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Cosmetics2017,4(1),1doi:10.3390/cosmetics4010001
CosmeticsEuropeGuidelinesonthe
ManagementofUndesirableEffectsand
ReportingofSeriousUndesirableEffectsfrom
CosmeticsintheEuropeanUnion
GeraldRenner1,*, FrancoiseAudebert2 , JensBurfeindt3 , BndicteCalvet4 ,
MadalinaCaratasPerifan5 , MarthaElenaLeal6 , RobertoGorni7 , AmandaLong8 ,
EmmaMeredith9 , naOSullivan10 , MarcPaye11 , ClmentinePerriere12 and
KordulaSchlotmann13
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*
CosmeticsEurope,Brussels1160,Belgium
FdrationdesEntreprisesdelaBeaut,Paris75007,France
IndustrieverbandKrperpflegeundWaschmittele.V.,FrankfurtamMain60329,
Germany
PierreFabreDermoCosmtique,Lavaur81500,France
LORALResearch&Innovation,Paris92100,France
KAOUSAInc.,Cincinnati,OH45214,USA
CosmeticaItalia,Milano20131,Italy
AvonCosmeticsLimited,NorthamptonshireNN15PA,UK
CosmeticsToiletriesandPerfumeryAssociationUK,LondonW1J0DR,UK
Procter&Gamble,SurreyKT130XP,UK
ColgatePalmolive,Milmort4041,Belgium
LVMHRecherche,SaintJeandeBraye45800,France
HenkelBeautyCare,Dsseldorf40589,Germany
Authortowhomcorrespondenceshouldbeaddressed.
AcademicEditor:LidiaSautebin
Received:6October2016/Revised:17November2016/Accepted:28November2016/
Published:3January2017
(ThisarticlebelongstotheSpecialIssueCosmeticSafety:Ingredients,TypeofReactions,
UndesirableEffects,Cosmetovigilance)
ViewFullText|DownloadPDF[382KB,uploaded3January2017]|BrowseFigure
Abstract
TheEuropeanUnion(EU)CosmeticsRegulation(EC)No.1223/2009requirescompanies
tocollectandassessreportsofadversehealtheffectsfromthecosmeticproducts
(undesirableeffects)theymarket.Furthermore,undesirableeffectsthatareconsideredas
seriousneedtobereportedtothenationalcompetentauthorities.CosmeticsEurope,
representingtheEuropeancosmeticsindustry,hasdevelopedtheseguidelinestopromote
aconsistentpracticalapproachforthemanagementofundesirableeffectsandthe
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notificationofseriousundesirableeffects.Followingtheseguidelinesallowscompanies
concernedtodemonstrateduediligenceandcompliancewiththelegalrequirements.View
FullText
Keywords:cosmetovigilancecausalityassessmentadverseeventreporting
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MDPIandACSStyle
Renner,G.Audebert,F.Burfeindt,J.Calvet,B.CaratasPerifan,M.Leal,M.E.Gorni,
R.Long,A.Meredith,E.OSullivan,.Paye,M.Perriere,C.Schlotmann,K.
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CosmeticsEuropeGuidelinesontheManagementofUndesirableEffectsandReportingof
SeriousUndesirableEffectsfromCosmeticsintheEuropeanUnion.Cosmetics2017,4,1.
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