Why does China’s NMPA database split cosmetics into “registered” special products and “filed” ordinary ones? Where does the requirement for a China-based responsible person on imported products come from? Both answers sit in the State Council’s Regulations on the Supervision and Administration of Cosmetics (化妆品监督管理条例).
The legal basis: State Council Decree No. 727
The Regulations were adopted at the 77th executive meeting of the State Council on 3 January 2020, promulgated as Decree No. 727 on 16 June 2020 and took effect on 1 January 2021. On that date they replaced the earlier Regulations on the Hygiene Supervision of Cosmetics (化妆品卫生监督条例). The text runs to six chapters and 80 articles.
Article 3 defines cosmetics as daily-use chemical products applied to the skin, hair, nails, lips or other external surfaces of the body by rubbing, spraying or similar methods, for the purpose of cleaning, protecting, beautifying or grooming. The State Council’s drug regulator, the National Medical Products Administration (NMPA), supervises cosmetics nationwide, while drug regulators at county level and above cover their own areas (Article 5). Registrants and filers are responsible for product quality and safety and for efficacy claims (功效宣称) (Article 6).
Registration vs filing: risk-based classification
Article 4 sets up risk-based classification of both products and ingredients. Cosmetics are either special cosmetics (特殊化妆品), which require registration (注册), or ordinary cosmetics (普通化妆品), which require filing (备案). Ingredients are either new or already in use; higher-risk new ingredients are registered and other new ingredients are filed.
| Category | Scope under the Regulations | Regime and authority |
|---|---|---|
| Special cosmetics (特殊化妆品) | Products for hair dyeing, perming, spot removal and whitening (祛斑美白), sun protection (防晒) and hair-loss prevention (防脱发), plus products claiming a new efficacy (Article 16) | May be manufactured or imported only after NMPA registration (Article 17) |
| Domestic ordinary cosmetics | All cosmetics other than special cosmetics | Filed with the provincial drug regulator where the filer is located, before sale (Article 17) |
| Imported ordinary cosmetics | All cosmetics other than special cosmetics | Filed with the NMPA before import (Article 17) |
| New ingredients, registration | New ingredients with preservative, sunscreen, colourant, hair-dye, or spot-removal and whitening functions (Article 11) | Usable only after NMPA registration |
| New ingredients, filing | All other new ingredients (Article 11) | Filed with the NMPA before use |
The two regimes differ in procedure. A special cosmetics application follows the same review track as a new-ingredient registration: the NMPA passes the file to its technical review body within 3 working days of acceptance, the review body delivers an opinion within 90 working days, and the NMPA decides within 20 working days of receiving that opinion (Articles 13 and 20). An ordinary cosmetics filing, by contrast, is complete as soon as the filer submits the required documents through the NMPA’s online government service platform (Article 20).
Which article stands behind each database
The Cosmetics (化妆品) tab of the NMPA search site lists the databases below. Article 20 requires regulators at provincial level and above to publish registration and filing information within 5 working days of a special cosmetics approval or an ordinary cosmetics filing, and Article 56 requires timely publication of licensing, filing and other supervision information.
| Database (original) | English | Related articles |
|---|---|---|
| 国产特殊化妆品注册信息 / 进口特殊化妆品注册信息 | Domestic / imported special cosmetics registrations | 16, 17, 20, 24 |
| 进口化妆品(《化妆品监督管理条例》实施以前批准) | Imported cosmetics approved before the Regulations took effect | 78, 80 |
| 化妆品新原料注册信息 / 化妆品新原料备案信息 | New ingredient registrations / filings | 11, 13, 14 |
| 化妆品注册和备案检验检测机构 | Testing institutions for registration and filing | 19, 49 |
| 化妆品生产企业 | Cosmetics manufacturers | 26, 27 |
| 国产牙膏备案信息 | Domestic toothpaste filings | 77 |
| 国产普通化妆品备案信息 / 进口普通化妆品（含牙膏）备案信息 | Domestic / imported (incl. toothpaste) ordinary cosmetics filings (external links) | 17, 20 |
| 已使用化妆品原料目录 | Catalogue of ingredients already in use (external link) | 14 |
For three years after a new ingredient enters use, its registrant or filer must report annually to the NMPA on use and safety. If no safety problem arises in that period, the ingredient moves into the catalogue of ingredients already in use (Article 14). Toothpaste is regulated under the rules for ordinary cosmetics. Soap falls outside the Regulations unless it claims a special-cosmetics efficacy (Article 77).
Certificate validity and import requirements
- Special cosmetics certificate. Valid for five years. Renewal must be requested at least 30 working days before expiry. It is refused if the registrant misses that deadline, or if the product no longer meets revised mandatory national standards or technical specifications (Article 24). A substantive change in production process or efficacy claims requires a change registration (Article 20).
- Production licence. Manufacturers apply to the provincial drug regulator, which inspects the site and decides within 30 working days of acceptance. The licence is valid for five years (Article 27).
- Contract manufacturing. Registrants and filers may manufacture themselves or contract a licensed manufacturer, and must supervise the contractor’s production (Article 28).
- Imported products. An overseas registrant or filer must designate a corporate entity in China to handle registration or filing and to assist with adverse-reaction monitoring and recalls (Article 23). Applications for imported products must include proof that the product is already on sale in its country or region of production, and proof that the overseas manufacturer complies with good manufacturing practice for cosmetics. Products made solely for export to China, which cannot show prior sale, must instead be supported by research and testing aimed at Chinese consumers (Article 19).
Efficacy disclosure and labelling duties
Article 22 requires efficacy claims to have sufficient scientific basis. Registrants and filers must publish a summary of the supporting literature, research data or efficacy evaluation on a website designated by the NMPA, where it is open to public scrutiny. This is the source of the 功效宣称依据摘要 (efficacy-claim summary) link on search records. Failing to publish the summary carries a warning and a fine of RMB 10,000–30,000, rising to suspension of production or business and a fine of RMB 30,000–50,000 in serious cases (Article 62).
Under Article 36, labels must show, among other things, the product name and special cosmetics certificate number, the names and addresses of the registrant or filer and of any contract manufacturer, the production licence number, the number of the product standard and the full ingredient list. Those printed numbers are what make a label searchable in the database. Imported products may use a Chinese label directly or affix one, and an affixed Chinese label must match the original (Article 35).
Duties for sellers, importers and platforms, and penalties
- Sellers. Cosmetics businesses must keep incoming-goods inspection records and check each supplier’s business registration, the product’s registration or filing status, and its factory inspection certificate (Article 38).
- Importers. Importers must verify that products are registered or filed and comply with the Regulations, mandatory national standards and technical specifications. Products that fail this check may not be imported (Article 45).
- E-commerce platforms. Platforms must register cosmetics merchants under their real names, stop violations they discover and report them to the provincial drug regulator. Merchants must disclose product information fully, truthfully, accurately and promptly (Article 41).
- Unregistered special cosmetics. Making, selling or importing them leads to confiscation of illegal gains and goods, plus a fine of RMB 50,000–150,000 where the goods are worth under RMB 10,000, or 15 to 30 times their value above that (Article 59).
- Unfiled ordinary cosmetics. Selling or importing them carries a fine of RMB 10,000–30,000 where the goods are worth under RMB 10,000, or 3 to 10 times their value above that (Article 61).
Products registered before the Regulations took effect for hair growth (育发), hair removal (脱毛), breast enhancement (美乳), body shaping (健美) or deodorising (除臭) were given a five-year transition period from the effective date, after which they may no longer be made, imported or sold (Article 78). Separately, the NMPA’s own FAQ (基础数据常见问题) states that the search lists are for lookup only and that record totals are not a statistical basis.
To check the corporate registration of a registrant or China-based responsible person, use China’s National Enterprise Credit Information Publicity System. For an importer’s customs credit rating, see the China Customs enterprise credit disclosure platform.
Coming up · We may follow up with a guide to searching the China Customs enterprise credit disclosure platform.
