commiss regul ec june lai principl assess risk man environ exist substanc accord council regul eec text eea relev commiss european commun regard treati establish european commun regard council regul eec march evalu control risk exist substanc articl thereof regul eec envisag system evalu control risk exist substanc articl thereof requir member state carri risk assess exist substanc prioriti respons risk assess li member state principl assess adopt commun level avoid dispar member state affect function intern market fail guarante level protect man environ assess risk base comparison potenti advers effect substanc forese exposur man environ substanc regard classif substanc accord council direct eec june approxim law regul administr provis relat classif packag label danger substanc amend commiss direct ec assess risk man account physico chemic toxicolog properti substanc regard classif accord direct eec assess risk environ account environment effect substanc result risk assess princip basi decis legisl reduc risk aris manufactur transport storag formul prepar process dispos recoveri exist substanc reduc minimum number anim experiment purpos accord council direct eec novemb approxim law regul administr provis member state protect anim experiment scientif purpos provis regul prejudic specif commun legisl safeti protect health worker work council direct eec place oblig employ evalu risk health safeti worker aris exist chemic substanc measur ensur protect worker measur set regul accord opinion committe set pursuant articl regul eec adopt regul articl object regul lai gener principl assess risk pose exist substanc man environ requir articl council regul eec articl definit definit contain articl regul eec applic regul purpos regul 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 sphere water soil air expos risk character estim incid sever advers effect occur human popul environment sphere due actual predict exposur substanc includ risk estim quantif likelihood articl principl risk assess risk assess entail hazard identif dose concentr respons effect assess exposur assess risk character base inform substanc submit accord articl regul eec inform conduct accord procedur set articl regul notwithstand paragraph relat effect ozon deplet procedur set articl impractic risk effect assess case case basi rapporteur includ full descript justif assess written report submit commiss accord articl conduct exposur assess rapporteur account human popul environment sphere exposur substanc forese light inform substanc regard manufactur transport storag formul prepar process dispos recoveri substanc risk assess carri accord articl regul eec appear prioriti list subsequ risk assess account previou risk assess articl risk assess human health substanc appear prioriti list accord articl regul eec rapporteur carri risk assess relat effect human health stage hazard identif address properti potenti advers effect annex ii conduct hazard identif rapporteur sequenc action carri accord guidelin set annex ii dose concentr respons effect assess ii exposur assess whichev human popul group worker consum man expos indirectli environ expos expos substanc risk character articl risk assess environ substanc appear prioriti list accord articl regul eec rapporteur carri risk assess relat environment effect stage hazard identif conduct hazard identif rapporteur proce sequenc action carri accord guidelin set annex iii dose concentr respons effect assess ii exposur assess environment sphere expos expos substanc risk character articl risk assess report carri risk assess accord articl rapporteur prepar report inform set annex data relev risk assess report summari thereof forward commiss accord articl regul eec articl final provis regul enter forc dai public offici journal european commun regul bind entireti directli applic member state brussel june commiss rené steichen member commiss oj oj oj oj oj annex risk assess human health toxic part risk assess conduct accord articl account potenti toxic effect popul expos liabl expos effect acut toxic irrit corros sensit repeat dose toxic mutagen carcinogen toxic reproduct human popul worker consum man expos indirectli environ part hazard identif object identifi effect concern review provision classif light data 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 toxic data deriv observ human exposur inform poison centr epidemiolog survei special consider data carri risk assess 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 account adequ measur exposur data ii quantiti substanc produc import iii form substanc produc import substanc substanc compon prepar iv pattern dege contain process data relev vi physico chemic properti substanc includ relev confer process aerosol format vii breakdown product transform product viii rout exposur potenti absorpt ix frequenc durat exposur type size specif expos popul inform adequ measur repres exposur data special consider conduct exposur assess calcul method estim exposur level adequ model appli relev monitor data substanc analog exposur pattern analog properti consid substanc contain prepar consider exposur substanc prepar classifi basi toxicolog properti substanc accord council direct eec reason ground concern risk character effect set annex 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 rapporteur result risk character relat effect effect set annex oael determin risk character relat effect entail evalu basi quantit qualit inform exposur relev human popul consider likelihood effect occur made evalu rapporteur result risk character relat effect carri risk character rapporteur account inter alia uncertainti aris factor variabl experiment data intra inter speci 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 rapporteur judg result risk character effect complet risk assess rapporteur review result produc integr result 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 psycho chemic properti part risk assess accord articl account potenti advers effect occur human popul expos liabl expos substanc properti properti explos flammabl oxid potenti human popul worker consum man expos indirectli environ part hazard identif object identifi effect concern review provision classif light data exposur assess risk character conduct accord articl determin forese condit risk character risk character entail evalu likelihood advers effect caus forese condit rapporteur result risk character integr accord provis articl risk character carri relat potenti advers effect human popul rapporteur judg result risk character effect complet risk assess rapporteur review result produc integr result annex iii risk assess environ hazard identif object identifi effect properti properti concern review provision classif light data dose concentr respons effect assess object predict concentr substanc advers effect environment sphere concern expect occur concentr predict effect concentr pnec case establish pnec qualit estim dose concentr repons effect relat made pnec calcul appli assess factor valu result test organ ld median lethal dose lc median lethal concentr ec median effect concentr ic concentr caus cent inhibit paramet growth noel observ effect level concentr loel lowest observ effect level concentr method 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 found environ concentr predict environment concentr pec case establish pec qualit estim exposur made pec qualit estim exposur determin environment sphere emiss discharg dispos distribut forese pec qualit estim exposur determin take account adequ measur exposur data ii quantiti substanc produc import iii form substanc produc import substanc substanc compon prepar iv pattern 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 breakdown product transform product viii pathwai environment sphere potenti absorpt desorpt degrad ix frequenc durat exposur adequ measur repres exposur data special consider conduct exposur assess calcul method estim exposur concentr adequ model appli case case basi relev monitor data substanc analog exposur pattern analog properti consid risk character environment sphere risk character entail comparison pec pnec pec pnec ratio deriv pec pnec ratio equal risk character result present inform test risk reduct measur appli ratio greater rapporteur judg basi size ratio relev factor 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 inform test requir clarifi concern risk reduct measur deriv pec pnec ratio risk character entail qualit evalu likelihood effect occur current condit exposur occur expect condit exposur made evalu take account relev factor list paragraph rapporteur result risk character relat effect integr accord provis articl risk character carri relat environment sphere rapporteur judg result risk assess sphere complet risk assess rapporteur review result produc integr result relat environment effect substanc assess factor order typic apli deriv result test acut toxic factor reduc light relev inform lower assess factor typic appli noec deriv result test long term chronic toxic annex iv integr result result produc conform section annex section annex ii section annex iii review rapporteur integr relat total risk identifi risk assess inform test requir recommend risk reduct measur justifi