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China Taiwan Cosmetics Regulation

  •   18 Jul 2019
  •    Ye Chen
  •  441707
  •   Post a comment

    On 1st July 2019, the overarching cosmetic regulation “Cosmetic Hygiene and Safety Act” in Taiwan entered into force, replacing the former one “Statue for Control of Cosmetic Hygiene”. The categories of cosmetics changes from general cosmetics and medicated cosmetics in the old regulation to general cosmetics and specific purpose cosmetics in the regulation.  

    The newly enforced cosmetic hygiene and safety act establishes a completely new administrative system including a new notification system and requires the establishment of a PIF (product information files). Starting from the effective date (1st July, 2019), all general cosmetics can start their notification procedure through an online platform.

    The actual implementation date for general cosmetic notification is 1st July, 2021. After that, cosmetic products without notification will be regarded as illegal. The notification functions as a record to help TFDA to assign liability in case of any safety problems. Specific purpose cosmetics are still subject to registration, but 5 years later (1st July, 2024), they will be subject to a notification and PIF system as well. TFDA has also strengthened provisions related to post-market surveillance. In addition, the registration of colorants has been abolished.

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    How do you define Medicated Cosmetics? What are the criteria? Thanks
    Tuesday, 22 August 2017
    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.
    Thursday, 24 August 2017
    Hi, may I check with you that, for the ingredient level in the whitening list, is it the efficacy level as well as the max limit? Take Arbutin (7%) for eg, the whitening product must have an exact concentration of 7%, while below 7% will have no whitening efficacy, correct?
    Monday, 14 May 2018
    Hi Dora, the max limit doesn't mean the efficacy level. The max limit is a limit for safe use. If you want to prove whitening efficacy, you can take tests for efficacy validation. So for the example you take, Arbutin (7%), the concentration should be no more than 7%.
    Thursday, 24 May 2018