I. What is the purpose of drafting the NMPA Announcement on Measures to Optimize the Management of Safety Assessment of Cosmetics (“the Announcement”)? 

The Regulations on Supervision and Administration of Cosmetics (“the Regulations”) specifically introduce a safety assessment system. The Regulations stipulate that before registration or filing of new cosmetic ingredients or cosmetics, the applicant for registration and the filing person shall make a safety assessment themselves or entrust a professional agency with such assessment. In order to implement the relevant provisions of the Regulations, the National Medical Products Administration (NMPA) has formulated and issued the Technical Guidelines for Cosmetic Safety Assessment (2021 edition) to guide the industry to carry out safety assessment. 

Generally speaking, the implementation of the cosmetics safety assessment system has significantly improved the safety assessment awareness and capabilities of cosmetics enterprises, thereby enhancing the overall safety level of cosmetics and contributing to the high-quality development of the cosmetics industry. At the same time, the NMPA focuses on the effects of the system's implementation, and pays attention to the difficulties and challenges reported by enterprises, such as the lack of assessment data, the absence of detailed rules for the application of assessment technology, and the need to strengthen team building of domestic safety assessment personnel. To guide and assist enterprises to carry out cosmetic safety assessment and effectively solve the problems and difficulties of cosmetic enterprises in carrying out safety assessment, the NMPA organized the drafting of the Announcement, and strives to improve the operability of industry safety assessment and the availability of raw material data under the premise of not reducing safety standards.

II. What is the main content of the Announcement? 

The Announcement is divided into two parts — the main text and the annex. The main text covers two aspects. First, it stipulates the classified management of safety assessment data, and specifies that for qualified ordinary cosmetics, enterprises can submit basic safety assessment conclusions, with the safety assessment report archived by them for future reference. Second, considering the long research and development (R&D) cycle of cosmetics and to avoid repeated investment in R&D, a one-year transitional period is set for products that have undergone assessment in accordance with the original requirements.

The annex to the Announcement, the Measures to Optimize the Management of Safety Assessment of Cosmetics, mainly involves strengthening technical guidance, integrating raw material data resources, innovating the assessment report management mechanism, and promoting the construction of the safety assessment system. Its highlights are as follows:

1. Developing technical guidelines to enhance enterprise assessment capabilities 

First, the Measures stipulate the formulation of technical guidelines, such as the read-across and the threshold of toxicological concern, to help solve the safety assessment issues of raw materials with significant safety data gaps such as plant extracts and fermentation raw materials. Second, they stipulate the formulation of three technical guidelines related to testing on stability, preservative challenges, and package material compatibility. They also specify that enterprises can carry out research through self-developed methods and submit only testing or assessment conclusions, providing them with sufficient operational flexibility.

2. Integrating raw material data resources to fill the gaps of raw material data 

The Measures clarify the necessity to fill the gaps of raw material data by collecting, sorting and releasing international authoritative cosmetic safety assessment data and the raw material information of products that are included in the registration and filing system and already on the market, as well as by accepting the historical data of raw material provided by enterprises. They will also lay the foundation for the establishment of China's raw material database in the future. Meanwhile, they set out the plan for formulating the Guidelines for the Use of Cosmetics Raw Material Data to guide enterprises in the standardized and rational utilization of relevant data, especially the three-year use history and safe consumption history data of the raw materials of enterprises.

3. Implementing classified management for the submission of safety assessment data to enhance regulatory efficiency

In order to improve the efficiency of registration and filing work and facilitate product marketing, it is necessary to implement classified management for the submission of safety assessment data based on the level of product risks. For products with higher risks, such as children's cosmetics and freckle whitening cosmetics, enterprises are required to continue to submit a complete safety assessment report. For products with lower risks, the enterprise can submit the basic conclusion of safety assessment, with the safety assessment report kept on file by the enterprise itself for future reference. In addition, it is clarified that in cases where there is a lack of safety assessment data for a small amount of raw materials, enterprises can supplement by conducting final product safety testing, with the conclusions included as part of the product safety evaluation, along with the safety assessment report.

4. Making long-term plans to promote the construction of a safety assessment system

The Measures incorporate a layout plan on basic construction of safety assessment, the implementation of enterprise management throughout the product lifecycle, safety assessment discipline development and talent training, as well as exchanges and technical cooperation in safety assessment, so as to improve China's cosmetic safety assessment system.

3. Why establishing a classification system for the submission of safety assessment reports is crucial

Cosmetics safety assessment is an important way for cosmetic registrants and filing persons to fulfill their main responsibilities for ensuring product quality and safety. Enterprises should conduct safety assessments based on the product and quality management system. Safety assessment requires strong scientific and professional expertise. The adoption of a classified management model is mainly considered from three aspects. First, it highlights the main responsibility of enterprises and guides them to improve their safety assessment system, which neither exempts enterprises from the responsibility of safety assessment nor reduces product safety requirements. Second, it improves the efficiency of supervision, focusing limited regulatory resources on the supervision of higher-risk products. The regulatory authorities will deal with any problems found in the inspection of enterprises in accordance with the law. Third, the classification system encompasses international experiences, including those of the European Union, in the management of safety assessment data, and is also in line with the current development of the domestic industry.

一、 《国家局发布关于优化化妆品安全评估管理若干措施的公告》（以下简称《公告》）起草的目的是什么？

《化妆品监督管理条例》（以下简称《条例》）专门引入安全评估制度，规定“化妆品新原料和化妆品注册、备案前，注册申请人、备案人应当自行或者委托专业机构开展安全评估。”为落实《条例》相关规定，国家药监局制定发布了《化妆品安全评估技术导则（2021年版）》，指导行业开展安全评估工作。

总体来讲，通过施行化妆品安全评估制度，化妆品企业的安全评估意识和能力水平显著提升，我国化妆品安全保障水平普遍提高，有助于化妆品行业高质量发展。同时，国家药监局重点关注安全评估制度实施效果，及时掌握企业反映的困难和挑战，如评估数据缺乏，评估技术的应用缺少细化规则、国内安全评估人员队伍建设有待加强等。为了帮助指导企业开展化妆品安全评估工作，解决企业在开展安全评估时的问题和困难，国家药监局组织起草了本公告，力求在不降低安全标准的前提下，提升行业安全评估的操作性和原料数据的获得性，切实解决化妆品企业在开展安全评估工作存在的问题和困难。

二、 《公告》的主要内容是什么？

《公告》分正文和附件两部分。正文部分主要有两方面内容：一是对安全评估资料实施分类管理，明确对于符合条件的普通化妆品，企业可以提交安全评估基本结论，安全评估报告由企业存档备查。二是考虑化妆品的研发周期较长，为避免研发重复投入，对已按照原有要求开展评估的产品设置了1年的过渡期。

《公告》附件为《优化化妆品安全评估管理若干措施》，主要涉及加强技术指导、整合原料数据资源、创新评估报告管理机制、推动安全评估体系建设等内容。其中重点内容如下：

（一） 制定技术指南，增强企业评估能力。

一是制定交叉参照、毒理学关注阈值等技术指南，帮助解决植物提取物、发酵原料等安全数据缺口较大原料的安全评估问题。二是制定稳定性、防腐剂挑战、包材相容性等3个测试相关技术指南，并明确企业可以通过自建方法开展研究，且仅提交测试或者评估结论，给予行业足够的操作空间。

（二） 整合原料数据资源，解决原料数据缺口问题。

通过收集、整理、发布国际权威化妆品安全评估数据、注册备案系统中已上市产品的原料使用信息，接受企业原料使用历史数据，缓解原料数据缺失的问题，也为将来我国原料数据库的建立打下基础。同时，制定《化妆品原料数据使用指南》，指导企业规范合理使用相关数据，特别是企业原料的3年使用历史和安全食用历史数据。

（三） 实施安全评估资料提交分类管理，提升监管效能。

为提升注册备案工作效能，助力产品上市的提质增速，有必要根据产品风险高低对安全评估资料提交实施分类管理。一方面，对于风险较高的产品，如儿童化妆品、祛斑美白类化妆品等产品，要求企业继续提交完整的安全评估报告；另一方面，对于风险较低的产品，企业可提交安全评估基本结论，其安全评估报告由企业留档备查。此外，明确企业在缺少少量原料安全评估数据时，可以补充开展终产品安全性测试，将其结论与安全评估报告一并作为产品安全性的评价依据。

（四） 谋划长远，推动安全评估体系建设。

主要围绕安全评估相关基础建设，落实企业对产品全生命周期的管理，安全评估学科建设和人才培养，安全评估工作交流和技术合作四个方面为我国化妆品安全评估体系的逐步完善谋划布局。

三、 为何建立安全评估报告分类提交制度？

化妆品安全评估是化妆品注册人、备案人落实产品质量安全主体责任的重要途径，企业应当根据产品和质量管理体系情况开展安全评估。安全评估工作具有较强的科学性和专业性。采取分类管理的模式主要考虑三个方面：一是更加突出企业主体责任，引导企业健全安全评估体系，既没有豁免企业安全评估的责任，也没有降低产品安全要求；二是提高监管效能，将有限的监管资源集中于较高风险产品的监管，监管部门对企业开展检查发现问题的，将依法予以处置；三是安全评估报告分类提交参照了欧盟对安全评估资料管理等国际经验，也符合当前国内行业发展实际。