By the end of 2019, there had been 6259 Chinese enterprises producing various disinfection products including disinfecting apparatus, disinfectants and sanitary products. By September 2020, over 12000 Category I and Category II disinfection products of 8000 enterprises have filed the hygiene and safety evaluation report with provincial health authorities. Disinfection products have turned from a niche product to daily necessities and China becomes a very attractive market for disinfectant producers，but disinfectants must comply with the local regulatory framework. During a special session of the 12th Chemical Regulatory Annual Conference & Asian Helsinki Chemicals Forum on December 3, Ms. Gu Jian from the Technical Committee on Disinfection Standardization of the National Health Commission offered her insight into China’s disinfectant regulation and implementation, based on her deep understanding of regulation system and rich enforcement experience.

Product Scope

The hygiene and safety evaluation of disinfection product refers to a comprehensive evaluation on product efficacy and hygiene & safety of the non-new Category I and Category II disinfection products, including product label(nameplate), manual, test reports, executive standard (quality standard), product formula (of disinfectant, indicator and antibacterial/bacteriostatic agent) and structural diagram of disinfecting apparatus, as well as necessary documentary evidence. Category I disinfection products are high-level disinfectants and disinfecting apparatus for medical devices, sterilizers and sterilization equipment, skin/mucosal disinfectants, biological indicators, and chemical indicators of sterilization effect and Category II disinfection products are disinfectants, disinfection equipment, chemical indicators, packed-sterilized articles with sterilization marking, and antibacterial (bacteriostatic) agents other than Class I disinfection products. It is important to notice that carrier disinfectants (disinfecting wipes, cotton balls and cotton swabs) boiling sterilizer and milk bottle sterilizer are not yet subject to the evaluation requirements.

Evaluation Requirements

Before the place of disinfection products on the market, indigenous manufacturers of homemade products, entrusting parties of OEM products and the Chinese responsible parties of imported products should conduct the evaluation and compile the evaluation report either by themselves or third-party organizations. The test reports and other information need to be incorporated into the “Hygienic Safety Evaluation Report of Disinfection Products” and filed at provincial health authorities. Companies will bear legal liabilities for the authenticity of the filed data as receiving authorities will only check the completeness and appropriateness. Post filing rectification measures would be implemented if inconsistency was identified during the market circulation stage.

The test scope, evaluation criteria and report compilation requirements were originally specified in a ministerial regulation, “Rules on the Hygiene and Safety Assessment on Disinfection Products”. In 2019, China regulation, “WS 628-2018 Technical Requirements for the Hygiene and Safety Evaluation of Disinfection Products”, which includes some technical amendments to the ministerial regulation and enacted in parallel with the ministerial regulation.

Follow-up Obligations

All Category I products need to be re-evaluated every 4 years and the evaluation of Category II products can be recognized permanently. If the Category II producer alters the production site, opens a new facility or entrusts new OEM factories, prolongs the shelf life of disinfectants, sterilization indicator, packed-sterilized articles with sterilization marking or alter the use scope or application method of disinfectants, disinfecting apparatus and antibacterial (bacteriostatic) agents, the products shall be re-evaluated.

Product Executive Standard

Product executive standards include necessary quality requirements of raw material, quality indicators and testing methods of final products. For homemade products, the standard can be an enterprise standard self-declared at the National Enterprise Standard Service Platform. For imported products, the standard refers to the quality standard of the products.

In recent 2 years, China promulgated/revised a dozen mandatory or voluntary standards of disinfectants. The voluntary ones can serve as an important reference in preparing an executive standard, but the mandatory ones are the minimum requirements for disinfection products. all executive standards need to comply with the specific requirements in corresponding mandatory standards:

Regulatory Trends

The Covid-19 has driven up huge demand for disinfecting wet wipes in China, but this category of products has not yet been included in the evaluation scope and is often perceived as gray-zone products. Ms. Gu explained that China Health Inspection Association has published a group standard called “Hygiene requirements for carrier disinfectants”. If disinfecting wet wipes were tested satisfying the group standard, the product can be recognized as a qualified product and placed on the market.

A national mandatory standard for label and manual of disinfection products is been working out, which will replace the current label and manual requirements.