Overseas cosmetic brands planning to sell products in mainland China through general trade must determine whether each SKU requires special cosmetics registration or general cosmetics filing before import, manufacturing, or market launch. Special cosmetics require registration approval, while imported general cosmetics must complete filing before import. Overseas registrants and filing persons also need a qualified Domestic Responsible Person in China.
REACH24H provides end-to-end China cosmetic compliance support for overseas brands, including product classification, Domestic Responsible Person arrangement, formula and ingredient review, testing coordination, safety assessment, efficacy claim substantiation, Chinese label review, dossier preparation, NMPA registration/filing submission, and post-market compliance maintenance.
What is China Cosmetic Registration and Filing/Notification?
China’s cosmetic regulatory framework is built on the Cosmetic Supervision and Administration Regulation (CSAR) and its supporting rules. CSAR was promulgated on June 29, 2020 and came into force on January 1, 2021.
Under China's CSAR framework, all cosmetic products imported or sold in mainland China must undergo a pre-market compliance procedure. The regulatory pathway is determined by the product classification, origin, claims, formula, target users, and sales channel.
China Cosmetic Registration (Special Cosmetics)
Including hair dyes, hair perming products, freckle-removing and whitening cosmetics, sunscreens, anti-hair loss products, and cosmetics claiming new efficacy. These products must obtain registration approval before production or import and are subject to registration testing, safety assessment, efficacy claim substantiation, technical review, and post-market compliance obligations.
China Cosmetic Notification / Filing (General Cosmetics)
Imported general cosmetics must complete filing before import, while domestic general cosmetics must complete filing before being placed on the market. Filing is not an approval process, but filed products remain subject to post-filing review, annual reporting, sampling inspections, adverse reaction monitoring, and other post-market obligations.
In industry practice, “filing” is sometimes referred to as “notification.”
Do You Need NMPA Registration or Filing Before Selling Cosmetics in China?
Companies should complete a China regulatory pathway assessment before collecting dossiers, arranging product testing, finalizing packaging, or confirming a launch date.
You should assess China cosmetics registration or filing requirements if your company plans to:
Import cosmetics into mainland China through general trade;
Manufacture cosmetics in China for domestic sale;
Launch skincare, makeup, cleansing products, perfumes, shampoos, conditioners, masks, or similar cosmetic products;
Register sunscreen, freckle-removing and whitening, anti-hair loss, hair dye, or hair perming products;
Sell children’s cosmetics in China;
Move products from cross-border e-commerce to general trade;
Change a product formula, label, manufacturer, brand owner, or Domestic Responsible Person;
Review whether a product is a cosmetic, drug, medical device, disinfection product, toothpaste, or another regulated product type in China.
Products Covered by China Cosmetic Registration and Filing/Notification
China cosmetic product registration and filing apply to cosmetics manufactured, imported, or sold in China through general trade.
Under China’s cosmetic regulatory framework, whether a product is a cosmetic depends not only on its product name, but also on its application area, route of use, intended purpose, product form, and label claims.
Common products that may fall under China cosmetic regulation include:
Skincare products, cleansers, masks, lotions, creams, serums, makeup, perfumes, shampoos, conditioners, and bath products;
Sunscreens, freckle-removing and whitening products, anti-hair loss products, hair dyes, and hair perming products;
Toothpaste, which is currently regulated with reference to general cosmetics requirements;
Beauty device gels, ampoules, oral care products, soaps, patches, and similar products, which require case-by-case classification based on use and claims.
Special cosmetics must obtain registration approval before production or import. Imported general cosmetics must complete filing before import, and domestic general cosmetics must complete filing before market launch.
Key Parties Responsible for China Cosmetic Registration and Filing
China cosmetic compliance involves several parties across the product responsibility chain.
Registrant or Notifier
The registrant or notifier is usually the brand owner or market authorization holder. It is responsible for product quality and safety, efficacy claims, dossier authenticity, dossier completeness, and traceability.
For imported cosmetics, and for products where the registrant or notifier is an overseas enterprise, the overseas registrant or notifier must designate a qualified enterprise legal person in China as the Domestic Responsible Person.
Domestic Responsible Person in China
The Domestic Responsible Person handles registration or filing matters on behalf of the overseas registrant or notifier and supports adverse reaction monitoring, product recall, regulatory communication, inspection response, and other post-market obligations.
Overseas brands should confirm the responsible person arrangement before starting the project, as unclear authorization, inconsistent company information, or an unsuitable responsible person may delay the submission.
Manufacturer
The manufacturer may be the brand’s own factory or an OEM/ODM manufacturer. It must provide production qualification documents, quality management documents, production information, and other required materials. The final product must be manufactured in accordance with the registered or notified dossier and product technical requirements.
Importer, Distributor, or Operator
Importers and distributors should verify product information, Chinese labeling, supply chain documents, purchase inspection records, sales channel compliance, and post-market cooperation responsibilities.
How to Choose a China Domestic Responsible Person
Overseas cosmetic registrants and filing persons must designate a qualified enterprise legal person in China as the Domestic Responsible Person. Choosing the right Domestic Responsible Person is important because it may affect dossier control, distributor independence, regulatory communication, and long-term compliance management.
Option | Advantages | Potential Concerns |
|---|---|---|
Own China subsidiary | Stronger internal control and direct regulatory ownership. | Requires local compliance capability, qualified personnel, and continuous maintenance. |
Chinese distributor | Convenient for early market entry and channel coordination. | May create dependency; distributor changes can affect dossier control and authorization management. |
Professional third-party regulatory agency | More independent from sales channels; supports professional submission and long-term maintenance. | Requires clear authorization, communication rules, and defined responsibilities. |
REACH24H can support overseas brands with Domestic Responsible Person arrangement, authorization review, submission coordination, dossier maintenance, and post-market compliance management.
Documents Required for China Cosmetic Registration and Filing
The required dossier depends on product type, origin, claims, formula, manufacturer, responsible person arrangement, and existing data. Common documents include:
Document Category | Typical Requirements | Common Gaps for Overseas Companies |
|---|---|---|
Company documents | Registrant/notifier information, domestic responsible person information, manufacturer information, quality and safety responsible person information | Inconsistent applicant, brand owner, manufacturer, and importer information |
Product name | Chinese product name, foreign product name, naming rationale | Chinese name implies medical effects or exaggerated efficacy |
Formula | Full formula, ingredient percentage, ingredient purpose, ingredient safety information, ingredient submission code where applicable | Incomplete compound ingredient data, missing supplier information, restricted substance risk |
Product technical requirements | Quality control indicators, test methods, product specifications | Inconsistency with formula, label, or test report |
Product label | Original sales packaging, Chinese label, instruction leaflet where applicable | Overclaiming, missing warnings, inconsistent responsible party information |
Test reports | Microbiological, physicochemical, toxicological, safety, and efficacy-related testing where applicable | Wrong testing items, inconsistent sample name, incomplete report scope |
Safety assessment | Product safety assessment report or supporting safety assessment documents | Insufficient toxicological data, weak exposure assessment, incomplete risk substance evaluation |
Efficacy claim substantiation | Evaluation basis and efficacy claim summary | Claims not supported by evaluation data or inconsistent with marketing copy |
Imported product documents | Certificate of free sale or market approval in the country/region of origin, GMP or quality management documents, authorization documents | Product name, manufacturer, applicant, or translation inconsistencies |
Before submission, REACH24H recommends conducting a dossier gap analysis covering classification, formula, label, testing, safety assessment, efficacy claims, import documents, and dossier consistency.
Step-by-Step NMPA Cosmetic Registration and Filing Process
General Cosmetics Filing / Notification Process
Product classification and regulatory pathway assessment
Confirmation of registrant/notifier, manufacturer, and domestic responsible person
Formula, ingredient safety information, and restricted substance review
Original packaging review
Chinese and foreign product name review
Testing item confirmation and sample testing
Review of production process, quality control, and claim substantiation documents
Dossier preparation
Safety assessment preparation
Online submission through the registration and filing platform
Completion of filing and market entry
Post-notification review, annual report, change management, and ongoing compliance maintenance
General cosmetics filing does not mean the product is free from future obligations. Companies must continue to manage annual reporting, post-notification review, product changes, label updates, adverse reaction monitoring, and regulatory inspections.
Special Cosmetics Registration Process
Special efficacy assessment and registration strategy
Formula, safety, efficacy, and label pre-review
Testing and efficacy claim substantiation plan
Registration dossier preparation and online submission
Formal review and technical review
Supplementary response and authority communication
Approval and issuance of the special cosmetics registration certificate
Certificate renewal, change management, and post-market compliance maintenance
Special cosmetics registration usually requires a longer lead time and more technical evidence. Sunscreen, whitening/spot-removing, anti-hair loss, hair dye, and hair perm products should be planned early due to testing, efficacy evaluation, safety assessment, and technical review requirements.
Timeline and Cost Drivers
The timeline and cost of China cosmetic registration or filing vary depending on product type, dossier readiness, testing requirements, efficacy claim evaluation, safety assessment complexity, label correction, and import document preparation.
Major factors include:
Product category: special cosmetics generally require more time and resources than general cosmetics.
Imported vs domestic products: imported products involve additional foreign documentation, translations, authorizations, and responsible person arrangements.
Efficacy claims: sunscreen, freckle-removing and whitening, anti-hair loss, anti-acne, repairing, and nourishing claims may require additional testing and evaluation.
Testing scope: dependent on dosage form, application area, target users, and claims.
Safety assessment difficulty: complex formulas and incomplete ingredient information can extend preparation time.
Label corrections: non-compliant labels may delay packaging production and dossier submission.
Ingredient safety information: missing submission codes or supplier documents may create dossier gaps.
Domestic responsible person arrangement and legacy product status: late or unclear arrangements, or changes in formula, label, or manufacturers, may require separate assessment and filing.
Submit your product name, formula, label, claims, and origin to receive a preliminary assessment of timeline and budget for your China cosmetic project.
Post-Market Compliance Obligations After Registration or Filing
China cosmetic compliance does not end after filing completion or registration approval.
Companies must continue to manage:
Annual reporting for general cosmetics;
Renewal of special cosmetics registration certificates;
Change management for formula, label, manufacturer, responsible person, and other product information;
Maintenance of efficacy claim substantiation documents;
Updates to safety assessment documents;
Adverse reaction monitoring and reporting;
Response to post-filing review, inspections, and sampling tests;
Product discontinuation, cancellation, re-filing, or re-registration assessment;
Import authorization and certificate management.
REACH24H provides long-term compliance maintenance for registered and filed cosmetic products in China.
How REACH24H Can Support
REACH24H provides full-process support for overseas and domestic cosmetic companies entering the China market.
Product classification and market access assessment;
Imported cosmetics registration and filing;
Domestic cosmetics registration and filing;
Domestic Responsible Person support;
Formula and ingredient compliance review;
Ingredient safety information and submission code review;
Original packaging review;
Chinese label review;
Testing coordination;
Safety assessment report preparation or review;
Efficacy claim evaluation;
Registration and filing dossier preparation;
Online submission and authority communication;
Supplementary response support;
Annual reporting, renewal, change management, cancellation, and post-market compliance maintenance.
Why Choose REACH24H?
REACH24H helps cosmetic companies navigate China’s evolving cosmetic regulatory framework with practical market-entry strategies and technical compliance support.
global branches
Specialists
enterprises served
certified toxicologists
Global Service Network
With 9 global branches and over 300 in-house specialists, we have served over 15,000 enterprises including 103 Fortune Global 500 firms, delivering prompt cross-border regulatory support.
Decades of Cosmetic Compliance Expertise
Backed by long-standing compliance experience and expert resources, we customize full-spectrum solutions covering regulatory planning and cosmetic safety evaluation. Recognized by top brands, Fortune 500 enterprises and industrial associations, we help clients resolve compliance hurdles and smoothly access global cosmetic markets.
Globally Accredited Toxicology Experts
We have a team with over 20 certified toxicologists holding China Toxicologist, US DABT and EU ERT credentials to underpin cosmetic safety assessment and registration submission.
FAQ
Official Regulatory Resources for China Cosmetic Compliance
For companies seeking official references, the following resources are useful starting points:
Provisions for Supervision and Administration of Manufacturing and Marketing of Cosmetics
NMPA Announcement on Several Measures to Optimize the Management of Cosmetic Safety Assessment
Related REACH24H Services and Insights
For further support, companies can refer to the following REACH24H resources:
