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Guidance in a Nutshell

Pre-Market Approval of
New Cosmetic Ingredients
in China
The document aims to explain in simple terms the regulatory requirement on
new cosmetic ingredients in China, the application procedures and information
requirements as well for companies with intentions to manufacture or export
concerned cosmetic ingredients into China.
Legal Notice
This document contains guidance on the pre-market application of new cosmetic ingredients in China, including the legal
requirements, definition, application procedure, the required information and the approved ingredients list. However, users are
reminded that the text of the <Regulations concerning the Hygiene Supervision over Cosmetics> and related implementation official
documents is the only authentic legal reference and that 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 send them back to us with the following contact information.

Revision History

Date Contents Subject to Amendation


30-May-2013 First Publication
27-Jan-2014 Add the new provision on ‘proprietary protection of 4-years’ of registered new ingredients

Contact Person ©REACH24H Consulting Group, 2014. Reproduction is authorised


provided the source is fully acknowledged in the form "Source:

Tommy Kong REACH24H Consulting Group, www.reach24h.com", and provided


Email: tommy.kong@reach24h.com written notification is given to us (info@reach24h.com).
T: 86-0571-8700-7517
F: 86-0571-8700-7566 Last Updated: 27-Jan-2014

Table of Contents
Regulatory Requirements 2
Definition of New Ingredients 2
Apply for Pre-Market Approval 2
Application Dossier 3
Safety Criteria and Evaluation 4
Toxicological Profile 4
Reduced Requirements 5
Quality Control 5
Must-Know 6
Approved New Ingredients 6
Proprietary Protection 6

Pre-Market Approval of New Cosmetic Ingredients in China 1


Regulatory Requirements Application Dossier
Article 8 of the Regulationsconcerning the Hygiene Supervision over Cosmetics required that any new cosmetic ingredients should Currently, CFDA only accept the paper application dossier with the appropriate signature and stamp for approval review, which
be approved by the Ministry of Health, currently China Food and Drug Administration (CFDA), prior to firstly being used in cosmetic consists of the following parts,
products for commercial purpose, furthermore, CFDA detailed the approval application procedures and related information
requirement. Contents Remarks
The application dossier The basic information on the applicants and responsible agent, if applicable, will be covered.
The information on the identification (eg. INIC original and Chinese name, IUPAC name and CAS#),
Definition of New Ingredients source of origin and physicochemical property should be provided, furthermore, the intended
R&D Report
CFDA defines the new ingredient as the raw material, synthesized or occurring in nature, which is firstly applied in cosmetic products function, applicable cosmetic type, recommended concentration in cosmetic products, regulatory

in China, in practice, the applicant can check the status of concerned ingredient through the following way, status in other countries and warning statement be involved as well.
Description on the The necessary procedures and process parameters should be reported both in narrative and flow
· if listed in Inventory of Existing Cosmetic Ingredient in China (IECIC) or,
manufacturing process chart way.
· if has been used in cosmetics for the nine special functions and approved in China or,
Specification and quality The Information on the purity and impurity should be specified, moreover, the quantitative/
· if it is the extraction of the whole plant that has been listed in IECIC, specially for botanical ingredients,
control qualitative analytical method for QC submitted as well.
An answer of ‘NO’ for any of the above three questions means it will be a new ingredient in China.
The safety on the ingredient and other impurities with risk concern should be evaluated based on
Safety evaluation
the required toxicological profile.
Apply for Pre-Market Approval Responsible agent
The authorization letter and business license on the responsible agent assigned by oversea
applicant are required.
The new ingredient manufacturers or cosmetic producers should apply for the pre-market approval from the CFDA. The basic
The verification reports on the testing sample for toxicological studies should be provided by
application procedures are presented below and for more detailed information requirement, you can refer to the Application Dossier Testing sample verification
the related testing facilities to demonstrate the consistency, or the statement to prove the new
part of this Guidance. reports
ingredient was employed in the actual toxicological testing be compiled by the applicants.
If the analytical method for identification and QC was developed by the applicant itself, not derived
Step Item Remarks Analytical method validation
from CFDA published testing guidelines, the validation should be carried out by three separate
1 Check the status of the concerned ingredients reports
CFDA approved testing institutes in China to meet the requirements.
The oversea companies should assign one Chinese Sample for marketing One packed sample for marketing should be provided.
2 Confirm the applicant or assign the responsible agent
responsible agent for application Other supportive material Other documents regarding the quality, safety and efficacy can be submitted as well.
3 Gap-analysis on the information requirements
4 Gap fill-in plan and execution
5 Application dossier preparation
Application dossier includes 1 original paper and
6 Submission
other 4 hardcopies
7 Technical review by the expert panel of CFDA
8 Feedback to any technical review outcome from CFDA
9 Approval granted

2 Pre-Market Approval of New Cosmetic Ingredients in China Pre-Market Approval of New Cosmetic Ingredients in China 3
Safety Criteria and Evaluation Reduced Requirements
Information on safety evaluation is part of the application dossier. In Nov-2010, CFDA issued the recommended guidance on safety Above required toxicological information can be reduced for some special types of ingredients as below,
evaluation for new cosmetic ingredients, which stated the safety criteria is that the normal, or foreseeable reasonable use of the final
cosmetic products containing the new ingredient should not present any harm to human raised by the new one, and the required Ingredient Types Remarks
toxicological profile was specified as well, however, there has no official publication on the safety evaluation methodology available, Refer to the ingredient without intention to be listed as restricted substance, preservative, UV Filter,
General ingredients
and the applicant can assess the safety on the ingredients based on the SCCS Guidance or other related documents. colorant or hair dye.
Refer to the above general ingredients which have been included in related list of regulated
Listed general ingredients
ingredients for over 4 years, such as Annexes of EU Cosmetic Regulation.
Toxicological Profile Refer to the ingredient with edible history or approved by Chinese or other national authorities for
Edible ingredient
food
In principle, CFDA require the applicant to submit the following toxicological information to identity the hazard of the new ingredients,
Polymer ingredients Refer to the polymer (n>3) with over 1,000 Da
to minimize the testing activities or avoid the issue on animal testing ban in EU, the applicant can provide the toxicological information
Refer to any new ingredients which has been subject to safety evaluation by oversea recognized
in the way of read-across (the referred substance must be already used in cosmetics), QSAR, and available clinical or epidemiological Reviewed new ingredients
institutes, such as SCCS or CIR, or approved by the authorities
data.

And the related exempted endpoints (marked as ‘X’) present below


Required toxicological endpoints
Listed general Polymer Reviewed new
Acute toxicity (oral and dermal) Endpoints General Ingredient Edible ingredient
ingredients ingredients ingredients
Irritation/Corrosion (skin and eye)
Acute toxicity √ √ X X X
Skin sensitization Irritation/Corrosion √ √ √ √ X
Photo-induced toxicity Skin sensitization √ √ √ X X
Mutagenicity/Genotoxicity Photo-induced
√ √ √ √ X
Sub-chronic toxicity (oral and dermal) toxicity
Teratogenicity toxicity Mutagenicity/
√ √ X X X
Chronic toxicity/Carcinogenicity Genotoxicity
Toxicokinetics Sub-chronic toxicity √ X X X
Teratogenicity
X X X X X
toxicity
Chronic toxicity/
X X X X X
Carcinogenicity
Toxicokinetic X X X X X

Quality Control
The expert panel of CFDA will carefully look into the impurity, and the ingredients specification should fully indicate the
impurity identities, contents, expired period and storage condition, furthermore, the quantitative/qualitative and other available
physicochemical analytical method for quality control should be provided as well.

4 Pre-Market Approval of New Cosmetic Ingredients in China Pre-Market Approval of New Cosmetic Ingredients in China 5
Must-Know About REACH24H
· Oversea supplier should assign one local responsible agent for pre-marketing application REACH24H Consulting Group, the member company of Centre Testing International Corporation, is a leading service provider of
· New cosmetic ingredient should be approved prior to being used in final products by CFDA professional regulatory consultancy and cost-effective solution for chemical regulatory compliance to various industries. Since 2009
· New ingredients regarded as the new chemicals under China chemical regulation, should be registered and approved by MEP before (business started as early as 2007), over 90 professionals with chemical, toxic, eco-toxic backgrounds have been continuously focusing
manufacturing or importing on deepening research on major chemical regulations such as EU Reach, China NCSN; combining various resources and delivering
· Information on the specification on quality control will be intensively reviewed by the expert panel valued products and services to meet demands from either companies those entitled with “Fortune Global 500” or small-and-medium
· Recommend having the safety of ingredients evaluated by local assessors in China with a good understanding of international enterprises worldwide.
principles
· Be proactive to commission any animal testing for Chinese new cosmetic ingredient application REACH24H is seeing its close communication with ECHA, US department of Commerce, CEFIC, EPA, CPCIA, also satisfying relationships
with China Rubber Industry Association, China national chemicals import and export chamber of commerce, China national chemicals

Approved New Ingredients import and export chamber of commerce, Singapore Chemical Industrial Association; Malaysia Chemical Industry Association, South
Korea Academy of Science.
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. REACH24H serves key areas :

INCI Name Function Applicants ApprovedYear · Global chemical control legislation consultancy
Alkyl (C12-C22) trimethyl · Execution of regulation compliance
ammonium, bromide and Non-preservative Not disclosed Jun 2004 (MoH) · Experiment/testing management and report review
chloride · Supply chain communication and compliance
Potassium Methoxysalicylate Brightener Shisheido Apr 2007 (MoH) · In-house technical training or workshop
Methylisothiazolinone Preservative Rohm Haas May 2007 (MoH)
· Chemlinked - the largest regulatory database in China
Carnitine Tartrate Active ingredient Not disclosed Jun 2008 (MoH)
· IT solutions for global GHS
Lathyrusodoratus flower extract Skin conditioning Not disclosed Aug 2008 (MoH)
· Multi-language translation, authoring and auditing
Fructooligosaccharides Humectant Not disclosed Aug 2008 (MoH)
DimethoxytolylPropylresorcinol Skin conditioning Unigen Mar 2012 (CFDA)
Polymethacryloyl Lysine Humectant Not disclosed Mar 2012 (CFDA) Specialties
Phenylethyl Resorcinol Brightener Symrise Dec 2012 (CFDA)
EU REACH regulation, new chemical notification in China, hazardous chemicals management, agrochemicals, cosmetics regulation,

Proprietary Protection
GHS / C&L, SDS authoring and auditing, chemical regulations in US, Japan, Korea and more.

In 23-Jan-2014, CFDA adjust the administrative management on registration of new cosmetic ingredients, and have the registered new
ingredient under proprietary protection of 4-years since the pre-market approval is issued, and other ingredient suppliers exclusion of
the pre-market application will not be authorized to market or formulate the related new registered ingredient, this revised provision is
implemented from 1-April-2014.

6 Pre-Market Approval of New Cosmetic Ingredients in China Pre-Market Approval of New Cosmetic Ingredients in China 7
COSMETIC
REGULATORY SERVICES
1.Pre-Market Application Service
(for nished product and new ingredient)

2.Responsible Agent Service


(for oversea companies)

3.All-round Consultancy
(from label/ingredient review to full market access)

4.Client-dependent Training
(for oversea companies and your China supplier/distributor)

5.Chinese Trademark Registration


(for clients with interests in Chinese brand name)

REACH24H Consulting Group


6F, Building 2, Hesheng Trade Center
No 327 Tian Mu Shan Road, Hangzhou, China (310023)
Tel: 86-0571-8700-7517 / Fax: 86-0571-8700-7566
Email: tommy.kong@reach24h.com

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