With the prolonged ups and downs of the epidemic in COVID-19, the market demand for disinfection products has continued to grow, and new situations and problems have emerged in disinfection products’s production and sales. In this issue, we introduce a case of operating disinfection products without a new disinfection products health permit approval document, and let’s see how the health supervision department finds problems, accurately identifies and solves problems in daily work, and protects consumers’ health rights and interests according to law.
Case introduction
In August, 2021, the supervision office of Shanghai Municipal Health and Wellness Committee received an investigation letter from the health administrative department of Z City (hereinafter referred to as "investigation letter"). The investigation letter said that a "Y disinfection spray" was found, and the enterprise provided a health and safety evaluation report with the product name "Y object surface disinfectant", which was suspected to be unqualified in health and safety evaluation. The manufacturer of the above products is Company A in Shanghai, and the responsible unit is Company B in Shanghai. The Shanghai Municipal Health and Wellness Committee Supervision Office conducted on-site supervision and inspection on the two companies the next day.
The health supervisor found a disinfection products with incomplete label at the site of company A, and the product label was marked with the words "Y garlic E new generation antibacterial disinfection spray (no-wash type)"; In both companies, the health and safety evaluation report of "Y-object surface disinfectant" mentioned in the investigation letter was found. Through inquiry and data comparison, the supervisor finally confirmed that "Y garlic E new generation antibacterial disinfection spray (wash-free type)" is "Y disinfection spray", and "Y object surface disinfectant" is another disinfectant produced and operated by two companies. The labels of both products are marked with garlic E as the main effective ingredient. The supervisor carefully checked the production records provided by Company A, and found that the dosage of garlic E in "Y Disinfection Spray" was 0.1%, and that in "Y Object Surface Disinfection Liquid" was 0.05%. Because the product names of the two products and the content of garlic E, one of the main effective components, were different, the supervisor decided that "Y Disinfection Spray" and "Y Object Surface Disinfection Liquid" were two different disinfectants.
It was confirmed by the supervisor that "Garlic E" was not included in the list of effective ingredients of disinfectant raw materials in the Judgment Basis for Producing Disinfectants and Disinfecting Instruments by Using New Materials, New Technology and New Sterilization Principles (hereinafter referred to as "Three New Judgment Basis"), nor was it included in the disinfection and antisepsis category in People’s Republic of China (PRC) Pharmacopoeia, nor was it included in the current national health standards and norms. According to the provisions of the Measures for the Administration of Disinfection, the two disinfectants can be produced and sold only after obtaining the approval document of the new disinfection products sanitation license. However, the above two products have not obtained the approval document of the new disinfection products sanitation license and belong to disinfection products without the approval document of the new disinfection products sanitation license.
The above-mentioned behavior of Company B belongs to disinfection products, which has no new disinfection products health permit approval document, and violates the provisions of Item (1) of Article 32 of the Measures for the Administration of Disinfection. According to the provisions of Article 43 of the Measures for the Administration of Disinfection, Company B is ordered to immediately correct the above-mentioned illegal behavior and impose an administrative penalty of RMB 3,000. Company A’s illegal act of producing disinfection products without the approval document of new disinfection products health permit has been dealt with separately. Company B fully fulfilled the administrative penalty decision, and the case was closed in December 2021. At the same time, the handling situation has been replied to the health administrative department of Z City.
Case analysis
This case is a typical case in which disinfection products was investigated by other provinces who were initially suspected of failing to pass the health and safety evaluation, and it was finally determined through investigation that the party concerned operated disinfection products without the approval document of the new disinfection products health permit. The "reversal" of this case has triggered the supervisor’s thinking on handling the investigation case. By responding to clues quickly, jumping out of inertia thinking, and conducting rigorous investigation and argumentation, the case embodies the characteristics of professional law enforcement, in-depth excavation and rigorous verification, which has certain reference significance for similar cases.
Break through inertia
Dig deep into the essence of the case
The initial investigation letter received in this case showed that the preliminary investigation result was that the health safety evaluation was unqualified. After receiving the investigation letter, the health supervisor did not make a preconceived and direct characterization, and was not confined to inertial thinking. Instead, he further tracked the clues and explored the problems in depth through on-site inspection, repeated inquiries, careful review of information and other means. Finally, taking the product label instructions and production records as a breakthrough, using solid professional knowledge and legal basis, it is judged that one of the main effective components of the two products is garlic E, which belongs to the "three new" products, thus directly hitting the core of the problem and determining the illegal facts.
go to the very source of sth
Comprehensively investigate illegal enterprises.
During the investigation, the supervisor not only limited his vision to the "Y Disinfection Spray" product in the investigation letter, but also inquired into the "suspicious" products in the field investigation and data collection, and faced with the messy materials provided by the parties, he tried to find clues patiently and carefully. The supervisor took a "delivery note" provided by Company B as the breakthrough point. From the initial suspicion that the case involved two kinds of disinfection products, to the final determination that the two disinfectants were different disinfection products through the differences in product names and main effective components, the supervisor made full use of his professional law enforcement level, so as to achieve rigorous argumentation logic and interlocking evidence, and thoroughly sort out the illegal acts of the enterprises involved.
Lay a solid foundation
Accurately characterize the "three new" products
Since the outbreak of Xinguan epidemic, Shanghai has filed several cases of illegal production and operation of disinfection products without the approval document of new disinfection products health permit. The qualitative determination of "Sanxin" products is different from the judgment of undocumented and unqualified health and safety evaluation, which puts forward higher requirements for the professional quality and basic skills of supervisors. The case-handling personnel should comprehensively refer to "Sanxin Judgment Basis", "People’s Republic of China (PRC) Pharmacopoeia" and other relevant national standards and regulations, make bold guesses, carefully demonstrate, and avoid abusing the cause of action and misjudging.
Comprehensive judgment
Qualitative enterprise "management" behavior
The case occurred during the disaster in Z city. During the investigation, Company B claimed that the two products involved were all donated to Z city for disaster relief. In order to determine whether the company had any business activities, the supervisor held a special discussion with the legal affairs department, and agreed that the donation certificate issued by "public welfare social organizations and public welfare non-profit institutions" was required to be recognized as "public welfare donation", but Company B did not provide any donation certificate in the end. During the epidemic, many enterprises donated disinfection products to reflect their corporate responsibilities, but the quality of their products was uneven. This case provides a reference solution to how to separate illegal products from the chaotic "donation" behavior.
Thinking suggestion
With the normalization of epidemic prevention and control in COVID-19, new problems are emerging in disinfection products. How to find problems, accurately identify and solve problems in the dazzling disinfection products in the market has become a new challenge for supervisors. Facing the new challenges, health supervisors should actively adapt to the situation, lay a solid foundation, master disinfection products’s laws, regulations, standards and professional knowledge, change constantly, grasp the basic nature of products, analyze them in detail, and directly attack the essence of the problem, so as to continuously improve their law enforcement level and case handling ability. At the same time, in the face of illegal clues such as investigation letters, supervisors should not only draw conclusions based on preliminary investigations, but should further trace them and find deeper problems; It should not be limited to the clues of the investigation letter itself, but should be thoroughly investigated, and there should be no dead ends to dig up illegal acts; We should not aim at punishment, but solve the existing problems of products and improve the main responsibility of enterprises, so as to reduce illegal acts from the source, standardize the disinfection products market and ensure the prevention and control of epidemic situation.
Contributed by Hu Dandan.
Original title: "Focus on 315 | Standardizing disinfection products Market and Ensuring Epidemic Prevention and Control"
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