Taiwan Updates Guidance Documents for Establishing the Product Information File (PIF)

On October 2, 2023, Taiwan Food and Drug Administration (TFDA) released the updated guidance documents for establishing the product information file (PIF) for cosmetics, including the Guidelines on the Establishment of PIF, Manual for the Establishment of PIF, and PIF Checklist. The main revisions made in these documents are related to the terminology of and references for documents, PIF templates, and the alternatives to animal testing, which entered into force upon their release.¹

July 1, 2024: Important Milestone for Specific Purpose Cosmetics

Based on functions, cosmetic products in Taiwan are categorized into general cosmetics and specific purpose cosmetics. The latter category includes products used for sunscreening, hair dyeing, permanent waving, antiperspirant, deodorant, tooth whitening, and other purposes specified in the List of Specific Purpose Ingredients in Cosmetic Products. 

Currently, specific purpose cosmetics are required to undergo pre-market registration with TFDA. However, starting from July 1, 2024, all specific purpose cosmetics will be regulated as general cosmetics, whose pre-market obligation will be changed to notification and the establishment of a PIF.

To align with the updated obligations of current specific purpose cosmetics and ensure compliance since July 1, 2024, TFDA has made revisions to the guidance documents for establishing the PIF.

Main Revisions to the Updated Documents

Compared to the respective previous versions of the guidance documents, the adopted revisions mainly pertain to the terminology of and references for documents, PIF templates, and the alternatives to animal testing.

• Terminology and references

In line with the upcoming changes on cosmetic category, the term "specific purpose ingredient" is replaced in three guidance documents. It now refers to cosmetic ingredients in general. Additionally, the references included in the documents are updated to ensure they reflect the latest versions.

• PIF templates

Five new PIF templates are included into the guidance documents. Among these templates, two are specifically designed for cosmetics intended for teeth whitening and antiperspirant, which are currently regulated and will continue to be regulated as specific purpose cosmetics until June 30, 2024.

• Alternatives to animal testing

Since the last update of the PIF guidance, the Organisation for Economic Co-operation and Development (OECD) has introduced a number of new alternatives to animal testing. Among these alternatives, three methods designed for testing the potential eye irritation and carcinogenicity are newly included in the guidance documents.