lyondellbasell P,w/'4 1 1 Ill Il Safety data sheet accordingto 1907/2006/EC,Article 31 Prinling dat, 17.05.2012 Version5 &vision: 12.04.2012
• l ldl'IIII{" ill/<111 of 1!1,· \lif11li1111 <' 11u11111 e a11d of rh,·, 0/JIJ'lflll' 1111d1'1111hm,:
-Prod11ctIden tifier - Trlllk name: PunitPE 1840 H -Arttckn1111Jber: 17751 -C.SN11mbt!r: 9002-88-4 -Rete,,,u,tùlen tijierlusà ofthe sulmanu ormbtture and uses adwsd against -AppliCtlliot, ofthe nbstuce I theprep,tndion Synthetic ,cs/11 -DdJülaof the SMppliero f the• tift!IJI dŒtaslm:t ·Mtu111fut11r,r/S"Pplier:Lyondel1Ba,ell lnd11&tries -lnformlllgt/epllrtmMJ: RegulatoryA ffalrsDepartment &search center G. Natta,Bass// Poliol�fine Italia ,.r.l., 4./100-Ferrara (Italy) Phone:+39/0532/468653; h 8.30-17.00 Fa:x.: + 39/0532/.168820 -Emergencytdq,l,Olf• n11mber:MSDSin [email protected]
l //11 au/\ u/,•1111/h allo�
- a.aif"u:admt ofthe subsfaNceor nwclllre - Qusljlcadml aecordingto /ùgfl l4llon(EC) No 1272/lfJOIJ The811bstance is not c/ass/jiedaccording to the CLP regulalion. - Cluslficatlon accordingto Directive67/541/EEC or Directive1999/45/EC Void -In/orPIUdionconcendng parti,:ular l,,wud& forl,11111411 ani environmMt: Tiit m,,/ten prodJlctadherrs to the sk/11a,.,J causes burnr. Spilledmateria/ may present a slipping hazurd. - a.nijicttlionsystem: Thisproduct is, accordlngto EEC dincm ..!)99145, J 6715-#J,Regulation 190712006/EC, and Jo/l""'•ingamendmentJ, no/ c/ossified oshazardow. -Lt,bdek,,t.,,r,, -Lobdllng accordingto EUgulù/û,ea: Not cl,m/jied - OtherI,a:ari• -Resllltsof PBT and �hB usasmart -PBT: Not applicable. - vhB: Not applicable.
i ( {J/11['0\fllOJJ ffl/Olllll/{/011 O}l lll!_;li'lflt'I/ 1
-C1iemlcalcl,art1cterlzatwn: S..battmcn - CAS No.IH rignatiml 9002�8-4 1-ethene homopolymer -Dat,rlption: Lowdensl lypolyet hylene
..J 1·11 \/ Ill(/ lltl'/1\/{/ ('
-Dncrlptwn of jint11ii meailllru - Generalin fonnatiml At room temperatun the produ<:tis neither an irritant nor gt,,e, offhazardous,•apoun. Th• m•asure1ll1ted below applylo critlcal s/1Uatlo11S (Fire, incorrectprocess conditionr ). -Afterlnhal4tlon ln case of excer,/ve illha/ationo ffinnesmove th• p,rwonto fresh air. Cali /or medica/help. -Ajterriin contact Aflor contact with the mo/ten product, cool raptdlywith cold water. Do no/ p..JIsolidi fied producl awayfro m th• skin. S•ek immediatemedical advice. -Aj'terey e contact Rinre opened eye for sn•eralminutes utuierrunning water. -Ajterswallawùrg No specijic meosures luwe to be talamif the productls swallowed -lnfornwloi,for doctor -Mostimportm, t qmptomsand eff ects, bolll ac11tet111d deuzyei No farth•r relevant i,ifonnation avatlablt. -lndictùlon oftmy lnuluiiate medictd llltentlon and spa:iallredtllrent nt!t!tldNo farther ,..,,,.,an,in formation a,•a/lahle.
) f II C/1!.j!t!JII!{ IJll'fl\l/J ('
-E;xti,,g,,àliingINt!IIJ11 -S.Jtabkexfùrg11ishing agotts Walerhaze Foam Chemical powder -For stifetyrellSOIIS ""mitable extingulahln g 11gmts Water jet. -Spedalhll%dl'IÜ ulsingfrom tJ,e s11bstaP1ce or Jnbctllre ln case offire it can re/eose water (H20}, carbon dioxltk( C02), and when /acklngœcygen ( 02), carbon monoxltk (CO) Th• products o/the bW'11ingan dangcrour. -Atlvlcefor jlN/ig ltters -P7otectiw,q11lpment: Us, a maskwilh 1111n>ersalfi/ter. Use seif-conlained bnathingapparatur wllhln conjinedrooms. -AdtlilionalIn formation Heat ,·almr: 12,2 kw,,,ig
6 1 ( ( 1(/i'lllilf I efell\(' J!l('{l\lll t -PersOlffll,,,_allons, pro1et,tive aJll ipment ani e,nergencyproceduns Pa11iculardanger of 1/lpplng on /eakedlspilledproduc/. Seepolnt8 -Enllironmentalprec11u timls: No specialmeasurrs rrquirrd. See points 12 allJi13. (C...td. an2) page œ
14.107.10 / 14.107.12 lyondellbasell Page2r4 1 1 Ill Il Safetydata sheet accordlngto 1907/2006/EC,Article 31 Prinlingdate 17.05.2012 VersionS Reei,ion: 12.04.2012
Trade1ttJ11U: l'Nrell PE 18'0 H
(Contd.of-1) • Mdflodsand mlllerÛllforr:ontllinment ar,d clanÎllg llp: Recycleproducl or disposeproperly. See point 13 • Referoiuto "'110ttetit»,s Colite/ sp/1/ed polymer:Il could cause/ails (Danger of slipping).
- lla11d/111� """ \foi (t� ·H111111/ing ·Prectlllti0111forsafe lt1J11dlb,g No special requiremen1111
@ Do not smou.
Grormd•quipmenl eleclrlcally. Open jlamts prohibited -1,iformfdior,11bout Jdor11g2 in Olle commtJII 1ùn'agefacilJJ;y:Not l't!q,ured -Furtlleil,for111Mlon aboM t � conditions: Protectfrom hea/ and direct sun/igl,I. Store container ln a wellventllated position. Storermder dry condilions. Do not ,tacleup the octobi,u. -Specifœ e11due(fJ For sllfe stackingfollawthe storagenccomendat/om apecljlc for this prodltct
S L 111 \flO\ltf c < 111111 o/\,pO \0111t! ote, u, 1 7. -AddJtiOlflllinforPlllllion obotll design oftecllnical systelffl: No fortherdata; ••• Item • Cor,tro/.pt1rameltn • Con,polfet1/switll lllflitwù11es tltat,..,,.,ire m011itoriJJg at tlte worllploce: Not required. ·AdtiiluJnlll�re limit Vlllilesfor ponlbk processi11g d011gers: 101.(}2-8 IIC1)>Wdeflyde 7 WELO Short-term,.,,ru., O. mglm', 0.3 ppm I Long-ternivalue: 0.23 11,glm� O. I ppm 5�0 fo,,,.,.lddtyde WEL O Shorl-termvalue: 2.5 mgln1� 2 ppm ILong-ternivalue: 2.5 nrgln,•, 2 ppm U-18°6 fom,lcacid WEL IO Loirg-term value: 9.6 mglm', 5 ppm -Addmm111l iltfar"""1or,: Vo1d -ExpoBllre contrais -PasonalprotectiuiltJlliplfunt - Ge1tel'IIIprotectlu Olld llyg{et1{c me1111llraDo not eat, drinkor ,mo/œwhi/e working. -Brathllfget/Uipmat: Use breathingprotection in ca,e ofinsufficienlventilation. -Proùdior, o/ltalfb: Healresi•tant gla.e• -M•tmal afgloves The ,e/ecllon ofthe sultan/• gim'l!sdoes nol onl.vdep,md on thematerlal, bul also on farthermarks qr,a/ity of and w1rlt1 /rommamifactuNr lo mamlfacturer. -Pttnl!Ùfltiolllime of glou mareri11/The exact break/rougir lime hasto be jinmdoui bythe mtmufactw'frof the protectivo gfm•es and has to bo obJerved -Eyeprotection: Not requlred.
- 11rn/ 11111/, 1 Y l'/11 hoJ/lc ol f" 01101" • 111/onttldion Oii baiepllysù:al and cltemlcalp,opertiu • Ger,ert1ll11for,,,lltion -Appeututce: Form: Pellets Co/Dllr: Neutra! variou.s colours -Odmu: Nearlyodourl••• -Cl,,u,geffl COPltiJtlOII Meltbrgpoir,t/Meltittg rt111ge: 50-140-C BoUillgpo/lft/BoiUng range: Nol applicable -F7,uJ,po int: Nol applicable (see al/achnrent to guidelint 92169/EEC.A.9) -/gllltiontempt:rabl,e: > 160"('
-Dar,ger of e,cplosion: Prodr,ctis oor7. e:rplostve. Seepolnt(s) -lhllsity Ill10"C 0.9-0.97 g!cm3 -Soblbllilyln/ Mlsclbility willl w.,..,., Insoluble (Cootd. ru,pogc 3) L-����������������������������������������������������oe
14.107.10 / 14.107.12 lyondellbasell Page314 l 1 111 11 Safety data sheet accordîngto 1907/2006/EC, Articl� 31 Prinlingdate 17.05.201] Version 5 &vision: Jl.04.2012
Trade name: PurellPE 1810 H
So/ubl• in bolllng. aromatlc ch/or/natedscm•ents.
Ili .\111/11/111 1111d 1,·1"'" r
-RuctivU,· -Chemlcalstabillly - Ther11UJId,;co,npa111tûm / conditionsto be IIVOÜled: Theproducl ;, stable when hondledand stored under normal conditions. Decamprues over J60 "C. -PouibiJJtyo f l,az,mlos,sreAdions Na dangerousreaclions known -Condltkmsto •voùlNo fintht!rrele,·ant informationaval/able. -lncomplllible matoials:No fartherrelevant Informai/onaval/able. -Haza.rdos,sdttomposflfon products: No hazardousdecomposition products lmown al room te�ratun.
I J 1 O\holo�1c al 111/()I 11wt11 , • Informationon tuxicologic,def! ttts -A.Ciiietoxidty : . Primaryirrittuit ef! ut: -an theskiti: No i"ilanl ejfect. - on the eye:No Irritant affect. -Serisiliulu>n:No sensitizingeffect larown. -AddJIJmtaltaxlcohigical itifomuuion: When w;ed and hmuiledaccording la specifica/lons, the praducl do,s 1101have any han,iful effecrs accordlng lo our experlenceand the leformationprovided IDIIS,
I: L( ofo�u al 1u/0111uff111�J
• Toxkity -A.qualktoxic fly: Nofarlher ref""anl h iformation availahle. -PersistBtceIUld tùgrad ttl,illtyNo fiirther relevantInformation availahle. -00.erillfar""'tû»t: The productis nor hlatkgradahle. -B1h111/ÛJJ/rmvironme11tlll ÛI tfYdemr: -Bioaccumulativepotutlal Floatron wator. There ls no hloaccumula/lon. -Mobilityü, sollNo farther relevant Information ,m,ilable. -Addltlon•lecolagict1l inf ornulllon: -Generalnota: Thepl'Oduct is nol loxlc, sma/1parlicles con have phy.rical effectJ on water andsoi/ organimls. -RllSllllsof PBT ,u,dvPvB ,w;essment -PBT: Nol Qf'Pllcable. - vPvB: Not Qf'Plicahf,. • Otheradvern: ef/ twtsNo fiO'lher relevant informai/on aval/able.
f) J )fl,f)ll\(I/ ( 01/Hd('ltffl(}J � - Wamtreatmerit mdl,ods -Recommettütlon Reuse or recycle Ifpossible. Dl,posal ihroughcontrolled incineratlon or authnrlaedwasle dump. -Europe,u,wtUte C11111log,,e 070213 - u11cleat1aJ14clragings: -Recummendatùm:Disposai must be dane accordi11gto officialngrJatiom.
11 J t ,,,,,11011111/tJJ 111,11w - UN-N11mhl!r -ADR, ADN, JMDG, IA.TA. Void - UN propershippi,,g name -A.DR,ADN, JMDG, IA.TA Void -Trt111,porth,u;artl cl11U(a} -ADR, ADN, JMDG, IA.TA -Oass Void -PIICkillggros,p -A.DR,IMDG, JATA. Void
-Speci,dpreca,,tiou for tuer -TrtulsportIll bullr accordûrgto Ânnex 11 ofMARPOL73178 """the JBC Code Not applicable. -Transport/AdditionalInformation: Accardingto nallonal andinternational gui L..����������������������������������������������������o• (Contd. onpap4) 14.107.10 / 14.107.12 lyondellbasell Pu�4-'4 I t 111 Il Safety data sheet accordingro 1907/2006/EC, Article 31 Printingdute 17.05.2012 Ver,lo,,5 Revision: 12.04.2012 T,,ulename: Purell PE 1840 H (Collld. ofpqo 3) / i Re:.:ulllro,r n1fu11u111uli -Sll/,tty,lua/Jlj ad mllÛOnmentlllrepltlttonsllq:islation sp«/Jic for tlles11bst1111ce mixture or -Deslg"lflioltaccording t,, EC gulddùtes: Not c/assified - Cl,emiclllsafety assessmmt: A Chemical SafetyAssessmenJ has no/ been ca"ied 0111. IMM&INMMThe Information suppuea nas oeen oosedupon ,ne currenr ,cvef oJ rn;ormanor, uvailable, for the purpose of specljj,lngthe requirements regarding environmenl, health and safely in conjunclion wlth the prodircl. They are nol to be interpreted as a warranly for specific producl characleristlcs.L.vondellbosell1a/œs no responslbllltyfor inapproprialeuse, processing and handlingby purchasers and users ofthe producl. -D�nt ü;s,,ürgdata ,q,edflcatitmshm: RegulaloryAffairs Department Researr:hCenter G. Natta, Ba,e/1 PoliolefineItalia s.r.1.- 44100Ferrara (Ira/y) • Colllut:Regulatory Ajfairs Doparrmen/ • Bibl/ography: - Dirtctiv• EEC 67/548 andfollowingadaptions • Directive 1999145/EC,os amended - 1907/2006/EC • Directive2001/58/EC (repealedby (EC)190712006) -RTECS (Registryoftoxic effecllof chemical substance, 1985-1986 edition) - EINECSIELINCS (REACH) -Frostllng.Hof.Jacobson,PfajJli,Zllllng."Thennal decomposition products from plastics •,-PolyethyletW and stircne (1982) -Abbrevilldoldacronyms, ad ADJ!; J.«ord.,.,.,,.,...,, i. d,rtruJuporl mardw,rd;ustlan g,,nusuRoNI• ,- (E•rapeœ,h;ru...,., coJl 14.107.10 / 14.107.12 lyondellbasell 1 1 Ill Il Regulatory Affairs Product Stewardshiplnformation / Certification Data Sheet (RAPIDS) Pure// PE 1840 H Product Manufacturer and/or Supplier This product is supplied by Basell Sales & Marketing BV This product is manufactured by Equistar Chemicals, LP. REACH {Requlation (EC) No. 1907 /2006) This product ls manufactured by affiliates and subsldiaries of the LyondellBasell group of compantes around the world. Under the EC Regulation REACh thls product is classifled as a preparatlon. If the product has been purchased from Basell Sales & Marketing Company B.V. BSM), we confirm that all substances of this preparatlon are compliant with the pre-registratlon requirements of REACh, and that we have the Intentions to proceed with the registration of these substances, or to procure substances only from suppliers from which confirmation has been recelved that the suppllers are aware of thelr REACh requirements, that they have pre-reglstered and/or wlll tlmely register their substances, and that they will supply the relevant Safety Data Sheets (SOS) with REACh reglstration numbers as soon as the registrations occur. BSM shall in no event be liable for any non compliance deriving from false or Incorrect statements of its suppliers. We remind you, if thls product ls purchased from any supplier other than BSM, includlng other companies of the LyondellBasell group, the importer into the European Economie Area (EEA) is responslble for compliance wlth the requirements of the REACh Regulation. Please contact our helpdesk If you need to discuss the potential compllance wlth REACh before lmporting this product lnto theEEA. Substances of Very High Concern (SVHC) This product does not contaln any of the Annex XIV candidate chemicals proposed to be Substances of Very High Concern (List as of June 18, 2012) above the 0.1% threshold as stated in REACH (Article 57, Regulation No. 1907/2006) determlned elther through (1) non-use of the substance, (Il) mass balance calculation, or (iii) speciflctesting. The current llst of all SVHCs can be found at the followlng link to the ECHA website: http:// echa .europa .eu/web/guest/ candidate-list-table Chemical Inventories Ali ingredients ln this product are ln compliance with the following chemical inventories: United States: Toxlcs Substances Control Act lnventory (TSCA) 14.107.10 / 14.107.12 Canada: Domestic Substances List (DSL) Europe: EINECS/ELJNCS replaced by REACH Australia: Australian Inventory of Chemlcal Substances (AICS) Korea: Korean Existing Chemicals List (KECL) Japan: Japanese Inventory of Existing and New Chemical Substances (ENCS) The Philippines: Philippines Inventory of Chemicals and Chemical Substances (PICCS) China: Inventory of Existing Chemical Substances Manufactured or Imported in Chlna(IECSC) New Zealand: New Zealand Inventory of Chemicals {NZioC) This product has no special requirements under US TSCA {e.g. consent orders, test rules, 12{b) requirements, etc.). Food contact European Union (EU) Food Contact This product complies with the relevant requirements of Regulation 1935/2004/EC (Framework Regulation), applicable to intermediate materials (e.g. plastic powders, plastic granules or plastic flakes}. This product complies with the relevant requirements of Regulation 2023/2006/EC (GMP), applicable to intermediate materlals (e.g. plastic powders, plastic granules or plastlc flakes). This product complies with the relevant requlrements of Regulation 10/2011/EC (PIM) as amended, applicable to intermediate materials (e.g. plastic powders, plastic granules or plastic flakes). The monomers and additives used to produce this product are listed in the Union List of Authorized Substances of Regulation 10/2011/EC. Dual Use Additives Dual use additives subject to restrictions in food as deflned in Regulation 10/2011/EC are not intentionally used in the manufacture of or formulation of this product. EU Regulation 10/2011/EC speclfies 10 mg/dm2 as the maximum overall migration (OML) from the finished plastic food contact material or article. The OML and SMLs (when applicable) should be determined according to the requirements specified in EU Regulation 10/2011/EC. The OML and SML determinations are the responsibility of the manufacturer of the finished plastic food contact materlal or article. In addition, we remind you that the manufacturers of the finished food contact material or articlemust verify that the finlshed material or article, manufactured according to good manufacturing practices, does not modify the organoleptic propertiesof the food. There are NO restrictions (SML;QMA) specified by the EU regulation 10/2011/EC for the components (monomers and additives) of this resin. The composition of this product complies wlth the following National Legislatlons, Recommendations or Communications for the production of food packaging. AUSTRIA: "K.V.O." N.476/2003 as amended at last by BGBI -Teil. Il - N.140/2009 BELGIUM: "Arrete royal du 5 juillet 2006 (amending Arrete royal du 11 mal 1992 and modlfying "Arrete royal du 3 juillet 2005") DENMARK:Bekendtgorelse N.579 (01/06/2011). 14.107.10 / 14.107.12 FINLAND: "KTM", Paatos 953/2002 of 12.11.2002 {amended by 107/2009 of 03/03/2009) FRANCE: "Materiaux au contact des aliments et de denre destine a l'alimentation humaine" Brochure n.1227 edition Janvier 1994 as updated. Arrete du 02 Janvier 2003 (as modified at last by Arrete 03/09/2010). GERMANY: Bedarfsgegenstaendeverordnung- 07 February2011 {BGBI I S.226) BfR Recommendation III - Polyethylene (last update as 01.01.2010) GREECE: AXE Decislon n.458/2003 modified by Decision n. 6/2011 IRELAND: S.I. No. 587 of 2007, as amended by S.I. No.301 of 2010 ITALY: "Decreto Ministeriale del 21/03/1973" amended on 26/4/1993 : D.M. N.220 and following updates (last update: D.M. of 16/02/2011). LUXEMBOURG: "Reglement Grand-Ducal" n. 163 du 05/11/2008. NORWAY; Regulations 21 December 1993 No 1381 on materials and articles intended to corne into contact with foostuffs Chaper I General regulations, as amended. PORTUGAL: Decreto-Lei n.o 62/2008 of 31/03/2008 and Amend. Decreto-Lel n.0 29/2009 of 02/02/2009 SPAIN: Real Decreto N.118 31/01/2003 modified by Real Decreto N.103/2009 of 06/02/2009. SWEDEN: Ordlnance of the National Food Administration on materials and articles lntended to corne into contact with foodstuffs LJVSFS 2011:7. THE NETHERLANDS: Staatscourant n.6861 of 06.05.2010. ENGLAND: "The Plastic Materials and Articles in Contact wlth Food (England) Regulations 2009" , Statutory Instrument 2009 n.205 SWITZERLAND: BGVO 817.023.21 of 23 November 2005, as amended. CZECH REPUBLJC: Regulation of the Ministry of Health N.551/2006 modifying N.38/2001 US Food and Drug Administration (FDA) The base resin in this product meets the FDA requirements contained ln the Code of Federal Regulations ln 21 CFR 177.1520(a)(2)(1) and (c)2.1, 2.2. According to our information, all other ingredlents used in thls product meet the requirements of their respective FDA regulations and 21 CFR 177.1520{b). This product meets the FDA criteria ln 21 CFR 177.1520 for food contact applications, including cooking, listed under conditions of use A through H in 21 CFR 176.170(c), Table 2 and can be used ln contact with ail food types as listed in 21 CFR 176.170(c), Table 1. Tallow Tallow derived additives are not intentlonally used in the manufacture of or formulation of this product. Bovine Sponqiform Encephalopathy {BSE)/Transmissible Sponglform Encephalopathy {TSEl/"Mad Cow" We do not use components derived from animal sources in the manufacture of or formulation of this product. Kosher 14.107.10 / 14.107.12 14.107.10 / 14.107.12 Packaqinq and Packaginq waste - EU Directive94/62/E C {as amended) Cadmium, chromlum (VI), lead and mercury are not used ln the manufacture of or the formulation of this product. This product meets the year 2001 requirements of less than 100 ppm for total lncldental cadmium, chromium {VI), lead and mercury. In addition, this product has the potentlal to be recycled accordlng to these requirements. California's Safe Drinking Water and Toxic Enforcement Act of 1986 {Proposition 65) This product presents "no significant rlsk" for cancer to the people of California. This product contains no substances known to the State of California to cause reproductive toxicity at a level of exposure subject to the requlrements of Proposition 65. BHT [butylated hydroxytoluenel {CAS number 128-37-0)/BHA [butylated hydroxyanisolel {CAS numbers 121-00·6 and 25013-16-5) BHT and BHA are not used ln the manufacture of or formulation of this product. However, this product has not been tested for these chemical substances. Ozone Depleting Çhemlcals{ODCsl Class I and Class II ODCs listed in the US Clean Air Act Amendments of 1990 are not used in the manufacture of or formulation of thls product. The ozone-depleting substances {ODS), listed ln the Annexes I 8t II of the Regulation { EC ) No 1005/2009 of 16 September 2009, are not lntentionally used in the manufacture of or formulation of this product. This product complies wlth the requirements ln CEN Standard EN71.3. The phthalates listed in Annex of Directive 2005/84/EC ( Annex l of Directive 76/769/EEC) are not intentionally added in the manufacture of or the formulation of this product in a concentration above the given limits. Phthalates Phthalates are not used ln the manufacture of or the formulation of this product. Acrylamide (CAS number 79-06-1} Acrylamide is not used in the manufacture of or the formulation of this product. However, we do not test this product for acrylamide. Aromatic Amines Aromatic amines are not used in the manufacture of or formulation of this product. However, this product has not been tested for these chemical substances. Asbestos Asbestos is not used ln the manufacture of or formulation of this product. However, we have do not test thisproduct for asbestos. Bisphenol A [chemical name: 2.2-bisf4-hydroxyphenyllpropanel {CAS# 80-05-7) Bisphenol A is not used in the manufacture of or the formulation of this product. However, this product has not been tested for this chemlcal substance. 14.107.10 / 14.107.12 Dioxln ls not used in the manufacture of or formulation of thls product. Dioxin ls not known to be formed during processlng of this product. Epichlorohydrin (CAS number 106-89-8) Epichlorohydrin ls not used in the manufacture of or the formulation of this product. However, we do not test this product for epichlorohydrln. Nonylphenol (CAS number 25154-52-3)/Nonylphenol ethoxylates Nonylphenol and Nonylphenol ethoxylates are not used in the manufacture of or the formulation of this product. However, thls product has not been tested for these chemical substances. Alkylphenol Alkylphenols are not used in the manufacture of or the formulation of this product. However, this product has not been tested for these chemical substances. Organo-tin Compounds Tributyl-tin {TBT), dibutyl-tin (DBT), monobutyl-tln {MBT) or any other organo-tin compounds are not used ln the manufacture of or the formulation of this product. However, this product has not been tested forthese chemical substances. Polychlorinated Biphenyls {PCBs), Polychlorlnated Terphenyls (PCTs), Polychlorinated Naphthalenes {PCNs), Polybrominated Biphenyls lPBBs), Polybrominated Diphenyl Ethers {PBDEs} and PolybrominatedJerphenyls {PBTsl Polychlorinated blphenyls (PCBs), polychlorinated terphenyls (PCTs), polychlorinated naphthalenes (PCNs), polybrominated biphenyls (PBBs), polybrominated diphenyl ethers {PBDEs) and polybrominated terphenyls (PBTs) are not used in the manufacture of or formulation of this product. However, this product has not been tested for these chemlcal substances. Styrene(CAS number 100-42-5) and Polystyrene Styrene (chemical name: ethenylbenzene) and polystyrene resins are not used in the manufacture of or the formulation of this product. However, we do not test thls product for these chemical substances. Vinyl Chlorlde (CAS number 75-01-4) and Polyvinyl Chloride (PVCl Vinyl chloride and PVC resins are not used in the manufacture of or the formulation of this product. However, we do not test this product for these chemical substances. Tris-Nonylphenol phosphite (TNPP) (CAS number 26523-78-4) TNPP ls not used in the manufacture of or the formulation of this product. However, this product has not been tested for this chemical substance. Benzotriazole and 2-Mercaptobenzothiazole(MBT) 2-(2H-1, 2, 3-Benzotriazol-2-yl)-4, 6-d i-tert-butylphenol [ also cal led 2-(2 '-Hydroxy-3' ,5'-di -t-butylphenyl) benzotriazole] (CAS No. 3846-71-7) and 2-Mercaptobenzothiazole [also called 2(3H)-Benzothiazolethlone or Benzothiazole-2-thiol or MBT] (CAS No. 149-30-4) are not used in the manufacture of or formulation of this product. However, this product is not tested for these substances. Regulation (EC) N.1895/2005 BADGE, NOGE and BFDGE are not used in the manufacture of or the formulation of this product according to requlrement of Regulatlon N.1895/2005. Nanomaterials 14.107.10 / 14.107.12 NANOMATERIALS (insoluble or biopersistent and intentionally manufactured materials with one or more extemal dimensions, or an internai structure, on the scale from 1 to 100 nm ) are not used in the manufacture of or the formulation of this grade. However, this product has not been tested for these chemical substances. Polycyclic Aromatlc Hydrocarbons {PAHsl We do not intentionally use the following polycyclic aromatic hydrocarbons {PAHs} in the manufacture of or formulation of this product: 1,2-dihydro-acenaphthene (CAS# 83-32-9) acenaphthylene (CAS# 208-96-8) 9H-fluorene (CAS# 86-73-7) anthracene (CAS# 120-12-7) benz(a}anthracene {CAS# 56-55-3) benzo(a)pyrene (CAS# 50-32-8) benzo(b)fluoranthene (CAS# 205-99-2) benzo(e)pyrene (CAS# 192-97-2) benzo{ghi)perylene (CAS# 191-24-2} benzo(j)fluoranthene(CAS# 205-82-3) benzo(k)fluoranthene (CAS# 207-08-9) chrysene (CAS# 218-01-9) dibenz(a,h)anthracene (CAS# 53-70-3) fluoranthene(CAS# 206-44-0) fluorene (CAS# 86-73-7) indeno(l,2,3-cd)pyrene {CAS# 193-39-5) naphthalene {CAS# 91-20-3} phenanthrene (CAS# 85-01-8} pyrene (CAS# 129-00-0) However, we do not test our resins for these substances. Dlmethyl Fumarate {DMFl - EU Commission Decision 2009/251/EC Dimethyl fumarate [2-butenedioic acid (2E)-, dimethyl ester] (DMF) (CAS#: 624-49-7) ls not used ln the manufacture of or formulation of thls product. However, we do not test this product for DMF. Plasticizers (e.g. DEHA, DINCH, BTHC. TOTM. etc.} The following chemlcal substances are not used ln the manufacture of or formulation of this product: DEHA bls(2-ethylhexyl) adipate - Cas. N.103-23-1 DINCH 1,2-Cyclohexanedicarboxyllc acid, 1,2-diisononyl ester, Cas N. 166412-78-B BTHC butyryl tri-n-hexyl citrate CAS 82469-79-2; TOTM tris ( 2-ethylhexyl) benzene-1,2,4-tricarboxylate CAS 3319-31-1 Glycerides, castor-oil mono-, hydrogenated, acetates CAS. N.736150-63-3 However, we do not test our resins for these substances. Trlclosan(2.4.4'-trlchloro-2'-hydroxydiphenyl etherl - Commission Declslon of 19 March 2010 -{2010/169/EUl Triclosan (2,4,4'-trichloro-2'-hydroxydiphenyl ether} Cas. N.3380-34-5 is not used in the manufacture of or formulation of this product. However, thls product has not been tested for this substance. Switzerland "VOC-LENKUNGSABGABE" This product contains less than 3% VOC's of the substances in the positive lists of the above Regulations. Restriction of Hazardous Substances in Electric and Electronic Eguipment (RoHSl At the light of our aknowledge, - PBDE - PBB - Chromium (VI) 14.107.10 / 14.107.12 - Lead - Mercury • Cadmium are not used nor intentionally added in the production of the resin. For a coloured grade, pigments/colourants may contain traces of the above heavy metals. The incidental sum of thetr concentrations does not exceed the limlts established by Declslon 2005/618/EC Composting - CEN Standard prEN 13432 This product rs not sultable forcomposting. Energy Reçovery - ÇEN Standard prEN 13431 The calorific gain from polyethylene in an energy recovery process is 22 MJ/Kg Ultimately customers must make their own determination that their use of our produçtis safe. lawful Cexcept as provided in the above certifications) and technically suitable in their intended applications. Because of possible changes in the law and in regulations. LyondellBasell recommends that çystomers contlnuing to use our prodyçt yerjfy status every year from the issue date of the RAPIDS. Certified by : Richard T. LeNoir Manager, NA Regulatory Affairs and Product Stewardship (Product Safety} LyondellBasell Coporate HSE/Product Safety Lyondell Chemical Company a LyondellBasell Industries company Newtown Square Technology Center 3801 West Chester Pike Newtown Square, PA 19073 USA Phone: 610-550-3242 Cell: 302-438-0988 email: [email protected] cO. j)JQ._A_. Alessandro Medri Corporate HS&.E Product Safety Manager - Europe Basell Poliolefine ItaliaS.r.l. a LyondellBasell Industries Company Centro Ricerche "G.Natta" P.le Donegani, 12 44100 - Ferrara - Italy Phone : +39 0532 467516 Fax : + 31107160863 E-mail : [email protected] Approved on Friday, July 20, 2012. Valid for1 year. 14.107.10 / 14.107.12 G)basell Polyolefins May 04.2006 ATI'N: DrugMaster File Staff Centerfor Drug Evaluation and Research Prot.PB/1Dp/171S7 Foodand Drug Administration CentralDocument Room 5901-BAmmendale Road BeltsvilleMD 20705-1266 To WhomIt MayConcem: Grant of Permission to Refer to Conf"ldentlal Information Supplled to the Food and Drug Administrationby Duel EuropeDrag Muter File 8410 BasellEurope hereby permissiongrants to theFood and Drug toAdministration utfüze c:onfideotial datasupplied by Basell relativeto Purell PE 1840H for thefollowing purposc: To supporta NewDmg Application or other applicationssubmltted. by: HelnleinPlastlk GmbH lndustrlestr.7 91522 An1bach Germany for theuse of PurellPE 1840 B reslnID NDA . The authorization is limitcd to information contained in Basell Confidential Drug Master File 8410 which you haYc establishcd for us. This letter docs not grant authorization to disclose the aforesaid confidential infonnation to Hcinlcin Plastik GmbH. Any additional pertinent information on this product or revisions in the Drug Master file will be submitted to the Food and Drug Administration by Bru;ell Europe. Purell PE 1840 H will be ma1mfactured in accordance with said Master File and in compliance with cuJTent GoodManufacturing Prac tices. Yours truly, PatriziaBusi � ;?' RegulatoryAffa irs )1E pe Manage r File:DMF 8410 Hcin1einOOOA:01 Soci.tà aoggoltaI Dliezlone Bueil Polloleflne lralla5.r.l. Ufflcl Commercial! e Coonllnamentodl SecleLegale PIUD tndro Montan1tlll ZD Uffld Ammlnlstrallvl llaHllltalr Holding s.�I. ViaG.I. r.i111olesl 25 1-2001»9 SestoS. Ctov;innl Ml PlazZale C, Don� 1 Z R1glstn1 lmpNH dl Mllano l-201Z4Mllano Tel: +39 02 243421 1-441 OO Ferraia Codlce FI� 1 Partita !VA c.p. Soc.41 180.000.000 l.v. Fu: +39 oz2434 ZIIOO Tel:+39 0532 46 7111 14.107.10 / 14.107.12 Basell Polyolefine- Rapids Preview Page 1 of 8 lyondellbasell 1 1 Ill Il Regulatory Affairs Product Stewardshiplnformation / Certification Data Sheet (RAPIDS) Pure// PE 1840 H Product Manufacturer and/or Supplier This product îs supplied by Basell Sales & Marketing BV This product ls manufactured by Equlstar Chemicals, LP. REAÇH {Regulation {EC} No. 1907 /20061 This product is manufactured by affiliates and subsidiaries of the LyondellBasell group of companies around the world. Under the EC Regulation REACh this product is classified as a preparatlon. If the product has been purchased from Basell Sales & Marketing Company B.V. BSM), we confirm that all substances of this preparation are compllant with the pre-registration requirements of REACh, and that we have the intentions to proceed with the registration of these substances, or to procure substances only from suppliers from which confirmation has been received that the suppllers are aware of thelr REACh requirements, that they have pre-registered and/or will timely register thelr substances, and that they will supply the relevant Safety Data Sheets (SDS) with REACh reglstration numbers as soon as the reglstrations occur. BSM shall in no event be liable for any non compllance deriving from taise or incorrect statements of its suppllers. We remlnd you, if thls product ls purchased from any supplier other than BSM, including other companies of the LyondellBasell group, the importer into the European Economie Area (EEA) ls responslble for compliance with the requirements of the REACh Regu\atlon. Please contact our helpdesk If you need to discuss the potential compliance with REACh before importing this product into the EEA. Substances of Very High Concern {SVHC) This product does not contain any of the Annex XIV candidate chemicals proposed to be Substances of Very High Concem (List as of December 19, 2012) above the 0.1% threshold as stated in REACH {Article 57, Regulation No. 1907/2006) determined elther through {i) non-use of the substance, {il) mass balance calculatlon, or {iii) specific testlng. The current list of all SVHCs can be found at the following link to the ECHA website: http:// echa .eu ropa. eu/web/ g uest/candi date-l lst-table Chemlcal Inventories Ali lngredients in this product are in compliance with the followlng chemical Inventories: United States: Toxics Substances Control Act Inventory {TSCA) 14.107.10 / 14.107.12 Basell Polyolefine- Rapids Preview Page 2of8 Canada: Domestic Substances List (DSL) Europe: EINECS/ELINCS replaced by REACH Australla: Australian Inventory of Chemical Substances (AICS) Korea: Korean Exlsting Chemicals List (KECL) Japan: Japanese Inventory of Existing and New Chemical Substances (ENCS) The Philippines: Philippines Inventory of Chemicals and Chemical Substances (PICCS) China: Inventory of Existing Chemical Substances Manufactured or Imported ln China(IECSC) New Zealand: New Zealand Inventory of Chemicals (NZioC) This product has no special requirements under US TSCA (e.g. consent orders, test rules, 12(b) requlrements, etc.). Food contact European Union (EU) Food Contact This product complies with the relevant requirements of Regulatlon 1935/2004/EC (Framework Regulation), applicable to intermediate materials (e.g. plastic powders, plastic granules or plastic flakes). This product complies with the relevant requirements of Regulation 2023/2006/EC {GMP), applicable to intermediate materials (e.g. plastic powders, plastic granules or plastic flakes). This product complies with the relevant requirements of Regulatlon 10/2011/EC {PIM) as amended, applicable to intermediate materials (e.g. plastic powders, plastic granules or plastic flakes). The monomers and additives used to produce this product are listed in the Union List of Authorized Substances of Regulation 10/2011/EC. Dual Use Additives Dual use additives subject to restrictions in food as deflned in Regulation 10/2011/EC are not intentionally used in the manufacture of or formulation of this product. EU Regulation 10/2011/EC specifies 10 mg/dm2 as the maximum overall migration (OML) from the flnlshed plastic food contact material or article. The OML and SMLs (when applicable} should be determlned according to the requirements specified in EU Regulatlon 10/2011/EC. The OML and SML determinations are the responsibility of the manufacturer of the finished plastic food contact materlal or article. In addition, we remind you that the manufacturers of the flnished food contact material or article must verlfy that the finished materlal or article, manufactured according to good manufacturlng practices, does not modify the organoleptic propertles of the food. There are NO restrictions (SML;QMA) specified by the EU regulation 10/2011/EC for the components (monomers and additives) of this resin. The composition of this product complies with the following National Legislations, Recommendations or Communications for the production of food packaglng. AUSTRIA: "K.V.O." N.476/2003 as amended at last by BGBI ·Teil.II - N.140/2009 BELGIUM: "Arrete royal du 5 juillet 2006 (amending Arrete royal du 11 mai 1992 and modifying "Arrete royal du 3 Julllet 2005") DENMARK:Bekendtgorelse N.579 (01/06/2011). 14.107.10 / 14.107.12 Basell Polyolefine - Rapids Preview Page 3 of 8 FINLAND: "KTM", Paatos 953/2002 of 12.11.2002 (amended by 107/2009 of 03/03/2009} FRANCE: "Materlaux au contact des aliments et de denre destine a l'alimentation humaine" Brochure n.1227 edition Janvier 1994 as updatecl. Arrete du 02 Janvier 2003 (as modifled at last by Arrete 03/09/2010). GERMANY: Bedarfsgegenstaendeverordnung- 07 February 2011 (BGBI I S.226) BfR Recommendation III - Polyethylene (last update as 01.01.2010) GREECE: AXE Decision n.458/2003 modified by Decision n. 6/2011 IRELAND: S.I. No. 587 of 2007, as amended by S.I. No.301 of 2010 ITALY: "Decreto Ministeriale del 21/03/1973" amended on 26/4/1993 : D.M. N.220 and following updates (last update: D.M. of 16/02/2011). LUXEMBOURG: "Reglement Grand-Ducal" n. 163 du 05/11/2008. NORWAY: Regulations 21 December 1993 No 1381 on materials and articles lntended to corne into contact with foostuffs Chaper I General regulatlons, as amended. PORTUGAL: Decreto-Lei n.0 62/2008 of 31/03/2008 and Amend. Decreto-Lei n.0 29/2009 of 02/02/2009 SPAIN: Real Decreto N.118 31/01/2003 modified by Real Decreto N.103/2009 of 06/02/2009. SWEDEN: Ordinance of the National Food Administration on materials and articles lntended to corne into contact with foodstuffs LIVSFS 2011:7. THE NETHERLANDS: Staatscourant n.6861 of 06.05.2010. ENGLAND: "The Plastic Materials and Articles in Contact with Food (England) Regulations 2009" , Statutory Instrument 2009 n.205 SWITZERLAND: BGVO 817.023.21 of 23 November 2005, as amended. CZECH REPUBLIC: Regulatlon of the Minlstry of Health N.551/2006 modifying N.38/2001 US Food and Drug Administration (FDA) The base resin in this product meets the FDA requirements contained in the Code of Federal Regulatlons in 21 CFR 177.1520(a)(2)(i) and (c)2.1, 2.2. According to our information, all other lngredients used in this product meet the requirements of their respective FDA regulations and 21 CFR 177.1520(b). This product meets the FDA criteria in 21 CFR 177.1520 for food contact appllcations, lncluding cooking, listed under conditions of use A through H in 21 CFR 176.170(c), Table 2 and can be used in contact with all food types as listed in 21 CFR 176.170(c}, Table 1. Tallow Tallow derived additives are not intentionally used in the manufacture of or formulation of this product. Bovine Sponqlform Encephalopathy (BSE)(Transmissible Sponqiform Encephalopathy {TSE)("Mad Cow" We do not use components derived from animal sources in the manufacture of or formulation of this product. Kosher 14.107.10 / 14.107.12 Basell Polyolefine- Rapids Preview Page 4 of 8 We do not certify our resins to be Kosher or in compllance with Kosher requirements. Food Allergens The food lngredients listed in the Annex IIIa of European Directive 2007/68/EC, are not used in the manufacture of or formulation of this product. However, this product has not been tested for these substances. European Pharmacopeia CEP) This product meets the EP requlrements for 3.1.3, Polyolefins - 7th Edition of European Pharmacopeia Drug MasterFiie CDMF) Information on this product is llsted in DMF N. 8410. Contact Basell for a DMF authorization letter to be sent to FDA. ISO 10993 Biological reactivity evaluatlons have been performed on representative samples of thls product, speclfically the <88> USP Biological Reactivlty Tests, In Vivo for a Class VI plastic (Systemic Injection Test, Intracutaneous Test, Implantation Test) and <87> Biological Reactivity Tests, in Vitro for polymerlc materials (Elution Test). These USP tests may fit the requirements of certain sections of ISO 10993-5 {tests for ln vitro cytotoxlcity), 10993-10 (tests for Irritation and skin sensitization) and 10993-11 (tests for systemic toxiclty). Despite this, the manufacturer of a medical device made with this product must still evaluate the medical device to show thatit fully meets the requlrements of theapplicable sections of ISO 10993. Results provided by Seller are intended to be representative in nature only and are not to be construed as a guarantee of future product performance. Seller makes no express or implied warranty by virtue of disclosing pass/fail status. US Pharmacopeia (USP) Representative samples of this product have passed the <88> USP Biological Reactivity Tests, In Vivo for a Class VI plastic (Systemic Injection Test, Intracutaneous Test, Implantation Test) and <87> Biological Reactivity Tests, in Vitro for polymerlc materials (Elution Test). In addition, Physico-chemlcal testing of this product met the USP limits. Results provided by Seller are intended to be representative ln nature only and are not to be construed as a guarantee of future product performance. Seller makes no express or implied warranty by virtue of disclosing pass/fall status. "Natural rubber latex", "dry natural rubber", "synthetlc latex" or "rubber that contains natural rubber" are not used in the manufacture of or the formulation of this product. ELV Directive 2000/53/EC and its following amendments At the best of our knowledge, based on the available documentation from raw materials suppliers, we deem that this product complies with the directive 2000/53/EC and its following amendments as concerns the defined limit(s) of heavy metals. Coalition of NortheasternGovernors [ÇONEGl Cadmium, chromium (VI}, 1eae1 and mercury are not used in the manufacture of or the formulation of this product. In addition, this product meets the CONEG requirements of less than 100 ppm for total incidental cadmium, chromium, lead and mercury. Packaqinq and Packaqlng Waste - EU Directive 94/62/EC( as amended) At the best of our knowledge, based on the avallable documentation from raw materials suppliers, we deem that thls product complies with the directive 94/62/EC and its following amendments as concerns 14.107.10 / 14.107.12 Basell Polyolefine- Rapids Preview Page5 of 8 the defined limlt(s}of heavy metals Californla's Safe Drinkinq Water and Toxic Enforcement Act of1986 {Proposition 65} This product presents "no signlficant risk" for cancer to the people of California. This product contains no substances known to the State of Californla to cause reproductive toxicity at a level of exposure subject to the requirements of Proposition 65. BHT [butylated hydroxytoluenel {CAS number 128-37·0)/BHA [butylated hydroxyanlsolel {CAS numbers 121-00-6 and 25013-16·5} BHT and BHA are not used in the manufacture of or formulation of this product. However, this product has not been tested forthese chemical substances. Ozone Depletinq Chemlcals {ODCsl Class I and Class II ODCs listed in the US Clean Air Act Amendments of 1990 are not used in the manufacture of or formulation of this product. The ozone-depleting substances (ODS), listed in the Annexes 1 & II of the Regulation { EC ) No 1005/2009 of 16 September 2009, are not intentionally used in the manufacture of or formulation of thls product. This product complies with the requirements in CEN Standard EN71.3. The phthalates listed in Annex of Directive 2005/84/EC ( Annex I of Directive 76/769/EEC) are not intentionally added in the manufacture of or the formulation of this product in a concentration above the given limits. Phthalates Phthalates are not used in the manufacture of or the formulation of this product. Acrvlamide {CAS number 79·06·1) Acrylamide is not used in the manufacture of or the formulation of thls product. However, we do not test thls product for acrylamide. Aromatiç Amines Aromatic amines are not used in the manufacture of or formulation of thls product. However, this product has not been tested for these chemical substances. Asbestos Asbestos is not used in the manufacture of or formulation of this product. However, we have do not test this product for asbestos. Bjsphenol A [chemiçal name: 2,2-bis{4-hydroxyphenyl)propaneJ {CAS# 80·05·7) Bisphenol A is not used in the manufacture of or the formulation of this product. However, thls product has not been tested for thls chemical substance. Dioxln is not used in the manufacture of or formulation of this product. Dioxin is not known to be formed during processing of this product. Epichlorohydrin {CAS number 106-89-8) 14.107.10 / 14.107.12 Basell Polyolefine- Rapids Preview Page 6 of 8 Epichlorohydrin is not used in the manufacture of or the formulatlon of this product. However, we do not test this product for epichlorohydrin. Nonylphenol {CAS number 25154·52·3)/Nonylphenol ethoxylates Nonylphenol and Nonylphenol ethoxylates are not used in the manufacture of or the formulation of thls product. However, this product has not been tested for these chemical substances. Alkylphenol Alkylphenols are not used in the manufacture of or the formulation of this product. However, this product has not been tested for these chemical substances. Orqano-tin Compounds Tributyl-tin (TBT), dibutyl-tin (DBT), monobutyl-tin (MBT} or any other organo-tin compounds are not used in the manufacture of or the formulation of thls product. However, thls product has not been tested forthese chemical substances. Polychlorinated Biphanyls {PCBs), Polychlorlnated Terphenyls {PCTs). Polychlorinated Naphthalenes (PCNs), Polybrominated Biphenyls [PBBs), Polybrominated Diphenyl Ethers (PBDEs) and Polybromlnated Terphenyls CPBTs) Polychlorinated biphenyls (PCBs), polychlorlnated terphenyls (PCTs}, polychlorinated naphthalenes (PCNs), polybrominated biphenyls (PBBs), polybromlnated diphenyl ethers (PBDEs) and polybrominated terphenyls (PBTs) are not used in the manufacture of or formulation of this product. However, this product has not been tested for these chemical substances. Styrene (CAS number 100-42·5) and Polystyrene Styrene (chemlcal name: ethenylbenzene) and polystyrene resins are not used ln the manufacture of or the formulation of thls product. However, we do not test thls productfor these chemlcal substances. Vlnyl Chloride (CAS number 75·01-4) and Polyvinyl Chloride (PVC) Vlnyl chloride and PVC resins are not used ln the manufacture of or the formulation of thls product. However, we do not test this product for these chemical substances. Melamine [chemlcal name: 1,3,5-trlazlne-2,4,&-trlamlne] {CAS# 108-78-1} We do not use melamlne in the manufacture of or formulation of this product. However, we do not test this product for melamine. Tris-Nonylphenol phosphite lTNPP) {CAS number 26523-78·4) TNPP is not used in the manufacture of or the formulation of this product. However, this product has not been tested for this chemical substance. Benzotriazole and 2-Mercaptobenzothiazole(MBT) 2-(2H-1, 2, 3-Benzotriazol-2-yl)-4,6-di-tert-butylphenol [also called 2-(2'-Hydroxy-3',5'-di-t-butylphenyl) benzotriazole] (CAS No. 3846-71-7) and 2-Mercaptobenzothiazole [also called 2(3H)-Benzothiazolethlone or Benzothiazole-2-thiol or MBT] (CAS No. 149-30-4) are not used in the manufacture of or formulation of thls product. However, thls product is not tested for these substances. Regulation (ECl N.1895/2005 BADGE, NOGE and BFDGE are not used in the manufacture of or the formulation of this product according to requirement of Regulation N.1895/2005. Na nomaterials 14.107.10 / 14.107.12 Basell Polyole:fine- Rapids Preview Page 7 of 8 NANOMATERIALS (insoluble or blopersistent and intentionally manufactured materials with one or more external dimensions, or an internai structure, on the scale from 1 to 100 nm ) are not used in the manufacture of or the formulation of thls grade. However, this producthas not been tested for these chemical substances. Polycycllc Aromatic Hydrocarbons{PAHs} We do not intentionally use the following polycyclic aromatic hydrocarbons (PAHs) in the manufacture of or formulation of this product: 1,2-dihydro-acenaphthene (CAS# 83-32-9) acenaphthylene (CAS# 208-96-8) 9H-fluorene (CAS# 86-73-7) anthracene (CAS# 120-12-7) benz(a)anthracene (CAS# 56-55-3) benzo(a)pyrene {CAS# 50-32-8) benzo(b)fluoranthene (CAS# 205-99-2) benzo(e)pyrene (CAS# 192-97-2) benzo(ghi)perylene (CAS# 191-24-2) benzo(j)fluoranthene (CAS# 205-82-3) benzo(k)fluoranthene (CAS# 207-08-9) chrysene (CAS# 218-01-9) dibenz(a,h)anthracene (CAS# 53-70-3) fluoranthene (CAS# 206-44-0) fluorene {CAS# 86-73-7) lndeno(l,2,3-cd)pyrene {CAS# 193-39-5) naphthalene (CAS# 91-20-3) phenanthrene (CAS# 85-01-8) pyrene (CAS# 129-00-0) However, we do not test our resins for these substances. Dimethyl Fumarate (DMF) - EU Commission Decision 2009/251/EC Dimethyl fumarate [2-butenedioic acid (2E)-, dimethyl ester} (DMF) (CAS#: 624-49-7) is not used in the manufacture of or formulation of this product. However, we do not test this product for DMF. Plastlclzers{e,q. DEHA. DINCH, BTHC, TOTM. etc.) The followlng chemical substances are not used in the manufacture of or formulation of this product: DEHA bis(2-ethylhexyl) adipate - Cas. N.103-23-1 DINCH 1,2-Cyclohexanedicarboxylic acid, 1,2-diisononyl ester, Cas N. 166412-78-8 BTHC butyryl tri-n-hexyl citrate CAS 82469-79-2; TOTM tris(2-ethyl h exyl)benzene-1, 2,4-tri ca rboxylate CAS 3 319-31-1 Glycerides, castor-oil mono-, hydrogenated, acetates CAS. N.736150-63-3 However, we do not test our reslns for these substances. Triclosan {2,4,4'-trichloro-2'-hydroxydiphenyl etherl - Commission Decision of 19 March 2010 -[2010/169/EU} Triclosan (2,4,4'-trichloro-2'-hydroxydiphenyl ether) Cas. N.3380-34-5 is not used in the manufacture of or formulation of this product. However, this product has not been tested for this substance. Switzerland "VOC-LENKUNGSABGABE" This productcontains less than 3% VOC's of the substances in the positive lists of the above Regulations. Restriction of Hazardous Substances in Electric and ElectronlcEquipment (RoHS} RoHS Regulation refers to electrical and electronlc equipment and not speclfically to plastic raw materials. Anyway, at the best of our knowledge, based on the available documentation from raw materials suppliers, we deem that this product complies wlth the requlrements of the Directives 14.107.10 / 14.107.12 Basell Polyole:fine - Rapids Preview Page 8 of 8 2002/95/EC ( as amended } and 2011/65/EC as concerns the limit of cadmium, lead, mercury, hexavalent chromium, polybromlnated biphenyls (PBB) and polybromlnated diphenyl ethers (PBDE). Compostinq - CEN Standard prEN 13432 This product ls not suitable for composting. Enerqy Recovery - CEN Standard prEN 13431 The calorific gain from polyethylene in an energy recovery process is 22 MJ/Kg Ultimately customers must make thelr own determination that their use of our productis safe. lawful {except as provided ln the above certifications} and technically suitable in their intended applications. Because of possible changes in the law and in reaulations. LyondellBasell recommends that customers contlnuing ta use our product verlfy status every year from the issue date of the RAPIDS, Certified by: Tamara Greathouse Sr. Product Steward Equistar Chemicals, LP LyondellBasell Tower 1221 McKinney St., Ste. 700 Houston, ne. 77010 Office: +1 713.309.7171 Mobile: +1 302.530.0116 email :[email protected] Alessandro Medri Corporate HS&E Product Safety Manager - Europe Basell Poliolefine Italia S.r.l. a LyondellBasell Industrles Company Centro Rlcerche "G.Natta" P.le Donegani, 12 44100 - Ferrara - Italy Phone : +39 0532 467516 Fax : + 31 107160863 E-mail : [email protected] Approved on Wednesday, January 23, 2013. Valld for 1 year. 14.107.10 / 14.107.12 lyondellbasell 1 1 Ill Il Pure// PE 1840 H Polyethylene, Low Denslty ProductDescription Purel/ PE 1840 H is a low density polyethylene with good flexlbllity and dellvered ln pellet form. It ls used by our customers mainly forsmall blow mouldlng of heathcare applications such as ampoules but also be used ln film appllcatlons and Injection mouldlng. Product Characterfstlcs Status Commercial: Active Test Method used ISO ASTM Avallabllfty Europe, North America, Asla-Padfic, Australia/NZ, Africa Middle East, Latin Amertca Processlng Method Injection Blow Moldlng, Blown Film, Injection Moldlng, Blow, FUI, & Seal, Extrusion Blow Molding Features Good Flexlblllty, Ethyleneoxlde sterlllsatlon Typlcal Customer Applications Medical Film, Blow-fill-seal ap plications, Botties and vials, Collapsible Tubes (Healthcare), Healthcare Applications Typlcal Properties Method Value Unit Physical Density ISO 1183 0.919 g/cm3 Melt flow rate (MFR) (190°C/2.16kg) ISO 1133 1.5 g/10 min Mechanlcal Tensile Modulus (23 °C) ISO 527-1, -2 200 MPa Tensile Stress at Yield (23 °C) ISO 527-1, -2 9.00 MPa Tensile Straln at Vield ISO 527-1, -2 15 o/o Tenslle Strength ISO 527-1, -3 17.0 MPa Note: TD 27.0 MPa Note: MD Tensile Straln at Break ISO 527-1, -3 600 Note: TD 200 o/o Note: MD Hardness Shore hardness (Shore D) ISO 868 45 Ball indentation hardness (H 49/30) ISO 2039-1 15.0 MPa Thermal Vlcat softenlng temperature (ASO {S0°C/h lON}) ISO 306 88.0 14.107.10 / 14.107.12 Melting Temperature ISO 3146 108 oc Additional Properties Film properties tested using 50 µm thickness blown film extruded at a melt temperature of 180°C and a blow-up ratio of 2: 1. Failure Energy, DIN 53373, 50 µm: 4.5 J/mm Coefficient of Friction, ISO 8295: 75% Recommended Film Thickness: 30 to 80 µm Recommended processing temperatures: 170°C to 220°C. Notes Typical propertles; not to be construed as specifications. Further Information Purell PE 1840 H Conveying: Conveying equipment should be designed to prevent production and accumulation of finesand dust particles that are contained in polymer resins. These particles can under certain conditions pose an explosion hazard. We recommend the conveying system used is equipped with adequate filters, is operated and maintained that no leak develops and adequate grounding exists at all times. Health and Safety: The resin is manufactured to the highest standards but, special requirements apply to certain applications such as food end-use contact and direct medical use. For specific information on regulatory compliance contact your local representative. Workers should be protected from the possibility of skin or eye contact with molten polymer. Safety glasses are suggested as a minimal precaution to prevent mechanical or thermal injury to the eyes. Molten polymer may be degraded if it is exposed to air during any of the processing and off-line operations. The products of degradation have an unpleasant odeur. In higher concentrations they may cause Irritation of the mucus membranes. Fabrication areas should be ventilated to carry away fumes or vapeurs. Legislation on the contrai of emissions and pollution prevention must be observed. If the principles of sound manufacturing practice are adhered to and the place of work is well ventilated, no health hazards are involved in processing the resin. The resin will burn when supplied with excess heat and oxygen. It should be handled and stored away from contact with direct flames and/or ignition sources. In burning the resin contributes high heat and may generate a dense black smoke. Startingfires canbe extinguished by water, developped fires should be extlnguished by heavy foams formlng an aqueous or polymeric film. For further information about safety in handling and processing please refer to the Material Safety Data Sheet. Storage: The resin is packed in 25 kg bags or in bulk containers protecting it from contamination, If it is stored under adverse conditions, 1. e. if there are large fluctuations in ambient temperature and the atmospheric humidity is high, moisture may condense inside the packaging. Under these circumstances, it is recommended to dry the resin before use. Unfavourable storage conditions may also intensify the resin 's slight characteristic odour. The resin is subjected to degradation by ultra-violet radiations or by high storage temperatures. Therefore the resin must be protected from direct sunlight, temperatures above 40°C and high atmospheric humidity du ring storage. The resin can be stored over a period of more than 6 month without significant changes in the specified properties, appropriate storage conditionsprovided. Higher storage temperatures reduce the storage time. 14.107.10 / 14.107.12 The information submitted is based on our current knowledge and experience. In view of the many factors that may affect processing and application, these data do not relieve processors of the responsibility of carrying out thelr own tests and experiments; neither do they imply any legally binding assurance of certain properties or of suitability for a specific purpose. The data do not relieve the customer from his obligatlon to contrai the resin upon arrivai and to complain about faults. It is the responsibility of those to whom we supply our products to ensure that any proprietary rights and existing laws and legislation are observed. © LyondellBasell Industries Holdings, B.V. 2011 LyondellBasell markets this product through the followlng entities: • Equistar Chemicals, LP • Basell Sales&.Marketing Company B.V. • Basell Asia PacifieLimited • Basell International Trading FZE • LyondellBasell Australia Pty Ltd For the contact details of the LyondellBasell company selling thls productin your country, please visit http://www,lyondellbasell.com/. Before using a product sold by one of the LyondellBasell family of companies, users should make their own lndependent deterrnlnation that the product is suitable for the intended use and can be used safely and legally. SELLER MAKES NO WARRANTY; EXPRESS OR IMPLIED (INCWDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE) OTHER THAN AS SEPARATELY AGREED BETWEEN THE PARTIES IN WRITTNG. This product(s) may not be used in the manufacture of any US FDA Class III Medical Device or Health Canada Class IV Medlcal Device and may not be used in the manufacture of any US FDA Class II Medical Device or Health Canada Class II or Class III Medlcal Device without the prior written approval by Seller of each speciftc product or application. Users should revlew the applicable Material Safety Data Sheet before handling the product. Addhere, Adflex, Adstlf, Adsyl, Akoafloor, Akoalit,Alastlan, Alathon, Alkylate, Amazing Chemistry, Aquamarlne, Aquathene, Arconate, Arcopure,Arcosolv, Arctic Plus, ArcticShleld, Avant, cata/loy, C/yre/1, CRP, Crystex, Dexflex, Duopac, Duoprime, Explore& Experfment, Filmex, F/exathene, Fue/lng the Power to Win, Get in touch with, G/acido, H/fax, Histif, Hostacom, Hosta/en, Jdeal, Integrate, Koattro, LIPP, Luca/en, Luflexen, Lupo/en, Lupo/ex, Luposim, Lupostress, Lupotech, Metocene, Microthene, Moplen, MPDIOL, Nero/ex, Nexprene, Petrothene, Plexar, Po/ymeg, Pristene, Prodffex, Pro-Fax, Punctilious, Pure//, SAA100, SAA101, Sequel, Softell, Spherilene, Spheripol, Spherfzone, Starflex, Stretchene, Superflex, TBAc , Tebol, T-Hydro, Toppyl, Trans4m, Tufflo, Ultrathene, Vacido and Va/teeare trademarks owned or used by the LyondellBasell family of companies. Adsyl, Akoafloor, Akoallt,Alastian, Alathon, Aquamarine, Arconate,Arcopure, Arcosolv, Arctic Plus, Arctic Shield, Avant, CRP, Crystex, Dexflex, Duopac, Duoprime, Explore & Experiment, Filmex, Flexathene, Hifax, Hostacom, Hosta/en, Ideal, Integrate, Koattro, Luca/en, Lupo/en, Microthene, Mop/en, MPDIOL, Nexprene, Petrothene, P/exar, Polymeg, Pristene, Pro-Fax, Punetilious, Pure/1, Sequel, Sorte//, Spheripol, Spherizone, Starflex, Tebol, T-Hydro, Toppyl, Tuffloand Ultrathene are registered in the U.S. Patent and Trademark Office. Release Date: 15 Jun 2012 14.107.10 / 14.107.12