October 8, 2026, China’s National Medical Products Administration (NMPA) officially issued Announcement No. 99 [2026], finalizing the implementation rules for the revised Safety and Technical Standards for Cosmetics (STSC). The announcement sets tailored compliance requirements across three product categories:
- Existing registered/filed products,
- Products currently under technical review, and
- New submissions.
These rules cover updated lists of prohibited, restricted, and permitted ingredients (now explicitly including toothpaste), revised limits for microorganisms and harmful substances, and updated testing methods.
Key Differences: Draft vs. Final NMPA Announcement
Compared with the draft for comments released in July, the final version further introduced refined terminology, precise enforcement dates, and structured compliance routes.
Based on the officially released announcement, CIRS Group has compared and summarized the differences between the final version and the previous draft for comments.
| Section/Content | Draft for Comments (July 15, 2026) | Final Version (No. 99 [2026]) | Note |
| Preamble of the Announcement | In view of the recent revisions to the Safety and Technical Standards for Cosmetics (2015 Edition) (hereinafter referred to as the “Standards”), matters concerning the implementation of the adjustment of the catalogs of prohibited/restricted and permitted ingredients, the adjustment of microbiological and harmful substance limits, and the supplementation and updating of test methods are hereby announced as follows | In accordance with the revisions to the Safety and Technical Standards for Cosmetics (hereinafter referred to as the “Standards”), matters concerning the implementation of the adjustment of the catalogs of prohibited/restricted and permitted ingredients of cosmetics (including toothpaste), the adjustment of microbiological and harmful substance limits, and the supplementation and updating of test methods are hereby announced as follows | |
| Section I heading | I. Matters Concerning the Change and Update of Registration/Filing Information of Marketed Products | I. Matters Concerning the Change and Update of Registration/Filing Information of Registered and Filed Products | |
| I (1), Paragraph 1 | For products registered or filed before the revision of the Standards that need to adjust their formulas, labels, etc. according to the revised requirements, cosmetic registrants and filers may submit change applications before the revised contents take effect. | For products registered or filed before the revision of the Standards that need to adjust their formulas, labels, etc. according to the revised requirements, registrants and filers may submit change applications before the revised contents take effect. | |
| I (1), Paragraph 2 | Where the relevant ingredients are replaced with matrix ingredients such as solvents or fillers, or their usage levels are reduced, …… an explanation of the formula change may be provided together with a safety assessment, without the need for registration/filing tests; however, where the adjusted ingredients affect the product efficacy, efficacy evaluation shall be re-conducted, and the product name, label draft, and other related contents shall be changed based on the evaluation results. | Where the relevant ingredients are replaced with matrix ingredients such as solvents or fillers, or their usage levels are reduced, …… an explanation of the ingredient adjustments may be provided together with a safety assessment, without the need for registration/filing tests; where the ingredient adjustments may affect the product efficacy, efficacy evaluation shall be re-conducted, and the product name, label, and other related contents shall be changed based on the evaluation results. | |
| I (2), Paragraph 2 | Where the test reports and assessment results in the original registration/filing dossiers can meet the revised requirements, …… the product standards applied may be updated by the enterprises themselves, and the registration/filing dossiers shall be archived for reference. | Where the test reports and assessment results in the original registration/filing dossiers comply with the revised requirements, …… the product standards applied may be updated by the enterprises themselves before the revised contents take effect, and the registration/filing dossiers shall be archived for reference. | |
| I (2), Paragraph 3 | Where they cannot meet the revised requirements, …… measures such as adjusting the production processes and quality control may be adopted, and registration/filing tests shall be re-conducted; change applications may be submitted once the requirements are met. | Where they do not comply with the revised requirements, …… measures such as adjusting the production processes and quality control may be adopted, and the corresponding registration/filing tests shall be re-conducted; where the revised requirements are met, change applications may be submitted before the revised contents take effect. | |
| I (3), Paragraphs 1–2 | …… a self-inspection shall be conducted to confirm whether the registered/filed products meet the revised requirements. For products meeting the requirements, the product standards applied shall be updated by the enterprises themselves before the revised contents take effect, and the relevant safety assessment documents, test reports, etc. shall be archived for reference. | …… a self-inspection and assessment of the registered/filed products shall be conducted. Where the test methods specified in the original registration/filing dossiers, compared with the revised test methods, do not affect the test results and their determination, registrants and filers may update the product standards applied by themselves before the revised contents take effect, and the registration/filing dossiers shall be archived for reference. | |
| I (3), Newly added paragraph | Where the test methods specified in the original registration/filing dossiers, compared with the revised test methods, affect the test results and their determination, registrants and filers may adopt measures such as adjusting the production processes and quality control, and re-conduct the corresponding registration/filing tests; where the revised requirements are met, change applications may be submitted before the revised contents take effect. | Newly added in the final version | |
| I (3), Final paragraph | Regarding the adjustments to the efficacy test methods for sun protection, whitening and anti-spot, and anti-hair loss products, products registered before the revised contents take effect need not re-conduct efficacy tests using the adjusted methods. | Regarding the adjustments to the efficacy test methods for sun protection, whitening and anti-spot, and anti-hair loss products, products for which registration tests have been conducted before the revised contents take effect need not re-conduct efficacy tests using the adjusted methods. | |
| II, Paragraph 2 | For products under technical review, cosmetic registrants are allowed to adjust the prohibited/restricted and permitted ingredients involved in the revision of the Standards during the supplementary documentation stage. Where the relevant ingredients are adjusted to matrix ingredients or their usage levels are reduced, an explanation of the formula change may be provided together with a safety assessment, without the need for registration tests; however, where the adjusted ingredients affect the product efficacy, the corresponding efficacy test documents for the changed formula shall be provided when supplementing documents; where the relevant ingredients are adjusted to non-matrix ingredients, registration tests and safety assessment shall be re-conducted, and relevant documents shall be provided. | For special cosmetics under technical review, registrants may adjust the prohibited/restricted and permitted ingredients involved in the revision of the Standards during the supplementary documentation stage. Where the relevant ingredients are replaced with matrix ingredients such as solvents or fillers, or their usage levels are reduced, an explanation of the ingredient adjustments may be provided together with a safety assessment, without the need for registration tests; where the ingredient adjustments may affect the product efficacy, the corresponding efficacy evaluation test documents after the adjustment shall be provided when supplementing documents. Where the relevant ingredients are adjusted to non-matrix ingredients, registration tests and safety assessment shall be re-conducted, and relevant documents shall be provided. | |
| II, Newly added sentence | Where the fragrance is adjusted, a safety assessment shall be conducted on the fragrance to be changed, and documents certifying its compliance with the relevant national standards of China or the standards of the International Fragrance Association (IFRA) shall be provided. | Newly added in the final version |
Note: This translation is for reference only. Please refer to the original Chinese text as the authoritative version.
Action Plan for Cosmetics & Toothpaste Manufacturers
Centered on three core pillars—ingredient catalogs, safety limits, and testing methods—the final version provide a structured compliance roadmap for all product stages.
To maintain regulatory compliance and prevent market interruptions, registrants and filers should immediately take the following actions:
- Perform Immediate Self-Inspections: Review current product formulas, safety dossiers, and test reports against the revised STSC standards.
- Plan Formula Modifications Early: Determine whether ingredient changes fall under simple matrix adjustments or require full re-testing
- Update Technical Dossiers: Ensure product standards, fragrance compliance documents (e.g., IFRA certificates), and safety assessments are fully updated and archived before the final effective enforcement dates.
What Can CIRS Do for You?
Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan, and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services from regulatory compliance, laboratory testing, and R&D to data services across multiple industries.
The CIRS cosmetic team provides expert support to ensure that cosmetic products meet stringent global cosmetic regulations and safety standards. We offer comprehensive, lifecycle-based solutions for personal care products, from early-stage cosmetic ingredient development through to final product registration. Our services include:
- Cosmetic ingredient development and regulatory strategy,
- Physical/chemical and analytical tests,
- Toxicological tests (in vivo & in vitro),
- Efficacy and claim substantiation studies (in vivo & in vitro), and
- Ingredient and product registration across global markets.
With deep expertise in cosmetic regulatory compliance and safety evaluations, our team enables brands to bring products to market efficiently and with confidence.
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