Updates on Revision of Taiwan Overarching Cosmetic Regulation: Abolishment of Pre-market Approval

Last year ChemLinked was told that Taiwan is revising the overarching cosmetic regulation Statute for Control of Cosmetic Hygiene. Only limited information related to the revision has thus far been released. Recently ChemLinked attended a meeting hosted by TFDA and obtained some first-hand information.

According to the presentation given by TFDA’s official, the Statute will be renamed as Cosmetic Hygiene Law. The guiding principle of the revision is to transfer government responsibility for product safety to manufacturers with the goal of fostering a self-regulating industry and a shift towards post market supervision. All the amendments of the revision are in accordance with this principle.

Compared to the previous version the most significant change is the abolishment of pre-market approval. In its place Taiwan will implement a system of notification which will align with the EU and ASEAN. In future 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. Consumers can also search for product compliance information on the online platform.

To supplement the notification system a PIF system will be established similar to that used in ASEAN. Companies are required to prepare product information by PIF for possible examination by the TFDA should safety problems be discovered. Before the implementation of the notification system, a 5-year grace period will be granted for cosmetic companies.

Apart from the above changes, in terms of the obligations for manufacturers and importers the following changes are also worthy of attention:

1.  It is confirmed that the definition of cosmetics will be changed. In future the legal scope of cosmetics will cover oral care products.
2. Registration of colorants will be abolished. The current List of Legal Colorants will remain as a positive list but may be updated after the release of the new law.
3. Voluntary GMP will be changed to mandatory with an aim to ensure the quality of cosmetics, health and safety of consumer and facilitate the export of cosmetics to foreign counties.
4. The pre-market examination of advertisements will also be abolished.
5. Recall and voluntary reporting will be prioritized

The law is now being reviewed by the Executive Yuan and then will be passed to Legislative Yuan for second review and release. There is no timeline as to when the law will be released but the waiting time is estimated to be lengthy.