[PPT] - Ca n Mo re Be L e ss? Asse ssing Da ta Ava ila b le fro m the PowerPoint Presentation

SLIDE 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

SLIDE 2

T

da y’ s Disc ussio n

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

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SLIDE 3

Using the C&L I nve nto ry Da ta b a se

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 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

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SLIDE 4

Using the C&L I nve nto ry Da ta b a se

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

4

SLIDE 5

Using the C&L I nve nto ry Da ta b a se

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

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SLIDE 6

Using the C&L I nve nto ry Da ta b a se

Information submitte d to E CHA Information available in database

I de ntity o f the no tifie r X I de ntity o f the sub sta nc e , inc luding impuritie s o r o the r info rma tio n E I NE CS na me , E C# , CAS# Cla ssific a tio n o f the sub sta nc e (a s de te rmine d b y the sub mitte r) I ndic a tio n o f re a so n fo r e mpty c la ss L a c k o f da ta o r do e s no t me e t c rite ria Spe c ific c o nc e ntra tio n limits

r M-fa c to rs

(re c o mme nda tio ns b y sub mitte r) L a b e l e le me nts

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SLIDE 7

Using the C&L I nve nto ry Da ta b a se

u F

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

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 .

7

SLIDE 8

Using the C&L I nve nto ry Da ta b a se

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

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SLIDE 9

Using the C&L I nve nto ry Da ta b a se

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

9

SLIDE 10

Using the C&L I nve nto ry Da ta b a se

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.

10

SLIDE 11

Using the C&L I nve nto ry Da ta b a se

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 ”

11

SLIDE 12

Using the C&L I nve nto ry Da ta b a se

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 u CL

P c rite ria ha s b e e n upda te d to GHS 4th e ditio n in the inte rim sinc e first no tific a tio ns

u Mo re ma y b e le ss….

12

SLIDE 13

Wha t is Re lia b le Da ta ?

u T

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

13

SLIDE 14

Wha t is Re lia b le Da ta ?

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

14

SLIDE 15

Wha t is Re lia b le Da ta ?

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

15

SLIDE 16

Re vie wing the RE ACH Da ta se ts

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

16

SLIDE 17

Re vie wing the RE ACH Da ta se ts

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

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

17

SLIDE 18

Re vie wing the RE ACH Da ta se ts

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

18

SLIDE 19

Re vie wing the RE ACH Da ta se ts

u F

urth: I

s the sub sta nc e ide ntity a lo ng with a ny a pplic a b le impuritie s pro vide d?

u Ye s. u T

his ma y re sult in multiple ide ntitie s a nd the re fo re multiple c la ssific a tio ns fo r the sub sta nc e J

u F

ifth: Wha t if the sub sta nc e a lre a dy ha d a ha rmo nize d c la ssific a tio n?

u So me pro vide d the ha rmo nize d c la ssific a tio n e ve n if the

a sse mb le da ta did no t c o inc ide

u So me pro vide d the ha rmo nize d c la ssific a tio n a nd a “se lf-

c la ssific a tio n”

19

SLIDE 20

20

SLIDE 21

Re vie wing the RE ACH Da ta se ts

u Sixth: Ca n I

do wnlo a d the re sults pre se nte d?

u No . Vie wing is the o nly o ptio n.

u Se ve nth: Ca n I

use the da ta fro m the re sults?

u Re pro duc tio n o r furthe r distrib utio n o f re sults ma y b e

sub je c t to c o pyrig ht pro te c tio ns.

21

SLIDE 22

Re vie wing the RE ACH Da ta se ts

u E

ig hth: Ho w c a n this info rma tio n b e use ful?

u I

n mo st c a se s, multiple stud ie s a re pre se nte d ra nking the m in a s ke y stud ie s, suppo rting stud ie s (we ig ht o f e vide nc e ) a s we ll a s inc lud ing “a lte rna te ” re sults.

u Assig ns K

limish sc o re s a nd re a so n fo r sc o ring whic h ma y b e use ful whe n c o mpa re d to yo ur “info rma tio n”

u T

hink a b o ut a n L D50 yo ur SDS ha s use d inde finite ly tha t c o me s up a s unre lia b le …

u T

hink a b o ut yo ur c la ssific a tio n a s a skin irrita nt whe n the studie s c o mpile d a nd re po rte d sho w de rma l studie s with no irrita tio n…

u T

hink a b o ut inha la tio n study re sults whic h yo u ma y ha ve (L C50 re sult) fo r whic h yo u do n’ t kno w if mist o r va po r…

u Ma y pro vide g re a te r c o nfide nc e in yo ur o wn c la ssific a tio n u Mo re ma y b e le ss….

22

SLIDE 23

I mplic a tio ns to GHS Cla ssific a tio ns

u We ha ve a we a lth o f info rma tio n tha t ha s

flo o de d o ur po te ntia l re so urc e s fo r to xic ity a nd e c o to xic ity da ta

u We c a n’ t use this info rma tio n witho ut po te ntia l

c o pyrig ht infring e me nt

u We ne e d to tho ro ug hly unde rsta nd the so urc e s

f the info rma tio n a nd re a so ns fo r the wide

ra ng e o f c o mpa ra tive re sults 23

SLIDE 24

I mplic a tio ns to GHS Cla ssific a tio ns

u We ne e d to ta ke the time to dig de e pe r o n

e ve ry sub sta nc e to kno w whe the r the a b se nc e

f a pa rtic ula r ha za rd c la ss is due to la c k o f da ta
r the da ta indic a te s it do e s no t me e t the

c rite ria

u Upda te s will o c c ur o n the se (C&L

I nve nto ry a nd RE ACH) so the y ne e d to b e re vie we d fre q ue ntly a nd a sse sse d a s to ho w yo u c a n (rig htfully) use the info rma tio n 24