Cosmetic Compliance
Intelligence & Solutions
China Mainland Cosmetic Regulation
Aug 13, 2021
ChemLinked Cosmetic Team
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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The new regulation is designed to overhaul the outdated regulatory framework and address issues revolving around cosmetic pre-market and post-market management in new situations, such as cosmetic classification, new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 It is designed to overhaul the outdated regulatory framework and address issues revolving around cosmetic pre-market and post-market management in new situations, such as cosmetic classification, new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

化妆品禁用原料目录

The Inventory is formulated based on the revision of the prohibited ingredient lists in STSC and included in the corresponding chapters in STSC.

May 28, 2021

In force

Inventory of Existing Cosmetic Ingredients in China 2021

已使用化妆品原料目录》(2021版)

IECIC is an objective and comprehensive collection of ingredients that have been used in cosmetics produced and sold in China. It serves as the sole reference for determining the regulatory status of cosmetic ingredients. All ingredients excluded from the Inventory are deemed "new ingredients" and subject to mandatory pre-market registration or notification with the NMPA under new cosmetic regulations.


The IECIC 2021 increases the total number of existing cosmetic ingredients in China to 8972.

May 1, 2021

In force

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

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

In force

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

In force

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

In force

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

In force

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

In force

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

In force

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

化妆品生产经营监督管理办法

The regulation optimizes production license management system, refines and clarifies production and operation management requirements, strengthens the supervisory responsibilities of the administration department, etc.

/

To be enforced

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

化妆品标签管理办法

The regulation specifies the requirements for cosmetic labeling and claims.

May 1, 2022

To be enforced

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

Working Rules for Management of Cosmetic Supplementary Testing Methods

化妆品补充检验方法管理工作规程

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

Jul. 1, 2021

To be enforced

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)

9482242b-877b-46e4-8e72-adb073aad28b.png


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 Domestic Cosmetics VS Imported Cosmetics

The only criterion for distinguishing between imported and domestic cosmetics is the area where the last process of contacting cosmetic contents is completed.

The last process of contacting cosmetic contents is completed in Chinese Mainland

Domestic cosmetics

The last process of contacting cosmetic contents is completed outside of Chinese Mainland

Imported cosmetics

Notes:

If the product’s last process of contacting cosmetic contents is completed in Hong Kong S.A.R, Macao S.A.R or Chinese Taipei, it shall be managed with reference to the requirements of imported cosmetics.

Usually, the last process of contacting cosmetic contents is the filling process.

  • If the ingredients used are imported, but the product contents are filled in a Chinese factory, they belong to domestic cosmetics;

  • If the cosmetics have completed the filling process in China, and only have the packaging process (without contacting contents) abroad, they belong to domestic cosmetics.

2.2 General Cosmetics VS Special Cosmetics

Previously, according to the use purpose, 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. The following three products are also regulated as cosmetics with new efficacies:

2.3 Cosmetic Classification Code

NMPA launches a classification coding system to subdivide all cosmetics according to their efficacy claims, application areas, target users, dosage forms, 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 connected 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 26 kinds of claims such as cleansing, makeup removing, moisturizing, sunscreen, deodorant, hair removal, etc.

01-26, A*

2nd layer

Application Areas

Includes 10 parts such as hair, body skin, head, face, etc.

01-10, B*

3rd layer

Target Users

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

01-03, C*

4th layer

Dosage Forms

Includes 11 dosage forms such as creams and emulsions, liquids, gels, powders, pastes, aerosols, sprays, etc.

00, 01-11

5th layer

Application Methods

Rinse-off and leave-on categories.

01, 02

Note:


1. "*": In any of the first three layers, products outside the prescribed sub-categories will be coded by letters and managed as cosmetics with new efficacies.

2. "◆": The code “00” of the fourth layer Dosage Forms means other forms that are not coved in the stipulated dosage forms.

For example:

The classification code of moisturizing masks may be 11-05-03-10-02;

The classification code of the baby shampoo may be 09-01/04-01-02-01.

More information about coding rules can refer to CL News.

3. Notification/Registration of Cosmetic Products

Under China's new cosmetic regulations, special cosmetics shall register with NMPA, while general cosmetics only require quick notification.

Classification

Pre-Market Obligation

Competent Authority

Certificate

Post-Market Obligation

Special cosmetics

Registration

NMPA

Registration license

(Valid for five years)

Registrational renewal

General cosmetics

Notification*

NMPA or local provincial MPA

e-certificate

(permanent)

Annual report submission

*It should be noted that the “cosmetic notification management” is a new notion proposed by CSAR, which differs from the previous “filing system” mainly in the following aspects.


Previous Filing Management

New Notification Management

Completion Time

Filing dossiers shall be submitted through the platform before product launch. Filing is completed after the format review within five working days.

Notification is completed upon the finishing of dossiers submission through the new platform.

Technical Review Period

The technical review is conducted within three months after filing.

The technical review is random, and no deadline is set.

Under the new notification management mechanism, after the notifier submits the required dossiers, the notification will be deemed as completed without waiting for the administration department to conduct a format review, which speeds time to market and improves the efficiency of the product listing. However, it does not mean that the notification reduces the safety requirements for the product but strengthens the in-market and post-market supervision. Enterprises now face a higher cost of violating the law.

3.1 Application Process

3.1.1 Involved Entities

  • Registrant/Notifier: the first responsible person of cosmetic safety, and he can produce cosmetics on his own or entrust other enterprises to produce cosmetics. The registrant or notifier shall be accountable for product life-cycle management, from development, production to marketplace circulation.

  • Responsible person (RP): overseas cosmetics registrants and notifiers shall designate an enterprise legal person within the territory of China as the domestic responsible person to handle cosmetic registration and notification, assist them in cosmetic adverse reaction monitoring and the product recall, and cooperate with supervision and inspection of medical products administration departments.

  • Entrusted Production Enterprises: entrusted by cosmetic registrants/notifiers to produce cosmetics for them. The entrusted production enterprise shall have corresponding production conditions, organize production per relevant laws, regulations, and contractual agreements, be responsible for production activities, and accept the supervision from cosmetics registrants and notifiers.

3.1.2 Detailed Steps for Imported Cosmetic Registration and Notification

application-process-2.jpgStep 1: Assign a Domestic Responsible Person in China

The prerequisite for imported cosmetic registration and notification is to designate an RP, who must be a legal entity in mainland China with a business license of cosmetic sales and import and export services. The RP could be:

  • A subsidiary based in China;

  • Chinese distributor;

  • A third party, like REACH24H Consulting Group.

The appointment of a capable RP is a hugely important step. The selected intermediate can timely communicate with NMPA technical review experts, respond quickly to any questions raised, and keep confidential key product information, such as production process and formula. An Authorization Letter to RP for Cosmetic Registration and Notification needs to be signed and notarized.

In the case of an entrusted production relationship, you can refer to the following table to determine whether an RP shall be designated.

No.

Registrant/Notifier

The Entrusted Manufacturer

Product Properties

Whether to designate an RP in China

1

Overseas

/

Imported Cosmetics

Yes

2

Overseas

Overseas

Imported Cosmetics

Yes

3

Overseas

Domestic

Domestic Cosmetics

Yes

4

Domestic

Overseas

Imported Cosmetics

No

5

China Taiwan, Hong Kong, Macau

Domestic

Domestic Cosmetics

Yes

6

China Taiwan, Hong Kong, Macao

Overseas

Imported Cosmetics

Yes

Step 2: Account Application and User Permission Opening

Then the RP needs to apply for a user account on the online service hall of the NMPA and bind it with the account of the Cosmetic Registration and Notification Information Service Platform (hereafter referred to as “new platform”). After that, the RP needs to submit the relevant documents, such as the Domestic Responsible Person Information Form, the Authorization Letter of the Domestic Responsible Person, etc., to obtain the user permission of the RP for cosmetic registration and notification.

Step 3: Arrange Product Testing

Cosmetic samples must be consistent with the marketed products and tested by the qualified labs in China to obtain eligible testing reports with sufficient data to substantiate the safety and efficacy of products.

The basic tests of the products include microbiological tests, physicochemical tests, toxicological tests, human safety tests, efficacy evaluation tests, etc. Specific testing items and duration shall depend on the type and property of cosmetic products. In general, the testing period is much longer for special cosmetics because they require additional tests on the human body. It takes about 5-8 months to complete all the tests for special cosmetics, while general cosmetics only need 1-2 months.

Apart from that, cosmetics whose efficacy claims need to be verified by the prescribed efficacy claim evaluation method should also contact testing institutions for relevant evaluation tests.

Step 4: Dossiers Submission

When all the registration/notification documents are ready, the RP shall first submit the electronic version through the new platform when applying for imported cosmetic registration or notification.

  • In the case of imported special cosmetics registration, the RP shall submit paper documents to the NMPA acceptance center after submitting the electronic registration documents. The format review will be conducted after receiving both the electronic and paper documents.

  • In the case of imported general cosmetics notification, the RP shall submit paper documents to the notification administration department before the public of the notification information.

Step 5: Review, Approval, and Certificate Issuance

The main procedures for registering special cosmetics and notifying general cosmetics are very similar, both requiring the authorization of a China RP, the opening of user permissions on the new platform, product testing, and the submission of necessary registration and notification dossiers. But there are some differences in the last step.

  • For general cosmetics: the notification is deemed to be completed after submitting all the necessary dossiers, which means that the RP could start product import and sales in China so long as submitting the qualified dossier online. The notification information will be regulated during the post-market supervision and inspection.

    The product notification information will be published uniformly on the NMPA government website within five working days upon receiving the notification documents. The new platform will automatically generate an electronic version of the notification information voucher, and the RP may download and print it by himself. The notification of the product is permanently valid, but the notifier needs to report product manufacture and import information annually.

  • For special cosmetics: it takes five working days for NMPA's Acceptance Institute to perform the format review on all application documents from the date of receiving the application, 90 working days for NMPA's Technical Review Institute to organize the technical review, 20 working days for the NMPA to approve the registration and ten working days for the Acceptance Institute to issue a cosmetic registration certificate. Under the new regulations, the registration certificate for special cosmetics is valid for five years.

    There are three possible results of technical review:

  1. Approval;

  2. Disapproval;

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

3.2 Duration and Cost

The duration and cost of the whole registration and notification depend on the category and property of cosmetic products. In general, it takes 3-6 months for general cosmetics to be notified and over ten months for special cosmetics to be registered. Products such as sunscreen, freckle-removing and whitening, anti-hair loss, etc., require more time because additional efficacy tests are required.

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

If you want to know more details, please contact us at contact@chemlinked.com.

3.3 Dossiers Necessary for Notification/Registration

Type

Required Dossiers

Account Application and User Permission Opening 

(Step 2)

  1. Registrant and notifier information form and resume of the person in charge of quality and safety

  2. Quality management system overview of registrants and notifiers

  3. Adverse reaction monitoring and evaluation system overview form of registrants and notifiers

  4. Domestic responsible person information form (applicable to overseas registrants and notifiers)

  5. The original authorization letter of the domestic responsible person and its original notarial certificate


  • Production enterprise information form and the information of the person in charge of quality and safety (applicable to registrants and notifiers who have self-production or entrust overseas production enterprises to produce)

  • The original certification documents of overseas manufacturing practices (applicable to overseas production enterprises)

Registration and Notification Application (Step 4)

  1. Cosmetics registration and notification information form and related documents (classification code)

  2. Product name information

  3. Product formula (ingredient submission code)

  4. Product executive standards

  5. Product label sample manuscript

  6. Product testing report

  7. Product safety assessment documents


  • Certification documents that the product has been sold in the market in the producing country (region) and the certification documents proving that the overseas production enterprise comply with the cosmetics production quality management standard (applicable to the imported cosmetics registered or notified for the first time)

  • Relevant documents of research and testing carried out based on Chinese consumers (applicable to products specially designed for the China market without the supporting documents that the product has been sold in the market in the producing country (region))

3.4 Safety Assessment

Safety assessment is a newly introduced mandatory pre-market requirement under China’s new cosmetic regulations. Starting from January 1, 2022, cosmetic registrants and notifiers are required to conduct safety assessments on their own or entrust professional institutions and submit the product safety assessment documents during registration and notification.

To assist companies with safety assessment, China has issued the Technical Guidelines for Cosmetic Safety Assessment (“Technical Guidelines”), which clarifies the requirements for conducting safety assessment on cosmetic ingredients and finished products, qualification requirements for safety assessors, and content necessary in the assessment report, and attach corresponding samples.

3.4.1 Safety Assessment of Cosmetic Ingredients

The safety of ingredients is the precondition of the safety of cosmetic products. Risk assessment of cosmetic ingredients includes assessment of ingredients themselves and of the risk substances that may be brought in.

Safety assessment reports of cosmetic ingredients usually include the abstract, physicochemical properties of ingredients, assessment process, assessment result analysis, risk control measures or suggestions, safety assessment conclusions, signatures and resumes of safety assessors, references and appendices, etc.

3.4.2 Safety Assessment of Cosmetic Products

Cosmetic product safety assessment should be based on the assessment of all the ingredients and possible risk substances. If there are chemical or biological interactions between certain ingredients, the risk substances or potential safety risks arising from the interactions should also be assessed.

Safety assessment reports of cosmetic products usually include the abstract, product brief introduction, product formula, formula design principles (only for children cosmetics), safety assessment of each ingredient in the formula, assessment of possible risk substances, risk control measures or suggestions, safety assessment conclusions, signatures and resumes of safety assessors, references and appendices, etc.

3.4.3 Recognized Evidence for Simplified Safety Assessment Report

Considering that there is a gap between the safety assessment capacity of China's cosmetic industry and that of the developed countries, NMPA introduced transitional measures. Cosmetic registrants and notifiers are allowed to submit a simplified version of the product safety assessment report before May 1, 2024.

Notably, the content of the simplified report is similar to the full report, but the simplified report does not need to clarify the percentages of all the ingredients, nor does it require product stability testing, packaging material compatibility, or preservative challenge testing. In addition, the simplified report can adopt one of the following four pieces of evidence in sequence to prove the safety of each ingredient in the formula.

  1. The limitation in Cosmetic Safety and Technical Standards for Cosmetics (STSC),

  2. Safety limits or conclusions published by domestic or foreign authoritative organizations,

  3. The highest use concentration in the company,

  4. The highest historical use concentration specified in IECIC 2021.

3.4.4 Safety Assessors

The safety assessment work of cosmetics shall be carried out by qualified safety assessors per the provisions of Technical Guidelines, with an assessment report issued. Resumes of assessors shall also be attached to the assessment report, including the assessors' educational experiences, cosmetics-related working experiences, professional training experiences, etc.

The specific qualification requirements for the safety assessors are as follows:

  1. Have professional knowledge of cosmetics quality and safety such as medicine, pharmacy, biology, chemistry, or toxicology, etc., understand the cosmetic or ingredient production process and quality and safety control requirements, and have more than five years of relevant professional working experience;

  2. Be able to consult and analyze chemistry, toxicology, and other related literature information, analyze, assess, and interpret relevant data;

  3. Be able to analyze cosmetics' safety fairly and objectively and conduct safety assessments based on a comprehensive analysis of all available data and exposure conditions, and be responsible for the scientificity, accuracy, authenticity, and reliability of the assessment report;

  4. Be able to receive corresponding professional training regularly, learn relevant safety assessment knowledge, understand and master new safety assessment theories, techniques and methods, and use them in practice.

3.5 Efficacy Claim Evaluation

Another new requirement presented by China’s new cosmetic regulations is the efficacy claim evaluation of cosmetics, which refers to the verification of cosmetic efficacy claims through various methods such as biochemistry, cell biology, and clinical evaluation. Pursuant to CSAR and the Standards for Cosmetic Efficacy Claim Evaluation (“Evaluation Standards”), the efficacy claims of cosmetics shall be supported by sufficient scientific basis, which includes literature documents, research data, or test reports of efficacy evaluation test (including human trial, consumer use test and laboratory test).

Starting from January 1, 2022, cosmetic registrants and notifiers shall complete the efficacy evaluation by themselves or entrusting an evaluation institution with corresponding capabilities, and disclose the abstract of efficacy evaluation basis on the special website designated by NMPA for public view at the time of registration and notification.

3.5.1 Efficacy Claims Requiring Evaluation

At present, there are a total of 20 kinds of efficacy claims requiring evaluation, as listed below:

No.

Efficacy Claim

Human Trial

Consumer Use Test

Laboratory Test

Literature Documents/

Research Data

1

Freckle-removing and whitening




2

Sunscreen




3

Anti-hair loss




4

Acne-removing




5

Nourishing




6

Repairing




7

Anti-wrinkle

*

*

*

8

Tightening

*

*

*

9

Relieving

*

*

*

10

Oil-control

*

*

*

11

Exfoliating

*

*

*

12

Hair breakage prevention

*

*

*

13

Anti-dandruff

*

*

*

14

Moisturizing

*

*

*

*

15

Hair care

*

*

*

*

16

Specific claims (claiming suitable for sensitive skins, tear-free formula)

*

*



17

Specific claims (efficacy of an ingredient)

*

*

*

*

18

Claim gentle (no stimulation)

*

*

*

19

Claim quantitative index (time, statistics, etc.)

*

*

*

20

Claim new efficacy

The evaluation method should be selected according to the specific efficacy claim.

Notes:

1. √ means mandatory

2. * means optional, but it is a must to choose at least one of them.

3. △ means "can be combined," but it is necessary to conduct human trials, consumer use tests, or laboratory tests simultaneously.

Annotations:

① If the effect area of the efficacy claim is hair, real hair in vitro can be chosen for evaluation.

② It must be validated that the ingredient has the claimed efficacy, and the efficacy claim of the ingredient should be fully related to that of the cosmetic product.

It is worth noting that the following two types of efficacies can be exempted from disclosing the evaluation abstracts:

  • Efficacy claims that can be directly recognized by vision, smell, and other senses, such as cleansing, makeup-removing, beautifying and embellishing, perfuming, body refreshing, hair dyeing, hair perming, hair color maintaining, depilating, deodorizing, auxiliary shaving and barbering, etc.

  • Efficacy claims that function through the simple physical covering, maintaining, friction, etc., and are clearly indicated on the label to have physical effects only, such as freckle-removing and whitening by physical covering, physical exfoliating, physical removal of blackheads, etc.

(* New efficacies that meet any of the above criteria can also be exempted from submitting efficacy claim evaluation documents.)

Also, note that except for freckle-removing and whitening, sunscreen, anti-hair loss products, and products with new efficacy (those not subject to the exemption from the disclosure of evaluation abstracts) must be evaluated by NMPA-accredited labs in China using the evaluation methods specified in the mandatory national standards or technical norms, other products can be evaluated by international institutions. International efficacy evaluation test methods and reports are also accepted, but the test method text or test report should be translated into standard Chinese.

3.5.2 Evaluation Abstracts and Efficacy Evaluation Reports

Below are the necessary contents and submission requirements for efficacy evaluation abstracts and reports. Most efficacy reports can be kept by companies, but sunscreen, freckle-removing and whitening, and anti-hair loss products must submit the human efficacy evaluation reports to the review department.

Documents

Necessary Contents

Submission Requirements

Efficacy Evaluation Abstracts

  1. Product basic information

  2. Efficacy claim evaluation items and evaluation institution

  3. An overview of evaluation method and result

  4. Evaluation conclusion (shall describe the correlation among the efficacy claim, its evaluation method, and evaluation result)

  • The evaluation abstract of all efficacies must be uploaded to the NMPA designated website for disclosure;

  • Evaluation abstracts shall be archived for future inspection together with the efficacy evaluation basis. If the efficacy evaluation basis is in a foreign language, it shall be translated into standard Chinese. The product formula for the efficacy evaluation shall be consistent with that for cosmetic registration and notification, the documents proving the consistency shall be archived together with the efficacy evaluation basis.

Efficacy Evaluation Reports

  1. Name and address of the cosmetic registrant, notifier or RP, and other related information

  2. Name and address of the efficacy evaluation institution and other related information

  3. Product name, quantity and specification, production date or batch number, color and physical state, and other related information

  4. Test items and basis, test start and end dates, materials and methods, test results, test conclusion, and other related information

  • The human efficacy evaluation test report of sunscreen, freckle-removing (whitening), and anti-hair loss products must be submitted to the review department together with the registration documents;

  • The reports of other efficacies effects can be archived by companies for future inspection.

More information about efficacy claim evaluation can refer to CL News.

3.6 Cosmetic Labeling 

Cosmetics labels are subject to compliance review, whether during cosmetics registration and notification or the customs inspection. 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 Chinese ports due to substandard labels.

According to Administrative on Cosmetic Labeling, the following information shall be indicated on labels of the imported cosmetics:

  1. Product name and special cosmetic registration license number

  2. The name and address of registrant or notifier

  3. The name and address of the production enterprise

  4. The product executive standard number

  5. Full ingredients listing

  6. Net content

  7. Durability

  8. Application method

  9. Safety warnings

  10. Other content prescribed by laws, administrative regulations, and mandatory national standards

Two options are available for labeling the imported cosmetics. Companies can design the label and sales packaging specifically for the Chinese market in line with Chinese regulations or use the original package with a compliant Chinese sticker affixed. If a Chinese sticker is affixed, the contents related to product safety and efficacy claims on the Chinese sticker must be consistent with the relevant contents on the original labels.

3.7 Custom Inspection of Imported Cosmetics

After NMPA approves the registration or the RP submits notification dossiers, foreign firms can immediately start exporting cosmetic products to China. Distributors or importers in China need to apply for Custom inspection by submitting required documents. The inspection process includes the on-site inspection, label inspection sampling and retention, laboratory test, and the issuance of the certificate of Inspection and Quarantine of Imported Goods, which is the ultimate requirement for customs clearance. The specific inspection contents are:

  • For on-site inspection: Check the conformity of goods and corresponding certificates, product packaging, product sensory properties, sanitary conditions of transportation, containers, or storage places.

  • For label inspection: Check whether the label conforms to the relevant laws, administrative regulations, and the mandatory requirements of national technical standards, including layout format, quality, and safety-related content, etc.

  • For laboratory tests: Customs determine the testing items and requirements and send the samples to the relevant qualified testing institutions. The testing items include microorganism items, contaminant items, prohibited and restricted substances, etc.

3.8 Post-Market Obligation

Types

Follow-up Supervision

Registered Cosmetics

  • In case of renewal of product registration certificate, the application shall be proposed within 90 to 30 working days before the certificate's expiration.

  • Registration applicants shall cooperate with the on-site verification, and if sampling and testing are required, they shall provide samples as required.

  • After obtaining the registration certificate, the registrants shall upload the picture of the marketed product labels to the information service platform for public inquiry before the products are put on the market.

Notified Cosmetics

  • The name of the products may not be changed at will without proper reasons.

  • The efficacy claims may not be changed at will without sufficient scientific basis.

  • The product formula may not be changed at will, except for minor changes in the product formula due to changes in ingredient source and other reasons.

  • The validity period of the notification e-certificate is no longer set. Notifiers shall submit the annual report of general cosmetics notified over one year through the new platform from January 1 to March 31 of each year. The annual report may include the production and import conditions, compliance with laws and regulations, mandatory national standards, and technical specifications.

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.

2021

87972

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

Inventory 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.

2021

1393

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 animal testing requirement for cosmetics registration has been a long-standing controversy that makes the Chinese cosmetics regulatory framework incompatible with that of the 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 the EU if they are marketed in China, and the European companies that stick to "cruelty-free" status cannot enter the Chinese market. 

4.1 Animal Testing Exemption for General Cosmetics

Encouragingly on May 1, 2021, China officially removed the mandatory animal testing for general cosmetics, whether imported or manufactured in China. As per the Provisions for Management of Cosmetic Registration and Notification Dossiers, overseas cruelty-free brands can now tap into the Chinese cosmetic market without animal testing, provided the three preconditions and three exceptions are met. 

Two Preconditions

Three Exceptions

  • The product must be general cosmetics. Special cosmetics like sunscreens, hair dyes are still required to be animal tested.

  • A certificate of compliance to the good manufacturing practices (GMP) issued by the competent authority of the country of origin shall be provided.

  • The safety assessment results can fully confirm product safety.

The following three cosmetic categories are not allowed to be exempt from animal testing:

  • Infant and children cosmetics

  • Cosmetics using new ingredients during their 3-year monitoring period

  • Cosmetics whose notifier/RP/manufacturer is listed as a key supervision target by the NMPA 

4.2 Animal Testing Requirements for New Cosmetic Ingredients

China also took a step forward towards the end of animal testing for NCI application. According to the Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers, data from the animal testing alternative method for NCI registration and notification can be conditionally accepted.

If the animal testing alternative methods (not included in China’s STSC but validated by an international authoritative alternative method validation agency such as OECD, ICCR, ICCVAM, EURL-ECVAM, JaCVAM, etc.) are used for toxicological tests for NCI, the evidence proving that the method can accurately predict the toxicological endpoint should be submitted.

In addition, during the evaluation of NCI safety, appropriate Integrated Approaches to Testing and Assessment (IATA) should be selected according to the ingredient's structural characteristics and specific toxicological endpoints.

For more animal testing-related regulations, please refer to ChemLinked Pedia: China Cosmetic Animal Testing Regulation

Part 5 Cross-border E-commerce

In addition to the general trade that shall complete pre-market approval in advance and require strict compliance with cosmetic regulations, 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. 

Under the current regulatory regime, commodities imported via the CBEC channel shall be regulated as personal articles, exempt from customs import license and registration or notification requirements. 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. As a result, CBEC offers a fast track for overseas cruelty-free brands to try out the Chinese market.

For more CBEC related regulations, please refer to ChemLinked Pedia: China Cross-border E-commerce Regulation (CBEC).