At the start of this new year, ZMUni Compliance Centre invites you to join us in a quick review of the major "compliance milestones" that shaped the Chinese cosmetics industry in 2024.
In 2024, the spotlight in the Chinese cosmetics industry undoubtedly centered on "safety assessments" (commonly known as "CPSR"). On April 22, the National Medical Products Administration (NMPA) of China issued the Announcement on Issuing Several Measures to Optimize Cosmetic Safety Assessment Management (No. 50 of 2024), introducing 12 specific measures categorized into four main areas.
Following the principles of risk-based management, the submission requirements for CPSR materials are categorized based on the product characteristics and the operational status of the company's quality management system. Cosmetics are divided into two categories:
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Cosmetic Classification |
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Category I Cosmetics |
i. Special Cosmetic |
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ii. Cosmetics for Infants and Children |
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iii. Cosmetics Containing New Cosmetic Ingredients under Safety Monitoring Period |
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Category II Cosmetics |
Situation 1: |
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i. Cosmetics containing nano materials; |
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ii. Non-sunscreen cosmetics containing sunscreen agents that are not listed in Table 5 of the Safety and Technical Standards for Cosmetics as light stabilizers; |
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iii. Cosmetics claiming efficacy such as anti-acne, anti-wrinkle (excluding physical anti-wrinkle), deodorization, dandruff removal, hair removal, and exfoliation (excluding physical exfoliation); |
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iv. Cosmetics in the form of patches, films, or containing substrates (such as patches, films, or substrates that include active ingredients or colorants) or aerosol products; |
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v. Cosmetics that must be used in conjunction with instruments or tools (excluding those that are only used for auxiliary application, such as brushes, cushions, perming tools, etc.). |
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Situation 2: |
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General cosmetics other than cosmetics under Situation 1 |
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To enhance support for CPSR, regulatory authorities have developed and issued more than ten technical guidelines and related documents, creating a comprehensive technical support framework. These resources provide clear guidance and support for enterprises. Key documents include:
Guidelines for Submission of Cosmetics Safety Assessment Dossiers
Technical Guidelines for Identification and Assessment of Cosmetic Risk Substances
Technical Guidelines for Application of Threshold of Toxicological Concern (TTC) Method
Technical Guidelines for Application of Read-across Method
Technical Guidelines for Cosmetic Preservative Challenge Testing
Technical Guidelines for Stability Testing and Assessment of Cosmetics
Technical Guidelines for Compatibility Testing and Assessment of Cosmetics with Packaging Materials
Technical Guidelines for Integrated Approaches to Testing and Assessment (IATA) of Skin Sensitization
Guidelines for Use of Cosmetic Ingredient Data
Index of Cosmetics Safety Assessment Data from International Authoritative Organizations
To accommodate enterprises'adaptation needs, the Announcement specifically allows cosmetics registrants or notifier to submit simplified CPSR compliant with the Technical Guidelines for Cosmetics Safety Assessment (2021 Edition) until May 1, 2025, when applying for registration or notification.
Over the past year, local regulatory authorities have actively responded to national policies, adopting various measures to promote the full implementation of the comprehensive CPSR system. For instance, Guangdong Province, as a pilot region, has effectively facilitated compliance among local cosmetics enterprises through enhanced training, technical support, and policy advocacy. As of December 15, 2024, nearly 150 cosmetics companies in Guangdong had submitted complete CPSR for over 900 products, leading the nation.
Looking back at 2024, the CPSR system has been steadily rolled out, with various policies and measures taking effect. Looking ahead to 2025, as more enterprises and products adapt to the new requirements, the comprehensive implementation of the full CPSR system is expected to advance further and more deeply.
In 2024, China's NMPA and the General Administration of Customs of China (GACC) continued rigorous supervision and inspection of cosmetics, maintaining cosmetics as a key regulatory focus and taking strict action against non-compliant products in the market.
The NMPA conducted a series of stringent sampling inspections across the domestic cosmetics market. As of December 29, 2024, the NMPA issued 19 sampling inspection notices, identifying 535 batches of non-compliant cosmetics in China. Among these 74 batches contained prohibited ingredients.
Categories such as sunscreens, hair dyes, shampoos, conditioners, bath products, and face masks accounted for 76.07% of the total non-compliant batches. The primary causes of non-compliance included:
Inconsistencies between labeling and registration information.
Non-compliant preservatives.
Detection of prohibited substances.
Microbial contamination exceeding permissible limits.
In 2024, the NMPA released several notices regarding unannounced inspection results. Five cases involved Chinese cosmetics companies, two cases concerned overseas cosmetics companies from Spain and South Korea. The Spanish company was found to have two products suspected of using the prohibited ingredient Diflorasone Diacetate, in violation of regulations.
According to the Interim Provisions on the Administration of Cosmetics Overseas Inspection (Draft), overseas inspections prioritize risk-based principles, targeting companies with issues identified during product registration, notification, testing, adverse reaction monitoring, or consumer complaints. Enterprises with large import volumes and significant market presence in China are also prioritized to ensure the inspections' relevance and effectiveness.
The GACC reported that between January and November 2024, a total of 71 batches of cosmetics were deemed non-compliant and denied entry at Chinese ports. The primary reasons included:
Failure to provide required certificates or valid documentation (40 batches).
Sensory inspection results not meeting national standards for food safety (9 batches).
Non-compliant labeling (6 batches).
On September 13, 2024, the NMPA publicly solicited opinions on the Administrative Measures on Cosmetic Safety Risk Monitoring (Draft for Comments). The Draft points out that risk monitoring should focus on key monitoring items based on the needs of the work, including:
i. Substances that are easily added to cosmetics and may pose a health risk to humans.
ii. Substances that have been added to or brought into cosmetics that have caused human health hazards abroad.
iii. Substances added to cosmetics that may have a significant health impact on vulnerable groups such as children.
iv. Substances that could affect cosmetics safety, identified through regulatory practices or literature research.
v. Risk substances potentially introduced during the use of cosmetic ingredients, production, and application processes.
vi. Items involved in the formulation or revision of cosmetics standards.
vii. Other key monitoring items.
Furthermore, based on the monitoring project requirements, priority should be given to monitoring cosmetics with a wide distribution range, high usage frequency, high risk, and frequent issues found during regulatory inspections.
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Type |
Description |
Effective Date |
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Prohibited Substances |
Addition of 5 substances: Bimatoprost, Latanoprost, Tafluprost,Tafluprost ethyl amide, Travoprost |
March, 21, 2024 |
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Testing Methods |
Introduction of 3 new methods: phenacetin, 10-hydroxydecanoic acid, azelaic acid and its salts |
July, 1, 2025 |
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Toxicological Testing |
Addition of 11 methods, including General Rule for Pretreatment of Cosmetic in Toxicological Testings, Acute Inhalation Toxicity Test Methods, and etc. |
December, 1, 2024 |
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Toothpaste Testing |
Introduction of 15 new methods, covering pH values, heavy metals (e.g., mercury, lead, arsenic, cadmium), risk substances (e.g., dioxane, methanol, free formaldehyde), microbial indicators, and etc. |
December, 1, 2024 |
Additionally, in May, 2024, the National Institutes for Food and Drug Control (NIFDC) sought comments on methods for detecting soluble fluoride and free fluoride in toothpaste.
Since the publication of the Working Rules for Management of Cosmetic Supplementary Testing Methods and the Technical Guidance for Studying and Drafting Cosmetics Supplementary Testing Methods in 2021, 11 announcements have been issued, detailing new methods. In 2024, two announcements added 11 new methods, including those for: Difluprednate, Hydroxyflutamide, Finasteride, Nilutamide, Bicalutamide, Flutamide, Cyproterone acetate, Dutasteride, and Epristeride.
In February 2024, the NIFDC issued five technical guidelines for toxicological studies:
i. Technical Guidelines for Acute Inhalation Toxicity Test of Cosmetic Ingredients
ii. Technical Guidelines for Acute Inhalation Toxicity Test and Acute Toxicity Classification Method for Cosmetic Ingredients
iii. Technical Guidelines for 28-day/90-day Repeated Dose Inhalation Toxicity Test of Cosmetic Ingredients
iv. Technical Guidelines for Reproduction/Development Toxicity Test of Cosmetics
v. Technical Guidelines for Immunotoxicity Test of Cosmetic Ingredients
In 2024, a total of 6 recommended national standards were introduced. Also, according to the National Group Standards Information Platform, 113 cosmetics-related group standards and 12 toothpaste group standards were issued throughout 2024.
In May 2024, the NMPA announced the establishment of the Cosmetics Standardization Technical Committee. The committee members are drawn from various sectors, including regulatory agencies, research institutions, universities, testing organizations, hospitals, and industry associations.
Concurrently, the NMPA issued the Provisions on the Working Procedures for the Formulation and Revision of Cosmetics Standards (Trial).
According to the Provisions, Cosmetic Standard refers to unified technical requirements developed or revised by the NMPA under statutory procedures. They guide activities such as cosmetics production, operation, and supervision. It concludes mandatory national standards for cosmetics, recommended national standards, industry standards, cosmetic safety and technical standards, supplementary testing projects and methods for cosmetics. The process of developing and revising cosmetics standards is fully digitized for efficiency and transparency.
In September 2024, the NMPA released the 2024 Cosmetics Standard Project Plan, comprising 54 projects. Highlights include standards for: Carbomer, Para-phenylenediamine, Hyaluronic acid derivatives, and Collagen-based ingredients.
The secretariat of the Committee annually solicits suggestions for cosmetics standards through the NIFDC's official website. On December 17, 2024, the NIFDC issued a notice inviting proposals for the 2025 cosmetics standards development and revision.
In 2024, new cosmetic ingredients(NCI) continued to break new ground, becoming another major topic following the CPSR in China.
According to data from the NMPA, 90 NCI have been notified for record in 2024, a significant increase compared to 69 last year. Since the implementation of the new policy CASR in China, a total of 207 new ingredients have been successfully notified. Notably, the first-ever whitening agent new ingredient—Isobutylamido Thiazolyl Resorcinol (Thiamidol 630)—was successfully registered this year. This breakthrough has garnered widespread attention across the industry and injected new vitality into ingredient innovation.
Despite the growing interest in NCI notification year on year, it is noteworthy that 13 NCI were either denotified or had their notification canceled this year. The main reason for the cancellations was the inclusion of these ingredients into the Inventory of Existing Cosmetic Ingredient in China. This trend suggests that the management of NCI is a dynamic process, and as regulations continue to improve, companies notifying for NCI must carefully control the definitions and application requirements when submitting documents.
In response to the growing focus on NCI, relevant authorities issued a series of policy documents and official Q&As in 2024, including:
Frequently Asked Technical Questions on New Cosmetic Ingredients (Vol. I)
Frequently Asked Technical Questions on New Cosmetic Ingredients (Vol. II)
In general, these policies aim to strengthen technical guidance services, encourage and support the research and innovation of NCI, enforce corporate responsibility to ensure the quality and safety of ingredients and products, and enhance supervision to promote the healthy development of the cosmetics industry.
On July 8, 2024, the NMPA announced the full implementation of electronic submission for cosmetics (including toothpaste) and new cosmetic ingredient (NCI) registration and notification materials. This measure will be officially implemented starting September 1, 2024, with a transition period provided to ensure it does not disrupt companies currently applying for registration and notification.
Despite the removal of paper submissions, companies must still retain electronic records of these documents for future reviews or inspections. For documents that originally required original copies, third-party certificates, or other paper-based materials, the registrants or notifier (or their Chinese responsible persons) must still certify the authenticity of these materials with their signatures and stamps.
Starting October 1, 2024, the NIFDC optimized and adjusted its consultation services for special cosmetics and new cosmetic ingredient. This includes a comprehensive range of services such as phone consultations, on-site consultations, email inquiries, meetings, remote support, and guidance on important considerations. The goal is to ensure that registrants, notifier, and Chinese responsible persons can quickly receive responses and efficient solutions to any issues they encounter during the registration and notification process for cosmetics and new cosmetic ingredient.
In 2024, the China NMPA signed memorandums of understanding (MOUs) on regulatory cooperation for pharmaceuticals, medical devices, and cosmetics with several countries, including Saudi Arabia, South Korea, Vietnam, and Thailand. These agreements aim to strengthen the exchange and collaboration between China and the relevant countries in the areas of pharmaceutical, medical device, and cosmetic regulation.
In 2024, the NMPA responded to several proposals from the National People's Congress of the People's Republic of China delegates, including:
Response to the Proposal on Improving Anti-Aging Cosmetics Regulations and Standards for High-Quality Development.
Response to the Proposal on Further Optimizing the New Ingredient Approval System for High-Quality Development of the Cosmetics Industry.
These responses reflect China's commitment to strengthening the regulatory framework around new and innovative ingredients like exosomes, which are becoming increasingly important in the cosmetic industry.
In April 2024, the NMPA issued an announcement regarding the safe use of spray sunscreens. The announcement highlighted the risks associated with improper use of these products and provided guidelines on their safe application. According to the Technical Guidelines for Children Cosmetics in China, it is recommended that children avoid the use of spray sunscreens. If it is necessary to use these products, precautions must be taken to minimize inhalation risks. The guidelines recommend labeling the products with warnings such as "Do not spray directly onto the face" and "Avoid inhalation."
In May 2024, the NMPA issued Frequently Asked Questions (FAQs) on the Cosmetics Manufacture and Operation(Vol. II). This addressed the responsibilities of platform operators in disclosing cosmetics label information.
According to the Supervision and Administration Measures on Online Operation of Cosmetics, platform operators are required to disclose cosmetics label information that is comprehensive, truthful, accurate, clear, and timely; ensure that the disclosed label information matches the registration or filing documents for the cosmetic products being sold. The label information must include all details as stated on the product's packaging.
Over the past year, we have witnessed the continuous updates and improvements in industry regulations, faced numerous challenges, and also encountered many opportunities. Looking ahead to 2025, more new regulations are set to be implemented, propelling the industry toward higher standards.
At the core of compliance is a people-centered approach. As we step into the new year, we wish all our industry peers the best of luck, as we work together to contribute to the high-quality development of the cosmetics industry.
*This article is based on our understanding of the 2024 updates to China’s cosmetics-related regulations and policies, intended for learning and reference purposes. any inaccuracies or omissions are found, we welcome your feedback and suggestions. Thank you for your attention and support.
