China Cosmetic Registration Update: NMPA Rule Changes

What the China Cosmetic Registration Update Changes

China-First Launches May Omit Overseas Proof of Marketing

An international cosmetic product launched first in China, or launched simultaneously in China and other countries or regions, may submit a China-first launch commitment statement instead of evidence that the product has already been marketed in the country or region of the registrant, filing person or manufacturer.

The sales packaging for the country or region of manufacture may also be submitted as a design drawing during registration or filing. This measure may allow international brands to include China in an initial global launch rather than waiting for prior commercialization elsewhere.

Conditional Exemption from Animal Testing

The following products may be exempt from submitting a product toxicological test report:

• Hair-perming products;

• Non-oxidative hair dye products;

• Spot-correcting and whitening products that function solely through physical coverage; and

• General cosmetics containing new cosmetic ingredients, excluding children's cosmetics.

The exemption is not automatic. The manufacturer must hold a qualification certificate relating to its production quality management system, issued by the competent government authority in the country or region where it is located. The product safety assessment must also adequately confirm product safety, including the assessment of ingredients and risk substances, product stability, preservative efficacy and packaging compatibility.

The Announcement therefore provides an exemption from submitting the specified toxicological test report under defined conditions; it should not be interpreted as an unconditional exemption from all safety-testing obligations.

Ingredient Safety Information Moves to Company Records

For cosmetic and toothpaste registration or filing, registrants and filing persons no longer need to enter the ingredient safety information document or ingredient submission code. They must still identify the ingredient manufacturer, while the supporting safety information must be retained by the company for regulatory inspection.

Where the Technical Specification for the Safety of Cosmetics or another applicable technical document specifies quality requirements for an ingredient, the relevant quality specification or test report must still be submitted in the formula section or safety assessment documentation.

For existing products, additions or changes to ingredient manufacturers or ingredient specifications must be updated or submitted as a change in accordance with the applicable dossier-management requirements.

Similar-Formula Products May Share Selected Data

Products under the same registrant or filing person and the same brand may share certain test reports when they meet the applicable definition of a similar formula system.

For safety-related data, a representative product may be used to generate:

• Microbiological and physicochemical test reports;

• Toxicological test reports; and

• Human safety test reports.

The other products must submit a formula-similarity explanation and an assessment confirming that sharing the reports is scientifically justified. Where products are manufactured at different sites, at least one representative product from each site must undergo microbiological and physicochemical testing.

The Announcement establishes separate similarity criteria for safety-data and efficacy-data sharing. For safety data, permitted formula differences are limited to specified components such as colorants, fragrances, pH adjusters, polymeric thickeners and pearlescent agents. The efficacy-data criterion also includes preservatives. Companies should therefore assess the two data-sharing pathways separately.

Additional Simplifications for International Companies

The Announcement also introduces the following changes:

• Cross-border manufacturing-site changes: Existing toxicological, human safety, safety assessment and efficacy evaluation reports may be reused when production is transferred between China and an overseas site, or when an additional cross-border manufacturer is added, provided the registrant or filing person, product name and formula remain unchanged and the applicable standard has not changed substantially. New microbiological and physicochemical testing remains required.

• Efficacy evaluation methods: For claims other than spot correcting and whitening, sun protection and prevention of hair loss, companies may use an applicable industry standard, international standard, technical guideline or validated in-house method, provided there is sufficient scientific support.

• Change of Domestic Responsible Person: Companies no longer need to submit the former Domestic Responsible Person's consent document or a court judgment confirming the change. The new submission must include the authorization letter and its notarized original, a product list, and a commitment that the proposed Domestic Responsible Person will assume the relevant responsibilities, including those for products marketed before the change.

Impact and Recommended Actions for Global Cosmetic Companies

International manufacturers, brand owners and exporters should review the Announcement before changing testing plans or submission strategies.

Recommended actions include:

• Confirm product eligibility before applying any exemption. Product classification, claim mechanism, target users, ingredient status and manufacturer documentation must all be assessed.

• Verify the issuing authority and scope of manufacturing certificates. A commercial GMP certificate may not necessarily satisfy the requirement for documentation issued by a competent government authority.

• Strengthen safety assessment records. Companies relying on a toxicological test report exemption must ensure that all relevant safety endpoints are adequately addressed.

• Establish inspection-ready ingredient files. Reduced online submission does not remove the obligation to maintain reliable and traceable supporting information.

• Map similar-formula portfolios carefully. Safety-data and efficacy-data sharing follow different similarity criteria and require separate scientific justifications.

• Review cross-border manufacturing and Domestic Responsible Person arrangements. Existing data may be reused only where the specified conditions are met, and responsibility for previously marketed products must be addressed clearly.