GuidanceinaNutsheell

Introd
ductionontheListsoffRegulatedCossmetic
Ingred
dientsin
nChina

The document aims to exp

plain in simp
ple terms th
he types of lists for reggulated cosm
metic
ingreedients,espeeciallytherelatedbackgro
ound,involve
edentriesandcurrentpro
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be useful
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on in
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na.

REEACH24HConsu
ultingGroup,20
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GuidanceinaNutshell
ListsofRegulatedCosmeticIngredientsinChina

LegalNotice

This document contains guidance on introduction of regulated cosmetic ingredients in China,

including the identities of related lists, the involved entries and updated. However, users are
reminded that official government regulation Regulation concerning Hygiene Supervision over
Cosmeticsandrelatedofficialdocumentsaretheonlyauthenticlegalreference.Theinformation
inthisdocumentdoesnotconstitutelegaladvice.REACH24HConsultingGroupdoesnotaccept
anyliabilitywithregardtothecontentsofthisdocument.

Ifyouhavequestionsorcommentsinrelationtothisdocumentpleasedonothesitatetocontact
us

ContactPerson

TommyKong
Email:tommy.kong@reach24h.com
T:86057187007517
F:86057187007566

REACH24H Consulting Group, 2013. Reproduction is authorized provided the source is fully
acknowledged in the form "Source: REACH24H Consulting Group, www.reach24h.com", and
providedwrittennotificationisgiventous(info@reach24h.com).

Latestupdated:14May2013

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ListsofRegulatedCosmeticIngredientsinChina

TableofContents

BackgroundHistory...........................................................................................................................4
ListsofRegulatedIngredients...........................................................................................................4
InventoryofExistingCosmeticIngredientsinChina(IECIC).............................................................4
ListofStandardizedChineseINCIName...........................................................................................5
ListofSubstancesProhibitedinCosmeticProducts.........................................................................5
ListofSubstancesRestrictedinCosmeticProducts..........................................................................5
ListofColorantsAllowedinCosmeticProducts................................................................................5
ListofPreservativesAllowedinCosmeticProducts..........................................................................6
ListofUVFiltersAllowedinCosmeticProducts................................................................................6
ListofHairColorantsAllowedinCosmeticProducts........................................................................6
ListofApprovedNewCosmeticIngredients.....................................................................................6

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BackgroundHistory
China established the current cosmetic regulatory scheme through the implementation of
Regulation on Hygienic Supervision over Cosmetic Products (Cosmetic Regulation), which came
into effect in 1989, and then promulgating and updating related lists of regulated ingredients,
such as preservative or UV filters, have been regarded as the useful instrument for regulatory
purpose, and the outcome of adoption of international regulatory progress, such as the 2003
amendmentsonEUCosmeticDirective,resultinmorerestrictedsubstanceslisted.

ListsofRegulatedIngredients
Thisdocumentintendstopresentalltheninelistsofregulatedingredients(hereafterreferredas
9Regulated Lists), and the table below shows the related name and firstly published, more
detailedpleaserefertothecorrespondingpartsoftheguidance.
ListName

FirstPublication

CurrentVersion

InventoryofExistingCosmeticIngredientsinChina

2003

2013

ListofStandardizedChineseINCIName

2007

2010

ListofSubstancesProhibitedinCosmeticProducts

1987

2007

ListofSubstancesRestrictedinCosmeticProducts

1987

2007

ListofColorantsAllowedinCosmeticProducts

1987

2007

ListofPreservativesAllowedinCosmeticProducts

1987

2007

ListofUVFiltersAllowedinCosmeticProducts

1987

2007

ListofHairColorantsAllowedinCosmeticProducts

2007

2007

ListofApprovedNewCosmeticIngredients

2004

2012

InventoryofExistingCosmeticIngredientsinChina(IECIC)
PriortothefirstpublicationoftheIECICin2003,Chinaregulatedthecosmeticingredientsbased
ontheHygienicStandardsofCosmeticsissuedin1987,whichcoveredtheregulatedingredients
of prohibited substances (359 entries), restricted substances (57 entries), preservatives (66
entries),UVFilters(36entries)andSkinColorants(67entries),andtilltheissuanceof2003IECIC,
thenewingredientscanbefiguredoutassubstanceswithoutinclusionandmustbeapprovedby
theauthorityforfistapplicationaccordingtoArticle8oftheCosmeticRegulation.
While here is no clearly stated rule on updating of the IECIC, China still try to reform this
inventorytomakeitmorecomprehensivewiththecosmetictechnologicalprogressandpublish
two parts of latest version in 7Feb and 10May in2013, separately, more detailed present as
below.

2003IECIC

2013IECIC

Entries

2824

2085(confirmed),1582(inreview)

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ListofStandardizedChineseINCIName
With the aim at standardizing the translation of INCI Name and regulate the labeling on
cosmeticsmarketedinChina(theindustrymustlabelthecosmeticsusingthestandardChinese
name),MinistryofHealth(theformerregulator)firstlypublishedtheListofStandardizedChinese
INCINamein2007(12,072entries),basedontheINCIHandbook(2004Version),andthenissued
the latest version in 2010 by CFDA to adopt the newly added entries of 2008 INCI Handbook
(15,649entries).

PleasedbewellawareofthattheingredientswithstandardizedChineseINCINameswillnotbe
regardedastheallowablesubstanceautomatically,thecompaniesshouldcarefullylookintothe
IECICtocheckthestatusofconcernedingredientasneworexisting,moredetailedpleaserefer
totheGuidanceonPreMarketofNewCosmeticIngredientsinChina.

ListofSubstancesProhibitedinCosmeticProducts
ChinaintroducedthenegativelistsystembydraftingtheHygienicStandardofCosmeticsin1987,
and then revised it at three times to come up with the latest version in 2007, regarding the
changesontheentries,pleaserefertothefollowingtable.
StandardVersion

1987

1999

2002

2007

2013(draft)

Publisher

MoH

MoH

MoH

MoH

CFDA

Entries

359

494

496

1286

Notclear

ListofSubstancesRestrictedinCosmeticProducts
The list for ingredients subject to restricted condition was adopted as the Table 3 of Hygienic
StandardofCosmeticsin1987,andhasbeenupdatedthreetimes,moredetailedpresentinthe
followingtable.
StandardVersion

1987

1999

2002

2007

2013(draft)

Publisher

MoH

MoH

MoH

MoH

CFDA

Entries

57

67

67

73

Notclear

ListofColorantsAllowedinCosmeticProducts
Allowed colorants were listed in Table 6 of Hygienic Standards of Cosmetics in 1987, more
detailedontheupdatedandchangesontheentriesasbelow,
StandardVersion

1987

1999

2002

2007

2013(draft)

Publisher

MoH

MoH

MoH

MoH

CFDA

Entries

67

157

157

156

Notclear

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ListofPreservativesAllowedinCosmeticProducts
Table 4 of the Hygienic Standards of Cosmetics (1987 version) firstly determine the allowed
preservative,moredetailedontheupdatedandchangesontheentriesasbelow,

StandardVersion

1987

1999

2002

2007

2013(draft)

Publisher

MoH

MoH

MoH

MoH

CFDA

Entries

66

55

55

56

Notclear

ListofUVFiltersAllowedinCosmeticProducts
ThelistofallowedUVfilterwasfirstlyestablishedin1987,andseveralentriesweredeletedby
therevision,moredetailedasbelow,

StandardVersion

1987

1999

2002

2007

2013(draft)

Publisher

MoH

MoH

MoH

MoH

CFDA

Entries

36

22

24

28

Notclear

ListofHairColorantsAllowedinCosmeticProducts
ThehaircolorantswasfirstlylistedforallowableuseincosmeticswithintheHygienicStandards
in 2007, which covered 93 entries mainly based on the outcome of safety assessment of EU
ScientificCommitteeofConsumersSafety

ListofApprovedNewCosmeticIngredients
Tilltheendof2012,herearenineingredientsintotalbeingapprovedforcosmeticapplicationby
CFDAtilltheendofandthepreviouscompetentauthority,MinistryofHealth(MoH),therelated
INCIname,suppliernameandapprovedyearpresentbelowforreference.

INCIName

Function

Applicants

ApprovedYear

Alkyl(C12C22)trimethyl
ammonium,bromideandchloride

Nonpreservative

Notdisclosed

Jun2004(MoH)

PotassiumMethoxysalicylate

Brightener

Shisheido

Apr2007(MoH)

Methylisothiazolinone

Preservative

RohmHaas

May2007(MoH)

CarnitineTartrate

Activeingredient

Notdisclosed

Jun2008(MoH)

Lathyrusodoratusflowerextract

Skinconditioning

Notdisclosed

Aug2008(MoH)

Fructooligosaccharides

Humectant

Notdisclosed

Aug2008(MoH)

DimethoxytolylPropylresorcinol

Skinconditioning

Unigen

Mar2012(CFDA)

PolymethacryloylLysine

Humectant

Notdisclosed

Mar2012(CFDA)

PhenylethylResorcinol

Brightener

Symrise

Dem2012(CFDA)

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