On June 15, 2026, China’s National Medical Products Administration (NMPA) released for public comment two mandatory national standards:
- Evaluation criteria and principles of management of cosmetic cheilitis (Draft for Comment); and
- Evaluation criteria and principles of management of cosmetic contact urticaria (Draft for Comment).
The two standards clarify the criteria for determining, and the norms for handling, two categories of cosmetic adverse reactions, further reinforcing the safeguards for public use of cosmetics. The public comment period runs from June 15 to August 15, 2026.
CIRS Group has compiled the main contents of the drafts for your reference.
Background
Since the Cosmetics Supervision and Administration Regulation (CSAR) took effect on January 1, 2021, China has established a cosmetic adverse reaction monitoring system.
Cosmetic adverse reactions refer to lesions of the skin and its appendages, as well as local or systemic damage to the human body, arising from consumers' normal use of cosmetics.
Cosmetic registrants and notifiers, entrusted manufacturers, cosmetic operators, and medical institutions that identify adverse reactions potentially associated with the use of cosmetics shall report them to cosmetic adverse reaction monitoring institutions; meanwhile, other entities and individuals are encouraged to report adverse reactions potentially associated with the use of cosmetics to cosmetic adverse reaction monitoring institutions and the drug regulatory departments. The Measures for the Supervision and Administration of Cosmetics Production and Operation stipulate that the reporting of cosmetic adverse reactions follows the principle of “report on suspicion.”
Both national standards are intended to technically clarify the criteria and handling principles for cosmetic adverse reactions, providing technical support for cosmetic adverse reaction monitoring and helping to elevate the level of public cosmetic-use safety.
Evaluation criteria and principles of management of cosmetic cheilitis (Draft for Comment)
Scope
- This document specifies the criteria and handling principles for cosmetic cheilitis.
- This document applies to cheilitis caused by the use of cosmetics.
Relationship with relevant laws, administrative regulations, other mandatory standards, and supporting recommended standards
Relationship with relevant laws, administrative regulations, and other mandatory standards:
Pursuant to the CSAR, cosmetic registrants and notifiers, entrusted manufacturers, cosmetic operators, and medical institutions that identify adverse reactions potentially associated with the use of cosmetics shall report them to cosmetic adverse reaction monitoring institutions. Other entities and individuals are encouraged to report adverse reactions potentially associated with the use of cosmetics to cosmetic adverse reaction monitoring institutions or the drug regulatory departments.
This document aligns the criteria and handling principles for cosmetic adverse reactions with current relevant laws, regulations, rules, and standards, including the CSAR, the Measures for the Supervision and Administration of Cosmetics Production and Operation, and the Measures for the Administration of Cosmetic Adverse Reaction Monitoring, and complies with the relevant provisions on national standardization management.
Recommended transitional period between the date of publication and the date of implementation of the mandatory national standard
A transitional period of 12 months is recommended between the date of publication and the date of implementation of this standard.
Recommendation and rationale on whether external notification is required (a rationale shall be provided regardless of whether notification is made)
No external notification is required. This document primarily specifies the criteria and handling principles for cosmetic cheilitis. As it sets out technical determination and handling requirements and does not involve product market-access conditions, trade-restriction measures, or differential treatment of imported products, it has a limited impact on domestic and international trade and therefore does not require WTO notification.
Evaluation criteria and principles of management of cosmetic contact urticaria
Scope
- This document specifies the criteria and handling principles for cosmetic contact urticaria.
- This document applies to contact urticaria caused by the use of cosmetics.
Relationship with relevant laws, administrative regulations, other mandatory standards, and supporting recommended standards
Relationship with relevant laws, administrative regulations, and other mandatory standards:
Pursuant to the CSAR, cosmetic registrants and notifiers, entrusted manufacturers, cosmetic operators, and medical institutions that identify adverse reactions potentially associated with the use of cosmetics shall report them to cosmetic adverse reaction monitoring institutions. Other entities and individuals are encouraged to report adverse reactions potentially associated with the use of cosmetics to cosmetic adverse reaction monitoring institutions or the drug regulatory departments.
This document aligns the criteria and handling principles for cosmetic adverse reactions with current relevant laws, regulations, rules, and standards, including the CSAR, the Measures for the Supervision and Administration of Cosmetics Production and Operation, and the Measures for the Administration of Cosmetic Adverse Reaction Monitoring, and complies with the relevant provisions on national standardization management.
Recommended transitional period between the date of publication and the date of implementation of the mandatory national standard
A transitional period of 12 months is recommended between the date of publication and the date of implementation of this standard.
Recommendation and rationale on whether external notification is required (a rationale shall be provided regardless of whether notification is made)
No external notification is required. This document primarily specifies the criteria and handling principles for cosmetic contact urticaria. As it sets out technical determination and handling requirements and does not involve product market-access conditions, trade-restriction measures, or differential treatment of imported products, it has a limited impact on domestic and international trade and therefore does not require WTO notification.
CIRS Reminder
Since the CSAR came into force, China has established a cosmetic adverse reaction monitoring system, and industry stakeholders must strictly implement the “report on suspicion” reporting requirement. The two national standards will provide a unified technical basis for adverse reaction monitoring, further standardize the entire workflow of identifying and handling adverse reactions, and comprehensively strengthen the safety of public cosmetic use.
Relevant enterprises may, with reference to the two draft standards and the detailed criteria for determining adverse reactions and the handling norms set out therein, comprehensively review and optimize their internal processes for the identification, recording, reporting, and subsequent risk handling of cosmetic adverse reactions; improve supporting management systems and operational procedures in advance; actively make use of the comment-feedback window to submit recommendations; complete compliance arrangements ahead of time; and effectively guard against subsequent regulatory risks.
About CIRS
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, R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.
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.
Our Services
- China Cosmetics Registration and Filing
- China New Cosmetic Ingredients Registration and Filing
- China Toothpaste Filing
- Cosmetics Safety Test
- Cosmetics Efficacy Claims Test
- Micrological analysis
- Physicochemical Analysis
- Being a Domestic Responsible Person
- Safety Assessment Report
- Cosmetic Ingredient Quality and Safety Info Code Application
- Formula/Label/Ingredient Review
- Regulatory Consulting/Reporting/Training
- Custom Clearance
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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