The requirement is part of Taiwan’s broader move towards a more structured, documentation-based system for demonstrating cosmetic safety. For international brands, the change means that product notification alone is no longer enough: the technical information supporting each cosmetic must also be complete, consistent and available for regulatory inspection.
The final phase brings almost all cosmetics into scope
Taiwan has introduced PIF obligations progressively rather than applying them to every cosmetic product at once.
The first phase, which began on 1 July 2024, covered products such as sunscreens, hair dyes, permanent-wave products, antiperspirants and certain home-use tooth-whitening products containing peroxide. From 1 July 2025, the requirement was extended to cosmetics for babies, products for the lips and eyes, as well as general toothpaste and mouthwash.
The final phase began on 1 July 2026 and extends the PIF requirement to virtually all remaining cosmetics. The main exception is handmade solid soap manufactured by entities that are exempt from factory registration.
This means that companies can no longer assume that a product falls outside the PIF system simply because it is a conventional or low-risk cosmetic.
What is a PIF and why does it matter?
A Product Information File is essentially the technical dossier supporting the safety and regulatory compliance of a cosmetic product.
The purpose is not simply to provide information at the time of market entry. The PIF must contain sufficient evidence to demonstrate that the product has been appropriately assessed and must be maintained so that the competent authorities can inspect it when necessary.
For companies exporting to Taiwan, this distinction is important. Product notification and the PIF are separate compliance elements. A notification does not replace the obligation to establish and maintain the underlying technical documentation.
Who is responsible for maintaining the file?
The legal responsibility to establish and maintain the PIF falls on the relevant cosmetic manufacturer or importer in Taiwan, depending on the circumstances.
For international brands, however, much of the information needed for the file will originate outside Taiwan. Overseas brand owners and manufacturers may therefore need to work closely with their Taiwanese importer or market partner to provide formulation, manufacturing, testing, packaging and safety information.
The PIF can be maintained in written or electronic form, but it must be available for inspection by the competent authorities.
What information must the PIF contain?
Taiwan’s PIF framework requires a substantial body of technical information. The dossier covers 16 categories of information, including the identity of the product, notification documentation, ingredients and their concentrations, packaging and labelling, manufacturing information and applicable GMP documentation.
Depending on the product, the file can also include information on conditions of use, adverse effects, physicochemical characteristics, ingredient toxicology, stability, microbiological quality, antimicrobial effectiveness and functional or efficacy testing.
A central element is the product safety assessment. The safety information must include the relevant safety conclusion and recommendation and must be signed and dated by a qualified person responsible for the safety report.
The documentation must be established in Chinese or English. Where supporting documents are originally prepared in another language, an appropriate Chinese or English translation must be provided.
The quality of the data matters as much as the presence of the documents
For manufacturers, one of the practical challenges of the new system is not simply assembling a large number of documents. The information must also be consistent across the product’s regulatory records.
Formula information, product notification data, labels, packaging details and safety documentation should correspond to the product actually placed on the Taiwanese market.
This can become particularly challenging for international portfolios where information is held by different departments, contract manufacturers, raw material suppliers and laboratories. Differences between versions of a formula, outdated packaging information or missing supplier documentation can create gaps in the PIF even when the individual documents themselves exist.
Existing global documentation can provide a starting point
International companies may already have substantial technical documentation prepared for other markets. Existing safety assessments, toxicological information, stability data, microbiological studies, manufacturing documentation and packaging records may therefore provide useful material for the Taiwan PIF.
However, companies should not assume that a dossier prepared for another jurisdiction can simply be transferred without review. Taiwan has its own requirements for product notification, documentation, language, local responsibilities and safety assessment.
For manufacturers operating in several markets, the most efficient approach may be to identify which existing documents can be reused and then fill the gaps created by Taiwan-specific requirements.
PIFs must remain up to date
The compliance obligation does not end once the PIF has been created.
Changes to a product’s formulation, manufacturing arrangements, packaging, labelling or other relevant technical information can affect the content of the file. Companies should therefore treat the PIF as a living compliance record, with appropriate version control and procedures for updating the documentation when a product changes.
Taiwan’s requirements also establish a retention period: the PIF must be kept for at least five years from the day after the product was last made available on the market.
What should cosmetic companies do now?
With the final implementation date now reached, companies selling cosmetics in Taiwan should review their product portfolios and confirm that every applicable SKU has an appropriate PIF in place.
Particular attention should be given to products with multiple variants, fragrances, shades or packaging formats, as companies should not automatically assume that one PIF can cover different products or variants when the relevant technical information differs.
Manufacturers should also check that their product notification information, formula, labels and supporting safety documentation are aligned. Missing supplier information, incomplete toxicological data, untranslated documents and outdated test reports are among the issues that can make a file difficult to defend during an inspection.
The introduction of the final phase therefore represents more than another filing deadline. It marks the completion of Taiwan’s transition towards a comprehensive PIF-based system covering almost the entire cosmetics market. For international manufacturers, maintaining accurate and inspection-ready technical documentation will now be an essential part of continued market access in Taiwan.
