"When Product Changes, Does the PIF Need Updating? Understand Common Scenarios at Once!"

Posted by Jolab on May 09, 2025

Since Taiwan implemented the cosmetic Product Information File (PIF) system in 2024, many brands often optimize packaging, adjust marketing copy, or even change manufacturing processes after a product's launch. However, do these "changes" require an update to the original PIF? This article will clarify common scenarios and compliance strategies to help you avoid the risk of non-compliance.

Why update the PIF after product changes?

The PIF is an official document used to prove that a product has "completed safety assessment before market launch" and contains comprehensive product information. If a product undergoes changes after its launch, and these changes affect the product's safety, ingredient information, labeling content, or manufacturing process, then the PIF should be updated. Otherwise, it will be considered "data inconsistent with reality" and may violate the "Cosmetic Hygiene and Safety Act."

Which situations require a PIF update? (Common examples)

The following lists common product change scenarios and explains whether the PIF should be updated and what content needs to be adjusted:

Type of Change	PIF Update Required	Explanation and Required Adjustments
Change in product formula	Yes	Update ingredient list and safety assessment report
Use of a different manufacturer	Yes	Update manufacturing information and batch control procedures
Change in container material (e.g., from glass bottle to plastic bottle)	Yes	If stability is affected, safety analysis must be updated
Change in product name	Yes	Update labeling samples and market information
Change in labeling content (e.g., uses, warnings, shelf life)	Yes	Update labeling documents and related descriptions
Only adjusting outer packaging design (e.g., color and layout)	No, but annotation is recommended	If labeling content is unchanged, only internal records are needed
Adding new packaging forms (e.g., launching travel-sized packaging)	Depends on the situation	If the formula is the same, it can be included in the same PIF, with differences noted
Updating marketing copy (e.g., on official website or promotional leaflets)	Usually no	If it does not conflict with labeling content and regulations, no update is needed

What actions should be taken when updating a PIF?

When it is determined that a product change involves the PIF, the following steps are recommended:

Confirm whether the change affects safety or compliance
It is recommended that internal regulatory personnel or qualified safety assessors conduct a preliminary review.
Update relevant sections in the Product Information File
This includes, but is not limited to, the ingredient list, safety assessment, labeling samples, and manufacturing information.
Retain update records and version management data
Document the time, reason, and content of each update for future inspections.
Ensure immediate availability for inspection by competent authorities
Whether in paper or electronic format, all documents should be properly stored and readily available for inspection.

Recommended practice: Establish PIF version control and update procedures

To ensure compliance and improve operational efficiency, companies should establish a clear internal SOP and version control system:

All product changes should first undergo a regulatory compliance assessment
Establish a "Product Information Update Record Form" to track all changes
If working with contract manufacturers, an agreement should be made beforehand regarding responsibility for PIF updates and submission deadlines

PIF is a "living document" that changes with the product

The PIF is not a static document completed once, but dynamic data that needs to be continuously maintained according to the product's status. Correctly understanding when to make changes and what content needs to be updated is an important step to comply with regulations and reduce risks. If in doubt, it is recommended to consult a professional regulatory consultant or thoroughly confirm data consistency with the manufacturer.