Taiwan Cosmetics Legislation

  •   13 Sep 2016
  •    Angelita Hu

     Taiwan Cosmetics Legislation

    Overarching Regulation
    Statute for Control of Cosmetic Hygiene
    Competent Authority
    Taiwan Food and Drug Administration (TFDA)
    Main Supporting Rules 
    June 12 2002Enforcement Rules of Statute for Control of Cosmetic Hygiene
    2 Feb 2016Standard List of Maximum Levels of Medical, Poisonous or Potent Drugs in Cosmetics
    1 Jan 2008Requirements for Cosmetic Labeling, Instruction and Packaging

    Like China mainland Taiwan also adopts a premarket approval system for supervising cosmetics, however premarket approval in Taiwan is only applicable to medicated cosmetics. The other cosmetic category namely general cosmetics is subject to notification or registration. There is an exception to this rule as Taiwan requires colorants to be registered with Food and Drug Administration (FDA) as well.

    According to the latest news Taiwan intends to abolish premarket approval. In its place a system of notification will be implemented, which will align with the EU and ASEAN. In future there will be no distinction between general cosmetics and medicated cosmetics. All cosmetics will be subject to notification through an online platform. The notification will function as a record to help TFDA to assign liability in case of any safety problems. TFDA will strengthen the postmarket surveillance and encourage industry self-regulation. In addition, the registration of colorants will be abolished as well.

    Contents

    Part 1 Regulatory Framework and Competent Authority

    1 Existing Key Cosmetic Regulations in Taiwan

    Types

    Regulations

    Date of Implementation

    Status

     

    Statute for Control of Cosmetic Hygiene (2002)

    2002-6-12

    In Force

     

    Enforcement Rules of Statute for Control of Cosmetic Hygiene

    2009-9-16

    In Force

    Manufacturing

    Standards for Cosmetics Manufactories

    2008-4-30

    In Force

    Key Points on the Implementation of Voluntary Cosmetics Good Manufacturing Practices

    2014-06-09

    In Force

    Ingredients

    Standard List of Maximum Levels of Medical, Poisonous or Potent Drugs in Cosmetics

    2016-2-22

    In Force

    List of Ingredients Prohibited in Cosmetics

    2016-2-22

    In Force

    Legal Colorants in Cosmetics

    2016-1-1

    In Force

    Maximum Levels of Preservatives Allowed in Cosmetics

    2014-5-15

    In Force

    Labeling

    Requirements for Cosmetic Labeling, Instruction and Packaging

    2008-01-01

    In Force

    2 Cosmetic Government Authorities

    Taiwan Food and Drug Administration, a department of Ministry of Health and Welfare is in charge of comprehensive supervision on cosmetics, including formulating and releasing cosmetic regulations, domestic cosmetics production and registration of medicated cosmetics and colorants.

    Part 2 Cosmetic Products

    1 Definition

    The “Statute for Control of Cosmetic Hygiene (2002)” stipulates that cosmetics refer to substance(s) for external use on the human body in order to improve the appearance of the hair or skin, to stimulate the sense of smell, to cover body odor or to improve facial appearance.

    2 Classification

    Taiwan regulates cosmetics based on ingredients, so the classification of cosmetics is in line with the regulatory model. Cosmetic products are categorized into general cosmetics and medicated cosmetics. The sole criterion to determine the category is to check if a cosmetic product contains the ingredient in the “Standard List of Maximum Levels of Medical, Poisonous or Potent Drugs in Cosmetics”. If yes, the product is considered as medicated cosmetics. Otherwise, it belongs to general cosmetics.

    3 Obligations of Manufacturers and Importers

    Categories

    Obligation

    General cosmetics

    No notification or registration

    Medicated cosmetics

    Registration

    General cosmetics don’t need to apply for notification or registration but the products must comply with related ingredients regulations and labels in accordance with Article 6 of “Statute for Control of Cosmetic Hygiene”.

    However both imported and domestic medicated cosmetics must be registered with TFDA prior to importation or manufacture. For domestic medicated cosmetics, the applicant can be the original cosmetic company or the distributer, agent or OEM entrusted by the original company. Imported companies shall appoint a distributer, agent or OEM in Taiwan to do the registration work.

    Registration Dossier

    The table below shows required documents for registration of imported and domestic medicated cosmetics:

    Registration Documents

    Domestic medicated cosmetics

    Imported medicated cosmetics

    Application form

    Application checklist

    Company business certificate

    Paste sheet of labels and packages

    Power of attorney

     

    Manufacturing and sale license from country of origin

     

    Testing specification, methods and reports from original manufacturer

    Ingredients list from manufacturers or entrusted manufacturers

     

    Previous review result report of the same series products (if have)

    Trial-manufacture record sheet (kept for post-market inspection)

     

    Review Procedures of Medicated Cosmetics

    Any question?

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    Comments

    How do you define Medicated Cosmetics? What are the criteria? Thanks
    According to Taiwan Overarching Regulation "Statue for Control of Cosmetic Hygiene" Article 7, for importation of any cosmetic containing medical, poisonous or potent drugs should submit an application stating therein the name and content of raw materials and other relevant documents. To detail the standard of this registration process, TFDA also release a provision called "Standard for Examination and Registration of Medicated Cosmetics and Colorants", and in this document cosmetic containing medical, poisonous or potent drugs are officially named as "Medicated Cosmetics". Cosmetic containing medical, poisonous or potent drugs listed on "standard list of maximum levels of medical poisonous or potent drugs in cosmetic" mentioned in above Pedia are defined as "Medical Cosmetics" and should registration before importing to Taiwan.