Cosmetic notification in Taiwan is straightforward, but compliance issues usually appear later. This may be during import checks or inspections. Or even 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. In Taiwan, products must be notified before sale, but they also need compliant labeling, verified ingredients, and a complete Product Information File (PIF) ready for inspection.
This guide focuses on what needs to be in place before market entry to avoid delays, shipment holds, or post-market corrections.
Which Products are considered as Cosmetics in Taiwan ?
In Taiwan, “cosmetics” refer to products applied externally to the human body, including the skin, hair, teeth, and mucous membranes. These products aim to moisturize, cleanse, enhance appearance, or alter body odors. If there is any uncertainty about whether a product qualifies as a cosmetic, the product owner can submit an application to the TFDA for regulatory clarification. The manufacturer or the important seeking the regulatory classification by TFDA shall pay the applicable fees.
Who Regulates Cosmetics in Taiwan?
The Taiwan Food and Drug Administration (TFDA) under the Ministry of Health and Welfare regulates cosmetics in Taiwan. The Cosmetic Hygiene and Safety Act is the governing law that defines cosmetics and provides requirements of notification, labeling, control of ingredients, GMP, and safety documentation.
Cosmetics Classification in Taiwan
Cosmetics in Taiwan refer to products that are applied to the human body, teeth, or oral mucosa to clean, beautify, enhance appearance, or control body odor.
Taiwan used to differentiate between general and specific-purpose cosmetics (e.g., sunscreens, hair dyes). As of July 2024, all cosmetics are subject to a single notification-based system, but more risky products will continue to need more stringent safety data and documentation.
TFDA Cosmetic Regulatory Guidelines in Taiwan
The compliance is based on proper documentation, manufacturing, and constant monitoring.
Product Information File (PIF)
The PIF has to be ready at the time of sale of the product, and it should be implemented gradually:
- Since July 1, 2024: Sunscreens, hair dyes, perm products, antiperspirants, and tooth whitening products using peroxide.
- Since July 1, 2025: Baby products, lip products, eye products, toothpaste (non-medicated), mouthwash.
- Since July 1, 2026: All cosmetics (except some handmade solid soaps)
The PIF should also contain formulation information (levels of ingredients), manufacturing process, safety evaluation, and other supporting information, like stability reports. It should be maintained and examined.
Compliance of the Responsible Person and Ingredient
The person in charge should:
- Assure product safety and compliance.
- Maintain and update the PIF.
- Cooperate with inspections
- Report severe adverse events.
Products should comply with TFDA ingredient regulations, such as:
- Prohibited ingredients.
- Ingredients permitted within a range.
- Accepted preservatives, colorants, and UV filters.
These requirements are revised on a regular basis and should be adhered to during the product lifecycle.
Cosmetic Product Notification System in Taiwan
Taiwan does not need pre-market approval. Cosmetics should be reported before sale, importation, display, or distribution.
Notification is a data submission (not a review) and consists of:
- 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.
Step-by-Step Cosmetic Registration in Taiwan
Below are the steps to follow for a smooth cosmetic registration process in Taiwan.
Step 1: Designate a Taiwan-Based Responsible Person
A local entity has to be involved with Taiwan cosmetic product notification and be legally responsible regarding compliance and product safety.
Step 2: Check Ingredient Compliance
Check formulation against the TFDA prohibited and restricted lists, which were not allowed to be submitted beforehand.
Step 3: Create the Product Information File (PIF)
Prepare all the necessary documentation, such as safety assessment, formulation details, and supporting data. The notification has to be accompanied by or before the completion of the PIF.
Step 4: Final Product Notification
Send product information via the TFDA notification system. No cosmetic product approval in Taiwan is involved, and all information provided should be correct and in line with the PIF.
Step 5: Before import, make sure the label complies
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
Once it is entered, the person in charge should:
- Keep current PIF records.
- Monitor product safety
- React to inspections and regulatory inspections.
GMP & Post-Market Enforcement in Taiwan
The manufacturing should be in accordance with the cosmetic GMP standards (according to ISO 22716), both local and foreign. This includes production controls, quality systems, and documentation, and is checked in the course of inspections.
Once in the market, TFDA oversees products by checking imports, conducting inspections, and reviewing products based on complaints. Failure to comply may lead to recall of the product, fines, or market suspension.
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
- 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
All the necessary information should be in Chinese. The names of ingredients may be in standard nomenclature (e.g., INCI).
Claims Must
Remain in cosmetic scope.
Not to be deceptive or suggest medical effects.
Cosmetics Ingredient Bans in Taiwan
The product notified or sold must be up to TFDA requirements in your formulation.
Restrictions Include
- Prohibited ingredients (not allowed)
- Restricted ingredients (allowed within limits)
- Approved preservatives, colorants, and UV filters
Safety Requirements
- Microbiological limits are to be fulfilled.
- 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.
Cosmetic Import Regulations in Taiwan
Cosmetics are not allowed to be imported without prior regulatory requirements.
You need to have a local representative before import, notification, ingredient compliance, labeling, and PIF.
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.
Taiwan Cosmetic Registration Cost
The Taiwan 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 |
Conclusion
You can meet Taiwan 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 the products have to be informed, which is normally done by a local partner who does 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 need product registration. Notifications of cosmetics have to be made before their sale, importation, or distribution.
What is the duration of cosmetic notification in Taiwan?
Average of 3-10 working days to provide notification when data is available; actual is 2-4 weeks with PIF, labeling, and compliance preparation.
