According to Article 4, Paragraph 1 of the "Cosmetic Hygiene and Safety Act" and Article 3 of the "Cosmetic Product Registration Regulations", starting from 2019, cosmetic products must be registered in accordance with regulations to be legally distributed and sold in the Taiwanese market. This article will provide a comprehensive understanding of the legal basis for product registration, the application process, required documents, and the risks of penalties for failure to register in accordance with regulations. This information is essential for both brand owners and contract manufacturers.

＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿

 

I. What is the legal basis for product registration?

According to Article 4, Paragraph 1 of the "Cosmetic Hygiene and Safety Act":

"For general cosmetics and medicated cosmetics that are imported or manufactured, the responsible person shall complete product registration with the central competent authority before the product is launched."

Article 3 of the "Cosmetic Product Registration Regulations" further specifies the data items that should be included in the registration.

In short, any cosmetic product intended for sale on the market, whether domestically manufactured or imported, must complete product registration and obtain a product registration code before its official launch.

 

II. Who is the responsible person for product registration?

The registrants are divided into:

• Domestic manufacturers (contract manufacturers)
  

• Cosmetic brand owners (including private labels)
  

• Importers (importers of cosmetics)

🔎 Reminder: If a brand entrusts a contract manufacturer for production, the brand owner is still the responsible person for product registration. The brand owner can negotiate with the contract manufacturer whether the latter will handle the registration on their behalf.*Zo-Yen Institute provides product registration agency services; please contact our sales representative for further inquiries.

 

III. What information is required for product registration?

1. Product registration number.

*A 22-digit number needs to be set up. The first 8 digits are the company's unified business number, which the system will automatically generate upon saving during registration. The latter 14 digits are to be edited by the company itself based on the product attributes and can include English letters or Arabic numerals. The registration number is the unique identification code for each registration case, so it cannot be reused regardless of the case status.

2. Product name in Chinese and English. However, for domestically produced cosmetics, the English name may be omitted.

3. Product category and intended use.

4. Product type; if it is a series of products, the model or color number should be listed.

5. Product dosage form.

6. Precautions for product use.

7. Name, address, and telephone number of the product manufacturer or importer.

8. Name, address, country of origin, and compliance with cosmetic good manufacturing practices of the product manufacturing site.

9. Full ingredient list of the product. For ingredients with usage limits set by the central competent authority, their content must also be listed by weight or volume percentage.

10. Other relevant product descriptions.

The aforementioned registration shall be made in Chinese, English, numbers, or internationally recognized symbols.

 

IV. What is the product registration process?

1. Log in to the platform:
   

• Access the MOHW [Cosmetic Product Registration Area]
  

2. Apply for an account:
   

• Apply for and confirm the registration platform account and password
  

3. Maintain manufacturer's basic information
   

4. Maintain manufacturing site information
   

5. Fill in registration information:
   

• Upload content based on the aforementioned information
  

6. System review:
   

• Complete payment after submitting the case according to the product registration process
  

7. Record and management:
   

• After registration is complete, the responsible person should still retain and list the information in the Product Information File (PIF) and continuously update the data
  
  

V. Fees

VI. FAQ

Q: Do I need to update my product registration after it's done?

A: Yes! If the product has any of the following situations, the data change registration should be performed:

• Ingredient changes (including slight concentration adjustments)
  

• Modification of precautions in the product insert
  

• Changes in manufacturer and manufacturing site information
  

• "Cancel registration" should also be done when production or sales are discontinued

Q: What happens if I don't register according to the law?

A: If a product sold on the market is not registered, according to Article 23 of the Cosmetic Hygiene and Safety Act, a fine of NTD 10,000 to NTD 1,000,000 may be imposed, and penalties may be imposed repeatedly; in serious cases, business suspension for one month to one year, or cessation of business, revocation or abolition of all or part of the company, business, or factory registration items, or cancellation or abolition of the cosmetic product's registration or license may be imposed.

📌 In practice, if an unregistered product is inspected, it will be required to be removed from shelves, recalled, and stopped from sale, which can cause significant damage to the brand's image and sales channels.

Q: Do cosmetics exported abroad need to be registered? 

A: If the product is solely for export, no registration is required. However, if a cosmetic production and sales certificate or a cosmetic manufacturing certificate needs to be applied for from the Food and Drug Administration due to export requirements, then the product should first complete product registration.

Q: When registering a product, full ingredients and concentrations must be filled in. Can general consumers access this information?

A: No. Although full ingredients and their added concentrations must be submitted to the competent authority during product registration, this information is only for internal government review and audit use and will not be publicly disclosed. Consumers only need to list the "full ingredient names" on the market in accordance with regulations, without having to disclose the actual concentrations. Therefore, the company's formulation secrets are still protected and there is no need to worry about being copied or leaked.

Cosmetic Product Registration Platform System - Public Inquiry

Q: If my private label product is only used in my own beauty studio and not for external sale, does it still need product registration?

A: Yes. According to Article 4, Paragraph 1 of the "Cosmetic Hygiene and Safety Act": "Before supplying, selling, giving away, publicly displaying, or providing samples to consumers, product registration should be completed."

👉 The key is: whether there is an act of "providing the product to others"; whether it is free or paid, it may be considered public use.

Q: Are product registration and PIF the same thing?

A: No, they are not. Product registration is the process of submitting basic product information to the government; whereas PIF is a complete technical documentation file, which must include product safety assessment, GMP documents, packaging labels, stability data, etc., and be reviewed by qualified safety assessors.

 

Conclusion: Product registration is not just an obligation, but also the cornerstone of brand trust.

With increasingly stringent regulations, product registration has become a basic threshold for brands and the foundation of market trust. Whether you are a new brand just starting out or an enterprise with a complete product line, it is imperative to ensure that each product is registered in accordance with the law and has a complete PIF to truly "legally launch and safely go to market."

If you have further questions about product registration procedures, data preparation, or PIF creation, please feel free to contact us. We provide integrated services from research and development, manufacturing to registration, helping you to quickly and legally enter the market.