We have collected the latest FAQs on ordinary cosmetics filing from the Guangzhou Administration for Market Regulation and translated them into English for your reference.

1. How to Ensure the Smooth Implementation of the Cosmetic Safety Assessment System?

In 2010, the release of the Guidelines for Risk Assessment of Potential Safety Risk Substances in Cosmetics officially introduced the concept of safety risk assessment into China’s cosmetic regulatory framework. In 2013, China’s national drug regulatory authority issued the Notice on Adjustments to the Registration and Filing Management of Cosmetics, which explicitly allowed domestically produced non-special use cosmetics to adopt a risk assessment approach for safety evaluation.

In 2021, China’s National Medical Products Administration (NMPA) formulated and released the Technical Guidelines for Cosmetics Safety Assessment (2021 Edition) (hereinafter referred to as the "Guidelines"), providing industry guidance on conducting safety assessments. The Guidelines aim to ensure product safety while aligning with industry development needs. To facilitate a smooth transition, the cosmetic registrants and filers are permitted to submit a simplified product safety assessment report in accordance with the Guidelines' requirements before May 1, 2024.

In 2024, China’s NMPA issued the Announcement on Several Measures to Optimize the Management of Cosmetic Safety Assessment (2024 No. 50), aiming to assist enterprises in conducting comprehensive safety assessments. This announcement introduces two key measures:

• Classification Management of Safety Assessment Documentation: For eligible general cosmetics, enterprises are allowed to submit only the basic safety assessment conclusion, while the full safety assessment report must be kept on file for future inspection.
• One-Year Transition Period for Products Assessed Under the Simplified Safety Assessment Requirements: Considering the long R&D cycle of cosmetics and to avoid redundant investment, a one-year transition period has been granted for products that have already undergone safety assessment based on the simplified version requirements. Until May 1, 2025, such products can still submit the simplified safety assessment report.

2. What is the significance of the cosmetic safety assessment system?

Cosmetic safety assessment is an essential framework established by the Cosmetics Supervision and Administration Regulations. It serves as a crucial measure to urge and guide enterprises in fulfilling their primary responsibility for product quality and safety, thereby ensuring consumer safety. By implementing the cosmetic safety assessment system, safety risks are prevented and minimized at the source, encouraging enterprises to upgrade their products and drive technological innovation. This has significantly enhanced the awareness and capability of cosmetic enterprises in conducting safety assessments, leading to an overall improvement in China’s cosmetic safety assurance standards and promoting the high-quality development of the industry.

Furthermore, cosmetic safety assessment is not only a domestic regulatory requirement but also an important bridge for international cooperation and exchange. By gradually establishing a safety assessment system aligned with international standards, China’s cosmetic industry can build a strong reputation in the global market and enhance its international competitiveness.

3. If a product that has submitted a simplified safety assessment report and completed filing undergoes changes after May 1, 2025, does the simplified report need to be replaced with a full safety assessment report?

According to the requirements outlined in the Announcement on the Technical Guidelines for Cosmetic Safety Assessment (2021 Edition) (NMPA Announcement No. 51, 2021) and the Announcement on Several Measures to Optimize the Management of Cosmetic Safety Assessment (NMPA Announcement No. 50, 2024), for products that have submitted a simplified safety assessment report and completed filing, there is no need to replace the simplified report with a full safety assessment report when making dossier modifications after May 1, 2025.

4. How does Guangzhou encourage cosmetic enterprises to implement the cosmetic safety assessment system?

Guangzhou has launched multi-channel mobilization and training support services while providing a series of preferential measures for pioneering enterprises:

• Fast-Track Processing: Establishing a green channel to prioritize the organization of product filing documents and expedite the public disclosure of filing information.
• Technical Support: Coordinating technical institutions to prioritize the acceptance and execution of toxicological, compatibility, stability, and preservative challenge tests.
• Optimized Evaluation Services: Allowing enterprises to schedule face-to-face consultations with evaluation institutions and receive one-on-one guidance from assessment experts.
• Incentive Mechanisms: Publicly recognizing and commendating enterprises that take the lead in conducting full-version safety assessments, while granting them priority invitations to participate in regulatory policy discussions.

5. How does Guangzhou supervise registrants to ensure the implementation of the cosmetic safety assessment system?

In 2024, the Guangzhou Municipal Administration for Market Regulation organized policy briefing sessions on cosmetic safety assessment for key enterprises within its jurisdiction. The administration also proactively engaged with major cosmetic registrants to gain a comprehensive understanding of their compliance status.

At the same time, regulatory officials and technical experts were mobilized to conduct special inspection and service actions focused on cosmetic safety assessment. On-site policy dissemination was carried out to clarify regulatory requirements, and enterprises were guided on standardizing their safety assessment practices. By adopting an approach of "enforcement through inspection and improvement through service," the administration aims to shift enterprises away from a passive "wait-and-see" mindset and encourage proactive compliance. Enterprises are urged to plan ahead and steadily implement the new cosmetic safety assessment regulations to ensure a smooth transition.

About CIRS

The CIRS cosmetic team is dedicated to ensuring that cosmetic products meet the stringent regulatory standards around the globe. It can provide one-stop services covering the whole life-cycle of a personal care product, which includes cosmetic ingredient development, physical/chemical tests, toxicological tests (in vivo & in vitro), efficacy studies (in vivo & in vitro), ingredient registration, and product registration.

Cosmetic services in China:

• China Cosmetic Registration and Filing;
• China New Cosmetic Ingredient Registration and Filing;
• China Cosmetic Ingredient Quality and Safety Information Code Application (NMPA Code);
• China Cosmetics Safety and Efficacy Test;
• China Cosmetic Safety Assessment Report;
• China Toothpaste Filing;
• China Disinfectant Notification; and
• China Cosmetic Formula/Label/Claim Review

If you need any assistance or have any questions, please get in touch with us via test@cirs-group.com.

Further Information

https://scjgj.gz.gov.cn/zmhd/cjwt/pthzpba/content/post_10027660.html