direct ec european parliament council februari place biocid product market european parliament council european union regard treati establish european commun articl thereof regard propos commiss regard opinion econom social committe act accord procedur laid articl treati light joint text approv decemb concili committe resolut februari commun programm polici action relat environ sustain develop council repres govern member state meet council approv gener approach strategi programm present commiss risk manag agricultur pesticid emphasis eighth amend council direct eec juli approxim law regul administr provis member state relat restrict market danger substanc prepar adopt discuss council direct eec place plant protect product market council express concern lack harmonis commun provis biocid agricultur pesticid invit commiss examin situat member state possibl action commun level biocid product control organ harm human anim health control organ damag natur manufactur product biocid product pose risk human anim environ varieti wai due intrins properti pattern commiss review show differ regulatori situat member state differ constitut barrier trade biocid product trade product treat affect function intern market commiss propos develop framework rule relat place market biocid product take condit high level protect human anim environ regard principl subsidiar decis commun level restrict proper function common market avoid duplic work member state direct biocid product establish framework framework rule provid biocid product market compli relev procedur direct account specif natur biocid product risk propos provid simplifi authoris procedur includ registr applic submit dossier inform evalu risk aris propos product common core data set activ substanc biocid product contain assist applic seek authoris carri evalu decid authoris specif data requir elabor product type cover direct biocid product authoris make properli purpos intend suffici effect unaccept effect target organ resist unaccept toler case vertebr anim unnecessari suffer pain light current scientif technic knowledg unaccept effect environ human anim health provid common principl evalu authoris biocid product ensur harmonis approach member state member state prevent impos addit requir biocid product addit requir conform commun law run counter provis direct provis intend protect environ human anim health mean epidem control food feedingstuff protect light divers activ substanc biocid product concern data test requir suit individu circumst result risk assess establish commun list activ substanc permit inclus biocid product commun procedur laid assess activ substanc enter commun list inform interest parti submit view admiss activ substanc list activ substanc list review period compar specif condit account develop scienc technolog due account product pose low risk activ substanc incorpor specif annex substanc main pesticid minor biocid directli product consist activ substanc simpl diluent incorpor separ specif annex activ substanc evalu entri relev annex direct evalu cover aspect cover evalu made direct eec april amend seventh time direct eec approxim law regul administr provis relat classif packag label danger substanc council regul eec march evalu control risk exist substanc risk assess concern risk product dispos activ substanc materi treat consid similar aforement legisl interest free circul biocid product materi treat authoris grant member state recognis member state subject specif condit contain direct envisag harmonis provis biocid product type includ intend control vertebr actual type give rise concern member state allow subject treati derog principl mutual recognit biocid product fall type biocid intend control kind vertebr derog justifi jeopardis purpos direct desir system mutual exchang inform establish member state commiss make request particular scientif document submit connect applic authoris biocid product member state authoris limit period time biocid product compli abovement condit event unforeseen danger threaten human anim environ contain mean commun procedur prevent member state authoris limit period time territori biocid product activ substanc enter commun list provid dossier meet commun requir submit member state concern believ activ substanc biocid product satisfi commun condit set essenti direct minimis number test anim test made depend purpos product close coordin ensur commun legisl direct eec direct concern protect water concern contain deliber releas genet modifi organ commiss draw technic note guidanc implement authoris procedur entri activ substanc annex annex relat data requir annex deal common principl order ensur requir laid respect authoris biocid product satisfi market member state make provis control inspect arrang implement direct adapt annex develop technic scientif knowledg inclus activ substanc annex necessit close cooper commiss member state applic case procedur stand committe biocid product appli constitut suitabl basi cooper agreement modu vivendi european parliament council commiss implement measur act adopt accord procedur laid articl ec treati reach decemb commiss appli modu vivendi implement measur flow direct envisag adopt includ annex ia ib full implement direct review programm achiev year direct eec framework complement develop posit list limit market activ substanc product group thereof review programm activ substanc account work programm framework commun legisl concern review authoris substanc product relev intern convent cost procedur oper direct recov seek place place biocid product market support entri activ substanc relev annex minimum rule biocid product work laid direct health safeti work desir develop rule area adopt direct articl scope direct concern authoris place market biocid product member state mutual recognit authoris commun establish commun level posit list activ substanc biocid product direct appli biocid product defin articl exclud product defin scope instrument purpos direct council direct eec januari approxim provis laid law regul administr action relat proprietari medicin product council direct eec septemb approxim law member state veterinari medicin product council direct eec decemb extend scope direct eec approxim law member state relat veterinari medicin product lai addit provis immunolog medicin product council direct eec septemb widen scope direct eec eec approxim provis laid law regul administr action relat medicin product lai addit provis homeopath medicin product council direct eec septemb widen scope direct eec approxim provis laid law regul administr action relat veterinari medicin product lai addit provis homeopath veterinari medicin product council regul eec juli lai commun procedur authoris supervis medicin product human veterinari establish european agenc evalu medicin product council direct eec june approxim law member state relat activ implant medic devic council direct eec june medic devic council direct eec decemb approxim law member state food addit authoris foodstuff intend human consumpt council direct eec june approxim law member state relat flavour foodstuff sourc materi product european parliament council direct ec februari food addit colour sweeten council direct eec decemb approxim law member state relat materi articl intend contact foodstuff council direct eec june lai health rule product place market raw milk heat treat milk milk base product council direct eec june hygien health problem affect product place market egg product council direct eec juli lai health condit product place market fisheri product council direct eec march lai condit govern prepar place market medic feedingstuff commun council direct eec novemb addit feedingstuff council direct eec june product anim nutrit council direct eec novemb market straight feedingstuff council direct eec juli approxim law member state relat cosmet product council direct ec februari amend direct eec condit grant temporari limit derog specif commun health rule product market product anim origin council direct eec juli place plant protect product market direct appli prejudic relev commun provis measur accord council direct eec juli approxim law regul administr provis member state relat restrict market danger substanc prepar direct eec decemb prohibit place market plant protect product activ substanc council regul eec juli export import danger chemic council direct eec novemb protect worker risk relat exposur chemic physic biolog agent work council direct eec june introduct measur encourag improv safeti health worker work individu direct base direct council direct eec septemb relat approxim law regul administr provis member state mislead advertis articl appli carriag biocid product rail road inland waterwai sea air articl definit purpos direct definit appli biocid product activ substanc prepar activ substanc put form suppli user intend destroi deter render harmless prevent action exert control effect harm organ chemic biolog mean exhaust list product type indic set descript type annex low risk biocid product biocid product activ substanc list annex substanc concern condit biocid product pose low risk human anim environ basic substanc substanc list annex major pesticid minor biocid directli product consist substanc simpl diluent substanc concern directli market biocid substanc potenti enter annex ib accord procedur laid articl inter alia carbon dioxid nitrogen ethanol propanol acet acid kieselguhr activ substanc substanc micro organ includ viru fungu gener specif action harm organ substanc concern substanc activ substanc inher capac advers effect human anim environ present produc biocid product suffici concentr creat effect substanc ground concern substanc classifi danger council direct eec june approxim law regul administr provis relat classif packag label danger substanc present biocid product concentr lead product regard danger mean articl council direct eec june approxim law regul administr provis member state relat classif packag label danger prepar harm organ organ unwant presenc detriment effect human activ product produc anim environ residu substanc present biocid product remain result includ metabolit substanc product result degrad reaction place market suppli return payment free charg subsequ storag storag consign custom territori commun dispos import biocid product custom territori commun deem constitut place market purpos direct authoris administr act compet author member state authoris applic submit applic place market biocid product territori part thereof frame formul specif group biocid product user type group product activ substanc specif composit present variat previous authoris biocid product affect level risk efficaci context variat allow reduct percentag activ substanc alter percentag composit activ substanc replac pigment dye perfum present lower risk decreas efficaci registr administr act compet author member state applic submit applic verif dossier meet relev requir direct place market low risk biocid product territori part thereof letter access document sign owner owner relev data protect provis direct state data compet author purpos grant authoris registr biocid product direct purpos direct definit substanc prepar scientif research develop process orient research develop laid articl council direct eec appli articl authoris place market biocid product member state prescrib biocid product market territori authoris accord direct derog paragraph member state subject registr place market low risk biocid product provid dossier accord articl submit verifi compet author provis relat authoris direct appli registr ii member state place market commod substanc biocid purpos enter annex ib applic authoris decid undu delai ii applic biocid product requir registr compet author decis period dai member state request initi relev establish frame formul commun applic issu authoris biocid product prejudic articl provid applic access frame formul form letter access subsequ applic authoris biocid product base frame formul compet author decis regard applic period dai member state prescrib biocid product classifi packag label accord provis direct prejudic articl authoris grant maximum period year date renew inclus activ substanc annex product type exceed deadlin activ substanc annex renew verif condit impos articl satisfi renew grant period compet author member state make verif applic renew made member state prescrib biocid product properli proper includ complianc condit establish pursuant articl label provis direct proper involv ration applic combin physic biolog chemic measur biocid product limit minimum biocid product work accord requir direct protect worker articl mutual recognit authoris prejudic articl biocid product authoris regist member state authoris regist member state dai dai applic receiv member state provid activ substanc biocid product includ annex conform requir thereof mutual recognit authoris applic includ summari dossier requir articl annex ii section certifi copi authoris grant mutual recognit registr low risk biocid product applic includ data requir articl efficaci data summari suffic authoris subject provis result implement measur accord commun law relat condit distribut biocid product intend protect health distributor user worker concern mutual recognit procedur prejudic measur member state pursuant commun law intend protect health worker accord articl member state establish target speci present harm quantiti unaccept toler resist target organ biocid product demonstr relev circumst climat breed period target speci differ significantli member state biocid product authoris unchang authoris present unaccept risk human environ member state request condit refer articl adjust circumst condit issu authoris laid articl satisfi member state believ low risk biocid product regist member state compli definit provid articl provision refus registr thereof immedi commun concern compet author respons verif dossier maximum period dai agreement reach author concern matter forward commiss decis accord procedur laid paragraph notwithstand paragraph member state believ biocid product authoris member state meet condit set pursuant articl propos refus authoris registr restrict authoris condit notifi commiss member state applic provid explanatori document product specif set ground propos refus restrict authoris commiss prepar propos matter accord articl decis accord procedur laid articl procedur laid paragraph lead confirm refus subsequ registr member state member state previous regist low risk biocid product deem stand committe refus consider review registr articl procedur confirm initi registr member state introduc procedur regist low risk biocid product concern derog paragraph member state refus subject treati mutual recognit authoris grant product type annex provid limit justifi jeopardis purpos direct member state inform commiss decis respect reason articl condit issu authoris member state authoris biocid product activ substanc includ list annex ia requir laid annex fulfil establish light current scientif technic knowledg shown apprais dossier provid articl common principl evalu dossier laid annex vi authoris regard normal condit biocid product materi treat consequ dispos biocid product suffici effect ii unaccept effect target organ unaccept resist cross resist unnecessari suffer pain vertebr iii unaccept effect result residu human anim health directli indirectli drink water food feed indoor air consequ place work surfac water groundwat iv unaccept effect result residu environ regard consider fate distribut environ contamin surfac water includ estuarian seawat groundwat drink water impact target organ natur quantiti activ substanc toxicolog ecotoxicolog signific impur formul residu toxicolog environment signific result authoris determin relev requir annex iia iib iiia iiib iva ivb physic chemic properti determin deem accept purpos storag transport product biocid product classifi articl toxic toxic categori carcinogen categori mutagen classifi toxic reproduct categori authoris market gener public authoris condit stipul condit relat market ensur complianc provis paragraph commun provis impos requir relev condit issu authoris biocid product intend protect health distributor user worker consum anim health environ compet author account issu authoris issu authoris subject requir articl review authoris period authoris grant review time inform receiv articl indic condit refer articl longer satisfi instanc member state requir authoris holder applic modif authoris grant accord articl submit inform review authoris prolong period complet review prolong period provid inform articl cancel modif authoris authoris cancel activ substanc longer includ annex ia requir articl condit mean articl obtain authoris longer satisfi discov fals mislead particular suppli fact basi authoris grant authoris cancel authoris holder request state reason cancel member state intend cancel authoris inform hear authoris holder cancel authoris member state grant period grace dispos storag market exist stock length accord reason cancel prejudic period provid decis pursuant direct eec connect paragraph member state consid basi develop scientif technic knowledg protect health environ modifi condit authoris manner amount authoris modifi authoris holder request state reason modif propos modif concern extens member state extend authoris subject condit activ substanc list annex ia propos modif authoris involv condit activ substanc list annex ia made evalu activ substanc regard propos accord procedur laid articl modif grant establish condit mean articl remain satisfi articl requir authoris applic authoris made behalf person respons place market biocid product member state compet author member state applic requir perman offic commun member state requir applic authoris biocid product submit compet author dossier letter access biocid product satisfi light current scientif technic knowledg requir set annex iib relev part annex iiib activ substanc biocid product dossier letter access satisfi light current scientif technic knowledg requir set annex iia relev part annex iiia derog paragraph member state requir dossier compris data low risk biocid product applic address manufactur biocid product activ substanc name address includ locat manufactur activ substanc letter access relev data need ii ident biocid product trade full composit biocid product physic chemic properti refer articl iii intend product type annex field categori user method iv efficaci data analyt method vi classif packag label includ draft label articl vii safeti data sheet prepar accord articl council direct eec june approxim law regul administr provis member state relat classif packag label danger substanc articl direct eec dossier includ detail full descript studi conduct method bibliograph refer method inform dossier suppli accord articl suffici evalu made effect properti refer articl submit compet author form technic dossier inform result studi refer annex iia iib relev part annex iiia iiib inform ow natur biocid product propos suppli appli scientif technic suppli inform case justif accept compet author submit justif exist frame formul applic access evalu dossier show inform includ data result test evalu risk biocid product compet author applic submit inform time period evalu dossier start dossier complet activ substanc regist list contain annex direct eec includ european inventori exist chemic substanc einec includ activ substanc intern standard organis iso common substanc design chemic design intern union pure appli chemistri iupac rule gener principl test conduct method annex direct eec event method inappropri method internation recognis justifi test conduct accord provis laid council direct eec novemb approxim law regul administr provis member state protect anim experiment scientif purpos council direct eec decemb harmonis law regul administr provis relat applic principl good laboratori practic verif applic test chemic substanc test data exist gener adopt direct method laid annex direct eec adequaci data purpos direct conduct test annex decid case case basi take account factor minimis test vertebr anim compet author refer mean articl ensur file compil applic file copi applic record administr decis member state applic dossier submit accord paragraph summari request member state make compet author commiss file provid paragraph suppli request inform full comprehens applic request ensur applic provid copi technic document laid paragraph member state requir sampl prepar ingredi provid member state requir applic authoris submit nation offici languag languag articl place market activ substanc member state prescrib substanc activ substanc biocid product market activ substanc market date refer articl dossier forward member state satisfi requir articl accompani declar activ substanc intend inclus biocid product appli substanc pursuant articl classifi packag label accord provis direct eec articl inclus activ substanc annex ia ib light current scientif technic knowledg activ substanc includ annex annex ia ib initi period exceed year expect biocid product activ substanc low risk biocid product compli definit articl commod substanc compli definit articl fulfil condit laid articl take account relev cumul effect biocid product activ substanc activ substanc includ annex ia classifi direct eec carcinogen mutagen toxic reproduct sensitis bioaccumul readili degrad entri activ substanc annex ia refer concentr rang substanc inclus activ substanc annex ia ib subject requir minimum degre puriti activ substanc natur maximum content impur product type manner area design categori user industri profession profession condit evalu inform made context direct ii establish accept oper exposur level aoel relev accept daili intak man adi maximum residu limit mrl fate behaviour environ impact target organ inclus annex ia ib activ substanc restrict product type annex relev data submit accord articl inclus activ substanc annex ia ib renew occas period exceed year initi inclus renew inclus review time indic requir refer paragraph longer satisfi renew grant minimum period complet review applic made renew grant period provid inform request accord articl entri activ substanc annex relev ia ib refus remov evalu activ substanc accord articl show normal condit authoris biocid product risk health environ give rise concern activ substanc annex product type light scientif technic knowledg present significantli risk health environ refus remov consid assess altern activ substanc substanc place demonstr similar effect target organ signific econom practic disadvantag user increas risk health environ assess circul accord procedur articl decis accord procedur laid articl ii refus remov annex relev ia ib entri carri condit chemic divers activ substanc adequ minimis occurr resist target organ appli activ substanc normal condit authoris biocid product present significantli level risk appli activ substanc product product type appli allow possibl acquir experi practic complet data dossier evalu serv serv entri annex ia ib put dispos committe refer articl iii decis remov annex entri effect delai period maximum year date decis articl procedur inclus activ substanc annex ia ib inclus subsequ inclus activ substanc annex ia ib consid applic forward compet author member state dossier activ substanc satisfi requir annex iva requir annex iia relev part annex iiia ii dossier biocid product activ substanc satisfi requir articl except paragraph thereof receiv compet author verifi dossier believ satisfi requir annex iva annex ivb requir annex iia annex iib relev annex iiia iiib accept agre applic forward summari dossier commiss member state receiv compet author month accept dossier carri evalu thereof copi evalu compet author commiss member state applic recommend inclus activ substanc annex ia ib dossier evalu appear inform full evalu made receiv compet author applic submit inform month period suspend date issu compet author request date inform receiv compet author inform member state commiss action inform applic avoid dossier evalu member state evalu carri member state receiv request dossier accept decis accord procedur laid articl decis latest month receipt commiss request receipt evalu commiss accord procedur articl prepar propos undu delai decis accord procedur laid articl decis latest month receipt commiss evalu refer paragraph articl data held compet author applic member state make inform refer articl benefit subsequ applic subsequ applic written agreement form letter access applic made inform case activ substanc market date refer articl period year date inclus annex ia case activ substanc market date refer articl period year date refer articl inform submit purpos direct inform protect exist nation rule relat biocid product case inform continu protect member state expiri remain period data protect provid nation rule maximum year date refer articl ii period year date entri activ substanc annex ia inform submit time support inclus annex ia activ substanc addit product type activ substanc case inform submit time variat requir entri annex ia ii mainten entri annex ia period year date decis receipt inform year period expir period provid paragraph case period year extend expir date period member state make inform refer articl benefit subsequ applic subsequ applic written agreement form letter access applic made inform case biocid product activ substanc market date refer articl period year date authoris member state case biocid product activ substanc market date refer articl period year date refer articl inform submit purpos direct case data protect exist nation rule relat biocid product case data protect member state expiri remain period data protect provid nation rule maximum year date refer articl ii period year date entri activ substanc annex ia inform submit time support inclus annex ia activ substanc addit product type activ substanc case data submit time variat condit authoris biocid product ii submiss data maintain entri activ substanc annex ia period year date receipt inform year period expir period paragraph case period year extend expir date period decis accord articl inform refer paragraph commiss scientif committe refer articl member state articl cooper data subsequ applic authoris case biocid product authoris accord articl prejudic oblig impos pursuant articl compet author agre subsequ applic authoris refer data provid applic subsequ applic provid evid biocid product similar activ substanc authoris includ degre puriti natur impur notwithstand articl applic authoris biocid product carri experi involv vertebr anim enquir compet author member state intend make applic biocid product applic made similar biocid product authoris grant address holder holder authoris authoris enquiri support evid prospect applic intend appli authoris behalf inform articl compet author member state satisfi applic intend appli provid address holder holder relev authoris time inform holder authoris address applic holder holder authoris applic reason step reach agreement share inform avoid duplic test vertebr anim compet author member state encourag data holder cooper provis request data view limit duplic test vertebr anim applic holder authoris product reach agreement share data member state introduc nation measur oblig applic holder authoris locat territori share data view avoid duplic test vertebr anim determin procedur utilis inform reason balanc interest parti concern articl inform member state prescrib holder authoris biocid product immedi notifi compet author inform awar expect awar activ substanc biocid product affect continu authoris notifi knowledg inform effect activ substanc biocid product human environ sourc composit activ substanc composit biocid product develop resist administr natur aspect natur packag member state immedi notifi member state commiss inform receiv potenti harm effect human environ composit biocid product activ substanc impur formul residu articl derog requir derog articl member state authoris temporarili period exceed dai place market biocid product compli provis direct limit control measur appear unforeseen danger contain mean case member state concern immedi inform member state commiss action justif commiss make propos decid delai accord procedur laid articl condit action member state extend period determin repeat revok derog articl activ substanc list annex ia member state authoris provision period exceed year place market biocid product activ substanc list annex ia market date refer articl purpos defin articl authoris issu dossier evalu accord articl member state believ activ substanc satisfi requir articl biocid product expect satisfi condit articl member state basi summari receiv make legitim object accord articl complet dossier object made decis complet dossier accord procedur laid articl undu delai procedur laid articl decid activ substanc satisfi requir articl member state ensur provision authoris cancel case evalu dossier purpos inclus activ substanc annex ia complet period year expir compet author provision authoris product period exceed year provid good reason activ substanc satisfi requir articl member state inform member state commiss action articl transit measur derog articl prejudic paragraph member state period year date refer articl continu appli current system practic place biocid product market nation rule authoris place market territori biocid product activ substanc list annex ia product type activ substanc market date refer articl activ substanc biocid product purpos defin articl adopt direct commiss commenc year programm work systemat examin activ substanc market date refer articl activ substanc biocid product purpos defin articl regul adopt procedur laid articl provid provis establish implement programm includ set prioriti evalu activ substanc timet year complet work programm commiss forward european parliament council report progress achiev programm year period date refer articl decid pursuant procedur laid articl activ substanc includ annex ia ib condit case requir articl satisfi requisit inform data submit prescrib period activ substanc includ annex ia ib decis includ includ activ substanc annex ia ib member state ensur authoris relev registr biocid product activ substanc compli provis direct grant modifi cancel review activ substanc conclud substanc meet requir articl includ annex ia ib commiss bring forward propos restrict market substanc accord direct eec provis council direct eec march lai procedur provis inform field technic standard regul continu appli transit period refer paragraph articl research develop derog articl member state prescrib experi test purpos research develop involv place market unauthor biocid product activ substanc intend exclus biocid product place case scientif research develop person concern draw maintain written record detail ident biocid product activ substanc label data quantiti suppli name address person receiv biocid product activ substanc compil dossier data effect human anim health impact environ inform request made compet author case process orient research develop inform requir notifi compet author place market occur compet author member state experi test conduct member state prescrib unauthoris biocid product activ substanc exclus biocid product market purpos experi test involv result releas environ compet author assess data issu authoris purpos limit quantiti area treat impos condit experi test take place member state member state place market occur applic obtain experi test authoris compet author member state territori experi test conduct propos experi test refer paragraph liabl harm effect human anim health unaccept advers influenc environ member state concern prohibit subject condit consid prevent consequ paragraph appli member state grant person concern undertak experi test determin condit experi test undertaken common condit applic articl maximum quantiti activ substanc biocid product releas experi minimum data submit accord paragraph adopt accord procedur laid articl articl inform exchang period month end quarter member state inform commiss biocid product authoris regist territori authoris registr refus modifi renew cancel indic busi applic holder authoris registr trade biocid product amount activ substanc amount danger substanc mean articl direct eec classif product type authoris type formul propos limit residu establish condit authoris relev reason modif cancel authoris indic product special type frame formul low risk biocid product member state receiv summari dossier accord articl legitim reason dossier incomplet immedi commun concern compet author respons evalu dossier undu delai inform commiss member state concern member state draw annual list biocid product authoris regist territori commun list member state commiss accord procedur laid articl standardis inform system set facilit applic paragraph commiss draw report implement direct function simplifi procedur frame formul low risk biocid product commod substanc year date mention articl commiss submit report council accompani propos articl confidenti text continu doc num prejudic council direct eec june freedom access inform environ applic compet author inform consid commerci sensit disclosur harm industri commerci wish confidenti person compet author commiss full justif requir case prejudic inform refer paragraph provis direct eec eec member state step ensur confidenti full composit product formul request applic compet author receiv applic decid basi documentari evid produc applic inform confidenti term paragraph inform accept confidenti receiv compet author treat confidenti compet author member state commiss authoris grant confidenti case appli address applic address biocid product manufactur address activ substanc manufactur name content activ substanc substanc biocid product biocid product name substanc regard danger mean direct eec contribut classif product physic chemic data activ substanc biocid product wai render activ substanc biocid product harmless summari result test requir pursuant articl establish substanc product efficaci effect human anim environ applic abil promot resist recommend method precaut reduc danger handl storag transport fire hazard safeti data sheet method analysi refer articl method dispos product packag procedur measur case spillag leakag aid medic advic case injuri person applic manufactur import biocid product activ substanc disclos previous confidenti inform compet author inform detail provis format make inform publicli implement articl decid accord procedur set articl articl classif packag label biocid product biocid product classifi accord provis relat classif direct eec biocid product packag accord articl direct eec addit product mistaken food drink feedingstuff packag minim likelihood mistak made product gener public mistaken food drink feedingstuff compon discourag consumpt biocid product label accord provis relat label direct eec label mislead give exagger impress product case mention indic low risk biocid product toxic harmless similar indic addit label show indel ident activ substanc concentr metric unit authoris number alloc biocid product compet author type prepar liquid concentr granul powder solid biocid product authoris wood preserv disinfect surfac biocid anti foul direct dose rate express metric unit provid term authoris particular direct indirect advers side effect direct aid accompani leaflet sentenc read attach instruct direct safe dispos biocid product packag includ relev prohibit reus packag formul batch number design expiri date relev normal condit storag period time need biocid effect interv observ applic biocid product applic product treat access man anim area biocid product includ particular decontamin mean measur durat ventil treat area particular adequ clean equip particular precautionari measur storag transport person protect cloth equip measur protect fire cover furnitur remov food feedingstuff direct prevent anim expos applic categori user biocid product restrict inform specif danger environ protect target organ avoid contamin water microbiolog biocid product label requir council direct eec novemb protect worker risk relat exposur biolog agent work member state requir item applic carri label product member state permit item carri packag accompani leaflet integr packag item inform regard label inform purpos direct biocid product identifi insecticid acaricid rodenticid avicid molluscicid authoris pursuant direct subject classif packag label council direct eec june approxim law member state relat classif packag label danger prepar pesticid virtu commun provis member state permit packag label product requir consequ provis conflict condit authoris issu direct member state requir provis sampl model draft packag label leaflet member state make place biocid product market territori subject label nation languag languag articl safeti data sheet member state measur ensur system specif inform establish enabl profession industri user user biocid product measur protect environ health health safeti workplac form safeti data sheet provid respons place market product safeti data sheet prepar biocid product classifi danger accord articl direct eec activ substanc exclus biocid product accord requir articl direct eec articl advertis member state requir advertis biocid product accompani sentenc biocid safe read label product inform sentenc distinguish relat advertis member state prescrib advertis replac word biocid prescrib sentenc accur descript product type advertis wood preserv disinfect surfac biocid anti foul product member state requir advertis biocid product refer product manner mislead respect risk product man environ circumst advertis biocid product mention low risk biocid product toxic harmless similar indic articl poison control member state appoint bodi bodi respons receiv inform biocid product market includ inform chemic composit product make inform case suspect poison aris biocid product inform meet medic demand formul prevent cur measur emerg member state ensur inform purpos member state step ensur appoint bodi provid requisit guarante maintain confidenti inform receiv member state ensur appoint bodi dispos inform requir carri task respons manufactur person respons market biocid product market date refer articl member state measur compli articl year date refer articl articl complianc requir member state arrang biocid product market monitor establish compli requir direct year date refer articl member state forward commiss novemb year report action matter inform poison involv biocid product commiss year receipt inform prepar publish composit report articl charg member state establish system oblig seek place biocid product market support entri activ substanc annex ia ib pai charg cost carri procedur provis direct articl compet author member state design compet author compet author respons carri duti impos member state pursuant direct member state inform commiss ident compet author compet author date refer articl articl commiss procedur commiss receiv member state evalu recommend activ substanc accord articl assess articl propos refus authoris registr explanatori document accord articl period dai member state applic submit comment write end period comment commiss basi document receiv member state evalu dossier advic obtain advisori scientif committe comment receiv member state applic relev inform prepar draft decis accord relev procedur laid articl commiss applic authoris repres submit remark favour decis envisag articl committe procedur commiss assist stand committe biocid product stand committe stand committe compos repres member state chair repres commiss stand committe adopt rule procedur matter refer stand committe virtu articl elabor specif data product type refer annex drawn annex iiia iiib annex iva ivb repres commiss submit committe draft measur committe deliv opinion draft time limit chairman lai urgenc matter opinion deliv major laid articl treati case decis council requir adopt propos commiss vote repres member state committe weight manner set articl chairman vote commiss adopt measur envisag appli immedi measur accord opinion committe commun commiss council forthwith event commiss defer applic measur decid period month date commun council act qualifi major decis time limit refer previou subparagraph matter refer stand committe virtu articl repres commiss submit committe draft measur committe deliv opinion draft time limit chairman lai urgenc matter opinion deliv major laid articl treati case decis council requir adopt propos commiss vote repres member state committe weight manner set articl chairman vote commiss adopt measur envisag accord opinion committe measur envisag accord opinion committe opinion deliv commiss delai submit council propos relat measur council act qualifi major expiri month date referr council council act propos measur adopt commiss save council decid measur simpl major articl adapt technic progress amend adapt annex iia iib iiia iiib iva ivb descript product type annex technic progress data requir product type adopt accord procedur laid articl articl modif adapt annex vi act propos commiss council european parliament accord procedur laid treati modifi adapt technic progress titl product type annex provis annex vi articl civil crimin liabil grant authoris measur conform direct prejudic gener civil crimin liabil member state manufactur applic person respons place biocid product market articl safeguard claus member state valid reason biocid product authoris regist bound authoris regist pursuant articl constitut unaccept risk human anim health environ provision restrict prohibit sale product territori immedi inform commiss member state action give reason decis decis matter dai accord procedur laid articl articl technic note guidanc commiss accord procedur laid articl draw technic note guidanc facilit dai dai implement direct technic note publish seri offici journal european commun articl implement direct member state bring forc law regul administr provis compli direct month entri forc 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 text provis nation law adopt field cover direct articl direct enter forc dai public articl direct address member state brussel februari european parliament presid gil robl council presid cunningham oj oj oj oj oj opinion european parliament april oj council common posit decemb oj decis european parliament oj council decis decemb decis european parliament januari oj oj oj direct amend direct ec oj oj direct amend direct ec oj oj oj oj oj direct amend direct eec oj oj direct amend direct eec oj oj oj oj oj oj direct amend direct eec oj oj oj direct amend direct ec oj oj direct amend direct eec oj oj direct amend direct ec oj oj oj direct amend direct ec oj oj direct amend act access oj direct amend direct ec oj oj oj direct amend direct ec oj oj direct amend direct ec oj oj direct amend act access oj direct amend direct ec oj oj oj direct amend direct ec oj oj direct amend direct ec oj oj direct amend act access oj regul amend regul ec oj oj direct amend act access oj oj oj direct amend direct ec oj oj oj direct amend direct eec oj oj oj oj direct amend direct ec oj oj oj direct amend direct ec oj oj direct amend direct eec oj annex list activ substanc requir agre commun level inclus biocid product annex ia list activ substanc requir agre commun level inclus low risk biocid product annex ib list basic substanc requir agre commun level annex iia common core data set activ substanc chemic substanc dossier activ substanc requir address point list dossier requir respons requir support data dossier requir line technic develop inform ow natur biocid product propos suppli appli scientif technic suppli inform case justif accept compet author submit justif exist frame formul applic access dossier requir applic ii ident activ substanc iii physic chemic properti activ substanc iv method detect identif effect target organ intend vi toxicolog profil man anim includ metabol vii ecotoxicolog profil includ environment fate behaviour viii measur protect man anim environ ix classif label summari evalu section ii ix data requir support submiss point applic address activ substanc manufactur address locat plant ii ident common propos accept iso synonym chemic iupac nomenclatur manufactur develop code number ca ec number molecular structur formula includ full detail isomer composit molecular mass method manufactur synthes pathwai term activ substanc specif puriti activ substanc kg ident impur addit stabilis structur formula rang express kg origin natur activ substanc precursor activ substanc extract flower exposur data conform annex viia direct eec iii physic chemic properti melt point boil point rel densiti vapour pressur pa appear physic state colour absorpt spectra uv vi ir nmr mass spectrum molar extinct relev wavelength relev solubl water includ effect ph temperatur solubl relev partit coeffici octanol water includ effect ph temperatur thermal stabil ident relev breakdown product flammabl includ auto flammabl ident combust product flash point surfac tension explos properti oxidis properti reactiv contain materi iv analyt method detect identif analyt method determin pure activ substanc relev degrad product isom impur activ substanc addit stabilis analyt method includ recoveri rate limit determin activ substanc residu thereof relev soil air water applic confirm substanc degrad product fall definit pesticid paramet annex council direct eec juli relat qualiti water intend human consumpt estim adequ reliabl mac direct individu pesticid anim human bodi fluid tissu effect target organ intend function fungicid rodenticid insecticid bactericid organ control product organ object protect effect target organ concentr activ substanc mode action includ time delai field envisag user industri profession gener public profession inform occurr occurr develop resist manag strategi tonnag market year vi toxicolog metabol studi acut toxic studi substanc gase administ rout oral rout choic rout depend natur substanc rout human exposur gase volatil liquid administ inhal rout oral dermal inhal skin ey irrit skin sensitis metabol studi mammal basic toxicokinet includ dermal absorpt studi studi requir rout administr oral rout justifi altern rout short term repeat dose toxic dai studi requir chronic toxic studi rodent subchron toxic dai studi speci rodent rodent chronic toxic rodent mammalian speci mutagen studi vitro gene mutat studi bacteria vitro cytogen studi mammalian cell vitro gene mutat assai mammalian cell posit vivo mutagen studi requir bone marrow assai chromosom damag micronucleu test neg posit vitro test undertak vivo studi examin mutagen evid dna damag demonstr tissu bone marrow posit test assess germ cell effect requir carcinogen studi rodent mammalian speci studi combin reproduct toxic teratogen test rabbit rodent speci fertil studi gener speci male femal medic data anonym form medic surveil data manufactur plant personnel direct observ clinic case poison incid health record industri sourc epidemiolog studi gener popul diagnosi poison includ specif sign poison clinic test sensitis allergen observ specif treatment case accid poison aid measur antidot medic treatment prognosi poison summari mammalian toxicolog conclus includ observ advers effect level noael observ effect level noel evalu regard toxicolog data inform activ substanc suggest worker protect measur includ summari form vii ecotoxicolog studi acut toxic fish acut toxic daphnia magna growth inhibit test alga inhibit microbiolog activ bioconcentr fate behaviour environ degrad biotic readi biodegrad inher biodegrad abiot hydrolysi function ph identif breakdown product phototransform water includ ident product transform adsorpt desorpt screen test result test test annex iiia part xii paragraph requir test annex iiia part xii paragraph summari ecotoxicolog effect fate behaviour environ viii measur protect man anim environ recommend method precaut handl storag transport fire case fire natur reaction product combust gase emerg measur case accid possibl destruct decontamin releas air water includ drink water soil procedur wast manag activ substanc industri profession user possibl recycl possibl neutralis effect condit control discharg includ leachat qualiti dispos condit control inciner observ undesir unintend side effect benefici target organ ix classif label propos includ justif propos classif label activ substanc direct eec hazard symbol indic danger risk phrase safeti phrase summari evalu section ii ix note oj oj direct amend direct eec oj data submit purifi activ substanc state specif data submit activ substanc state specif ey irrit test activ substanc shown potenti corros properti long term toxic carcinogen activ substanc requir full justif demonstr test except circumst claim test unnecessari claim fulli justifi annex iib common core data set biocid product chemic product dossier biocid product requir address point list dossier requir respons requir support data dossier requir line technic develop inform ow natur biocid product propos suppli appli scientif technic suppli inform case justif accept compet author submit justif exist frame formul applic access inform deriv exist data justif accept compet author provid provis direct eec minimis anim test dossier requir applic ii ident biocid product iii physic chemic properti biocid product iv method identif analysi biocid product intend biocid product efficaci vi toxicolog data biocid product addit activ substanc vii ecotoxicolog data biocid product addit activ substanc viii measur protect man anim environ ix classif packag label summari evalu section ii ix data requir support submiss point applic address formul biocid product activ substanc name address includ locat plant ii ident trade propos trade manufactur develop code number prepar detail quantit qualit inform composit biocid product activ substanc impur adjut inert compon physic state natur biocid product emulsifi concentr wettabl powder solut iii physic chemic technic properti appear physic state colour explos properti oxidis properti flash point indic flammabl spontan ignit acid alkalin ph water rel densiti storag stabil stabil shelf life effect light temperatur humid technic characterist biocid product reactiv contain materi technic characterist biocid product wettabl persist foam flowabl pourabl dustabl physic chemic compat product includ biocid product authoris iv method identif analysi analyt method determin concentr activ substanc biocid product cover annex iia paragraph analyt method includ recoveri rate limit determin toxicolog ecotoxicolog relev compon biocid product residu thereof relev soil air water includ drink water anim human bodi fluid tissu treat food feedingstuff intend efficaci product type field envisag method applic includ descript system applic rate final concentr biocid product activ substanc system prepar cool water surfac water water heat purpos number time applic relev inform relat geograph variat climat variat wait period protect man anim function fungicid rodenticid insecticid bactericid pest organ control product organ object protect effect target organ mode action includ time delai cover annex iia paragraph user industri profession gener public profession efficaci data propos label claim product efficaci data support claim includ standard protocol laboratori test field trial limit efficaci includ resist vi toxicolog studi acut toxic studi biocid product gase administ rout oral rout choic rout depend natur product rout human exposur gase volatil liquid administ inhal rout oral dermal inhal biocid product intend authoris biocid product mixtur product test acut dermal toxic skin ey irrit skin ey irrit skin sensitis inform dermal absorpt toxicolog data relat toxicolog relev activ substanc substanc concern inform relat exposur biocid product man oper test annex iia requir toxicolog relev activ substanc prepar vii ecotoxicolog studi forese rout entri environ basi envisag inform ecotoxicolog activ substanc product extrapol inform activ substanc ecotoxicolog inform relat ecotoxicolog relev activ substanc substanc concern inform safeti data sheet viii measur adopt protect man anim environ recommend method precaut handl storag transport fire specif treatment case accid aid measur antidot medic treatment emerg measur protect environ cover annex iia paragraph procedur clean applic equip ident relev combust product case fire procedur wast manag biocid product packag industri profession user gener public profession user possibl reus recycl neutralis condit control discharg inciner possibl destruct decontamin releas air water includ drink water soil observ undesir unintend side effect benefici target organ repel poison control measur includ prepar present prevent action target organ ix classif packag label propos packag label propos safeti data sheet justif classif label principl articl direct hazard symbol indic danger risk phrase safeti phrase packag type materi size compat prepar propos packag materi includ summari evalu section ii ix note ey irrit test biocid product shown potenti corros properti annex iiia addit data set activ substanc chemic substanc dossier activ substanc requir address point list dossier requir respons requir support data dossier requir line technic develop inform ow natur biocid product propos suppli appli scientif technic suppli inform case justif accept compet author submit justif exist frame formul applic access iii physic chemic properti solubl organ solvent includ effect temperatur solubl stabil organ solvent biocid product ident relev breakdown product iv analyt method detect identif analyt method includ recoveri rate limit determin activ substanc residu thereof food feedstuff product relev vi toxicolog metabol studi neurotox studi activ substanc organophosphoru compound indic activ substanc neurotox properti neurotox studi requir test speci adult hen test speci justifi delai neurotox test requir anticholin esteras activ detect test respons reactiv agent consid toxic effect livestock pet studi relat exposur activ substanc human food feedingstuff activ substanc prepar food human consumpt prepar consum store feedingstuff livestock prepar consum store test refer section xi part requir test relat exposur activ substanc human propos biocid product consid test refer section xi part requir activ substanc product action plant test assess toxic effect metabolit treat plant identifi anim requir mechanist studi studi clarifi effect report toxic studi vii ecotoxicolog studi acut toxic test aquat target organ result ecotoxicolog studi intend activ substanc danger environ test section xii xiii requir result test paragraph annex iia neg rout dispos activ substanc sewag treatment test section xiii part requir biodegrad test relev result paragraph annex iia phototransform air estim method includ identif breakdown product result paragraph annex iia paragraph activ substanc low absent abiot degrad test section xii part part part requir viii measur protect human anim environ identif substanc fall scope list list ii annex direct eec protect groundwat pollut caus danger substanc note xi human health relat studi food feedingstuff studi identif degrad reaction product metabolit activ substanc treat contamin food feedstuff behaviour residu activ substanc degrad product relev metabolit treat contamin food feedstuff includ kinet disappear materi balanc activ substanc suffici residu data supervis trial demonstr residu aris propos concern human anim health estim potenti actual exposur activ substanc human diet mean residu activ substanc remain feedingstuff signific period time feed metabol studi livestock requir permit evalu residu food anim origin effect industri process domest prepar natur magnitud residu activ substanc propos accept residu justif accept inform relev summari evalu data submit test relat exposur human suitabl test reason case requir xii studi fate behaviour environ fate behaviour soil rate rout degrad includ identif process involv identif metabolit degrad product soil type condit absorpt desorpt soil type relev absorpt desorpt metabolit degrad product mobil soil type relev mobil metabolit degrad product extent natur bound residu fate behaviour water rate rout degrad aquat system cover annex iia paragraph includ identif metabolit degrad product absorpt desorpt water soil sediment system relev absorpt desorpt metabolit degrad product fate behaviour air activ substanc prepar fumig appli sprai method volatil inform relev rate rout degrad air determin cover section vii part summari evalu part xiii ecotoxicolog studi effect bird acut oral toxic avian speci select studi section vii part short term toxic dai dietari studi speci chicken effect reproduct effect aquat organ prolong toxic speci fish effect reproduct growth rate speci fish bioaccumul speci fish daphnia magna reproduct growth rate effect target organ acut toxic honeybe benefici arthropod predat test organ chosen section vii part toxic earthworm soil target macro organ effect soil target micro organ effect specif target organ flora fauna believ risk effect activ sludg respir inhibit test summari evalu part data submit purifi activ substanc state specif data submit activ substanc state specif oj annex iiib addit data set biocid product chemic product dossier biocid product requir address point list dossier requir respons requir support data dossier requir line technic develop inform ow natur biocid product propos suppli appli scientif technic suppli inform case justif accept compet author submit justif exist frame formul applic access inform deriv exist data justif accept compet author provid provis direct eec minimis anim test xi human health relat studi food feedingstuff studi residu biocid product remain feedingstuff signific period time feed metabol studi livestock requir permit evalu residu food anim origin effect industri process domest prepar natur magnitud residu biocid product test relat exposur human suitabl test reason case requir biocid product xii studi fate behaviour environ relev inform requir annex iiia section xii test distribut dissip soil water air test requir applic ecotoxicolog relev compon biocid product xiii ecotoxicolog studi effect bird acut oral toxic accord annex iib section vii effect aquat organ case applic surfac water studi fish aquat organ residu data fish activ substanc includ toxicolog relev metabolit studi refer annex iiia section xiii part requir relev compon biocid product biocid product sprai surfac water oversprai studi requir assess risk aquat organ field condit effect target organ toxic terrestri vertebr bird acut toxic honeybe effect benefici arthropod bee effect earthworm soil target macro organ believ risk effect soil target micro organ effect specif target organ flora fauna believ risk biocid product form bait granul supervis trial assess risk target organ field condit studi accept ingest biocid product target organ thought risk summari evalu part annex iva data set activ substanc fungi micro organ virus dossier activ organ requir address point list dossier requir respons requir support data dossier requir line technic develop inform ow natur biocid product propos suppli appli scientif technic suppli inform case justif accept compet author submit justif exist frame formul applic access dossier requir applic detail ii ident activ organ iii sourc activ organ iv method detect identif biolog properti activ organ includ pathogen infect target target organ includ man vi effect intend vii toxicolog profil man anim includ metabol toxin viii ecotoxicolog profil includ environment fate behaviour organ toxin produc ix measur protect man target organ environ classif label xi summari evalu section ii data requir support submiss point applic applic address manufactur address plant locat ii ident organ common organ includ altern supersed name taxonom strain indic stock variant mutant strain virus taxonom design agent serotyp strain mutant collect cultur refer number cultur deposit method procedur criteria establish presenc ident organ morpholog biochemistri serolog iii sourc organ occurr natur isol method organ activ strain cultur method product method includ detail contain procedur maintain qualiti ensur uniform sourc activ organ mutant strain detail inform provid product isol differ mutant strain parent natur occur strain composit final activ organ materi natur puriti ident properti content impur extran organ method prevent contamin seed stock loss virul seed stock procedur wast manag iv method detect identif method establish presenc ident organ method establish ident puriti seed stock batch produc result obtain includ inform variabl method show microbiolog puriti final product show contamin control accept level result obtain inform variabl method show human mammalian pathogen contamin activ agent includ case protozoa fungi effect temperatur relev temperatur method determin viabl viabl toxin residu treat product foodstuff feedingstuff anim human bodi fluid tissu soil water air relev biolog properti organ histori organ includ gener natur histori relev geograph distribut relationship exist pathogen vertebr invertebr plant organ effect target organ pathogen kind antagon host detail host specif rang includ transmiss infect dose mode action includ inform presenc absenc product toxin inform natur ident chemic structur stabil potenc effect target organ close relat target organ includ infect pathogen transmiss transmiss target organ biolog effect target organ properli infect physic stabil properli genet stabil environment condit propos pathogen infect man anim condit immunosuppress pathogen infect parasit predat target speci vi effect intend harm organ control materi substanc organ product treat protect envisag insecticid disinfect anti foul product inform observ undesir unintend side effect inform occurr occurr develop resist manag strategi deal effect target organ categori user vii toxicolog metabol studi acut toxic case singl dose set rang find test carri reveal highli toxic agent infect oral dermal inhal skin ey irrit skin sensitis respiratori sensitis virus viroid cell cultur studi purifi infect viru primari cell cultur mammalian avian fish cell chronic toxic dai studi speci rodent rodent oral administr rout inhal dermal virus viroid test infect carri bio assai suitabl cell cultur dai administr test anim chronic toxic speci rodent mammal oral administr rout carcinogen studi combin studi rodent mammal mutagen studi annex iia section vi part reproduct toxic teratogen test rabbit rodent speci fertil studi speci minimum gener male femal metabol studi basic toxicokinet absorpt includ dermal absorpt distribut excret mammal includ elucid metabol pathwai neurotox studi requir indic anticholinerteras activ neurotox effect delai neurotox test adult hen perform immunotox studi allergen incident exposur studi requir activ substanc product human food anim feedingstuff prepar consum store human livestock pet expos treat area materi human exposur data includ medic data anonym form health record medic surveil data manufactur plant personnel epidemiolog data poison incid data poison diagnosi sign symptom includ detail analyt test propos treatment poison prognos summari mammalian toxicolog conclus includ noael noel adi evalu regard toxicolog pathogen infect data inform activ organ suggest user protect measur includ summari form viii ecotoxicolog studi acut toxic fish acut toxic daphnia magna effect alga growth inhibit test acut toxic aquat target organ pathogen infect honeybe earthworm acut toxic pathogen infect target organ believ risk effect flora fauna case toxin produc data outlin annex iia section vii part produc fate behaviour environ spread mobil multipl persist air soil water case toxin produc data outlin annex iia section vii part ix measur protect human target organ environ method precaut storag handl transport event fire incid circumst environment condit activ organ possibl render activ organ infect method consequ contamin air soil water drink water emerg measur case accid procedur wast manag activ organ includ leachat qualiti dispos possibl destruct decontamin releas air water soil classif label propos alloc risk group outlin articl direct eec justif propos indic product carri biohazard sign annex ii direct eec xi summari evalu section ii annex ivb data set biocid product fungi micro organ virus dossier biocid product requir address point list dossier requir respons requir support data dossier requir line technic develop inform ow natur biocid product propos suppli appli scientif technic suppli inform case justif accept compet author submit justif exist frame formul applic access inform deriv exist data justif accept compet author provid provis direct eec minimis anim test dossier requir applic ii ident composit biocid product iii technic properti biocid product biocid properti addit activ organ iv method identif analysi biocid product intend efficaci vi toxicolog inform addit activ organ vii ecotoxicolog inform addit activ organ viii measur adopt protect human target organ environ ix classif packag label biocid product summari section ii ix data requir support submiss point applic address manufactur biocid product activ organ includ locat plant ii ident biocid product trade propos trade manufactur develop code number biocid product detail quantit qualit inform composit biocid product activ organ inert compon extran organ physic state natur biocid product emulsifi concentr wettabl powder concentr activ organ materi iii technic biolog properti appear colour odour storag stabil shelf life effect temperatur method packag storag retent biolog activ method establish storag shelf life stabil technic characterist biocid product wettabl persist foam suspens suspens stabil wet siev test dry siev test particl size distribut content dust fine attrit friabil case granul siev test indic weight distribut granul fraction particl size bigger mm content activ substanc bait particl granul treat materi emulsifi emulsifi emuls stabil flowabl pourabl dustabl physic chemic compat product includ biocid product authoris wet adher distribut applic biolog properti organ result formul pathogen infect iv method identif analysi analyt method determin composit biocid product method determin residu biotest method show microbiolog puriti biocid product method show biocid product free human mammalian pathogen pathogen harm target organ environ techniqu ensur uniform product assai method standardis intend efficaci product type wood preserv insecticid detail intend type harm organ control materi treat applic rate light test result specif circumst environment condit product method applic number time applic propos instruct efficaci data preliminari rang find test field experiment inform occurr develop resist effect qualiti materi product treat vi toxic inform addit requir activ organ oral singl dose percutan singl dose inhal skin relev ey irrit skin sensitis toxicolog data relat activ substanc oper exposur percutan absorpt inhal depend formul method applic oper exposur field condit includ relev quantit analysi oper exposur vii ecotox inform addit requir activ organ observ undesir unintend side effect benefici target organ persist environ viii measur adopt protect man target organ environ recommend method precaut handl storag transport entri period wait period precaut protect human anim emerg measur case accid procedur destruct decontamin biocid product packag ix classif packag label propos includ justif classif packag label regard biolog compon product accord direct eec hazard symbol indic danger risk phrase safeti phrase ii regard activ organ label risk group outlin articl direct eec biohazard sign direct packag type materi size compat biocid product propos packag materi specimen propos packag summari section ii ix annex biocid product type descript refer articl direct product type exclud product cover direct mention articl direct purpos direct subsequ modif main group disinfect gener biocid product product type exclud clean product intend biocid effect includ wash liquid powder similar product product type human hygien biocid product product group biocid product human hygien purpos product type privat area public health area disinfect biocid product product disinfect air surfac materi equip furnitur direct food feed contact privat public industri area includ hospit product algaecid usag area includ inter alia swim pool aquarium bath water air condit system wall floor health institut chemic toilet wast water hospit wast soil substrat playground product type veterinari hygien biocid product product group biocid product veterinari hygien purpos includ product area anim hous transport product type food feed area disinfect product disinfect equip contain consumpt utensil surfac pipework product transport storag consumpt food feed drink includ drink water human anim product type drink water disinfect product disinfect drink water human anim main group preserv product type preserv product preserv manufactur product foodstuff feedingstuff contain control microbi deterior ensur shelf life product type film preserv product preserv film coat control microbi deterior order protect initi properti surfac materi object paint plastic sealant wall adhes binder paper art work product type wood preserv product preserv wood includ mill stage wood product control wood destroi wood disfigur organ product type includ prevent cur product product type fibr leather rubber polymeris materi preserv product preserv fibrou polymeris materi leather rubber paper textil product rubber control microbiolog deterior product type masonri preserv product preserv remedi treatment masonri construct materi wood control microbiolog algal attack product type preserv liquid cool process system product preserv water liquid cool process system control harm organ microb alga mussel product preserv drink water includ product type product type slimicid product prevent control slime growth materi equip structur industri process wood paper pulp porou sand strata oil extract product type metalwork fluid preserv product preserv metalwork fluid control microbi deterior main group pest control product type rodenticid product control mice rat rodent product type avicid product control bird product type molluscicid product control mollusc product type piscicid product control fish product exclud product treatment fish diseas product type insecticid acaricid product control arthropod product control arthropod insect arachnid crustacean product type repel attract product control harm organ invertebr flea vertebr bird repel attract includ human veterinari hygien directli indirectli main group biocid product product type preserv food feedstock product preserv food feedstock control harm organ product type antifoul product product control growth settlement foul organ microb higher form plant anim speci vessel aquacultur equip structur water product type embalm taxidermist fluid product disinfect preserv human anim corps part thereof product type control vertebr product control vermin annex vi common principl evalu dossier biocid product definit hazard identif identif advers effect biocid product inher capac dose concentr respons effect assess estim relationship dose level exposur activ substanc substanc concern biocid product incid sever effect exposur assess determin emiss pathwai rate movement activ substanc substanc concern biocid product transform degrad order estim concentr dose human popul anim environment compart expos risk characteris estim incid sever advers effect occur human popul anim environment compart due actual predict exposur activ substanc substanc concern biocid product includ risk estim quantif likelihood environ water includ sediment air land wild speci fauna flora interrelationship relationship live organ introduct annex lai principl ensur evalu made decis member state authoris biocid product provid chemic prepar result harmonis high level protect human anim environ accord articl direct order ensur high harmonis level protect human anim health environ risk aris biocid product identifi achiev risk assess carri determin accept risk identifi propos normal biocid product carri assess risk relev individu compon biocid product risk assess activ substanc substanc present biocid product requir carri purpos annex ia ib risk assess entail hazard identif dose concentr respons effect assess exposur assess risk characteris quantit risk assess made qualit assess produc addit risk assess carri manner substanc concern present biocid product relev biocid product order carri risk assess data requir data detail annex ii iii iv recognis wide varieti product type flexibl product type risk data requir minimum carri risk assess member state due consider requir articl direct order avoid duplic data submiss minimum set data requir activ substanc biocid product type detail annex viia direct eec data submit assess part risk assess requir entri activ substanc annex ia ib direct data requir substanc concern present biocid product result risk assess carri activ substanc substanc concern present biocid product integr produc assess biocid product make evalu take decis authoris biocid product member state consider relev technic scientif inform regard properti biocid product compon metabolit residu evalu relev justif submit applic suppli data member state compli requir mutual recognit state articl direct biocid product present minor differ composit account evalu dossier concept frame formul relev biocid product consid pose low risk biocid product compli requir annex subject simplifi procedur detail articl direct applic common principl lead member state decid biocid product authoris authoris includ restrict condit case member state conclud data requir authoris decis made process evalu decis make member state applic cooper order resolv question data requir quickli identifi earli stage addit studi requir amend propos condit biocid product modifi natur composit order ensur full complianc requir annex direct administr burden small medium size enterpris sme minimum prejud level protect afford human anim environ judgment made member state evalu decis make process base scientif principl prefer recognis intern level made benefit expert advic evalu gener principl data submit support applic authoris biocid product examin complet scientif receiv member state accept data member state utilis carri risk assess base propos biocid product risk assess activ substanc present biocid product carri addit substanc concern present biocid product risk assess carri risk assess cover propos normal biocid product realist worst case scenario includ relev product dispos issu biocid product materi treat activ substanc substanc concern present biocid product risk assess entail hazard identif establish observ advers effect level noael includ dose concentr respons effect assess exposur assess risk characteris result arriv comparison exposur effect level concentr activ substanc substanc concern integr produc risk assess biocid product quantit result result qualit assess integr similar manner risk assess determin risk human anim risk environ measur protect human anim gener environ propos normal biocid product realist worst case situat case conclud data requir risk assess finalis addit data request minimum complet risk assess effect human risk assess account potenti effect aris biocid product popul liabl exposur effect previous mention result properti activ substanc substanc concern present acut chronic toxic irrit corros sensitis repeat dose toxic mutagen carcinogen reproduct toxic neurotox special properti activ substanc substanc concern effect due physico chemic properti popul previous mention profession user profession user human expos indirectli environ hazard identif address properti potenti advers effect activ substanc substanc concern present biocid product result biocid product classifi requir articl direct dose concentr respons effect assess exposur assess risk characteris requir case test hazard identif relat potenti effect activ substanc substanc concern present biocid product conduct result lead classif biocid product risk characteris relat effect reason ground concern advers environment effect unaccept residu member state appli paragraph carri dose concentr respons effect assess activ substanc substanc concern present biocid product repeat dose toxic reproduct toxic dose respons relationship assess activ substanc substanc concern observ advers effect level noael identifi identifi noael lowest observ advers effect level loael identifi acut toxic corros irrit deriv noael loael basi test conduct accord requir direct acut toxic ld median lethal dose lc median lethal concentr fix dose procedur discrimin dose deriv effect suffici determin activ substanc substanc concern inher capac effect product mutagen carcinogen suffici determin activ substanc substanc concern inher capac effect biocid product demonstr activ substanc substanc concern identifi carcinogen genotox identifi oael paragraph respect skin sensitis respiratori sensitis consensu possibl identifi dose concentr advers effect occur subject sensitis substanc suffici evalu activ substanc substanc concern inher capac effect biocid product toxic data deriv observ human exposur inform gain manufactur poison centr epidemiolog survei special consider data carri risk assess exposur assess carri human popul profession user profession user human expos indirectli environ exposur biocid product occur foreseen object assess make quantit qualit estim dose concentr activ substanc substanc concern popul expos biocid product exposur assess base inform technic dossier provid conform articl direct relev inform account adequ measur exposur data form product market type biocid product applic method applic rate physico chemic properti product rout exposur potenti absorpt 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 model make estim relev process take account realist paramet assumpt subject analysi take account element uncertainti reliabl valid measur carri circumst relev model relev condit area relev monitor data substanc analog exposur pattern analog properti consid effect set paragraph noael loael identifi risk characteris entail comparison noael loael evalu dose concentr popul expos noael loael establish qualit comparison made effect anim relev principl section deal effect human member state risk pose anim biocid product effect environ risk assess account advers effect aris environment compart air soil water includ sediment biota biocid product hazard identif address properti potenti advers effect activ substanc substanc concern present biocid product result biocid product classifi requir direct dose concentr respons effect assess exposur assess risk characteris requir case test hazard identif relat potenti effect activ substanc substanc concern present biocid product conduct result led classif biocid product risk characteris relat effect reason ground concern ground deriv properti effect activ substanc substanc concern biocid product indic bioaccumul potenti persist characterist shape toxic time curv ecotox test indic advers effect basi toxic studi classif mutagen data structur analog substanc endocrin effect dose concentr respons effect assess carri order predict concentr advers effect environment compart concern expect occur carri activ substanc substanc concern present biocid product concentr predict effect concentr pnec case establish pnec qualit estim dose concentr respons effect made pnec determin data effect organ ecotox studi submit accord requir articl direct 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 specif assess factor elabor note technic guidanc end base indic commiss direct eec juli lai principl assess risk man environ substanc notifi accord council direct eec environment compart exposur assess carri order predict concentr found activ substanc substanc concern present biocid product concentr predict environment concentr pec case establish pec qualit estim exposur made pec qualit estim exposur determin environment compart emiss discharg dispos distribut includ relev contribut materi treat biocid product forese pec qualit estim exposur determin take account adequ measur exposur data form product market type biocid product applic method applic rate physico chemic properti breakdown transform product pathwai environment compart potenti adsorpt desorpt degrad frequenc durat exposur adequ measur repres exposur data special consider conduct exposur assess calcul method estim exposur level adequ model appli characterist model list paragraph case case basi relev monitor data substanc analog exposur pattern analog properti consid environment compart risk characteris entail comparison pec pnec pec pnec ratio deriv deriv pec pnec ratio risk characteris entail qualit evalu likelihood effect occur current condit exposur occur expect condit exposur unaccept effect data submit evalu member state assess biocid product unnecessari suffer effect target vertebr includ evalu mechan effect obtain observ effect behaviour health target vertebr intend effect kill target vertebr time obtain death target vertebr condit death occur evalu member state relev evalu possibl develop resist activ substanc biocid product target organ indic unaccept effect occur member state evalu possibl effect occur unaccept effect advers reaction fasten fit wood applic wood preserv efficaci data submit evalu ascertain efficaci claim biocid product substanti data submit applic held member state demonstr efficaci biocid product target organ accord condit authoris test carri commun guidelin applic method shown list relev accept field data exist iso cen intern standard method nation standard method industri standard method accept member state individu produc standard method accept member state data actual develop biocid product accept member state summari area risk assess carri effect man anim environ member state combin result activ substanc result substanc concern produc assess biocid product account synergist effect activ substanc substanc concern biocid product biocid product activ substanc advers effect combin produc effect biocid product decis make gener principl subject paragraph member state decis authoris biocid product result integr risk aris activ substanc risk substanc concern present biocid product risk assess cover normal biocid product realist worst case scenario includ relev dispos issu biocid product materi treat make decis authoris member state arriv conclus product type area biocid product applic made biocid product authoris biocid product authoris subject specif condit restrict data requir decis authoris made conclus arriv member state addit inform data requir authoris decis made inform data justifi addit inform data minimum carri risk assess member state compli principl mutual recognit detail articl direct member state appli rule concept frame formul make authoris decis biocid product member state appli rule concept low risk product make authoris decis biocid product member state grant authoris biocid product condit authoris present unaccept risk human anim environ efficaci activ substanc permit commun level biocid product member state impos condit restrict give authoris natur sever select basi natur extent expect advantag risk aris biocid product decis make process member state consider result risk assess relationship exposur effect natur sever effect risk manag appli field biocid product efficaci biocid product physic properti biocid product benefit biocid product member state take decis authoris biocid product account uncertainti aris variabl data evalu decis make process member state prescrib biocid product properli proper includ applic efficaci dose minimis biocid product member state measur ensur applic propos label relev safeti data sheet biocid product fulfil requir articl direct inform protect user requir commun legisl worker protect specifi condit restrict biocid product issu authoris member state confirm requir satisfi member state measur ensur applic propos packag procedur destruct decontamin biocid product packag relev materi biocid product conform relev regulatori provis effect human member state authoris biocid product risk assess confirm forese applic includ realist worst scenario product present unaccept risk human member state effect human popul profession user profession user human expos directli indirectli environ make decis authoris biocid product member state examin relationship exposur effect decis make process number factor consid examin relationship import natur advers effect substanc effect includ acut toxic irrit corros sensitis repeat dose toxic mutagen carcinogen neurotox reproduct toxic physico chemic properti advers properti activ substanc substanc concern member state compar result obtain obtain previou risk assess ident similar advers effect decid margin safeti mo make authoris decis mo typic mo higher lower depend thing natur critic toxicolog effect member state impos condit authoris wear person protect equip respir breath mask overal glove goggl order reduc exposur profession oper equip readili profession user wear person protect equip method reduc exposur product authoris relationship exposur effect reduc accept level authoris member state biocid product biocid product classifi articl direct toxic toxic categori carcinogen categori mutagen classifi toxic reproduct categori authoris gener public effect anim member state authoris biocid product risk assess confirm normal biocid product present unaccept risk target anim relev criteria section deal effect human member state risk pose anim biocid product make authoris decis effect environ member state authoris biocid product risk assess confirm activ substanc substanc concern degrad reaction product present unaccept risk environment compart water includ sediment soil air includ assess risk target organ compart unaccept risk member state come final decis accord paragraph account criteria paragraph basic tool decis make pec pnec ratio qualit estim due consider accuraci ratio due variabl data measur concentr estim determin pec model take account environment fate behaviour biocid product environment compart pec pnec ratio equal risk characteris inform test pec pnec ratio greater member state judg basi size ratio relev factor inform test requir clarifi concern risk reduct measur product authoris relev factor consid previous mention paragraph water member state authoris biocid product propos condit forese concentr activ substanc substanc concern relev metabolit breakdown reaction product water sediment unaccept impact target speci aquat marin estuarin environ scientif demonstr relev field condit unaccept effect member state authoris biocid product propos condit forese concentr activ substanc substanc concern relev metabolit breakdown reaction product groundwat exce lower concentr maximum permiss concentr laid direct eec maximum concentr laid procedur includ activ substanc annex ia ib direct basi data toxicolog data scientif demonstr relev field condit lower concentr exceed member state authoris biocid product forese concentr activ substanc substanc concern relev metabolit breakdown reaction product expect surfac water sediment biocid product propos condit exce surfac water area envisag intend abstract drink water valu fix council direct eec june qualiti requir surfac water intend abstract drink water member state direct eec impact deem unaccept target speci scientif demonstr relev field condit concentr exceed propos instruct biocid product includ procedur clean applic equip likelihood accident contamin water sediment minimis soil unaccept contamin soil occur member state authoris biocid product activ substanc substanc concern contain biocid product test field persist soil year laboratori test form extract residu amount exceed initi dose dai mineralis rate dai unaccept consequ effect target organ scientif demonstr field condit unaccept accumul soil air member state authoris biocid product forese possibl unaccept effect air compart scientif demonstr relev field condit unaccept effect effect target organ member state authoris biocid product forese possibl target organ expos biocid product activ substanc substanc concern pec pnec establish risk assess field condit unaccept effect occur biocid product propos condit bioconcentr factor bcf relat fat tissu target vertebr establish risk assess field condit unaccept effect occur directli indirectli product propos condit member state authoris biocid product forese possibl aquat organ includ marin estuarin organ expos biocid product activ substanc substanc concern pec pnec establish risk assess field condit viabil aquat organ includ marin estuarin organ threaten biocid product propos condit bioconcentr factor bcf greater substanc readili biodegrad greater readili biodegrad establish risk assess field condit unaccept impact directli indirectli occur viabil expos organ includ marin estuarin organ biocid product propos condit derog paragraph member state authoris anti foul product commerci public servic naval seago vessel period year date direct enter forc similar foul control achiev practic mean implement provis member state account relev intern maritim organis imo resolut recommend member state authoris biocid product forese possibl micro organ sewag treatment plant expos biocid product activ substanc substanc concern relev metabolit breakdown reaction product pec pnec ratio establish risk assess field condit unaccept impact directli indirectli occur viabil micro organ unaccept effect develop resist activ substanc biocid product member state step minimis consequ resist involv modif condit authoris refus authoris authoris biocid product intend control vertebr death synchron extinct conscious death occur immedi vital function reduc gradual sign obviou suffer repel product intend effect obtain unnecessari suffer pain target vertebr efficaci member state authoris biocid product possess accept efficaci accord condit propos label condit authoris level consist durat protect control intend effect minimum similar result suitabl refer product product exist mean control refer product exist biocid product give defin level protect control area propos conclus perform biocid product valid area propos area member state propos label prescrib biocid product intend specif circumst member state evalu dose respons data gener trial includ untreat control involv dose rate lower recommend rate order assess recommend dose minimum achiev desir effect summari area risk assess carri effect human anim environ member state combin conclus arriv activ substanc substanc concern produc conclus biocid product summari made efficaci assess unaccept effect result summari effect biocid product human summari effect biocid product anim summari effect biocid product environ summari efficaci assess summari unaccept effect integr conclus member state combin individu conclus arriv regard effect biocid product sector human anim environ arriv conclus global effect biocid product member state due consider relev unaccept effect efficaci biocid product benefit biocid product take authoris decis biocid product member state ultim decid biocid product authoris authoris subject restrict condit conform annex direct oj oj direct amend direct eec oj