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【China】China Opens Public Comment on Two Mandatory National Standards for Cosmetic Adverse Reactions

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Editor's note

The body cites the CSAR as the regulatory foundation for these new standards, signaling to buyers that tighter post-market surveillance and adverse reaction reporting obligations are imminent for cosmetic and aesthetic device suppliers in China.

China has released two draft mandatory national standards for public comment, focusing on the evaluation and management of cosmetic cheilitis and cosmetic contact urticaria. These standards aim to clarify adverse reaction criteria and handling norms, reinforcing safety oversight under the Cosmetics Supervision and Administration Regulation (CSAR). For overseas suppliers of aesthetic devices, injectables, and skincare products, this signals tighter post-market surveillance requirements that may affect product compliance and reporting obligations in the Chinese market.

Regulatory context

Since the CSAR took effect on January 1, 2021, China has established a cosmetic adverse reaction monitoring system. Under this system, cosmetic registrants, notifiers, entrusted manufacturers, operators, and medical institutions must report suspected adverse reactions to monitoring institutions, following the "report on suspicion" principle. Other entities and individuals are also encouraged to report. These two new standards provide technical guidance for identifying and managing specific adverse reactions, further strengthening public safety.

Draft standard: cosmetic cheilitis

This document specifies the criteria and handling principles for cheilitis caused by cosmetic use. It aligns with 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. The standard does not impose market-access conditions or trade restrictions, and thus does not require WTO notification. It focuses solely on technical determination and management of this adverse reaction.

Draft standard: cosmetic contact urticaria

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Similarly, this document defines criteria and handling principles for contact urticaria resulting from cosmetic use. It follows the same regulatory alignment and reporting framework as the cheilitis standard. Like the other draft, it does not affect product market access or discriminate against imported products, so no WTO notification is needed. Both standards aim to unify technical approaches across the industry.

What buyers should watch

For importers and distributors of cosmetic products and aesthetic devices in China, these standards highlight the importance of robust post-market surveillance and adverse reaction reporting systems. Suppliers should ensure their products comply with the CSAR’s reporting obligations and consider updating internal protocols to align with the new technical criteria. The public comment period runs from June 15 to August 15, 2026, offering a window for stakeholders to provide feedback.

Sourcing context

These standards are part of China’s broader effort to enhance cosmetic safety regulation since the CSAR. While they do not directly restrict imports, they increase the technical burden on market participants to monitor and report adverse reactions. Overseas manufacturers and brand owners should review their quality management and pharmacovigilance practices to meet these evolving requirements.

Source: Read the original report | Published: June 17, 2026