Cosmetica
Compliance checkingAsia-Pacific

Taiwan cosmetic regulations

TFDA · Statute for Cosmetic Hygiene and Safety (2018, fully effective 2021)

Taiwan's Statute for Cosmetic Hygiene and Safety took effect in stages between 2019 and 2021, replacing the older Statute for Control of Cosmetic Hygiene. The new regime requires per-product notification, a Product Information File maintained by the responsible party, GMP for manufacturers from 2024, and adverse event reporting.

Last updated:

See pricing

Key facts

Statute
Statute for Cosmetic Hygiene and Safety (2018)
Notification
Per product, prior to sale
PIF requirement
Yes — maintained by responsible party
GMP
Mandatory for manufacturers (phased through 2024)

What Taiwan requires

The core obligations every brand selling cosmetics in Taiwan must meet.

Product notification

Every cosmetic must be notified to TFDA prior to sale. Notification covers product identity, intended use, formulation summary, and manufacturer/importer details.

Product Information File

The responsible party (Taiwan-based manufacturer or importer) must maintain a PIF for each product, accessible to TFDA on request. PIF content closely mirrors EU requirements.

GMP

Manufacturers must comply with cosmetic GMP standards consistent with ISO 22716. GMP requirements have phased in across product categories through 2024.

Adverse event reporting

The responsible party must report serious adverse events to TFDA within specified timeframes and maintain records.

Traditional Chinese labeling

All mandatory labeling must be in Traditional Chinese. Imported products typically add a Chinese-language label sticker.

How Cosmetica helps

Cosmetica coverage for Taiwan

Ingredient compliance against TFDA prohibited and restricted lists, PIF data preparation, notification data structure ready for a Taiwan-based responsible party.

Primary sources

Always verify current requirements against the regulator's official publications. Cosmetica's analysis cites these primary sources directly in every compliance finding.