China Cosmetic Regulations: NMPA Filing, Testing, and Labeling

To sell cosmetics in China, an overseas brand must comply with the Cosmetic Supervision and Administration Regulation (Decree No. 727), which took effect on January 1, 2021 and is enforced by the National Medical Products Administration (NMPA).¹ In practice, that means appointing a China-based Domestic Responsible Person, classifying each product as special or general, preparing a technical dossier with only permitted ingredients, and completing either NMPA registration or filing before a single unit ships.² The path, the timeline, and the cost all follow from those first decisions.

Special Versus General Cosmetics

Every product sold in China is either a special cosmetic or a general cosmetic, and the label determines the regulatory route. Special cosmetics are products intended for hair dyeing, hair perming, spot removal or whitening, sun protection, or hair loss prevention, plus any product making a new function claim not yet catalogued by the NMPA. Everything else, including moisturizers, shampoos, and standard makeup, is a general cosmetic.²

Special cosmetics require a full registration approved by the NMPA before sale. General cosmetics use a lighter notification-based filing. A moisturizer that adds a whitening claim jumps categories and picks up months of additional review, so marketing language deserves the same scrutiny as the formula itself.

Appointing a Domestic Responsible Person

Before touching any paperwork, an overseas company must designate a Domestic Responsible Person (DRP). The DRP has to be an enterprise legal person registered in mainland China, not an individual and not a foreign entity, and its business scope must cover cosmetics sales and distribution.²

Under Article 8 of the Provisions for Registration and Filing of Cosmetics, the DRP submits registration and filing materials on the brand’s behalf, monitors adverse reactions, coordinates recalls, and cooperates with NMPA inspections. It also carries contractual liability for the safety and quality of products in the Chinese market, which is why choosing a capable DRP matters as much as choosing a distributor. Regulators contact this entity first when something goes wrong.

Building the Product Dossier

The dossier is the technical backbone of both registration and filing. It contains the complete formula, a description of the manufacturing process, evidence that the facility runs a quality management system, and stability data for the finished product. Since July 2022, every manufacturer supplying China, foreign or domestic, must comply with the Good Manufacturing Practice for Cosmetics, which sets baseline standards for production environments, equipment, and quality controls.³

Every ingredient in the formula has to appear on the Inventory of Existing Cosmetic Ingredients in China. Anything absent is treated as a new cosmetic ingredient and must clear its own registration or filing first.

Prohibited and Restricted Ingredients

The Safety and Technical Standards for Cosmetics (STSC 2015) is the master reference. It lists 1,284 banned chemical ingredients, 109 banned plant and animal ingredients, and a separate restricted substances list that sets concentration limits, usage scope, and labeling requirements for permitted-but-conditional ingredients. Additional positive lists govern preservatives, sunscreen agents, colorants, and hair dyes. If an ingredient is not explicitly permitted or addressed, treat it as new.

Animal Testing and the Exemption Route

Since May 2021, imported general cosmetics can qualify for an exemption from China’s traditional mandatory animal testing.⁴ The prerequisite is a Good Manufacturing Practice certificate issued by a government authority in the product’s country of origin. In place of animal test data, the company submits a safety assessment report prepared by qualified professionals under China’s Technical Guidelines for Cosmetic Safety Assessment, drawing on toxicological data and existing scientific literature.

Several categories are still ineligible for the exemption:

Any cosmetic intended for children or infants.
Products containing a new cosmetic ingredient still within its three-year safety monitoring period.
Products from a manufacturer, DRP, or registrant flagged for intensified supervision by the NMPA.

Registration and Filing Procedures

All submissions run through the NMPA’s online information service platform, which is the official public record for every cosmetic sold in China. Approvals and filings are published within five working days.²

Filing a General Cosmetic

General cosmetics use a notification-based filing. The DRP uploads the complete electronic dossier, and the product can generally proceed toward import while authorities conduct post-filing technical verification. The NMPA handles filings for imported general cosmetics directly and may delegate to provincial drug regulatory departments with the relevant capabilities. Filing is lighter-touch than registration but not automatic; the NMPA can order corrections or cancel filings for deficient dossiers.

Registering a Special Cosmetic

Special cosmetics require a technical review by an NMPA expert panel that evaluates safety data, quality controls, and efficacy claims against national standards. The agency may also request on-site inspections of manufacturing facilities; domestic inspections must finish within 45 working days, and inspection time does not count against the overall review clock.⁵ The full review often takes several months in practice, and requests for supplementary data extend it further.

A successful application produces a registration license valid for five years.⁵ Electronic certificates have replaced paper licenses, so customs and regulators can verify status in real time. Brands must keep their platform profiles current for the life of the license.

New Cosmetic Ingredients

If a formula contains an ingredient that does not appear on the Inventory of Existing Cosmetic Ingredients, that ingredient needs its own approval before it can be used. High-risk new ingredients require registration; other new ingredients follow a filing process, mirroring the special/general split for finished products. The NMPA’s technical assessment agency reviews safety and quality control data.

Approved new ingredients then face a three-year safety monitoring period. During that window the manufacturer submits semi-annual safety update reports and maintains adverse reaction tracking. If concerns emerge, the NMPA can impose risk controls or withdraw the approval and add the ingredient to the banned list.⁵ Any finished product built around an ingredient still in monitoring is automatically ineligible for the animal testing exemption.

Children’s Cosmetics

Products for children aged 12 and under fall under the Provisions on the Supervision and Administration of Children’s Cosmetics, issued by the NMPA in September 2021.⁶ Formulation must follow the principle of “safety as priority, efficacy as necessity, and formula minimization.” The NMPA classifies these products as higher risk, which means companies must submit a full safety assessment report rather than the abbreviated safety conclusion available for lower-risk adult products.⁷ Factories producing children’s skincare must meet the full Good Manufacturing Practice standard, and every product must display the mandatory “Little Golden Shield” logo on the upper left of the main display panel.

Labeling

All cosmetics sold in China must carry Chinese-language labels using standard Chinese characters. The Chinese font size must be at least as large as any other characters on the label, with narrow exceptions for registered trademarks, website addresses, foreign company names, and conventional technical terms like Colour Index numbers and SPF values. Imported products may use Chinese sticker labels over original packaging, but the sticker’s safety information and efficacy claims must match the original exactly. Adding new claims through a sticker is not allowed.

The label must include the product name, the DRP’s name and address, the complete ingredient list, the manufacturing license number for domestic products, and the special cosmetics registration certificate number where applicable.⁶ Medical terminology and any suggestion that a cosmetic can diagnose, treat, or prevent disease are prohibited. Regulators verify compliance by cross-checking physical packaging against the registered or filed information in the NMPA database.

Substantiating Efficacy Claims

Every functional claim, from moisturizing to anti-aging to sun protection, needs credible supporting evidence, and a summary of that evidence must be uploaded to a public-facing government platform where consumers and competitors can inspect it.

For most categories, companies choose the evaluation method: human trials, laboratory testing, or published scientific literature. Three claim types have prescribed methods that cannot be substituted: spot correction and whitening, sunscreen, and hair loss prevention.⁸ Products within the same brand that differ only in colorants, fragrances, or preservatives may share efficacy test data, which lightens the load for line extensions. Unsupported or misleading claims can trigger fines, product seizures, and in serious cases revocation of the business license under Decree No. 727.

Post-Market Duties

Approval is the beginning of an ongoing obligation. The NMPA runs a risk-based classification system for post-market supervision, assigning each brand and DRP a tier based on quality control performance, filing track record, and inspection results.⁵ A clean record means lighter oversight; problems escalate scrutiny across current and future products.

The NMPA can order safety re-evaluations at any time if new science raises concerns. If a re-evaluation cannot confirm safety, the agency withdraws the registration, cancels the filing, and adds the ingredient to the banned list.⁵ An ingredient that passed initial review years ago can still be pulled if the evidence shifts.

Adverse Reaction Reporting Deadlines

The DRP reports adverse reactions through China’s National Cosmetics Adverse Reaction Monitoring System on a tiered schedule:

General reactions: within 30 days.
Serious reactions: within 15 days.
Reactions with broader social impact: within 3 days.

Missed deadlines can push a company into intensified supervision, which brings more frequent inspections and disqualifies its products from the animal testing exemption. Monitoring continues for as long as the product remains on the Chinese market.

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National Medical Products Administration. Promulgation of the Regulations on Supervision and Administration of Cosmetics
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National Medical Products Administration. The Provisions for Registration and Filing of Cosmetics
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National Medical Products Administration. NMPA Announcement on the Good Manufacturing Practice for Cosmetics
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EU SME Centre. Update on New Regulations and Animal Testing Exemption for Cosmetics
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National Medical Products Administration. The Provisions for Registration and Filing of Cosmetics
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National Medical Products Administration. Do Not Use Cosmetic Toys on Children
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National Medical Products Administration. Policy Interpretation of the NMPA Announcement on Measures to Optimize the Management of Safety Assessment of Cosmetics
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National Medical Products Administration. NMPA’s Opinions on Deepening the Reform of Cosmetics Regulation and Promoting High-Quality Industry Development