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Taiwan Specifies Documents Required for Cosmetic Product Information Files

  •   14 Jan 2019
  •    Hedy He
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    Takehome: Taiwanese authorities specified the documents required for PIF (product information files), criteria for serious product labeling claim or advertising violation, and the implementation date of cosmetics notification and PIF.

    On Dec 26, 2018, Taiwan FDA released 4 drafts of cosmetic regulations, which are 1) Administrative Measures for Product Information Files 2) Enforcement Rules of Cosmetic Hygiene Safety Administration Act 3) Cosmetic Product Category that should Complete Product Notification 4) Cosmetic Category that should Establish Product Information Files. Public consultation will last until Feb 25, 2019. Any suggestions can be submitted on Taiwan Public Policy Participation Platform or mail elainefang@fda.gov.tw.

    Administrative Measures for Product Information Files

    Cosmetic Hygiene Safety Administration Act stipulated that cosmetics manufacturers and importers shall complete product notification and establish product information files prior to supply, sales, gifts, public displays or trials for consumers. This measure specifies the qualifications of the manufacturer and importer who can establish the PIF, documents required for PIF, the time PIF should be kept, the qualifications for product safety data signers, etc.

    Qualifications of manufacturers and importers who can establish the PIF:

    1. Company that completed registration
    2. Factory that completed registration
    3. Except for handmade soap manufacturers and the first 2 kinds of enterprises, groups or legal persons that manufacture or import cosmetics.

    *PIF of products entrusted to be manufactured shall be established by the entrusting party.

    Documents required for PIF (Chinese and English are both acceptable):

    Product basic information (name, category, formulation, usage, name and address of manufacturer, importer’s information)
    Documents that can prove products have completed notification
    Full ingredients and concentration
    Product label, instruction, outer packaging or container
    GMP certificate
    Manufacture method and process
    Use method, application area, usage amount, frequency and target users
    Adverse reaction data
    Physical and chemical properties of products and ingredients
    Ingredients’ toxicological data
    Product stability test report
    Microbiological test report
    Anticorrosion efficacy test report
    Functional assessment supporting data
    Packaging materials information in contact with products
    Product safety data
    1) safety assessment conclusions and advices signed by safety data signer
    2) certificate of safety data signers’ qualifications

    PIF should be kept for at least 5 years (hardcopy or electronic) and stored at the manufacturer or importer’s address marked on the packaging. The competent authority will notify the enterprise 5 days before checking PIF.

    Enforcement Rules of Cosmetic Hygiene Safety Administration Act

    The Enforcement Rules specify the definition of cosmetic country of origin and manufacturing site and conditions of claim or advertising violation, etc.

    Compared with the previous version, the main amendments include:

    1. Add the provisions that cosmetics should establish PIF and complete notification, GMP certification;
    2. Delete the provisions about medicated cosmetics and colorants registration and pre-market approval of advertisements;
    3. Specify the definition of cosmetic country of origin and manufacturing site and conditions of serious claim or advertising violation

    • Claim or advertise medical efficacy;
    • Mislead consumers in way that leads to morbidity or mortality.

    Cosmetic Product Category that should Complete Product Notification and Cosmetic Category that should Establish Product Information Files

     Product categoryEffective date
    Product notificationGeneral cosmetics2 years after the implementation of Cosmetic Hygiene Safety Administration Act
    Special-use cosmetics5 years after the implementation of Cosmetic Hygiene Safety Administration Act
    Product PIFSpecial-use cosmetics5 years after the implementation of Cosmetic Hygiene Safety Administration Act
    General cosmetics used for infants, used around the eyes or mouth6 years after the implementation of Cosmetic Hygiene Safety Administration Act
    General cosmetics (except for special-use cosmetics, cosmetics used for infants, used around the eyes or mouth)7 years after the implementation of Cosmetic Hygiene Safety Administration Act

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    ChemLinked Editor

    Tracking regulatory change news in Asia Pacific area and focusing on cosmetic ingredient requirements, registration/filing/notification procedures of China and South Korea.

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