China Cosmetics Regulation: NMPA Filing, Dossier, and Labels

To sell a cosmetic product in mainland China, a foreign brand must work through the China cosmetics regulation framework known as the CSAR and complete either NMPA notification or NMPA registration before the product reaches shelves. The correct path depends on what the product does: everyday items go through a faster notification, while higher-risk products go through full registration with expert review. Either way, a foreign company cannot file directly. It must appoint a Chinese-based Domestic Responsible Person, assemble a detailed safety dossier, and keep meeting obligations long after the product is approved.

The Cosmetics Supervision and Administration Regulation took effect on January 1, 2021 and, together with its implementing rules, governs every cosmetic sold in China.

General Cosmetics or Special Cosmetics

Category drives everything else. General cosmetics cover everyday items like shampoos, lotions, lipsticks, and fragrances. They go through a streamlined notification and can reach the market relatively quickly.¹

Special cosmetics face far more scrutiny. This category covers hair dyes, perming products, skin-whitening and freckle-removal products, sunscreens, anti-hair-loss treatments, and any product claiming a function the NMPA has not previously recognized. Special cosmetics require full registration, with expert review panels and potentially additional rounds of testing before approval.¹

Filing a special cosmetic as a general one does not just get rejected. It can flag the company for heightened scrutiny on later submissions. When the classification is unclear, the safer assumption is the stricter category.

Appointing a Domestic Responsible Person

Foreign companies cannot interact with the NMPA directly. They must appoint a Domestic Responsible Person, a legally established business entity in China whose business license covers cosmetic sales. The role is not passive. The Domestic Responsible Person shares legal liability with the foreign company for every product they represent.

Their responsibilities span the full lifecycle: managing the NMPA account, preparing and submitting dossiers, coordinating sample imports for testing, drafting compliant Chinese labels, and handling post-market adverse reaction monitoring and recalls. They also submit annual reports and respond to inquiries from national and provincial regulators.²

Choosing carefully matters. If the Domestic Responsible Person is listed as a key supervision target by the NMPA, meaning they have a poor compliance record or open investigations, products filed through them lose eligibility for regulatory benefits, including the animal testing exemption. Vet a potential partner’s regulatory history as closely as their service capabilities.

Building the Registration Dossier

Whether the product goes through notification or full registration, the dossier must cover composition, manufacturing process, and safety. Every ingredient is checked against the Inventory of Existing Cosmetic Ingredients in China. Any ingredient not on the Inventory is automatically classified as a new cosmetic ingredient and triggers a separate approval process before it can be used in a finished product.³

The product safety assessment report sits at the center of the dossier. Recent reforms let some lower-risk general cosmetics submit a condensed version with basic conclusions while keeping the full report on file internally. Higher-risk products, including children’s cosmetics and skin-whitening products, still require a complete safety assessment submitted directly to the regulator.⁴

The dossier also requires raw material safety data, a description of the manufacturing process, and, for special cosmetics, toxicological testing covering skin irritation, eye irritation, and systemic toxicity. A misreported ingredient percentage or an undocumented manufacturing change can send the whole dossier back to the start.

Animal Testing Exemption

Since May 2021, imported general cosmetics can qualify for exemption from mandatory animal testing. Three conditions must all be met: the product must be a general cosmetic, the manufacturer must hold a Good Manufacturing Practices certificate issued by a government authority in its home country, and the safety assessment must be thorough enough to confirm safety without animal data.¹

Several product types are excluded even when the three conditions are met:

Children’s cosmetics always require animal testing regardless of category.
Any product containing a new ingredient still inside its three-year safety monitoring period cannot use the exemption.
If the notifier, Domestic Responsible Person, or manufacturer is listed as a key supervision target by the NMPA, the exemption is unavailable.

The GMP certificate itself trips up many companies. It must come from a government authority, not an industry association or private certifier, and it must cover the entire manufacturing process and quality control system. If more than one manufacturer contributes to a product, each needs a qualifying GMP certificate. Partial coverage disqualifies the product.

Notification and Registration Timelines

Notification for General Cosmetics

General cosmetics are filed on the NMPA’s online platform. The filer submits the complete dossier and receives a filing number, which authorizes the product for sale. The NMPA’s technical assessment agency then conducts a post-filing verification. This is not a rubber stamp. If review turns up problems, the filing can be revoked after the product is already on shelves.¹

Registration for Special Cosmetics

Special cosmetics need upfront approval before any sales activity. The technical assessment agency has 90 working days from receiving the application to complete its evaluation. If it requests supplementary documents, the company has 90 working days to respond, and the evaluation clock resets when those documents are submitted. After technical evaluation ends, the NMPA has 20 working days to review it and decide, then 10 working days to issue the certificate.⁵

On paper that runs about five to six months. In practice, most applications go through at least one round of supplementary documents, and the NMPA can order on-site inspections of manufacturing facilities. Those take 45 working days for domestic inspections and longer for overseas ones, and they pause the evaluation timeline. A realistic expectation for most special cosmetics is closer to nine to twelve months from initial submission to certificate.⁵

Labels and Efficacy Claims

Every cosmetic sold in China must carry a label meeting national standard GB 5296.3. The label must be in Chinese and include the product name, manufacturer name and address, net content, shelf life, production date, and a complete ingredient list in descending order of concentration for ingredients above 1%. Imported products must also show the country of origin and the name and address of the Chinese distributor or Domestic Responsible Person.

Safety warnings are mandatory for products with certain restricted ingredients or those intended for sensitive populations, and they must be printed at a legible size. For special cosmetics, the registrant must upload an image of the product label to the NMPA’s information platform before the product goes on sale, so the label becomes publicly accessible.⁵

Any benefit the product claims, from moisturizing to anti-aging to oil control, must be backed by evidence, and a summary of that evidence must be uploaded to an NMPA-designated online platform during notification or registration. Competitors, regulators, and consumers can all review it. Whitening, sun protection, and anti-hair-loss claims must be supported by mandatory testing under the Safety and Technical Standards for Cosmetics. Other claims can be substantiated through human efficacy tests, consumer use tests, laboratory testing, or published scientific literature. Purely descriptive claims such as cleansing or makeup removal are exempt from substantiation.

Children’s Cosmetics

Products intended for children face the strictest requirements in the framework. Beyond the standard safety assessment, they require an added evaluation covering specific risk substances, including certain surfactant components, sensitizing compounds in fragrances and essential oils, and contaminants such as diethylene glycol in glycerin.

Every children’s cosmetic must carry the mandatory “Little Golden Shield” logo on its packaging, placed on the upper left of the main display panel and shown as a single intact image. Children’s cosmetics also cannot use the animal testing exemption, no matter how strong the safety assessment. Every children’s product destined for the Chinese market goes through traditional testing.

New Cosmetic Ingredients

If a formula contains any ingredient not found in the IECIC, that ingredient must go through its own separate registration or notification before it can be used in a finished product. High-risk new ingredients require full registration; others go through notification.¹

Once approved, the new ingredient enters a three-year safety monitoring period beginning on the date the first cosmetic product containing it is registered or notified. During those three years, the registrant or notifier must submit annual reports covering commercial use, adverse reaction data, risk monitoring results, and any recall activity. Safety concerns arising in that window can lead to revocation.³

Ingredients that clear the monitoring period without safety issues are added to List II of the IECIC and no longer require separate approval for future products. The pathway is resource-intensive, but competitors cannot use that ingredient until it clears the monitoring period or they file their own application.

Cross-Border E-Commerce

China maintains a separate regulatory track for cosmetics sold through cross-border e-commerce platforms. Products sold that way are not subject to standard NMPA registration or notification, provided they fall within the categories on the government’s Positive List. This channel lets brands test the Chinese market without the full regulatory investment.

The trade-offs are real. Individual transactions are capped at 5,000 RMB, with an annual per-consumer spending limit of 26,000 RMB. Qualifying products receive preferential tax treatment, including a 30% reduction on value-added tax. Cross-border e-commerce products cannot be sold through domestic retail channels and remain subject to separate supervision rules for imported cross-border goods. Many brands use this route as a stepping stone before committing to full NMPA registration.

Post-Market Obligations

Approval is not the finish line. Companies selling general cosmetics must submit an annual report between January 1 and March 31 confirming that the product remains in production and unchanged. It applies to every product that has been on file for at least one full year.⁶

Adverse reaction monitoring is ongoing. Registrants and filers must collect and analyze reports of health problems, from mild skin irritation to serious allergic reactions, and report them to the authorities. E-commerce platform operators must pass along adverse reaction reports and quality complaints to the seller and notify provincial regulators directly when significant safety concerns arise.²

Regulators run spot checks and sampling tests at retail locations and distribution centers, comparing the actual product against the data submitted during filing or registration. Discrepancies can trigger immediate recalls and public disclosure of the violation. Manufacturing license violations can result in fines ranging from RMB 10,000 to RMB 30,000, with repeated offenses or concealment of safety information pushing penalties to the maximum end of whatever range applies. At the extreme, individuals responsible for serious violations can face a lifetime ban from producing or selling cosmetics in China.²

1
National Medical Products Administration. The Provisions for Registration and Filing of Cosmetics
2
National Medical Products Administration. Provisions for Supervision and Administration of Manufacturing and Marketing of Cosmetics
3
National Medical Products Administration. Announcement of the National Medical Products Administration on Matters Related to the Administration of the Inventory of Existing Cosmetic Ingredients
4
National Medical Products Administration. Policy Interpretation of the NMPA Announcement on Measures to Optimize the Management of Safety Assessment of Cosmetics
5
National Medical Products Administration. The Provisions for Registration and Filing of Cosmetics – Section III Registration Administration
6
National Medical Products Administration. NMPA Announcement on Issues about Implementing the Rules for Registration and Notification Dossiers of Cosmetics