Measures to optimize China cosmetic safety assessment management were announced by the National Medical Products Administration (NMPA) on April 22, 2024. The measures are based on the following existing regulations and seek to further improve the safety of cosmetics:
- Cosmetic Supervision and Administration Regulations
- Measures for the Registration and Filing Management of Cosmetics
- Cosmetic Safety Assessment Technical Guidelines (2021 Edition).
- Cosmetic safety assessment data will now be managed in categories, permitting some permitting some qualified general cosmetics to submit basic conclusions of safety assessment, and the Product Safety Assessment Report must be kept on record by cosmetics companies.
- Cosmetic registrants and filers can submit simplified Product Safety Assessment Reports until May 1, 2025. This takes into account the time requirements to obtain documentary evidence.
In addition to the above, welcomed extensions to the PSAR requirements, the NMPA also released information on their plans to introduce various guidelines, principles, systems and indices as well as their desire to open industry communication. Some guidelines may already have been released.
Some of the proposed China cosmetic safety measures:
1. Strengthening Technical Guidance to Enhance Cosmetic Safety Assessment Capabilities:
- Developing and releasing technical guidelines on cross-references, toxicology thresholds, and integration strategies to clarify the scope and procedures of methods used in safety assessments. This aims to improve the applicability and operability of methods, enhancing the application capabilities of cosmetic enterprises through various forms of reference examples.
- Issuing guidelines for identifying and assessing safety risks associated with cosmetic ingredients, guiding enterprises in hazard identification and assessment, thus improving the levels of risk identification, analysis, and control of cosmetic raw materials.
- Releasing technical guidelines on physicochemical stability testing, preservative challenge testing, and packaging material compatibility assessment to provide references for relevant tests or evaluations conducted by cosmetic enterprises.
2. Integrating Raw Material Data Resources to Enhance Accessibility:
- Issuing guidelines for the use of cosmetic raw material data, instructing enterprises to conduct safety assessments based on the principles of evidence weight and using various types of cosmetic raw material data such as those from the Cosmetic Safety Technical Specifications, assessments from international authoritative institutions, and historical usage data of raw materials in marketed products.
- Collecting, organizing, and publishing international authoritative cosmetic safety assessment data indexes and information on the use of raw materials in marketed products, gradually improving the database of cosmetic raw material information, and providing a reference basis for safety assessments conducted by cosmetic enterprises.
- Establishing and improving a raw material data sharing platform, guiding authoritative organizations in the cosmetics industry to coordinate the sharing of safety information on raw materials between raw material enterprises and cosmetic enterprises, gradually building a cosmetics raw material data sharing platform for the entire industry.
3. Innovating Assessment Report Management Mechanisms to Promote Quality and Speed of Product Listing:
- Establishing a system for categorically submitting Product Safety Assessment Reports (PSAR), based on international rules and risk management principles, and considering product and enterprise quality management, to allow certain qualified general cosmetics to submit basic safety assessment conclusions, with the PSAR archived by cosmetic enterprises.
- Clarifying the principles for the application of safety testing for cosmetic end products, guiding enterprises in conducting safety testing for end products that lack individual raw material safety data but meet relevant requirements, using the results as a reference for product safety assessment.
4. Advancing the Creation of Safety Assessment Systems to Improve Product Safety Assurance Levels:
- Strengthening the basis of safety assessment by enhancing scientific research in cosmetics regulation, mobilizing technical forces from various sectors, focusing on basic, cutting-edge, and innovative technical support for cosmetic safety assessment, and promoting the application of new technologies, methods, and standards to continuously improve the scientific and standardized nature of cosmetic safety assessment.
- Implementing the management responsibility of cosmetic enterprises for the entire life cycle of products by guiding enterprises to establish and continuously improve safety assessment systems, strengthen safety assessments before product listing, continuously improve quality management systems, conduct post-market adverse reaction monitoring and safety reassessment, and enhance the ability to ensure product quality and safety.
- Supporting the creation of educational disciplines related to cosmetic safety assessment and the training of professional talents by encouraging universities to offer relevant courses, establishing a sound professional talent training system, developing training materials for cosmetic safety assessment regulations and practices, and promoting the establishment of a safety assessment officer system.
- Strengthening exchanges and technical cooperation in cosmetic safety assessment work by establishing communication and exchange mechanisms related to cosmetic safety assessment, building communication platforms with industry associations, cosmetic enterprises, raw material enterprises, safety assessment institutions, experts, and scholars, and promoting the continuous improvement of safety assessment systems.
Further information
Read the original NMPA announcement on Measures to optimize China cosmetic safety assessment management.
Read our previous article on Guidelines on Cosmetic Ingredient Safety Information via Annex 14.
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