法规英文

NICNASCOSMETICSGUIDELINES

17SEPTEMBER2007

Modified28July2011

Tableofcontents

TermsandacronymsudintheGuidelines....................................................3

heGuidelines.................................................................................4

yofRequirementsforCosmetics....................................................6

rinformationaboutthedefinitionofCosmetic....................................8

tsthatareregulatedascosmetics.....................................................9

esofproductsthatcontinuetoberegulatedastherapeuticgoods.14

itedorRestrictedCosmeticChemicalsinAustralia..........................15

sunscreeningagentsforuincosmeticproducts...........................17

quencesofnon-compliancewiththerequirementsinrelationto

cosmetics....................................................................................................21

unitiestoekfurtherinformation....................................................22

NICNASCosmeticsGuidelines2007(Modified28July2011)Page2of22

TermsandacronymsudintheGuidelines

AICSAustralianInventoryofChemicalSubstances

CosmeticsGuidelinesThisdocumentisthe‘CosmeticsGuidelines’.Thisis

intendedtobeaplain-Englishguideforstakeholders

anadministrativedocumentonlyandisnotalegally

bindingdocument.

CosmeticsStandardThisistheStandardforCosmeticsmadebythe

CosmeticsStandardtsoutthe“rules”or

“conditions”

CosmeticsStandardisalegislativeinstrumentmade

undertheICNAActandmustbecompliedwith.

FailuretocomplywiththeCosmeticsStandardisan

offenceundertheICNAAct.

ICNAActIndustrialChemicals(NotificationandAsssment)

Act1989

NICNASNationalIndustrialChemicalsNotificationand

AsssmentScheme

RegulationsThedefinitionof‘cosmetic’enablescertaintypesof

productstobeincluded,andexcluded,fromthe

donebythemakingof

‘Regulations’recurrently

noRegulationsmadeundertheICNAActinrelation

tothedefinitionofacosmetic.

SUSMPStandardfortheUniformSchedulingofMedicines

andPoisons

TGATherapeuticGoodsAdministration

NICNASCosmeticsGuidelines2007(Modified28July2011)Page3of22

heGuidelines

TheGuidelinesareissuedbytheDirectoroftheNationalIndustrialChemicals

NotificationandAsssmentScheme(NICNAS)toexplaintherecentchangesto

theIndustrialChemicals(NotificationandAsssment)Act1989(theICNAAct)

inrelationtocosmeticsandtoprovidegeneralguidanceonthenewlegislative

end,theGuidelinesdescribe:

therequirementsapplyingtocosmeticsregulatedbyNICNAS(referPartB);

furtherinformationaboutthedefinitionofcosmetic(referPartC);

productsthatareregulatedascosmetics(includingspecificconditions

applyingtocertaincosmetics)(PartD);

examplesofproductsthatarenotregulatedascosmeticsandcontinuetobe

regulatedastherapeuticgoods(PartE);

thechemicalsthatareprohibitedfromuincosmetics,orrestrictedintheir

uincosmetics(referPartF);

listofrecommendedsunscreeningagentsforuincosmeticproducts(Part

G);

theconquencesofnon-compliancewiththerequirementsinrelationto

cosmetics(referPartH);and

opportunitiestoekfurtherinformation(referPartI).

TheGuidelinesreplacetheNICNASCosmeticsGuidelinesdatedFebruary

uirementsrelatingtocosmeticsremainlargelythesame;however

thestructureofthenewGuidelinesdiffersfromtheoldGuidelines(which

relied,forexample,onconceptsofcosmeticcriteriaandcosmeticproduct

categories).ThisisbecauthenewGuidelineshavebeendraftedin

accordancewiththeamendmentstotheICNAActwhichdistinguishbetween:

productsthatareregulatedascosmeticsandproductsregulatedas

therapeuticgoods;and

cosmeticsthataresubjecttoCosmeticsStandardsandcosmeticsthatare

not.

ThisixplainedinmoredetailintheGuidelines.

Itisimportanttonotethattheguidelinesdonotconstitutelegaladviceandurs

areencouragedtoekprofessionaladviceabouttheapplicationofthe

eguidelines,someaspectsof

sofdiscrepancybetween

theguidelinesandthelegislation,thelegislationshouldbereliedon.

AnyupdatestotheGuidelineswillbepublishedontheNICNASwebsiteand

stakeholderswillhavetheopportunitytoekamendmentstotheguidelines

NICNASCosmeticsGuidelines2007(Modified28July2011)Page4of22

fromtimetotime,enttothe

GuidelineswillbeatthediscretionoftheDirector.

NICNASCosmeticsGuidelines2007(Modified28July2011)Page5of22

yofRequirementsforCosmetics

Ingeneral,cosmeticsmustmeetthefollowingcriteriaorrequirements:

TheproductmustmeetthedefinitionofcosmeticinAustraliaunderthe

IndustrialChemicals(NotificationandAsssment)Act1989,namely:

cosmeticmeans:

(a)asubstanceorpreparationintendedforplacementincontactwith

anyexternalpartofthehumanbody,including:

(i)themucousmembranesoftheoralcavity;and

(ii)theteeth;

withaviewto:

(iii)alteringtheodoursofthebody;or

(iv)changingitsappearance;or

(v)cleansingit;or

(vi)maintainingitingoodcondition(alsoePartCofthe

Guidelines);or

(vii)perfumingit;or

(viii)protectingit;or

(b)asubstanceorpreparationprescribedbyregulationsmadefor

thepurposofthisparagraph;

butdoesnotinclude:

(c)atherapeuticgoodwithinthemeaningoftheTherapeuticGoods

Act1989;or

(d)asubstanceorpreparationprescribedbyregulationsmadefor

thepurposofthisparagraph.

Note:PartCoftheguidelinesprovidesmoreexplanatoryinformationabout

thisdefinition.

AND

TheproductmustNOTbeforpreventing,diagnosing,curingoralleviatinga

dia,ailment,r,thisdoesnotpreclude

uofthewordsprevent/preventing/preventionforgeneralcosmetic

purpos.

AND

TheproductmustnotbescheduledinS2,S3orS4orS8oftheStandardfor

theUniformSchedulingofMedicinesandPoisons(SUSMP).

NICNASCosmeticsGuidelines2007(Modified28July2011)Page6of22

AND

Theproductmustbemarketedasacosmetictakingintoaccountthe

labelling,packaging,advertisingand/orthelabelstatements:

-theproductmusthavefullingredientdisclosureinaccordancewiththe

TradePractices(ConsumerProductInformationStandards)(Cosmetics)

Regulations1991;

-theproductmaybeprentedasbeingexplicitlyforcosmeticpurpos

only;and

-theproductnamewouldNOTofitlfmaketheproductatherapeutic

good,unlessthatnamemakesareferencetoadia,ailment,defect

orinjuryinpersons.

AND

Theproductmustmeetanyapplicableconditionsdetailedinthenew

CosmeticsStandard(madeunderction81oftheICNAAct).The

CosmeticsStandardtsoutthestandards(orconditions)thatapplyto

equirementsaredescribedinTableBof

PartDoftheGuidelines.

AND

TheproductmustNOTcontainchemicalsprohibitedforuincosmeticsor

meetsrestrictionsspecifiedforchemicalsudincosmetics(ethePartF:

ProhibitedorRestrictedCosmeticChemicalsinAustralia).

NICNASCosmeticsGuidelines2007(Modified28July2011)Page7of22

NICNASCosmeticsGuidelines2007(Modified28July2011)Page8of22

rinformationaboutthedefinitionofCosmetic

ThepurpoofthisctionoftheGuidelinesistodescribethenewdefinitionof

‘cosmetic’intheICNAActandalsotoprovidesomeguidanceregardingthe

rationaleforthedefinitionandtheinterpretationsofsomeofthetermsudin

thedefinition.

Thedefinitiondrawsonthewordingcurrentlycontainedinthedefinitionof

chemicalproductwithintheTradePractices(ConsumerProductInformation

Standards)(Cosmetics)uslythedefinitionofcosmetic

purpoof

clarity,thedefinitionhasnowbeenincluded,infull,

inclusionofthedefinitiondoesnotreprentanychangeinpolicy.

Forthepurposofclarification:

ingeneral,“maintainingingoodcondition”includescontrollingthrough,for

example,cleansing,moisturising,exfoliatingand/ordrying;

thedefinitionofacosmeticdoesnotprecludetheuofthewordsprevent,

preventingorpreventionforgeneralcosmeticpurposspecificallyqualified

bythepurposdetailedin(a)(iii)-(viii)ofthedefinitionofcosmetic;

thedefinitionstatesthatacosmeticdoesnotincludeatherapeuticgood

,thishasbeen

includedforclarity,andtoaddressinterfaceissuesbetweenNICNASandthe

ewillalsobemadetothe

therapeuticexcludedgoodsorder,toprovidethatanyproductmeetingthe

definitionofacosmetic,asdefinedintheICNAAct,andtherequirementsin

rinformation

aboutthoproductsthatarecosmeticsandthothataretherapeuticgoods

isincludedinthefollowingpartsoftheGuidelines;and

thedefinitionincludes,andexcludes,anysubstanceorpreparationtoutin

ertomakeRegulationshas

beenincludedtoensureflexibility,enablingthelegislationtorespond,where

appropriate,to:anysignificantchangesinthenatureofthecosmetics

industry(whichisrecognidasanevolvingandinnovativeindustry);andany

changesinnationalorinternationaldefinitionsthatmayoccurovertime.

RatherthanneedingtoamendtheAct(whichcantakeaconsiderableperiod

oftime)Regulationscanbemademorequicklytoensurethatproductsdonot

“fallthroughthegaps”.AsatAugust2007,therearenoRegulationsin

relationtothedefinitionofcosmetics.

1Thedefinitionof‘therapeuticgoods’canbefoundinction3oftheTherapeuticGoodsAct1989which

isavailableviathefollowingweblink:/legis/

tsthatareregulatedascosmetics

TableA

Thespecifictypesofproductscontainedintheright-handcolumnofTableA

mustcomplywiththegeneralrequirementsrelatingtocosmetics(detailedinPart

Bofthisdocument).However,theNICNASCosmeticsStandard(madeunder

ction81oftheICNAAct)r

words,therearenoproduct-specificconditions(standards)fortheproducts.

onfromtheTable

doesnotnecessarilystopaproductfrombeingclassifiedasacosmetic.

Product

category

Producttype

Productsfornailcare(includingpreparationsthatareappliedtopicallytothe

nailstohardenortodeterbitingofthenails)

Productsformakeup

Productsforcolouringnails/varnish

Tintedbas/foundation(liquids,pastes,powders)withoutSPF

Productsformaking-upandremovingmake-upfromthefaceandeyes.

ProductsintendedforapplicationtothelipswithoutSPF

FaceandNail

Facemasksandscrubs

Hairtintsanddyesandbleaches

Productsforwaving,straightening,andfixing

Settingproducts

Cleansingproductssuchaslotions,powders,shampoos

Conditioningproducts(s,creams,oils)

Haircareand

hairdressing

products

Hairdressingproducts(s,lacquers,brilliantines)

OralHygiene

Productsforcareoftheteethandthemouth(otherthandensitising

toothpastes/gels)includingdentalbleaches/whitenersanddenturecleanrs

andadhesives

Perfumes

Toiletwaters

Perfumes

Eaudecolognes

Femininehygieneproducts

Deodorants

Antiperspirants

Cleanrssuchastoiletsoap,deodorantsoap,astringentandskinwashes

Shavingproducts(,foams,lotions)

Bathandshowerpreparations(,foams,oils,gels,etc.)

Depilatories

After-bathpowders

Personal

hygiene

Hygienicpowders

Moisturisingproductsfordermalapplicationegcreams,lotions,gels,foams

(withoutSPF)

Skincare

Sunbathingproducts(withoutSPForSPF<4).

NICNASCosmeticsGuidelines2007(Modified28July2011)Page9of22

Emollientgcreams,emulsions,lotions,gelsandoilsfortheskin(hands,

face,feet,etc)

Productsfortanningwithoutsun(withoutSPF)

Skin-whiteningproducts(withoutSPF)

Anti-wrinkleproducts(withoutSPF)

Anti-ageingproducts(withoutSPF)

TableB

ThespecificproducttypescontainedinthecentrecolumnofTableBmust

complywiththegeneralrequirementsthatapplytoallcosmeticsaswellasthe

products-specificrequirementsdetailedintheNICNASCosmeticsStandard(and

summaridintherighthandcolumn).

ProductcategoryProducttypeAdditionalrequirementsasdescribedin

theCosmeticsStandard

Tintedbasorfoundations

(liquids,pastes,powders)with

sunscreen

FaceandNail

Productsintendedfor

applicationtothelipswith

sunscreen

TheCosmeticsStandardrequiresthatthe

productsmust:

containasunscreenforacondary

purpoonly

meetthedefinitionofcondary

sunscreenproductasdefinedinAS/NZS

2604:1998

iftheproductstatesanSPForequivalent

categorydescriptiononthelabel,theSPF

orequivalentcategorydescriptiononthe

labelmustmeettherequirementsof

claus6.2and6.3ofAS/NZS

2604:1998

NICNASCosmeticsGuidelines2007(Modified28July2011)Page10of22

Skincare

Moisturisingproductswith

sunscreenfordermal

application,includingbutnot

limitedtoanti-wrinkle,anti-

ageingandskinwhitening

products

Sunbathingproducts(,

creamsorgels,including

productsfortanningwithout

sunandaftersuncare

products)withSPF≥4and

≤15

TheCosmeticsStandardrequiresthatthe

productsmust:

containasunscreenforacondary

purpoonly

meetthedefinitionof“condary

sunscreenproduct”asdefinedinAS/NZS

2604:1998

notbeprentedashavingSPF>15

notbeprentedasbeingwater-resistant

includeanexpirydateoru-bydateon

thelabeliftheproductisnotstableforat

least36months

haveapacksizethatdoesnotexceed

300mLor300g

nothavetherapeuticclaimsmadein

relationtotheproduct,includingany

reprentationaboutskincancer

onlymakereprentationsabout

prematureskinageinglinkedtosun

exposureiftheproductmeetsthe

performancerequirementsforabroad-

spectrumproductinclau7.2ofAS/NZS

2604:1998

iftheproductsstatesanSPFor

equivalentcategorydescriptiononthe

label,theSPForequivalentcategory

descriptiononthelabelmustmeetthe

requirementsofclaus6.2and6.3of

AS/NZS2604:1998

NICNASCosmeticsGuidelines2007(Modified28July2011)Page11of22

Skincare

(continued)

AntibacterialskinproductsTheCosmeticsStandardrequiresthatthe

products:

mustonlybeprentedasbeingactive

againstbacteria;

mustnotbeprentedasbeing:

-activeagainstvirus,fungior

othermicrobialorganisms(other

thanbacteria),or

-foruinconnectionwithdia,

disordersormedicalconditions,or

-activeagainstanamedbacterium

thatisknowntobeassociated

withadia,disorderor

medicalcondition,or

-foruinconnectionwithpiercing

oftheskinormucousmembrane,

whetherforcosmeticoranyother

purpo,or

-foruinconnectionwithany

procedureassociatedwiththerisk

oftransmissionofdiafrom

contactwithbloodorotherbodily

fluids,or

-forubeforeanyphysical

contactwithanypersonwhois

accessingmedicalorhealth

rvices,orwhoisundergoing

anymedicalorhealthcare

procedure,or

-foruinconnectionwithany

procedureinvolvingvenipuncture

ordeliveryofaninjection

Antiacneproducts(including

spottreatments,facescrubs,

cleanrsandmasks)

TheCosmeticsStandardrequiresthatthe

products:

mustbeprentedascontrollingor

preventingacneonlythroughcleansing,

moisturising,exfoliatingordryingtheskin

NICNASCosmeticsGuidelines2007(Modified28July2011)Page12of22

NICNASCosmeticsGuidelines2007(Modified28July2011)Page13of22

Oralhygiene

Productsforcareoftheteeth

andthemouth(suchas

dentifrices2,mouthwashes

andbreathfresheners)

TheCosmeticsStandardrequiresthat:

wherebenefitsareclaimedtoresultfrom

theuofthegoods,suchbenefitsmust

berestrictedtothoconquentialon

improvementstooralhygiene,including

forthepreventionoftoothdecay,and/or

theuoffluorideforthepreventionof

toothdecay

theproductmustnotclaimbenefitsin

relationtootherdiasorailments

suchasgum,oraldiaorperiodontal

condition

Haircare

Anti-dandruffproductsTheCosmeticsStandardrequiresthatthe

products:

mustbeprentedascontrollingor

preventingdandruffonlythrough

cleansing,moisturising,exfoliatingor

dryingthescalp

2Theterm“preventionoftoothdecay”maybeudfordentifricesthataremarketedas

clusionfromthetherapeuticgoodslegislationisstrictlylimitedtotoothdecay

andisnottobeextendedtootherdiasorailmentssuchasgumorotheroraldiaor

condition.

NICNASCosmeticsGuidelines2007(Modified28July2011)Page14of22

esofproductsthatcontinuetoberegulatedas

therapeuticgoods

Thefollowingproductswillcontinuetoberegulatedastherapeuticgoodsandwill

notberegulatedascosmetics:

ProductsthatmeetthedefinitionofatherapeuticgoodintheTherapeutic

GoodsAct1989includingproductsthatareforpreventing,diagnosing,curing

oralleviatingadia,ailment,defectorinjuryinpersons.

PrimarysunscreenswithSPF≥4asdefinedinAS/NZS2604:1998.

Antibacterialskinproductswhereinformationisprentedonthelabel,orby

otherpromotionalmeans(ising,internetsite,pointofsalematerial)

toindicatetheproducts:

-areactiveagainstvirus,fungiorothermicrobialorganismsotherthan

bacteria;or

-aretobeudinconnectionwithaspecificdia,disorderormedical

condition;or

-areactiveagainstanamedbacteriumthatisknowntobeassociated

withaspecificdia,disorderormedicalcondition.

-aretobeudinconnectionwithpiercingoftheskinormucous

membranewhetherforcosmeticoranyotherpurpo;or

-aretobeudinconnectionwithanyprocedureassociatedwiththerisk

oftransmissionofdiafromcontactwithbloodorotherbodilyfluids;

or

-aretobeudbeforeanyphysicalcontactwithanypersonwhois

accessingmedicalorhealthrvices,orwhoisundergoinganymedical

orhealthcareprocedure;or

-aretobeudinconnectionwithanyprocedureinvolvingvenipuncture

ordeliveryofaninjection3.

Personallubricants.

3

ThisguidanceisconsistentwiththeInfectioncontrolguidelinesforthepreventionof

transmissionofinfectiousdiasinthehealthcaretting,AustralianGovernment,Department

ofHealthandAgeing.“Medicalorhealthrvices”includehospitals,generalpractice,day

surgerycentres,domiciliarynursingrvices,residentialagedcare,communityrvicesoroffice

practicessuchasdentistryorpodiatry.

itedorRestrictedCosmeticChemicalsinAustralia

Thefollowingsourcesofinformationcontainnamesorreferencestochemicals

thatmustnotbeudincosmeticsormustonlybeudinthelimitedway

tofsourcesbelowisforinformationonlyandmaynotbe

exhaustive.

Asthesourcesarefrequentlyupdated,itisrecommendedthatallimporters

andmanufacturersofcosmeticsregularlycheckthewebsitestoensurethey

haveacompletelistofprohibitionsandrestrictions.

InAustralia,cosmeticproductsmustnotbescheduledinS2,S3,S4orS8ofthe

StandardfortheUniformSchedulingofMedicinesandPoisons(SUSMP),

PoisonsStandard2010.

1)SourcesofInformationOnRestrictions/ProhibitionsofCosmetic

ChemicalsinAustralia:

StandardfortheUniformSchedulingof

MedicinesandPoisonsNo.1(theSUSMP1),

PoisonsStandard2010

/Details/F2010L02386

AustralianInventoryofChemicalSubstances

(AICS)

/Industry/

HazardousSubstancesInformationSystem

(chemicalsudintheworkplace)

/

AustralianCompetition&Consumer

Commission(ACCC)ProductSafetyRecalls–

Haircare,Oral&DentalCare,SkinCare&

Cosmetics

/content//ite

mId/952831

Customs(ProhibitedImports)Regulations

1956,prepared03/03/2010

/Details/F2010C00858

NationalTransportCommission–Australian

DangerousGoodsCode7thedition(16

October2009)–Part3DangerousGoods

Lists,SpecialProvisionsandLimitedQuantities

Exceptions

/filemedia/Publications/AD

G7_Volume_1_Part_

CodeofPracticeforSupplyDiversionintoIllicit

DrugManufacture

/?FileID=41

2)OtherUfulInformationSources:

HealthCanada–ListofProhibitedandRestrictedCosmeticIngredients(The

CosmeticIngredientHotlist)

/cps-spc/cosmet-person/indust/hot-list-critique/

NICNASCosmeticsGuidelines2007(Modified28July2011)Page15of22

dDrugAdministration(FDA)–IngredientsProhibited&Restrictedby

FDARegulations

/Cosmetics/ProductandIngredientSafety/SelectedCosmeticIngredients/uc

EUCosmeticsDirective(EuropeanCommission)-

ANNEXII:Listofsubstanceswhichmustnotformpartofthecompositionof

cosmeticproducts

ANNEXIII:Listofsubstanceswhichcosmeticproductsmustnotcontainexcept

subjecttotherestrictionsandconditionslaiddown.

Clickon“ConsolidatedversionofCosmeticsDirective76/768/EEC”todownloadpdf

/consumers/ctors/cosmetics/documents/directive/

RAPEX–EUrapidalertsystemfordangerousconsumerproducts

/consumers/dyna/rapex/rapex_archives_

EuropeanCommission–OpinionsoftheScienceCommitteeonConsumerSafety

(SCCS)

/health/scientific_committees/consumer_safety/opinions/index_

NICNASCosmeticsGuidelines2007(Modified28July2011)Page16of22

sunscreeningagentsforuincosmeticproducts

Thefollowinglistofsunscreeningagentsandconcentrationcut-offlevelsis

recommendedforuincosmeticsunscreenproductsbelongingtothefollowing

categories:

Moisturisingproductsfordermalapplication(recreams/lotions)

withSPFupto15.

SunbathingproductswithsunprotectionforacondarypurpoSPFup

to15.

Untintedlipproducts(ms)withSPF.

Forothercosmeticproductscontainingsunscreenssuchastintedlipproducts

(cks)withSPFandtintedbas/foundationswithSPF,uof

sunscreeningagentsfromthislistisalsorecommended,asiscompliancewith

theappropriatecut-offconcentrations.

Notethattheproductcategoriesarealsosubjecttocertainrulesunderthe

CosmeticStandard2007.

________________________________________________________________________

Listofsunscreeningagentsforuincosmeticproductscontainingsunscreen

Benzophenone3

2-Benzoyl-5-methoxyphenol

Oxybenzone(AAN)

131-57-710%

Benzophenone4

5-Benzoyl-4-hydroxy-2-

methoxybenzenesulphonicacid

Sulisobenzone(AAN)

4065-45-610%

Benzophenone5

5-Benzoyl-4-hydroxy-2-

methoxybenzenesulphonicacid,

sodiumsalt

Sulisobenzonesodium(AAN)

6628-37-110%

Benzophenone8

Dioxybenzone(AAN)131-53-33%

Benzylidenecamphor

sulfonicacid**

[=AAN]

alpha-(2-Oxoborn-3-ylidene)toluene-4-

sulphonicacid

MexorylSL

56039-58-86%

Bis-

ethylhexyloxyphenol

methoxyphenoltriazine

Bemotrizinolum(AAN)

TinosorbS

Bemotrizinol

187393-00-610%

Butylmethoxy

dibenzoylmethane

[=AAN]

BMDM

4-tert-butyl-4’-methoxy

dibenzoylmethane

70356-09-15%

NICNASCosmeticsGuidelines2007(Modified28July2011)Page17of22

NICNASCosmeticsGuidelines2007(Modified28July2011)Page18of22

1-(4tertbutylphenyl)-3(4-

methoxyphenyl)-propane-1,3-dione

Avobenzone

Camphor

benzalkonium

methosulfate

[=AAN]

N,N,N-Trimethyl-4-(oxoborn-3-

ylidenemethyl)aniliniummethylsulfate

MexorylSO

52793-97-26%

Cinoxate

[=AAN]

2-Ethoxyethylpara-methoxycinnamate104-28-96%

Diethylamino

hydroxybenzoylhexyl

benzoate**[=AAN]

Benzoicacid,2-[4-(diethylamino)-2-

hydroxybenzoyl]-hexylester

UvinulAPlus

302776-68-710%

Disodiumphenyl

dibenzimidazole

tetrasulfonate**

[=AAN]

1H-Benzimidazole-4,6-disulfonicacid,

2,2’-(1,4-phenylene)bis-,disodiumsalt

Bisimidazylate

NeoHeliopanAP

180898-37-7

10%

Drometrizole

trisiloxane

[=AAN]

2-(2H-Benzotriazol-2-yl)-4-methyl-

6[2-methyl-3-[1,3,3,3-tetramethyl-1-

[(trimethylsilyl)oxy]-disiloxanyl]-

propyl-phenol

Silatrizole

MexorylXL

155633-54-815%

Ethylhexyldimethyl

PABA

2-Ethylhexyl4-

dimethylaminobenzoate

OctyldimethylPABA

PadimateO(AAN)

21245-02-3;

58817-05-3

8%

Ethylhexyl

methoxycinnamate

Octinoxate

Octylmethoxycinnamate(AAN)

5466-77-310%

Ethylhexylsalicylate

2-Ethylhexylsalicylate

Octisalate

Octylsalicylate(AAN)

118-60-55%

Ethylhexyltriazone

2,4,6-Trianalino-(p-Carbo-2'-

ethylhexyl-1'oxy)-1,3,5-triazine

Octyltriazone(AAN)

88122-99-05%

Homosalate

[=AAN]

Homomenthylsalicylate

3,3,5-Trimethylcyclohexyl2-

hydroxybenzoate

118-56-915%

NICNASCosmeticsGuidelines2007(Modified28July2011)Page19of22

Isoamylp-

methoxycinnamate

Isoamyl-4-methoxycinnamate(AAN)

Isopentenyl-4-methoxycinnamate

Amiloxate

Isoamylmethoxycinnamate

71617-10-210%

Menthylanthranilate

[=AAN]

Menthyl2-aminobenzoate

5-Methyl-2-(1-methylethyl)

cyclohexanol-2-aminobenzoate

Meradimate

134-09-85%

4-Methylbenzylidene

camphor

[=AAN]

3-(4-Methylbenzylidene)-dl-camphor

Enzacamene

36861-47-9;

38102-62-4

4%

Methylenebis-benzo-

triazolyltetramethyl-

butylphenol

[=AAN]

2,2'-Methylene-bis-6-(2H-benzotriazol-

2yl)-4-(tetramethyl-butyl)-1,1,3,3-

phenol

TinosorbM

103597-45-110%

Octocrylene

[=AAN]

Octocrilene

2-cyano-3,3-diphenylacrylicacid,2-

ethylhexylester

2-Ethylhexyl-2-cyano-3,3

diphenylacrylate

6197-30-410%

PEG-25PABA

[=AAN]

Ethoxylatedethyl4-aminobenzoate

PEG25PABA

113010-52-9;

116242-27-4

10%

Phenylbenzimidazole

sulfonicacid

[=AAN]

2-Phenylbenzimidazole-5-sulfonicacid

2-Phenyl-5-sulfobenzimidazole

Ensulizole

27503-81-74%

Polysilicone-15

[=AAN]

Dimethicodiethylbenzalmalonate

Diethylbezylidenemalonate

dimethicone

Diethylmalonylbenzylidene

oxypropenedimethicone

ParsolSLX

207574-74-110%

TEA-salicylate

Trolaminesalicylate

Triethanolaminesalicylate(AAN)

2174-16-512%

Terephthalylidene

dicamphorsulfonic

acid

MexorylSX

Ecamsule(AAN)

90457-82-2;

92761-26-7

10%

Titaniumdioxide

[=AAN]

E17113463-67-725%

Zincoxide

[=AAN]

Pigmentwhite41314-13-2Nolimit

**ThesunscreeningagentsarenotcurrentlylistedontheAustralianInventory

ofChemicalSubstances(AICS)hemicalsare

permittedforuasasunscreeningagentincosmeticproductsappliedtothe

skinwithinthespecifiedmaximumconcentrationlevels,withoutanasssment

wishingtouthechemicalsforotherpurpos

mustsubmitanewchemicalsnotificationtoNICNAS.

NICNASCosmeticsGuidelines2007(Modified28July2011)Page20of22

quencesofnon-compliancewiththe

requirementsinrelationtocosmetics

Asnotedpreviously,itistheresponsibilityofeachmanufacturerorimporterof

cosmeticstoensurethattheycomplywiththelegislationincludingthenew

CosmeticsStandard(whereapplicable).Non-compliancemayhavesignificant

mple,undertheICNAActitisanoffenceto:

importinto,ormanufacturein,Australiaacosmeticthatissubjecttoa

standardtunderction81(meticsStandard)andthatdoes

notmeetthestandard;and

importinto,ormanufacturein,Australiaanindustrialchemicalthatissubject

toaconditionunderction13(tionofulistedontheAustralian

InventoryofChemicalSubstances)andthatbreachesthecondition.

Themaximumpenaltyforfailuretocomplywitheachoftheoffencesis120

penaltyunitswhichiquivalentto$13,200foranindividualor$66,000fora

corporation.

NICNASCosmeticsGuidelines2007(Modified28July2011)Page21of22

NICNASCosmeticsGuidelines2007(Modified28July2011)Page22of22

unitiestoekfurtherinformation

Forfurtherinformationrelatingtotheregulationofcosmetics,pleacontact

NICNAS.

Level7,260ElizabethStreet

SURRYHILLSNSW2010

GPOBox58

SYDNEYNSW2001

Phone(02)85778800

Fax(02)85778888

FreeCall1800638528

Emailinfo@