Introduction
In recent years, China has significantly overhauled its cosmetic regulatory framework, placing greater emphasis on product safety assessment as a key pillar of compliance. With the gradual implementation of the Cosmetics Supervision and Administration Regulation (CSAR) and its supporting guidelines, all cosmetic registrants and notifiers must now navigate increasingly stringent safety reporting obligations.
China's Cosmetic Safety Assessment Reform
According to Article 19 of the CSAR, applicants for special cosmetics registration and general cosmetics notification must submit safety assessment documents. In response, the National Medical Products Administration (NMPA) released the Technical Guidelines for Cosmetic Safety Assessment (2021 Edition), which became fully effective on May 1, 2021. By January 1, 2022, safety assessments conducted in accordance with the Guidelines became mandatory for all product registrations and notifications.
To ease the transition, authorities initially allowed the submission of simplified safety assessment reports until April 30, 2024. However, starting May 1, 2024, only complete safety assessment reports will be accepted—unless specific exemptions apply.
New Optimization Measures Introduced in April 2024
On April 22, 2024, the NMPA issued Announcement No. 50, introducing a more flexible tiered management system for safety assessment reports. Under these rules, certain general cosmetics may submit a “basic safety conclusion” instead of a full report, provided that the complete assessment is internally archived and available for inspection.
Recognizing the lengthy product development cycle, the NMPA also extended the transition period for eligible products: until May 1, 2025, these products may still submit simplified reports under defined conditions.
Simultaneously, the China National Institutes for Food and Drug Control (NIFDC) published several technical guidance documents to support industry implementation, including:
Guidelines for Submission of Cosmetics Safety Assessment Dossiers
Guidelines for Using Cosmetic Ingredient Data
Technical Guidelines for Identification and Assessment of Cosmetic Risk Substances
Technical Guidelines for Application of Threshold of Toxicological Concern (TTC) Method
Why Safety Assessment Matters
Cosmetic safety assessments serve two key purposes:
Ensuring Product Safety
Toxicological data from raw materials—often used across cosmetics, chemicals, and food—are analyzed to verify that the final product is safe under intended use.
Replacing Animal Testing
In line with global efforts to phase out animal testing, China is promoting safety assessments as a scientifically sound alternative. Inspired by the EU’s Cosmetics Regulation (EC No. 1223/2009), which bans animal testing, many countries, including India and Israe,l have followed suit.
When Can Safety Assessment Replace Toxicological Testing?
Under the Provisions for Management of Cosmetic Registration and Notification Dossiers, general cosmetics can waive toxicology test reports if:
The manufacturer holds GMP certification issued by a governmental authority, and
The safety risk assessment confirms product safety.
Exemptions do not apply to:
Products intended for infants or children
Products containing new cosmetic ingredients under safety monitoring
Manufacturers or notifiers listed as key supervision entities by authorities
When Is a Full Report Required?
The new rules divide cosmetics into two main categories:
- Category I: Must submit a full safety assessment report. This includes:
Special cosmetics
Infant or children's products
Products with new ingredients under monitoring
Category II: General cosmetics. There are two different situations depending on whether higher-risk ingredients are used or whether they must be used with devices or tools.
Situation 1: Products that use higher-risk ingredients or must be used with instruments or tools can submit basic safety assessment conclusions, but need to supplement safety assessment data for higher-risk ingredients, devices or tools;
Situation 2: Other general cosmetics except for situation 1 can submit basic safety assessment conclusions.
Acceptable Data Sources for Ingredient Safety
When preparing full reports, the following data types are accepted:
Restricted ingredients, permitted preservatives, permitted sunscreens, permitted colorants and permitted hair dyes listed in China’s Safety and Technical Standards for Cosmetics
Assessment conclusions from international cosmetic safety authorities
Limits or conclusions published by WHO, FAO, or other authoritative organizations
Ingredient usage information of marketed products from regulatory authorities
Historical use (≥3 years)
Safe dietary use
High molecular weight polymers with stable structures and properties (except those with high biological activity)
Who Can Conduct Cosmetic Safety Assessments?
Safety assessors must:
Have a background in medicine, pharmacy, biology, chemistry, or toxicology
Understand cosmetic manufacturing and quality control
Possess at least 5 years of relevant experience
Be capable of independent analysis of chemical and toxicological data
Stay current through regular training in cosmetic safety assessment
REACH24H's Cosmetic Safety Assessment Services
As mandated by the Technical Guidelines for Cosmetic Safety Assessment (2021 Edition) issued by China’s NMPA, all cosmetic products registered or notified in China must undergo a comprehensive safety evaluation. Our standardized safety assessment report includes the following core components:
| No | Section | Description |
| 1 | Product Information | Includes product name, average daily exposure and other information. |
| 2 | Physicochemical & Stability Evaluation | Assesses formulation type (e.g., lotion, powder), appearance, pH (under specified conditions), viscosity, and overall stability under various temperature and humidity conditions. |
| 3 | Microbiological Evaluation | Identifies potential microbial contamination sources and highlights special concerns for children’s, eye, and lip products. |
| 4 | Formulation Design Rationale | Required specifically for children’s cosmetics. |
| 5 | Fragrance Compliance | IFRA certificates or statements conforming to GB/T 22731-2022 (Daily Use Fragrance Standard). |
| 6 | Preservative Challenge Test | Validates the product’s ability to resist microbial growth. |
| 7 | Packaging Compatibility Report | Evaluates potential interactions between the product and packaging materials. |
| 8 | Risk Control Recommendations | Includes warning labels, intended user groups, and usage instructions. |
| 9 | Final Safety Assessment Conclusion | Integrates data from all above sections, as well as human safety evidence such as clinical studies, consumer surveys, and adverse event records. |
| 10 | Assessor’s Signature and CV | To ensure traceability and accountability. |
| 11 | Annexes and References | Includes lab test reports, specifications of potential risk substances, and relevant literature. |
Why Choose REACH24H?
Scientific Expertise
Our safety assessors and toxicologists hold degrees in pharmacy, traditional Chinese medicine, chemistry, and related fields.
Regulatory Experience
We bring years of hands-on experience navigating cosmetic regulations in China, the EU, and other major markets.
Top Laboratory Resources
We collaborate with a network of accredited laboratories worldwide to provide tailored, cost-effective testing solutions.
Multilingual Support
Our team offers services in English, Japanese, and Chinese, delivering responsive support for international clients.
Conclusion
As China aligns more closely with global cosmetic safety practices, companies exporting to or manufacturing in China must adapt to these evolving compliance requirements. Whether you need help drafting full safety assessment reports, reviewing your ingredient data, or identifying exemption opportunities, it’s essential to stay ahead of the curve.
If you’re seeking professional support for China cosmetic regulatory compliance, our team of experts is ready to assist. Please feel free to contact us at customer@reach24h.com.
