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FDA Proposes Amendment to the Statute for Control of Cosmetic Hygiene

March 16, 2015

The Taiwan Food and Drug Administration (FDA) is proposing amendments to the Statute for Control of Cosmetic Hygiene. The proposal takes into consideration that current cosmetic regulations are inadequate in the face of practical requirements.

The amendments include the following:

  • Cosmetics category has been extended to include oral care products,
  • Registration and market approval for cosmetics containing medical, poisonous or potent drug(s) and premarket filing for other cosmetics are not required to have product notification and product information files created
  • Labeling requirements
  • Cosmetics manufacturers should comply with Good Manufacturing Practices (GMPs) and be supervised by pharmacists or personnel with professional skills in the field of cosmetics
  • Increased legal responsibility on advertisement of cosmetics
  • Data should be kept on direct supply sources and destinations of products as well as reporting of serious adverse effects generated by cosmetics
  • Announcement of certain cosmetics categories or items that may pose a hazard to hygiene and safety requiring test checks and inspection at the time of importation
  • A public consultation is open for this for 60 days from the date of the notification (January 16, 2015).

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