Since July 1, 2024, Taiwan, China has officially abolished the inspection and registration system for "specified-use" cosmetics, removed the dual-track management model of ordinary/special cosmetics, and fully implemented the cosmetic product notification system. Many beauty brands are planning to enter the Taiwan market; however, numerous enterprises have only completed the online notification while neglecting the establishment of the PIF (Product Information File), exposing themselves to risks of inspection fines and product delisting.
Based on the regulations of Taiwan, China, this article summarizes the practical essentials of notification and PIF to help brands achieve compliant market entry.
I. Regulatory Framework and Regulatory Updates
The competent authority for cosmetics regulation in Taiwan, China is the Food and Drug Administration, Ministry of Health and Welfare (TFDA). Its Medical Devices and Cosmetics Division is responsible for rule-making, product notification review, license issuance, post-market safety surveillance, and industry guidance. Compliance consists of two major parts: pre-market access and post-market supervision. Before any product is sold, gifted, or displayed for trial use, product notification must be completed and a PIF must be established; after products are placed on the market, the authority conducts market spot checks, and enterprises must report serious cosmetic adverse reactions in accordance with the regulations.
Cosmetics are defined as preparations applied to the external human body, teeth, or oral mucosa for moisturizing, perfuming, embellishing appearance, or cleansing the body; pharmaceuticals fall outside the regulatory scope of cosmetics. Products are classified into 14 major categories, covering skin and hair care, color cosmetics, fragrances, and lip and eye makeup — tooth whitening oral cosmetics are likewise regulated as cosmetics. In November 2024, the TFDA announced an amendment to the category table, which will take effect on July 1, 2026; enterprises should keep tracking category adjustments.
The core regulation is the Cosmetics Hygiene and Safety Act and its Enforcement Rules. The new regulation officially came into force on July 1, 2024, terminating the 5-year transition period for legacy "specified-use" cosmetics and applying the notification system uniformly to all categories. Supporting regulations include the Regulations Governing Cosmetic Product Notification, the Regulations Governing the Management of Cosmetic Product Information Files, prohibited and restricted ingredient lists, labeling provisions, and adverse reaction reporting measures, together forming a complete compliance system.
II. Product Notification: The "Ticket" to Market Access
The responsible entity for product notification is limited to local manufacturers or importers; application accounts are not open to overseas enterprises. If the same product is supplied to multiple Taiwan traders, each trader must complete the notification independently; placing a product on the market without notification constitutes unlawful circulation.
Only solid handmade soaps that are exempt from factory registration may be exempted from notification; all other cosmetics must complete notification before being placed on the market. A notification is valid for 3 years, and renewal must be processed within 3 months before expiry. Fees: NTD 800 (notification), NTD 700 (amendment), and NTD 600 (renewal).
The notification number is a unique 22-digit code: the first 8 digits are the enterprise's Unified Business Number, automatically imported by the system, while the last 14 alphanumeric characters can be customized by the enterprise. A code can never be reused.
Core Data Required for Notification
When notifying through the cosmetics system, the following information must be provided:
- Product notification number
- Product name in Chinese and English; however, products manufactured locally in Taiwan, China do not require an English name
- Product category and intended use
- Product type; for a product series, the model or shade number should be specified
- Product form
- Precautions for use
- Name, address, and telephone number of the manufacturer or importer
- Name, address, and country of the manufacturing site, and its compliance with cosmetics GMP
- Full ingredient names; for ingredients subject to restrictions, the concentration (% by weight or volume) must be provided
Notification of Series Products & Sets
- Products in the same series with identical form and intended use, differing only in colorants or fragrances, may be notified under one case;
- Combination travel sets whose individual items are not sold separately may be notified as a single combined product;
- If an item in a set is later split and sold separately, that item must complete notification independently.
III. PIF (Product Information File): The Core Basis for Regulatory Inspection
A common misconception among enterprises is that completing product notification means full compliance. However, notification does not equal PIF compliance. The PIF is the core documentation for on-site regulatory verification. Importers, self-manufacturing enterprises, or responsible enterprises that entrust manufacturing must establish a PIF; commissioned contract manufacturers and solid handmade soap manufacturers exempted from notification are not required to do so.
The file may be kept in paper or electronic form. If original documents are not in Traditional Chinese or English, accompanying translations must be provided. From the day following the product's final placement on the market, the file must be retained for at least 5 years, ready for inspection.
PIF Phased Implementation Timetable (TFDA Letter Wei-Shou-Shi-Zi No. 1131604608)
- July 1, 2024: PIF was first required for products containing restricted ingredients listed in the annexes, such as sunscreen products, hair dyes, hair perming products, antiperspirants/deodorants, and at-home tooth whiteners containing peroxides;
- July 1, 2025: extended to baby products, lip products, eye-area cosmetics, and non-medicinal toothpaste and mouthwash;
- July 1, 2026: all cosmetics, except exempted solid handmade soaps, are required to establish a PIF.
Note: Key annex ingredients include 26 UV filters, 104 hair dye ingredients, 9 perming agents, and 5 antiperspirant/deodorant ingredients; hydrogen peroxide and carbamide peroxide; salicylic acid, sulfur, allantoin, etc.
16 Core Contents and Key Points
1. Basic product information: Notification data cannot be directly reused; for products with split-stage production, information on all manufacturing sites must be recorded.
2. Documentary proof of completed product notification: Download the case preview PDF from the notification platform, confirming the status is "Closed" and within the validity period; update the file accordingly after renewal.
3. Full ingredient names and respective concentrations: Compound (pre-mix) raw materials must be broken down, and the contents of identical ingredients merged; concentration ranges should be avoided wherever possible — where unavoidable, the safety assessment shall calculate exposure based on the highest concentration.
4. Product labels, leaflets, outer packaging, or containers: All commercially available packaging sizes must be retained; foreign-language packaging materials must be translated; if an imported product's packaging bears medicinal wording, the statement "This product is a cosmetic and has no medical efficacy" must be added. A supervision reminder is recommended for children's products.
5. Documentary evidence or declaration of the manufacturing site's compliance with cosmetics GMP: A TFDA GMP certificate or an ISO 22716 certificate may be provided; ISO 9001 and ISO 13485 cannot substitute for cosmetics GMP evidence; all sites involved in split-stage production must comply with GMP.
6. Manufacturing method and process: Briefly describe the entire production process — raw material mixing, filling, and labeling; process parameters such as temperature need not be recorded.
7. Method of use, application sites, amount, frequency, and target population: Usage method, application sites, amount, frequency, and target population must be consistent with the outer packaging, and are used for ingredient exposure calculation in the safety assessment.
8. Adverse reaction data: Collect post-market adverse reactions; if there are none, provide a written statement that no adverse reaction cases have occurred since launch.
9. Physical and chemical characteristics of the product and each ingredient: Physicochemical properties of the finished product, such as pH, viscosity, and appearance; raw material information may include CAS number, solubility, purity, etc. Particle size distribution data is required for nano ingredients.
10. Toxicological data on ingredients: Safety data such as irritation, sensitization, and genotoxicity; literature from authoritative databases such as SCCS, CIR, and ECHA may be cited.
11. Stability test report: Accelerated testing can be used to estimate shelf life, but long-term stability verification should also be performed. The test formulation and packaging materials must be identical to the commercial product.
12. Microbiological test report: Strictly follow the TFDA microbiological limits; stricter limits apply to products for children under three, eye products, and mucosa-contacting products; products with high ethanol content may be exempted, but sealed, non-openable products may not be exempted.
| Microbiological indicator | Products exclusively for children under three, eye products, or products contacting mucous membranes | Other products |
| Aerobic plate count | ≤100 CFU/g or CFU/ml | ≤1000 CFU/g or CFU/ml |
| Escherichia coli | Not detectable /g or ml | Not detectable /g or ml |
| Pseudomonas aeruginosa | Not detectable /g or ml | Not detectable /g or ml |
| Staphylococcus aureus | Not detectable /g or ml | Not detectable /g or ml |
| Candida albicans | Not detectable /g or ml | Not detectable /g or ml |
13. Preservative efficacy test report: Verify the contamination resistance of the preservative system; retesting is recommended when packaging materials are changed. Some products may be exempted from preservative efficacy testing, but exemption requires justification through safety assessment.
14. Function assessment evidence: Efficacy claims must be supported by test evidence. Claims such as anti-acne, anti-dandruff, whitening, sunscreen, and antibacterial require test reports; medical efficacy claims are prohibited; for a series differing only in colorants or fragrances, representative samples may be used for efficacy testing.
15. Information on packaging materials in contact with the product: List the packaging materials, specifications, and capacities, and provide supplier material reports; data on all packaging sizes must be retained.
16. Product safety information: It must be signed by a qualified safety assessor; any change to the formula, raw materials, or packaging materials that affects safety requires a new safety assessment and signed documentation.
IV. FAQs & Compliance Recommendations
Q1: Does the PIF need to be uploaded to the official TFDA platform? How do the authorities inspect the PIF?
A1: The PIF does not need to be uploaded to the regulatory system; importers/manufacturers in Taiwan, China keep paper or electronic files locally for reference. The competent authority may conduct on-site file reviews, generally with 7 days' advance notice; in emergencies involving public safety, unannounced inspections may be carried out directly. The PIF is an enterprise-held file; missing or incomplete files discovered during inspection may result in fines.
Q2: Under the contract manufacturing model, does the PIF responsibility lie with the brand or the contract manufacturer?
A2: The statutory responsibility belongs to the local importer/manufacturer in Taiwan, China (generally the Taiwan importer). The commissioned contract manufacturer bears no statutory obligation to establish the PIF, but is obliged to provide the responsible party with technical materials such as process descriptions, test reports, and raw material SDS, so that the importer can compile the PIF.
Q3: Do samples, gifts, and PR trial sizes require product notification and a PIF?
A3: Under the regulations, "gifting, public display, and providing consumers with trial use" are equally subject to regulation. Samples, gifts, and trial sizes must also complete product notification with a corresponding PIF; their non-sale status does not exempt them from compliance obligations.
Q4: Are minor discrepancies allowed among the notification information, the label, and the PIF?
A4: Core information across the three must remain consistent: the full ingredient list, restricted substance concentrations, product name, product form, and manufacturing site must not contradict one another. During inspection, the notification system, outer packaging labels, and the PIF will be cross-checked; inconsistencies may be judged non-compliant. If the formula is fine-tuned, the notification amendment must be completed before launch, and the entire set of PIF documents updated at the same time.
With the new regulation in place, cosmetics regulation in Taiwan, China has shifted toward self-managed risk management across all categories. Since stability, preservative efficacy, and toxicological data collection involve long cycles, early planning is advisable. Our CIRS cosmetics team provides a full suite of services including product notification, label review, PIF compilation, and safety assessment to support compliant market entry.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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- Taiwan, China Cosmetics Product Notification
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