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Chinese Disinfection Product Regulation System and Compliance Strategy

  •   14 Nov 2017
  •    Kaden Yang

    Contents

     

    PART ONE China Hygienic Disinfection Product Regulation

    1.1 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.

    1.2 Chinese Disinfection Regulation

    Measures for the Administration of Disinfection

    History

    Date

    Content

    18 Sep 1987

    First issued Administration of Disinfection

    31 Aug 1992

    Revised by MoH

    28 Mar 2002

    Revised by MoH Decree 27

    19 Jan  2016

    Ammended by NHFPC Order 8

    Main supporting legislation in force

    14 Nov 2003

    Notice of Removal of Disposable Consumer Products from Disinfectant Product Scope

    30 May 2005

    Notice on Adjustment of Supervision and Approval Scope of Disinfectant Products

    23 Jul 2013

    Cancellation and Decentralization of Part of the Administrative Approval for Disinfection and Aquatic Products

    20 Dec 2013

    Criteria for Determining of Disinfectants and Disinfection Devices Produced by the Use of New Materials, New Technology and New Principle of Sterilization

    11 Feb 2014

    Regulations on Administrative License of new Disinfection and Aquatic Products

    27 Jun 2014

    Regulations On Hygiene and Safety Assessment of Disinfectant Products

     

    1.3 Ministry/Administration Involved in Disinfection Regulation

    Ministry/Administration

    Regulatory Duties

    National Health and Family Planning Commission (MoH before 2013, NHFPC after 2013)

    - draw up related regulations, policies, plans, standards and technical specifications;

    - evaluate new disinfection product registration and issue registration approval.

    Provincial Health Administrative Departments

    -evaluate and approve existing product notification application;

    -being responsible for land investigation and product sampling.

     

    1.4 Chinese Disinfection Legislative Framework

    Regulations

    Issuing Body

    Scope

    Measures on Administration of Disinfection Products

    National Health and Family Planning Commission

    -the essential measures to regulate disinfections production and sales;

    -contains sanitary standards for sterilization;

    -production and management requirements of disinfection product;

    -regulation for sterilizing institutions and penalty.

    Criteria for Determining of Disinfectants and Disinfecting Devices Produced by the Use of New materials, New Technology and New Principle of Sterilization

    National Health and Family Planning Commission

    -to sift and determine the regulatory compliance requirement for disinfectant products

    Regulations on Hygiene and Safety Assessment of Disinfectant Products

    National Health and Family Planning Commission

    -requires that responsible units conduct the hygiene and safety assessment for disinfectants, disinfecting devices and anti-bacteria agents, and other existing disinfection products;

    -guarantee the hygiene and quality of the products.

     

    Regulations on Administrative License of New Disinfection and Aquatic Products

    National Health and Family Planning Commission

    -clearly stipulate the requirements of content, time limit, application acceptance criteria, examination and determination;

    -details the application procedures, documents and other materials required.

     

    PART TWO Compliance Approach and responsibility for Existing and New Disinfection Product

    2.1 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

    2.2 Compliance approach for disinfection products

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

     

    Existing disinfection product

    New disinfection product

    Compliance approach

    Complete hygienic safety evaluation and make file-record with local authority

    Applying for health administrative approval

    Accepting authority

    Local health administrative department where manufacturer or responsible entity based

    National health and family planning commission (NHFPC)

     Review authority

    Local health administrative department  where manufacturer or responsible entity based

    China Centers for Disease Control (China CDC)

     

    2.2.1 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:

    Classification

    Category 1 (high risk)

    Category 2 (medium risk)

    Category 3  (low risk)

    Products

    ·High-level disinfectants, disinfecting devices for medical articles

    ·Sterilizing agents and devices

    ·Disinfectants for skin and mucosa,

    ·Biological indicators

    ·Chemical indicators for sterilization effect.

    ·Disinfectants, disinfecting devices and medical indicators that do not belong to Category 1

    ·Packaging for sterilization articles with sterilization mark

    ·Antimicrobial (bacteriostatic) agents.

    ·Hygienic products excluding Antimicrobial(bacteriostatic) agents

    Compliance requirement

    Hygienic safety evaluation and recoding in provincial level

    Meeting label requirement

    Validity period

    4 years

    No expiration data

    No expiration data

    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

    Items

    Content

    Physiochemical property

    -Appearance

    -Active ingredient and its content

    -pH value

    -Stability test

    -Continuous use stability test

    -Corrosive to metals

    -Heavy metals (Hg As Pb)

    Microbiological property

    -Lab germicidal efficacy test

    -Field simulation or field germicidal efficacy test

    Toxicological property

    -Acute oral toxicity test

    -Mutagenicity test

    -Extra tests needed based on the results

    Procedure and timeline

    Fig 1-Existing disinfection product record in China

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

    2.2.2 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.

     

    PART THREE What we can do for you?

    3.1 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.

    China disinfection product regulation

    EU BPR

    Disinfection products applying to skin, mucosa and hand

    PT1.Humann hygiene biocidal products

    Disinfection products applying to pool water, hospital waste water, air, general surface and fabric

    PT2.Provate area and public health area disinfectant and other biocidal products

    Veterinary drugs under regulation on veterinary drugs administration

    PT3.Veterinary hygiene biocidal products

    Disinfection products for medical devices &supplies

    Not regulated under EU BPR

    Disinfection products for tableware, fruits & vegetables

    PT4.Food and feed area disinfectants

    Disinfection products for drinking water

    PT5.Drinking water disinfectants

    3.2 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

    3.3 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