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On July 15, 2026, China's National Medical Products Administration (NMPA) released a draft announcement for public consultation on the implementation of recent revisions to the Safety and Technical Standards for Cosmetics (2015 Edition) (STSC 2015).
The draft announcement clarifies the implementation arrangements and operational requirements for the revised STSC 2015, aiming to provide regulatory certainty for cosmetic registrants and notifiers, ensure a smooth transition, and support product innovation and industry development while maintaining compliance.
STSC 2015 serves as the core technical requirements for cosmetic safety supervision in China. Since their implementation, they have been continuously updated based on regulatory needs and scientific progress, covering prohibited and restricted ingredients, microbial and hazardous substance limits, testing methods, and efficacy evaluation requirements. The latest draft focuses on transition arrangements and provides further clarification on implementation timelines and operational procedures.
For products already on the market, the draft announcement introduces differentiated approaches based on the specific revisions to STSC 2015, aiming to minimize the impact on companies’ normal production and operations while ensuring product safety.
For certain formula adjustments, a simplified change pathway is available. If companies replace relevant ingredients with base materials such as solvents or fillers, or reduce their usage levels, they only need to explain the formula changes and complete a safety assessment, without repeating registration or notification testing. However, if such adjustments affect product efficacy, companies are required to conduct a new efficacy evaluation and update relevant product information, including product names and labels, to ensure the accuracy of efficacy claims.
For adjustments involving microbial limits, hazardous substance limits, or testing methods, the draft announcement allows companies to conduct self-assessments and maintain relevant records independently. Companies are encouraged to evaluate whether their existing registration or notification documents meet the updated requirements. If the existing documents remain compliant, they may update their product implementation standards and retain supporting documents for inspection, without submitting a change application.
In particular, for special cosmetics such as sunscreens, whitening products, and anti-hair loss products, the draft clarifies that products registered before the implementation of the revised requirements do not need to undergo repeated efficacy evaluation tests using the updated methods, avoiding unnecessary duplicate testing and reflecting a science-based and consistent regulatory approach.
For products that have not yet entered the market, the draft announcement balances the integrity of existing registration and notification procedures with flexibility in response to regulatory changes, ensuring a smooth transition between existing and updated requirements.
For products that completed registration or notification testing before the implementation of the STSC 2015 revisions, existing test reports will remain valid during the registration or notification process. This approach recognizes companies'previous compliance efforts and avoids unnecessary duplication of resources.
For products undergoing technical review, the draft allows companies to make formula adjustments during the supplementary document submission stage. Similar to products already on the market, if relevant ingredients are replaced with base materials or their usage levels are reduced, companies may provide explanations and submit safety assessment materials without repeating testing. This provides companies with greater flexibility during the review process and helps them adapt to updated requirements efficiently.
Source: China pharmaceutical News
