Cosmetic notification in Taiwan is straightforward, but compliance issues usually appear later. This may be during import checks or inspections. It may even happen when labeling is incomplete, safety data is missing, or ingredient declarations do not align with Taiwan Food and Drug Administration (TFDA) requirements.
The common mistake is treating notification as market readiness. The products need to be notified before sale. But they should also have compliant labeling, verified ingredients, and a complete Product Information File (PIF) that’s comprehensively ready for inspection.
The July 1, 2026, guidance expands PIF requirements across all cosmetics, except handmade solid soaps produced by entities exempted from factory registration. With this in mind, this guide explains the cosmetic market entry process in Taiwan.
Cosmetic Regulatory Authority in Taiwan
The Taiwan Food and Drug Administration (TFDA) under the Ministry of Health and Welfare regulates cosmetics in the country. The Cosmetic Hygiene and Safety Act is the governing law that defines cosmetics. It provides requirements for notification, labeling, control of ingredients, GMP, and safety documentation.
Meaning of Cosmetics
Cosmetics in Taiwan refer to products applied to the human body, teeth, or oral mucosa. These products moisturize, cleanse, enhance appearance, or alter body odors.
TFDA can provide you with regulatory clarification if there is any uncertainty about the qualification of the product as a cosmetic. All the owner needs to do is submit an application. The manufacturer or the importer seeking the regulatory classification by TFDA shall pay the applicable fees.
Cosmetic Classification in Taiwan
Taiwan moved away from the previous distinction between general and specific-purpose cosmetics. It has now shifted to a notification-based management system. Cosmetic products are subject to notification requirements, but additional safety, documentation, and manufacturing requirements may still apply. It just depends on the product category and risk.
TFDA Cosmetic Regulatory Guidelines in Taiwan
Proper documentation, manufacturing, and constant monitoring are a must in the country. For that, companies need to know the applicable guidelines provided below:
1. Product Information File (PIF) & Retention
The PIF should be established before the product is marketed, sold, or provided to consumers and must be maintained for inspection.
Taiwan’s PIF requirements now apply to all cosmetics except handmade solid soaps that entities exempt from factory registration produce. The gradual way in which this requirement was introduced is as follows:
| Implementation Date | Products Covered |
| July 1, 2024 | Sunscreens, hair dyes, perm products, antiperspirants, and tooth whitening products using peroxide. |
| July 1, 2025 | Baby products, lip products, eye products, toothpaste (non-medicated), mouthwash. |
| July 1, 2026 | All remaining cosmetics (Subject to the stated handmade-soap exception |
The PIF should also contain formulation information (levels of ingredients), manufacturing process, safety evaluation, and other supporting information, like stability reports. TFDA’s framework specifies 16 categories of information, and the safety assessment must be signed by a qualified safety assessor.
PIF records must also be retained for at least five years from the day after the product was last available on the market.
Responsible Person and Ingredient Compliance
The manufacturer/importer should ensure product safety and compliance. They must maintain and update the PIF while cooperating with inspections. Moreover, they must fulfill applicable adverse-event reporting and post-market safety obligations.
Products should comply with TFDA current ingredient restrictions. These discuss prohibited ingredients, ingredients permitted within a range, and accepted preservatives, colorants, and UV filters. These requirements are revised on a regular basis and should be adhered to during the product lifecycle.
2. Product Notification System
Taiwan generally operates a product notification rather than a conventional pre-market approval system for cosmetics. Instead, they should be reported before sale, importation, display, or distribution.
A notification is a data submission (not a review) and consists of the following:
- Product identity and category.
- Full ingredient list
- Details of manufacturers and importers.
- Label information
Both imported and locally produced cosmetics are subject to notification, with a few exemptions (e.g., handmade soaps).
It should be backed by a Product Information File (PIF), which should be accessible for inspection at any time. The notification has a validity of 3 years, and updates or renewals are necessary in case of a change in product information or the expiry of the validity.
3. GMP & Post-Market Enforcement in Taiwan
Taiwan’s Cosmetics GMP regulations are based on the principles of ISO 22716. These requirements were introduced in phases, and from July 1, 2026, the final phase extends them to the remaining general cosmetic manufacturing facilities (subject to the exception). Both domestic and overseas manufacturing facilities face them.
Although Taiwan’s GMP framework is based on ISO 22716, it should not automatically be treated as identical to compliance with Taiwan’s Cosmetics GMP Regulations. TFDA may assess compliance and determine the need for on-site inspection based on risk
Once in the market, TFDA oversees products by checking imports, conducting inspections, and reviewing products based on complaints. If compliance is absent, it may lead to recall of the product, fines, or market suspension.
4. Taiwan Cosmetic Labelling Requirements
Labeling is checked at import and during inspections, and mistakes in this case cause shipment holds or relabeling.
Mandatory label information includes the following:
- Name and use of product
- Use and storage instructions
- Full ingredient list
- Net content
- Details of the manufacturer or importer and country of origin
- Batch number
- Production or expiry date
- Warnings and precautions
Mandatory labeling information must generally be provided in Chinese or internationally recognized symbols; ingredient names may be provided in English. Claims should remain within the permitted cosmetic scope. They must not be false, misleading, or imply therapeutic/medical effects that would place the product outside the cosmetic framework.
5. Cosmetics Ingredient Bans & Safety Requirements
The product notified or sold must be up to TFDA requirements in your formulation. The restrictions include prohibited and restricted ingredients and approved preservatives, colorants, and UV filters.
For safety, microbiological limits are to be met. The levels of ingredients should be safe. The PIF should have a safety assessment. TFDA regularly changes the lists of ingredients, and even after entering the market, products need to be in compliance.
6. Cosmetic Import Regulations
Cosmetics are not allowed to be imported without meeting prior regulatory requirements. Imported cosmetics must have the applicable Taiwan-based importer arrangements in place and meet notification, labeling, ingredient, PIF, and any applicable border-inspection requirements before entering the market.
During inspections and at import, the authorities check the status of notification, labeling, declaration of ingredients, and documentation. Failure to comply results in shipment detentions or remedial measures.
Cosmetic Notification Process in Taiwan
The cosmetic notification and compliance process is a step-wise ladder that companies should follow. It includes the following:
Step 1: Designate a Responsible Party
Manufacturers/importers have to be involved in product notification for imported cosmetics, becoming legally responsible for their compliance and safety.
Step 2: Check Ingredient Compliance
Check the formulation against the TFDA prohibited and restricted lists before notification.
Step 3: Create the Product Information File (PIF)
Have all the needed documentation like safety assessments, formulation details, and supporting data. Prepare the required PIF documentation and ensure the PIF is established and available as required before the product is marketed
Step 4: Final Product Notification
Send product information via the TFDA notification system. Notification doesn’t mean product approval. This system just provides the required product info to TFDA.
Step 5: Confirm Label Compliance Before Import
The product should be labeled according to Taiwan requirements before it gets to the market. Lack of compliance at this stage results in shipment holds or relabeling.
Step 6: Post-Market Compliance
After entering the market, the person in charge should keep current PIF records and monitor product safety. They should be ready to react to regulatory inspections.
Taiwan Cosmetics Registration vs Notification
Registration and notification are different terms in the Taiwanese cosmetic regulation process. Here are the differences:
| Traditional registration | Taiwan cosmetic system |
| Pre-market approval | Product notification |
| Regulatory review before sale | Notification/data submission |
| Approval certificate | Notification record |
| Registration-focused | Notification + PIF + labeling + GMP + ongoing compliance |
Taiwan Cosmetic Notification Cost
Government expenditures are the principal fixed and predictable expenses. The key fees are:
| Fee Item | Cost (NT$) |
| Cosmetic product notification | 800 per product |
| Amendment to notification (single) | 700 per application |
| Amendment (multiple products) | 700 (up to 30 products) + 100 per additional 30 |
| Extension of the validity of the notification | 600 per product |
| Product classification inquiry | 3,500 per application |
Note: Fees are subject to TFDA’s current administrative fee schedule and may change; the figures below reflect the schedule effective July 1, 2026.
Conclusion
You can meet Taiwan’s cosmetic regulations by classifying, formulating, labeling, local representation, and post-market compliance. Most delays and enforcement activities are caused by gaps in implementation and not the process.
If you wish to enter the Taiwan cosmetics market, Artixio can assist you in the cosmetics regulatory process in Taiwan. We deal with classification, formulation checks, notification, labeling, and compliance to ensure your products comply with TFDA requirements prior to and after entering the market. To get support, contact us at info@artixio.com.
FAQs
What are the approval procedures for cosmetics in Taiwan by companies?
No company-level approval. All products have to be notified, which is normally done by a local partner who handles the process.
What is covered by the Cosmetic Hygiene and Safety Act?
It establishes the regulations for cosmetics in Taiwan, such as product notification, ingredients, labeling, and safety standards.
Are foreign firms allowed to sell cosmetics in Taiwan?
Yes. It is possible to sell foreign brands in Taiwan, but a local company must take care of the notification and compliance.
Are cosmetics registered in Taiwan?
No. Taiwan does not require product registration. Notifications of cosmetics have to be made before their sale, importation, or distribution.
