NMPA Opens Consultation on Two Draft Cosmetic Adverse Reaction Standards: Cosmetic Cheilitis & Cosmetic Contact Urticaria

On June 15, 2026, China's National Medical Products Administration (NMPA) released two draft mandatory national standards for public consultation:

• "Evaluation Criteria and Management Principles for Cosmetic Cheilitis"
• "Evaluation Criteria and Management Principles for Cosmetic Contact Urticaria."

The consultation period is open until August 15, 2026. While a finalized timeline for implementation remains unannounced, these standards will apply to all special and general cosmetics produced or sold within China, including imported goods.

Key Proposals in the Drafts

The two drafts establish proposed national technical criteria for identifying and handling cosmetic cheilitis and cosmetic contact urticaria. Each draft covers:

• Terminology and definitions
• Clinical subtypes
• Judgment criteria
• Severity determination
• Handling principles

The drafts also introduce the following clinical distinctions:

• Cosmetic Cheilitis: Distinguishes between irritant, allergic, phototoxic, and photoallergic types.
• Cosmetic Contact Urticaria: Differentiates between non-immunological and immunological reactions.

Both drafts mandate a specific response pathway: immediately discontinue use of the suspected product, cleanse the affected area, manage the reaction according to clinical principles, and fulfill all required adverse reaction reporting obligations.

Regulatory Impact

The NMPA has indicated that these drafts do not create new obligations for overseas cosmetic registrants or their China Responsible Person, nor are they expected to impose additional administrative burdens on producers and operators.

Despite this, international manufacturers and brand owners should review their current adverse reaction evaluation, handling, and reporting procedures to ensure alignment with these emerging technical criteria.

Submitting Feedback

The current consultation period provides a strategic opportunity for companies to offer technical feedback and verify that their internal cosmetovigilance processes remain compliant with the evolving regulatory landscape in China.

Need assistance? Contact Cisema for expert guidance on interpreting these standards and submitting your feedback.

Further Information

• For broader support regarding cosmetics compliance in China, explore Cisema’s services for cosmetics registration and filing in China.

References

• The General Affairs Department of the National Medical Products Administration is publicly soliciting opinions on two mandatory national standards, including the "Standards for Diagnosis and Treatment Principles for Cosmetic Cheilitis (Draft for Comments)."

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