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LocationHome>ServiceProject>ApplicationandEvaluationofnewcosmeticingredientsguideDate2011-05-12CosmeticsrawmaterialsontheissuanceofnewguidelinesforthereviewofthenotificationandreportingStateFoodandDrugAdministrationXu[2011]No.
207May12,2011releaseProvinces,autonomousregionsandmunicipalitiesFoodandDrugAdministration(DrugAdministration),theunit:Newcosmeticingredientstoenhancetheadministrativelicensingworktoensurequalityandsafetyofcosmeticproducts,basedon"cosmeticsHealthSupervision"anditsImplementingRulesandotherrelevantprovisionsoftheStateFoodandDrugAdministrationtodevelopa"declarationofnewcosmeticrawmaterialsandguidelinesforthereview.
"Isherebyissued,pleasecomply.
ApplicationandEvaluationofnewcosmeticingredientsguideStateFoodandDrugAdministrationMay12,2011Attachment:ApplicationandEvaluationofnewcosmeticingredientsguideThisguideisintendedtoguidethedeclarationofnewcosmeticingredientsandreview.
First,thedefinitionofnewcosmeticingredientsNewcosmeticrawmaterialisusedincosmeticsinthecountryforthefirsttimetheproductionofnaturalorartificialmaterials.
Second,thesecurityrequirementsofnewcosmeticingredientsNewcosmeticingredientsinthenormalandreasonableforeseeableconditionsofuseshallnotcauseharmtohumanhealth.
Toxicologicalevaluationofnewinformationoncosmeticingredientsshouldincludetoxicologicalsafetyevaluationreview,thenecessarytoxicologytestinginformationsecurityrisksandpossiblematerialsforsafetyassessmentdata.
Cosmeticsrawmaterialsaregenerallyinneedofnewtoxicologytestsfollowing:(A)acuteoralandacutedermaltoxicitytest;(B)theskinandacuteeyeirritation/corrosiontest;(C)theskinallergytest;(D)andlight-sensitiveskinphototoxicitytest(UVabsorptionpropertiesofrawmaterialshastobedonewhenthetrial);(E)mutationtest(shouldatleastincludeagenemutationtestandachromosomeaberrationtest);(F)sub-chronicoralanddermaltoxicitytest;(G)teratogenictest;(H)chronictoxicity/carcinogenicitytestcombination;(Ix)toxicokineticsanddynamicstest;(X)accordingtothecharacteristicsanduseofrawmaterials,butalsoconsiderothernecessarytests.
Ifthenewmaterialhasbeenusedincosmeticsandchemicalstructureandpropertiesofsimilarmaterials,youcanconsiderreducingsomeofthetest.
Thisguideprovidesinformationfortheprinciplerequirementsoftoxicologytests,accordingtothephysicalandchemicalpropertiesofrawmaterials,QSAR,toxicology,clinicalresearch,epidemiologyandpopulationsimilartothetoxicityofcompounds,suchasinformationapilotprojecttoincreaseorreduce.
Third,newcosmeticingredientsadministrativelicensingrequirementsfordisclosureofinformationApplyfornewcosmeticingredientscosmeticadministrativelicenseshallaccepttheadministrativelicensingrequirementstosubmitinformationreturns.
Specificrequirementsareasfollows:(A)newcosmeticrawmaterials,administrativelicensingapplicationform(B)developmentreport1MaterialsR&Dbackground,processandrelatedtechnicalinformation.
(2)thenameofrawmaterial,origin,molecularweight,molecularformula,chemicalstructure,physicalandchemicalproperties.
(1)Name:rawmaterials,includingthechemicalname(IUPACnameand/orCASname),INCInameandtheirChinesetranslation,tradenamesandCASnumbers.
Materialshouldalsoindicatethenameoftheuseofrawmaterialsspecifications.
NaturalrawmaterialsshouldalsoprovidetheLatinscientificname.
(2)Source:rawmaterialsshouldnotbeacompoundformedinthematerialduetounavoidabletechnicalreasons,theexistenceofsolvents,stabilizers,carriers,etc.
,except.
Naturalmaterialsshouldbeasinglesource,andprovidestheuseofpartsandsoon.
Allplantshavebeenallowedtobeusedascosmeticrawmaterials,notallpartsoftheplantmaterialandthenanewdeclaration.
(3)molecularweight,molecularformula,chemicalstructure:chemicalstructureshouldprovidethebasisforconfirmation(eg,NMR,elementalanalysis,massspectrometry,infraredspectra,etc.
)andanalyticalresults,shouldalsoprovidepolymerrelativetotheaveragemolecularweightanditsdistribution.
(4)physicalandchemicalpropertiesinclude:color,odor,state,solubility,meltingpoint,boilingpoint,specificgravity,vaporpressure,pHvalue,pKavalue,refractiveindex,opticalrotationandsoon.
3ingredientsincosmeticsintendeduse,scopeofuseforsecurityandtheuseoflimitedbasis,cautions,warnings,etc.
4ingredientsinaforeigncountry(region)isusedincosmeticscasedescriptions.
(C)theproductionprocessdescriptionanddiagramShouldindicatethenewcosmeticrawmaterialstoproducethemajorstepsinvolvedintheprocess,proceduresandparameters,suchasrawmaterialsshouldbelisted,thereactionconditions(temperature,pressure,etc.
),additives(catalysts,stabilizers),intermediatesandby-productsandthepreparationstepsetc.
;thecaseofnaturalextracts,shouldindicatetheprocessing,extractionmethod,extractionconditions,theuseofsolvents,mayberesidualimpuritiesorsolvent.
(D)rawmaterialqualityandsafetycontrolrequirementsShouldincludespecifications,testmethods,theremaybeasecurityrisksubstancesandcontrolmeasuresandsoon.
1.
Specificationsinclude:purityorcontentofimpurityspeciesandtheirrespectivecontent(residualmonomerandpolymercontenttobedescribed)andotherindicatorsofqualityandsafetycontrol,duetounavoidabletechnicalreasonsexistintherawmaterialsofsolvent,stabilizer,carrier,etc.
typesandtheirrespectivecontent,otherphysicalandchemicalparameters,shelflifeandstorageconditions;thecaseofnaturalplantextracts,shouldbeclearindicatorsofitsqualityandsafetycontrol.
2detectionmethods:qualitativeandquantitativematerialtestingmethods,testingmethodsimpurities.
3possiblesecurityrisksubstancesandtheircontrolmeasures.
(E)toxicologicalsafetyevaluationdata(includingrawmaterials,theremaybesecurityrisksinthesafetyassessmentofmaterialinformation)Toxicologytestdatacanbetheapplicant'stestdata,scientificliteratureanddomesticandforeigngovernmentofficialwebsite,thecontentofwebsitesofinternationalorganizations.
1applyfornewcosmeticingredients,cosmetics,newmaterialsgenerallyshouldberequiredtosubmitsafetydatatoxicologytests.
(2)oneofthefollowingcircumstances,accordingtothefollowingrequirementstosubmittoxicologytestdata.
Accordingtothecharacteristicsanduseofrawmaterials,ifnecessary,mayrequestanincreaseorreductionrelatedtoexperimentaldata.
(1)whodonothavepreservatives,sunscreens,colorantsanddyes,andfunctionalingredientsfromasafetypointofviewnotincludedinthe"HygienicStandardforCosmetics"Restrictedsubstancestablesnewcosmeticrawmaterials,shouldsubmitthefollowinginformation:1)Theacuteoralandacutedermaltoxicitytest;2)skinandacuteeyeirritation/corrosiontest;3)skinallergytest;4)andlight-sensitiveskinphototoxicitytest(UVabsorptionpropertiesofrawmaterialshastobedonewhenthetwotrials);5)mutationtest(shouldatleastincludeagenemutationtestandachromosomeaberrationtest);6)sub-chronicoralordermaltoxicitytest.
Iftherawmaterialsusedincosmetics,thepossibilityoforalintakeoflarge,shouldprovidesub-chronicoraltoxicitytest.
(2)complywiththeconditions(1),andbyforeign(regional)authoritiesoncosmeticingredientscatalogreproducesmorethanfouryears,involvesnoharmtohumanhealthmayberelatedtoliterature,shouldsubmitthefollowinginformation:1)Theacuteoralandacutedermaltoxicitytest;2)skinandacuteeyeirritation/corrosiontest;3)skinallergytest;4)andlight-sensitiveskinphototoxicitytest(UVabsorptionpropertiesofrawmaterialshastobedonewhenthetwotrials);5)mutationtest(shouldatleastincludeagenemutationtestandachromosomeaberrationtest).
(3)Whereahistoryofsafehumanconsumption,suchasdomesticandforeigngovernmentofficialoragencyorauthorityissuedbythesafetyassessmentoffoodingredientsconsideredsafeanditsextracts,theStateCounciladministrativedepartmentannouncedasbothfoodandpharmaceuticalitems,etc.
shouldsubmitthefollowinginformation:1)skinandacuteeyeirritation/corrosiontest;2)Theskinallergytest;3)andlight-sensitiveskinphototoxicitytest(UVabsorptionpropertiesofrawmaterialshastobedonewhenthetrial).
(4)byoneormorestructuralunitsconnectedbycovalentbonds,relativetotheaveragemolecularweightgreaterthan1000daltonsnewpolymersascosmeticrawmaterials,shouldsubmitthefollowinginformation:1)skinandacuteeyeirritation/corrosiontest;2)skinphototoxicitytest(UVabsorptionpropertiesofrawmaterialshastobedonewhenthetrial).
(5)Whereaforeign(regional)authoritiesevaluationconcludedthatitissafetouseincosmeticsofthenewmaterial,reportingisnotrequiredtoprovidetoxicologicaltestdata,butshouldbesubmittedtoforeigncountries(regions)toassesstheconclusionsofevaluationreportsandrelatedinformation.
Foreign(region)approvedanewcosmeticingredients,shouldbesubmittedtotheapprovalcertificate.
(F)importsnewcosmeticrawmaterials,theapplicantshallbesubmittedtotheadministrativelicensinghasbeenfiledtodeclaretheresponsibleunitsinChina,powerofattorneyandacopyoftheirreportingresponsibilitiesontheadministrativelicensingunitinChinabusinesslicenseandofficialseal.
(G)maycontributetotheadministrativelicensingandotherinformation.
Applicantsshouldbebasedonthenewmaterialpropertiesaccordingtotheaboverequestedinformation,unlesstherelevantrequirementsdonotapply.
Attachedasamplesentforscreening.
Fourth,theprincipleofnewcosmeticingredientsreview(A)fortheapplicanttosubmitthesafetyevaluationofnewcosmeticingredientsdataintegrity,reasonableandscientificconductofthereview:1safetyevaluationofinformationcontentiscompleteandconsistentinformationrequirements;2basedonwhetherthescientific,criticaldataisreasonable,analysisislogical,conclusioniscorrect;3keynewsourceofrawmaterialsofcosmeticsreview,physicalandchemicalnature,purpose,scope,andlimitedusebasis,productionprocesses,qualityandsafetycontrolrequirementsandthenecessarytoxicologicalevaluationofinformation.
(B)Thereviewconsideredcosmeticsafetyevaluationofnewrawmaterialproblems,theexpertsshouldreviewtherelevantprovisionsofcosmeticsregulatoryandscientificbasis,tomakespecificcomments.
Theapplicantwithintheprescribedtimelimitshouldprovideappropriatesafetyevaluation.
(C)Withthedevelopmentofscientificresearch,theStateFoodandDrugAdministrationhasapprovedcosmeticscanre-evaluationofnewmaterials.
Fifth,aspecialtypeofreportingandreviewofnewcosmeticrawmaterialrequirementswillbeforthcoming.
VIAbbreviations(A)IUPAC,InternationalUnionofPureandAppliedChemistry(InternationalUnionofPureandAppliedChemistry)abbreviations.
(B)CAS,theAmericanChemicalAbstractsService(ChemicalAbstractsService)abbreviations.
(C)INCI,Internationalcosmeticingredientsnamed(InternationalNomenclatureCosmeticIngredient)abbreviation.
ThisguidebytheStateFoodandDrugAdministrationresponsiblefortheinterpretation.
ThisguideisfromJuly1,2011shallcomeintoforce.
Previouslypublishedreportandreviewofnewcosmeticingredientsregulationsinconsistentwiththisguideinordertoprevailinthisguide.
BeijingTongRuiLianTechnologyCo.
,Ltd.
Tel:86-10-6428460586-10-64132180Fax:86-10-64132180E-mail:bj500@126.
combj2180@gmail.
com
207May12,2011releaseProvinces,autonomousregionsandmunicipalitiesFoodandDrugAdministration(DrugAdministration),theunit:Newcosmeticingredientstoenhancetheadministrativelicensingworktoensurequalityandsafetyofcosmeticproducts,basedon"cosmeticsHealthSupervision"anditsImplementingRulesandotherrelevantprovisionsoftheStateFoodandDrugAdministrationtodevelopa"declarationofnewcosmeticrawmaterialsandguidelinesforthereview.
"Isherebyissued,pleasecomply.
ApplicationandEvaluationofnewcosmeticingredientsguideStateFoodandDrugAdministrationMay12,2011Attachment:ApplicationandEvaluationofnewcosmeticingredientsguideThisguideisintendedtoguidethedeclarationofnewcosmeticingredientsandreview.
First,thedefinitionofnewcosmeticingredientsNewcosmeticrawmaterialisusedincosmeticsinthecountryforthefirsttimetheproductionofnaturalorartificialmaterials.
Second,thesecurityrequirementsofnewcosmeticingredientsNewcosmeticingredientsinthenormalandreasonableforeseeableconditionsofuseshallnotcauseharmtohumanhealth.
Toxicologicalevaluationofnewinformationoncosmeticingredientsshouldincludetoxicologicalsafetyevaluationreview,thenecessarytoxicologytestinginformationsecurityrisksandpossiblematerialsforsafetyassessmentdata.
Cosmeticsrawmaterialsaregenerallyinneedofnewtoxicologytestsfollowing:(A)acuteoralandacutedermaltoxicitytest;(B)theskinandacuteeyeirritation/corrosiontest;(C)theskinallergytest;(D)andlight-sensitiveskinphototoxicitytest(UVabsorptionpropertiesofrawmaterialshastobedonewhenthetrial);(E)mutationtest(shouldatleastincludeagenemutationtestandachromosomeaberrationtest);(F)sub-chronicoralanddermaltoxicitytest;(G)teratogenictest;(H)chronictoxicity/carcinogenicitytestcombination;(Ix)toxicokineticsanddynamicstest;(X)accordingtothecharacteristicsanduseofrawmaterials,butalsoconsiderothernecessarytests.
Ifthenewmaterialhasbeenusedincosmeticsandchemicalstructureandpropertiesofsimilarmaterials,youcanconsiderreducingsomeofthetest.
Thisguideprovidesinformationfortheprinciplerequirementsoftoxicologytests,accordingtothephysicalandchemicalpropertiesofrawmaterials,QSAR,toxicology,clinicalresearch,epidemiologyandpopulationsimilartothetoxicityofcompounds,suchasinformationapilotprojecttoincreaseorreduce.
Third,newcosmeticingredientsadministrativelicensingrequirementsfordisclosureofinformationApplyfornewcosmeticingredientscosmeticadministrativelicenseshallaccepttheadministrativelicensingrequirementstosubmitinformationreturns.
Specificrequirementsareasfollows:(A)newcosmeticrawmaterials,administrativelicensingapplicationform(B)developmentreport1MaterialsR&Dbackground,processandrelatedtechnicalinformation.
(2)thenameofrawmaterial,origin,molecularweight,molecularformula,chemicalstructure,physicalandchemicalproperties.
(1)Name:rawmaterials,includingthechemicalname(IUPACnameand/orCASname),INCInameandtheirChinesetranslation,tradenamesandCASnumbers.
Materialshouldalsoindicatethenameoftheuseofrawmaterialsspecifications.
NaturalrawmaterialsshouldalsoprovidetheLatinscientificname.
(2)Source:rawmaterialsshouldnotbeacompoundformedinthematerialduetounavoidabletechnicalreasons,theexistenceofsolvents,stabilizers,carriers,etc.
,except.
Naturalmaterialsshouldbeasinglesource,andprovidestheuseofpartsandsoon.
Allplantshavebeenallowedtobeusedascosmeticrawmaterials,notallpartsoftheplantmaterialandthenanewdeclaration.
(3)molecularweight,molecularformula,chemicalstructure:chemicalstructureshouldprovidethebasisforconfirmation(eg,NMR,elementalanalysis,massspectrometry,infraredspectra,etc.
)andanalyticalresults,shouldalsoprovidepolymerrelativetotheaveragemolecularweightanditsdistribution.
(4)physicalandchemicalpropertiesinclude:color,odor,state,solubility,meltingpoint,boilingpoint,specificgravity,vaporpressure,pHvalue,pKavalue,refractiveindex,opticalrotationandsoon.
3ingredientsincosmeticsintendeduse,scopeofuseforsecurityandtheuseoflimitedbasis,cautions,warnings,etc.
4ingredientsinaforeigncountry(region)isusedincosmeticscasedescriptions.
(C)theproductionprocessdescriptionanddiagramShouldindicatethenewcosmeticrawmaterialstoproducethemajorstepsinvolvedintheprocess,proceduresandparameters,suchasrawmaterialsshouldbelisted,thereactionconditions(temperature,pressure,etc.
),additives(catalysts,stabilizers),intermediatesandby-productsandthepreparationstepsetc.
;thecaseofnaturalextracts,shouldindicatetheprocessing,extractionmethod,extractionconditions,theuseofsolvents,mayberesidualimpuritiesorsolvent.
(D)rawmaterialqualityandsafetycontrolrequirementsShouldincludespecifications,testmethods,theremaybeasecurityrisksubstancesandcontrolmeasuresandsoon.
1.
Specificationsinclude:purityorcontentofimpurityspeciesandtheirrespectivecontent(residualmonomerandpolymercontenttobedescribed)andotherindicatorsofqualityandsafetycontrol,duetounavoidabletechnicalreasonsexistintherawmaterialsofsolvent,stabilizer,carrier,etc.
typesandtheirrespectivecontent,otherphysicalandchemicalparameters,shelflifeandstorageconditions;thecaseofnaturalplantextracts,shouldbeclearindicatorsofitsqualityandsafetycontrol.
2detectionmethods:qualitativeandquantitativematerialtestingmethods,testingmethodsimpurities.
3possiblesecurityrisksubstancesandtheircontrolmeasures.
(E)toxicologicalsafetyevaluationdata(includingrawmaterials,theremaybesecurityrisksinthesafetyassessmentofmaterialinformation)Toxicologytestdatacanbetheapplicant'stestdata,scientificliteratureanddomesticandforeigngovernmentofficialwebsite,thecontentofwebsitesofinternationalorganizations.
1applyfornewcosmeticingredients,cosmetics,newmaterialsgenerallyshouldberequiredtosubmitsafetydatatoxicologytests.
(2)oneofthefollowingcircumstances,accordingtothefollowingrequirementstosubmittoxicologytestdata.
Accordingtothecharacteristicsanduseofrawmaterials,ifnecessary,mayrequestanincreaseorreductionrelatedtoexperimentaldata.
(1)whodonothavepreservatives,sunscreens,colorantsanddyes,andfunctionalingredientsfromasafetypointofviewnotincludedinthe"HygienicStandardforCosmetics"Restrictedsubstancestablesnewcosmeticrawmaterials,shouldsubmitthefollowinginformation:1)Theacuteoralandacutedermaltoxicitytest;2)skinandacuteeyeirritation/corrosiontest;3)skinallergytest;4)andlight-sensitiveskinphototoxicitytest(UVabsorptionpropertiesofrawmaterialshastobedonewhenthetwotrials);5)mutationtest(shouldatleastincludeagenemutationtestandachromosomeaberrationtest);6)sub-chronicoralordermaltoxicitytest.
Iftherawmaterialsusedincosmetics,thepossibilityoforalintakeoflarge,shouldprovidesub-chronicoraltoxicitytest.
(2)complywiththeconditions(1),andbyforeign(regional)authoritiesoncosmeticingredientscatalogreproducesmorethanfouryears,involvesnoharmtohumanhealthmayberelatedtoliterature,shouldsubmitthefollowinginformation:1)Theacuteoralandacutedermaltoxicitytest;2)skinandacuteeyeirritation/corrosiontest;3)skinallergytest;4)andlight-sensitiveskinphototoxicitytest(UVabsorptionpropertiesofrawmaterialshastobedonewhenthetwotrials);5)mutationtest(shouldatleastincludeagenemutationtestandachromosomeaberrationtest).
(3)Whereahistoryofsafehumanconsumption,suchasdomesticandforeigngovernmentofficialoragencyorauthorityissuedbythesafetyassessmentoffoodingredientsconsideredsafeanditsextracts,theStateCounciladministrativedepartmentannouncedasbothfoodandpharmaceuticalitems,etc.
shouldsubmitthefollowinginformation:1)skinandacuteeyeirritation/corrosiontest;2)Theskinallergytest;3)andlight-sensitiveskinphototoxicitytest(UVabsorptionpropertiesofrawmaterialshastobedonewhenthetrial).
(4)byoneormorestructuralunitsconnectedbycovalentbonds,relativetotheaveragemolecularweightgreaterthan1000daltonsnewpolymersascosmeticrawmaterials,shouldsubmitthefollowinginformation:1)skinandacuteeyeirritation/corrosiontest;2)skinphototoxicitytest(UVabsorptionpropertiesofrawmaterialshastobedonewhenthetrial).
(5)Whereaforeign(regional)authoritiesevaluationconcludedthatitissafetouseincosmeticsofthenewmaterial,reportingisnotrequiredtoprovidetoxicologicaltestdata,butshouldbesubmittedtoforeigncountries(regions)toassesstheconclusionsofevaluationreportsandrelatedinformation.
Foreign(region)approvedanewcosmeticingredients,shouldbesubmittedtotheapprovalcertificate.
(F)importsnewcosmeticrawmaterials,theapplicantshallbesubmittedtotheadministrativelicensinghasbeenfiledtodeclaretheresponsibleunitsinChina,powerofattorneyandacopyoftheirreportingresponsibilitiesontheadministrativelicensingunitinChinabusinesslicenseandofficialseal.
(G)maycontributetotheadministrativelicensingandotherinformation.
Applicantsshouldbebasedonthenewmaterialpropertiesaccordingtotheaboverequestedinformation,unlesstherelevantrequirementsdonotapply.
Attachedasamplesentforscreening.
Fourth,theprincipleofnewcosmeticingredientsreview(A)fortheapplicanttosubmitthesafetyevaluationofnewcosmeticingredientsdataintegrity,reasonableandscientificconductofthereview:1safetyevaluationofinformationcontentiscompleteandconsistentinformationrequirements;2basedonwhetherthescientific,criticaldataisreasonable,analysisislogical,conclusioniscorrect;3keynewsourceofrawmaterialsofcosmeticsreview,physicalandchemicalnature,purpose,scope,andlimitedusebasis,productionprocesses,qualityandsafetycontrolrequirementsandthenecessarytoxicologicalevaluationofinformation.
(B)Thereviewconsideredcosmeticsafetyevaluationofnewrawmaterialproblems,theexpertsshouldreviewtherelevantprovisionsofcosmeticsregulatoryandscientificbasis,tomakespecificcomments.
Theapplicantwithintheprescribedtimelimitshouldprovideappropriatesafetyevaluation.
(C)Withthedevelopmentofscientificresearch,theStateFoodandDrugAdministrationhasapprovedcosmeticscanre-evaluationofnewmaterials.
Fifth,aspecialtypeofreportingandreviewofnewcosmeticrawmaterialrequirementswillbeforthcoming.
VIAbbreviations(A)IUPAC,InternationalUnionofPureandAppliedChemistry(InternationalUnionofPureandAppliedChemistry)abbreviations.
(B)CAS,theAmericanChemicalAbstractsService(ChemicalAbstractsService)abbreviations.
(C)INCI,Internationalcosmeticingredientsnamed(InternationalNomenclatureCosmeticIngredient)abbreviation.
ThisguidebytheStateFoodandDrugAdministrationresponsiblefortheinterpretation.
ThisguideisfromJuly1,2011shallcomeintoforce.
Previouslypublishedreportandreviewofnewcosmeticingredientsregulationsinconsistentwiththisguideinordertoprevailinthisguide.
BeijingTongRuiLianTechnologyCo.
,Ltd.
Tel:86-10-6428460586-10-64132180Fax:86-10-64132180E-mail:bj500@126.
combj2180@gmail.
com
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