commiss direct eec juli lai principl assess risk man environ subtanc notifi accord council direct eec commiss european commun regard treati establish european econom commun regard council direct eec june approxim law regul administr provis relat classif packag label danger substanc amend direct eec articl thereof accord provis direct eec substanc market notifi compet author member state mean notif inform articl direct eec requir compet author receiv notif substanc carri assess risk man environ accord gener principl respons risk assess li member state gener principl adopt commun level avoid dispar member state affect function intern market guarante level protect man environ thorughout commun articl council direct eec commiss lai gener principl assess risk base comparison potenti advers effect substanc forese exposur man environ substanc regard classif accord direct eec assess risk man account physico chemic toxicolog properti substanc regard classif accord direct eec assess risk environ account environment effect substanc assess risk substanc concern compet author acquir inform includ result test determin substanc intrins hazard properti accord council direct eec result risk assess princip basi decis legisl reduc risk aris place substanc market carri assess risk compet author inform notifi danger substanc conclus compet author forward written report thereon commiss reduc minimum number anim experiment purpos accord council direct eec novemb approxim law regul administr provis member state protect anim experiment scientif purpos provis direct prejudic specif commun legisl safeti protect health worker work council direct eec june introduct measur encourag improv health safeti worker work place oblig employ evalu risk health safeti worker aris exist chemic substanc measur ensur protect worker measur set direct accord opinion committe set pursuant articl direct eec adopt direct articl object direct lai gener principl assess risk pose substanc man environ requir articl direct eec articl definit definit contain articl direct eec applic direct purpos direct hazard identif identif advers effect substanc inher capac dose concentr respons effect assess estim relationship dose level exposur substanc incid sever effect exposur assess determin emiss pathwai rate movement substanc transform degrad order estim concentr dose human popul environment compart expos risk character estim incid sever advers effect occur human popul environment compart due actual predict exposur substanc includ risk estim quantif likelihood recommend risk reduct recommend measur enabl risk man environ connect market substanc lessen includ modif classif packag label substanc propos notifi notif submit accord articl direct eec ii modif safeti data sheet propos notifi notif submit accord articl direct eec iii modif recommend method precaut emerg measur set section annex viia viib viic propos notifi technic dossier notif submit accord articl direct eec iv advic relev control author measur protect man environ risk identifi articl principl risk assess risk assess entail hazard identif dose concentr respons effect assess exposur assess risk character conduct accord procedur set articl notwithstand paragraph relat effect ozon deplet procedur set articl impractic risk effect assess case case basi compet author includ full descript justif assess written report submit commiss accord articl conduct exposur assess compet author account human popul environment compart exposur substanc forese light inform substanc regard storag formul prepar process dispos recoveri risk assess conclus substanc concern consid inform made accord articl direct eec ii substanc concern compet author decid inform requir revis assess defer request inform quantiti market reach tonnag threshold articl direct eec iii substanc concern inform request immedi iv substanc concern compet author immedi make recommend risk reduct risk assess conclus paragraph ii iii iv appli notifi inform compet author conclus opportun comment conclus provid addit inform compet author relev inform revis risk assess send commiss accord articl direct eec make recommend risk reduct relat substanc compet author account possibl reduc exposur human popul environment compart increas exposur human popul environment compart articl risk assess human health substanc notifi accord articl articl articl direct eec compet author carri risk assess stage hazard identif address minimum properti potenti advers effect annex ia iia conduct hazard identif compet author proce sequenc action carri accord guidelin set annex ib iib dose concentr respons effect assess ii exposur assess whichev human popul worker consum man expos indirectli environ expos substanc risk character derog paragraph test hazard identif relat effect properti conduct result led classif substanc accord direct eec risk assess relat effect properti includ action paragraph conclus articl appli reason ground concern ii test hazard identif relat effect properti conduct effect properti consid risk assess reason ground concern articl risk assess environ substanc notifi accord articl direct eec compet author carri risk assess relat environment effect stage hazard identif conduct hazard identif compet author proce sequenc action carri accord guidelin set annex iii dose concentr respons effect assess ii exposur assess environment compart aquat environ terrestri environ air expos substanc risk character derog paragraph substanc notifi accord articl direct eec classifi danger environ risk assess includ action paragraph conclus articl appli reason ground concern ii substanc notifi accord articl direct eec insuffici data determin classif danger environ hazard identif entail consider reason ground concern relat environment effect basi data data physico chemic toxic properti reason ground risk assess includ action paragraph conclus articl appli articl risk assess conclus carri risk assess accord articl conform annex ii iii compet author determin conform annex iv conclus articl applic action articl addit inform receiv accord articl direct eec risk assess carri accord articl conform annex ii iii review revis articl content written report commiss carri risk assess accord articl made conclus accord articl compet author prepar written report inform set annex report commiss accord articl direct eec updat revis assess light addit inform updat report commiss accord articl direct eec compet author reach agreement written report risk assess revis thereof copi made notifi request articl final provis member state adopt publish provis compli direct octob forthwith inform commiss member state adopt provis refer direct accompani refer time offici public procedur refer adopt member state articl direct address member state brussel juli commiss yanni paleokrassa member commiss oj oj oj oj annex risk assess human health toxic part risk assess conduct accord articl account potenti toxic effect popul liabl exposur effect acut toxic irrit corros sensit repeat dose toxic mutagen carcinogen toxic reproduct human popul worker consum man expos indirectli environ part hazard identif case test hazard identif relat potenti effect conduct result led classif articl risk character relat effect reason ground concern posit vitro test result mutagen case test hazard identif relat potenti effect conduct articl ii risk character relat effect reason ground concern exposur consider indic potenti toxic structur activ relationship dose concentr respons effect assess repeat dose toxic reproduct toxic dose respons relationship assess observ advers effect level noael identifi identifi noael lowest dose concentr advers effect lowest observ advers effect level loael identifi acut toxic corros irrit deriv noael loael basi result test conduct accord requir direct eec acut toxic ld lc fix dose procedur discrimin dose deriv effect suffici determin substanc inher capac effect mutagen carcinogen suffici determin substanc inher capac effect demonstr substanc identifi carcinogen genotox identifi noael loael paragraph respect skin sensit respiratori sensit consensu possibl identifi dose concentr advers effect occur subject sensit substanc suffici evalu substanc inher capac effect exposur assess exposur assess conduct human popul worker consum man liabl exposur indirectli environ exposur substanc foreseen object assess make quantit qualit estim dose concentr substanc popul expos estim account spatial tempor variat exposur pattern exposur assess base inform technic dossier provid conform section annex vii vii vii direct eec relev inform account adequ measur exposur data ii quantiti substanc market iii form substanc market substanc compet prepar iv categori degre contain process data relev vi physico chemic properti substanc includ relev confer process aerosol format vii rout exposur potenti absorpt viii frequenc durat exposur ix type size specif expos popul inform predict method estim exposur level prefer relev monitor data substanc analog exposur pattern substanc contain prepar consider exposur substanc prepar classifi basi toxicolog properti substanc accord council direct eec reason ground concern risk character effect set annex ia noael loael identifi risk character relat effect entail comparison noael loael estim dose concentr popul expos quantit estim exposur exposur level oael ratio deriv basi comparison quantit qualit estim exposur oael compet author decid conclus articl applic effect set annex ia oael determin risk character relat effect entail evalu basi quantit qualit inform exposur relev human popul consider likelihood effect occur made evalu compet author decid conclus articl applic decid conclus articl applic compet author account inter alia uncertainti aris factor variabl experiment data intra interspeci variat ii natur sever effect iii human popul quantit qualit inform exposur appli integr accord provis articl risk character carri relat potenti advers effect human popul case compet author judg conclus articl applic effect complet conclus produc integr conclus relat toxic substanc oj oael determin test result demonstr relationship dose concentr sever advers effect connect test method entail dose concentr evalu rel sever effect inform account evalu likelihood effect occur annex ii risk assess human health physico chemic properti part risk assess accord articl account potenti advers effect occur human popul liabl exposur substanc properti properti explos flammabl oxid potenti human popul worker consum man expos indirectli environ part hazard identif case test hazard identif relat properti conduct result led classif articl risk character relat properti reason ground concern case test hazard identif relat properti conduct articl ii risk character relat properti reason ground concern exposur assess risk character conduct accord articl determin forese condit basi inform substanc includ technic dossier set section annex vii vii vii direct eec risk character risk character entail evalu likelihood advers effect caus forese condit evalu advers effect caus conclus articl appli evalu advers effect caus conclus articl iv appli integr recommend risk reduct made relat effect human popul review risk assess complet compet author produc integr recommend annex iii risk assess environ hazard identif substanc classifi danger environ articl compet author reason ground conduct risk character account indic bioaccumul potenti ii shape toxic time curv ecotox test iii indic advers effect basi toxic studi classif mutagen toxic toxic harm risk phrase risk irrevers effect danger damag health prolong exposur iv data structur analog substanc compet author consid reason ground conduct risk character substanc classifi danger environ insuffici data effect organ articl ii action accord articl ii iii dose concentr respons effect assess object predict concentr substanc advers effect environment compart concern expect occur concentr predict effect concentr pnec pnec determin basi inform notif dossier relat effect organ set section annex vii vii direct eec ecotox studi list annex viii level direct pnec calcul appli assess factor valu result test organ ld median lethal dose lc median lethal concentr ec median effect concentr ic concentr caus inhibit paramet growth noel observ effect level concentr loel lowest observ effect level concentr assess factor express degre uncertainti extrapol test data limit number speci real environ gener extens data longer durat test smaller degre uncertainti size assess factor exposur assess object exposur assess predict concentr substanc eventu found environ concentr predict environment concentr pec case establish pec qualit estim exposur made pec qualit estim exposur determin environment compart emiss discharg dispos distribut reason forese pec qualit estim exposur estim basi inform includ technic dossier set annex vii vii vii annex viii direct eec includ adequ measur exposur data ii quantiti substanc market iii form substanc market substanc compon prepar iv categori degre contain process data relev vi physico chemic properti substanc melt point boil point vapour pressur surfac tension water solubl partit coeffici octanol water vii pathwai environment compart potenti adsorpt desorpt degrad viii frequenc durat exposur substanc market quantiti tonn annum tonn cumul pec qualit estim exposur determin gener local environ releas substanc occur risk character environment compart risk character entail comparison pec pnec pec pnec ratio direv pec pnec ratio equal conclus articl appli ratio greater compet author judg bai size ratio relev factor list paragraph iv conclus articl ii iii iv deriv pec pnec ratio risk character entail qualit evalu likelihood effect occur expect condit exposur made evalu take account relev factor list paragraph compet author decid conclus articl integr accord provis articl risk character carri relat environment compart case compet author judg conclus articl applic compart complet risk assess compet author review conclus produc integr conclus relat environment effect substanc assess factor order typic appli deriv result test acut toxic factor reduc light relev inform lower assess factor typic appli noec deriv result test chronic toxic annex risk assess human health toxic part risk assess conduct accord articl account potenti toxic effect popul liabl exposur effect acut toxic irrit corros sensit repeat dose toxic mutagen carcinogen toxic reproduct human popul worker consum man expos indirectli environ part hazard identif case test hazard identif relat potenti effect conduct result led classif articl risk character relat effect reason ground concern posit vitro test result mutagen case test hazard identif relat potenti effect conduct articl ii risk character relat effect reason ground concern exposur consider indic potenti toxic structur activ relationship dose concentr respons effect assess repeat dose toxic reproduct toxic dose respons relationship assess observ advers effect level noael identifi identifi noael lowest dose concentr advers effect lowest observ advers effect level loael identifi acut toxic corros irrit deriv noael loael basi result test conduct accord requir direct eec acut toxic ld lc fix dose procedur discrimin dose deriv effect suffici determin substanc inher capac effect mutagen carcinogen suffici determin substanc inher capac effect demonstr substanc identifi carcinogen genotox identifi noael loael paragraph respect skin sensit respiratori sensit consensu possibl identifi dose concentr advers effect occur subject sensit substanc suffici evalu substanc inher capac effect exposur assess exposur assess conduct human popul worker consum man liabl exposur indirectli environ exposur substanc foreseen object assess make quantit qualit estim dose concentr substanc popul expos estim account spatial tempor variat exposur pattern exposur assess base inform technic dossier provid conform section annex vii vii vii direct eec relev inform account adequ measur exposur data ii quantiti substanc market iii form substanc market substanc compet prepar iv categori degre contain process data relev vi physico chemic properti substanc includ relev confer process aerosol format vii rout exposur potenti absorpt viii frequenc durat exposur ix type size specif expos popul inform predict method estim exposur level prefer relev monitor data substanc analog exposur pattern substanc contain prepar consider exposur substanc prepar classifi basi toxicolog properti substanc accord council direct eec reason ground concern risk character effect set annex ia noael loael identifi risk character relat effect entail comparison noael loael estim dose concentr popul expos quantit estim exposur exposur level oael ratio deriv basi comparison quantit qualit estim exposur oael compet author decid conclus articl applic effect set annex ia oael determin risk character relat effect entail evalu basi quantit qualit inform exposur relev human popul consider likelihood effect occur made evalu compet author decid conclus articl applic decid conclus articl applic compet author account inter alia uncertainti aris factor variabl experiment data intra interspeci variat ii natur sever effect iii human popul quantit qualit inform exposur appli integr accord provis articl risk character carri relat potenti advers effect human popul case compet author judg conclus articl applic effect complet conclus produc integr conclus relat toxic substanc oj oael determin test result demonstr relationship dose concentr sever advers effect connect test method entail dose concentr evalu rel sever effect inform account evalu likelihood effect occur annex ii risk assess human health physico chemic properti part risk assess accord articl account potenti advers effect occur human popul liabl exposur substanc properti properti explos flammabl oxid potenti human popul worker consum man expos indirectli environ part hazard identif case test hazard identif relat properti conduct result led classif articl risk character relat properti reason ground concern case test hazard identif relat properti conduct articl ii risk character relat properti reason ground concern exposur assess risk character conduct accord articl determin forese condit basi inform substanc includ technic dossier set section annex vii vii vii direct eec risk character risk character entail evalu likelihood advers effect caus forese condit evalu advers effect caus conclus articl appli evalu advers effect caus conclus articl iv appli integr recommend risk reduct made relat effect human popul review risk assess complet compet author produc integr recommend annex iii risk assess environ hazard identif substanc classifi danger environ articl compet author reason ground conduct risk character account indic bioaccumul potenti ii shape toxic time curv ecotox test iii indic advers effect basi toxic studi classif mutagen toxic toxic harm risk phrase risk irrevers effect danger damag health prolong exposur iv data structur analog substanc compet author consid reason ground conduct risk character substanc classifi danger environ insuffici data effect organ articl ii action accord articl ii iii dose concentr respons effect assess object predict concentr substanc advers effect environment compart concern expect occur concentr predict effect concentr pnec pnec determin basi inform notif dossier relat effect organ set section annex vii vii direct eec ecotox studi list annex viii level direct pnec calcul appli assess factor valu result test organ ld median lethal dose lc median lethal concentr ec median effect concentr ic concentr caus inhibit paramet growth noel observ effect level concentr loel lowest observ effect level concentr assess factor express degre uncertainti extrapol test data limit number speci real environ gener extens data longer durat test smaller degre uncertainti size assess factor exposur assess object exposur assess predict concentr substanc eventu found environ concentr predict environment concentr pec case establish pec qualit estim exposur made pec qualit estim exposur determin environment compart emiss discharg dispos distribut reason forese pec qualit estim exposur estim basi inform includ technic dossier set annex vii vii vii annex viii direct eec includ adequ measur exposur data ii quantiti substanc market iii form substanc market substanc compon prepar iv categori degre contain process data relev vi physico chemic properti substanc melt point boil point vapour pressur surfac tension water solubl partit coeffici octanol water vii pathwai environment compart potenti adsorpt desorpt degrad viii frequenc durat exposur substanc market quantiti tonn annum tonn cumul pec qualit estim exposur determin gener local environ releas substanc occur risk character environment compart risk character entail comparison pec pnec pec pnec ratio direv pec pnec ratio equal conclus articl appli ratio greater compet author judg bai size ratio relev factor list paragraph iv conclus articl ii iii iv deriv pec pnec ratio risk character entail qualit evalu likelihood effect occur expect condit exposur made evalu take account relev factor list paragraph compet author decid conclus articl integr accord provis articl risk character carri relat environment compart case compet author judg conclus articl applic compart complet risk assess compet author review conclus produc integr conclus relat environment effect substanc assess factor order typic appli deriv result test acut toxic factor reduc light relev inform lower assess factor typic appli noec deriv result test chronic toxic annex iv integr conclus conclus produc conform section annex section annex ii section annex iii review compet author integr relat total risk identifi risk assess inform requir articl ii iii recommend risk reduct articl iv justifi account articl annex inform includ summari risk assess written report submit commiss accord articl includ element gener summari conclusionh produc accord articl conform annex iv ii conclus articl appli substanc relat potenti advers effect human popul environment compart statement basi inform substanc concern consider unnecessari notifi submit addit inform accord articl direct eec iii conclus articl ii iii appli relat potenti advers effect human popul environment compart descript justif inform requir iv conclus articl iv appli relat potenti advers effect human popul environment compart descript justif recommend risk reduct action provid articl summari notifi comment compet authoritii propos relev addit inform made risk character entail exposur effect ratio section annex ib section annex iii assess factor section annex iii ratio factor state