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Guidance in a Nutshell Lists of Regulated Cosmetic Ingredients in China

© REACH24H Consulting Group, 2013 2 / 8

Legal Notice

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

Cosmetics” and related official documents are the only authentic legal reference. The information

in this document does not constitute legal advice. REACH24H Consulting Group does not accept

any liability with regard to the contents of this document.

If you have questions or comments in relation to this document please do not hesitate to contact

us

Contact Person

Tommy Kong

Email: [email protected]

T: 86‐0571‐8700‐7517

F: 86‐0571‐8700‐7566

© REACH24H Consulting Group, 2013. Reproduction is authorized provided the source is fully

acknowledged in the form "Source: REACH24H Consulting Group, www.reach24h.com", and

provided written notification is given to us ([email protected]).

Latest updated: 14‐May‐2013



Table of Contents

Background History ........................................................................................................................... 4

Lists of Regulated Ingredients ........................................................................................................... 4

Inventory of Existing Cosmetic Ingredients in China (IECIC) ............................................................. 4

List of Standardized Chinese INCI Name ........................................................................................... 5

List of Substances Prohibited in Cosmetic Products ......................................................................... 5

List of Substances Restricted in Cosmetic Products .......................................................................... 5

List of Colorants Allowed in Cosmetic Products ................................................................................ 5

List of Preservatives Allowed in Cosmetic Products .......................................................................... 6

List of UV Filters Allowed in Cosmetic Products ................................................................................ 6

List of Hair Colorants Allowed in Cosmetic Products ........................................................................ 6

List of Approved New Cosmetic Ingredients ..................................................................................... 6



Background History

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

amendments on EU Cosmetic Directive, result in more restricted substances listed.

Lists of Regulated Ingredients

This document intends to present all the nine lists of regulated ingredients (hereafter referred as

9‐Regulated Lists), and the table below shows the related name and firstly published, more

detailed please refer to the corresponding parts of the guidance.

List Name First Publication Current Version

Inventory of Existing Cosmetic Ingredients in China 2003 2013

List of Standardized Chinese INCI Name 2007 2010

List of Substances Prohibited in Cosmetic Products 1987 2007

List of Substances Restricted in Cosmetic Products 1987 2007

List of Colorants Allowed in Cosmetic Products 1987 2007

List of Preservatives Allowed in Cosmetic Products 1987 2007

List of UV Filters Allowed in Cosmetic Products 1987 2007

List of Hair Colorants Allowed in Cosmetic Products 2007 2007

List of Approved New Cosmetic Ingredients 2004 2012

Inventory of Existing Cosmetic Ingredients in China (IECIC)

Prior to the first publication of the IECIC in 2003, China regulated the cosmetic ingredients based

on the Hygienic Standards of Cosmetics issued in 1987, which covered the regulated ingredients

of prohibited substances (359 entries), restricted substances (57 entries), preservatives (66

entries), UV Filters (36 entries) and Skin Colorants (67 entries), and till the issuance of 2003 IECIC,

the new ingredients can be figured out as substances without inclusion and must be approved by

the authority for fist application according to Article 8 of the Cosmetic Regulation.

While here is no clearly stated rule on updating of the IECIC, China still try to reform this

inventory to make it more comprehensive with the cosmetic technological progress and publish

two parts of latest version in 7‐Feb and 10‐May in2013, separately, more detailed present as

below.

2003 IECIC 2013 IECIC

Entries 2824 2085 (confirmed), 1582 (in review)



List of Standardized Chinese INCI Name

With the aim at standardizing the translation of INCI Name and regulate the labeling on

cosmetics marketed in China (the industry must label the cosmetics using the standard Chinese

name), Ministry of Health (the former regulator) firstly published the List of Standardized Chinese

INCI Name in 2007 (12,072 entries), based on the INCI Handbook (2004 Version), and then issued

the latest version in 2010 by CFDA to adopt the newly added entries of 2008 INCI Handbook

(15,649 entries).

Pleased be well aware of that the ingredients with standardized Chinese INCI Names will not be

regarded as the allowable substance automatically, the companies should carefully look into the

IECIC to check the status of concerned ingredient as new or existing, more detailed please refer

to the Guidance on Pre‐Market of New Cosmetic Ingredients in China.

List of Substances Prohibited in Cosmetic Products

China introduced the negative list system by drafting the Hygienic Standard of Cosmetics in 1987,

and then revised it at three times to come up with the latest version in 2007, regarding the

changes on the entries, please refer to the following table.

Standard Version 1987 1999 2002 2007 2013 (draft)

Publisher MoH MoH MoH MoH CFDA

Entries 359 494 496 1286 Not clear

List of Substances Restricted in Cosmetic Products

The list for ingredients subject to restricted condition was adopted as the Table 3 of Hygienic

Standard of Cosmetics in 1987, and has been updated three times, more detailed present in the

following table.




List of Colorants Allowed in Cosmetic Products

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

detailed on the updated and changes on the entries as below,






List of Preservatives Allowed in Cosmetic Products

Table 4 of the Hygienic Standards of Cosmetics (1987 version) firstly determine the allowed

preservative, more detailed on the updated and changes on the entries as below,




List of UV Filters Allowed in Cosmetic Products

The list of allowed UV filter was firstly established in 1987, and several entries were deleted by

the revision, more detailed as below,




List of Hair Colorants Allowed in Cosmetic Products

The hair colorants was firstly listed for allowable use in cosmetics within the Hygienic Standards

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

Scientific Committee of Consumers Safety

List of Approved New Cosmetic Ingredients

Till the end of 2012, here are nine ingredients in total being approved for cosmetic application by

CFDA till the end of and the previous competent authority, Ministry of Health (MoH), the related

INCI name, supplier name and approved year present below for reference.

INCI Name Function Applicants Approved Year

Alkyl (C12‐C22) trimethyl

ammonium, bromide and chloride

Non‐preservative Not disclosed Jun 2004 (MoH)

Potassium Methoxysalicylate Brightener Shisheido Apr 2007 (MoH)

Methylisothiazolinone Preservative Rohm Haas May 2007 (MoH)

Carnitine Tartrate Active ingredient Not disclosed Jun 2008 (MoH)

Lathyrus odoratus flower extract Skin conditioning Not disclosed Aug 2008 (MoH)

Fructooligosaccharides Humectant Not disclosed Aug 2008 (MoH)

Dimethoxytolyl Propylresorcinol Skin conditioning Unigen Mar 2012 (CFDA)

Polymethacryloyl Lysine Humectant Not disclosed Mar 2012 (CFDA)

Phenylethyl Resorcinol Brightener Symrise Dem 2012 (CFDA)



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