Taiwan FDA’s new Cosmetic Regulations

The cosmetic products industry of Taiwan always had strict regulations to manage the safety and efficacy of its beauty products. To ensure the supply of safe cosmetics is continued in the country, the Food and Drug Administration (FDA) of Ministry of Health and Welfare of Taiwan has recently modified the regulations for cosmetic products to align with the international standards.

As of July 1, 2019, the Cosmetic Hygiene Safety Act has officially replaced the Statute for Control of Cosmetic Hygiene in Taiwan. While most parts of the new Act are already in force, some major changes will be implemented on later dates to help manufacturers adapt to the changes.

Below listed are some of the highlights of the new Act:

  • The medicated cosmetics category has now been renamed as specific purpose cosmetics.
  • A new cosmetic registration notification system has been introduced under the Act from July 1, 2019. All general cosmetics’ manufacturers may initiate their notification procedure via the online notification platform.
  • The formal date of compulsory implementation of the new notification system is July 1, 2021. All the general cosmetics are required to be notified through the new system by the said date in order to be in the market.
  • Special purpose cosmetics still require pre-market registration; however, this requirement is subject to change by July 1, 2024.
  • The Act has also established the requirements for a new Product Information File (PIF) and its related information.

Apart from these, there are a few additional administrative changes under the Act, which have also come into force from July 1, 2019. Those include:

  • The Cosmetic Hygiene Safety Administration Act’s implementation rules provide clear definitions for various aspects of the cosmetic life cycle such as for the responsible person, PIF, manufacturing sites, or situations wherein advertisement of cosmetic products is in violation, etc.
  • Required documentation for border inspection methodology for imported cosmetics and fees are also established under the Act.
  • The Act provides implementation dates for product categories that require Good Manufacturing Practices (GMP).
  • The Act has established labeling requirements for imported cosmetic products that use the term “Medicated,” and are regulated as drug products in the origin country, along with few other modifications. The new labeling rule will come into effect from July 1, 2021.
  • For specific purpose cosmetics that require an update or modifications, the Act provides a list of documents required for the change of registration and license information for cosmetics.

Though most of the changes are already into effect, companies are yet to figure out their way around the new regulations. In such a situation, it is highly advisable for cosmetic product companies to consult Regulatory expert in the domain to ensure successful market entry in Taiwan. Stay compliant. Stay up to date.