This article aims to provide you a general understanding of how China Taiwan cosmetics are regulated and also lists the resources that you can access to acquire the product’s compliance. Due to the major change of the overarching cosmetic regulation, “the Cosmetic Hygiene and Safety Act” , this article suits for the readers who are already in or planning to enter the Taiwan cosmetic market.
Overview of Taiwan Cosmetics Regulations
The current in forcing overarching cosmetic regulation in Taiwan is called the “Cosmetic Hygiene and Safety Act” which is published on 1st July 2019. It reshapes the structure of the cosmetic supervision system and comes into the new era of the Taiwan cosmetics act.
Since 1st July 2019, in order to enter Taiwan’s cosmetic markets, both general cosmetics and special cosmetics are required to do the product notification or TFDA registration first.
For general cosmetics, you need to fill the product information on the cosmetic notification system and to establish full product information files (PIF) for TFDA inspection. “Product information file” means a number of documents containing data about the quality, safety, and functions of cosmetics. Currently, the policy is still under a grace period that allows importing companies to adjusting the process but will come to mandatory on 1st July 2021.
For special cosmetics, it is required to complete the registration process before the market placement. But the notification policy is also on the way that they will be required to do the notification and PIF as will later on 1st July 2024.
Taiwan Cosmetics Regulatory Framework
The main authority to supervise the cosmetic market and regulatory affairs is the Taiwan Food and Drug Administration(TFDA). The current general director is Shou-Mei Wu.
Overarching regulation: Cosmetic Hygiene and Safety Act, it provides definitions of cosmetic definition. General policy on cosmetic supervises, GMP, industry obligations, advertisements.
The rules to explain the overarching law and detailed the specific act: Enforcement Rules of Cosmetic Hygiene and Safety Act.
Regulations for notification of cosmetic products and Product Information File Management.
Classification of Cosmetics in Taiwan
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.
Based on the product’s function, TFDA defines cosmetics as general cosmetics and Specific Purpose Cosmetics (formerly named medicated cosmetics). The specific purpose of cosmetics includes sunscreen, hair-dyeing, permanent waving, antiperspirant, deodorant, tooth-whitening or other purposes. And all other types of cosmetics that fit the definition of cosmetics will be recognized as general cosmetics which may include: skincare, makeup, perfume, oral care products and so on.
The product compliance requirements for general and specific purpose cosmetics are different in the current regulatory framework.
|Notification + PIF (includes safety assessment reports)
|Mandatory on 1st July 2021
|Specific Purpose Cosmetics
|Shift to notification + PIF after 1st July 2024
Notification and PIF requirements for general cosmetics
The following information is required in order to complete the notification and PIF preparation.
|PIF (English version is accepted)
|1. Number of products.
2. Chinese and English names of products
3. Category and usage of products.
4. Type of products. Model number and color code for series products.
5. Dosage of products.
6. Precautions of products.
7. Contact information of manufacturers or importers of products.
8. cosmetics Good Manufacturing Practice (GMP) information.
9. Full ingredients of products.
10. Other relevant descriptions.
|1. Basic information of the product: the name of the product, the category of the product, dosage form, purpose, the names and addresses of manufacturing facilities, information of product manufacturers or importers.
2. Evidentiary documents of completing product notification.
3. Full ingredient names and the individual content.
4. The outer packaging of the products, containers, labels or leaflets.
5. GMP compliance certificates or self-declarations which the manufacturing facilities comply with cosmetic Good Manufacturing Practice Regulations
6. Manufacturing methods and procedures.
7. Usage methods, body parts, dosage, frequencies and the targeted population.
8. Adverse effects of the product application.
9. Physical and chemical characteristics of the products and individual ingredients.
10. Toxicological data of the ingredients.
11. The product stability test reports.
12. The microbiological test reports.
13. The antimicrobial effectiveness test reports.
14. Supporting information of the functional assessments.
15. Information about the packaging materials which have contact with the products.
16. Product safety information: Safety evaluation conclusion and suggestion and Qualification certificates
Registration requirements for Specific Purpose Cosmetics
Once again, specific purpose cosmetics include sunscreen, hair-dyeing, permanent waving, antiperspirant, deodorant, tooth-whitening or other purposes. For imported cosmetics, you need to provide the following information to complete the registration.
- A copy of company registration or business registration certificate.
- Drafts of product labels, leaflets, and packaging.
- The authorization letter issued within the past two years.
- The MFSC issued within the past two years.
- An ingredient list issued within the past two years.
- The certificate of analysis.
- For the contract manufacturer, a certificate identifies the relationship between the hiring firm and contract manufacturer.
Cosmetics Labeling in Taiwan Cosmetics Regulation
In terms of Cosmetic Hygiene and Safety Act, the outer packaging or containers of cosmetics shall conspicuously label the following information:
- Product name;
- Usage and storage instructions;
- Net weight, volume, or amount;
- Full ingredient names. For specific purpose cosmetics, the content of specific purpose ingredients contained therein shall be labeled separately;
- Precautions for use;
- Name, address, and telephone number of manufacturer or importer; country of origin of the imported product;
- Manufacturing date and shelf life, or manufacturing date and expiration date, or shelf life and expiration date;
- Lot number;
- Other information required to be labeled as per the public announcement of the central competent authority.
- The above requirements shall be provided in Chinese or internationally common symbols excerpt that point 5 may be listed in English.
- if it cannot be labeled due to the surface area of outer packaging or container being too small or other special circumstances, said information shall be stated on the label, in the leaflet, or by other means.
Please check your ingredient’s compliance before initiate the regulatory compliance procedure. The following list you may need to self-check if your products contain the relevant ingredient types.
Prohibited and Restricted ingredients:
List of Prohibited Ingredients
List of Restricted Ingredients
List of Preservatives
List of Colorants
The standard for Usage of Antimicrobial Ingredients in Cosmetics
List of Micro-organisms Limits in Cosmetic Products
List of Specific Purpose Ingredients’ name and usage
In terms of the Cosmetic Hygiene Act, Taiwan bans cosmetic animal testing for both finished products and cosmetic ingredients since 2019.