China Cosmetics Registration and Notification Guidance

Background Introduction

On June 29, 2020, the State Council of China officially promulgated the Cosmetics Supervision and Administration Regulation (CSAR, State Council Order No. 727), which came into effect on January 1, 2021. The introduction of this regulation marks a new era in China's cosmetics regulatory system, establishing a modernized management framework centered on safety and scientific supervision.

As the core regulation governing the cosmetics industry in China, CSAR introduces comprehensive and systematic reforms in various aspects, including product classification, registration and notification requirements, manufacturing and operational management, ingredient management, efficacy claims, labeling, supervision and inspection, and legal liabilities. The new regulation strengthens the primary responsibility of enterprises, requiring cosmetics registrants, notifiers, and manufacturers to establish and maintain robust product quality and safety management systems to ensure product safety and regulatory compliance. Additionally, CSAR incorporates risk management principles, introduces an ingredient safety assessment system, and imposes stricter scientific validation requirements for efficacy claims, thereby enhancing consumer protection.

Under the CSAR framework, the National Medical Products Administration (NMPA) has successively issued a series of supporting regulations and technical guidelines, including the Cosmetic Classification Rules and Classification Catalog, the Measures for the Administration of Cosmetic Registration and Filing, the Measures for Administration of Cosmetics Labeling, the Standards for the Evaluation of Cosmetics Efficacy Claims, and the Provisions on the Management of Cosmetic Registration and Filing Data, among others. These regulations further refine regulatory requirements to ensure the effective implementation of CSAR. The introduction of these regulations not only raises the market entry threshold for the cosmetics industry but also promotes a more scientific, transparent, and internationally aligned regulatory environment.

This guidance document aims to help cosmetics enterprises gain a comprehensive understanding of and strictly comply with CSAR and its supporting regulations, ensuring regulatory compliance and product safety in the Chinese market. Additionally, it seeks to mitigate compliance risks, enhance market competitiveness, and drive the industry's healthy and sustainable development.

Definition of Cosmetics

"Cosmetics refer to daily chemical industrial products that are applied to the surface of the human body—such as the skin, hair, nails, and lips—by rubbing, spraying, or similar methods, with the purposes of cleansing, protecting, beautifying, or enhancing appearance."

— (Chapter 1, Article 3 of the Cosmetics Supervision and Administration Regulation, CSAR)

Classification of Cosmetics

Cosmetics are classified into special cosmetics and ordinary cosmetics. The state implements a registration-based management system for special cosmetics and a notification-based management system for general cosmetics. (Chapter 1, Article 4 of the Cosmetics Supervision and Administration Regulation, CSAR)

• Special cosmetics include products for hair dye, hair perm, anti-freckle and whitening, sunscreen, and anti-hair loss, as well as cosmetics claiming new efficacy.
• Ordinary cosmetics refer to all cosmetics other than special cosmetics.

• Soap is not regulated under CSAR. However, if a soap product claims any special cosmetic efficacy, it falls under the scope of CSAR. (Chapter 6, Article 77 of CSAR)
• Cosmetic products for hair growth, hair removal, breast enhancement, body slimming, and deodorization are subject to a five-year transition period from the implementation date of CSAR. During this period, such products can continue to be manufactured, imported, and sold. However, after the transition period expires, their production, import, and sale will be prohibited. (Chapter 6, Article 78 of CSAR)

Regulatory Authorities for Cosmetics in China

China's cosmetics industry is regulated by the following key authorities.

• National Medical Products Administration (NMPA) is responsible for formulating policy, regulations and standards, pre-market approval, post-market risk management, sampling, flight check, etc.
• National Institutes for Food and Drug Control (NIFDC), the directly affiliated unit of NMPA which is responsible for formulating technical standards/testing methods, undertaking the technical review work of pre-market registration, etc.
• Local Medical Products Administrations (Local MPAs) are responsible for pre-market filing, undertaking the administrative licensing of production, sampling, carrying out adverse reaction monitoring, evaluation and disposal, etc.
• State/Local Administration for Market Regulation (State/Local AMR) is responsible for comprehensive market supervision and management, unified registration of market entities, supervise and manage market order, etc.
• National Center for Adverse Drug Reaction Monitoring (NCADRM) is responsible for adverse reaction monitoring and post-marketing safety evaluation, formulating related technical standards, etc.

Requirements for Cosmetics Market Entry in China (General Trade)

Cosmetics entering the Chinese market mainly follow two channels: general trade and online channels. The regulatory requirements and approval process for the general trade channel are detailed below.

1. Cosmetics Market Entry Process

Cosmetics are classified into special cosmetics and ordinary cosmetics. Special cosmetics are subject to registration management, while ordinary cosmetics are subject to notification management. Different product categories follow different approval processes.

2. Responsibilities and Qualification Requirements for Cosmetic Registrants, Notifiers, and Domestic Responsible Persons

2.1 Registrant/Notifier

Registrant/Notifier: Refers to an entity that has obtained a special cosmetics registration certificate or has completed cosmetic notification. The registrant/notifier places the product on the market under its own name and is responsible for the quality, safety, and efficacy claims of the product throughout its entire lifecycle.

Requirements:

• A legally established enterprise or other organization;
• A quality management system appropriate for the registered or notified product;
• The capability to monitor and evaluate adverse reactions of cosmetics.

Cosmetic registrants, filing parties, and entrusted manufacturing enterprises shall set up quality and safety control persons with the professional knowledge related to the quality and safety of cosmetics and more than 5 years of experience in cosmetic production or quality and safety management.

2.2 Domestic Responsible Person (DRP)

If the registrant/notifier is located outside China, they must designate a Chinese enterprise legal entity as the Domestic Responsible Person (DRP).

Obligations:

• Handle cosmetic registration and notification on behalf of the registrant/notifier;
• Assist the registrant/notifier in cosmetic adverse reaction monitoring;
• Assist the registrant/notifier in cosmetic recall procedures;
• Assume corresponding quality and safety responsibilities for cosmetics placed on the Chinese market, in accordance with the agreement with the registrant/notifier;
• Cooperate with the drug regulatory authorities in supervision and inspection activities.

3. Documentation Requirements for Cosmetics Registration and Filing

3.1 Overview of Cosmetic Registration and Filing Documentation

According to the Provisions on the Management of Cosmetic Registration and Filing Data, when applying for registration or filing, the registrant or filer shall submit the following documents:

• Cosmetic Registration and Filing Information Form and related materials: product name, company information, classification code, proof of market availability, etc.
• Product name information
• Product formula
• Product Implementation Standards
• Product label mock-up
• Product testing report
• Product safety assessment documentation

In accordance with the Cosmetic Supervision and Administration Regulation (CSAR) and its supporting regulations, starting from January 1, 2022, all general and special cosmetics sold in the Chinese market with efficacy claims (such as "whitening," "moisturizing," "anti-wrinkle," etc.) must provide a summary of the basis for the efficacy claim. This summary must be uploaded to the designated website of the National Medical Products Administration (NMPA) for public access.

3.2 Product Formula

The product formula includes the ingredient serial number, ingredient name, percentage content, intended use, trade name, ingredient manufacturer, and ingredient safety information.

Key Points:

• Safety Information for Ingredient: The registrant/filer must provide the ingredient manufacturer’s information and upload the the safety documentation issued by the manufacturer. Alternatively, the registrant/filer may provide the submission code to link the ingredient safety information file.
• Submission Code Application: The application process follows the requirements outlined in the Guidelines for the Submission of Safety-Related Information on Cosmetic Ingredients. The submission must be completed through the ingredient safety information service platform of the National Medical Products Administration (NMPA).

3.3 Product Implementation Standards

The product implementation standards include product name, full ingredient list, manufacturing process, sensory indicators, microbiological and physicochemical indicators and quality control measures, usage instructions, storage conditions, and shelf life, etc.

3.4 Product Inspection Report

The product inspection report for registered or filed cosmetic products shall be issued by a cosmetic registration and filing inspection institution in accordance with the relevant regulations, including the Safety and Technical Standards for Cosmetics and the Inspection Work Standards for the Registration and Filing of Cosmetics.

3.4.1 Contents of the Product Inspection Report

The product inspection report includes:

• Microbiological and physicochemical testing
• Toxicological testing
• Human safety testing report
• Human efficacy testing report

3.4.2 Exemption from Submitting a Toxicological Testing Report

For ordinary cosmetics, if the manufacturing enterprise has obtained quality management system certification issued by the competent authority of its country (or region), and the product safety risk assessment can fully confirm the product’s safety, submission of a toxicological testing report may be exempted, except in the following cases:

• The product is claimed for use by infants and children.
• The product contains new cosmetic ingredients under safety monitoring.
• The registrant, domestic responsible person, or manufacturer has been classified as a key regulatory target based on the quantitative grading and scoring system.

If a product is manufactured by multiple production enterprises, all manufacturing enterprises must have obtained quality management system certification issued by the competent authority of their respective country (or region) to qualify for the exemption from submitting a toxicological testing report.

3.5 Safety Assessment

Before the registration or filing of a cosmetic product, the registration applicant or filer shall conduct a safety assessment either independently or by entrusting a professional institution. Personnel engaged in safety assessment must possess professional knowledge related to cosmetic quality and safety and have at least five years of relevant industry experience.

Starting from May 1, 2025, when applying for cosmetic product registration or filing, registrants and filers must submit a complete safety assessment report that complies with the Technical Guidelines for Cosmetics Safety Assessment (2021 Edition) and other relevant regulations.

4. Requirements for Cosmetics Registration and Filing Tests

According to the the Cosmetics Supervision and Administration Regulations and the Provisions on the Management of Cosmetic Registration and Filing Data, cosmetics must undergo relevant testing during registration or filing to ensure product safety and the truthfulness of efficacy claims.

4.1 Safety Testing

As stipulated in the Inspection Work Standards for the Registration and Filing of Cosmetics, all registered or filed cosmetics must undergo safety testing to ensure that the product does not pose risks to human health.

Safety testing includes: physicochemical index testing, icrobiological testing, toxicological testing (certain general cosmetics may be exempted from toxicological testing under specific conditions).

4.2 Efficacy Evaluation Testing (Based on Efficacy Claims)

According to the Standards for the Evaluation of Cosmetics Efficacy Claims, when applying for cosmetic registration or filing, if the product makes specific efficacy claims (such as whitening, anti-wrinkle, moisturizing, sun protection, etc.), the company must provide supporting evidence for the claim. Additionally, a summary of the supporting evidence must be uploaded to the designated website of the National Medical Products Administration (NMPA) for public inquiry and regulatory review.

Claims that can be directly identified through visual, olfactory, or other sensory perception (such as cleansing, makeup removal, beauty modification, fragrance, refreshing, hair dyeing, perming, hair color care, hair removal, deodorization, and shaving or hair removal assistance), or those that achieve effects through simple physical coverage, adhesion, or friction (such as physical coverage for spot removal and whitening, physical exfoliation, and physical blackhead removal), and are explicitly labeled as having only physical effects on the product packaging, are exempt from the requirement to publish a summary of the supporting evidence for efficacy claims.

Explanation:

• A checkmark (√) in the options column indicates a mandatory item.
• An asterisk (*) in the options column indicates an optional item, but at least one must be selected.
• A triangle (△) in the options column indicates a complementary item, which must be used in conjunction with human efficacy evaluation tests, consumer use tests, or laboratory tests.

Notes:

① If the spot-lightening and whitening efficacy is achieved solely through physical coverage, and this is explicitly stated on the label as a physical effect, submission of product efficacy claim evaluation data may be exempted.

②If the claimed efficacy applies only to hair, evaluation may be conducted using in vitro tests on real hair.

Key Analysis:

Microbiological testing, physicochemical testing, toxicological testing, human safety testing, and efficacy tests for special claims (such as sunscreen, spot-lightening and whitening, anti-hair loss, and new efficacy claims) must be conducted at registered and accredited cosmetic testing institutions in China for cosmetic registration and filing purposes.

5. Requirements for Cosmetics Registration and Filing Labels

On May 31, 2021, the National Medical Products Administration (NMPA) issued the Announcement on the Measures for Administration of Cosmetics Labeling (2021 No. 77). The announcement encourages cosmetic registrants and filers to comply with the Measures for cosmetic labeling from the date of its release.

Starting from May 1, 2022, all cosmetics applying for registration or filing must comply with the provisions and requirements of the Measures. For cosmetics that were registered or filed before this date but have not yet been labeled in accordance with the Measures, the registrants or filers must update the product labels by May 1, 2023, to ensure compliance with the Measures.

5.1 Definition of Cosmetic Labels

A cosmetic label refers to the text, symbols, numbers, patterns, and other markings on the product's sales packaging that identify and describe the product's basic information, attributes, and safety warnings. It also includes packaging containers, boxes, and instruction manuals that contain labeling information. The cosmetic registrant or filer is responsible for ensuring the legality, authenticity, completeness, accuracy, and consistency of the cosmetic label.

Key Points to Note:

• The smallest sales unit of a cosmetic product should have a label.
• In addition to text, symbols, numbers, and patterns on the label are also considered part of the cosmetic label. If other languages or symbols are used, a standard Chinese explanation must be provided on the visible surface of the product's sales packaging.

5.2 Mandatory Labeling Information

Cosmetic labels must include the following information:

(1) Product Chinese Name and Special Cosmetic Registration Certificate Number

(2) Name and Address of the Registrant/Filer

If the registrant or filer is a foreign company, the name and address of the domestic responsible person must also be indicated.

(3) Name and Address of the Manufacturer

For domestically produced cosmetics, the manufacturer’s production license number must also be included.

(4) Product Standard Number

(5) Full Ingredient List

The visible surface of the sales packaging must display the Chinese standard names of all ingredients. The ingredient list should be introduced with the term "成分" (Ingredients). Ingredients must be listed in descending order of concentration in the formulation. If an ingredient is present at a concentration of 0.1% (w/w) or lower, all such ingredients should be grouped under “其他微量成分” (Other Trace Ingredients) and listed separately, without the requirement to follow the descending order rule.

Note: The category "Other Trace Ingredients" includes ingredients present at exactly 0.1% (w/w).

(6) Net Content

(7) Expiry Date

There are two acceptable formats for indicating the product's usage period:

• Format 1: Production Date + Shelf Life
• Format 2: Batch Number + Expiry Date

① For products with an outer packaging box, when the expiry date is labeled on the direct-contact packaging container, in addition to the aforementioned labeling formats, it is also permissible to indicate the batch number and the period after opening (PAO) directly.

② For products with an outer packaging box, the Chinese product name and expiry date must also be labeled on the direct-contact packaging container.

(8) Directions for Use

(9) Necessary Safety Warning Statements

(10) Other Information Required by Laws, Administrative Regulations, and Mandatory National Standards

For cosmetics with an affixed Chinese label (e.g., imported cosmetics at the time of market entry), the Chinese label content related to product safety and efficacy claims must correspond to the relevant content on the original label. This means that the safety and efficacy claims made for the product in China must be consistent with those in the country of origin.

6. Cosmetics Registration and Filing Timeline

6.1 Cosmetics Registration and Filing Process

According to the Measures for the Administration of Cosmetic Registration and Filing, the National Medical Products Administration (NMPA) implements a registration management system for special cosmetics and a filing management system for ordinary cosmetics.

Special Cosmetics

Ordinary Cosmetics

Note: The validity period of the special cosmetics registration certificate is five years and should be renewed before expiration. The filer of ordinary cosmetics shall report the production and import status annually to the drug regulatory authority responsible for filing management.

6.2 Cosmetics Registration and Filing Timeline

*The actual timeline depends on the specific product type, testing requirements, and the collection of various supporting documents.

7. Cosmetics Registration and Filing Modification & Renewal

7.1 Modification of Cosmetics Registration and Filing

According to the Provisions on the Management of Cosmetic Registration and Filing Data, if there is any change in the registration items of a registered product, the corresponding documents should be submitted before the modified product is manufactured or imported. The modification should be completed before the product can be produced or imported.

For a filed product, if there is any change in the filing items, the corresponding documents should be submitted before the modified product is marketed or imported. The modification should be completed before the product can be marketed or imported. Products that have already been manufactured, marketed, or imported before the modification may continue to be sold until the end of their shelf life.

The types of modifications involved include:

• Changes in the name or address of the registrant, filer, domestic responsible person, or manufacturer (provided that the production site remains unchanged)
• Change in the product name of a registered or filed product
• Change in production site
• Change in the manufacturer or quality specifications of raw materials used in a registered or filed product
• Change in product implementation standards
• Change in product label artwork
• Change in the content of product safety assessment documents
• Change in product classification
• Change in registrant
• Change in domestic responsible person

For changes involving other matters, an explanation of the proposed modification should be submitted, along with relevant supporting documents as required based on the specific circumstances.

7.2 Renewal of Cosmetics Registration and Filing

According to the Measures for the Administration of Cosmetic Registration and Filing, if the registration certificate of a special cosmetics product is about to expire and needs to be renewed, the registrant must submit a renewal application within 90 to 30 working days before the certificate expires. The registrant should also commit to complying with mandatory national standards and technical regulations. The registrant is responsible for the authenticity and legality of the submitted documents and commitments. If the renewal application is not submitted within the specified period, it will not be accepted.

According to the Provisions on the Management of Cosmetic Registration and Filing Data, the following documents should be submitted for the renewal of a special cosmetics registration certificate:

• Registration renewal application form
• Product self-inspection statement
• Corresponding product inspection report to be submitted based on current regulatory and standard adjustments

8. Post-Market Supervision Requirements for Cosmetics

After registration or filing and market launch, cosmetics remain subject to continuous supervision by the National Medical Products Administration (NMPA) and local regulatory authorities to ensure product safety, efficacy authenticity, and compliance.

Starting from January 1, 2022, a unified annual reporting system has been implemented for ordianry cosmetics. The filer should submit the annual report for general cosmetics that have been on record for one year through the registration and filing platform between January 1 and March 31 each year.

8.1 Product Quality and Safety Supervision

In accordance with the Cosmetics Supervision and Administration Regulation, the Measures for the Cosmetics Supervision and Administration Regulations, the Measures for the Supervision and Administration of Cosmetics Production and Operation, and the Safety and Technical Standards for Cosmetics, regulatory authorities conduct regular random sampling inspections of cosmetics on the market to ensure compliance with national standards.

8.2 Adverse Reaction Monitoring

In accordance with the Measures for the Administration of Cosmetics Adverse Reaction Monitoring, a cosmetics adverse reaction monitoring system has been established to collect consumer feedback. The National Medical Products Administration (NMPA) regularly publishes cosmetics adverse reaction monitoring reports. If a product poses a serious safety risk, the enterprise may be required to recall or suspend sales of the product.

Cosmetics registrants and filers shall monitor adverse reactions of their marketed cosmetics, conduct timely evaluations, and report to the cosmetics adverse reaction monitoring institution in accordance with the regulations of the State Drug Regulatory Authority. Entrusted manufacturing enterprises, cosmetics operators, and medical institutions shall report to the cosmetics adverse reaction monitoring institution if they identify any suspected adverse reactions related to the use of cosmetics.

Requirements for Marketing Cosmetics in the Chinese Market (Online Channels)

In the Chinese market, cosmetics can also be marketed and sold through online channels. The main online channels include domestic E-Commerce platforms and Cross-Border E-Commerce (CBEC).

1. Regulatory Requirements for Sales on Domestic E-commerce Platforms

This applies to domestically produced or imported cosmetics that have completed registration or filing and are sold through domestic e-commerce platforms. E-commerce platforms are required to review merchants' qualifications to ensure that all listed products have completed the necessary registration or filing. Platforms must establish complaint and reporting mechanisms and cooperate with regulatory authorities in handling non-compliant products. Additionally, products should carry Chinese labels and comply with the Measures for Administration of Cosmetics Labeling, with false advertising strictly prohibited.

2. Regulatory Requirements for Sales on Cross-Border E-Commerce (CBEC)

This applies to imported cosmetics that have not been registered or filed in mainland China. These products enter the Chinese market through the cross-border e-commerce retail import model, where consumers place orders on CBEC platforms, and products are delivered via bonded warehouse shipment or direct mail from overseas.

The CBEC model provides a fast-track entry for overseas cosmetics by simplifying filing and inspection procedures. However, it is subject to restrictions, such as the "Positive List" (which specifies permissible product categories) and designated sales channels.

2.1 Cosmetic Entry Requirements

Compared with the general trade model, where all imported cosmetics should complete registration or filing with the National Medical Products Administration (NMPA), cosmetics imported through cross-border e-commerce (CBEC) do not require domestic registration or filing. However, they should comply with China’s "Positive List" (Cross-Border E-Commerce Retail Import Goods List) and ingredient safety requirements.

• According to the Notice on Improving the Regulation of Cross-Border E-Commerce Retail Imports issued by the Department of Finance, Ministry of Commerce, CBEC retail imports are regulated as "for personal use", meaning they are exempt from first-time import licensing, registration, or filing requirements. However, they must be included in the Positive List.
• China’s Cross-Border E-Commerce Retail Import Goods List (Positive List): Only cosmetics listed in this Positive List are permitted for import via CBEC.

2.2 Labeling Requirements

Product labels should comply with the Cosmetics Supervision and Administration Regulations and the Measures for Administration of Cosmetics Labeling, ensuring that labeling information is truthful, complete, and standardized. For cosmetics sold online, the labeling should also comply with the E-Commerce Law, ensuring that the product information displayed on the platform is consistent with the registered or filed information.

2.3 "Personal Use" Restrictions for Consumers

Cosmetics purchased through CBEC are strictly for personal use and cannot be resold. Buyers should undergo real-name authentication when making purchases. Purchases should comply with the annual personal purchase limit for CBEC, which is RMB 26,000 per person.

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