With the revision of the “Cosmetics Hygiene and Safety Management Act,” Taiwan’s cosmetics industry has officially entered the era of the “Product Information File (PIF).” For many brand owners and manufacturers, transitioning from the old filing system to the high-standard PIF framework is not only a challenge in terms of regulatory compliance but also critical to the successful market launch of their products.
As your professional testing partner in regulatory compliance, we have specifically focused on the core elements and implementation timeline of PIF development to help you stay firmly grounded amidst the regulatory changes.
I. What is a PIF? Why is it essential to act now?
In the past, placing cosmetics on the market might have involved a simple registration or filing process; now, regulatory authorities require the industry to establish a comprehensive “Product Information File,” which is the PIF. Regulations stipulate that cosmetic manufacturers or importers must establish a product information file prior to product supply, serialization, or testing, and keep it at the address indicated on the product label or in the filing records. The requiredfile
must be retained for 5 years starting from the day following the product’s last day on the market.
The core objective is to ensure that products undergo appropriate safety assessments to demonstrate that they pose no risk to human health. This means that future products entering the market will no longer be approved based solely on the premise that “the formulation is safe,” but will require a comprehensive set of scientific data to support their safety.
II. Implementation Timeline: When Will Your Product Require a PIF?
According to the latest announcement from the Ministry of Health and Welfare, the PIF system will be implemented in phases. Please be sure to check which category your product falls under to avoid missing the grace period: 1. Effective (July 1, 2024): Cosmetics for specific uses (including products containing specific ingredients such as sunscreen, hair dye, hair perming agents, antiperspirants and deodorants, and teeth whitening products).