Implementing Electronic Cosmetics Registration Certificate to Raise the Threshold for Inspection Agencies
my country's cosmetics industry has entered the era of strong supervision
□ Our reporter Wan Jing
Recently, a series of normative policy documents related to the standardized management of cosmetics production and operation have been issued intensively or are brewing, sending a strong signal to all sectors of society: the era of strong supervision of my country's cosmetics industry is coming.
These documents include: The State Drug Administration recently issued an announcement stating that from October 1, 2022, special cosmetics and new cosmetic ingredients approved for registration in accordance with the "Administrative Measures for Registration and Filing of Cosmetics" (hereinafter referred to as the "Measures"), and approved For special cosmetics whose registration certificate has been changed or renewed, an electronic registration certificate will be issued.
The previously issued paper registration certificate will continue to be valid during its validity period.
In mid-August, in order to standardize the qualification accreditation of cosmetic inspection and testing institutions, the State Food and Drug Administration publicly solicited opinions from the public on the "Qualification Accreditation Conditions for Cosmetics Inspection Institutions (Draft for Comment)" (hereinafter referred to as the "Draft for Comments").
The "Draft" requires that inspection agencies should establish and implement a management system suitable for the cosmetics inspection activities they carry out, and have management personnel and key technical personnel suitable for the inspection activities carried out.
On July 1, the "Cosmetics Production Quality Management Specification" (hereinafter referred to as the "Specification") was officially implemented.
The "Specifications" not only put forward basic requirements for quality management of cosmetic registrants, filers, and entrusted production enterprises in the production process, but also more stringently investigate and punish the upstream producers of the cosmetic industry.
Implement electronic cosmetic registration certificate
The issuance of electronic registration certificates to cosmetics-related enterprises is an inevitable result of my country's strengthened supervision of the cosmetics market in recent years.
On January 1, 2021, the new "Cosmetics Hygiene Supervision Regulations" (hereinafter referred to as the "Regulations") were officially implemented, marking a new page in my country's cosmetics supervision work.
The "Regulations" put forward the system of cosmetics registrants and filers for the first time in combination with the actual supervision. It is clear that the cosmetics registrants and filers shall bear the main responsibility for the claims of cosmetic quality, safety and efficacy. To ensure the continuous stability of product quality and safety.
On May 1 of the same year, the "Measures" came into effect.
This is my country's first departmental regulation specifically for cosmetics registration and filing management.
The "Measures" further clarified the optimized and adjusted registration and filing management procedures, and fixed the reform in the form of regulations on the basis of summarizing the results of reform measures such as the reform of the approval and filing of imported non-special-purpose cosmetics in the early stage and the approval of the extension of the commitment system for the administrative license of special-purpose cosmetics. measure.
For example, before it is clear that ordinary cosmetics are listed or imported, the filing person will complete the filing after submitting the filing materials through the information service platform in accordance with the requirements of the State Food and Drug Administration.
Dong Shufen, technical director of China Fragrance, Flavor and Cosmetics Industry Association, pointed out that the establishment of the registrant and filing system is to solve the problem of uneven product quality in the cosmetics market.
The registrant who has obtained the cosmetic registration certificate or the filing person who has passed the cosmetic filing, puts the product on the market in his own name, that is, he is responsible for the quality, safety and efficacy of the whole life cycle of the product, and fulfills the relevant obligations of pre-marketing registration and filing management. Perform post-marketing adverse reaction monitoring, evaluation and reporting, product risk control and recall, re-evaluation of product and raw material safety and other related obligations, and assume the main responsibility for the quality and safety of registered products.
Raise the barriers to entry for inspection agencies
In recent years, with the development of the national economy and the improvement of people's living standards, my country's cosmetics industry has also grown and expanded under the impetus of consumer demand.
At present, there are more than 5,400 licensed cosmetic manufacturers, more than 87,000 registered and filed entities for various types of cosmetics, and nearly 1.6 million valid registered and filed products.
The scale of the cosmetics market continues to expand, the related inspection demand continues to rise, and the number of inspection institutions increases rapidly.
Along with the establishment of a large number of cosmetic inspection agencies, the chaos of some unqualified inspection qualifications, failure to carry out inspections in accordance with the prescribed methods, and issuance of false inspection reports also began to appear.
In March of this year, the State Food and Drug Administration issued the "Notice on the Disposal of the Results of the Capability Evaluation of Cosmetics Registration and Filing Inspection and Testing Institutions", which showed that 46 testing institutions were suspended from using the cosmetics registration and filing inspection information system, and 12 institutions were required to conduct Rectification, a total of 58 cosmetics testing institutions failed the assessment.
Most of these notified institutions have problems such as irregular testing work, inadequate testing equipment, lack of relevant qualifications for personnel, and arbitrary charges.
Therefore, it is imperative to control the cosmetics market access and regulate cosmetics inspection agencies.
The "Draft" makes clear requirements for cosmetic inspection agencies in terms of organizational structure, management system, inspection capabilities, personnel, facilities and environment, equipment and other aspects.
Among them, for the personnel engaged in cosmetics inspection and testing, the requirements of the "Draft" can be described as "strict": it stipulates that inspection agencies shall not employ personnel who have already worked in other cosmetic inspection agencies, that is, inspection agencies are required not to work part-time; The inspection agency for the safety and efficacy evaluation and inspection shall be equipped with two or more (including two) with dermatology-related professional medical practitioner qualification certificates; it is stipulated that personnel engaged in cosmetics inspection activities shall hold certificates, and the inspection personnel shall have intermediate or above (including The proportion of personnel with intermediate) professional and technical titles or equivalent abilities shall not be less than 20%.
The "Draft" also mentioned that inspection agencies should have experimental sites and environmental facilities that are compatible with the cosmetics inspection activities they carry out, and have independent control and use rights over them.
The basic facilities and working environment of an inspection agency shall meet the requirements of inspection methods, normal operation of instruments and equipment, storage of technical files, preparation and storage of samples, prevention of cross-contamination, guarantee of personal health and environmental protection.
The inspection area and the office area should be set up independently.
In this regard, Yang Weidong, a professor at the National School of Administration, pointed out that inspection agencies are like "referees" of cosmetic quality. If their level is too poor, the evaluation will be unfair, unfair or even falsified, which will not only damage the rights and interests of consumers, but also affect the entire cosmetics inspection industry. In other words, there is a risk of "bad money drives out good money".
The "Draft" raises the entry threshold for the cosmetics inspection and testing industry from the rigid requirements of ability assessment, professional title, and certification, which also means that the industry's demand for professionals will greatly increase.
Clarify the main responsibility of production and operation
my country's supervision and management of cosmetics covers all aspects from raw materials to production and operation activities.
The "Specification" is to put forward the basic requirements for quality management of cosmetic registrants, recorders, and entrusted production enterprises from the production process: establish a production quality management system, and realize the whole process of purchasing, production, inspection, storage, sales and recall of cosmetic materials. Control and traceability to ensure continuous and stable production of cosmetics that meet quality and safety requirements.
According to the requirements of the "Specification", enterprises should establish and implement a traceability management system, formulate clear batch management rules for raw materials, internal packaging materials, semi-finished products, and finished products, and all records related to the production of each batch of products should be related to each other to ensure material procurement, product production. , quality control, storage, sales and recalls are all traceable.
Enterprises shall set up production workshops according to the production process flow and environmental control requirements, and shall not change the functional area division of production workshops without authorization.
There should be no pollution sources in the production workshop, and the flow of materials, products and personnel should be reasonable to avoid pollution and cross-contamination.
Due to historical reasons, in the relevant regulations of cosmetics supervision, the main body of corporate responsibility is often expressed as "manufacturing enterprise", "producer" or "cosmetics manufacturer", "cosmetics distributor" and "cosmetics operator", not only the expressions are not uniform, It is not clear what responsibilities should be assumed by the participants in various production and business activities in terms of product quality and safety.
The reporter found that in response to the above-mentioned problems, the "Specification" not only clarifies the responsibilities and obligations of the main bodies in all aspects of cosmetics production and operation, but also makes the investigation and punishment of violations of upstream producers in the cosmetics industry more severe. It not only requires enterprises to independently set up quality management departments, The establishment of a cosmetic quality and safety responsibility system further clarifies the responsibilities of the legal representative (or the main person in charge), the person in charge of quality and safety, the person in charge of the quality management department, the person in charge of the production department, and other positions related to the quality and safety of cosmetics.
It is worth noting that, according to data from the State Food and Drug Administration, since January 2022, at least hundreds of companies have cancelled their cosmetics production licenses.
From the perspective of production scale, the vast majority of these enterprises are small and micro enterprises, and in terms of production type, most of them are cleaning and skin care enterprises.
Industry insiders believe that under the overall situation of the new strong supervision, my country's cosmetics industry may be reshuffled.