Q1｜What is a PIF?

PIF (Product Information File) is a product technical document established in accordance with the "Cosmetic Hygiene and Safety Act." Its purpose is to ensure the safety, quality, and traceability of cosmetic products and to provide relevant information when inspected by the competent authority.
A PIF is not a certificate issued by the government. Instead, it is a complete set of product information and technical documents that must be established and maintained by the Responsible Person in accordance with the law.

Q2｜Is a PIF approved by the government?

No.
A PIF does not need to be submitted to the government for review and approval before a product can be launched.
Products may be legally marketed and sold, but the Responsible Person must complete the PIF and provide complete documentation when inspected by the competent authority.

Q3｜Which products require a PIF?

Under current regulations, cosmetics marketed and sold in Taiwan are generally required to have a PIF established in accordance with the law.
If a product is classified as a specific-purpose cosmetic or subject to other regulatory requirements, the relevant announcements and requirements of the competent authority shall apply.

Q4｜What does a PIF include?

The contents of a PIF vary depending on the characteristics of the product and generally include:

• Basic product information
• Product formulation information
• Raw material information
• Manufacturing process
• Quality management documents
• Stability testing data
• Packaging compatibility data
• Microbiological data
• Safety assessment report
• Adverse reaction monitoring data (if applicable)

Q5｜Who is responsible for the PIF?

By law, the Responsible Person is responsible for establishing and maintaining the Product Information File.
OEM/ODM manufacturers can provide product manufacturing, formulation, and related technical documents to assist brand owners in completing the PIF.

Q6｜What assistance can OEM/ODM manufacturers provide?

Our company can provide the following based on the products involved:

• Formulation technical data
• Raw material documentation
• Manufacturing process data
• Quality management documents
• Stability testing planning
• Microbiological testing planning
• Packaging compatibility recommendations
• Technical documents required for PIF preparation

The actual documentation required should still be determined based on the product characteristics and applicable regulatory requirements.

Q7｜How long does it take to prepare a PIF?

The preparation time varies depending on the product type, completeness of the documentation, and required testing items.
If stability testing or other tests are required, brands are advised to allow sufficient preparation time before product launch to avoid affecting the launch schedule.

Q8｜What happens if a PIF is not prepared?

If the Responsible Person fails to establish or maintain a PIF in accordance with the law, the competent authority may require corrective action within a specified period during an inspection. In serious cases, relevant provisions of the "Cosmetic Hygiene and Safety Act" may apply.