“Three New” Disinfectants in China: Compliance and Registration Guide

Market Opportunity and Regulatory Landscape

Since the outbreak of COVID-19 in 2020, public awareness regarding hygiene and disinfection has grown significantly, fueling the continuous expansion of the disinfectant market. According to industry research, China’s disinfectant market is estimated at RMB 8–10 billion, with the total market size increasing from RMB 11.03 billion in 2019 to RMB 12.16 billion in 2021. This indicates substantial potential in China’s disinfection industry.

Alongside this growth, rising demand for broad-spectrum, eco-friendly, and food-grade disinfectant solutions is transforming consumer expectations. The shift is driving companies to innovate and develop next-generation disinfectants using new materials, advanced processing technologies, and novel antimicrobial mechanisms.

In this context, registering a “new disinfectant product”—known in China as a “Three New” disinfectant—represents a promising opportunity for businesses seeking both regulatory compliance and market advantage.

What Are “Three New” Disinfectant Products?

The term “Three New” refers to disinfectant products that incorporate:

1. New Materials
2. New Processing Technologies
3. New Sterilization Mechanisms

These products must demonstrate improved safety, efficacy, and environmental adaptability compared to existing disinfectants. While this product category is still in its infancy in China, submitting a registration application, whether successful or not, can showcase a company’s innovation capabilities and regulatory readiness.

Current Approval Status by the NHC

Unlike conventional disinfectants, which only require provincial-level filing, new disinfectants must be approved by the National Health Commission of China (NHC) before being manufactured or sold. This process involves a comprehensive technical review conducted by the NHC’s expert evaluation committee. Only upon approval will the NHC issue a sanitation permit.

However, gaining this approval is challenging. Factors contributing to the difficulty include:

• The underdeveloped review system and undefined evaluation standards.
• The complexity and volume of required documentation.
• High costs and uncertain timelines.
• Technical scrutiny of innovative product mechanisms.

According to the National Health Commission, just one “Three New” disinfection products has been approved since 2014, and many products have even struggled to pass the initial acceptance stage. Still, following the pandemic, the number of accepted applications has increased. For example, while only one product was accepted in 2019, 12 were accepted in 2020, and 8 in 2021. These shifts suggest a more receptive regulatory environment, encouraging more enterprises to consider applying.

Source: National Health Commission Government Service Platform, as of July 2022

Compliance Pathway: How to Register “Three New” Disinfectants in China

Determine Product Eligibility

To qualify as a “Three New” disinfectant, the product must meet at least one of the following criteria:

• New Material: Not listed in the disinfectant active ingredient directory, the Pharmacopoeia of the People’s Republic of China, or any existing national health standards or regulations.
• New Processing Technology: Significant changes in manufacturing parameters or processes that result in improved safety, efficacy, or environmental adaptability.
• New Sterilization Mechanism: Use of physical, chemical, or biological disinfection factors—or combinations thereof—not yet listed in existing official disinfectant or indicator lists.

Relevant standards include GB 38850-2020 and the guideline document “Criteria for Determining Novel Disinfectant Products.”

Prepare Application Documentation

If the product meets the “Three New” definition, companies must gather comprehensive documentation, including:

• Application form.
• Production capability assessment from a provincial health supervision agency.
• R&D report.
• Quality standards and testing methods.
• Proof of market authorization in the country of origin.
• Authorization letter for a domestic responsible party.
• Product samples.

Example: For new disinfectants, the R&D report must contain global research background, detailed development history, CAS numbers of all ingredients, mechanism of action for each active component, concentration rationale, and more. Quality standards should be backed by extensive physicochemical testing.

Given the complexity, professional consultation from an experienced regulatory agency can significantly improve the success rate and efficiency.

Submit Application and Undergo Review

Once the application is complete:

• Submit online via the NHC’s platform.
• First-time applicants must undergo a pre-review process.
• Upon passing the pre-review, submit the physical dossier at the NHC’s service center.

The NHC will then forward the application to its evaluation committee, which has 60 working days to organize a technical assessment and solicit specialist feedback.

In case of incomplete documentation or unclear data, applicants will receive a review postponement notice and must supplement the required information accordingly. Once the product is recommended for approval, the NHC has 20 working days to make a final decision and publish the approval on its website.

Why Work with REACH24H?

Due to the complexity of China’s approval pathway for novel disinfectants, many companies hesitate to initiate the process. The combination of technical, legal, and procedural hurdles makes regulatory navigation difficult without localized expertise.

However, with China’s regulatory climate becoming increasingly supportive of innovation, more enterprises are seeking to enter this space.

Partnering with REACH24H can provide:

• Regulatory interpretation and strategic planning.
• Technical support for dossier preparation.
• Communication with evaluation authorities.
• Streamlined project management.

Final Thoughts

While registering a new disinfectant product in China is undoubtedly complex, it also offers significant benefits in terms of market positioning, brand credibility, and long-term growth. Companies with innovative technologies are encouraged to seize this opportunity and prepare strategically.

With the right support and preparation, success is no longer out of reach.