Product notification
Every cosmetic must be notified to TFDA prior to sale. Notification covers product identity, intended use, formulation summary, and manufacturer/importer details.
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.
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The core obligations every brand selling cosmetics in Taiwan must meet.
Every cosmetic must be notified to TFDA prior to sale. Notification covers product identity, intended use, formulation summary, and manufacturer/importer details.
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.
Manufacturers must comply with cosmetic GMP standards consistent with ISO 22716. GMP requirements have phased in across product categories through 2024.
The responsible party must report serious adverse events to TFDA within specified timeframes and maintain records.
All mandatory labeling must be in Traditional Chinese. Imported products typically add a Chinese-language label sticker.
Ingredient compliance against TFDA prohibited and restricted lists, PIF data preparation, notification data structure ready for a Taiwan-based responsible party.
Always verify current requirements against the regulator's official publications. Cosmetica's analysis cites these primary sources directly in every compliance finding.