The Safety Data Sheet under REACH a closed book?

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1 Th Safty Data Sht undr RECH a closd book? Tips for a bttr undrstanding of th Safty Data Shts D RC S U G R Z i i t t t 6 s d a C H C P R OC B P E d a E r C

2 Dar Customrs, Th rquirmnts of th RECH rgulation has also impact on th structur and contnts of Safty Data Shts. Thy hav bcom significantly mor complx. In providing you with this information, w would lik to support you with th task of filtring out th ky data for you. W ar also making th BSF Safty Data Shts asir to rad by assigning th annx a structur that corrsponds to th standards of th Europan Chmicals gncy (ECH). It is structurd in moduls and faturs an indx for th frquntly xtnsiv annx. s usual, w will snd you vry nw vrsion of th Safty Data Sht and highlight important changs. W hav compild th following xplanations for you: What changs hav bn mad to th Safty Data Sht du to RECH. What xtndd Safty Data Sht (SDS) mans and whn you will rciv on. Maning of xposur scnarios. What th rcipint of an xtndd Safty Data Sht must do. What obligations do downstram usrs hav according to RECH. Glossary and contact prsons. If you hav any qustions, plas lt us know. Your BSF RECH Tam What changs hav bn mad to th Safty Data Sht du to RECH? Major changs hav bn mad in a numbr of sctions of th nw Safty Data Sht: Sction 1: Idntification of th substanc/mixtur and of th company/undrtaking If th chmical has bn rgistrd undr RECH, th rgistration numbr must b indicatd in this chaptr. Furthr information on rgistration can b found on pag 5. In som cass, a Safty Data Sht will not fatur a rgistration numbr. Thr ar various valid rasons for this, for instanc du to a chmical bing xmpt from RECH; th chmical is a polymr; th RECH rgistration dadlin has not yt bn rachd. part from th rgistration numbr, this sction also lists th rlvant uss of th chmical substanc or mixtur and, if applicabl, uss advisd against. In this rgard, BSF rstricts itslf to a brif dscription of th us, th us dscriptors ar spcifid in th annx of th Safty Data Sht. Sction 2: Hazards idntification Sinc Dcmbr 1, 2010, Safty Data Shts for chmicals must fatur th classification and labling according to GHS (Globally Harmonizd Systm for Classification and Lablling). Sction 3: Composition/Information on ingrdints This sction spcifis th chmical idntity of th ingrdint(s) of th chmical substanc or mixtur. If th substancs in th mixtur hav bn rgistrd at th Europan Chmicals gncy, for th hazardous ingrdints, this sction also spcifis all th BSF rgistration numbrs rlvant for ths. Sction 8: Exposur controls/prsonal protction If national or EU-wid valid limit valus xist for a chmical, ths will b listd in this sction. If DNEL (drivd no ffct lvl) and /or PNEC (prdictd no ffct concntration) valus hav bn calculatd within th scop of a chmical safty assssmnt, th valus rlvant for th xposur scnarios will b spcifid in this sction. In addition, th protctiv masurs to b hdd ar also spcifid hr. Sction 15: Rgulatory information mong othr things, this sction contains information about whthr th chmical has bn subjctd to rstrictions or rquirs authorisation. In individual cass, you hav to chck rsulting obligations for downstram usrs. This sction also contains information whthr or not a chmical safty assssmnt has bn carrid out undr RECH. nnx Th nw Safty Data Sht may b availabl in th form of an xtndd Safty Data Sht. In this cas, it will hav an annx. 2 3

3 What dos xtndd Safty Data Sht (SDS) man and whn will I rciv on? Undr crtain conditions, th Safty Data Sht will contain an annx with xposur scnarios. In ths cass, th trm xtndd Safty Data Sht is usd. Exposur scnarios dscrib th conditions undr which th chmical can b usd safly. Th xposur scnarios can, abov all, b vry xtnsiv if thy rfr to all th applications of an industrial association of downstram usrs (for xampl ISE, CEPE, and so on). n xtndd Safty Data Sht is rquird undr th following conditions: Th SDS is for a chmical that has bn rgistrd according RECH with th Europan Chmicals gncy (ECH). Th chmical is manufacturd or importd in quantitis > 10 t / a. Th chmical is classifid as hazardous. Which chmicals hav alrady bn rgistrd? Th rgistration rquirmnt applis to all chmicals manufacturd by a lgal ntity in th EU in a quantity of ovr 1 ton pr annum or which ar importd in this quantity into th EU by a lgal ntity. Transition priods xist for all chmicals that wr alrady on th markt at th tim of RECH coming into forc. > 1000 t / a R50 / 53*+ > 100 t / a CMR** Kat t /a > 100 t / a > 1 t / a *R50 / 53 = Vry toxic to aquatic organisms, may caus long-trm advrs ffcts on th aquatic nvironmnt **CMR = carcinognic, mutagnic or toxic to rproduction Click on th following link to display a list of all th substancs that hav alrady bn rgistrd with th agncy by at last on lgal ntity in th EU: 4 5

4 What ar xposur scnarios? Exposur scnarios dscrib th conditions undr which a chmical substanc can b manufacturd, usd and handld safly. Thy ar th outcom of a dtaild risk assssmnt by th rgistrant. Exposur scnarios ar mad availabl to customrs as an annx to th Safty Data Sht. Th xposur scnarios of BSF always follow th sam structur: short titl for th scnario, highlighting th uss assssd. This is followd by a tabl that lists th dtaild conditions (conditions of us such as tmpratur, duration and risk managmnt masurs such as local xhaust vntilation, chmical protctiv glovs) for saf us. Th basic structur follows th rcommndations of th Europan Chmicals gncy (ECH). Th indx of th BSF SDS t BSF, th annx to th SDS faturs an indx of th xposur scnarios to bttr guid our customrs through th BSF SDS. Th indx contains all th short titls of th xposur scnarios along with th corrsponding us dscriptors. Exampl: 1) Formulation & packaging /rpackaging of chmical substancs and compounds SU 3; SU 10; ERC 2; PROC 1, PROC 2, PROC 3, PROC 4, PROC 5, PROC 8a, PROC 8b, PROC 9, PROC 15 2) Us as a monomr /intrmdiat SU 3; SU 8, SU 9; ERC 6a; PROC 1, PROC 2, PROC 3, PROC 4, PROC 8a, PROC 8b, PROC 9 3) Us in coatings /printing inks /adhsivs SU 3; ERC 4; PROC 1, PROC 2, PROC 3, PROC 4, PROC 5, PROC 7, PROC 8a, PROC 8b, PROC 9, PROC 10, PROC 13, PROC 15 list comprising th prcis dscriptions of th us dscriptors (. g. SU 3 or PROC 7 in th abov xampl) can b found in th guidanc documnt of th Europan Chmicals gncy (ECH)

5 What do I nd to do as th rcipint of an SDS? In addition to th chcks prformd thus far in sctions 1 to 16 of th SDS, in th cas of an SDS, th annx also has to b incorporatd into th chcking procdur. ccording to RECH th following procdur is rcommndd: r you daling with an xtndd Safty Data Sht (SDS)? Chcking th contnts of sctions 1 to 16 (.g. obsrvanc of th limit valus in sction 8) Is on of my uss listd in sction 1 as a us that is advisd against? Prparation of a sparat Chmical Safty Rport and notification to ECH Is my us covrd in th indx (incl. dscriptors as pr ECH guidanc documnt 1 ) Do th conditions of us and risk managmnt masurs dscribd in dtail corrspond to th actual conditions on sit? 2 Optional: a) Prparation of a sparat assssmnt b) Contacting th supplir No furthr nd for action towards supplirs Is 'scaling' possibl? (s Practical guid) If working plac limit valus ar kpt th us can b sn as saf for occupational halth & safty. 8 9

6 Glossary of th most important trms usd in th SDS Us dscriptors: Harmonizd dscription of uss with th aid of dscriptors subdividd into: SU (sctor of us): Dscribs th industry (sctor) in which th chmical is usd. PROC (procss catgory): Dscribs th application tchniqus and typs of procsss during th manufactur and us of th chmical, which impact dirctly on th xposur and, as such, on th ncssary risk managmnt masurs. ERC (nvironmntal rlas catgory): Dscribs th faturs of a us that ar rlvant from an nvironmntal protction viwpoint. Various industry sctors hav dvlopd mor spcific dscriptions of th nvironmnt-rlatd conditions of us. Ths ar rfrrd to as spercs. PC (chmical product catgory): Dscribs th us of a chmical substanc by th typ of th ndconsumr products in which it is usd. C (articl catgory): Rlats to th us of chmicals in articls. Emission factors: Th mission factors spcify which proportion of th chmical quantity usd is takn into account as mission into th corrsponding mdia (air, ground, watr) within th scop of th xposur stimation. Rciving surfac watr: In th rciving surfac watr, th mission from a swag tratmnt plant is dilutd. Gnrally, a 10-fold dilution is assumd in frsh watr; for th marin nvironmnt, a 100-fold dilution is assumd. Ths standard assumptions can b adaptd to th actual situation on sit. M-Saf (maximum allowabl sit tonnag): M-Saf dscribs th maximum amount of substanc that can still b usd safly undr th spcifid conditions of us and assumptions (for xampl for dilution). In othr words, M-Saf corrsponds to th amount of substanc with which th PEC/PNEC ratio (RCR) would still just b lss than 1. Contributing xposur scnario: concpt introducd by ECH that maks it possibl to dscrib multipl uss in a structurd form in on ES. complt xposur scnario (ES) consists of on contributing ES rlating to th nvironmnt (ERCs) and on or mor contributing ES rlating to human xposur (PROCs). This form of rprsntation prmits th dscription of diffrnt activitis with various conditions in on ES. PNEC (prdictd no ffct concntration): This rlats to th calculatd maximum concntration of a chmical in th nvironmnt for which no chang to th cosystm is assumd. PNEC can b calculatd for various scnarios (marin watr or frsh watr, air or soil or watr body or sdimnt, swag tratmnt plant or opn watr) and is spcific to th dfind basic conditions. DNEL (drivd no ffct lvl): This rfrs to th dos drivd by taking account of safty factors and which is valuatd as saf for humans. DNEL can b drivd for diffrnt groups of prsons (workrs or consumrs), xposur priods (long trm or short trm), typ of ffcts (local or aftr distribution in th body) and routs of xposur (oral, drmal, inhalativ) and is spcific to th dfind basic conditions. RMM (risk managmnt masurs): Masurs for a chmical, which rduc both th mission and xposur and, accordingly, th risk during us for workrs and th nvironmnt. LEV (local xhaust vntilation): valu for LEV dscribs th ffctivnss with which an xhaust vntilation systm has to b opratd from th manufacturr s viwpoint in ordr to nsur th saf us of th chmical product. RCR (risk charactrization ratio): Th risk that manats from a us is rprsntd by th comparison of xposur and possibl hazard. If th RCR is lss than 1, th saf us of th chmical is nsurd assumd that th conditions dscribd in th scnario ar kpt

7 Whr can I gt mor hlp? Qustions about th Safty Data Sht: n -mail addrss is providd on vry BSF Safty Data Sht. Plas snd any qustions about th Safty Data Sht to this addrss. Furthr information Furthr information is availabl via th following links: RECH Rgulation ECH databas with RECH trms ECH Guidanc Documnt VCI Practical Guid (s Praxisführr/Practical Guid) h s D bn S t G t 2 r h 5

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