An Explanation to “Announcement of the National Medical Products Administration on Issuing Several Measures for Optimizing the Management of Cosmetic Safety Assessment”
1.Purpose of “Announcement of the National Medical Products Administration on Issuing Several Measures to Optimize the Management of Cosmetic Safety Assessment” (hereinafter referred to as “Announcement”)
The "Cosmetics Supervision and Administration Regulations (CSAR)" specifically introduced a safety assessment system, which stipulates that "before the registration and notification of new cosmetic ingredients and cosmetics, the registration applicants and notifiers shall conduct safety assessments themselves or entrust professional institutions". In order to implement the relevant provisions of CSAR, the National Medical Products Administration (NMPA) has formulated and issued the “Technical Guidelines for Cosmetic Safety Assessment (2021 Edition)” to guide the industry in carrying out safety assessment work.
Overall, through the implementation of the cosmetics safety assessment system, the awareness and ability of cosmetics enterprises in safety assessment have significantly enhanced, and the level of cosmetics safety assurance in China has generally improved, which is conducive to the high-quality development of the cosmetics industry. At the same time, NMPA focuses on the implementation effect of the safety assessment system, timely grasping the difficulties and challenges reflected by enterprises, such as the lack of evaluation data, the lack of detailed rules for the application of assessment technology, and the need to strengthen the construction of the China domestic safety assessment personnel team. In order to assist and guide enterprises in conducting cosmetic safety assessments, and to solve the problems and difficulties encountered by enterprises in conducting safety assessments, NMPA has organized the drafting of this announcement, aiming to improve the operability of industry safety assessments and the availability of ingredients data, and effectively solve the problems and difficulties that cosmetics enterprises face in conducting safety assessments, without reducing safety standards.
2.Main Content of the “Announcement”
The “Announcement” is divided into two parts: the main text and the appendix. The main body of the text mainly includes two aspects: firstly, implementing classified management of safety assessment materials, clarifying that for ordinary cosmetics that meet the conditions, enterprises can submit basic safety assessment conclusions, and the safety assessment report is archived by the enterprise for future reference. Secondly, considering the long research and development period of cosmetics, a grace period of one year has been set for products that have already been assessed according to the original requirements to avoid duplicate investment in research and development.
The appendix of the “Announcement” is "Several Measures for Optimizing the Management of Cosmetic Safety Assessment ", which mainly involves improving technical guidance, integrating ingredients data resources, innovating assessment report management mechanisms, and promoting the construction of safety assessment systems. The key contents are as follows:
(1)Develop Technical Guidelines to Enhance Evaluation Capabilities of Enterprises.
The first is to develop technical guidelines such as guidelines for Read-across and Threshold of Toxicological Concern (TTC) to help address the safety assessment issues of plant extracts, fermentation materials, and other ingredients with significant safety data gaps. The second is to develop technical guidelines related to three testing s of stability, preservative challenges, and packaging material compatibility, and clarify that enterprises can conduct research through self-built methods, in this case, they can only submit testing or evaluation conclusions, which provides sufficient operational space for the industry.
(2)Integrate Ingredients Data Resources to Solve the Problem of Ingredients data gaps
By collecting, organizing, and publishing internationally authoritative cosmetic safety assessment data, as well as information on the use of ingredients for listed products in the registration and notification system, and receiving historical data on the use of ingredients by enterprises, we can alleviate the problem of missing ingredients data and lay a foundation for the establishment of China's ingredients database in the future. At the same time, develop a "Guidelines for the Use of Cosmetic Ingredients Data" to guide enterprises in the standardized and reasonable use of relevant data, especially the data of 3-year use history and history as safe food of enterprises’ ingredients.
(3)Implement Classified Management of Safety Assessment Data Submission to Enhance Regulatory Efficiency
In order to improve the efficiency of registration and notification work and assist in the improvement and growth rate of product launch, it is necessary to implement classified management of safety assessment data submission based on the level of product risk. On the one hand, for high-risk products such as children's cosmetics, freckle removal and whitening cosmetics, enterprises are required to continue to submit full-version safety assessment reports; On the other hand, for products with lower risks, enterprises can submit basic safety assessment conclusions, and their safety assessment reports should kept by the enterprise for future reference. In addition, it is clear that when enterprises lack a small amount of ingredeints safety assessment data, they can supplement the final product safety testing and use its conclusions along with the safety assessment report as the assessment basis for product safety.
(4)Make a Long-term Plan for Promoting the Construction of the Safety Assessment System
The main focus is on the basic construction of safety assessment, the implementation of enterprise management of the entire product life cycle, the construction of safety assessment disciplines and talent cultivation, as well as the exchange and technical cooperation of safety assessment work, to gradually improve the layout of China's cosmetics safety assessment system.
3.The Reason for Establishing a Classified Submission System for Safety Assessment Reports
Cosmetic safety assessment is an important way for cosmetic registrants and notifiers to fulfill their main responsibility for product quality and safety. Enterprises should conduct safety assessments based on the situation of product and quality management system. The safety assessment work has strong scientificity and professionalism. The adoption of a classified management model mainly considers three aspects: firstly, it highlights the main responsibility of enterprises to guide them to improve their safety assessment system. It neither exempts the responsibility of enterprise on safety assessment nor reduces product safety requirements; Secondly, it improves regulatory efficiency by concentrating limited regulatory resources on the supervision of high-risk products. If regulatory agencies conduct inspections of enterprises and find problems, they will be dealt with in accordance with the law; The third is that the classified submission of safety assessment reports refers to international experience such as the EU's management of safety assessment data, and also conforms to the current development reality of the industry in China.
From National Medical Products Administration
