Most of the cosmetic raw materials are chemicals, and their quality and use methods directly determine the quality and safety of cosmetics. Special inspections on the use of cosmetic raw materials (hereinafter referred to as "special inspections of raw materials") are of great significance for ensuring the quality and safety of cosmetics. In order to fully implement the requirements of “strengthening the compliance inspection of the use of cosmetic raw materials” in the “Thirteenth Five-Year” National Drug Safety Plan, the Food and Drug Inspection Center of the State Drug Administration in 2019 cooperated with the State Drug Administration in the distribution of cosmetics manufacturers. 12 more provinces have carried out inspections of cosmetic raw materials, and the inspections in the remaining provinces are organized by the Provincial Drug Administration. This article conducts a statistical analysis of the special inspections of the use of raw materials for 24 companies organized by the Food and Drug Inspection Center of the State Drug Administration in 2019, and makes recommendations.
Implementation of special inspection of raw materials
The special inspection of raw materials is based on the "Work Regulations for Cosmetics Production Licensing" and "Cosmetic Safety Technical Specifications (2015 Edition)", focusing on the inspection of the company's raw material quality management system, raw material supplier management, raw material procurement and purchase inspection, raw material storage and use, etc., and the company The compliance awareness of relevant personnel in the use of raw materials and their ability to control the quality of raw materials. In order to ensure the effectiveness of inspections, special inspections are carried out by way of unannounced inspections.
Among the 24 production enterprises inspected, according to scale statistics, 13 are larger enterprises and 11 are small and medium-sized enterprises; according to statistics, 19 are private enterprises and 5 are foreign or joint ventures.
Basic situation of raw material usage management in cosmetics manufacturing enterprises
The special inspection of raw materials found that most cosmetics manufacturers are basically able to purchase, inspect, manage and use raw materials in a relatively standardized manner.
2.1 Raw material quality management system
The 24 cosmetics manufacturers have established basic raw material quality management systems, including raw material supply management, certificate and invoice, inspection management, release management, production process management, and non-conforming product management systems. Some companies can start with product development and formulate "raw material quality specifications" (safety data) agreements with raw material manufacturers for functional compound materials such as preservatives, freckle whitening agents, and plant extracts; for plant extracts, Know the extraction process of plant extracts in advance and formulate relevant testing standards; the quality management department attaches importance to the identification, evaluation and control of prohibited and restricted substances and risk substances.
2.2 Raw material supplier management
All 13 large-scale cosmetics manufacturers have established supplier screening, evaluation and management systems, which can collect supplier information in advance, establish supplier files, and conduct on-site inspections of important raw material suppliers. Some other companies conduct on-site inspections of key raw material suppliers, conduct on-site audits, evaluations and selections of suppliers, and implement quality assurance agreements with raw material suppliers, and impurity and hazardous substances limit requirements to suppliers. Source control of impurities and harmful substances.
2.3 Raw material procurement and purchase inspection management
Most of the 24 cosmetics manufacturers have formulated procurement plans, procurement lists, procurement agreements, procurement contracts and other procurement documents, and purchase in accordance with the procurement documents. For the purchased raw materials, companies can review the chemical technical data sheet (Chemicals Technical Data Sheet, CTDS), chemical safety data sheet (MSDS), and certificate of analysis (COA) of the raw materials. ) And other related information.
2.4 Raw material storage and use management
Most companies can basically store raw materials in accordance with requirements and start production according to approved recipes. During the inspection, no use of banned raw materials, unapproved new raw materials, or excessive use of restricted raw materials by cosmetic manufacturers was found.
Statistical analysis of problems found in special inspection of raw materials
A total of 113 defective items were found in the special inspection of raw materials. Among them, 20 items were seriously defective, accounting for 17.7%. According to the proportions of the four major aspects of raw material quality management, the defective items are raw material storage and use, quality management system implementation, raw material procurement and purchase inspection, and supplier management (Figure 1).
3.1 Implementation aspects of raw material quality management system
The inspection found that 15 companies had problems in the implementation of the raw material quality management system, including: relevant personnel did not effectively perform their duties, materials and product release were not implemented in accordance with regulations, substandard products were not stored as required, personnel training was not in place, and documentation Imperfect management, etc. (Figure 2). A total of 28 defective items were found in the implementation of the raw material quality management system, accounting for 24.78% of all defective items found, of which 14 were seriously defective items. The problems involved in serious defects are shown in Table 1.
3.2 Management of raw material suppliers
It was found that 9 small and medium-sized enterprises had 11 general defects in the management of raw material suppliers, accounting for 9.73% of all defects found, mainly including: failure to evaluate suppliers, incomplete audit files of some raw material suppliers, and lack of system Provisions on supplier selection, changes or additions, etc.
3.3 In terms of raw material procurement and purchase inspection
It was found that 12 companies had 21 general defective items in raw material procurement and purchase inspection, accounting for 18.58% of the total number of defective items found, mainly including: incomplete request for evidence, missing items in the raw material management ledger, and lack of correctness There are research and judgment of risky substances, failure to master the extraction process of plant extract materials, lack of inspection standards, and incomplete inspection records.
3.4 The storage and use of raw materials
A total of 52 defective items in the storage and use of raw materials were found in 22 companies, accounting for 46.02% of the total number of defective items found, including 10 serious defective items. Among them, the major defect items are the lack of identification and evaluation of possible risk substances in raw materials or incomplete evaluation. General defect items are mainly concentrated in the aspects of incomplete raw material labeling information, raw materials not stored in accordance with conditions, untimely return, and water equipment that does not meet the standards.
3.5 The raw material compliance awareness and quality control ability of relevant personnel of the company
3.5.1 Not familiar with the relevant regulations of raw materials
Except for the person in charge of quality, most companies do not know enough about the "Regulations on Cosmetics Hygiene Supervision", "Cosmetic Safety Technical Specifications", "Materials Licensing Work Inspection Points" and other regulations and normative documents; most employees cannot clearly distinguish "New raw materials", "prohibited components", "restricted components" and other concepts; individual employees of foreign-funded enterprises have little knowledge of domestic cosmetics regulations.
3.5.2 Weak awareness of raw material safety risks
Most small and medium-sized enterprises basically do not understand the process flow of compound raw materials and animal and plant extracts, and have not established relevant quality standards; for the few enterprises that have established standards for such raw materials, their standard items are also limited to color, appearance, smell, etc. Indicators, inadequate identification and evaluation of possible risk substances in raw materials.
Suggestions on the management of cosmetic raw materials
The quality of raw materials is the source of cosmetics quality. The "Regulations on the Supervision and Administration of Cosmetics" will be promulgated soon, and the enhancement of the concepts and methods for the management of cosmetic raw materials will become an important guarantee for the promotion of cosmetic raw materials management. It is recommended to take this as an opportunity to strengthen the following aspects of work.
4.1 Further improve and strictly implement the company's raw material management system
To achieve the compliance management of raw materials, the establishment of a complete raw material quality management system is the prerequisite, and strict and effective implementation is the key. Enterprises should implement their main responsibilities, and strengthen management for key issues such as personnel failure to perform their duties, failure to label and store raw materials and products, and failure to reasonably evaluate risk substances, and timely rectification and improvement, so that the quality management system is truly implemented.
4.2 Regulatory authorities should promote risk material assessment and strengthen management and control capabilities
Risk material assessment is the technical support to ensure the safety of raw materials. At present, most companies have not considered the risk substances that may exist in the raw materials, and the identification and evaluation of the risk substances in the raw materials is not sufficient; in addition, the identification of the safety risk substances of the raw materials is highly professional, and the specific implementation and operation have certain difficulties. Therefore, the regulatory authorities should strengthen the assessment of safety risk substances, and further improve the cosmetic risk assessment procedures and requirements by formulating and issuing guidance documents, so that manufacturers have standards to follow, thereby enhancing the ability to control risk substances.
4.3 Strengthen the promotion and training of relevant laws and regulations, and enhance the company's awareness of raw material use compliance
After the "Regulations on the Supervision and Administration of Cosmetics" is promulgated and implemented, the regulatory authorities should carry out targeted publicity of the relevant laws and regulations of cosmetic raw materials, increase the publicity and implementation of the relevant laws and regulations of enterprises and employees, and strengthen the ability of enterprises to implement the main responsibility and consciously comply with the laws and regulations; At the same time, companies must strictly implement the personnel training system, train raw material-related staff to ensure that they are familiar with relevant regulations, and enhance employees' awareness of raw material use compliance.
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