Measures for Optimizing the Management of Cosmetic Safety Assessment

In order to guide the cosmetics industry to improve its ability and level of cosmetic safety assessment, standardize the implementation of cosmetic safety assessment work, and promote the orderly implementation of the cosmetic safety assessment system, in accordance with regulations such as the “Cosmetics Supervision and Administration Regulations (CSAR)”, the “Management Measures for Cosmetics Registration and Notification”, and the “Technical Guidelines for Cosmetic Safety Assessment (2021 Edition)” (shorted as the "Guidelines"), the following measures are formulated.

1.More Technical Guidance to Enhance the Ability of Cosmetic Safety Assessment

(1)Technical guidelines related to Read-across, Threshold of Toxicological Concern (TTC) and integration strategies, etc. will be developed and published, to clarify the scope of application and assessment procedures of the methods, improve the applicability and operability of the methods, and enhance the application ability of safety assessment methods in cosmetics enterprises through various forms such as example reference.

(2)“Technical Guideline for Identifying and Assessing Risk Substances in Cosmetics” will be developed and released, guiding cosmetics companies to identify and assess potential hazards of safety risk substances in cosmetics, and improving the level of risk identification, risk analysis, and risk prevention and control of cosmetic ingredients.

(3)Technical guidelines for physical and chemical stability testing, preservative challenge testing, packaging compatibility testing and evaluation, etc. will be developed and released, to provide reference for cosmetic enterprises to carry out relevant testing or assessment. Cosmetic companies can conduct relevant research on product stability, anti-corrosion system, packaging material compatibility, etc. based on national standards, technical specifications, industry standards, international standards, technical guidelines, or their own methods, and submit relevant testing or assessment conclusions in the safety assessment report.

2.Integrate Ingredients Data Resources to Improve the Convenience of Using Ingredients Data

(4)“Guidelines for the Use of Cosmetic Ingredient Data” will be developed, guiding cosmetic companies to conduct safety assessments with different types of cosmetic ingredients data, such as the “Safety and Technical Standards for Cosmetics”, assessment data from international authoritative agencies, and the history of ingredients used for marketed products, in accordance with the requirements of the “Guidelines” and the principle of Weight of Evidence ( WoE ).

(5)Data and information related to the safety assessment of cosmetic ingredients will be integrated and released. International authoritative cosmetic safety assessment data indexes, as well as information on the use of ingredients for marketed product will be collected, organized, and published, to gradually improve the cosmetic ingredients information database, and provide reference basis for cosmetic enterprises to carry out safety assessments.

(6)An ingredients data sharing platform will be built and improved, to guide authoritative organizations in the cosmetics industry to coordinate the sharing of ingredients safety information between cosmetic ingredients enterprises and cosmetic enterprises, conduct cosmetic ingredients safety assessments in accordance with internationally recognized methods, gradually building a cosmetic ingredients data sharing platform for the entire industry.

3. Innovate Management Mechanism of Assessment Report to Promote Product Quality Improvement and Growth Rate on the Markets

(7) Establish a classification and submission system for safety assessment reports. We should refer to international regulations and based on risk management principles, combined with product and enterprise quality management to formulate the guidelines for submitting safety assessment materials for cosmetics. The submission of safety assessment reports is classified, and some eligible common cosmetics are allowed to submit basic safety assessment conclusions. The safety assessment reports are archived and kept by cosmetics enterprises for future reference.

(8) Clarify the applicable principles for safety testing of cosmetics end products, guide cosmetic companies to conduct safety testing on cosmetic end products that meet relevant requirements in the absence of individual ingredient safety data, and use the results as a reference for product safety assessment.

4. Promote the Construction of Safety Assessment System and Improve the Level of Product Safety Assurance

(9) Strengthen the infrastructure construction related to safety assessment. Strengthen scientific research on cosmetics regulation, and fully mobilize technical forces from all sectors of society in order to focus on researching the fundamental, cutting-edge and innovative technological support for cosmetics safety assessment, and strengthen the transformation and application of new technologies, methods and standards, so as to continuously improve the scientificity and standardization of cosmetics safety assessment.

(10) Implement the Management Responsibility of Cosmetics Enterprises for Entire Product Life Cycle (PLC). To guide enterprises to build and continuously improve the safety assessment system, strengthen pre-market safety assessments, and promote the quality management system, monitor adverse reactions and safety re-assessment after product launch, and enhance the capabilities of product quality and safety assurance.

(11) Support the construction of cosmetics safety assessment disciplines and the cultivation of professional talent teams. Encourage universities to set up courses related to cosmetics safety assessment and improve the professional talent training system. Organize the development of training materials, carry out cosmetics safety assessment regulations and practical training, and promote the establishment of a safety assessor system.

(12) Strengthen the exchange and technical cooperation of cosmetics safety assessment work. Establish a communication and exchange mechanism related to cosmetics safety assessment, and establish a communication platform with industry associations, cosmetic enterprises, cosmetic ingredients enterprises, safety assessment institutions, experts and scholars, and promote the continuous improvement of safety assessment system.

From National Medical Products Administration