Taiwan Implements Three New Cosmetic Regulatory Systems in July

In line with the Cosmetic Hygiene and Safety Act, Taiwan has implemented three new cosmetic regulatory systems from July 1, 2021. The highlights are as follows:

• General cosmetics are subject to notification;

• New labeling requirements for cosmetic packaging, containers, labels, or directions are implemented;

• Unmedicated toothpaste and mouthwash are classified as general cosmetics.

1. Notification of General Cosmetics

Since July 1, 2021, manufacturers and importers shall notify general cosmetics (except solid handmade soaps produced by cosmetic manufacturing sites where are exempt from factory registration) with TFDA prior to placing them on the market. The notification is conducted via an online system at https://cos.fda.gov.tw/TCAL/. Applicants shall first contact TFDA to obtain an account and password for the system and then proceed with the notification. After the notification information is filled out and the notification fee (600 TWD) is paid, the notification is deemed as completed. 

Notification information

• Notification number of products

• Chinese and English names of product. No need to notify the English name of domestic product

• Category and usage of products

• Type of products. Model number and color code for series products

• Dosage of products

• Precautions of products

• Names, addresses and telephone number of the manufacturer or importer of products

• Names, addresses nationalities of the premises where products manufactured and other criteria conforming to cosmetics Good Manufacturing Practice (GMP)

• Full components of products. Weight or capacity percentage identifying its content inclusion if the limitation of usage set forth by the central competent authorities

• Other relevant descriptions

The validity period for product notification is 3 years. During the validity period, only products with ingredient changes require re-notification. For other circumstances, just a modification of notification is needed. Before the expiration date of notification, the applicant will receive a reminder email to renew the notification. The renewal shall be completed within 3 months before the expiration date.

2. New labeling requirements for cosmetic packaging, containers, labels and directions

Since July 1, 2021, cosmetics shall comply with the new labeling requirements for cosmetic packaging, containers, labels, and directions. According to the new labeling requirements, the mandatory information required on labels is as follows:

• Product name;

• Function;

• 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 the manufacturer or importer; country of origin of 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.

(With regards to detailed requirements, please refer to Labeling Requirements for Cosmetic Packaging, Containers, Labels or Directions.)

It is worth noting that there are two special requirements for cosmetic labeling apart from the requirements specified in the Labeling Requirements for Cosmetic Packaging, Containers, Labels or Directions.

1. 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 inTaiwan") on the outer packaging or container.

2. 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".

3. Management of unmedicated toothpaste and mouthwash

Since July 1, 2021, unmedicated toothpaste and mouthwash have been managed as general cosmetics. The labeling, ingredients, quality, hygiene and safety, and manufacturing sites of the products must comply with cosmetics management regulations. Accordingly, unmedicated toothpaste and mouthwash shall be notified with the TFDA as well like other general cosmetics.

Related Resource

Understanding Taiwan New Cosmetic Notification, Labeling and Ingredient Regulation