1. What was the purpose of drafting the Announcement of the National Medical Products Administration on Several Measures to Optimize Cosmetic Safety Assessment Management (hereinafter referred to as the "Announcement")?
The Cosmetics Supervision and Administration Regulation (hereinafter referred to as the "Regulation") specifically introduces a safety assessment system, stipulating that "before new cosmetic raw materials and cosmetics are registered or filed, the registration applicant or filing person shall conduct a safety assessment on their own or entrust a professional institution to carry out the assessment." To implement the relevant provisions of the Regulation, the National Medical Products Administration has formulated and issued the "Technical Guidelines for Cosmetic Safety Assessment (2021 Edition)" to guide the industry in conducting safety assessment work.
Generally speaking, through the implementation of the cosmetic safety assessment system, cosmetic companies' awareness of safety assessment and their capability levels have significantly improved, and the level of cosmetic safety assurance in China has generally risen, which is conducive to the high-quality development of the cosmetics industry. At the same time, the National Medical Products Administration focuses on the implementation effects of the safety assessment system and promptly grasps the difficulties and challenges reported by enterprises, such as the lack of assessment data, the lack of detailed rules for the application of assessment techniques, and the need to strengthen the development of the domestic safety assessor workforce. In order to help guide enterprises in carrying out cosmetic safety assessment work and solve the problems and difficulties they encounter in conducting safety assessments, the National Medical Products Administration organized the drafting of this announcement, striving to improve the operability of industry safety assessment and the availability of ingredient data without lowering safety standards, and to effectively solve the problems and difficulties existing in cosmetic companies' safety assessment work.
II. What are the main contents of the Announcement?
The Announcement consists of two parts: the main text and the attachments. The main text mainly covers two aspects: first, it implements classified management of safety assessment materials, clarifying that for ordinary cosmetics meeting the conditions, enterprises may submit a basic conclusion of the safety assessment, and the safety assessment report shall be kept by the enterprise for record and inspection. Second, considering the relatively long R&D cycle of cosmetics, to avoid duplicate investment in R&D, a one-year transition period has been set for products that have already been assessed in accordance with the original requirements.
The attachment to the Announcement is the Several Measures for Optimizing Cosmetics Safety Assessment Management, which mainly involve strengthening technical guidance, integrating raw material data resources, innovating the management mechanism for assessment reports, and promoting the development of the safety assessment system. The key contents are as follows:
(1) Develop technical guidelines to enhance enterprises' assessment capabilities.
First, formulate technical guidelines such as read-across and toxicological threshold of concern to help address the safety assessment issues of raw materials with large safety data gaps, such as plant extracts and fermentation-derived ingredients. Second, formulate three test-related technical guidelines, including stability, preservative challenge, and packaging material compatibility, and clarify that enterprises may conduct research through self-established methods and only submit test or assessment conclusions, giving the industry sufficient operational space.
(2) Integrate raw material data resources to address the raw material data gap issue.
By collecting, organizing, and publishing internationally authoritative cosmetic safety assessment data and ingredient-use information for products already on the market in the registration and filing system, and by accepting historical ingredient-use data from enterprises, [we] alleviate the problem of missing ingredient data and lay the foundation for the future establishment of our country's ingredient database. At the same time, the Guidelines for the Use of Cosmetic Ingredient Data are formulated to guide enterprises in the standardized and rational use of relevant data, especially the data on the three-year use history and safe consumption history of enterprise ingredients.
(3) Implement classified management of security assessment data submissions to improve regulatory effectiveness.
To improve the efficiency of registration and filing work and help enhance the quality and speed of product launches, it is necessary to implement classified management of the submission of safety assessment data based on product risk levels. On one hand, for higher-risk products, such as children's cosmetics and anti-spot and whitening cosmetics, enterprises are required to continue submitting complete safety assessment reports; on the other hand, for lower-risk products, enterprises may submit the basic conclusions of the safety assessment, while the safety assessment report is kept on file by the enterprise for inspection. In addition, it is clarified that when enterprises lack a small amount of raw material safety assessment data, they may supplement this by conducting safety testing of the final product, and use its conclusions together with the safety assessment report as the basis for evaluating product safety.
(4) Plan for the long term and promote the development of a safety assessment system.
It mainly revolves around four aspects—safety assessment-related infrastructure, implementation of enterprises' management of products across the full life cycle, development of the safety assessment discipline and talent cultivation, and safety assessment work exchange and technical cooperation—to plan and lay out the gradual improvement of China's cosmetics safety assessment system.
III. Why establish a classified submission system for safety assessment reports?
Cosmetics safety assessment is an important means for cosmetics registrants and filers to implement the primary responsibility for product quality and safety. Enterprises should conduct safety assessments based on the product and quality management system conditions. Safety assessment work is highly scientific and professional. The adoption of a classified management model mainly considers three aspects: First, more prominently highlight the primary responsibility of enterprises and guide enterprises to improve their safety assessment systems, neither exempting enterprises from safety assessment responsibilities nor lowering product safety requirements; Second, improve regulatory effectiveness, concentrate limited regulatory resources on the supervision of higher-risk products, and where regulatory authorities identify problems during inspections of enterprises, they will handle them in accordance with the law; Third, the classified submission of safety assessment reports draws on international experience such as the EU's management of safety assessment data, and also conforms to the current realities of domestic industry development.
Original title: Policy Interpretation of the Announcement of the National Medical Products Administration on Issuing Several Measures to Optimize Cosmetic Safety Assessment Management》
