Request a DemoIn 2021, the Cosmetic Supervision and Administration Regulation (CSAR) introduced a new mandatory pre-market requirement—cosmetic safety assessment. As stipulated in the Technical Guidelines for Safety Assessment of Cosmetics (2021), cosmetic registrants and notifiers are required to conduct safety assessments by themselves or entrusting professional institutions and submit safety assessment reports during the registration and notification process.
The establishment of the safety assessment system marks a new phase in China’s cosmetics regulation and indicates China’s efforts to align with international standards in the cosmetics field, fostering greater global integration and competitiveness.
Explore our Featured News: China’s Cosmetic Safety Assessment Regulatory Landscape for essential updates. ChemLinked will continue to provide updates on safety assessment requirements in China. Please stay tuned for the latest information.
Part 1 Regulatory Framework and Competent Authority
1. Major Safety Assessment Regulations and Technical Guidelines
Types | Regulations/Technical Guidelines | Remarks | Effective Date |
Regulations | CSAR is the overarching cosmetic regulation in China. It specifies that cosmetics shall undergo safety assessments before being marketed. | January 1, 2021 | |
It provides samples of full and simplified versions of cosmetic product safety assessment reports, covering cosmetic ingredients and products. | May 1, 2021 | ||
Several Measures to Optimize Cosmetic Safety Assessment Management | This notice consists of four parts: to strengthen technical guidance, to integrate ingredient data resources, to classify assessment reports and manage them accordingly, and to promote the construction of the safety assessment system | May 1, 2024 | |
Technical Guidelines | Index of Cosmetics Safety Assessment Data from Authoritative Organizations | The Index is an objective collection of ingredients that have been used in cosmetics available in China, not included in the Safety and Technical Standards for Cosmetics (STSC), and whose assessment conclusions have been published by authoritative agencies such as SCCS and CIR. | April 30, 2024 |
It serves as a reference for ingredient safety assessments, complementing the Index of Cosmetics Safety Assessment Data from Authoritative Organizations by providing detailed safety data for 999 listed ingredients and 2,879 specific usage entries. | April 10, 2025 | ||
Ingredient Usage Information of Marketed Products (2025 Edition) | The Ingredient Information is an objective collection of ingredients in cosmetics registered and notified validly in China and not included in both STSC and the Index of Cosmetics Safety Assessment Data from Authoritative Organizations. | February 9, 2025 | |
Guidelines for Submission of Cosmetics Safety Assessment Dossiers | This guideline categorizes cosmetics into two main groups based on their risk levels and provides corresponding requirements for safety assessment dossier submission. | April 30, 2024 | |
Technical Guidelines for Identification and Assessment of Cosmetic Risk Substances | This guideline summarizes common types of risk substances in cosmetics along with their limitation requirements. Guided by risk management principles, this guideline refines and categorizes the submission requirements for assessment dossiers concerning these risk substances into several situations. | April 30, 2024 | |
It clarifies the data types that can be used to prove ingredient safety in cosmetic safety assessments, and outlines the principles and requirements for using ingredient data, as well as necessary supporting documents for the assessment. | April 30, 2024 | ||
Technical Guidelines for Application of Threshold of Toxicological Concern (TTC) Method | The TTC Technical Guidelines consists of six sections and four appendices, stipulating the application scope, terminology and definition, substance classification, evaluation procedures, etc. pertinent to the TTC method. | April 30, 2024 | |
The Read-across Technical Guidelines consists of five sections and two appendices, and outlines the application scope, basic principles, as well as the evaluation procedures of Read Across, along with a flowchart and an example of its application in cosmetic safety assessments. | April 30, 2024 | ||
Technical Guidelines for Stability Testing and Assessment of Cosmetics | This guideline specifies the test requirements, test methods and result evaluation for cosmetic stability testing. | July 8, 2024 | |
Technical Guidelines for Preservative Challenge Testing and Assessment of Cosmetics | This guideline prescribes the test methods for cosmetics preservative challenge testing, as well as the requirements for equipment, materials, culture mediums and reagents, test strains, and procedural standards. | July 8, 2024 | |
Technical Guidelines for Compatibility Testing and Assessment of Cosmetics with Packaging Materials | This guideline provides instructions on the requirements, test methods, and result evaluation for conducting compatibility evaluation between cosmetic contents and the containers/carriers in direct contact with them. | July 8, 2024 | |
This guideline is applicable to the skin sensitization assessment of cosmetic ingredients. | July 8, 2024 |
2. Competent Authority
Currently, there are two main authorities managing safety assessment regulation in China:
National Medical Products Administration (NMPA): NMPA is established under the governance of the State Administration for Market Regulation (SAMR). It is responsible for reviewing and approving the registration and notification of cosmetics and new cosmetic ingredients (including safety assessment) in China.
National Institutes for Food and Drug Control (NIFDC): To better facilitate the implementation of the safety assessment system, China NIFDC continues to introduce a series of supporting technical guidelines, providing a data and methodological basis for safety assessment.
Part 2: Safety Assessment Requirements
1. Background
According to the Technical Guidelines for Cosmetic Safety Assessment 2021 (hereinafter referred to as the Technical Guidelines), before the registration or notification of new cosmetic ingredients or cosmetic products, the registrant or notifier is required to conduct a safety assessment on their own or through professional institutions and submit safety assessment reports. Safety assessment documents shall be updated in a timely manner as needed and kept for at least 10 years after the expiration of the last batch of marketed products. Additionally, as the Technical Guidelines outlines:
Cosmetic ingredient: Ingredient safety is the precondition of cosmetic product safety. The risk assessment of cosmetic ingredients includes the assessment of ingredients themselves and the risk substances that may be brought in.
Cosmetic product: Cosmetic products are generally recognized as a combination of various ingredients. All the ingredients and risk substances shall be assessed. If certain ingredients are confirmed to be linked with chemical and/or biological and other interactions, the risk substances generated and/or the potential safety risk arising from the interactions shall be assessed.
2. Safety Assessment Report Submission Requirements
2.1 Submission Requirements by Cosmetic Category
On April 30, 2024, the NIFDC released the Guidelines for Submission of Cosmetics Safety Assessment Dossiers. The submission guideline categorizes cosmetics into two main groups based on their risk levels, with corresponding safety assessment dossier submission requirements. The specific classification requirements are as follows.
Category I Cosmetics: Special cosmetics, infant and children’s cosmetics, and those with new cosmetic ingredients under safety monitoring period.
Category II Cosmetics: This category encompasses all other cosmetics and is subdivided based on ingredient risk and whether it should be used with instruments or tools. Please refer to the table below for specific product types.
For Category I cosmetics, safety assessment reports are mandatory. For Category II cosmetics, enterprises may either submit safety assessment reports or provide safety assessment conclusions along with supporting materials. Besides, the safety assessment reports shall be archived for future reference.
Classification | Product Type | Submission of Safety Assessment Dossiers | ||
Basic Requirements | Additional Requirements | |||
Category I Cosmetics |
| Safety assessment report | ||
Category II Cosmetics | Situation 1 | i. Cosmetics added with nano ingredients | Enterprises can choose any of the following methods: Option 1: Submit safety assessment conclusions and specific assessment materials (if any) and archive the safety assessment report for future reference. Option 2: Submit the safety assessment report | Safety assessment dossiers for nano ingredients |
ii. Non-sunscreen cosmetics added with sunscreen agents that are not listed in Table 5 of the STSC as light stabilizers | Safety assessment dossiers for light stabilizers | |||
iii. Cosmetics with claims of anti-acne, anti-wrinkle (except physical anti-wrinkle), deodorant, anti-dandruff, depilating, and exfoliation (except physical exfoliation) efficacies | Safety assessment dossiers for the functional ingredients in efficacy claims | |||
vi. Cosmetics in the form of patches or films, cosmetics containing base materials (those contain functional raw materials or pigments), or aerosols | Safety assessment dossiers for functional ingredients/colorants contained or propellants | |||
v. Cosmetics that must be used with instruments or tools (except brushes, air cushions, perming tools, etc. that only assist in the application of the cosmetics). | Safety assessment dossiers on the mechanism of action of the instrument or tool on the cosmetic product and its impact on product safety. | |||
Situation 2 | General cosmetics other than Situation 1 in Category II Cosmetics | / | ||
2.2 Timeline for Full Safety Assessment Reports
The Technical Guidelines specified that, starting from January 1, 2022, cosmetic registrants and notifiers shall submit product safety assessment documents when applying for special cosmetics registration or general cosmetics notification. Considering that there is a gap between the safety assessment capacity of China’s cosmetic industry and that of the developed countries, China’s NMPA introduced transitional measures, allowing registrants and notifiers to submit a simplified version of the product safety assessment report before May 1, 2025. With the transition period concluded, the full version is now mandatory.
Additionally, enterprises can submit their safety assessment reports through the Cosmetics Intelligent Application and Review System, per the Guidelines for Filing in the Full Version of Cosmetic Safety Assessment Materials released by the NIFDC.
3. Qualification Requirements for Safety Assessors
According to the Technical Guidelines, cosmetic safety assessors shall meet the following requirements:
Have professional knowledge of cosmetics quality and safety, e.g., medicine, pharmacy, biology, chemistry, or toxicology, etc., understand the cosmetic or ingredient production process and quality and safety control requirements, and have more than five years of relevant professional working experience;
Be able to consult and analyze literature information related to chemistry and toxicology, etc., and analyze, assess, and interpret relevant data;
Be able to analyze cosmetics’ safety fairly and objectively, and conduct safety assessments based on a comprehensive analysis of all available data and exposure conditions; and be responsible for the scientificity, accuracy, authenticity, and reliability of the assessment report.
Be able to, by receiving corresponding professional training and other ways regularly, learn related safety assessment knowledge, understand and master new safety assessment theories, techniques, and methods, and apply them in practice.
Part 3 Safety Assessment Reports
1. Cosmetic Ingredient/Product Safety Assessment Report
According to the Technical Guidelines, the contents of safety assessment reports of cosmetic ingredients and products are listed as follows.
Type | Main Contents |
Cosmetic Product Safety Assessment Report | 1. Abstract 2. Product introduction 3. Product formula (including all ingredients and their percentages in descending order) 4. Formula design principles (only for children’s cosmetics) 5. Safety assessment of each ingredient in the formula: hazard identification, dose-response assessment, exposure assessment, and risk characterization 6. Assessment of possible risk substances 7. Risk control measures or recommendations (such as warning, application methods, and target users) 8. Safety assessment conclusions, generally including the product’s physical and chemical stability assessment conclusions; the product’s microbiological stability assessment conclusions; human safety data, including clinical data, consumer use research, adverse reaction records; testing conclusions, and assessment conclusions of each ingredient) 9. Signature of the safety assessor 10. Resume of the safety assessor, including the assessor’s educational experience, cosmetic industry experience, professional training experience, etc. 11. References 12. Annexes, including testing reports, proof of involved ingredients quality specifications, etc. |
Cosmetic Ingredient Safety Assessment Report | 1. Abstract 2. Ingredient’s physical and chemical properties 3. Safety assessment process: hazard identification, dose-response assessment, exposure assessment, risk characterization 4. Analysis of assessment results, including the analysis of the completeness, reliability, and scientificity of the documents in the assessment process and data uncertainty analysis. 5. Risk control measures or recommendations 6. Conclusion of safety assessment 7. Signature of the safety assessor 8. Resume of the safety assessor, including the assessor’s educational experience, cosmetic industry experience, professional training experience, etc. 9. References 10. Annexes, including testing reports, proof of involved ingredients specifications. If there is any risk substance, the risk substance assessment conclusion and documents or the risk substance testing report shall be provided. |
2. Full Safety Assessment Report
There are two major differences between the full and simplified versions safety assessment report. First, in the full version of the safety assessment report, the Inventory of Existing Cosmetic Ingredients in China 2021 (IECIC) is not considered as a type of evidence anymore. Second, the full version includes an assessment of both physical and chemical stability of the product (i.e., stability testing and compatibility testing with packaging materials), as well as microbiological assessment (i.e., preservative challenge testing).
Types | Simplified Version | Full Version |
Acceptable evidence | According to Technical Guidelines, evidence that can be used in the simplified version of safety assessment report:
If none of the above three types of evidence can be used for assessments:
| The Guidelines for Use of Cosmetic Ingredient Data clarifies seven types of ingredient data that cosmetic registrants and notifiers can use for safety assessments. Historical use concentration from the enterprise and IECIC is not considered a type of evidence. Accepted evidences include:
|
Additional tests | Microbiological testing Heavy metal testing Risk substance testing | Microbiological testing Heavy metal testing Risk substance testing Stability testing Compatibility testing with packaging materials Preservative challenge testing |
Further reading:
News:
CSAR Subsidiary Regulations: China Details Cosmetic Safety Assessment Requirements
China Unveils the Finalized Guidelines for Cosmetics Safety Assessment Dossiers Submission
FAQs:
FAQs Vol. 19 | China Answers Questions about Cosmetic Safety Assessment Requirements
FAQs Vol. 20 | China Clarifies the Identification and Assessment of Cosmetic Risk Substances
Free webinar:
Decoding the Full Version of Safety Assessment in China: Regulatory Updates and Changes
