China's Taiwan Cosmetic Regulation

The Cosmetic Hygiene and Safety Act, Taiwan's overarching cosmetic regulation, came into force on July 1, 2019. It classified cosmetics into specific purpose cosmetics and general cosmetics based on their functions. Specific purpose cosmetics included sunscreens, hair dyes, hair perms, deodorants, and teeth whitening products, while all other cosmetics were categorized as general.

To align with international trends in cosmetics management, Taiwan discontinued the classification of specific purpose cosmetics, unifying all cosmetics under a single regulatory framework starting on July 1, 2024. This new framework mandates cosmetics safety data signatories to assess product safety, fully implements the product notification system, and phases in new practices such as the product information file (PIF) and good manufacturing practice (GMP). Through these initiatives, Taiwan aims to effectively manage the manufacturing and distribution of cosmetics, strengthen regulatory oversight, and ensure product safety.

Part 1 Regulatory Framework and Competent Authority

1.1 Existing Key Cosmetic Regulations in China's Taiwan

1.2 Cosmetic Competent Authorities

In Taiwan, the Food and Drug Administration (TFDA) under the Ministry and Welfare is responsible for ensuring the safety and quality of cosmetics. Regarding the oversight of cosmetic products, TFDA's main duties include:

• Formulating cosmetics-related policies and regulations;

• Overseeing cosmetics notification and registration;

• Performing cosmetic research and examination, manufacturing and advertisement management;

• Carrying out cosmetic post-market audit, as well as border inspection and examination; and,

• Offering guidance on cosmetic regulations, safety, and best practices to cosmetic stakeholders.

Part 2 Cosmetic Products

2.1 Definition and Classification

The Cosmetic Hygiene and Safety Act stipulates that "cosmetics" refers to substance(s) for external use on the human body to freshen the hair or skin, to stimulate the sense of smell, to cover body odor, or to improve facial appearance. In line with this definition, the Scope and Categories of Cosmetics defines 14 distinct product categories within the scope of cosmetics. Any products excluded from this regulation are not considered cosmetics, and are not subject to TFDA supervision. These 14 categories include:

• Hair cleansing products

• Face cleansing and makeup removing products

• Bath and shower products

• Bar soaps

• Hair products

• Toner, oil, cream, and lotion products

• Aromatic products

• Antiperspirants and deodorants

• Lip products

• Foundation and setting makeup

• Eye products

• Nail products

• Tooth whitening products

• Non-medicated toothpastes and mouthwashes

2.2 Obligations of Manufacturers and Importers

In accordance with Article 5 and Article 8 of Cosmetic Hygiene and Safety Act, for cosmetics placed on the Taiwan market, corresponding cosmetics manufacturers and importers in Taiwan bear three major obligations, including fulfilling product notification, establishing PIF, and complying with cosmetics GMP.

2.2.1 Product Notification

Notification Procedures

The TFDA established an online notification system for cosmetic companies to notify their products and print the notification certification. Applicants shall first contact TFDA to obtain an account and password for the system and then proceed with the notification. If it is necessary to confirm whether the notification information is true, the competent authority will inspect the applicant's workplace or business place and check relevant supporting documents.

What is worth noting is that the notification shall be completed before the marketing of cosmetic products rather than the manufacture/import of cosmetics. Therefore, international companies can export directly without the need to submit a notification certificate for Custom clearance.

The validity period for product notification is three years. During the validity period, only products with ingredient changes require re-notification; for other circumstances, just a modification of notification is fine. Before the expiration date of notification, the applicant will receive a reminder email. The extension shall be completed within three months before the expiration date.

2.2.2 Product Information File (PIF)

As per the Cosmetic Hygiene and Safety Act, cosmetics manufacturers and importers in Taiwan shall establish a PIF before engaging in the supply, sale, giveaway, public display, and free trial offer of cosmetics. 

The PIF dossiers include 16 documents, shown in the table below. These documents shall be updated on a timely basis if any of the information changes. For the language of PIF, both Chinese and English versions are acceptable. However, if the original version is in another language, a translation into either Chinese or English is required.

The manufacturer or importer shall keep the PIF (hardcopy or electronic) for future inspections for at least five years starting from when the product is first sold on the market. Generally, the competent authority will notify the enterprise seven days before checking PIF. 

The Cosmetic Categories Required to Establish the Product Information File and Effective Dates (2024) specifies the applicable scope of PIF requirements and their respective effective dates. To be specific, 

2.2.3 Manufacturing Requirements

Under the cosmetic regulatory frameworkset forth by the Cosmetic Hygiene and Safety Act, GMP is mandatory for both manufacturers and importers. According to the Cosmetic Categories for Which Manufacturing Premises Shall Comply with Cosmetics Good Manufacturing Practice Regulations, the implementation dates for GMP compliance are as follows: 

Starting from the implementation date, corresponding cosmetic companies shall comply with the new GMP regulation—Cosmetic Good Manufacturing Practice Regulations. A domestic manufacturer complying with this GMP can submit the following documents to apply for a GMP compliance certificate:

• Application form

• Applicant's copy of company/business registration certificate

• A copy of the factory registration certificate

After receiving the application, the competent authority will conduct an on-site inspection and issue the certificate to the qualified manufacturers.

GMP will also be an essential requirement for pre-market approval of both domestic and imported cosmetics. The information relating to the compliance status of GMP is required to submit for notification, and the GMP certificate or self-commitment is necessary for PIF. For registration of domestic specific purpose cosmetics, if the manufacturer has a GMP certificate, he can be exempted from submission of product testing reports. But the exemption rule is not applicable for imported specific purpose cosmetics. 

As for overseas companies, it is also worth noting that TFDA also accepts ISO 22716 or equivalent regulations, and TFDA may conduct on-site inspections to overseas manufacturing sites to confirm the compliance status if necessary.

2.3 Animal Testing

Starting from November 9, 2019, animal testing is banned in Taiwan unless one of the following conditions applies and has been approved by the central competent authority:

• The ingredient is widely used, and its function cannot be replaced by other ingredients

• Those that require animal testing to be conducted, having evaluation data that demonstrate the potential for harming human health

Cosmetics in violation of this provision shall not be sold.

2.4 Labeling & Claims & Advertisements

For cosmetics made available on the market, their containers or outer packaging shall conspicuously bear the following information:

Starting from July 1, 2021, cosmetics imported but re-packaged in Taiwan shall mark the words "臺灣分裝" or "臺灣改裝" ("re-packaged in Taiwan" or "sub-packaged in Taiwan") on the outer packaging or container. If imported cosmetics have "drug", "quasi drug", "medicated" or similar words on the outer packaging or container and are regulated in the places (countries) of origin or countries of sale as OTC drugs or quasi drugs, a notice should be labeled on the outer packaging or container, which is "This product is a cosmetic without medical effect".

Advertisement

Taiwan's existing pre-market approval of advertisements has been invalidated according to explanation No. 744 of Grand Justice. And according to Regulations Governing of Criteria for the Label, Promotion and Advertisement of Cosmetic Products Identify False, Exaggerated or Having Medical Efficacy, cosmetics advertisements, labels or claims shall not be exaggerated, fake or related to medical efficacy. If a product advertisement violates related regulations, the manufacturer will be subject to fines. Severe violations of the regulations are subject to product recall and rectification of all future advertisements.

2.5 Post-market Surveillance

Compared to the previous cosmetic regulation system in Taiwan, the new system focuses more on post-market surveillance and strengthens enterprises' obligations:

• Establish and maintain source and flow data of products (products directly sold to consumers excluded)

• Report the serious adverse effects

• Notify sellers and recall incompliant products from the market

• Criminal liability for illegal cosmetic operation activities is abolished while fines are increased

• Cosmetics businesses are subject to random sampling checks and shall give their cooperation, and shall not evade, obstruct, or refuse inspection.

Part 3 Ingredients

On January 4, 2024, TFDA revealed its plans to adjust the cosmetic ingredient lists. The proposed amendments were finalized on May 30, 2024, and came into force on July 1, 2024. As a result of these changes, Taiwan's cosmetic ingredient lists now align with those of the EU and ASEAN under the new structure. This new structure comprises five ingredient lists, as shown in the table below: