direct ec european parliament council decemb gener product safeti text eea relev european parliament council european union regard treati establish european commun articl thereof regard propos commiss regard opinion econom social committe act accord procedur refer articl treati light joint text approv concili committe august articl council direct eec june gener product safeti council decid year date set implement direct basi report commiss experi acquir propos adjust direct eec amend direct eec respect order complet reinforc clarifi provis light experi relev develop consum product safeti made treati articl public health consum protect light precautionari principl direct eec recast interest clariti recast leav safeti servic scope direct commiss intend identifi possibl prioriti commun action safeti servic liabil servic provid view present propos import adopt measur aim improv function intern market compris area intern frontier free movement good person servic capit assur absenc commun provis horizont legisl member state product safeti impos gener oblig econom oper market safe product differ level protect afford consum dispar absenc horizont legisl member state liabl creat barrier trade distort competit intern market order ensur high level consum protect commun contribut protect health safeti consum horizont commun legisl introduc gener product safeti requir provis gener oblig produc distributor enforc commun product safeti requir rapid exchang inform action commun level case contribut aim difficult adopt commun legisl product exist develop broad base legisl framework horizont natur deal product cover lacuna pend revis exist specif legisl complement provis exist forthcom specif legisl view ensur high level protect safeti health consum requir articl treati establish commun level gener safeti requir product market suppli made consum intend consum consum forese condit intend case product consider pose risk health safeti consum prevent hand good exclud natur direct appli product irrespect sell techniqu includ distanc electron sell safeti product assess take account relev aspect categori consum vulner risk pose product consider children elderli direct cover servic order secur attain protect object question provis appli product suppli made consum context servic provis safeti equip servic provid suppli servic consum scope direct dealt conjunct safeti servic provid equip consum ride travel oper servic provid exclud scope direct product design exclus profession subsequ migrat consum market subject requir direct pose risk consum health safeti forese condit absenc specif provis framework commun legisl cover safeti product concern provis direct appli order ensur consum health safeti specif commun legisl set safeti requir cover risk categori risk regard product concern oblig econom oper respect risk determin provis specif legisl gener safeti requir direct appli risk provis direct relat oblig produc distributor oblig power member state exchang inform rapid intervent situat dissemin inform confidenti appli case product cover specif rule commun law rule oblig order facilit effect consist applic gener safeti requir direct import establish european voluntari standard cover product risk product conform nation standard transpos european standard presum complianc requir regard aim direct european standard establish european standardis bodi mandat set commiss assist committe order ensur product complianc standard fulfil gener safeti requir commiss assist committe compos repres member state fix requir standard meet requir includ mandat standardis bodi absenc specif regul european standard establish mandat set commiss recours made standard safeti product assess take account nation standard transpos relev european intern standard commiss recommend nation standard intern standard code good practic state art safeti consum expect context commiss recommend facilit consist effect applic direct pend introduct european standard risk product standard deem independ certif recognis compet author facilit proof complianc applic product safeti criteria supplement duti observ gener safeti requir oblig econom oper action oper prevent risk consum circumst addit oblig produc includ duti adopt measur commensur characterist product enabl inform risk product present suppli consum inform enabl assess prevent risk warn consum risk pose danger product suppli withdraw product market resort recal involv depend provis applic member state form compens exchang reimburs distributor ensur complianc applic safeti requir oblig distributor appli proport respect respons prove imposs context charit activ provid compet author inform document risk origin product case isol object provid privat individu produc distributor cooper compet author action aim prevent risk inform conclud product suppli danger condit provis inform set direct facilit effect applic avoid excess burden econom oper author order ensur effect enforc oblig incumb produc distributor member state establish design author respons monitor product safeti power measur includ power impos effect proportion dissuas penalti ensur coordin design author measur includ power member state order organis immedi effici withdraw danger product market resort order coordin organis recal consum danger product suppli power appli produc distributor fail prevent risk consum accord oblig power procedur author decid appli measur rapidli safeti consum depend great extent activ enforc commun product safeti requir member state establish systemat approach ensur effect market surveil enforc activ ensur open public interest parti collabor enforc author member state ensur attain protect object direct promot oper european network enforc author member state facilit coordin manner commun procedur commun rapid inform system rapex improv collabor oper level market surveil enforc activ risk assess test product exchang expertis scientif knowledg execut joint surveil project trace withdraw recal danger product purpos ensur consist high level consum health safeti protect preserv uniti intern market commiss inform measur restrict place market product requir withdraw recal market measur complianc provis treati articl thereof effect supervis product safeti requir set nation commun level system rapid exchang inform situat risk requir rapid intervent respect safeti product direct set detail procedur oper system give commiss assist advisori committe power adapt direct establish bind guidelin aim indic simpl clear criteria practic rule chang purpos allow effici notif measur restrict place market product case refer direct whilst take account rang situat dealt member state econom oper guidelin includ criteria applic definit risk order facilit consist implement relev provis case risk primarili member state complianc treati articl thereof measur regard danger product locat territori member state differ approach deal risk pose product differ entail unaccept dispar consum protect constitut barrier intra commun trade deal product safeti problem requir rapid intervent affect affect futur signific part commun view natur safeti problem pose product dealt effect manner commensur degre urgenc procedur laid specif rule commun law applic product categori product question provid adequ mechan allow resort adopt measur applic commun form decis address member state cope situat creat product present risk decis entail ban export product question case point except circumst partial ban ban decid system prior consent establish addit ban export examin view prevent risk health safeti consum decis directli applic econom oper member state measur implement measur adopt procedur interim measur save appli individu identifi product batch product order ensur assess prepar measur commiss assist committe light consult member state scientif question involv fall compet commun scientif committe scientif committe compet risk concern measur implement direct adopt accord council decis ec june lai procedur exercis implement power confer commiss order facilit effect consist applic direct aspect applic discuss committe public access inform author product safeti ensur profession secreci refer articl treati protect compat ensur effect market surveil activ protect measur direct affect victim right mean council direct eec juli approxim law regul administr provis member state liabil defect product member state provid mean redress compet court respect measur compet author restrict place market product requir withdraw recal addit adopt measur import product ban export view prevent risk safeti health consum compli commun intern oblig commiss period examin manner direct appli result obtain relat function market surveil system rapid exchang inform measur adopt commun level issu relev consum product safeti commun submit regular report european parliament council subject direct affect oblig member state deadlin transposit applic direct eec adopt direct chapter object scope definit articl purpos direct ensur product market safe direct appli product defin articl provis appli specif provis object rule commun law govern safeti product concern product subject specif safeti requir impos commun legisl direct appli aspect risk categori risk cover requir mean articl appli product concern risk categori risk cover specif legisl articl appli specif provis govern aspect cover articl object articl purpos direct quot product quot product includ context provid servic intend consum forese condit consum intend suppli made consider commerci activ recondit definit appli hand product suppli antiqu product repair recondit prior provid supplier inform person suppli product effect quot safe product quot product normal forese condit includ durat applic put servic instal mainten requir present risk minimum risk compat product consid accept consist high level protect safeti health person take account point characterist product includ composit packag instruct assembl applic instal mainten ii effect product forese product iii present product label warn instruct dispos indic inform product iv categori consum risk product children elderli feasibl obtain higher level safeti avail product present lesser degre risk constitut ground product quot danger quot quot danger product quot product meet definit quot safe product quot quot risk quot risk includ effect requir rapid intervent public author quot produc quot manufactur product establish commun person present manufactur affix product trade mark distinct mark person recondit product ii manufactur repres manufactur establish commun repres establish commun import product iii profession suppli chain activ affect safeti properti product quot distributor quot profession suppli chain activ affect safeti properti product quot recal quot measur aim achiev return danger product suppli made consum produc distributor quot withdraw quot measur aim prevent distribut displai offer product danger consum chapter ii gener safeti requir conform assess criteria european standard articl produc oblig place safe product market product deem safe aspect cover relev nation legisl concern absenc specif commun provis govern safeti product question conform specif rule nation law member state territori product market rule drawn conform treati articl thereof lai health safeti requir product satisfi order market product presum safe risk risk categori cover relev nation standard concern conform voluntari nation standard transpos european standard refer publish commiss offici journal european commun accord articl member state publish refer nation standard circumst refer paragraph conform product gener safeti requir assess take account element exist voluntari nation standard transpos relev european standard refer paragraph standard drawn member state product market commiss recommend set guidelin product safeti assess product safeti code good practic forc sector concern state art technolog reason consum expect safeti conform product criteria design ensur gener safeti requir provis mention paragraph bar compet author member state take measur impos restrict market requir withdraw market recal evid conform danger articl purpos direct european standard refer subparagraph articl drawn requir intend ensur product conform standard satisfi gener safeti requir determin accord procedur laid articl basi requir commiss accord direct ec european parliament council june lai procedur provis inform field technic standard regul rule inform societi servic call european standardis bodi draw standard satisfi requir basi mandat european standardis bodi adopt standard accord principl contain gener guidelin cooper commiss bodi commiss report year european parliament council framework report refer articl programm set requir mandat standardis provid subparagraph report includ analysi decis requir mandat standardis refer subparagraph standard refer subparagraph includ inform product commiss intend set requir mandat question product risk consid result preparatori work launch area commiss publish offici journal european commun refer european standard adopt drawn accord requir refer paragraph standard adopt european standardis bodi entri forc direct ensur complianc gener safeti requir commiss decid publish refer offici journal european commun standard ensur complianc gener safeti requir commiss withdraw refer standard public part case refer subparagraph commiss initi request member state decid accord procedur laid articl standard question meet gener safeti requir commiss decid publish withdraw consult committe establish articl direct ec commiss notifi member state decis chapter iii oblig produc oblig distributor articl limit respect activ produc provid consum relev inform enabl assess risk inher product normal forese period risk immedi obviou adequ warn precaut risk presenc warn exempt person complianc requir laid direct limit respect activ produc adopt measur commensur characterist product suppli enabl inform risk product pose choos action includ avoid risk withdraw market adequ effect warn consum recal consum measur refer subparagraph includ indic mean product packag ident detail produc product refer applic batch product belong give indic justifi case carri sampl test market product investig keep regist complaint keep distributor inform monitor action refer subparagraph undertaken voluntari basi request compet author accord articl recal place resort measur suffic prevent risk involv instanc produc oblig measur compet author effect framework code good practic matter member state concern code exist distributor requir act due care ensur complianc applic safeti requir suppli product presum basi inform possess profession compli requir limit respect activ particip monitor safeti product market pass inform product risk keep provid document trace origin product cooper action produc compet author avoid risk limit respect activ measur enabl cooper effici produc distributor basi inform possess profession product market pose risk consum incompat gener safeti requir immedi inform compet author member state thereof condit laid annex give detail action prevent risk consum commiss accord procedur refer articl adapt specif requir relat oblig provid inform laid annex produc distributor limit respect activ cooper compet author request action avoid risk pose product suppli suppli procedur cooper includ procedur dialogu produc distributor concern issu relat product safeti establish compet author chapter iv specif oblig power member state articl member state ensur produc distributor compli oblig direct product market safe member state establish nomin author compet monitor complianc product gener safeti requir arrang author power measur incumb direct member state defin task power organis cooper arrang compet author commiss inform commiss pass inform member state articl member state lai rule penalti applic infring nation provis adopt pursuant direct measur ensur implement penalti provid effect proportion dissuas member state notifi provis commiss januari notifi delai amend affect articl purpos direct articl thereof compet author member state entitl inter alia measur product organis market safe check safeti properti adequ scale final stage consumpt ii requir inform parti concern iii sampl product subject safeti check product pose risk condit requir mark suitabl word easili comprehens warn offici languag member state product market risk present ii make market subject prior condit make safe product pose risk person order warn risk good time form includ public special warn product danger period need safeti evalu check control temporarili ban suppli offer suppli displai danger product ban market introduc accompani measur requir ensur ban compli danger product market order organis actual withdraw alert consum risk present ii order coordin organis produc distributor recal consum destruct suitabl condit compet author member state measur provid paragraph refer act accord treati articl thereof implement measur manner proport serious risk take due account precautionari principl context encourag promot voluntari action produc distributor accord oblig incumb direct chapter iii thereof includ applic develop code good practic organis order measur provid paragraph action undertaken produc distributor fulfil oblig unsatisfactori insuffici recal place resort effect framework code good practic matter member state concern code exist compet author power action appli due dispatch measur mention paragraph case product pose risk circumst determin member state assess individu case merit take account guidelin refer point annex ii measur compet author articl address produc limit respect activ distributor parti respons stage distribut nation market person view cooper action avoid risk aris product articl order ensur effect market surveil aim guarante high level consum health safeti protect entail cooper compet author member state ensur approach emploi mean procedur put place includ establish period updat implement sector surveil programm categori product risk monitor surveil activ find result follow updat scientif technic knowledg safeti product period review assess function control activ effect revis surveil approach organis put place member state ensur consum interest parti opportun submit complaint compet author product safeti surveil control activ complaint member state activ inform consum interest parti procedur establish end articl commiss promot part oper european network author member state compet product safeti form administr cooper network oper develop coordin manner exist commun procedur rapex object facilit exchang inform risk assess danger product test method result recent scientif develop aspect relev control activ establish execut joint surveil test project exchang expertis practic cooper train activ improv cooper commun level regard trace withdraw recal danger product chapter exchang inform rapid intervent situat articl member state take measur restrict place market product requir withdraw recal provid articl member state extent notif requir articl specif commun legisl inform commiss measur reason adopt inform commiss modif lift measur notifi member state consid effect risk territori notifi measur concern involv inform interest member state product safeti standpoint respons risk report notif accord procedur laid articl direct commiss ensur effect proper function system adopt guidelin refer point annex ii propos content standard form notif provid articl provid precis criteria determin condit notif relev purpos subparagraph commiss forward notif member state conclud examin basi inform contain notif measur compli commun law case immedi inform member state initi action articl member state adopt decid adopt recommend agre produc distributor compulsori voluntari basi measur action prevent restrict impos specif condit market territori product reason risk immedi notifi commiss thereof rapex inform commiss delai modif withdraw measur action notifi member state consid effect risk territori follow procedur laid articl take account relev criteria propos guidelin refer point annex ii prejudic subparagraph decid adopt measur action member state pass commiss inform possess exist risk case risk notifi commiss voluntari measur laid articl direct produc distributor receiv notif commiss check compli articl requir applic function rapex forward member state turn immedi inform commiss measur adopt detail procedur rapex set annex ii adapt commiss accord procedur refer articl access rapex open applic countri countri intern organis framework agreement commun countri intern organis arrang defin agreement agreement base reciproc includ provis confidenti applic commun articl commiss awar risk product health safeti consum member state consult member state scientif question aris fall compet commun scientif committe scientif committe compet deal risk concern adopt decis light result consult accord procedur laid articl requir member state measur list articl time emerg prior consult member state differ significantli approach adopt adopt deal risk risk dealt view natur safeti issu pose product manner compat degre urgenc case procedur laid specif commun legisl applic product concern risk elimin effect adopt measur applic commun level order ensur consist high level protect health safeti consum proper function intern market decis refer paragraph valid period exceed year confirm procedur addit period exce year decis specif individu identifi product batch product valid time limit export commun danger product subject decis refer paragraph prohibit decis member state measur implement decis refer paragraph dai period decis compet author respons carri measur refer paragraph month give parti concern opportun submit view inform commiss chapter vi committe procedur articl measur implement direct relat matter refer adopt accord regulatori procedur provid articl measur refer articl standard adopt european standardis bodi decis refer articl requir member state measur list articl measur implement direct respect matter adopt accord advisori procedur provid articl articl commiss assist committe refer made paragraph articl decis ec appli regard provis articl thereof period laid articl decis ec set dai refer made paragraph articl decis ec appli regard provis articl thereof committe adopt rule procedur chapter vii final provis articl inform author member state commiss relat risk consum health safeti pose product gener public accord requir transpar prejudic restrict requir monitor investig activ public access inform product identif natur risk measur member state commiss step ensur offici agent requir disclos inform obtain purpos direct natur cover profession secreci duli justifi case inform relat safeti properti product made public circumst requir order protect health safeti consum protect profession secreci prevent dissemin compet author inform relev ensur effect market monitor surveil activ author receiv inform cover profession secreci ensur protect articl direct prejudic applic direct eec articl measur adopt direct involv restrict place product market requir withdraw recal state reason base notifi parti concern remedi provis forc member state question time limit appli remedi parti concern feasibl opportun submit view adopt measur advanc urgenc measur opportun due measur implement measur requir withdraw product recal consider encourag distributor user consum contribut implement measur member state ensur measur compet author involv restrict place product market requir withdraw recal challeng compet court decis virtu direct involv restrict place product market requir withdraw recal prejudic assess liabil parti concern light nation crimin law appli case question articl commiss bring committe refer articl matter applic direct relat market monitor surveil activ year januari commiss submit report implement direct european parliament council report includ inform safeti consum product improv traceabl product function market surveil standardis work function rapex commun measur basi articl end commiss conduct assess relev issu approach system practic put place member state light requir direct commun legisl relat product safeti member state provid commiss assist inform carri assess prepar report articl commiss identifi possibl prioriti commun action safeti servic submit european parliament council januari report accompani propos subject articl member state bring forc law regul administr provis order compli direct effect januari forthwith inform commiss thereof member state adopt measur refer direct accompani refer occas offici public method make refer laid member state member state commun commiss provis nation law adopt field cover direct articl direct eec repeal januari prejudic oblig member state deadlin transposit applic direct annex iii refer direct eec constru refer direct read accord correl tabl annex iv articl direct enter forc dai public offici journal european commun articl direct address member state brussel decemb european parliament presid fontain council presid vandenbrouck oj oj oj opinion european parliament oj council common posit oj decis european parliament publish offici journal decis european parliament council decis oj oj oj direct amend direct ec european parliament council oj oj direct amend direct ec oj annex requir inform product compli gener safeti requir provid compet author produc distributor inform articl applic specif requir commun rule product concern pass compet author appoint purpos member state product question market suppli consum commiss assist committe refer articl defin content draw standard form notif provid annex ensur effect proper function system put forward possibl form guid simpl clear criteria determin special condit isol circumst product notif relev relat annex event risk inform includ inform enabl precis identif product batch product question full descript risk product question present inform relev trace product descript action undertaken prevent risk consum annex ii procedur applic rapex guidelin notif rapex cover product defin articl pose risk health safeti consum pharmaceut direct eec eec exclud scope rapex rapex essenti aim rapid exchang inform event risk guidelin refer point defin specif criteria identifi risk member state notifi articl provid detail notif inform stipul guidelin refer point inform enabl product identifi descript risk involv includ summari result test analys conclus relev assess level risk natur durat measur action decid applic inform suppli chain distribut product destin countri inform transmit special standard notif form mean stipul guidelin refer point measur notifi pursuant articl articl seek limit market chemic substanc prepar member state provid summari refer relev data relat substanc prepar consid substitut inform commun anticip effect measur consum health safeti assess risk carri accord gener principl risk evalu chemic substanc refer articl regul eec case exist substanc articl direct eec case substanc guidelin refer point defin detail procedur inform request respect member state inform commiss accord articl subparagraph risk decid adopt measur inform commiss dai confirm modifi inform commiss shortest time verifi conform provis direct inform receiv rapex consid order assess product safeti carri investig initi case investig member state suppli commiss request inform abil receipt notif refer articl member state request inform commiss latest set period time stipul guidelin refer point product market territori measur product question adopt light circumst state reason includ differ assess risk special circumst justifi decis lack action follow relev supplementari inform obtain risk involv includ result test analys carri guidelin refer point provid precis criteria notifi measur limit nation territori deal notif risk consid member state territori member state immedi inform commiss modif lift measur action question commiss prepar regularli updat accord procedur laid articl guidelin manag rapex commiss member state commiss inform nation contact point product pose risk import export commun european econom area respons inform provid li notifi member state commiss ensur proper function system classifi index notif degre urgenc detail procedur laid guidelin refer point oj direct amend commiss direct ec oj oj direct amend commiss direct ec oj oj oj direct amend commiss direct ec oj annex iii period transposit applic repeal direct refer subparagraph articl gt tabl gt annex iv correl tabl refer subparagraph articl gt tabl gt