On July 29, 2026, the Announcement on Matters Concerning Cosmetic Registration and Filing (hereinafter referred to as the "Announcement") was officially released. At the same time, the National Medical Products Administration (NMPA) released the relevant policy interpretation to facilitate a better understanding of the Announcement. CIRS Group has now compiled and organized the interpretation below for reference.
I. What is the background and purpose of formulating the Announcement on Matters Concerning Cosmetic Registration and Filing (hereinafter the "Announcement")?
On November 17, 2025, the NMPA issued the Opinions on Deepening Cosmetic Regulatory Reform to Promote High-Quality Development of the Industry (Guo Yao Jian Zhuang [2025] No. 18, hereinafter the "Opinions"). Centered on improving the efficiency of cosmetic registration and filing administration, it proposed a series of measures to deepen registration and filing reform, including encouraging the first launch of new cosmetic products in China, optimizing cosmetic registration and filing data, and improving the quality and efficiency of technical review. While maintaining the safety baseline, these reform measures will effectively reduce the R&D and filing burden on enterprises, lower production and operating costs, and further stimulate the industry's innovation vitality, and have attracted high attention and broad acclaim from the industry.
To promote the implementation of various reform tasks and meet the needs of industry development, it is necessary to refine the cosmetic registration and filing management requirements in accordance with the policy direction and development path determined in the Opinions, and to clarify them in the form of NMPA normative documents, so as to reduce burdens and enhance efficiency for the high-quality development of the industry.
II. What principles were followed in the formulation of the Announcement?
In the formulation of the Announcement, the following principles were followed:
First, upholding law-based administration. In strict accordance with the Cosmetics Supervision and Administration Regulation and the Measures for the Administration of Cosmetic Registration and Filing, the registration and filing procedures and related requirements were optimized within the regulatory framework, without lowering quality and safety standards, upholding the safety baseline.
Second, upholding science-based regulation. Based on the reform direction determined in the Opinions, specific measures were studied and proposed, and experts were organized to conduct repeated research, ensuring clear management rules and rigorous technical standards.
Third, broadly soliciting opinions. During the document drafting process, multiple field investigations and industry seminars were conducted to broadly solicit opinions from enterprises and local regulators, striving to meet the development demands of the industry, and refining and clarifying each measure to ensure effective implementation.
III. What optimization measures does the Announcement propose for cosmetic registration and filing management?
First, encouraging the first launch of international new cosmetic products in China. Benchmarking against international high-standard economic and trade rules and fostering a first-launch economy in China's cosmetics sector, eligible foreign new products are treated by reference to the provisions for products exclusively exported to China, and are exempted from submitting proof-of-market-sale documents. This helps consumers access the latest global, fashionable and popular high-quality beauty products at the earliest opportunity.
Second, reducing and exempting animal testing for cosmetics. Toxicology test reports are reduced/exempted for perm products, non-oxidative hair dye products, skin-whitening (freckle-removing) products with only physical masking effects, and general cosmetics using new ingredients (excluding children's cosmetics). While reducing enterprise R&D costs, this also aligns with the internationally recognized 3R principles of animal testing (Replacement, Reduction, Refinement), and facilitates the overseas expansion of Chinese beauty brands. Based on the development of scientific research, the NMPA's cosmetic technical review department may, through formulating technical guidelines, adjust the scope of products eligible for animal testing reduction/exemption in a timely manner.
Third, adjusting ingredient safety-related information to enterprise archiving for inspection. During the registration and filing of cosmetics and toothpastes, cosmetic enterprises are no longer required to fill in ingredient safety information files and reporting codes; the relevant materials are archived by the enterprise for inspection. On one hand, this refines and clarifies the quality and safety responsibilities of cosmetic registrants and notifiers; on the other hand, it reduces the data submission burden on enterprises.
Fourth, allowing products with similar formulation systems to share safety and efficacy claim evaluation data. Relying on the continually improving safety assessment system, for products with similar formulation systems under the same registrant/notifier and the same brand, one representative product may be selected for testing, and the relevant test reports may be shared by other products during registration and filing. This optimization measure can significantly reduce the testing costs of color cosmetics such as lipsticks, blushes, and eyeshadows, as well as perfumes, and accelerate the pace of product launch, meeting consumers' needs for the fashion and trendiness of color cosmetics and perfumes. Based on the development of scientific research, the NMPA's cosmetic technical review department may, through formulating technical guidelines, adjust the recognition scope of products with similar formulation systems in a timely manner.
Fifth, simplifying the registration and filing data requirements for products undergoing cross-border transfer of production sites. To facilitate the cross-border transfer of product production sites, when an enterprise re-registers or re-files a product due to a change in production location, it is allowed to use the corresponding content of the original data for materials other than the microbiological and physicochemical test reports. This facilitates the international flow of production factors, further attracts foreign investment and expands opening-up, and also helps guard against the adverse effects brought by trade barriers.
Sixth, expanding the acceptance scope of efficacy claim evaluation test methods for cosmetics. For efficacy claims other than skin-whitening (freckle-removing), sun protection, and anti-hair loss, cosmetic registrants and notifiers are allowed to independently select efficacy claim evaluation test methods for efficacy claim evaluation. This better leverages the role of enterprises as innovation entities, provides greater flexibility for cosmetic efficacy claims, and, while actively utilizing the role of industry self-regulation, strives to build a co-governance pattern of positive interaction between government regulation and industry self-discipline.
Seventh, simplifying the data for changes of the Domestic Responsible Person. When changing the Domestic Responsible Person of a product, there is no longer a need to submit materials such as the informed consent form of the original Domestic Responsible Person. This removes procedural obstacles for enterprises in adjusting commercial cooperation and facilitates product registrants and notifiers in making autonomous decisions based on market trends.
IV. What data must international new cosmetic products first-launched in China submit during registration and filing to be exempted from submitting proof-of-market-sale documents?
For international new cosmetic products first launched and marketed in China, or simultaneously marketed in China and other countries (regions), during product registration and filing, the registrant or notifier may provide a declaratory statement of the product's first launch in China. This mainly includes: the name and address of the registrant or notifier; the name and address of the Domestic Responsible Person; the name and address of the manufacturer; the product name; and a commitment that the product will first be marketed in China, etc. This exempts the submission of proof-of-market-sale documents from the country (region) where the registrant/notifier is located or the country (region) of manufacture.
V. For perm, non-oxidative hair dye, and skin-whitening (freckle-removing) cosmetics with only physical masking effects, as well as general cosmetics using new ingredients (excluding children's cosmetics), what supporting documents must be submitted during registration and filing to qualify for the reduction/exemption of animal testing data?
For special cosmetics — perm products, non-oxidative hair dye products, and skin-whitening (freckle-removing) products with only physical masking effects — and general cosmetics using new ingredients (excluding children's cosmetics), during registration and filing, a qualification certificate related to the production quality management system issued by the competent government authority of the country (region) where the manufacturer is located must be provided, such as China's cosmetic production license. At the same time, if, within the product safety assessment data, the assessment results for ingredients and their risk substances, product stability, preservative efficacy, and packaging material compatibility can sufficiently confirm the safety of the product, the toxicology test report for that product may be exempted.
VI. What should be noted when archiving ingredient safety-related information for inspection?
During the registration and filing of products (including toothpastes), registrants and notifiers are not required to fill in the ingredient safety information files and ingredient reporting codes of the ingredients used in the product; the relevant materials are archived by the enterprise itself for inspection. Where technical documents such as the Safety and Technical Standards for Cosmetics have relevant requirements for ingredient quality specifications, registrants and notifiers shall submit the quality specifications or test reports of the ingredients in the product formula section or the safety assessment data. Where only the basic conclusions of the safety assessment are submitted in accordance with the requirements of the Guidelines for Submitting Cosmetic Safety Assessment Data, the aforementioned ingredient quality specifications or test reports shall also be submitted.
In accordance with the Provisions on the Administration of Cosmetic Registration and Filing Data, registrants and notifiers shall fill in the name of the ingredient manufacturer. For already registered or filed products where the ingredient manufacturer or ingredient quality specifications are added or changed: if the content of the ingredient used in the formula and the types and proportions of the specific components in the ingredient both remain unchanged, the ingredient manufacturer information shall be self-updated and maintained through the registration and filing information platform; if the content of the ingredient in the formula and the content of the main functional components and solvents in the ingredient remain unchanged, but changes occur in the types or content of trace stabilizers, antioxidants, preservatives and other components added to ensure ingredient quality, or the purity of the main functional components increases due to reasons such as production process optimization, an application for change shall be filed in accordance with the relevant requirements.
Registrants and notifiers may refer to the relevant content of Annex 14 of the Provisions on the Administration of Cosmetic Registration and Filing Data to retain ingredient safety-related information.
VII. For cosmetics (including toothpastes) with similar formulation systems produced at different production sites, how can safety technical data be shared?
For products with similar formulation systems under the same product registrant/notifier, if produced at different production sites, at least one representative product shall be selected from each site to conduct microbiological and physicochemical testing. During product registration and filing, the toxicology test and human safety test reports may be shared, while the products of each site shall separately submit the microbiological and physicochemical test reports of their representative products.
CIRS Reminder
This new cosmetic registration and filing policy introduces multiple measures simultaneously: by streamlining filing data, simplifying approval procedures, and relaxing innovation restrictions, it effectively reduces enterprise costs in R&D testing, efficacy evaluation, and compliance filing, fully unleashing the industry's innovation vitality, and helping enterprises accelerate the pace of new product launch and broaden the space for product innovation. It is recommended that cosmetic enterprises promptly gain a thorough understanding of the detailed rules of the new regulations, optimize the full-process management of R&D, testing, and filing, and achieve compliance-based cost reduction and efficiency gains, so as to seize the development opportunities of the industry!
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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