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On September 14, 2024, China National Medical Products Administration (NMPA) released the draft of Administrative Measures on Cosmetic Safety Risk Monitoring (hereinafter referred to as "Measures"), open for public comment until October 8. 1
The Measures applies to the safety risk monitoring of cosmetics and toothpaste, excluding special monitoring conducted due to emergencies. It consists of 30 articles across six chapters: general provisions, plan formulation, sampling and inspection, investigation and handling, application of monitoring results, as well as supplementary provisions.
The Measures aims to replace the Working Rules for Cosmetic Risk Monitoring implemented in January 2018. Compared to the current Rules, the draft Measures provides more detailed and comprehensive guidelines for cosmetic risk monitoring. The key points of the Measures are as follows.
1. Clarifying responsibility division and monitoring objectives
Cosmetics risk monitoring refers to the inspection and testing activities of medical products administration (MPA) departments to monitor, analyze and effectively manage risk factors that may impact the quality and safety of cosmetics. The goal is to identify and prevent safety risks, thus to provide a scientific basis for developing quality and safety control measures, conducting sampling inspections, and communicating potential safety concerns.
The Measures outlines the responsibilities of NMPA and local MPAs:
NMPA is responsible for overseeing national risk monitoring management, establishing a national risk monitoring information system, and formulating a national risk monitoring plan. This plan should be possible to identify potential risks and provide a scientific basis for the formulation and revision of standards;
Provincial and local MPAs are responsible for risk monitoring within their administrative regions, focusing primarily on identifying potential risks.
2. Specifying key monitoring products and items
Risk monitoring prioritizes cosmetics that are widely circulated, frequently used, with high risk, or associated with numerous supervision issues. Based on actual situation, the following seven items will be monitored:
1. Substances commonly added to cosmetics that may pose risks to human health;
2. Substances added or brought into cosmetics that have caused harm to human health abroad;
3. Substances that could affect the health of vulnerable groups, such as children;
4. Substances identified in regulatory practices or specified in literature that may influence cosmetic safety;
5. Risk substances introduced through raw materials or generated during the production and use of cosmetics;
6. Items involved in the standards to be formulated or revised;
7. Other critical monitoring items.
3. Defining risk monitoring process
The Measures outlines the risk monitoring process, which includes the following steps: sampling, inspection and testing, result reporting, investigation and handling, risk control, and case filing.
Sampling should be conducted at the cosmetics operation stage through purchase, either on-site or online. The number of samples should generally meet inspection and testing requirements. The sampling units and personnel must not notify cosmetics operators in advance.
Sampling information must at least include the name of the sampled cosmetics operator, sampling address, product name, as well as the name and address of cosmetics registrant/notifier.
If all samples pass inspection, the testing institution should submit a testing report to the MPA within seven working days. If any non-compliant samples are identified, the testing institution must submit relevant materials to the MPA within two working days. The MPA will then assess the problematic samples, investigate safety risks associated with the cosmetics, and implement necessary risk control measures. If any manufacturer or operator is suspected of legal violations, a case will be filed for investigation.
4. Application of monitoring results
MPAs will implement the following risk management measures based on specific circumstances:
Situation | Measures |
Incomplete monitoring data, with uncertainty about potential safety risks | Continue risk monitoring of relevant items and collect additional monitoring data |
Potential safety risks identified, with manufacturers suspected of illegal activities | Exclude these items from this product’s routine risk monitoring, and supervise cosmetic safety through sampling inspections or regular oversight |
Potential safety risks not directly related to the product, possibly due to misuse or impurities | Enhance communication with consumers and the industry, facilitating information exchange about cosmetic safety risks |
Potential safety risks identified, with standards deemed inadequate | Formulate or revise relevant cosmetic standards, or provide recommendations for their development and revision |
Potential safety risks present, but no official testing methods for prohibited ingredients or substances that may endanger human health | Develop supplementary testing methods |
NMPA shall coordinate with the Cosmetics Standardization Technical Committee and local MPAs to formulate and revise standards annually based on the results of risk monitoring.
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