Taiwan, China Cosmetics Notification Guidance

1. Background Introduction

In order to ensure product safety and consistency in market supervision, Taiwan, China first promulgated the Cosmetic Hygiene Regulation on December 28, 1972. The regulation was revised in 2018 and renamed the Cosmetic Hygiene and Safety Act, which officially came into effect on July 1, 2019. The implementation of the Cosmetic Hygiene and Safety Act and its related regulations marks a new phase in Taiwan, China's cosmetic regulatory framework, gradually establishing a more transparent, scientific, and modernized supervision system. The new law not only strengthens the safety management of cosmetic products but also provides the industry with clearer legal grounds and operational standards, contributing to improved product quality and better protection of consumer rights.

This guidance document is developed in accordance with the Cosmetic Hygiene and Safety Act and its relevant regulations. It aims to assist cosmetic enterprises in understanding and properly completing the product notification process, ensuring compliance with Taiwan, China’s regulatory requirements and facilitating smooth market entry into Taiwan, China.

2. Definition of Cosmetics

According to the Cosmetic Hygiene and Safety Act, "cosmetics" means products applied externally to the human body, teeth, or oral cavity mucous membranes, and used to moisturize hair and skin, stimulate the sense of smell, improve body odors, change appearance, or cleanse the body. However, this is not applicable to those that are regarded as drugs in accordance with other laws or regulations.

3. Classification of Cosmetics

According to the Cosmetic Hygiene and Safety Act, cosmetics are classified into 14 categories, as shown in the table below.

The current classification table and scope of cosmetics was promulgated in 2019. On July 26, 2024, the Taiwan Food and Drug Administration (TFDA) issued a draft announcement titled “Proposed Amendments to the Classification and Scope of Cosmetics,” which includes revisions to the categories of “tooth whitening products” and “non-medicinal toothpastes and mouthwashes.” The amendments are expected to take effect on July 1, 2026.

4. Regulatory Authorities for Cosmetics in Taiwan, China

The competent regulatory authority for cosmetics in Taiwan, China is the Taiwan Food and Drug Administration (TFDA), which operates under the Ministry of Health and Welfare (MOHW). The TFDA is responsible for safeguarding public health and ensuring product safety.

In the field of cosmetics, the TFDA’s key functions include: formulating and revising relevant laws and regulations, managing product registration and market access, supervising product labeling and advertising, conducting sampling inspections, and monitoring adverse reactions.

5. Responsible Party for Cosmetic Product Notification

Pursuant to Article 4, Paragraph 1 of the Cosmetic Hygiene and Safety Act, the manufacturer or importer of a cosmetic product is required to complete product notification. For imported cosmetics, the responsibility for product notification lies with the importer.

The cosmetics manufacturers or importers of a certain scale (the “Cosmetics Manufacturers or Importers”) shall refer to below entities in the business of manufacturing or importing cosmetics products:

• A corporate or a firm to be established and registered pursuant to Company Act and/or Business Registration Act.
• A factory to be registered pursuant to Paragraph 1 of Article 8 of the Act.
• The groups and corporations which engage in cosmetics manufacturing or importing, except the handmade soap entities which are exempt from industry registration, excluding the entities mentioned in preceding two subparagraphs.
  

The responsible party for product notification shall be accountable for the authenticity and accuracy of the submitted product information, the safety of the product, and the compliance of product claims. In addition, the responsible party is obliged to update the product notification information after the product is placed on the market, cooperate with the competent authority in the inspection of technical and safety documentation, and report any serious adverse reactions.

6. Requirements for Cosmetics Market Entry in Taiwan, China

In Taiwan, cosmetic products must undergo product notification in accordance with the Cosmetic Hygiene and Safety Act prior to being placed on the market. Products must also comply with ingredient standards and Chinese labeling requirements.

Starting from July 1, 2024, Taiwan, China will fully implement the cosmetic product notification system. Before any cosmetic product is supplied, sold, given away, publicly displayed, or provided for consumer trial, product notification must be completed and a product information file must be established. According to the Types of Cosmetics Subject to Mandatory Product Notification issued by the Taiwan authorities, all cosmetics-except for solid handmade soaps produced in manufacturing facilities exempt from factory registration-should complete product notification.

Cosmetics Notification Procedure

The validity period of product registration is 3 years. Registration renewal should be completed within 3 months before the expiration of the registration period.

7. Documentation Requirements for Cosmetics Notification

In Taiwan, China, the Product Information File (PIF) serves as the core documentation required for cosmetic product notification. It contains detailed information on product composition, safety evaluation, and other critical data, and is a key basis for ensuring that cosmetic products are legally and compliantly placed on the market.

7.1 PIF and Effective Implementation Timeline

The Taiwan Food and Drug Administration (TFDA) under the Ministry of Health and Welfare has released a draft regulation titled “Categories of Cosmetics Required to Establish a Product Information File (PIF) and Their Implementation Dates”, which serves as a comprehensive update and supplement to the 2019 version. According to the draft, effective July 1, 2024, manufacturers and importers of certain functional cosmetics-including sunscreens, hair dyes, hair perms, antiperspirants/deodorants, and at-home tooth whitening products-are required to establish a complete and compliant Product Information File (PIF).

The implementation will be carried out in three phases, with specific timelines and product categories defined for each phase, ensuring a progressive transition toward full compliance.

7.2 Main Contents of the Product Information File (PIF)

According to the Cosmetic Product Information File Management Regulations (No. 1081604087), the PIF should be stored in written or electronic form and retained for at least 5 years from the day following the last market release. The following data should be compiled in Chinese or English:

• Basic Product Data: Product name, category, form, purpose, manufacturer name and address, and information on the manufacturer or importer
• Proof of Product Registration
• Complete Ingredient List and Concentrations
• Product Labels, Leaflets, Outer Packaging, or Containers
• GMP Compliance Documentation
• Manufacturing Method and Process
• Usage Method, Application Area, Dosage, Frequency and Target Demographic
• Adverse Reaction Data
• Physical and Chemical Properties
• Toxicological Data of Ingredients
• Stability Test Report
• Microbial Test Report
• Preservative Efficacy Test Report
• Functionality Assessment Documentation
• Packaging Material Information
• Product Safety Information

7.3 Labelling

According to Taiwan’s Cosmetic Hygiene and Safety Act and the Regulations for Labeling on Outer Packaging, Containers, Labels, or Package Inserts of Cosmetics (Document No.1081603869), the following information must be clearly indicated on cosmetic product labels:

• Product Name: For products with both inner and outer packaging, the Chinese product name must be clearly labeled on the outer packaging. The container must also bear the product name, either in Chinese or a foreign language.
• Intended Use
• Directions for Use and Storage Instructions
• Net Weight, Volume, or Quantity
• Full Ingredient List
• Warnings and Precautions: Specific warnings are required for products such as hair perming, hair dyeing, and bleaching products.
• Name, Address, and Telephone Number of the Manufacturer or Importer; For imported products, the Country of Origin must be indicated. For products manufactured in multiple stages, the country of origin refers to the place where the final product is produced.
• Manufacturing Date and Expiry Date, or Manufacturing Date and Shelf Life, or Expiry Date and Shelf Life: If only the year and month are indicated for the manufacturing date or shelf life, the last day of that month shall be deemed the manufacturing or expiration date.
• Batch Number
• Other items as publicly announced by the competent authority

Labels may be presented in Chinese or other internationally recognized languages; however, the full ingredient names must be indicated in English.

7.4 Factory Requirements-Good Manufacturing Practice (GMP)

On June 28, 2024, the Taiwan Food and Drug Administration (TFDA) officially repealed the regulation titled “Types of Cosmetics Required to Comply with Good Manufacturing Practice Guidelines” and promulgated a new regulation entitled “Types of Cosmetics Manufactured in Facilities Required to Comply with Cosmetic Good Manufacturing Practice (GMP) Guidelines”. The implementation of this regulation will be carried out in three phases:

8. Tests Requirements for Cosmetics Notification

In Taiwan, China, pursuant to the Cosmetic Hygiene and Safety Act and relevant regulations issued by the Ministry of Health and Welfare’s Taiwan Food and Drug Administration (TFDA), certain products or ingredients are still required to be supported by testing data or safety assessment documentation. The testing involved in the cosmetic product notification process in Taiwan may include: microbiological testing, stability testing, preservative efficacy testing and other tests, such as packaging, efficacy, and toxicology.

8.1 Microbiological Testing

Specific microbiological criteria and requirements are detailed in the table below. Products with low microbiological risk (e.g., those containing more than 20% alcohol, high levels of organic solvents, or with extremely high/low pH values) may be exempted from microbiological testing.

8.2 Stability Testing

Prior to market launch, cosmetic products should be supported by data from accelerated stability testing or long-term stability testing. As there is currently no globally harmonized standard method for cosmetic stability testing, companies may refer to relevant pharmaceutical testing guidelines for execution. It is particularly important to ensure that the formulation composition and packaging materials used in the stability testing are identical to those of the final marketed product, in order to ensure the validity of the test results.

8.3 Preservative Efficacy Testing

Preservative efficacy testing should be conducted in accordance with the Guidelines for the Evaluation of Cosmetic Preservative Efficacy or other applicable international or national standard methods. Products identified as having low microbiological risk may be exempted from such testing, provided that the exemption is justified and documented by the responsible safety assessor.

8.4 Packaging Material Documentation

At present, there is no unified standard testing method for cosmetic packaging materials. Therefore, the safety assessor responsible for signing the safety assessment report may conduct an appropriate safety evaluation based on the product formulation and practical experience with the packaging materials that are in direct contact with the product. The evaluation may include aspects such as the stability of the packaging materials, potential risks of leachables, and compatibility with the product, to ensure the safety and suitability of the packaging materials throughout the intended use.

• Animal Testing：Where animal testing is employed for the safety assessment of cosmetics or cosmetic ingredients, prior approval must be obtained from the competent authority.

9. Exosomes Derived from Human Cells as Cosmetic Ingredients

On March 21, 2024, the Taiwan Food and Drug Administration (TFDA) under the Ministry of Health and Welfare issued a regulatory document titled “Documentation Requirements for Case-by-Case Applications for the Use of Exosomes Derived from Human Cells in Cosmetics”. This document also amends the List of Prohibited Ingredients in Cosmetics, adding specific restrictions on the use of human cells, tissues, or human-derived products.

According to the updated regulation, exosomes derived from human cells, tissues, or human-origin materials are prohibited in cosmetics unless they are approved on a case-by-case basis by the competent authority. Applicants who obtain such approval for the use of exosomes from human-derived materials will be exempt from this prohibition. This regulation came into effect on March 21, 2024.

Required Documentation for Case-by-Case Application to Use Exosomes Derived from Human Cells in Cosmetics (Taiwan):

Notes:

1. “○” indicates that the corresponding document must be submitted. “△” indicates that submission is case-dependent.
2. Donors must be healthy adults without infectious diseases, sepsis, or congenital/chronic illnesses and cancers that may affect cells/tissues.
3. Donor pathogen test reports should include the following items, such as: Hepatitis B virus (HBV), Hepatitis C virus (HCV), Human Immunodeficiency Virus (HIV), Human T-lymphotropic Virus (HTLV), Cytomegalovirus (CMV), Transmissible Spongiform Encephalopathy, Treponema pallidum (syphilis), etc. Additional screening and/or testing should be considered based on product characteristics or the donor’s external environment (e.g., travel history or residence history).
4. Preparation process and quality control data: Physicochemical properties should include identification of the cell source/type, characterization of contents, and purity, along with a description of the intended use of the exosomes. The facility for culturing cells/tissues and the exosome preparation site must establish and comply with relevant hygiene management standards. The exosome preparation site and process must ensure the absence of endotoxins and mycoplasma contamination, and ensure that each batch is free from cross-contamination risk.
5. Test reports must be submitted for at least three consecutive batches.
6. All tests must be conducted using exosomes prepared through the intended manufacturing process.
7. Stability testing methods must include the storage method of the exosomes.
8. Safety testing of cosmetics or cosmetic ingredients by individual applicants should preferably follow the OECD Guidelines for the Testing of Chemicals, or alternative test methods published by other countries. If other methods are used, their validation or a rationale for the design and effectiveness of the method must be provided in advance.
9. Subacute toxicity, chronic toxicity, and carcinogenicity tests should be evaluated by individual applicants based on the case, such as physicochemical properties and results of other safety tests. The competent authority may require relevant tests based on the case review.
10. Antigenicity tests include skin sensitization tests and photosensitization or phototoxicity tests; local irritation tests include skin irritation and mucosal irritation tests.
11. If human studies are conducted, they must comply with the relevant provisions of the Human Subjects Research Act.

10. Cosmetics Notification Timeline

In Taiwan, China, the registration of cosmetics (particularly for specific purpose cosmetics) involves multiple stages, including documentation preparation, testing (if required), and application submission. The time required for key stages may vary depending on the product category, formulation complexity, and testing arrangements. Below is a reference table outlining the Taiwan cosmetic notification process and estimated timelines. For further professional assistance, please contact CIRS Group (cosmetic@cirs-group.com).

11. Post-Market Supervision Requirements for Cosmetics

According to the Regulations for Reporting Serious Adverse Reactions and Sanitary Safety Hazards of Cosmetics, cosmetic manufacturers, importers, and other responsible parties in Taiwan must proactively report to the Taiwan Food and Drug Administration (TFDA) within 15 days upon becoming aware of any serious adverse reaction associated with their products. The report shall include basic product information, details of the adverse reaction, symptoms experienced by the affected individual(s), handling measures taken, and the corrective or preventive actions implemented or planned by the company.

To ensure post-market safety and regulatory compliance, companies are also required to establish a robust adverse reaction monitoring system and cooperate with the competent authority in follow-up investigations and risk assessments.

In addition, Taiwan’s cosmetic regulatory framework places greater emphasis on post-market surveillance. This system is designed to ensure that products continue to meet safety and compliance requirements after entering the market, while reinforcing the primary responsibility of enterprises throughout the product life cycle. Post-market obligations include, but are not limited to: cooperating with regulatory authorities for product sampling and inspection; establishing a comprehensive product traceability system to track raw material sources and product distribution; proactively reporting any serious adverse reactions; and promptly notifying distributors to withdraw non-compliant or potentially hazardous products from the market.

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• Taiwan, China Cosmetics Product Notification
• Taiwan, China Cosmetics PIF Documentation
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If you need any assistance or have any questions, please get in touch with us via cosmetic@cirs-group.com.