Exporting Cosmetics to Taiwan: TFDA Registration, PIF and Labels

Who registers: the Taiwan importer

Under Article 4 of the Act, the manufacturer or importer must register each product (產品登錄) and establish its PIF before the product is supplied, sold, given away, publicly displayed or offered for consumer trial. Registrants must be companies, businesses or factories registered in Taiwan, so a foreign brand works through its importer, a distributor or its own Taiwan subsidiary or branch. That company is legally responsible for the product, and each importer, including a parallel importer, registers the products it brings in.

Registration is made on TFDA's cosmetic product registration platform (化粧品產品登錄平台系統). It covers the product name in Chinese and English, category, use, dosage form, precautions, the registrant's name, address and phone number, the manufacturing site and the full ingredient list. It is valid for 3 years and is renewed in the 3 months before expiry. A change of ingredients needs a new registration; other changes are made as amendments.

From 1 July 2026 the fee (化粧品行政規費收費標準) is NT$800 per registration, NT$700 per change and NT$600 per renewal. Non-medicinal toothpaste and mouthwash are cosmetics too. Only handmade solid soap from makers exempt from factory registration is outside registration and the PIF.

The Product Information File (PIF)

The PIF (產品資訊檔案) was phased in: former specific-purpose cosmetics from 1 July 2024; baby, lip and eye products and non-medicinal toothpaste and mouthwash from 1 July 2025; and all other cosmetics from 1 July 2026. The importer keeps it, in Chinese or English, at the address given in the registration, for at least 5 years after the product was last placed on the market. It has 16 items under TFDA's PIF rules, grouped here:

• Basic product data and proof of product registration
• Full ingredient names and amounts
• Label, leaflet and packaging text
• Proof of GMP compliance, and the manufacturing method and process
• Directions for use, adverse reaction data, and physical and chemical properties
• Ingredient toxicology data, and stability, microbial and preservative efficacy test reports
• Evidence for claimed effects, and packaging material data
• Safety assessment signed and dated by a qualified safety assessor (安全資料簽署人員)

GMP and the safety assessor

Taiwan's cosmetic GMP rules (化粧品優良製造準則) apply to factories in Taiwan on the same timetable as the PIF, and to all of them since 1 July 2026. For a product made abroad, TFDA's PIF guidance accepts a cosmetic GMP certificate issued by a government authority, an ISO 22716 certificate issued by a certification body, or the manufacturer's declaration that it complies with Taiwan's GMP rules.

The safety assessor needs a relevant degree, for example in medicine, pharmacy, cosmetic science or toxicology, plus prescribed training and at least 8 hours of continuing education a year. Assessors trained abroad can qualify, but ask your importer to confirm that yours meets Taiwan's rules before the safety assessment is signed.

Specific-purpose cosmetics, ingredients and animal testing

Until 30 June 2024, sunscreens, hair dyes, perms, antiperspirants and deodorants, and at-home teeth whitening products were specific-purpose cosmetics (特定用途化粧品) that needed a TFDA permit before manufacture or import. The permit system (Article 5) ended on 1 July 2024, and Taiwan now manages all cosmetics as one category. Products made or imported since then must not show a permit number or a separate statement of specific-purpose ingredient content; list all ingredients in descending order instead.

Since 9 November 2019, testing cosmetics or ingredients on animals in Taiwan for safety assessment is banned unless TFDA approves an exception, for a widely used ingredient that cannot be replaced or where data suggest a risk to human health; products that break the ban may not be sold. Glass ampoules (安瓿) may not be used as cosmetic containers (TFDA notice of 8 June 2016).

Cosmetics may not contain mercury, lead or other prohibited ingredients (Article 6). Check each formula against TFDA's lists, which are updated regularly:

• Prohibited ingredients (化粧品禁止使用成分表): the revision in force since 1 January 2025 added 9 entries, including PFAS
• Restricted ingredients (化粧品成分使用限制表): a revised list applies from 1 October 2027; goods made or imported by 30 September 2027 may be sold until their labelled expiry
• Preservatives (化粧品防腐劑成分名稱及使用限制表) and colourants (化粧品色素成分使用限制表)
• UV filters (化粧品防曬劑成分使用限制表), in force since 1 July 2024

Chinese labels

Under Article 7 and the labelling rules in force since 1 July 2021, the outer package or container shows the items below in Chinese or internationally used symbols; ingredient names may be in English. The outer package needs a Chinese product name. The manufacturer's name and the registration number are not required.

If the largest surface is under 40 cm², the pack may show only the name, use, importer and date information, with the rest on a leaflet, card or tag. Imported cosmetics divided into smaller packs in Taiwan (分裝) must be marked 臺灣分裝 or equivalent words. Sellers may not alter labels or packaging, so the importer applies the Chinese label before supply.

• Product name and use
• Directions for use and storage
• Net weight, volume or quantity
• All ingredients in descending order; those at 1% or less, and colourants in make-up, may follow in any order
• Precautions for use
• Name, address and phone number of the Taiwan importer, and the country of origin
• Two of: manufacturing date, expiry date and shelf life
• Batch number

Claims, customs clearance and after-sale duties

Labels, promotion and advertising must not be false or exaggerated or claim medical effects (Article 10), judged under the Criteria for False, Exaggerated or Medical Efficacy Claims (化粧品標示宣傳廣告涉及虛偽誇大或醫療效能認定準則). Fines are NT$40,000 to NT$200,000 for false or exaggerated claims and NT$600,000 to NT$5 million for medical claims (Article 20).

Article 14 lets TFDA designate cosmetics that must pass border sampling before import (輸入化粧品邊境查驗辦法), but TFDA's Q&A on the Act states that none have been designated, and since July 2024 there is no import permit for former specific-purpose products. The law ties registration to supply rather than import; still, register before the first shipment so goods can be sold on arrival, and ask your customs broker what it will check. Cosmetics fall mainly under HS headings 3303 to 3307, declared with Taiwan's 11-digit CCC codes; Triplicate's free invoice and packing list generator and HS code lookup help keep names and codes consistent with the registration.

After launch, report serious adverse reactions within 15 days of learning of them through TFDA's online system (Article 12), keep records of direct suppliers and business buyers (Article 11), and renew each registration every 3 years. Rules change, so confirm current requirements with TFDA, your importer and a licensed customs broker before shipping.