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Evaluation&LicensingDivision

PharmaceuticalandFoodSafetyBureau
MinistryofHealth,Labor&Welfare
Seminar on Regulation of Cosmetics
Regulation of Cosmetics in J apan
Contents
ThePharmaceuticalAffairsActandCosmetics
ThePharmaceuticalAffairsActandQuasiDrugs
CosmeticsManufacturingandSales
CosmeticsManufacturing
StandardsforCosmetics
ScopeofEffectiveness,Labelling,andAdvertising
ofCosmetics
DefinitionofCosmetic
Article23ofthePharmaceuticalAffairsAct
Under this law, cosmetic refers to any item
having mild effects on the human body that is
rubbed, spread, or otherwise applied in a similar
manner for the purpose of cleansing, beautifying,
or enhancing the attractiveness of the human
body, to change physical appearance, or to
maintain skin or hair in a healthy condition.
(Examples:Beautylotion,perfume,soap,
toothpaste,lipstick,shampoo,bathadditive,hair
manicure,etc.)
OutlineofCosmeticsRegulations
Approvalsystem
Manufacturingandsales
managementsystem
Distribution
managementsystem
Safetymanagement
system
Approvalfor
manufactureandsale
Qualitystandards
system
GVP
Postmarketingsurvey
system
Development
stage
Manufacturingand
salesstage
Usestage Distributionstage
Permissionformanufacturing
andsales
GVP
GQP
generalmanagerof
manufacturingandsales
Permissionformanufacturing
Regulationsforbuildingsand
facilities
Personnelrequirements,etc.
Headtechnician
Regulationsonhandling,
labelling,andadvertising
Cosmetic
Onsiteinspectionandremovaltest
Administrative
guidance
Administrative
punishment
Pharmaceuticalinspectionsystem
(Order)
Regulationson
guidanceand
supervision
Regulationson
guidanceand
supervision
Regulationson
cosmeticshandling
Regulationson
cosmeticshandling
Regulationson
qualificationsand
requirementsfor
cosmeticsbusinesses
Regulationson
qualificationsand
requirementsfor
cosmeticsbusinesses
Regulationsforcosmetic
designationthatarerequired
forapproval
Regulationsforcosmetic
designationthatarerequired
forapproval
(Voluntaryindustrial
standardsfor
manufacturingand
qualitycontrol)
(Cosmetics
standards)
DefinitionofQuasiDrug
Article 2-2 of the Pharmaceutical Affairs Act
Under this law, Quasi drug refers to an item for the
purpose of:
1. Preventing nausea and other discomfort.
2. Preventing heat rash, soreness, etc.
3. Encouraging hair growth or removing hair, or
4. Exterminating and preventing mice, flies, mosquitoes,
fleas, etc.
The item shall have mild effects on the human body, shall
not be a utensil or device, and shall be designated by
the Minister of Health, Labor, and Welfare based on
these characteristics.
OutlineofQuasiDrugRegulations
Approvalsystem
Manufacturingandsales
managementsystem
Distribution
managementsystem
Safetymanagement
system
Approvalfor
manufactureand
sale
Qualitystandards
system
GVP
Postmarketingsurvey
system
Development
stage
Manufacturingand
salesstage
Usestage
Distributionstage
Permissionformanufacturing
andsales
GVP
GQP
generalmanagerof
manufacturingandsales
Permissionformanufacturing
Regulationsforbuildingsand
facilities
Personnelrequirements,etc.
Headtechnician
Regulationsonhandling,
labelling,andadvertising
Quasidrug
Onsiteinspectionandremovaltest
Administrative
guidance
Administrative
punishment
Pharmaceuticalinspectionsystem
(Order)
Regulationson
guidanceand
supervision
Regulationson
guidanceand
supervision
Regulationsonhandling
ofquasidrugs
Regulationsonhandling
ofquasidrugs
Regulationson
qualificationsand
requirementsofquasi
drugbusinesses
Regulationson
qualificationsand
requirementsofquasi
drugbusinesses
Regulationsoneffectiveness,
safety,andqualityofquasi
drugs
Regulationsoneffectiveness,
safety,andqualityofquasi
drugs
7
BusinessPermitsinCosmetics
Manufacturing and sales of cosmetics (permit
requirements)
*Personnelrequirements(applicantandgeneralmanagerof
manufacturingandsales)
*GQP/GVPconformity:Executionofoperationsforqualitycontrol
andpostmanufacturing/salessafetymanagement,andappropriate
managementofmanualsandrecords.
Manufacturing of cosmetics (permit requirements)
*Personnelrequirements(applicantandheadtechnician)
*Physicalrequirements(buildingsandfacilitiesofmanufacturing
plant)
WhenDomesticallyManufacturedorImported
ProductsaretobeSoldorOffered
Whendomesticallymanufacturedproductsare
shipped
Permitformanufacturingofcosmetics(permitclassification:
general)
Permitformanufacturingandsalesofcosmetics
Whenimportedproductsareshipped
Permitformanufacturingofcosmetics(permitclassification:
packaging,labelling,storage)
Permitformanufacturingandsalesofcosmetics
Cosmetics Manufacturing
and Sales
OutlineoftheCosmeticsApproval
andPermitSystem
Cosmetic
Cosmeticforwhichallingredients
arelabelled
Cosmeticforwhichnotall
ingredientsarelabelled
Manufacturingandsalesapproval(Article14ofthe
Act)
Foreignexceptionapproval(Article192oftheAct)
Permitrenewableforeachbusiness(every5years)
Permitformanufacturingandsales
(Article12oftheAct)
Onlywhenallingredientsofthecosmeticwillbelabelled
Manufacturingandsalesnotification
(Article69oftheAct)
Permitstandards(GQP,GVP)
Manufacturingandsalesstandards
(generalmanagerofmanufacturingand
sales)
Complianceitems
(Procedures,etc.)
Notification
(Notificationofcessationorabolition,
notificationofchange,etc.)
Applicationfee
Approval
Approval
Permit
Permit
CosmeticsManufacturingandSales
Assignmentofgeneralmanagerofmanufacturingandsales
Criteriaforgeneralmanagerofmanufacturingandsales(Article
852oftheenforcementregulations)
1 Pharmacist
2 Personwhocompletedaspecializedcourseinpharmaceuticalsciencesor
chemistryatajuniorhighschoolundertheprewarschoolsystem,high
school,orschoolequaltoorabovetheaforementionedschools
3 Personwho,aftercompletingaspecializedcourseinpharmaceutical
sciencesorchemistryatajuniorhighschoolundertheprewarschool
system,highschool,orschoolequaltoorabovetheaforementioned
schools,engagedindutiespertainingtoqualitycontrolorpost
manufacturing/salessafetymanagementofpharmaceuticals,quasidrugs,
orcosmeticsforthreeormoreyears
4 PersonwhoisrecognizedbytheMinisterofHealth,LaborandWelfareas
possessingknowledgeandexperiencethatisequaltoorabovetheperson
mentionedinparagraph3above.
Cosmetics Manufacturing and Sales GQP Ministerial Order
(MHLWOrderNo.136ofSeptember22,2004)
1. Sufficientstaffhavingcapabilitytoappropriatelyand
smoothlyexecuteoperations
2. Dutiesofgeneralmanagerofmanufacturingandsales
3. Assignmentofqualityassuranceofficer
4. Dutiesofqualityassuranceofficer
5. Preparationofproceduremanualsforqualitycontrol
6. Implementationofdutiesforqualitycontrol
7. Managementofdocumentsandrecords
CosmeticsManufacturingandSales
Preparationofproceduremanualsforqualitycontrol
Article18oftheGQPMinisterialOrder
1. Proceduresforpreparingrecordsonshipmenttomarket
2. Proceduresforensuringappropriatemanufacturingcontroland
qualitycontrol
3. Proceduresforprocessinginformationonqualityaswellas
defects
4. Proceduresforrecoveryanddisposal
5. Proceduresformanagingdocumentsandrecords
6. Proceduresforothernecessaryqualitycontroloperations
CosmeticsManufacturingandSales GVPMinisterialOrder
(MHLWOrderNo.135ofSeptember22,2004)
1. Sufficientstaffhavingcapabilitytoappropriatelyand
smoothlyexecuteoperations
2. Dutiesofgeneralmanagerofmanufacturingandsales
3. Assignmentofsafetymanagementofficer
4. Dutiesofsafetymanagementofficer
5. Implementationofdutiesforsafetymanagement
6. Recordkeeping
CosmeticsManufacturingandSales OtherMatters
Provisionofinformationtoconsumers
Asystemthatcanprovidepreciseinformationtoconsumerinquiriesmust
be established. And a system for handling complaints/recoveries and for
preparingnecessaryrecordsregardingproductqualitymustbesetup.
Reportsonsideeffects,etc.
Wheneverresearchreportscometolightindicatingthepossibilitythat
manufactured/soldcosmeticscouldhaveharmfuleffects,thispossibility
mustbereportedtotheMinisterofHealth,LaborandWelfarewithin30
days.
Reportsonproductrecoveries
Wheneveranefforttovoluntaryrecovermanufactured/soldcosmetics
begins,thiseffortmustbereportedtotheMinisterofHealth,Labor,and
Welfareimmediately.
NotificationofCosmeticManufactureandSales
(Article701oftheAct)
Forthemanufacturingandsellingofcosmeticsthatdonotrequire
approval(i.e.,allingredientsarelabelled),amanufacturingandsales
notificationforeachitem mustbesubmittedbeforehand tothegovernor
oftheprefectureinwhichtheofficeinchargeofthemainfunctionsofthe
manufacturingandsellingbusinessislocated.
Productsmanufactured domestically
NotificationofCosmeticManufacturingandSales Prefecture
Productsmanufacturedoverseas
NotificationofCosmeticManufacturingandSales Prefecture
Notification of Overseas Cosmetics Manufacturing and Sales Business
(OverseasManufacturer) PMDA
Notification of Import of Cosmetics for Manufacture and Sales
BureauofHealthandWelfare
Cosmetics Manufacturing
CosmeticsManufacturing Qualificationsof
HeadTechnician
Assignmentofaheadtechnician(Article175ofthePharmaceuticalAffairs
Act)
1. Pharmacist
2. Personwhocompletedaspecializedcourseinpharmaceuticalsciencesor
chemistryatajuniorhighschoolundertheprewarschoolsystem,high
school,orschoolequaltoorabovetheaforementionedschools
3. Personwho,aftercompletingaspecializedcourseinpharmaceutical
sciencesorchemistryatajuniorhighschoolundertheprewarschool
system,highschool,orschoolequaltoorabovetheaforementioned
schools,engagedindutiespertainingtomanufacturingof
pharmaceuticalsorcosmeticsforthreeormoreyears
4. PersonwhoisrecognizedbytheMinisterofHealth,LaborandWelfareas
possessingknowledgeandexperiencethatisequaltoorabovetheperson
mentionedinparagraph3above.
CosmeticsManufacturing
BuildingsandFacilitiesRegulations
(GeneralClassification)
a. Ventilationisappropriateandsanitary.
b. Buildingsandfacilitiesareclearlydistinguishedfromplacesofordinaryresidence
andunsanitaryplaces.
c. Buildingsandfacilitieshavespacethatcausesnohindrancetooperations.
d. Buildingsandfacilitieshaveequipmentandstructuresforpreventionofdustand
insects.
e. Floorsaremadeofwoodpanels,concrete,oramaterialthatisequaltothese
materials.
f. Buildingsandfacilitieshaveequipmentanddevicesneededtoprocesswaste
waterandwasteproducts
3. Themanufacturerhasthenecessaryequipmentforhygienicandsafestorageof
products,basicingredients,andmaterials.
4. Themanufacturerhasequipmentanddevicesnecessaryfortesting and
inspectionofproductsandmaterials.However,theabovedoesnotapplywhen
therelevantmanufacturertakesresponsibilityforconductingsaidtestingand
inspectionusingothertestingandinspectionequipmentorother testingand
inspectioninstitutionsanditisrecognizedthatthatsuchactivitydoesnot
interferewithtestingandinspection.
CosmeticsManufacturing
BuildingsandFacilitiesRegulations
(Packaging,Labelling,StorageClassification)
1. Themanufacturerhasthenecessarybuildingsandfacilities
forhygienicandsafestorageofproductandmaterials.
2. Thebuildingandfacilitieshavespacethatcausesno
hindrancetooperations.
3. Thebusinesshasequipmentanddevicesnecessaryfortesting
andinspectionofproductsandmaterials.However,the
abovedoesnotapplywhentherelevantmanufacturertakes
responsibilityforconductingsaidtestingandinspectionusing
othertestingandinspectionequipmentorothertestingand
inspectioninstitutionsanditisrecognizedthatthatsuch
activitydoesnotinterferewithtestingandinspection.
21
Standardsareestablishedbasedonthestipulations
ofArticle422ofthePharmaceuticalAffairsAct
(Necessarystandardscanbeestablishedfor
characteristics,quality,performance,etc.,when
deemednecessarytopreventsanitationrelated
harm)(MHLWNotification331of2000).
StandardsforCosmetics
Basic ingredients (general)
1.Generalprovisions
Ingredientsofcosmetics,includinganyimpuritiescontainedtherein,shallnotcontainanything
thatmaycauseinfectionorthatotherwisemakestheuseofthecosmeticsapotentialhealth
hazard.
Negative list
2.Prohibitionofinclusionofingredientsotherthanpreservatives,UV
absorbers,andtarcolours
Inprinciple,cosmeticscontainingmedicaldrugsareprohibited
IngredientsthatdonotmeettheStandardsforBiologicalMaterials
ClassISpecifiedChemicalSubstancesorClassIISpecifiedChemicalSubstancesprovidedinthe
LawConcerningtheEvaluationofChemicalSubstancesandRegulationofTheirManufacture,etc.,
substancesdeterminedbytheMinisterofHealth,LaborandWelfare,oranyofthecompound
listedinAppendix 1 (Compound-Prohibited Materials).
StandardsforCosmetics
Positive list
3.Limitationoninclusionofingredientsotherthanpreservatives,UV
absorbers,andtarcolours
Types,intendedpurposes,incorporatedamountsofcosmeticswithingredientslistedin
Appendix 2 (Compound-Prohibited Materials) mustbewithinthedesignatedranges.
4.Limitationoninclusionofpreservatives,UVabsorbersandtarcolours
Preservatives havingingredientsandincorporatedamountslistedinAppendix 3 mustbe
withinthedesignatedranges.
UVabsorbers havingingredientsandincorporatedamountslistedinAppendix 4 mustbe
withinthedesignatedranges.
OnlytarcolourslistedinArticle3oftheMinisterialOrdinancefortheDesignationofTar
ColoursThatMayBeUsedinMedicalDrugs,etc.(MinistryofHealthandWelfareOrdinance
No.30of1966)canbeincludedincompounds.However,RedNo.219andYellowNo.204
maybeincorporatedonlyincosmeticsappliedtohairandnails.
Other matters
5.Theamountofdiethyleneglycolin100gofglycerinemustbe 0.1gorless
(February21,2008).
StandardsforCosmetics
Othermatters
TheStandardsforCosmeticsarepredicatedon
corporateresponsibility.Manufacturingandsales
businessesareexpectedtotakeresponsibilityfor
makingjudgementsontheappropriatenessof
ingredientstobeincorporatedintocosmeticsbased
onfullawarenessoftheirsafety.
Manufacturingandsalesbusinessesshallcollect,
prepare,andstorematerialsonthesafetyof
incorporatedingredientsandproducts.
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Cosmeticsand MedicinalCosmetics(QuasiDrugs)
Medicinalcosmeticsarequasidrugs.Theirpharmacological
effectscanbeadvertisedwithinanapprovedscope.
Thescopeofeffectivenessofcosmeticsislimitedto55items.
Becauseacosmeticsingredientsasawholebringoutthe
sensationsandeffectsofitsuse,sayingtheeffective
ingredientis isnotallowed.
Cosmeticsareonlyeffectiveasmakeup.
Amongquasidrugs(medicatedcosmetics),therearesome
productsthatarepermittedtohaveeffectsthat,forexample,
protectagainstsunburncausedspotsandfrecklesby
controllingproductionofmelanin.
Whitening effect
Labelling:ItemsNotedDirectlyonContainersor
DirectlyonExternalPackaging
(Article61ofthePharmaceuticalAffairsAct)
1 Nameandaddressofthemanufacturingandsalesbusiness
2 Nameofproduct(brandname)
3 Manufacturersserialnumberandmanufacturerscode
4 Namesofallingredientsincludedintheproduct
5 Usebydate(cosmeticscontainingascorbicacidoritsester,ortheir
saltsorenzymes;cosmeticswhosecharacteristicsorqualitychange
withinthreeyearsbasedonappropriatestorageconditionsfollowing
manufactureorimport)
29
ThreeBasicPrinciplesofAdvertising
underthePharmaceuticalAffairsAct
1. Theintentiontoattractcustomers(toarouse
customers desiretopurchase)isclear.
2. Thebrandnamesofspecificmedicaldrugsareclearly
provided.
3. Theadvertisementisinaformthatcanbeeasily
recognizedbymembersofthepublic.
Whenanyoftheaboverequirementsissatisfied
30
ExamplesofItemsconsideredto
beAdvertising
1. Presentationsoftheproductscontainer,packaging,packageinsert,etc.
2. Handouts,pamphlets,etc.,featuringtheproduct
3. Advertisementsoftheproductdeliveredviatelevision,radio,newspapers,magazines,the
Internet,etc.
4. Leafletsandbooks
5. Clubnewslettersandinformationmagazines
6. Clippingsfromnewspapersandmagazines,etc.;excerptsfrombooksandacademicjournals,
etc.
7. Productexplanations(productrelatedmaterials)distributedtoagenciesanddealersas
educationalmaterials
8. Lettersofgratitudeorcompilationsofexperiencesfromproduct users
9. Bannersinstoresoronvehicles
10. Slides,videos,ororalstatementsusedinstores,placesvisited,briefings,consultationmeetings,
onthestreetsales,etc.
11. Otheritemscorrespondingtoabovementioneditemsthatareusedinconnectionwithsalesof
aparticularproduct.
AdvertisingRegulationsandVoluntary
Standards
Article66(Exaggeratedadvertisement,etc.)
AppropriateAdvertisingStandardsforDrugs
(NotificationfromtheDirectorofthePharmaceuticalAffairsBureau,
MinistryofHealthandWelfare,YakuhatsuNo.1339ofOctober9, 1980)
GuidelinesforFairAdvertisingofCosmetics,etc.
(voluntarystandards)
Thank you for your kind
attention.

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