio n de a dline wa s fo r c o mpa nie s ma nufa c turing / impo rting ≥ 100 to ns/ ye a r u 2018 re g istra tio n de a dline is fo r c o mpa nie s ma nufa c turing / impo rting ≥ 1 to ns/ ye a r u http:/ / e c ha .e uro pa .e u/ info rma tio n-o n- c he mic a ls/ re g iste re d-sub sta nc e s

  17. Re vie wing the RE ACH Da ta se ts 17 u Se c o nd: Who a re the no tifie rs? u Ma nufa c ture rs a nd impo rte rs in the E U u F o re ig n supplie rs c a n b e re pre se nte d b y a n E U “Only Re pre se nta tive ” who “c o mplie s“ o n the ir b e ha lf u No tifie rs o f a sing le sub sta nc e a re g ro upe d to g e the r to c o mpile a nd sub mit da ta jo intly. T he se g ro ups a re c a lle d SI E F s u A c o mpa ny c a n o pt o ut o f a SI E Fso yo u ma y se e a re g iste re d c he mic a l tha t is b o th a “Jo int Sub missio n” a nd a n “I ndividua l Sub missio n” u T he no tifying c o mpa nie s a re ide ntifie d in the pub lic a lly a va ila b le RE ACH re g istra tio n da ta

  18. Re vie wing the RE ACH Da ta se ts 18 u T hird: Who ve rifie s the info rma tio n sho wn in the da ta se t? u No o ne . Ne ithe r E CHA no r a ny o the r a utho rity ve rifie s the info rma tio n b e fo re its disse mina tio n u Co mpa nie s in pre pa ring the re g istra tio n we re o b lig e d to e va lua te the da ta the y c o mpile d u Vie we rs o f the da ta c a n se e the K limish sc o re a ssig ne d to pa rtic ula r da ta a nd the “re a so n” fo r the sc o re

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