China Mainland Cosmetic Regulation
Mar 15, 2021
ChemLinked Cosmetic Team
Pedia Details Reference Our Service Read More
CONTENTS

On Jan. 1, 2021, the overarching cosmetic regulation Cosmetic Supervision and Administration Regulation (CSAR) in China entered into force, replacing the former Cosmetics Hygiene Supervision Regulations (CHSR). With the entry into force of the CSAR, China's cosmetic sector is now ushering in a new era.

The new regulation is designed to overhaul the outdated regulatory framework and address issues revolving around cosmetic pre-market and post-market management in new situations, such as cosmetic classification, new ingredient management, efficacy evaluation, safety assessment, online cosmetic supervision, accountability system, and punitive measures. To support the new regulation, China has been releasing and will implement a series of subsidiary regulations in the next few years.

Given that the CSAR puts forward several new requirements for cosmetic enterprises, transitional measures were also released. Prior to implementing the subsidiary regulations on registration and notification, the registrants and notifiers shall submit registration and notification dossiers in accordance with the current regulations and requirements. The notification is deemed completed after the submission of notification dossiers. The medical products administration departments will carry out the registration management in accordance with the procedures and time limit stipulated in the CSAR.

Part 1 Regulatory Framework and Competent Authority

1 Existing Main Cosmetic Regulations in China

Type

Regulation

Remark

Effective Date

Status

Overarching

Cosmetic Supervision and Administration Regulation (CSAR)

《化妆品监督管理条例》

CSAR is the overarching cosmetic regulation in China. It is designed to overhaul the outdated regulatory framework and address issues revolving around cosmetic pre-market and post-market management in new situations, such as cosmetic classification, new ingredient management, efficacy evaluation, safety assessment, online cosmetic supervision, accountability system, and punitive measures.

Jan. 1, 2021

In force

Ingredient

Safety and Technical Standards for Cosmetics 2015 (STSC 2015)

《化妆品安全技术规范》

STSC contains the prohibited, restricted, and permitted cosmetic ingredients, physical and chemical testing methods for cosmetics, microbiological testing methods, toxicological testing methods, human body safety testing methods, and human body efficacy evaluation testing methods.

Dec. 1, 2016

In force, but is being revised

Inventory of Prohibited Cosmetic Ingredients (Draft)

化妆品禁用原料目录》草案

The Inventory is drafted based on the revision of the prohibited ingredient lists in STSC. It will be released and finalized as separated technical regulation or mandatory national standard in the future.

/

Draft

Inventory of Existing Cosmetic Ingredients in China 2015 (IECIC 2015)

《已使用化妆品原料名称目录》

IECIC 2015 contains 8783 ingredients that have already been used in cosmetics in China. Ingredients listed in the IECIC are regarded as "existing" substances, which do not require registration or notification with the NMPA prior to use in cosmetic products.

Dec. 23, 2015

In force, but is being revised

Inventory of Existing Cosmetic Ingredients in China (Draft)

已使用化妆品原料目录》草案

The draft IECIC 2021 increases the total number of existing cosmetic ingredients to 8980 in comparison with the 2015 version.

/

Draft

INCI Chinese Version 2010 Catalogue of Standard Chinese Name of International Cosmetic Ingredients

国际化妆品原料标准中文名称目录

In the Catalogue, there are 15649 ingredients sorted in alphabetical order according to the English names in INCI, corresponding translated Chinese names and CAS numbers.

Dec. 14, 2010

In force, but is being revised

INCI Chinese Version 2018: Catalogue of Standard Chinese Name of International Cosmetic Ingredient (Draft)

《国际化妆品原料标准中文名称目录》草案

The 2018 Chinese version of INCI was drafted with reference to NMPA's translation of PCPC’s International Cosmetic Ingredient Dictionary and Handbook. In the draft Catalogue, there are 22620 cosmetic ingredients.

/

Draft

Registration and Notification

Requirements for Filing of Domestic Non-special Use Cosmetic Products

国产非特殊用途化妆品备案要求

Prior to the finalization and implementation of CSAR subsidiary regulations on registration and notification, cosmetic registrants and notifiers shall submit registration and notification dossiers of cosmetic products and new cosmetic ingredients in accordance with these regulations.

Jun. 30, 2014

In force, but will be replaced.

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

Dec. 1, 2017

Guidance for Filing Management of First Import Non-Special Use Cosmetics in Shanghai

上海进口非特殊用途化妆品备案办事指南

Nov. 16, 2018

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

Dec. 1, 2017

Guidance on Application and Review of New Cosmetic Ingredient

化妆品新原料申报与审评指南

Jul. 1, 2011

Guidance on Application and Review of Children's Cosmetics

儿童化妆品申报与审评指南

The regulation stipulates the requirements for children cosmetics application and review.

Feb. 1, 2013

In force

Administrative Measures on Cosmetics Registration and Notification

《化妆品注册备案管理办法》

The regulation clarifies the basic requirements for registration and notification management of cosmetic products and new cosmetic ingredients.

May 1, 2021

To be enforced

Provisions for Management of Cosmetic Registration and Notification Dossiers

《化妆品注册备案资料管理规定》

The regulation stipulates the documentation requirements for the application, modification,renewal, and cancellation ofcosmetic product registrationand notification.

May 1, 2021

To be enforced

Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers

化妆品新原料注册备案资料管理规定


The regulation stipulates the documentation requirements for the new cosmetic ingredients registration and notification.

May 1, 2021

To be enforced

Cosmetic Classification Rules and Catalogs

《化妆品分类规则和分类目录》

The regulation stipulates the classification and coding of cosmetics.



May 1, 2021

To be enforced

Technical Guidelines for Cosmetic Safety Assessment

化妆品安全评估技术导则

The regulation clarifies the detailed requirements for conducting safety assessment, requirements for safety assessors, content necessary in the assessment report, attach corresponding samples, and set transitional measures.

May 1, 2021

To be enforced

Standards for Cosmetic Efficacy Claim Evaluation 

化妆品功效宣称评价规范

The regulation clarifies the evaluation principles, exemptions, accepted evaluation methods and institutions, obligations of institutions and registrants/notifiers, and necessary content in the evaluation report.

May 1, 2021

To be enforced

Manufacture and Operation

Practice for Cosmetics Production Licensing

化妆品生产许可工作规范

The regulation stipulates the requirements, procedures, required documents, supervision and inspections, etc. for enterprises that want to engage in cosmetics production in China to apply for production licenses.

Jan. 1, 2016

In force

Supervision and Administration Measures on Cosmetics Manufacture and Operation (Draft)

化妆品生产经营监督管理办法》草案

The regulation covers details about production license management, production quality management, operation quality management, network operation management, and legal responsibilities.

/

Draft

Good Manufacturing Practices for Cosmetics (Draft)

《化妆品生产质量管理规范》草案

The regulation covers all aspects of cosmetic production and quality control such as ingredients, personnel, equipment, sanitation, inspection, packaging, storage, transportation, sales, and recall.

/

Draft

Labeling and Naming

Administrative Provisions on Cosmetics Labeling

化妆品标识管理规定

The regulation stipulates the labeling of cosmetics produced (including sub-packaging) and marketed within the territory of China, which mainly concentrates on requirements for the content and form of labels.

Sep. 1, 2008

In force, but will be replaced.

GB 5296.3-2008 Instruction for Use of Consumer Products—General Labelling for Cosmetics

GB 5296.3-2008 消费品使用说明 化妆品通用标签

The regulation stipulates the general labeling format for cosmetics sales packaging, including where to print labels, basic principles of labeling contents, required information on labels, items needed printing if necessary and general requirements.

Oct. 1, 2009

In force, but will be replaced.

Requirements for Sunscreens Labeling

防晒化妆品防晒效果标识管理要求

The regulation stipulates the labeling requirements relating to the sun protection effect for sunscreens.

Jun. 1, 2016

In force

Requirements on Naming of Cosmetics

《化妆品命名规定》

The regulation stipulates the requirements for cosmetic naming.

Feb. 5, 2010

In force, but will be replaced

Administrative Measures on Cosmetics Labeling (Draft)

化妆品标签管理办法》草案

The regulation specifies the requirements for cosmetic labeling and claims.

/

Draft

Post-market   Surveillance

Measures for the Management of Cosmetic Adverse Reaction Monitoring (Draft)

化妆品不良反应监测管理办法》草案

The regulation specifies the application scope, division of responsibility, and cosmetic adverse reaction monitoring procedures.

/

Draft

Standards for the Management of Cosmetic Sampling Inspection (Draft)

化妆品抽样检验管理规范》草案

The regulation stipulates the requirements and procedures for sampling inspection, and corresponding obligations of all stakeholders.

/

Draft

Interim Provisions on the Administration of Cosmetics Overseas Inspection (Draft)

《化妆品境外检查暂行管理规定》草案

The regulation specifies details on overseas cosmetic inspection procedures, including inspection scope, the competent authority, results, and penalties for violation of the regulation. It shall apply to the inspection of overseas development and production related processes of cosmetics that have been marketed or are to be marketed in China.

/

Draft

Testing

Working Rules for Cosmetic Registration and Notification Testing

化妆品注册和备案检验工作规范

The regulation specifies the testing procedures for cosmetics registration and notification, management requirements of testing institutions, testing item requirements for different types of products as well as the templates and styles of testing reports.

Sep. 10, 2019

In force

Measures for the Management of Cosmetic Supplementary Testing Methods (Draft)

化妆品补充检验方法管理办法》草案

The regulation specifies the application scope, competent authorities, drafting procedures, technical guidelines, and compilation rules of cosmetic supplementary testing methods.

/

Draft

Import and 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

The regulation stipulates the requirements for cosmetics import and export.

Nov. 23, 2018

In force

Toothpaste

Administrative Measures on Toothpaste (Draft)

《牙膏监督管理办法》草案

The regulation stipulates the definition of toothpaste and new toothpaste ingredients, the obligations of toothpaste manufacturers, importers, and operators, and the management scheme of new toothpaste ingredients.

/

Draft

Instructions for Toothpaste Notification Dossiers (Draft)

牙膏备案资料规范》草案

The regulation stipulates the documentation requirements for toothpaste notification.

/

Draft

2 Competent Authority

China underwent a largescale institutional reform in 2018. Currently, there are three major competent authorities in the cosmetic sector.

Competent Authority

Main Responsibility

State Administration for Market Regulation (SAMR)

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SAMR takes overall charge of market supervision of food, cosmetics, pharmaceuticals, and medical devices. Its main responsibilities include:

 

  • Market management

  • Market entity registration

  • Quality and safety supervision

  • Standardization work

National Medical Products Administration (NMPA)

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NMPA is established under the governance of SAMR to take all the work undertaken by the former CFDA. It is responsible for the registration of imported/domestic special cosmetics, the notification of imported general cosmetics, and the registration and notification of new cosmetic ingredients. Other responsibilities include:

 

  • Safety supervision management

  • Standard management

  • Quality control

  • Post-market risk management

  • Supervision and inspection

  • Foreign exchange and cooperation

 

Medical products administration departments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the supervision and management of cosmetics in their administrative areas, including the notification of domestic general cosmetics and the issuance of production licenses for cosmetic manufacturers.

General Administration of Customs (GAC)

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GAC is responsible for the customs import and export inspection and quarantine of cosmetics.

Part 2 Cosmetic Products

Before being marketed or imported into China, cosmetic products must get approval from NMPA or medical products administration departments of provinces, autonomous regions, and municipalities directly under the Central Government according to the product category.

1 Definition of Cosmetic Products

Cosmetic products refer to daily chemical products intended to be applied on the external part of the human body (such as skin, hair, nails, lips, etc.) by spreading, spraying, or other similar ways for cleansing, protecting, beautifying, or grooming purposes.

The definitions of cosmetics vary 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

Cosmetics

Not Cosmetics

Usage

Spreading, spraying or other similar ways like rubbing

Oral administration or injection­­­

Applied body parts

External parts of the human body, such as skin, hair, nails, lips

Teeth or oral mucosa

Functions and purposes of use

Skin care, to keep the body clean, to improve appearance and beauty

Prevent and treat diseases

  • Toothpastes are not defined as cosmetics but shall be regulated with reference to general cosmetics regulations, requiring notification, testing, safety assessment, efficacy evaluation, new toothpaste ingredient application, etc. After toothpaste notifiers conduct the efficacy evaluation in accordance with national standards and industry standards, they can claim that the toothpaste has efficacy such as anti-caries, plaque inhibition, anti-dentine hypersensitivity, and relieve gingiva problems, etc. More information can refer to CL News.

  • CSAR does not apply to soaps, excluding those claimed to have special cosmetics efficacy (e.g., whitening). Soaps that claim to have the efficacy of special cosmetics shall apply for the registration and obtain a registration certificate in accordance with the CSAR.

2 Classification of Cosmetic Products

2.1 Cosmetic Category

According to the previous CHSR, cosmetics in China were categorized as special use (9 categories) and non-special use cosmetics. Under the new CSAR, cosmetics are categorized as special cosmetics and general cosmetics. The categories of special cosmetics are reduced to 5+1. Other cosmetics are general cosmetics.

Cosmetic Categories Under CHSR (Previous)


a. Special Use Cosmetics

  • Hair growth products 1

  • Hair dyes

  • Hair perming products

  • Depilating products 2

  • Breast beauty products 2

  • Slimming products 2

  • Deodorants 2

  • Freckle-removing (whitening) products

  • Sunscreens

 

b. Non-Special Use Cosmetics

Other cosmetics except for special use cosmetics.

Cosmetic Categories Under CSAR (Current)

a. Special Cosmetics

  • Hair dyes

  • Hair perming products

  • Freckle-removing (whitening) products

  • Sunscreens

  • Anti-hair loss products

  • Cosmetics with new efficacy

 

b. General Cosmetics

Other cosmetics except for special cosmetics.

Notes:

1. Under CSAR, hair growth products are subdivided into 3 categories for supervision:

  • General Cosmetics: products that prevent hair breakage by improving hair quality;

  • Special Cosmetics: products that prevent hair loss by improving the condition of the scalp;

  • Drugs: products that promote hair growth by participating in human physiological activities.

 

2. Under CSAR, depilating products, breast beauty products, slimming products, and deodorants are no longer supervised as special cosmetics. They may be managed as general cosmetics, drugs or disinfection products depending on their mechanism of action.

 

*Hair growth, depilating, breast beauty, slimming, and deodorant products registered before Jan. 1, 2021, can continue to be manufactured, imported, and sold in China during the 5-year transition period. More information can refer to CL News.

 

3. Cosmetics with efficacies, application areas and dosage forms not listed in the Cosmetic Classification Rules and Catalog will be regulated as special cosmetics.

 

4. Cosmetics applicable to pregnant women, breastfeeding women, and infant and children cosmetics with efficacies not listed in the Cosmetic Classification Rules and Catalog will be regulated as special cosmetics.

2.2 Cosmetic Classification Code

In the future, NMPA will launch a classification coding system to subdivide all cosmetics according to their efficacy claims, application areas, dosage forms, target users, and application methods to facilitate product statistics, supervision, and determination of product subcategories.

The cosmetics classification code is composed of 5 layers of numbers, and each layer is separated by "-" and represented by a 2-digit number or letters. Specifically, the 5 layers are:

5 Layers

Subcategories

Range of Codes

1st layer

Efficacy Claims

Includes 28 kinds of claims such as cleansing, makeup removing, moisturizing, beauty modifying, hair styling, sunscreen, deodorant, hair removal, etc.

01-28, A*

2nd layer

Application Areas

Includes 13 parts such as hair, scalp, body skin, face, eyes, underarms, etc.

01-13, B*

3rd layer

Dosage Forms

Includes 14 categories such as creams, emulsions, water aquas, gels, powders or solids, pastes, aerosols, etc.

01-14, C*

4th layer

Target Users

Includes 3 categories, namely ordinary people, infants (between birth and the age of 3), and children (aged between 3 and 12).

01-03, D*

5th layer

Application Methods

Rinse-off and leave-on categories.

01, 02

*: In any of the first four layers, products outside the prescribed subcategories will fall under a separate class, be coded by letters, and managed as special cosmetics.

For example:

The classification code of children's sunscreen is 09-03-01-03-02;

The classification code of the whitening moisturizing body lotion is 0310-03-02-01-02.

More information about coding rules can refer to CL News.

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 Lists

Currently China adopts 9 lists to regulate the cosmetic ingredients, as shown below:

List Name

Remark

Current Version (year)

Number Contained

Inventory of Existing Cosmetic Ingredients in China (IECIC)

Ingredients listed in the IECIC are regarded as "existing" substances, which do not require registration or notification with the NMPA prior to use in cosmetic products.

2015

8783

Limits of Hazardous Ingredients in Cosmetics

The content is contained in the Safety and Technical Standards for Cosmetics 2015, which specifies the general safety   standards, defines prohibited/restricted/permitted ingredients and sets testing methods.

2015

7

List of Prohibited Ingredients Used in Cosmetics

The list is contained in the Safety and Technical Standards for Cosmetics 2015, which specifies the general safety standards, defines prohibited/restricted/permitted ingredients and sets testing   methods.

2015

1388

List of Restricted Ingredients Used in Cosmetics

2015

47

List of Permitted Preservatives Used in Cosmetics

2015

51

List of Permitted Sunscreens Used in Cosmetics

2015

27

List of Permitted Colorants Used in Cosmetics

2015

157

List of Permitted Hair Dyes Used in Cosmetics

2015

75

The INCI Chinese Version

It is translated with the main purpose to standardize the translation of INCI name and cosmetic labeling and instructions.

2010

15649

2 New Cosmetic Ingredients (NCI)

2.1 Definition

According to Article 11 of the CSAR, 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 the NMPA. 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. 

2.2 Classification

Under China's new cosmetic regulations, NCI are divided into 2 categories: high-risk NCI and low-risk NCI.

Classification

Specifics

High-risk NCI

  1. Preservatives

  2. UV filters

  3. Colorants

  4. Hair dyes

  5. Freckle removal or whitening agents

Low-risk NCI

All NCI except for the high-risk NCI

High-risk NCI require registration with NMPA and obtain approval, while low-risk NCI is subject to notification.

2.3 Notification/Registration of NCI

Cosmetic companies who want to utilize the NCI or cosmetic ingredient companies who want to export NCI to China shall apply for notification or registration with the NMPA.

Application Process

210222-cos-pedia-流程图.jpgChina regulates that overseas companies shall authorize a domestic enterprise as the Responsible Person (RP) to apply for notification/registration. The RP is responsible for applying for an account for applications, arranging the testing of NCI and prepare the application dossiers.

Dossiers Necessary for Notification/Registration 

Type

Dossiers

Account Application

  • Information of registrant and notifier of new cosmetic ingredient;

  • Safety risk monitoring and evaluation system overview of registrant and notifier of new cosmetic ingredient;

  • Original authorization letter of the domestic responsible person and the original notarial certificate (for overseas registrant/notifier).

NCI Registration/Notification

  • The name, address, and contact information of the registrant, notifier, and domestic responsible person;

  • New cosmetic ingredient R&D report;

  • Research documents on the NCI preparation techniques, stability, and quality control standards;

  • Safety assessment documents for NCI;

  • Technical requirements (available for public).

For notification, after successful submission of the documents online the notifier can directly export the NCI or to use the NCI. In the case of registration, there will be a complicated review process for the application documents, including format review, technical review, etc., which takes a maximum of 128 working days. Only companies passing the review and obtaining the registration certificate can export the NCI or use the NCI.

2.4 Safety Monitoring and Reporting

After successful registration or notification of NCI, registrants and notifiers shall establish a safety monitoring system for the notified/registered NCI within 3 years of completing the notification or obtaining the registration certificate. During the 3 years, they shall report the NCI's use and safety data to the NMPA annually and may be required to conduct a safety assessment.

If there are no safety issues found within the 3 years, the NCI will be included in theInventory of Existing Cosmetic Ingredients in China (IECIC).

2.5 Safety Re-assessment

For the NCI already added into the IECIC, the registrants or notifiers may be ordered to carry out re-assessment and further submit a safety assessment report if there is a new recognition on its safety or there is evidence showing that the NCI may have any safety risks. If the NCI is confirmed to have safety risks after re-assessment, they will be prohibited for use in the production of cosmetics or be subject to a use restriction.

3 List of Approved New Cosmetic Ingredients 

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

Dec 2012   (CFDA)

10

Elaeagnus mollis diel Oil

琪尔康翅果油

琪尔康

Oct 2014   (CFDA)

11

ETHYL LAUROYL ARGINATE HCL


-

Dec 2020   (NMPA)

12

Methoxy Peg-23 Methacrylate/Glyceryl Diisostearate Methacrylate Copolymer

ISPolymer

-

Dec 2020   (NMPA)

13

Calcium Phosphoryl Oligosaccharides

POs-Ca

-

Dec 2020   (NMPA)

14

Steareth-200

Brij S200

-

Dec 2020   (NMPA)

From 2004 to 2014, there were only 10 new cosmetic ingredients that got approval from MOH and NMPA, indicating the extreme difficulty in the registration of an NCI in China. However, the situation is about to change with the introduction of the CSAR

On December 28, 2020, the NMPA newly approved 4 new cosmetic ingredients. The approval of the 4 NCI is an active signal that the regulatory stance on new cosmetic ingredients is being softened and the classified management of such ingredients is being put in place. It is expected that more advanced ingredients will be approved and used legally in the Chinese market, and the industry will enter a new era of rapid development.

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.