China Hygienic Disinfection Product Regulation

General introduction

The scope of disinfection in China is the treatments that kill or eliminate pathogenic microorganisms on the transmitting vector and making it harmless. Disinfectant products can be classified according to application for drinking water-related area, veterinary area, and others (e.g. fruits and vegetables, tableware and food contact materials, human skin/mucosa, environment and object surface, air, medical articles, chemical indicators). Currently, the regulatory administration on disinfectant products includes the National Health and Family Planning Committee (NHFPC) for food and non-food related products and Ministry of Agriculture (MOA) for veterinary disinfectant. The management of water-related and others are different. The disinfectant products that covered in this article focus on the others area. The Chinese government started to regulate disinfectant products since 1987 with hygiene licenses. In the year of 2000, the authority requires all disinfectant products much have final review by former Ministry of Health (MOH). But after that, the Ministry of Health excluded registration requirements on unnecessary product types step by step to make the whole management more scientific. Not until 2011, the MOH issued administrative approval measures for disinfection products and drinking water-related products, and in 2014 the NHFPC issued Regulations on Administrative License of New Disinfection and Aquatic Products, the comprehensive regulatory system is finally established as we know today. Through the regulation reform, disinfectant management has transferred from a strict and all-encompassing pre-market approval to an increased focus on post-market supervision.

Chinese Disinfection Regulation

 Ministry/Administration Involved in Disinfection Regulation

Chinese Disinfection Legislative Framework

Compliance Approach and responsibility for Existing and New Disinfection Product

Responsible party

First of all, any disinfectant product compliance should be conduct by a responsible party within China mainland. Especially for foreign exporters, they should have a Chinese responsible party for their product recording or registration. It can be its distributor or branch office.

• Manufacturer of domestic disinfection products

• Responsible entity in China for foreign enterprise usually as a distributor or subsidiary

Compliance approach for disinfection products

Currently, there are two compliance requirements refer to disinfection products in China. There are great differences between the two.

 Non-new/Existing disinfection products

Decades ago, all disinfectant products were required to absorb approval license, while, after a series of regulation reform, the safety assessment accountability of existing disinfectant products has moved from the government to manufacturers. Products that fall in the scope of existing disinfectant product are required to do self-assessment by companies themselves. Based on the different risk levels of the products, the compliance requirement differs. Existing disinfectant products are classified into 3 categories based on the product application area and risk level:

Note: When the same disinfectant product involves different categories, it shall be regulated as the category of higher risk.

Requirements for existing products

For a disinfectant product in either Category 1 or Category 2, the responsible party must conduct a hygienic safety evaluation before marketing for the first time. This evaluation is to be conducted either by the responsible party or by entrusting a third party. A disinfectant product can only be marketed after being qualified by the hygienic safety evaluation.

a. Basic information form (See the picture on the right)

b. Content of hygienic safety evaluation report

    · Product label

    · Use direction

    · Test report （See data requirements below）

    · Product formula

    · Product standard

    · Hygienic license (Domestic products)

    · Custom declaration(Imported products)

    · Production and sales permit 

Data requirements for existing products

Procedure and timeline

Fig 1-Existing disinfection product record in China

Note: Timeline for file-record period if everything goes smoothly: 6-12 months

New disinfection products

Generally, currently, there are two compliance requirements refer to disinfection products, one is registration of new disinfection products and the other is hygiene and safety assessment of non-new disinfectant products and filing proper records with the competent health administrative agency. According to the regulation issued by NHFPC, new disinfectant products are mainly referred to products that apply new materials, new processes and technologies, and new sterilization principles, which are also called the “three new types of disinfectants”.

On Dec.26, 2013, NHFPC released an announcement to establish the criteria of new materials, new processes and technologies and new sterilization principles (No.9 Announcement of NHFPC〔2013〕), which is known as Criteria for New Disinfectant Products. You can see Fig.2 to estimate the product whether it is “three new types of disinfectants” or not.

Fig 2- Three new types of disinfectants

Requirements for new disinfection products

Before a new disinfectant product enters Chinese market, it should submit a new disinfectant product application and get approval from the NHFPC. Whether a product is in the scope of “three new types of disinfectant products” is sometimes difficult to determine, especially for new developed products. Normally, new disinfectant products should have equivalent or better performance comparing to existing products in terms of effective ness, safety and environmental adaptability. In general, the registry process is very clear. To registry “three new types of disinfectant products”, companies should prepare and submit application materials, and then the experts of NHFPC shall conduct a risk assessment review, and the outcome will be publicized.

Application materials include:

• hygiene administrative approval application form for new disinfectant;

• outcome of assessment on production capacity by a provincial-level health supervision agency;

• research and production report;

• description of features of the new product;

• formula or structure chart;

• introduction and sketch of production processes;

• corporate standard or product quality standard;

• product description, label or plate;

• certificate for production and sales of producing state or region (for imported new disinfectants);

• letter of authorization for a liability entity in China (for imported new disinfectants);

• letter of entrustment for application (if entrustment is needed);

• other possibly supporting document.

It should be noted that the expert review committee need applicants to answer questions to verify the result or method of testing in the application. And for those foreign companies that apply the new disinfectant products for first time in China, the authority demands to collect sample by personnel sent by local health administrative agency.

Application process for new disinfection products

Fig 3- Application process for new disinfection products

Note: Timeline for new disinfection product is unpredictable because of official complex review and more supporting reports.

 What we can do for you?

Comparison between China disinfection product regulation and EU BPR

In China, most biocidal products in EU countries is are widely known as the hygienic disinfection product. You can see corresponding products under China disinfection product regulation and EU BPR from following Table.

Challenges for foreign companies

Because of great differences between China disinfection product regulation and EU BPR , for most enterprises, especially for foreign enterprises who are familiar with the biocidal product regulation in Europe and America, they are often confused that how to develop the compliance work in view of fragmented and complex regulatory system and many regulatory authorities in China.

Main challenges and key problems

• A thorough understanding of Chinese regulation

• Selecting qualified test lab in China

• Communication with China authority

Insufficient Materials

• Lack of the relevant test report, claim items in label and detailed use instruction

• Lack of Chinese brand names for product

• Insufficient information for product formula

• Original documents, copies and translated documents are inconsistent with each other

Our services

In view of the facts above, our REACH24H has rich experience in deal with Chinese disinfection product regulation and we can make custom-made compliance service for enterprises.

Our one-stop services:

• Regulatory advice and strategy

• Compliance analysis report

• Hygienic safety evaluation

• Legal document translation

• Test lab selecting and study monitoring

• Discussion, liaison and negotiation with authorities