1、REACH Workshop ASIA 2011Internatio NISHIMIYA kojilCmRe busmanagementJapans practice on chemicalsAsia 2011assessmentand riskul ineIntetional Chemgci al NooEAorkshopAis a 2011http:/www.kantei.go.jp/foreign/incident/pdf/road_to_recovery.pdf2InteA1. Current trend of ChemicalCHnRof ausmal Crna0113Managem

2、entEAine Japan- Enforcement egultheineChemical SubstancesAct on the Evaluation of Chemical Substancesand Regulation of Their Manufacture, etc.11(Chemical Substances Control Law (CSCL)rk(two major amendments in 1986 andH2003)oand other hazardous chemicalsBased on two pillars:- prior evaluation of new

3、 chemicals- regulationI Three Ministries are in charge: MHLW, METI, MOE(No role of local governments under CSCL)4Enacted in 1973 shpollution from PCBsEA Aiming to prevent environmental eon manufacture/import and useal CExcluded: specific chemicals covered by other regulationse.g. agrochemicals, phar

4、maceuticals, food, fertilizersnRegulation OverviewAct on the Evaluation of Chemical Substances and Regulation2 Regulations on Manufacturing, etc. A- Elements and natural productsSpecific usage EAGeneral usage- Agricultural- Generalproducts lm- Radioactive substances- Stimulant poison materials for s

5、timulants- aRegulations on EmissionsWater Pollution Control Air Pollution Control Soil Contamination Countermeasures Regulations on WasteWaste Management and Public Cleansing5of Their Manufacture, etc. (Chemical Substances Control Law)0- Chemical substances CHW-Foods, additives, n Rchemicalsit s use

6、containers and packaging, toys and detergentso-Ordinary fertilizersu es(industrial)- Feeds and feed additivesindustrial chemical s- Drugs, quasi-drugs, cosmetics and medical equipmentsci a No- Specified al CNarcoticrnInand rawKey Points of Amendment in 2009 (1)11siaorkHazard: Potential adverse effec

7、ts of chemicals for human health and the environmentAmount of Exposure: Potential Exposure to humangAfter the AmendmentheRegulationsmainly based on risks ofchemicals chemicals6(1) Shift to Risk-based chemical management20Risk = Hazard × Potential Exposureand ecosystemCBefore the Amendmentoare m

8、ainlyal CRegulations shall bebased on hazards ofKey Points of Amendment in 2009 (2)11(2) Introduction of a comprehensive management system that covers the existingchemical substances Ashincluding existing one, in excess of the specified amountsnotify quantity and other information for every fiscal y

9、ear.(b) Chemical substances which the government identifies from contents of theof hazardous properties shall beuR u(c) Manufacturers and importersrequired to submithinformation on hazardous properties, and companies handlingthem are required to report their uses when necessary.(d) Among theconcerns

10、manufacture and use as “Class II Specified Chemical Substances,” whichcategory is stipulated in the previous law.7substance,p(a) Companies that have manufactured or imported any chemicaloare newly obliged toknotifications and available knowledge theirion usedesignated as “Priority Assessment Chemica

11、l Substances, which have higherlapriority in the risk assessment.”eof the Priority Assessment Chemical Substances areal o bPriority Assessment Chemical Substances, substances which raiseit oabout adverse effects on humans or the environment through thernagathered information and the risk assessment

12、shall be subject to regulations onIKey Points of Amendment in 2009 (2) contd(2) Introduction of a comprehensive management system that coversthe existing chemical substancespkshave been under control, “chemical substances which isAg esto prevent environmental No Non- persistent chemicalsare also reg

13、ulated, becausechemical substances that they may have adverse effecton the environment, when theysuch chemicals remain in are emitted more than that canthe environment for a longterm.be decomposed throughnatural processes.8(e) In addition to “chemical substances which is persistent in thehenvironmen

14、t,” whichenvironment” are regulated in the amended law.CHBefore the Amendment ulapollution causedChbyaretepersistent, becauseKey Points of Amendment in 2009 (3)(3) Appropriate control on chemical substances in the supply chain12To prevent environmental pollution by Class II Specified Chemical Substa

15、nces andproducts containing those, the law requires companies handlinghthosespecific technical standards and to label those as needed for transactions.ABefore the Amendment tion After the AmendmentgCompanies Companies handlingand specified chemicals andchemicals are required to also required to adhe

16、re toadhere to specific handling specific technical standardsstandards and to label thoseas needed for transactions.and to label them as needed fortransactions.9manufacturingChemimporting specified products containing those areCSCL amended in 2009(Enforced at April 1, 2011)Existing Chemical Substanc

17、esGeneral Chemical SubstancesDetermination by availableknowledge, the state of itsmanufacture, import, etc.Monitoring Chemical Substancesif necessaryInstruction to reportthe state of handlingif necessaryOrder to investigateINew Chemical SubstancesSpecified Cases> 1 ton/year 1 ton/year (e.g.,inter

18、mediates)prkPrior verificationand monitoringDeterminationthe uical R No b Chemical Substancesif necessaryInstruction to reportthe state of handlingif necessaryOrder to Investigatelong-term toxicity*P:PersistentClass I SpecifiedChemical SubstancesClass II SpecifiedChemical SubstancesB:Bioaccumulation

19、T:ToxicityObligatory reporting of hazard information obtained by business10Polymers 0of LowiConcernEvaluation of PBT*Types of chemicals regulated under CSCL(April 1, 2011)Asia201111NameExplanationpQuantityClass-I SpecifiedChemical SubstancesPersistent, bioaccumulative, and toxicity (long-term toxici

20、ty forhumans or long-term toxicity for predator animalso at higher trophiclevel) HW28Class-II SpecifiedChemical SubstancesToxicity (long-term toxicity for humans or long-term toxicity forRenvironmentconsiderableflora and faunaamountoverinetheagsubstantiallyuofhumanlathetiochemicallivingnesextensives

21、environment)usubstancese area remainingwith concernin thefor a23Monitoring ChemicalSubstancesPersistent and bioaccumulative, but toxicity properties unknown(Candidatesic for theNoClass-I Specified Chemical Substances)37Priority AssessmentSubstancesChemical tionrnaInteNot found that it is clear chemi

22、cal substance does not pose long-term toxicityConsiderable amount of chemical substance remains in theenvironmentNot thought not to pose a risk88General ChemicalSubstancesIndustrial chemical substances other than those aboveKey Points of Amendment in 2009 (4)(4) Rationalization of the framework on e

23、valuation and regulation in light ofinternational trendsThe government eliminates international inconsistencies in its regulations, forexample, by reviewing regulations on Class I Specified Chemical Substancesin order to permit the exceptional use of substances thatrwillStockholm Convention in the f

24、uture under strict control.ABefore the Amendment usgClass I Specified Chemicalbe Substances are permitted inused, when there is no case of the exceptional uselisted under the Stockholmuse mainly Convention. While, obligationslives of consumers and to adhere to specific handlinghave no risks of causi

25、ngstandards and label them areenvironmental pollution.added.12Substances couldhemonlysubstituteti, and they dontKey Points of Amendment in 2009 (5)011(5) Notification to related Ministers of informationon chemical substances rkAallow related Ministrieseeordinances in the future under strict control1

26、3The government aims to tion usto share qualitative andula inequantitativeminformation gathered under thelawhamendedla Cenforce more effective regulations on chemicalsubstances pursuant to relevant laws andntInte0Aork2. Risk Assessment in JapanRE eRe busmtio1114I(3)0AorSo far screening assessments h

27、ave beenconducted. Methods forEfurther assessmentsare under development.s(2) PBT assessmentbunder CSCL: explainssubstances to be regulated.aAssessment of Chemicals: conducted bythe Ministry of the Environment.152. Risk Assessment in Japan 11(1) Step-wise risk assessment under CSCL:data andemcriteria

28、 for the designation of PBT(1) Step-wise risk assessmentCSCL Chemical Inventory 2Existing Chemicals + Evaluated New Chemicals-Notify annual quantity of manufactureetc. (mandatory)- SubmitlaDesignation of PACSs - Submit requested hazard informationm - Report requested for handling situationsRisk Asse

29、ssment (I)- Conduct administratively instructedhazardous properties study (long-termtoxicity tests) (mandatory upon instruction)Class II Specified Chemical Substances*Risk Assessment Scheme is under consideration in external committee of 3 Ministries-Notify planed annual quantity ofmanufacture etc.-

30、Technical guidance for use etc.16Industrys roleiaNotified Chemical SubstancesScreening Assessment useScreening AssessmentSTEP1 : Classification of ExposureArHAggregate the data for the target chemical substances ofeach assessment using MITI numbergulEmission Factor TabletioEstimation of Environmenta

31、l ReleaseClassification of Exposure*Threshold for risk assessment:Total annual quantity of manufacture etc. is less than 10t/year17EmissionClassTotal nationalemissions (tons)Class1Over 10,000Class21,000 10,000Class3100 1000Class410 100Class51-10Notified Information : Annual Quantity of Manufacture e

32、tc. / Use categoryScreening AssessmentSTEP2 : Classification of HazardHazard information collectedby the government the industriesrkHClassification of HazardCSCL Screening Scale(based on GHS, previous CSCL rule etc.)If no data available,default class (class 2)will be applied forRepeated Dose Toxicit

33、yand Mutagenicity.(default class will not be not applied forcarcinogenicity and reproductive toxicity)*We do not consider that “No data” means“Not hazardous”Hazard ClassThe Highest Class in the four categorieswill be chosen as Hazard Class 18Class1Class2Class3Class4Repeated DoseToxicityimCarcinogeni

34、cityN od a t a av a i l a bl eMutagenicityNo dataavailableReproductiveIToxicityHazard information submittediafromScreening AssessmentSTEP2 : Classification of HazardDetails of Hazard Classes (human health)opoCHAis a 2011Int(*) HAV = Hazard Assessment Value (see next page)19Class1Class2Class3Class4Re

35、peated DoseToxicityN/AHAV(*)0.005tion s0.005<HAV 0.050.05<HAV 0.5CarcinogenicityIARC1letc icaIARC 2A, 2BbetcoNN/AN/AMutagenicitynaltioGHS1AGHS 1B,CSCL StronglyPositiveCSCL DualPositive (*)CSCL SinglePositive (*)ReproductiveToxicityN/AHAV0.0050.005<HAV 0.050.05<HAV 0.5(*) CSCL requires Am

36、es test and Chromosomal aberration test for new chemicalsScreening AssessmentSTEP2 : Classification of Hazard 011Details of Hazard Classes (human health, contd)W HAV = NOAEL etc / Uncertainty Factors (UFs)10· Intra-Species 10110I · Length of Study Less than 90 days Less than 1 year6220

37、3; Determination of Hazard Assessment UFs tion s us· Inter-Species lDifference · Use of 10Screening AssessmentSTEP2 : Classification of HazardADetails of Hazard Classes (environment)o011InternatioPNECNLowest toxicity value/the product of UFDeemed chronic toxicity value/1021Class1Class2CCla

38、ss3Class4Eco-toxicitytestPNEC0.001ulegon0.001<PNECe0.01ss use0.01<PNEC0.10.1<PNEC1Screening AssessmentFlow of Classification of Hazard for Eco-systemNotavailableNotavailableChronic pANotavailableChronicChronictoxicitytestsfromResultsofToxicitytestsfromtoxicitytestsfromToxicitytest2trophicle

39、velsAvailable3levelsoftrophic0AcutetoxicityLevelsofacuteAvailableAcutetoxicityToxicitytesttestFromthemissingAvailable2or1levelsValuebetweenvaluebetweenChronicNOEC/5NotchronicChoosethelavailableowestvalueChoosethebetweenChroniclowestvalueChoosethelowestNOEC/10fromAcuteValuefromandL(E)C/ACRChronicNOEC

40、/5AcuteL(E)C/ChoosethelowestvaluefromChronicNOECChooselowestValuefrom3trophiclevels:fish,crustacea,algaeACR:AcuteChronicRatioPNECChoosethelowestvalue/10ClassifyHazardbasedonthePNECvalueAcuteL(E)C/(ACR*10)ClassifyHazardbasedonnodata221trophiclevel3trophiclevelsNumberAvailableAvailablefor2trophiclevel

41、stestfromthemissingtrophiclevelstrophicAvailableforNotLevelChoosethe1trophiclevelavailablelowestChoosethelowestNOEC/10andAcuteL(E)C/ACRandUseChronicacuteNOEC/10L(E)C/ACRNodata(ACR*10)Screening AssessmentSTEP3 : Classification of EmissionUse Category TableorkshopAis a 2011IntaSub Use Categories (about 280 categories)Use Categories (50 categories)are used for general chemicalare used for PACSs , Monitoring ChemicalSubstances and Class II Specified ChemicalsubstancesSubstances.23Use Categorycode(#)Use CategorySub UseCategory codeSub Use Category01Intermedi