Definition Cosmetics Taiwan

As defined by the Taiwan Food and Drug Administration: 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 contours, change appearance, or
cleanse the body.

• Special use cosmetics:

Special cosmetics containing active ingredients considered to be close to the drug (e.g.
antiperspirants, sun products, hair dyeing, etc.)

How does it work?

BIORIUS’ experts analyze the formulas and review the labels for both cosmetics and Special use cosmetics.

Formula Review

Toxicological and regulatory assessment of ingredients and impurities, establishment of the INCI and establishment of warnings and precautions for use.

A formula review report is issued, which highlights the following elements:

• Ingredients names (INCI names)
• Percentage of each ingredient
• Regulations and restrictions
• Margins of safety
• Comments from the experts (amendments needed)

Label & Claims Review

Evaluation of product labels (ingredients list, symbols, legal requirements, etc.) and claims substantiation.

Labelling

The mandatory statements must be labelled in Chinese, with the exception of the list of ingredients,
which may be written in INCI. These statements are as follows:

• Name and function of the product
• Use and storage instructions
• Net weight or volume
• List of ingredients (for special use, the ingredient and concentration of the special use
  active must be indicated separately)
• Precautions for use
• Name, address and telephone number of importer and country of origin for imported products
• Date of manufacture and expiry
• Batch number
• Other necessary information

For cosmetics imported in bulk and packaged in Taiwan, the labelling should include the words
“packaging in Taiwan”.
There are specific safety precautions for hair dyes, perms and bleaches. These precautions must be
included on the label.

Claims

The definition of a claim takes into account the general context: texts but also symbols, images,
presentation. Exaggerations, deception and claims with a medical content are prohibited.
List of permitted claims by product type and list of prohibited claims because exaggerated, misleading
or medical have been published by the Taiwanese FDA.

Product Information File (PIF)

The PIF becomes mandatory for all cosmetics and must be established before any import or placing
on the market. In addition to all product-related documents, the PID must include a safety report
signed by a qualified person.
The obligation to establish a DIP will be effective:

• On July 1, 2024 for special-use cosmetics
• By 1 July 2025 for children’s cosmetics, eye contour, lips and oral products
• On July 1, 2026 for general cosmetics

Notification of general cosmetics

Before any import or manufacture and placing on the market of general cosmetic products, the
notification will have to be made through an electronic portal set up by the authorities. The validity
period is 3 years. The notification of general cosmetics will become mandatory on 1 July 2021.