China Mainland Cosmetic Regulation
Jan 28, 2014
Echo Cao
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CONTENTS

China's current cosmetic regulatory system is founded on the overarching "Regulations Concerning the Hygiene Supervision over Cosmetics (1989)", supported by a series of subsidiary rules, standards and guidance documents issued by the former regulator, the Ministry of Health (MOH) and the current competent authority, National Medical Products Administration (NMPA).   

In the last two decades, China's cosmetics industry has undergone tremendous change. Currently, the Chinese cosmetic market ranks as the third largest globally and is also the worlds' emerging market, exhibiting the greatest average annual growth rate. To make the cosmetic regulatory framework consistent with the current industry situation, in the second half of 2013, the former CFDA (now NMPA) initiated a program to reform Hygiene Supervision of Cosmetics Regulation 1989 aiming to further standardize cosmetic production and operation as well as reinforce cosmetic supervision and administration and the written draft was released in 2015. On June 29, the final version of Cosmetic Supervision and Administration Regulation was released by China State Council  and will come into force on January 1, 2021. All stakeholders will be significantly affected by the revised regulation. The amendment is not simply a refinement of its predecessor but represents a complete overhaul, which will see the definition, classification and registration requirements of cosmetics completely changed. Once effective, the new regulation will necessitate that, both domestic and overseas cosmetic companies adopt new compliance strategies.

Part 1 Regulatory Framework and Competent Authority

1 Existing Main Cosmetic Regulations in China

TypeRegulationRemarkEffective DateStatus

Overarching

Regulations Concerning the Hygiene Supervision over Cosmetics 1989 《化妆品卫生监督条例》

Promulgated by the former MOH and acts as the overriding regulation for cosmetics in China

1-Jan-1990

In force, but being revised

Cosmetic Supervision and Administration Regulation 2020 

《化妆品监督管理条例》

Once takes affect, the Regulations concerning the Hygiene Supervision over Cosmetics shall be repealed simultaneously1-Jan-2021To be enforced

Hygiene Standard

Safety and Technical Standards for Cosmetics 2015《化妆品安全技术规范》

The revised version of Hygienic Standard for Cosmetics 2007

1-Dec-2016

In Force

Classification

Cosmetic Classification Rules and Catalog (Draft for Comments)《化妆品分类规则和分类目录(征求意见稿)》

Details the classification and coding of cosmetics/Draft

Licensing

Supervision and Administration Measures on Cosmetics Manufacture and Operation (Draft for Comments) 《化妆品生产经营监督管理办法(征求意见稿)》Requirements for production license management, production quality management, operation quality management, network operation management/Draft
Administrative Measures on Cosmetic Registration (Draft for Comments) 《化妆品注册管理办法(征求意见稿)》Requirements for registration and filing management of cosmetics and new cosmetic ingredients/
Draft

Requirements for Application and Acceptance of Administrative Licensing for Cosmetics 2009《化妆品行政许可申报受理规定》

Specifies registration dossiers for imported cosmetics, domestic special use cosmetics and new cosmetic ingredient

1-Apr-2010

In Force

Requirements for Filing of Domestic Non-special Use Cosmetic Products 《国产非特殊用途化妆品备案要求》

Guidance for filing of domestic non-special use cosmetics

30-Jun-2014

In Force

Guidelines for Registration Review and Approval of Domestic Special Use Cosmetics《国产特殊用途化妆品审批服务指南》Guidance for registration review and approval of domestic special use cosmetics1-Dec-2017In Force
Guidelines for Registration Review and Approval of Imported Special Use Cosmetic Products《首次进口的化妆品审批——进口特殊用途化妆品的审批服务指南》Guidance for registration review and approval of imported special use cosmetics1-Dec-2017In Force
Guidelines for Registration Review and Approval of Imported Non-special Use Cosmetic Products《首次进口的化妆品审批——进口非特殊用途的化妆品的审批服务指南》Guidance for registration review and approval of imported non-special use cosmetics1-Dec-2017In Force

Guidance on Application and Review of New Cosmetic Ingredient 2011《化妆品新原料申报与审评指南》

Formulated especially for registration of new cosmetic ingredients

1-Jul-2011

In Force

Guidance on Application and Review of Children's Cosmetics 2012 《儿童化妆品申报与审评指南》

Formulated especially for registration of children’s cosmetics

1-Feb-2013

In Force

Testing

Working Rules for Cosmetic Registration and Filing Testing 《化妆品注册和备案检验工作规范》

Sets out testing requirements for cosmetic registration and filing

10-Sept-2019

In Force

Safety Assessment

Technical Guidelines for Cosmetic Safety Assessment (Draft for Comments) 《化妆品安全评估技术导则》

Clarifies the requirements for safety assessors, the requirements and operating guidelines for safety assessment reports, attaches corresponding samples and sets transitional measures/Draft

Labeling

Administrative Measures on Cosmetics Labelling《化妆品标签管理办法》

Standardizes required info in label and instruction of cosmetic products

/

A draft

GB 5296.3-2008 General Labeling for Cosmetics《GB 5296.3-2008消费品使用说明化妆品通用标签》

Details required info on cosmetic labels

1-Oct-2009

In Force

Naming

Requirements on Naming of Cosmetics《化妆品命名规定》

Details requirements for naming

5-Feb-2010

In Force

IECIC

Inventory of Existing Cosmetic Ingredients in China 2015《已使用化妆品原料名称目录》

Ingredients included in it need not registration

/

In Force

Import & Export

Administrative Measures on Inspection and Quarantine of Import and Export Cosmetics 《进出口化妆品检验检疫监督管理办法》

Regulating the import and export of cosmetics

23-Nov-2018

In Force

2 Competent Authority

During the 2018 NPC conference, the Stated Council launched government institution reform, and established “State Administration for Market Regulation” to fully regulate cosmetics in place of three institutions: CFDA, AQSIQ and SAIC. There sets an independent Drug Administration Bureau named "National Medical Products Administration" under the “State Administration for Market Regulation”.

1) SAMR major responsibilities include:

  • Market management

SAMR is responsible for development, oversight and enforcement of regulation, policy and standards related to market supervision. It will also develop standardization strategies to create an honest and fair market environment.

  • Market entity registration

It is responsible for registration of market entities conducting business in China, including representative office of overseas enterprises.

  • Quality and safety supervision

SAMR will carry out risk monitoring on product quality and safety, as well as implement national sampling inspection across the country.

  • Standardization work

SAMR is obliged to notify new GB standards to the public and draft GB/T standards.

In addition, SAMR should coordinate with other ministries to optimize market supervision with major interactions summarized below:

  • National Medical Products Administration is responsible for formulating cosmetic regulatory systems, as well as licensing, inspection and penalties for cosmetics research and manufacture. 

  • SAMR should cooperate with Ministry of agriculture and rural affairs to establish mechanisms related to origin exit market access and traceability.

  • National Health Commission (NHC) should give timely feedback on results of risk assessment studies to SAMR to guide policy.

  • An information sharing system should be set up between SAMR and GAC to avoid redundancy and overlap of administrative duties and to aid in information dissemination related to safety and quality issues associated with import/export cosmetics.

2) In term of cosmetics, National Medical Products Administration is in charge of comprehensive supervision on cosmetics, including domestic production and registrtion/filing of cosmetic products (special use cosmetics and imported non-special use cosmetics) and new ingredients. NMPA is under the governance of SAMR.

NMPA's major responsibilities include:

  • Safety Supervision Management

NMPA is responsible for cosmetics, drug and medical devices' safety supervision management, including formulating supervision policies, drafting regulations, supervising its implementation, as well as formulating management and service policies that encourage new technologies for cosmetics, drug and medical devices.

  • Standard Management

NMPA is obliged to draft cosmetic standards, formulate a cosmetic classification management system and supervise its implementation.

  • Registration Management

NMPA is responsible for formulating cosmetic, drug and medical device registration management system. It will also strictly conduct market entry review and approval.

  • Quality Control

NMPA is responsible for formulating cosmetic, drug and medical device quality control practices. 

  • Post-market Risk Management

NMPA will carry out monitoring, evaluation, rectifications and recalls associated with cosmetic adverse reactions, as well as undertake cosmetic safety emergency management.

  • Supervision and Inspection

NMPA is obliged to formulate inspection rules, penalize illegal activities in cosmetic registration and manufacturing.

  • Foreign Exchange and Cooperation

NMPA will participate in the formulation of international regulatory rules and standard.

3) NMPA consists of 9 subordinate departments, including a “Cosmetic Safety Supervision Department”(化妆品监督管理司), which will undertake cosmetics registration and filing, drafting and supervising the implementation of cosmetic standards, classification rules, technical guidelines and censorship, as well as conducting on-site and sampling inspection, penalizing illegal activities and monitoring adverse reactions.

» See CL News about the reform.
 
4) Medcial Products Administration at provincial level under NMPA are in charge of filing of domestic non-special use cosmetics and issuance of cosmetics manufacturers’ production license, namely the Administrative License for Production Enterprises of Cosmetics.

Domestic responsible person located in the pilot zones capable of filing management including Tianjin, Liaoning, Shanghai, Zhejiang, Fujian, Henan, Hubei, Guangdong, Chongqing, Sichuan and Shanxi shall complete filing to provincial Medical Products Administration. Domestic responsible person located outside pilot zones in China shall complete filing to NMPA.

5) China General Administration of Customs is responsbible for import and export inspection of cosmetics.

Part 2 Cosmetic Products

Before being used, marketed or imported into China, cosmetic products must get approval from NMPA or provincial Medical Products Administration according to the product category.

1 Definition of Cosmetic Products

Cosmetic products refer to chemical products for the daily use intended to be applied on any external part of human body (such as skin, hair, nails, lips etc.) by spreading, spraying or other similar ways to keep the body clean, eliminate unpleasant odor, protect skin, and improve appearance and beauty.

Cosmetics have various definitions in different countries (regions). How to determine whether a product falls in the scope of cosmetics in China? You may take into consideration the following three aspects:

Aspects

Yes

No

Usage

Smearing, spraying or other similar ways like rubbing

Oral administration or injection­­­

Applied body parts

Any external part of the human body, such as skin, hair, nails, lips

Teeth or oral mucosa

Functions and purposes of use

Skin care, to make the body hygienic, to eliminate undesirable odors, to enhance the beauty of the appearance

Prevent and treat diseases

The above table clearly shows products in contact with teeth and mucous membranes of the oral cavity, such as toothpastes, are not cosmetics in China. According to the draft for second public consultation of Regulations concerning the Hygiene Supervision over Cosmetics 1989, oral hygiene products only require compliance with national or industrial standards such as GB 8372-2017 Toothpaste, GB 22115-2008 and GB 29337-2012 instead of registration or filing. Efficacy claims (such as “anti-caries”, “inhibit plaque” and ect.) of these products are permitted to be used provided adequate standard-based evaluation data supports the claims.

2 Classification of Cosmetic Products

Cosmetic products in China are divided into two categories.

Non-special Use Cosmetics

(Non-SUC)

 

  • Skin care products;

  • Hair care products;

  • Nail (toe) care products;

  • Make-up;

  • Fragrance.

Special Use Cosmetics

(SUC)

  1. Hair growth products

  2. Hair dyes

  3. Hair perming products

  4. Depilating products

  5. Breast beauty products

  6. Slimming products

  7. Deodorants

  8. Freckle-removing products (Whitening products)

  9. Sunscreens

2.1 The adjustment of the classification

In the second draft of Regulations Concerning the Supervision and Administration over Cosmetics, China has changed the classification and categories of cosmetics. In the draft, cosmetics are regulated as general cosmetics and special cosmetics. Special cosmetics include:

  • Hair dye products;

  • Hair perming products;

  • Whitening products;

  • Sunscreens;

  • Other special cosmetics deemed by the NMPA.

The draft defines general cosmetics as all other cosmetics not classified as special cosmetics. The former CFDA is responsible for formulating and publishing the cosmetic categories inventory and will also adjust the scope of special cosmetics based on the monitoring of cosmetics adverse reaction and R&D outcomes. It is estimated that breast beauty products and slimming products are likely to be managed as pharmaceutical products once it is enforced.

In the draft for second public consultation of Regulations concerning the Hygiene Supervision over Cosmetics 1989, special use cosmetics are adjusted as following 5 categories:

  • Hair dye products

  • Hair perming products

  • Whitening products

  • Sunscreens

  • Other cosmetics claimed new efficacies

3 Registration/Filing of Cosmetic Products

At present, imported and domestic special use cosmetics and new ingredients require pre-market registration with NMPA; domestic non-special use cosmetics are subject to pre-market filing with the provincial Medical Products Administration; and situation is divided for imported non-special cosmetics that through the specific 11 FTZs, imported non-SUC cosmetics are subject to filing management with provincial Medical Products Administration, while through other ports, imported non-SUC require filing management with NMPA.

Category

Obligation

Certificate

Department

Imported non-SUC

Pre-market filing

Filing certificate

NMPA

Provincial Medical Products Administration in the 11 FTZs

Imported SUC

Pre-market administrative licensing

Administrative license

NMPA

Domestic non-SUC

Pre-market filing

no certificate

Provincial Medical Products Administration

Domestic SUC

Pre-market administrative licensing

Administrative license

NMPA

New ingredient

Pre-market administrative licensing

NMPA's approval announcement

NMPA

3.1 The filing of domestic non-special use cosmetics

Cosmetics manufacturers shall notify provincial Medical Products Administration through an online platform of the product formula and sales packaging (including labels and instructions for use) prior to marketing. Applicants are required to record the product information, including formula, packaging, description of the production process, product technical requirements and testing reports for future examination. In order to assist producers in China, SAMR (the former CFDA) has prepared a guidance document, "Requirements for Filing of Domestic Non-special Use Cosmetic Products", which details all information required and the filing procedures.

 

Figure 3. Filing Procedure of Domestic Non-special Use Cosmetic Products (new)

Figure 1. Filing Procedure of Domestic Non-special Use Cosmetic Products 

3.2 Filing of Imported Non-special Use Cosmetics

China has implemented a new policy for initially imported non-special use cosmetics through Shanghai Pudong New Area since Mar 1 2017. The cosmetics only require filing with Shanghai MPA instead of registration with NMPA and the MPA grants a filing certificate to the applicant after a priliminary review of application dossiers, then the applicant can start to import. After a year NMPA officially expanded the practice of imported non-special use cosmetics filing management in Pudong to other 10 FTZs including Tianjin, Liaoning, Zhejiang, Fujian, Henan, Hubei, Guangdong, Chongqing, Sichuan and Shanxi. On Nov. 9, 2018, China National Medical Products Administration announced that registration of first-imported non-specials cosmetics shall be replaced by filing management nationwide from Nov. 10.

Comparison of the new filing system and previous registration of first-imported non-specials cosmetics

 

Registration

Filing after Nov.11 (essentially the same as Pudong filing)

Subjects

First-imported non-special use cosmetics

First-imported non-special use cosmetics

Applicant

Responsible agent

Responsible person

Guidance document

Guidelines for Registration Review and Approval of Imported Non-special Use Cosmetic Products

Currently can refer to previous CFDA’s notice: Procedures of Filing Management for First Import Non-special Use Cosmetics through Shanghai Pudong New Area (Interim)

Animal testing

Mandatory requirements

Mandatory requirements

Documents receiving window

NMPA

  • RP located in 11 FTZs shall submit dossiers to the local authorities (previous provincial FDA);

  • RP located outside the 11 FTZs are still required to submit dossiers to NMPA.

Review

Review paper documents

Online review

Procedures

Certificate

Paper registration certificate

Electronic filing certificate

Post-market supervision

No requirements

Within 3 months after the approval

3.3 Registration Procedures for Imported & Domestic Special Use Cosmetics

Step 1: Assign a Responsible Agent in China (imported special use products)

The pre-condition for registering imported cosmetics is to designate a Responsible Agent (RA), who must be a Chinese legal entity. The RA could be:

  • A subsidiary based in China;

  • Importer; 

  • A third party, like REACH24H Consulting Group.

Figure 4. General Registration Procedures of Cosmetic Products Large

Figure 2. General Registration Procedures of Cosmetic Products

Appointment of a capable Chinese responsible agent is a hugely important step. The selected intermediate can timely communicate with NMPA technical review experts and make quick responses to any questions raised and keep confidential key product information, such as production process and formula. A power of attorney needs to be signed and filed with NMPA.  

Step 2: Check the compliance of formula, label and claim

It is not allowed to contain any prohibited substances or use restricted substances beyond permitted concentrations and applications scopes outlined in the Hygienic Standard for Cosmetics 2007. Meanwhile, it is also necessary to check if there is any new ingredient contained in the formula because new cosmetic ingredients also need NMPA's approval.

Step 3: Arrange Product Testing

Cosmetic samples must be tested by NMPA-approved labs in China even if they have been tested and assessed as "safe" abroad. Testing items and duration depend on the type and property of cosmetic products.

Step 4: Submit Dossier, Technical Review and Approve 

Applicants should submit registration documents and product samples to NMPA. Generally speaking, it takes 5 days for NMPA's Administrative Service Center to perform a format check on all submitted documents and issue an acceptance notice, 90 days for the Registration Review Center to conduct the technical review of the product and 20 days for the NMPA to issue an approval certificate.

» There are four possible results of technical review:

  1. Approval;

  2. Approval subject to amendment of the submitted dossier (if product Chinese name modifies or the description, format and writing of submitted documents need to be further improved);

  3. Additional information requested (if contents of dossier need to be revised; additional testing data or a verification test is needed; etc.)

  4. Rejection (if the dossier contents or product samples are false; the formula or testing result shows safety problem; etc.)

» The NMPA expert panel will extensively review the following aspects:

  • Product label and name: the applicant should concentrate on mandatory labeling items, warning statement, the authentic Chinese translation of imported product label, appropriate efficacy claims and the correct SPF identification.

  • Product formula: the use of prohibited ingredients listed in Hygienic Standard for Cosmetic 2007 is not permitted; cosmetics for increasing hair growth, slimming and breast beautification need a full description of efficacy ingredients and explanation and rationale for their usage, in addition to information of production process and quality specification.

  • Hygienic chemical and microbiological testing data: all testing results analyzing the presence of heavy metals, microorganism, restricted and active ingredients must meet relevant requirements and confirm with formula statement.

  • Toxicological data: the product should not cause obvious skin and eye irritation and elicit no obvious skin allergic reaction and /or phototoxicity; Infant or children products will be subjected to higher safety standards.

  • Human safety evaluation: animal testing is required prior to human trials; human trials should demonstrate no obvious adverse reactions of cosmetics to the human body.

3.4 Registration Duration and Cost

The duration and cost of testing and the whole registration process depend on the category and property of cosmetic products.

In general, it takes 80 days for SUC to be tested and 6 months to be registered. Sunscreens and products for hair growth, body shaping and breast enhancement need more time since additional efficacy tests are required.

ProductTesting Time Whole Cycle 
Special use80 days6 months
Special use cosmetics for hair growth, slimming, breast beauty or sun protection (need efficacy additional test)150 daysDependable

The registration cost consists of the testing fee, translation fee, notary fee and consulting fee (if a regulatory consultant is involved). NMPA does not charge any administration fee for registration.

3.5 Registration Dossier

The table below shows required documents for registration of imported and domestic special use cosmetics:

Registration Documents

Imported SUC

Domestic SUC

Application form

Chinese product naming statement

Product formula

 

Description and diagram of the production process

Quality control specification

Original packaging (including label and instructions for use)

Testing reports

Safety assessment report (for risk-concern substance)

Scientific reference of efficacy ingredients and their use for hair growth, slimming and breast beautification cosmetic products

Power of Attorney and business license of the NMPA-recorded responsible person in China

 

Letter of commitment that cosmetic ingredients meet the requirements for prohibited or restricted high-risk substances from Mad Disease Area

 

Documents to prove manufacture and sale of the product in the country/region of origin

 

Other documents that are helpful and necessary for review

 

Product Technical Specification

One sample

4 Labeling of Cosmetic Products

Cosmetics labels are subject to review by NMPA expert panel during registration and also checked by Custom when products arrive at the port. Many exporters lack adequate knowledge about correct Chinese compliant labeling for their cosmetics, demonstrated by a high volume of cosmetic products destroyed or rejected at the port due to substandard labels.

According to Instruction for Use of Consumer Products—General Labelling for Cosmetics (GB 5296.3-2008), the following information shall be indicated on labels of the imported cosmetics:

  1. Product name (in line with Requirements on Naming of Cosmetics);

  2. Name and address of the manufacturer, distributor;

  3. Country of origin;

  4. Approval ID number (the ID number on the administrative license or record-filing certificate, such as “国妆备进字J20130000”);

  5. List of ingredient (all ingredients with concentration over 1.0% must be indicated with Chinese INCI names and listed in descending order of "quantity"; in absence of INCI name, the corresponding name in Chinese Pharmacopoeia, its chemical or botanical name can also be adopted);

  6. Net content;

  7. Production date and shelf life or the batch number and expiration date;

  8. Warnings (for products containing restricted substance, e.g. Zinc phenolsulfonate, the term "avoid to contact with eyes" shall be indicated on the label; and special use cosmetics e.g. hair dye);

  9. Instruction and storage condition (provided if inadequate storage impacts safety);

  10. Other info (the local distributor or wholesaler can be indicated as well).

Two options are available for labeling the imported cosmetics. Companies can design the label especially for the Chinese market according to Chinese labeling regulations or use the original package with a China compliant over-label.

5 Claim of Cosmetic Products

Cosmetic companies cannot claim functions or features that the products do not possess. Medicinal or therapeutic function claims and any misleading wordings are prohibited. Local expertise will be necessary for balancing compliance with Chinese claim requirements and addressing the interests of manufacturers who rely on the added value derived from the inclusion of certain claims in their marketing strategies. Claims on some imported products, such as "hypoallergenic", "dermatologically tested" or "100% natural", would be challenged by NMPA's expert panel.

6 Custom Inspection of Imported Cosmetics

After the products are approved by NMPA, foreign firms can start exporting cosmetic products to China immediately. Distributors or importers in China need to apply for Custom inspection by submitting required documents, such as NMPA product approval license or certificate, product formula, Chinese label samples, etc. The inspection process includes on-site examination of the label and package, sampling and testing and the issuance of the certificate of Inspection and Quarantine of Imported Goods, which is the ultimate requirement for custom clearance.

7 Manufacture License of Cosmetics in China

From January 1st, 2016, all new cosmetics manufacturers should apply for a Cosmetics Manufacture License from provincial MPA.  All cosmetic products which are manufactured after July 1st, 2017 must use new labels with information of Cosmetics Manufacture License. The validity of the Cosmetics Manufacture License is 5 years. Rules above are also applicable to toothpaste products.

Part 3 Cosmetic Ingredient

1 Cosmetic Ingredient Classifications

China divides cosmetic ingredients into:

  1. New cosmetic ingredient; (need registration with NMPA)

  2. Existing cosmetic ingredient.

Type

List Name

Current Version (year)

Number Contained

Existing

Inventory of Existing Cosmetic Ingredients in China (IECIC)

2015

8783

Restricted substances

in cosmetic products

List of Substances Restricted in Cosmetic Products

2015

73

List of Preservatives Permitted in Cosmetic Products

2015

56

List of UV Filters Permitted in Cosmetic Products

2015

28

List of Colorants Permitted in Cosmetic Products

2015

156

List of Hair Dyes Permitted in Cosmetic Products

2015

93

New

List of Approved New Cosmetic Ingredients

2014

10

Prohibited

List of Substances Prohibited in Cosmetic Products

2015

1388

INCI Chinese Version

List of Standardized Chinese INCI Name

2010

15649

Inventory of Existing Cosmetic Ingredients in China (IECIC)

Ingredients listed in the IECIC are regarded as "existing" substances, which need not approval by CFDA prior to use in cosmetic products.

The issue of IECIC can be traced back to 2003, since when the government started to regulate the allowable cosmetic ingredients through the positive list. On 27 April 2003, the Ministry of Health (MOH) released the IECIC 2003, which is an internally circulated list among related departments. A large number of recognized and globally accepted ingredients that have been scientifically established safety and have a long history of safe usage are not included in the IECIC, which creates a major issue for multinational companies. In order to facilitate the registration of new cosmetic ingredients, CFDA started to improve the existing ingredient inventory.  In 2012, the CFDA drafted three batches of existing cosmetic ingredients, totaling 3,667 ingredients. While in 2013 CFDA just finalized the first two batches, leaving the number of ingredients in the third batch a mistery. 

The third batch was expected to be finalized. However, CFDA has chosen to abandon a batch-wise approach and instead published the integrated existing cosmetics inventory. After releasing two consolidated lists of IECIC 2014(draft) on 21 Jan 2014 and 11 Mar 2014 separately, the CFDA announced the release of the final version of the much anticipated Inventory of Existing Cosmetic Ingredients in China (IECIC 2014), containing 8783 ingredients that have already been used in cosmetic in China on 30 June 2014.

At the end of 2015, CFDA announced that they had amended the previous formal version of IECIC 2014 which was released on June 30th 2014. The main changes made by the CFDA is the correction of the ingredient naming errors made in the 2014 IECIC. There are also 9 new ingredients and 1 deleted prohibited ingredient (papaver somniferum seed extract). The total ingredients still equals 8783.

The 9 new ingredients are as follows:

  • harungana madagascariensis extract;

  • undeceth-3;

  • decyl isostearate;

  • tris(PPG-3 benzyl ether) citrate;

  • chondrus crispus (carrageena);

  • raspberry ketone glucoside;

  • hesperidinase;

  • PEG-50 hydrogenated palmamide;

  • PEG/PPG-150/30 copolymer.

The inventory serves as the sole reference for determining the regulatory status of a cosmetic ingredient. Cosmetic companies and ingredient suppliers are strongly recommended to check whether their ingredients number among the inventory. All ingredients excluded from the list are subject to mandatory pre-market registration under new cosmetic ingredients regulations with the NMPA.

In case that an ingredient in the IECIC is also a restricted substance in the Safety and Technical Standards for Cosmetics 2015, it should be used in conformity with corresponding restriction requirements, such as application scope, maximum permitted concentration in the finished cosmetic products, warnings, etc. 

List of Approved New Cosmetic Ingredients

During 2004 to 2014, there were only 10 new cosmetic ingredients that got approval from MOH and NMPA, indicating the extreme difficulty in registration of a NCI in China. From 2008 to 2014, 4 years has witnessed a meagre 4 NCIs successfully approved by NMPA in spite of the continued submission of application dossiers. According to statistics from NMPA, more than 130 dossiers have been submitted for the administrative licensing of NCIs.

The List of 10 Approved New Cosmetic Ingredients during 2004-2014

No.

INCI   Name

Trade   Name

Applicants

Approved   Year

1

Alkyl     (C12-C22) trimethyl ammonium, bromide and chloride

-

-

Jun   2004 (MoH)

2

Potassium Methoxysalicylate

4MSK

Shisheido

Apr   2007 (MoH)

3

Methylisothiazolinone

Kathon

Rohm   Haas

May   2007 (MoH)

4

Carnitine Tartrate

-

-

Jun   2008 (MoH)

5

Lathyrus odoratus flower extract

-

-

Aug   2008 (MoH)

6

Fructooligosaccharides

-

-

Aug   2008 (MoH)

7

Dimethoxytolyl Propylresorcinol

Nivitol

Unigen

Mar   2012 (CFDA)

8

Polymethacryloyl Lysine

-

-

Mar   2012 (CFDA)

9

Phenylethyl Resorcinol

Symwhite 377

Symrise

Dem   2012 (CFDA)

10

Elaeagnus mollis Oil

琪尔康翅果油

琪尔康

Oct 2014   (CFDA)

Lists of Prohibited and Restricted Ingredients

China regulates substances banned and restricted in cosmetic products in a way similar to in EU Cosmetic regulation, which includes lists of prohibited and restricted substances, colorants, preservatives, and UV filters. In China, these kinds of lists are contained in the Hygienic Standard for Cosmetics 2007, the standard that all cosmetic products and ingredients must adhere to, which also contains methods of toxicological test, hygienic chemical test and microbiological test along with efficacy evaluation methods.

Substances that draw the most attention of the CFDA review experts are usually  substances banned from use in cosmetic products, such as Dioxane, Phenol, Acrylamide, Asbestos, Nitrosamines, etc.

If some prohibited substances are present in cosmetics as by products or impurities, which during the prodcution process cannot be technically avoided, an exception is made providing that the finished products meet the general requirements outlined in the Hygienic Standard for Cosmetics 2007. Namely, the finished products may not harm human health under normal, reasonable and forseeable conditions of use. For instance, Dioxane is banned but it is currently technically impossible to prevent residual carryover, so CFDA set a maximum limit of 30mg/kg, which is deemed toxicologically acceptable.

The Safety and Technical Standard for Cosmetics 2015 also prescribes limits for heavy metals and methanol in cosmetic products:

Toxic Substance

Limit (mg/kg)

Revised Limit (mg/kg)

Mercury

1

1

Lead

40

10

Arsenic

10

2

Methanol

2000

2000

The release of Safety and Technical Standards for Cosmetics 2015

In an effort to develop regulatory protocols and standards which match the technical and supervisory capacity of the cosmetic industry, the CFDA is revising the 2007 Hygienic Standard for Cosmetics. To date the most significant progress made in amending this standard was the release of the revised body of the 2007 Hygienic Standard (renamed Technical Safety Standard for Cosmetics) in 30 Nov 2012. In 2015, two drafts were released for public consultation. Finally on Dec 23, CFDA annouced the promulgation of Safety and Technical Standards for Cosmetics, which will be taken into implementation since December 1st 2016.

The main revisions of the new Cosmetic Safety Technical Standard are:
  • Making clear explanations of certain terms;

  • Detailing cosmetic safety technical universal requirements:

    • The limit of lead is adjusted from 40mg/kg to 10mg/kg. 

    • The limit of arsenic is adjusted from 10mg/kg to 2mg/kg. 

    • The limit of cadmium is newly set as 5mg/kg. The limit of dioxane is 30mg/kg. 

    • No asbestos should be tested out.

  • Revising lists of cosmetic prohibited and restricted ingredients and lists of cosmetic permitted ingredients:

    • Currently, there are 1388 kinds of prohibited ingredients, 47 kinds of restricted ingredients, 51 kinds of permitted preservatives, 27 kinds of permitted sun screeners, 157 kinds of colorants and 75 kinds of hair tints in Cosmetic Safety Technical Standard 2015.

  • And revising physical-chemical inspection methods:

    • 60 kinds of testing methods for prohibited and restricted ingredients in cosmetics are newly added.

    • All testing methods are standardized and classified for more convenient reference.

    • Few mistakes in the previous Hygienic Standard for Cosmetics have been corrected.

2 Definition of New Cosmetic Ingredient (NCI)

According to the article 9 of the overarching cosmetic regulation, a new cosmetic ingredient is a natural or artificial ingredient that is applied in cosmetic products for the first time in China. Before being used to make cosmetics, it must be approved by CFDA. Basically, an ingredient is deemed as "new" if not included in IECIC.

In the case that a new ingredient is identified as a new chemical under the China chemical regulation, it should be notified to the Ministry of Environment (MEP) before manufacture or import [See Chempedia China NCSN (China REACH)] for exhaustive compliance guidance].

In this instance, double registration under two different regulatory schemes is required prior to placing a cosmetic ingredient on the Chinese market. 

3 Registration of New Cosmetic Ingredients

The NCI registration procedure is similar to that of cosmetic products but more costly and time-consuming. Applicants can refer to the Guidance on Application and Review of New Cosmetic Raw Materials to fulfill registration, which details the registration dossier, required toxicological tests and testing exemptions. 

CFDA adjusts registration of NCI

In the past once CFDA announced the approval of a NCI, all subsequent companies wishing to utilize the substance were permitted. The old policy has been complained as unfair to the applicant who has paid extensive efforts to gain the permit, which will ultimately hurt companies' initiative to do registration. 

Under the new management scheme, cosmetic companies who want to utilize the same new ingredient are subject to separate registration. CFDA will no longer release online announcements to approve new cosmetic ingredients but issue “new cosmetic ingredient trial use certificate” for the applicant only. The period of validity is four years, during which applicants can manufacture, sell and use this new ingredient. If no adverse events are observed during the 4 years, the ingredient will be listed into IECIC allowing all cosmetics companies to freely utilize the substance. That is to say the applicant can enjoy the exclusive protection period of 4 years (CL news on 26 Jan 2014). 

► Registration Procedure

The registration procedure of new cosmetic ingredients is similar to that of special-use cosmetics shown in Figure 3.

► Registration Dossier

1. New cosmetic ingredient administrative license application form;

2. Research & Development Report:

  • R&D background, processes and other related technical information.

  • The name and source of the ingredient, relative molecular weight, molecular formula, chemical structure and physical-chemical properties.

  • The intended use and application scope of the ingredient in cosmetics, safe use limit, warning statement, etc.

3. Basic description and diagram of the production process;

4. The quality and safety control requirements of the ingredients, including specifications, quantitative/qualitative analytical methods, impurities and their control measures;

5. Toxicological safety evaluation material, including:

  • A summary of the evaluation;

  • Toxicological testing data;

  • Safety evaluation data on potential risk substances (i.e., prohibited substances).

6. The Power of Attorney and the Business License of the SFDA-recorded responsible agent by the overseas applicant;

7. Testing sample verification reports (to demonstrate the consistency or to prove the new ingredient was employed in the actual toxicological tests);

8. Analytical method validation reports (if the analytical method for identification and quality control was developed by the applicant itself, not derived from NMPA-published testing guidelines, the validation should be carried out by three separate NMPA-approved testing institutions);

9. Other supportive documents.

The toxicological safety assessment mainly focuses on identifying prohibited substances or toxic impurities present in cosmetic ingredients. For example, phenol is a common impurity in phenoxyethnol and a testing report of phenol would normally be provided either for phenoxyethanol itself or a finished cosmetic product containing this preservative. Dioxane, methanol, acrylamide and N-nitrosodiethanolamine are normally tested for certain ingredients and their safe concentration should be calculated to demonstrate their safety if trace levels are present in the finished formulation. Impurities that pose potential risks and toxicological evaluation data will be extensively reviewed by NMPA expert panel.

► Toxicological Test

Applicants need to entrust a NMPA-accredited lab to prepare toxicological data demonstrated table below. The table below is a sample from Shanghai CDC, showing required testing items, duration, sample quantity and testing fee for an NCI:

No.

Testing Item

Testing Fee (RMB)

Duration (Month)

Sample (g/ml)

1

急性经口毒性试验

Acute Oral Toxicity Test

5000 (small rat)

8000 (big rat)

2

100-200

2

急性经皮毒性试验

Acute Dermal Toxicity Test

8000

2

150

3

急性皮肤刺激性试验

Dermal Irritation/Corrosion Test

6000

1.5

50

4

多次皮肤刺激性试验

Repeated Dermal Irritation Test

10000

2.5

100

5

急性眼刺激性/腐蚀性试验

Acute Eye Irritation/Corrosion Test

6000

2

50

6

皮肤变态反应试验

Skin Sensitisation Test

10000

3

100

7

皮肤光毒性试验

Skin Phototoxicity Test

6000

1.5

100

8

鼠伤寒沙门氏菌/回复突变试验

Salmonella typhimurium/reverse mutation assay

8000

2

50

9

体外哺乳动物细胞染色体畸变试验

In Vitro Mammalian Cells Chromosome Aberration Test

15000

3

50

10

体外哺乳动物细胞基因突变试验

In Vitro Mammalian Cell Gene Mutation Test

17000

4

50

11

哺乳动物骨髓细胞染色体畸变试验

In Vivo Mammalian Bone Marrow Cell Chromosome Aberration Test

10000

2.5

50

12

体内哺乳动物细胞微核试验/小鼠骨髓细胞微核试验

Mammalian Erythrocyte Micronucleus Test

10000

2.5

100

13

睾丸生殖细胞染色体畸变试验

Testicle Cells Chromosome Aberration Test

10000

3.5

100

14

亚慢性经口毒性试验/90天经口毒性试验

Subchronic Oral Toxicity Test

170000

9

2000

15

亚慢性经皮毒性试验/90天精品毒性试验

Subchronic Dermal Toxicity Test

180000

9

250

16

致畸试验

Teratogenicity Test

100000

6.5

1000-2000

17

慢性毒性/致癌性结合试验

Combined Chronic Toxicity/Carcinogenicity Test

1800000

36-48

5000-10000

 The above table displays a full set of toxicological tests a new cosmetic ingredient may go through but in real case, some tests will be exempt according to the property and use of the NCI. 

Test

Exemption Cases

1. The ingredient is not used as a preservative, sunscreen, colorant or hair dye; and needs not to be added to restricted substances list in Hygienic Standard for Cosmetics 

2. The ingredient has met criteria (1) and has been listed in the inventory of existing ingredients in overseas authoritative orgs for more than 4 years and  is not found to be hazardous in relevant literature

3. The ingredient is proven to have a history of  safe use as food ingredient by government or authoritative orgs

4. Polymer with average molecular weight above 1000 Daltons

5. Risk assessment of the cosmetic ingredient has been carried out by overseas authoritative orgs and the conclusion is that the ingredient is safe to be used in cosmetics

acute oral and acute dermal toxicity

  

All data are exempt but the conclusion, report of safety evaluation and other supportive documents in overseas countries are required.

skin and eye irritation/corrosion

skin sensitization

 

skin phototoxicity and photosensitivity

 (for UV-filters)

mutagenicity

√ (include at least a gene mutation test and a chromosome aberration test)

  

sub-chronic oral or dermal toxicity

  

teratogenicity

    

chronic toxicity/carcinogenicity

    

toxicokinetics and dynamics

    

In principle, it is mandatory for applicants to submit animal testing data. However, applicants could also provide the toxicological information utilizing read-across data, QSAR and available clinical or epidemiological data to prove the safety of the NCI. There is, however, a risk that this data will be inadequate and ultimately prolong registration as the NMPA expert panel may be unsatisfied with these kinds of data and require re-submission of animal testing data. 

Part 4 Animal Testing Issue

China's mandatory requirement of animal testing for cosmetics registration has been a long-standing controversy that makes current Chinese cosmetics regulatory framework incompatible with that of EU and Israel where such testing is prohibited for both cosmetic products and ingredients. The different animal testing policies have made global trade between these regions difficult. Chinese companies cannot sell cosmetics in EU if they are marketed in China and the European companies that stick to "cruelty-free" status cannot enter the Chinese market. 

Under the existing regulatory regime, cosmetic companies are obliged to assign NMPA-approved labs to perform animal tests on their cosmetic finished products or ingredients even if they have been assessed as "safe" and used or marketed in other countries. Testing results drawn from non-animal testing methods are not likely to be trusted and accepted by NMPA technical review experts. However, the past few years witnessed a turning point for animal testing policy in China. 

Removal of mandatory animal testing requirements for domestically-made non-special use cosmetics

The abolishment of the obligatory animal testing requirement for domestic non-special use cosmetics is the most significant cosmetics policy shift in 2013. Toxicological tests can be exempted as long as the ingredients and the finished products are proven to be safe after risk assessment.

Although it is still uncertain whether the new change will be extended to imported products, it is nonetheless a major milestone for China on its way to the modernization of its animal testing policy and alignment of its regulatory framework with the global cruelty-free trends. 

Latest Developments in Alternative Testing Methods in China

On Nov 11, 2016, China included 3T3 NRU Phototoxicity Test as a toxicology test method into Safety and Technical Standards for Cosmetics. Then on Aug 15, 2017, Skin Corrosion: Transcutaneous Electrical Resistance Test was accepted as in vitro test method for skin corrosion.

On Feb 5, 2018, China opened public consultation on 2 new draft standards for 2 additional alternative testing methods to public consultation namely:

  1.  Skin Sensitivity: Direct Peptide Reactivity Assay

  2.  Eye Irritation(Corrosion): Short Time Exposure

On Jun 27, 2018, China opened public consultation on 2 new draft standards for two more alternative testing methods namely:

  1. Skin Sensitivity: Murine Local Lymph Node Assay: DA

  2. Skin Sensitivity: Local Lymph Node Assay: BrdU-ELISA

Currently, Eye Irritation (corrosion): Porcine Corneal Opacity Permeability and Genotoxicity: In Vitro Micronucleus are under research. The research on Eye Irritation (corrosion): Fluorescent Leakage test and Skin Sensitivity: 442E(h-CLAT), 442D will commence soon.

Time

Status

Alternative Methods

2016

Approved

Phototoxicity: 3T3

2017

Approved

Skin Corrosion: TER

2018

Draft

Skin Sensitivity: DPRA

Eye Irritation(Corrosion): STE

Skin Sensitivity: LLNA: DA

Skin Sensitivity: LLNA: BrdU-ELISA

/

Under research

Eye Irritation(corrosion)- PCOP

Genotoxicity: In Vitro Micronucleus

Going to be start

Eye Irritation(corrosion): FL

Skin Sensitivity: 442E(h-CLAT), 442D

On Sep 19, 2018, China Working Group for the Validation of Alternative Methods was newly established. This working group is organized by NIFDC and covers 15 units including cosmetics testing institutions, scientific research institutions and representatives of the cosmetics industry.

The working group's major goal is to improve the validation and utilization of alternative testing methods which can act as viable surrogate markers in the assessment of potential toxicities, adverse effects and hazards of cosmetics and ultimately reduce China's reliance on the use of animal testing. Feasibility criteria are based on the inherent characteristics of China's cosmetic industry, consumers and product lifecycle.

Although China has not yet established a Center for the Validation of Alternative Methods, the establishment of the working group is also a major step forward.

Animal testing for non-special use cosmetics may be exempt

On 27th May 2019, China National Medical Products Administration (NMPA) released a draft version of Administrative Measures for Filing of Non-special Use Cosmetics. The regulation stipulates: if the production enterprise has obtained the Good Manufacturer Practices certificate and product safety risk assessment results can fully confirm this product's safety, the toxicological testing for this product is not required, except in the following situations...

There is a big possibility that imported non-special cosmetics will be exempt from mandatory animal testing.Animal testing is still mandatory for the following products: children's products, products which contain the new ingredient that has filed and been approved but not included in the IECIC, products manufactured by enterprises which have bad records.

Part 5 Cross Border E-commerce

In addition to the general trade that shall complete pre-market approval in advance, China also developed another trade channel for international stakeholders’ entry into its cosmetic market, and that is Cross Border E-commerce (short for “CBEC”), which generally refers to the online purchase of a select list of goods that are imported from overseas countries via China government-sanctioned third-party e-commerce platforms such as Tmall Global, Vipshop, Kaola, JD using the bonded warehouse mode or the direct mail mode.

1 Development History

Over the years, China has flip-flopped on its CBEC policies. For a long time, commodities imported via CBEC channel were supervised as personal goods and were subject to personal postal articles tax. In 2016 China initiated a regulatory reform on CBEC policies which was scheduled to be effective on Apr. 8, 2016 to mainly address 3 key issues: taxation, positive list and supervision method. However, as the reform sparked huge controversy among the public, two-year buffer period was granted for stakeholders to prepare for the new regulatory scheme until the end of 2018. During the grace period, a transitional policy that “temporarily” exempted the verification of customs clearance sheet and pre-market approval for first imported cosmetics, infant formula, medical device, special foods (such as health food and food for special medical purposes) via CBEC channel was launched in 15 CBEC pilot cities. Besides the supervision method, the new tax scheme and positive lists were in effect in the 2016 CBEC reform.

2 CBEC New Policies

At the end of CBEC grace period in 2018, China determined to further extend the transitional policies of CBEC retails beyond the January 1st, 2019 deadline. Given no new deadline has been specified, ChemLinked expects current measures to remain stable in the short to medium term.

As per the official circulars, the regulatory updates mainly include 3 aspects:

(1) The continuation of previous supervision method

Commodities imported via CBEC channel has been essentially regulated as personal articles, exempt from mandatory registration or filing requirements of first-imported cosmetics, infant formula powder, medical device and special food (such as health food and food for special medical purposes).

Additionally, the number of CBEC pilot cities where the new policies apply has also been increased from the previous 15 to 37.

(2) The increase in the number of the positive list

The previous two lists of products permitted to be imported via CBEC were merged into one list and were appended to include 63 types of new commodities in great demand. For the full list of cosmetics, please refer to the cosme-list.

(3) The increase in the transaction limits for both single purchases and total annual purchases

The consumers’ transaction limit of CBEC commodities was raised from 2000 RMB to 5000 RMB per transaction and from 20,000 RMB to 26,000 RMB per person per year.

3 CBEC New Tax Rate

According to the CBEC tax scheme, commodities imported in this way are subject to a comprehensive tax which is a combination of three taxes—tariffs, VAT (value-added tax) and consumption tax.

1. Within the transaction limits, consumers are eligible for preferential tax policy in which the import tariff rate is temporarily fixed at 0.0%, and the import VAT and consumption tax are levied at 70% of the statutory tax payable. The calculation rules are:

CBEC Comprehensive Tax Rate = [(VAT rate + Consumption tax rate) ÷ (1 - Consumption tax rate)] × 70%

Significantly, since China officially dropped the VAT rate of imported goods from 16% to 13% on April 1, 2019, the CBEC comprehensive tax was accordingly reduced and the updated rates are as follows:

CategoryItemsUpdated VAT (%)Consumption tax (%)Updated CBEC comprehensive tax rate (%)
Cosmetics, skin care productsMask130/159.1/23.05
Lipstick130/159.1/23.05
Eye Gel130/159.1/23.05
Nail Polish130/159.1/23.05
Perfume130/159.1/23.05
Skin Care130/159.1/23.05
Cleaning care productsShampoo1309.1
Body Wash1309.1
Toothpaste1309.1
Note:
  • The consumption tax of ordinary cosmetic is 0.0%.

  • The 15% consumption tax is only levied on high-end cosmetics which refer to products with an after-tax wholesale import price in excess of 10 RMB/ml (g) or 15 RMB/piece and includes high-end make-up cosmetics, skin care cosmetics and cosmetic kits.

2. On the contrary, the products imported via CBEC will be taxed in full in line with the general trade mode in any of the following cases:

Tax Payable = Tariff + VAT + Consumption tax
  • A single transaction is over 5,000 RMB but within the annual limit of 26,000 RMB, it is allowed to be imported via CBEC but is subject to full tax.

  • Any excess beyond the annual limit will be regulated as general trade.

4 CBEC vs. Animal Testing

Under the current regulatory regime, the significant time and financial investment associated with standard pre-market approval along with the necessity to produce Chinese labels and toxicology test reports can all be avoided because CBEC-imported cosmetics are regulated as personal articles and not subject to cosmetics regulations. Thus it offers an excellent market access route for international cosmetic stakeholders who intend to circumvent animal testing and mandatory general trade registration requirements in consideration of ethical issues and/or expedited market access.

5 Future Trends

As widely predicted, the prosperity of CBEC business is expected to continue in the second half of 2019, fueled by a series of favorable policies including China State Council’s plan to expand the positive list of CBEC imported commodities and the convening of the 2nd China International Import Expo.