NATIONAL PROFILE on Chemicals Management - UNITAR

Diagram 4-1Scheme of the notification, etc. under the amended Law Concerning the Evaluation ofChemical Substances and Regulation of Their Manufacture, etc. (Overview)ExistingchemicalsubstancesPlanned manufacture andimport (nationwide)over certain amount (1t/y)*New chemical substancesPlanned manufacture andimport (nationwide)up to certain amount (1t/y)*Chemical substances for certain use(e.g. intermediate)*with extremely low potential forrelease into the environmentHazard assessment(Notification)Prior evaluation** of persistence,bioaccumulation, long-termtoxicity for humans, ecotoxicity** before manufactureand/or importPersistentNot highly bioaccumulativePlanned manufactureand import (nationwide)up to certain amount (10t/y)** To be determinedby cabinet orderPrior verificationPriorverificationApproval formanufacture and/or importPersistentHighlybioaccumulativePersistentNot highlybioaccumulativeSuspected long-termtoxicity for humans(screening level)PersistentNot highlybioaccumulativeHas ecotoxicityEx-post monitoring(collection of reportonsite and on-the-spotinspection)Type I MonitoredChemical SubstanceMandatory reporting of actualamounts manufactured and/orimported, etc.Guidance, advice, etc.Government directsmanufactures and importersto investigate long-termtoxicity for human / toxicityfor top predators(when necessary)Type II MonitoredChemical Substance("Designated Chemical Substance"before revision of the law)Mandatory reporting of actualamounts manufactured and/orimported, etc.Guidance, advice, etc.Government directsmanufactures and importersto investigate long-termtoxicity for humans (whennecessary)Type III MonitoredChemical SubstanceMandatory reporting of actualamounts manufactured and/orimported, etc.Guidance, advice, etc.Government directs manufactures andimporters to investigate long-termtoxicity for flora and fauna in thehuman living environment (whennecessary)PersistentHighly bioaccumulativeHas long-term toxicity forhumans, ortoxicity for top predatorsPersistentNot highly bioaccumulativeHas long-term toxicity for humansConfirmed to have the potential tocause damage by environmentalpollutionPersistentNot highly bioaccumulativeHas toxicity for flora and faunain the human living environmentConfirmed to have the potentialto cause damage by environmentalpollutionClass I SpecifiedChemical SubstancePrior permission is required formanufacture and/or import (virtuallyprohibited)Any uses other than specified uses areprohibitedImport of certain productsspecified by cabinet order is prohibitedOther restrictionsClass II SpecifiedChemical SubstanceMandatory reporting of planned and actualamounts manufactured and importedIf deemed necessary, government issues orders tochange the planned manufacture and importamountsGovernment provides technical guidelines,recommendationsMandatory labeling, related recommendationsfrom government, etc.Note: If a substance doesnot meet any abovementionedcriteria, it willnot be subject to regulationunder the ChemicalSubstances Control LawManufacturers and importers of chemical substances are required to reportvoluntarily-obtained hazard information of the substances(Latest revisions to the law are marked with )29