Taiwan’s Cosmetic PIF Framework Enters Full Implementation: Requirements and Official FAQs

In line with the global trend toward enhanced corporate responsibility and post-market surveillance in cosmetic safety regulation, Taiwan has implemented the cosmetic product information file (PIF) system in phases since 2024. Following the completion of the phased implementation on July 1, 2026, Taiwan's cosmetic regulatory framework has entered a new stage of full implementation of PIF requirements. Except for solid handmade soaps manufactured in factories enjoying exemption from registration, all cosmetics placed on the market are required to have a complete PIF available for review by the competent authority.

This article outlines Taiwan's PIF framework, covering key aspects such as PIF management, required content, safety data signatory qualifications, and practical compliance considerations based on official FAQs issued by the competent authority.

Taiwan's PIF Regulatory Framework

1. PIF Management Overview

Taiwan's PIF system is based on a post-market surveillance model, where companies are responsible for maintaining product safety documentation and the competent authority conducts reviews when necessary. Companies do not need to submit PIFs for pre-market review but must ensure that complete PIF information is available upon request.

When preparing and maintaining a PIF, companies should consider the following key aspects:

• Responsible Parties: The cosmetic manufacturer or importer is responsible for maintaining the PIF. Contract manufacturers, while not responsible for the PIF under the regulations, should support the process by providing relevant technical information;

• Language Requirements: PIF documents should be prepared and maintained in Traditional Chinese or English. Documents originally prepared in other languages should be accompanied by accurate translations into either of these languages;

• PIF Maintenance and Retention: PIFs can be maintained in paper or electronic form, and should be kept at the address of the manufacturer or importer indicated on the product label. The information should be updated, supplemented, or adjusted as necessary, and retained for at least five years from the day following the date on which the product was last placed on the market.