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China Mainland Cosmetics Regulation

  •   28 Jan 2014
  •    Echo Cao
  •  361583
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     China Cosmetics Legislation

    Overarching Regulation
    Regulations Concerning the Hygiene Supervision over Cosmetics
    Competent Authority

    State Administration for Market Regulation (SAMR)

    Main Supporting Rules 
    1 Jul 2007Hygienic Standard for Cosmetics
    1 Apr 2010Requirements for Application and Acceptance of Administrative Licensing for Cosmetics 
    1 Jul 2011Guidance on Application and Review of New Cosmetic Ingredients 
    1 Oct 2009GB 5296.3-2008 General Labeling for Cosmetics

    China's current cosmetic regulatory system is founded on the overarching "Regulations Concerning the Hygiene Supervision over Cosmetics (1989)", supported by a series of subsidiary rules, standards and guidance documents issued by the former regulator, the Ministry of Health (MOH) and the current competent authority, State Administration for Market Regulation (SAMR).

    In the last two decades, China's cosmetics industry has undergone tremendous change. Currently, the Chinese cosmetic market ranks as the third largest globally and is also the worlds' emerging market, exhibiting the greatest average annual growth rate. To make the cosmetic regulatory framework consistent with the current industry situation, in the second half of 2013, SAMR (the former CFDA) launched a far-reaching campaign set on thoroughly amending the overarching cosmetics regulation. All stakeholders will be significantly affected by the revised regulation. The amendment is not simply a refinement of its predecessor but represents a complete overhaul, which will see the definition, classification and registration requirements of cosmetics completely changed. Once effective, the new regulation will necessitate that, both domestic and overseas cosmetic companies adopt new compliance strategies.  

    Contents

     

    Part 1 Regulatory Framework and Competent Authority

    Existing Main Cosmetic Regulations in China

    Type

    Regulation

    Remark

    Effective Date

    Status

    Overarching

    Regulations concerning the Hygiene Supervision over Cosmetics 1989 《化妆品卫生监督条例》

    Promulgated by the former MOH and acts as the overriding regulation for cosmetics in China

    1 Jan 1990

    In force, but

    being revised

    Regulations concerning the Supervision and Administration over Cosmetics 《化妆品监督管理条例》

    The revision of Regulations concerning the Hygiene Supervision over Cosmetics 1989/A draft
    《化妆品监督管理条例》(第二次书面征求意见稿)
    The draft for second public consultation of Regulations concerning the Hygiene Supervision over Cosmetics 1989/The draft for second public consultation

    Hygiene Standard

    For Product

    Safety and Technical Standards for Cosmetics 2015《化妆品安全技术规范》

    The revised version of Hygienic Standard for Cosmetics 20071 Dec 2016In force, but being revised

    For Manufacturer

    Hygienic Standard for Production Enterprises of Cosmetics 2007 《化妆品生产企业卫生规范》

    A GMP-like guidance for cosmetic manufacturers in China

    1 Jan 2008

     

    In Force

    Licensing

    Requirements for Application and Acceptance of Administrative Licensing for Cosmetics 2009

    《化妆品行政许可申报受理规定》

    Specifies registration dossiers for imported cosmetics, domestic special use cosmetics and new cosmetic ingredient

    1 Apr 2010

     

    In Force

    Requirements for Filing of Domestic Non-special Use Cosmetic Products 《国产非特殊用途化妆品备案要求》Guidance for filing of domestic non-special use cosmetics30 Jun 2014In Force
    Guidelines for Registration Review and Approval of Domestic Special Use Cosmetics《国产特殊用途化妆品审批服务指南》Guidance for registration review and approval of domestic special use cosmetics1 Dec 2017In Force
    Guidelines for Registration Review and Approval of Imported Special Use Cosmetic Products《首次进口的化妆品审批——进口特殊用途化妆品的审批服务指南》Guidance for registration review and approval of imported special use cosmetics1 Dec 2017In Force
    Guidelines for Registration Review and Approval of Imported Non-special Use Cosmetic Products《首次进口的化妆品审批——进口非特殊用途的化妆品的审批服务指南》Guidance for registration review and approval of imported non-special use cosmetics1 Dec 2017In Force

    Guidelines for Registration Review and Approval of Cosmetic New Ingredients《化妆品新原料审评服务指南》

    Formulated especially for registration of new cosmetic ingredients

    1 Dec 2017

    In Force

    Guidance on Application and Review of Children's Cosmetics 2012 《儿童化妆品申报与审评指南》

    Formulated especially for registration of children’s cosmetics

    1 Feb 2013

    In Force

    Testing

    Requirements for Cosmetic Administrative Licensing Testing 2010 《化妆品行政许可检验规范》

    Sets out Testing requirements for imported cosmetics, domestic special use cosmetics and new cosmetic ingredient

    11 Feb 2010

    In Force

    Labeling

    Administrative Measures on Cosmetics Labelling

    《化妆品标签管理办法》

    Standardizes required info in label and instruction of cosmetic products

    /

    A draft

    GB 5296.3-2008 General Labeling for Cosmetics

    《GB 5296.3-2008消费品使用说明化妆品通用标签》

    Details required info on cosmetic labels

    1 Oct 2009

    In Force

    Naming

    Guide to the Naming of Cosmetics 2010《化妆品命名规定》

    Details requirements for naming

    5 Feb
    2010

    In Force

    IECIC

    Inventory of Existing Cosmetic Ingredients in China 2015

    《已使用化妆品原料名称目录》

    Ingredients included in it need not registration

    /

    In Force

    Import & Export

    Administrative Measures on Inspection and Quarantine of Import and Export Cosmetics 《进出口化妆品检验检验监督管理办法》

    Regulating the import and export of cosmetics

    1 Feb 2012

    In Force

    Competent Authority of Cosmetics

    During the 2018 NPC conference, the Stated Council launched government institution reform, and established “State Administration for Market Regulation” to fully regulate cosmetics in place of three institutions: CFDA, AQSIQ and SAIC. There sets an independent Drug Administration Bureau named "National Medical Products Administration" under the “State Administration for Market Regulation”.

    1. SAMR major responsibilities include:

    • Market management

    SAMR is responsible for development, oversight and enforcement of regulation, policy and standards related to market supervision. It will also develop standardization strategies to create an honest and fair market environment.

    • Market entity registration

    It is responsible for registration of market entities conducting business in China, including representative office of overseas enterprises.

    • Quality and safety supervision

    SAMR will carry out risk monitoring on product quality and safety, as well as implement national sampling inspection across the country.

    • Standardization work

    SAMR is obliged to notify new GB standards to the public and draft GB/T standards.

    In addition, SAMR should coordinate with other ministries to optimize market supervision with major interactions summarized below:

    • NMPA is responsible for formulating cosmetic regulatory systems, as well as licensing, inspection and penalties for cosmetics research and manufacture. 
    • SAMR should cooperate with Ministry of agriculture and rural affairs to establish mechanisms related to origin exit market access and traceability.
    • National Health Commission (NHC) should give timely feedback on results of risk assessment studies to SAMR to guide policy.
    • An information sharing system should be set up between SAMR and GAC to avoid redundancy and overlap of administrative duties and to aid in information dissemination related to safety and quality issues associated with import/export cosmetics.
    2. In term of cosmetics, National Medical Products Administration is in charge of comprehensive supervision on cosmetics, including domestic production and registrtion/filing of cosmetic products (special use cosmetics and imported non-special use cosmetics) and new ingredients. NMPA is under the governance of SAMR.

    NMPA's major responsibilities include:

    1. Safety Supervision Management

    NMPA is responsible for cosmetics, drug and medical devices' safety supervision management, including formulating supervision policies, drafting regulations, supervising its implementation, as well as formulating management and service policies that encourage new technologies for cosmetics, drug and medical devices.

    1. Standard Management

    NMPA is obliged to draft cosmetic standards, formulate a cosmetic classification management system and supervise its implementation.

    1. Registration Management

    NMPA is responsible for formulating cosmetic, drug and medical device registration management system. It will also strictly conduct market entry review and approval.

    1. Quality Control

    NMPA is responsible for formulating cosmetic, drug and medical device quality control practices. 

    1. Post-market Risk Management

    NMPA will carry out monitoring, evaluation, rectifications and recalls associated with cosmetic adverse reactions, as well as undertake cosmetic safety emergency management.

    1. Supervision and Inspection

    NMPA is obliged to formulate inspection rules, penalize illegal activities in cosmetic registration and manufacturing.

    1. Foreign Exchange and Cooperation

    NMPA will participate in the formulation of international regulatory rules and standard.

    3. NMPA consists of 9 subordinate departments, including a “Cosmetic Safety Supervision Department”(化妆品监督管理司), which will undertake cosmetics registration and filing, drafting and supervising the implementation of cosmetic standards, classification rules, technical guidelines and censorship, as well as conducting on-site and sampling inspection, penalizing illegal activities and monitoring adverse reactions.

    » See CL News about the reform.
     
    4. Medcial Products Administration at provincial level under NMPA are in charge of filing of domestic non-special use cosmetics and issuance of cosmetics manufacturers’ production license, namely the Administrative License for Production Enterprises of Cosmetics.
    Domestic responsible person located in the pilot zones capable of filing management including Tianjin, Liaoning, Shanghai, Zhejiang, Fujian, Henan, Hubei, Guangdong, Chongqing, Sichuan and Shanxi shall complete filing to provincial Medical Products Administration. Domestic responsible person located outside pilot zones in China shall complete filing to NMPA.

    5. China General Administration of Customs is responsbible for import and export inspection of cosmetics.

    Part 2 Cosmetic Products

    Before being used, marketed or imported into China, cosmetic products must get approval from NMPA or provincial Medical Products Administration according to the product category.

    Definition of Cosmetic Products

    Cosmetic products refer to chemical products for daily use intended to be applied on any external part of human body (such as skin, hair, nails, lips etc.) by spreading, spraying or other similar ways to keep the body clean, eliminate unpleasant odor, protect skin, and improve appearance and beauty.

    Cosmetics have various definitions in different countries (regions). How to determine whether a product falls in the scope of cosmetics in China? You may take into consideration the following three aspects:

    Aspects

    Yes

    No

    Usage

    Smearing, spraying or other similar ways like rubbing

    Oral administration or injection­­­

    Applied body parts

    Any external part of the human body, such as skin, hair, nails, lips

    Teeth or oral mucosa

    Functions and purposes of use

    Skin care, to make the body hygienic, to eliminate undesirable odors, to enhance the beauty of the appearance

    Prevent and treat diseases

    The above table clearly shows products in contact with teeth and mucous membranes of the oral cavity, such as toothpastes, are not cosmetics in China. According to the draft for second public consultation of Regulations concerning the Hygiene Supervision over Cosmetics 1989, oral hygiene products only require compliance with national or industrial standards such as GB 8372-2017 Toothpaste, GB 22115-2008 and GB 29337-2012 instead of registration or filing. Efficacy claims (such as “anti-caries”, “inhibit plaque” and ect.) of these products are permitted to be used provided adequate standard-based evaluation data supports the claims.

    Classification of Cosmetic Products

    Cosmetic products in China are divided into two categories.

    non-special use cosmetics

    (non-SUC)

     

    • Skin care products;
    • Hair care products;
    • Nail (toe) care products;
    • Make-up
    • Fragrance

    special use cosmetics

    (SUC)

    1. Hair growth products
    2. Hair dyes
    3. Hair perming products
    4. Depilating products
    5. Breast beauty products
    6. Slimming products
    7. Deodorants
    8. Freckle-removing products
    9. Sunscreens
    10. Whitening products

    The adjustment of the classification

    In the second draft of Regulations concerning the Supervision and Administration over Cosmetics, China has changed the classification and categories of cosmetics. In the draft cosmetics are regulated as general cosmetics and special cosmetics. Special cosmetics include:

    • Hair dye products
    • Hair perming products
    • Whitening products
    • Sunscreens
    • Other special cosmetics deemed by the CFDA

    The draft defines general cosmetics as all other cosmetics not classified as special cosmetics. The former CFDA is responsible for formulating and publishing the cosmetic categories inventory and will also adjust the scope of special cosmetics based on the monitoring of cosmetics adverse reaction and R&D outcomes. It is estimated that breast beauty products and slimming products are likely to be managed as pharmaceutical products once it is enfored.

    In the draft for second public consultation of Regulations concerning the Hygiene Supervision over Cosmetics 1989, special use cosmetics are adjusted as following 5 categories:

    • Hair dye products
    • Hair perming products
    • Whitening products
    • Sunscreens
    • Other cosmetics claimed new efficacies

    Registration of Cosmetic Products

    At present, imported special use cosmetics, domestic special use cosmetics and new cosmetic ingredients require pre-market registration with NMPA, while domestic non-special use cosmetics are subject to pre-market filing with the provincial Medical Products Administration, imported non-speical use cosmetics are subject to filing with NMPA or the provincial Medical Products Administration in the 11 FTZs. The registration of non-SUC is less stringent and demanding than that of SUC.

    CategoryObligationCertificateDepartment
    Imported non-SUCPre-market filingFiling certificateNMPA or Provincial Medical Products Administration in the 11 FTZs
    Imported SUCPre-market administrative licensingAdministrative licenseNMPA
    Domestic non-SUCPre-market online filingno certificateProvincial Medical Products Administration
    Domestic SUCPre-market administrative licensingAdministrative licenseNMPA
    New ingredientPre-market administrative licensingNMPA’s approval announcementNMPA

    ► The filing of domestic non-special use cosmetics

    Cosmetics manufacturers shall notify provincial Medical Products Administration through an online platform of the product formula and sales packaging (including labels and instructions for use) prior to marketing. Applicants are required to record the product information, including formula, packaging, description of production process, product technical requirements and testing reports for future examination. In order to assist producers in China, SAMR (the former CFDA) has prepared a guidance document, “Requirements for Filing of Domestic Non-special Use Cosmetic Products”, which details all information required and the filing procedures.

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    Comments


    According to my researches the limit of Arsenic is now 2 mg/kg or 2 ppm. Thank you for your article
    Wednesday, 21 March 2018