A lipstick or foundation developed for the US or European market cannot simply ship to Chinese retailers. Since May 1, 2021, when the Provisions for Registration and Filing of Cosmetics (SAMR Order No. 35) took effect, imported general cosmetics enter China through a filing system rather than pre-market approval [1][3]. That sounds like a lighter burden, and in one sense it is: no regulator approves the product before it goes on sale. But the filing route replaces approval with paperwork the company itself must get right, because the state supervises the product after it reaches the market. Understanding what must be in place before the first unit ships is the difference between a smooth launch and a product that gets pulled.
First decision: filing or registration
China's framework under the Cosmetics Regulation divides products into two tracks. Special cosmetics and high-risk new cosmetic ingredients go through registration, which is a pre-market approval process; general cosmetics and other new ingredients go through filing, where the regulator accepts the dossier for reference rather than approving it [3]. NMPA, the National Medical Products Administration, handles registration and filing for special cosmetics and imported general cosmetics directly, and may delegate the filing of imported general cosmetics to provincial drug regulators with the necessary capacity [3].
For a typical makeup line this classification is the first compliance decision. Lipstick, foundation, blush and similar color cosmetics are general cosmetics and follow the filing track. A lip product claiming sun protection moves into the special cosmetics track and requires registration instead. The 2021 reform specifically converted imported general cosmetics from review-and-approval to notification, as SAMR's announcement of the Provisions makes clear [1]. The practical consequence is timing: a filing is completed when the dossier is properly submitted, so a brand does not wait for an approval letter. The flip side is that the legal responsibility for the dossier's authenticity and scientific soundness sits with the registrant or filing person, not with a reviewing official [3].
The prerequisite: a domestic responsible person
Before any dossier can be submitted, an overseas brand must appoint what the regulation calls a domestic responsible person. Article 8 of the Provisions requires overseas registrants and filing persons to designate an enterprise legal person within China as the domestic responsible person [3]. This is a structural requirement, not a courier service: without one, the filing process cannot begin.
The role carries real obligations. The domestic responsible person handles the registration and filing of cosmetics and new ingredients in the name of the overseas registrant or filing person, assists with adverse reaction monitoring and safety monitoring and reporting, assists in implementing recalls, and assumes corresponding quality and safety responsibilities for products released into the domestic market, as agreed with the registrant [3]. In other words, this entity is the legal contact point inside China for three things a brand hopes never to need: monitoring problems, reporting them, and recalling product. Choosing a domestic responsible person without the capacity to carry those duties transfers liability onto an entity that cannot honor it, which is a risk brands tend to underestimate when the relationship is purely commercial.
What the filing must contain
The substance of a filing is the technical dossier. NMPA's own guidance states that before cosmetics go on the market, technical documentation including the product formula, test report and safety assessment data must be submitted as required, and products can be sold only after registration or filing [2]. For an imported makeup brand, this means testing and safety assessment must be completed against Chinese requirements before the product enters circulation in China, not retrofitted afterward.
These three categories are the core of the dossier rather than its entirety. The detailed item list is set out in the Rules for Registration and Notification Dossiers of Cosmetics, issued by NMPA on March 4, 2021 and effective the same day as the Provisions, May 1, 2021 [5]. A brand preparing its first filing should work from that document with its domestic responsible person; the sources reviewed here confirm the three core categories without reproducing the full checklist.
The Chinese-language label is mandatory
Alongside the dossier, the physical product must carry a compliant label. NMPA's published guidance states that imported cosmetics should have Chinese labels, that labels should mark the full composition of the product, and that special cosmetics should be marked with their special cosmetics registration certificate number [2]. For an imported lipstick, the original-market label cannot simply be left as is; compliant Chinese labeling, including the full ingredient list, must be on the product before it is sold.
One caveat on scope: this summary of label requirements comes from an NMPA science-popularization article rather than the full text of the Cosmetics Labeling Measures, so the complete set of mandatory label fields is not covered here. What the source establishes clearly is the principle that Chinese-language labeling and full ingredient disclosure are required for imported cosmetics, and that special cosmetics must display their registration certificate number [2].
Filing is not the finish line
A common misreading of the reform is that filing means the regulator has stepped back. The opposite is true in structure. The Provisions assign NMPA's technical assessment agency the task of technical verification of imported general cosmetics after filing [3]. The regulator checks the submitted dossier's technical substance after the product is already on shelves.
Layered on top of that, post-market regulation includes sampling and testing, adverse reaction monitoring and risk monitoring, as NMPA's guidance describes [2]. Because the filing person is responsible for the authenticity and scientific soundness of the submitted dossier [3], any gap between the paperwork and the actual product surfaces during verification or sampling. The consequence is that compliance risk in the filing system sits after launch rather than before it: a defective dossier may not stop a product from reaching shelves, but it determines what happens when the regulator looks. Brands used to approval systems should treat the post-filing period as the active regulatory phase, not a quiet one.
Labeling rules on the US side: enforcement after the border
For a brand selling in both markets, the US labeling regime differs in language, structure and enforcement point, though this comparison covers only the labeling rules documented on FDA's labeling summary. There, all required label statements must be in English; ingredients must be declared in descending order of predominance, though color additives and ingredients present at one percent or less may be declared without regard for predominance [4]. The Tariff Act of 1930 requires imported articles to state the English name of the country of origin on the label [4].
The enforcement mechanism is where the systems diverge most visibly. FDA can examine products, inspect establishments, and seize adulterated or misbranded cosmetics; adulterated or misbranded foreign products may be refused entry into the United States [4]. A labeling failure on an imported lipstick therefore becomes a border problem, not a paperwork problem.
Set against the Chinese regime, the contrast holds on what is documented here: China requires a pre-market action before sale, namely a filed dossier, a domestic responsible person and a Chinese-language label on the product, while the US obligations described in the FDA summary concentrate on label content and are enforced through entry checks and post-market action [4]. This article does not attempt a full accounting of US pre-market obligations, which fall outside the labeling summary reviewed here. For a dual-market brand, the practical takeaway is narrower but firm: both regimes treat label language as a hard gate, Chinese in China and English in the US, and neither tolerates it as a translation afterthought.
For a brand planning its first China launch of imported makeup, the sequence follows from the rules themselves: classify the product to confirm the filing track, appoint a domestic responsible person capable of carrying the statutory duties, prepare the formula, test report and safety assessment data, submit through the platform, and finalize the Chinese label before distribution. What follows the filing, technical verification and post-market surveillance, is where the system tests whether the paperwork told the truth.