China Cosmetics Regulation

  •   28 Jan 2014
  •    Echo Cao
    Cosmetics

     China Cosmetics Legislation

    Overarching Regulation
    Regulations concerning the Hygiene Supervision over Cosmetics
    Competent Authority
    China Food and Drug Administration (CFDA)
    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, China Food and Drug Administration (CFDA).   

    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, 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 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

    Hygiene Standard

    For Product

    Hygienic Standard for Cosmetics 2007

    《化妆品卫生规范》

    A fundamental standard for cosmetic products and ingredient, containing prohibited and restricted substance lists and testing methods

    1 Jul 2007

    In force, but will be repealed since December 1st 2016

     

    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 2016To be enforced

    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

    Administrative Measures on Filing of Domestic Non-Special Use Cosmetics 《国产非特殊用途化妆品备案管理办法》Guidance for filing of domestic non-special use cosmetics

    1 Oct 2011

    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》New Guidance for filing of domestic non-special use cosmetics30 Jun 2014Replaces the  above  measures since 30 Jun 2014

    Guidance on Application and Review of New Cosmetic Ingredient 2011《化妆品新原料申报与审评指南》

    Formulated especially for registration of new cosmetic ingredients

    1 Jul 2011

    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 2 010

    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

    1.    China Food and Drug Administration (CFDA) was established on the basis of the former State Food and Drug Administration (SFDA), rebranded and elevated to a ministerial-level agency following a governmental restructuring in March 2014. CFDA is created to largely reduce the overlap of supervisory power shared by several departments and streamline regulation of food, drug and cosmetics safety.

    In term of cosmetics, CFDA is in charge of comprehensive supervision on cosmetics, including domestic cosmetics production and registration of cosmetic products (special use cosmetics and imported non-special use cosmetics) and new ingredients, under which there are three sub-departments related to cosmetics:  

    Figure 1: Cosmetics-related Departments under CFDA

     

    2. The Cosmetic Registration Review Center under CFDA focuses on the technical review of cosmetic products and new cosmetic ingredients applying for registration. There is a technical Review Committee for cosmetics, mainly consisting of four distinct expert panels:

    • Expert group to review product name/label
    • Expert group to review product formula
    • Expert group to review micro and chemical data
    • Expert group to review toxicology data

    3. The Food and Drug Administrations at provincial level under CFDA are in charge of registration of domestic non-special use cosmetics and issuance of cosmetics manufacturers’ production license, namely the Hygiene License for Production Enterprises of Cosmetics.

    4. The General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ)’ main supervisory scope is the import and export inspection of cosmetics.

    5. The State Administration for Industry & Commerce (SAIC) manages cosmetic advertising, cosmetics trade mark registration and commercial activities.

    Part 2 Cosmetic Products

    Before being used, marketed or imported into China, cosmetic products must get approval from CFDA or provincial FDAs 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. However, according to the Regulations concerning the Supervision and Administration over Cosmetics, toothpastes will be incorporated into cosmetic products.

    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 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. 

    Registration of Cosmetic Products

    At present, imported cosmetics, domestic special use cosmetics and new cosmetic ingredients require pre-market registration with CFDA, while domestic non-special use cosmetics are subject to post-market filing with the provincial FDA. The registration of non-SUC is less stringent and demanding than that of SUC.

    CategoryObligationCertificateDepartment
    Imported non-SUCPre-market filingFiling certificateCFDA
    Imported SUCPre-market administrative licensingAdministrative licenseCFDA
    Domestic non-SUCPre-market online filingno certificateProvincial FDA
    Domestic SUCPre-market administrative licensingAdministrative licenseCFDA
    New ingredientPre-market administrative licensingCFDA’s approval announcementCFDA

     The filing of domestic non-special use cosmetics

    Cosmetics manufacturers shall notify provincial FDA 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, 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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