Product Information File (PIF) for Cosmetics: EU and Taiwan

In short: a product information file (PIF) is the dossier that the party placing a cosmetic on the market keeps for each product, ready for inspection by the authorities.

In the EU, the responsible person keeps it for ten years after the last batch is placed on the market, and it must include a product description, the safety report, a GMP statement, proof of claimed effects and animal-testing data.

Taiwan requires a 16-item PIF from manufacturers and importers, phased in from 1 July 2024 to 1 July 2026, with a signed safety assessment by a qualified assessor.

Sources: Articles 8, 10 and 11 of Regulation (EC) No 1223/2009¹; Taiwan’s Cosmetic Hygiene and Safety Act², the Regulations Governing Cosmetic Product Information Files³ and the TFDA announcement of PIF categories and dates⁴ (Chinese). Translations are ours.

Step 1: Identify who must keep the product information file

• EU: Article 11(1) puts the duty on the responsible person, who must keep a PIF for each cosmetic product placed on the market. A Korean brand without an EU entity cannot hold it; its EU responsible person does. See EU CPNP notification for how the responsible person role works.
• Taiwan: Article 4(1) of the Cosmetic Hygiene and Safety Act requires manufacturers and importers, for the categories and business sizes the authority announces, to complete product registration and build a PIF before the product is supplied, sold, given away, displayed or offered for trial.

In both cases, the Korean manufacturer or exporter supplies most of the underlying data, but the file belongs to the local party.

Step 2: Check when the duty applies to your products

Taiwan phased the PIF in by product type, under a TFDA announcement of 26 June 2024:

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As of this guide’s date, all three phases are in force. Product registration on the TFDA platform is a separate step; see Taiwan cosmetics product registration.

In the EU there is no phase-in: every cosmetic product placed on the market needs a PIF.

Step 3: Assemble the product description and formula

The EU file starts with a description that lets the PIF be clearly tied to the product (Article 11(2)(a)). Taiwan’s list is more granular. Its first items are basic product data (name, category, form, use, manufacturer and importer details), proof of product registration, the full ingredient list with each ingredient’s concentration, and the label, leaflet, outer pack or container.

From the Korean side, this means a formula with percentages, the INCI list, the manufacturer’s details and final artwork. Keep version control: the PIF must match what is actually sold.

Step 4: Get the safety assessment done by a qualified assessor

• EU: the file must contain the cosmetic product safety report under Article 10(1).
• Taiwan: item 16 is the product safety information, including a safety assessment signed by a safety assessor. The regulations set qualifications: a degree in medicine, pharmacy, cosmetic science, toxicology or a related field (chemistry or chemical engineering graduates qualify only if they graduated before 30 June 2019 with at least five years’ cosmetic safety assessment experience), a training course covering at least 54 hours across four subjects, and at least eight hours of continuing training each year. Assessors from places with a mutual recognition agreement with Taiwan may be exempt.

The assessor relies on the test data in Step 6, so plan the tests before you book the assessment.

Step 5: Add manufacturing method and GMP evidence

The EU file needs a description of the manufacturing method and a statement on compliance with good manufacturing practice under Article 8 (Article 11(2)(c)). Taiwan asks for proof or a declaration that the manufacturing site complies with its cosmetic GMP rules, plus the manufacturing method and process.

For a Korean factory, the usual evidence is a Korean CGMP certificate or an ISO 22716 certificate. The difference between the two is covered in CGMP vs ISO 22716.

Step 6: Collect test reports, claim support and animal-testing data

Taiwan lists the technical data item by item: directions (method, area, amount, frequency, user group); adverse reaction data; physical and chemical properties of the product and ingredients; ingredient toxicology; stability, microbiological and preservative efficacy test reports (the last three can be omitted if the safety assessor justifies it); efficacy support; and packaging material data.

The EU file must include proof of the effect claimed where the nature or effect of the product justifies it (Article 11(2)(d)), and data on any animal testing by the manufacturer, its agents or suppliers relating to the product or its ingredients, including testing done for other countries’ requirements (Article 11(2)(e)).

Step 7: Set language, location and retention

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Related pages

SEONGWOO GLOBAL is a Korean cosmetics wholesale exporter with companies in Seoul and Hong Kong. If you need product documents for a PIF, tell us the products and market when you enquire, and we will discuss what the brand side can provide.

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