Abstract: On April 23, the National Health Commission of China (NHCC) issued a list of active ingredients for anti-bacterial agents (draft for comments), solicit opinions from enterprises, institutions and individuals, and publish it at an option after revision.

Background and process

In order to thoroughly implement the China State Council policies about “Delegate power and optimize service”, optimize the supervision mode, improve the efficiency of law enforcement, guide enterprises to standardize production, strengthen the implementation of corporate responsibility, effectively promote the healthy and orderly development of the anti-bacterial market, and effectively protect the health rights and interests of the people. The NHCC organized and analyzed anti-bacterial agent active ingredients of non-plants, studied the substances that are prohibited from adding, and combed the regulatory models of anti-bacterial agents in main countries, such as the United States, Japan, and the European Union, and formulated a list of effective ingredients and inclusion principles in line with Chinese actual conditions. At the same time, NHCC has organized many experts and relevant personnel of the health and health administrative department, the disease control organization, the supervision organization, the National Health Industry Enterprise Management Association Antibacterial Industry Branch and related enterprises to conduct demonstrations and revisions to form the list of active ingredients for antibacterial agents (Consultation Draft).

Main content

(1) Clear management scope. The prescribed range of use is an antibacterial agent and a bacteriostatic agent which are directly used for intact skin and oral mucosa, vaginal mucosa.

(2) Defining terminology. The antibacterial agent directly contact with human skin or mucous membrane (not including for specific parts such as human foot, eyes, nails, ankle, scalp, hair, nasal mucosa, anorectal, etc.), and has a certain bactericidal effect and the killing rate is ≥90%, not the purpose of treating diseases or improving symptoms of skin and mucous membranes. The bacteriostatic agent directly contact with human skin or mucous membrane (not including for specific parts such as human feet, eyes, nails, ankles, scalp, hair, nasal mucosa, anorectal, etc.), and has a certain antibacterial effect and the inhibition rate is ≥50. %, not the purpose of treating diseases or improving symptoms of skin and mucous membranes. The active ingredient is a substance which has a killing or inhibiting action on microorganisms in an antibacterial agent. Prohibited substances are substances that are prohibited from being added in antibacterial agents, including chemical and biological substances.

(3) Limited ingredients and prohibited substances. The first is a list of ingredients, which lists the active ingredients of non-plant resistant antibacterial agents. The second is the list of the banned substances. It is forbidden to add drugs listed in the Pharmacopoeia of the People’s Republic of China (2015) (excluding disinfectant and antiseptic drugs) and their raw materials of the same name; prohibit to use microbes, cells, animals or human tissues and body fluids as starting materials; prepared by biological techniques, for the prevention, treatment and diagnosis of human diseases, such as vaccines, blood products, biotechnology drugs, microecological preparations, immunomodulators, diagnostic products, etc. (excluding lysozyme and lysococcus) are prohibited to use; banned substances listed in the “Technical Specifications for Cosmetics Safety” (2015) (excluding iodine); other prohibited substances prescribed by NHCC.

Questions to be explained

(1) The source of the list of active ingredients. US FDA’s OTC drug monograph, EU ECHA approved list of active ingredients for human biocides, list of active ingredients of non-pharmaceutical of Labor and Welfare of Japan, Chinese Pharmacopoeia 2, Chinese Pharmacopoeia 4, national standard “disinfectant raw materials” List and Prohibited Substances (reported for approval) and active ingredients in anti-bacterial products sold in China.

(2) The principle of inclusion. The FDA’s OTC drug monograph, the list of active ingredients for human biocides approved by the European Union’s ECHA, and list of active ingredients of non-pharmaceutical of Labor and Welfare of Japan are all included. The disinfectant and antiseptics in Chinese Pharmacopoeia 2, Chinese Pharmacopoeia 4 are all included, and the disinfectant active ingredients for human skin mucosa are included in the national standard “Disinfectant raw material list and prohibited substances” (reported for approval). However, substances that are clearly harmful to the human body or are not a single active ingredient are excluded from the above six sources.

(3) The conditions for the active ingredients of the anti-bacterial agents in China. Firstly, the products are widely used in China and have been sold for more than three years. Secondly, the active ingredient content can be determined by existing experimental methods. Thirdly, the antibacterial (or antibacterial) effect of the product has a corresponding legal and effective inspection report. The fourthly is the toxicological test report of the active ingredients, including acute oral toxicity test, multiple or one skin irritation test, mucosal irritation test and mutagenic test. Fifthly, the active ingredients have not been banned internationally. The last, the product has instructions for use, enterprise standards, small package products and labels.

Attachment：

List of active ingredients of anti-bacterial agents