The "Regulations on Supervision and Administration of Cosmetics" will come into effect on January 1, 2021. On September 28, the State Food and Drug Administration again issued three supporting management measures for soliciting comments. Among them, the "Cosmetics Production Quality Management Regulations (Draft for Comment)" (hereinafter referred to as the "Draft for Comments") was issued to resolve the current three major issues facing China’s cosmetics industry: product quality improvement, industrial upgrading, and lack of consumer confidence. Supervise quality, standardize production behavior, ensure the safety of consumer makeup, and promote the healthy and sustainable development of China's cosmetics industry. Reading through the "Draft for Solicitation of Comments", you will find that the focus of control lies in the raw material management, traceability system, semi-finished product management, and commissioned production of cosmetics manufacturers , Illegal addition and other key links.

　　1. Solve three major problems

　　After more than 30 years of development, China's cosmetics industry has quickly entered a beautiful era. The increasing demand in the cosmetics market will inevitably bring huge room for industrial development. Cosmetics are health products, which are related to people's livelihood and popular sentiment. The rapidly growing demand is in sharp contrast with the small and chaotic industry structure. With the improvement of consumer safety awareness and self-protection awareness, more cosmetics quality and supervision are proposed. High demands.

　　The status quo of cosmetics manufacturers in China: large-scale enterprises have better plant facilities, faster replacement of production equipment, higher automation, and more standardized quality management systems; medium-sized enterprises are equipped with basic production facilities and equipment, inspection instruments for routine inspection items, and quality management systems The framework has been formed, but the operation situation is not optimistic; some small enterprises are sales-oriented, pay more attention to product development, and do not pay enough attention to quality management. There are problems of poor production environment, insufficient production facilities, equipment, and inspection conditions. Quality management personnel Not taken seriously, lack of technical personnel, and many defects in the quality management system. In terms of the number of cosmetics companies, SMEs account for the majority, but the total output value is mainly concentrated in large companies. Since the implementation of "Inspection Points for Cosmetics Production Licensing" (hereinafter referred to as "Inspection Points"), the entry barriers for enterprises have been raised, and the requirements for quality management have increased. Cosmetic manufacturers have established quality management institutions, introduced talents, system design, and system development. The investment in resources for operation, internal review, and external training has increased significantly.

　　Current status of cosmetics supervision in my country: The "Inspection Points" absorbs the whole-process supervision and risk management concepts, and integrates inspection standards such as the "Hygiene Regulations for Cosmetics Manufacturers (2007 Edition)" and "Implementation Rules for the Renewal (Issuance) of Cosmetics Product Licenses". "Inspection Points" improved the supervision level of supervisors and helped supervisors discover outstanding quality management problems in cosmetics companies in terms of institutions and personnel, materials and products, production management, etc., hitting the quality management of most manufacturers at present Weak underbelly, forcing enterprises to reform and upgrade, prompting the industry to become more standardized. However, some problems were discovered during the implementation of the "Inspection Points", such as consignment production, intermediate product management, raw material management, and traceability management. Some companies felt "powerless" and "unable to do" in the face of common problems in the industry. At the same time, supervisors have different levels of understanding of the "Inspection Points" and the implementation standards are not uniform, which affects the credibility of supervision.

　　The current situation of consumer demand for cosmetics in my country: The demand for cosmetics from domestic cosmetics consumers has risen from the budding state twenty or thirty years ago to a relatively mature stage. The development of the Internet has realized the real-time sharing of information and solved the barriers of information asymmetry. At the same time, overseas shopping and global shopping have matured consumers' aesthetic and quality needs for cosmetics in advance. The maturity of consumers has far exceeded that of domestic cosmetics. The growth rate of production enterprises.

　　In summary, no matter from the demand side, the supply side or the supervision side, the release of the cosmetics production quality management norms as soon as possible is already on the line.

　　To formulate cosmetics production quality management regulations, there are three key issues to be solved: one is to integrate quality risk management into the cosmetics production quality management system; the second is to combine the progress of the cosmetics industry and the current regulatory status to form a nationwide operable cosmetics production Quality management standards ensure that the inspection standards of all provinces (autonomous regions and municipalities) remain relatively uniform; the third is to make cosmetics production quality management standards in line with the development trend of China’s cosmetics industry and at the same time in line with the international advanced level.

　　2. Grasp the overall structure

　　It is understood that the "Draft for Comments" drafting research group focused on the general idea of ​​"highlighting the characteristics of cosmetics, combining with the actual development of the cosmetics industry, and learning from international advanced concepts and experience", combining quality risk management, full life cycle management and other concepts through the seminar , Questionnaire surveys, expert interviews, opinion solicitation and other methods to carry out subject research, systematically analyze and sort out the domestic cosmetics regulatory system and related regulations, and fully learn from the laws and regulations and advanced experience of developed countries and regions to make the relevant provisions of the "Draft for Comments" It is consistent with the relevant provisions of the upper law and is in line with the international advanced level, which is operability and forward-looking. A number of research reports have been completed at the same time, such as: research on domestic cosmetics regulatory regulations and standard systems, research on foreign cosmetics industry development and regulatory changes, cosmetics industry market survey research reports, cosmetic production license inspection and unannounced inspection analysis reports, and special topics on cosmetics production quality management standards For surveys (companies and regulators), the research team drafted the "Draft for Soliciting Comments" on the basis of the survey report.

　　The "Draft for Solicitation of Comments" consists of nine chapters and seventy-seven articles, including general rules, institutions and personnel, quality management, quality control, plant facilities and equipment, materials and products, production management, product sales management, and appendices. The main content is shown in the table below:

　　The chapters of the "Draft for Comment" are set up reasonably, which reflects the basic requirements of the classic quality management theory for the quality management system. The three levels of quality planning, quality control, and quality improvement are organized in an orderly manner, interlocking and echoing each other; clause distribution The details are appropriate and the key points are prominent.

　　Three, seize the seven highlights

　　The "Draft for Comment" released this time reflects the requirements of the above three aspects as a whole, and has the following seven characteristics:

　　First, the "Draft for Comment" incorporates concepts such as risk management and full life cycle management. For example, Article 19 stipulates: "Enterprises shall implement quality and safety risk management, conduct quality risk assessment on key links in the production process, and formulate corresponding monitoring measures based on the assessment results and implement them effectively."

　　Second, the "Draft for Comment" further clarifies the qualifications and responsibilities of key personnel, and implements the main responsibility of the enterprise. As stipulated in Article 8: “The legal representative of the enterprise (or the main person in charge, the same below) is the primary responsible person for cosmetics production quality management, and shall be responsible for providing necessary resources, reasonable planning, organization and coordination, and ensuring that the enterprise realizes the quality policy and aims."

　　Third, distinguishing from drugs, highlight the characteristics of cosmetics and reflect risk adaptability. Cosmetics belong to the fashion industry, and product updates and upgrades are relatively fast. Common cosmetics are subject to filing management. Therefore, the management mode and drugs should be distinguished. The "Draft for Comments" differs from pharmaceuticals in terms of environmental control requirements and verification in the production workshop. As shown in Annex 2, the "Environmental Requirements for Cosmetics Workshops" divides the environment into clean areas, quasi-clean areas, and general areas. At the same time, the environmental indicators of each area are clarified, so that both the enterprise and the supervisor have implementation standards.

　　Fourth, the "Draft for Comments" puts forward more scientific and reasonable requirements in software to ensure the quality of cosmetics production. As stipulated in Article 17: “Enterprises should establish and implement a traceability management system, formulate clear batch number management rules for materials and finished products, and each batch of products should have corresponding batch numbers and production inspection records to ensure product production, quality control, storage and Logistics and other activities can be traced.” Traceability management is an important means of tracing product quality problems, and it is also the basis for quality improvement. The implementation of traceability management will enhance the quality management concept and level of cosmetics manufacturers.

　　Fifth, the "Draft for Solicitation of Comments" puts forward specific and clear requirements for the current outstanding problems in the cosmetics industry, such as co-line production, semi-finished product management, commissioned production, raw material management, illegal addition, etc., which is more adapted to the needs of industry development and supervision. For example, Article 30 stipulates that “non-cosmetic products that adversely affect the quality of cosmetics shall not be produced in the cosmetics production workshop. The raw materials used in the non-cosmetic products meet the requirements of the relevant regulations and specifications of cosmetic raw materials, and the quality specifications can be produced on the same line as the cosmetics. Provide a management system and risk analysis report to ensure the safety of cosmetics.” Article 49 stipulates that “a company that purchases semi-finished products directly for filling, the manufacturer of the semi-finished product purchased shall obtain a cosmetics production license, and overseas production companies shall obtain a local The relevant qualification certification of the production quality management system of the regulatory agency.” Article 75 clarifies the responsibilities and obligations of the entrusted production parties, and provides specific and powerful control measures for solving the current cosmetics entrusted production chaos.

　　Sixth, the "Draft for Solicitation of Opinions" is linked to the "Inspection Points" and is operable. The "Draft for Solicitation of Comments" draws on some of the provisions of the "Inspection Points" that have a better implementation effect, enhances the legal status of the corresponding points and standards, and reduces the cost of hardware transformation of cosmetics companies as much as possible.

　　Seventh, it is in line with the international advanced level and is forward-looking. The "Draft for Comment" fully draws on the laws, regulations and advanced experience of developed countries and regions, such as American cosmetics GMPC, European ISO22716, Japanese cosmetics regulatory policy, ASEAN cosmetics directive, etc. For example, Annex 1 "Requirements for Electronic Records of Cosmetics Production" represents the requirements of advanced cosmetics manufacturers and the development trend of cosmetics production automation. It is forward-looking, plans for the future, and has a long-term layout.

　　Of course, the promulgation of cosmetics production quality management norms did not happen overnight. At present, the production level of my country's cosmetics manufacturers is quite different, and the quality management level is uneven. The use of the same standard to require all cosmetics companies is bound to be full of resistance and objections. Only when there is pressure can there be motivation. After more than 20 years of standardization and transformation in my country's drug production, the quality has been recognized by the international market, and the products are exported overseas. I believe that with the promulgation of the cosmetics production quality management norms, the quality of cosmetics supervision in my country will be greatly improved, the production behavior of cosmetics will be standardized, the safety of consumer cosmetics will be guaranteed, and the healthy and sustainable development of China's cosmetics industry will be promoted.

　　(Author's unit: Zhejiang Medical College)