DistantNews
Support us
🇹🇼 Taiwan /Economy & Trade

Taiwan's New Cosmetic Rules: FDA Denies 'Approval System' Claims Amid Small Business Concerns

From Liberty Times · () Chinese

Translated from Chinese, summarized and contextualized by DistantNews.

At a glance

News Sources not specified New plan
  • Taiwan's Food and Drug Administration (FDA) will implement a new cosmetic product information file (PIF) system in July.
  • The PIF system requires businesses to maintain relevant data for product safety and quality, not a pre-market approval process.
  • The FDA stated that existing product data can be used, and costs will not exceed NT$200,000 per product, countering claims of excessive financial burdens on small manufacturers.

Taiwan's Food and Drug Administration (FDA) is set to launch its cosmetic product information file (PIF) system in July, a move intended to align with international standards. Despite industry concerns about potential high costs, the FDA emphasizes that the PIF is not an approval or certification process. Instead, it requires businesses to maintain readily available data concerning product safety, quality, and efficacy.

The PIF system is not a certification, review, or pre-market approval system, nor does it have a certification mark.

— Chien Chia-hungTaiwan FDA official explaining the nature of the PIF system.

FDA official Chien Chia-hung clarified that companies can utilize existing product specifications, ingredient data, test reports, manufacturing quality control documents, and safety assessments. Information can also be sourced from original manufacturers, ingredient suppliers, safety data sheets, scientific literature, or international databases. This approach aims to prevent the need for entirely new data generation, mitigating the NT$200,000 cost per product alleged by some businesses.

Businesses only need to ensure they have the data content required by PIF for record-keeping.

— Chien Chia-hungTaiwan FDA official clarifying the compliance requirements for the PIF system.

The PIF system is being rolled out in three phases. The first phase, covering specific-use cosmetics like sunscreens, hair dyes, and antiperspirants, began in July 2024. The second phase, starting July 2025, will include general cosmetics such as baby products, lip products, eye products, and non-medicated toothpaste. The third and final phase, commencing this July, will encompass all cosmetic products.

Existing product specifications, ingredient data, test reports, manufacturing quality control documents, and safety assessment data can be used as the foundation for building the PIF.

— Chien Chia-hungTaiwan FDA official detailing the types of data acceptable for the PIF system.
DistantNews Editorial

Originally published by Liberty Times in Chinese. Translated, summarized, and contextualized by our editorial team with added local perspective. Read our editorial standards.

More Stories

From Our Blog