Cosmetic Regulations Guide of Taiwan,China

Official Channels for Regulation Inquiry

Ministry of Health and Welfare (MOHW)-Laws & Regulations Search System

Taiwan Food and Drug Administration (TFDA)-Cosmetics Regulations Portal

Regulatory Framework at a Glance

Core statute
Statute for Control of Cosmetic Hygiene and Safety and its Enforcement Rules, consolidated with related regulations (Edition: December 2024).

Six Key Compliance Modules

1. Ingredient Standards

• Prohibited or Restricted Ingredients List-substances that are banned or subject to concentration limits (e.g., heavy metals, hormones).
• Maximum limits for preservatives and UV filters-positive lists with permitted concentrations.

2. Labelling & Advertising

• Outer-packaging labelling requirements-product name, full ingredient list, intended use, etc. must be clearly indicated.
• Prohibited medical claims-cosmetics shall not bear medical terminology or exaggerated, misleading promotional wording.

3. Manufacturing Licensing

• Cosmetic GMP compliance–manufacturers shall conform to the Good Manufacturing Practice standards for cosmetics to assure quality and safety.
• Factory establishment standards–requirements on site selection, layout, facilities and equipment to prevent cross-contamination.

4. Product Notification

• Mandatory product notification–specified categories of cosmetics must be notified prior to market placement.
• Product Information File (PIF)-a dossier containing formulation, safety assessment, manufacturing method, etc. must be maintained and made available for inspection.

5. Testing & Certification

• SPF testing-sun-protection products shall undergo in-vivo or validated in-vitro testing to substantiate the labelled SPF value.
• Patch-test guideline-ingredients with potential sensitising properties should be evaluated through human skin patch testing.

6. Special Provisions

• Children’s cosmetic safety guideline-mild, low-irritancy ingredients are required; additional safety margin applies.
• Nano-ingredient risk assessment-products containing nanomaterials must undergo specific safety and toxicological evaluation.

(All information is based on the latest announcements by the Taiwan Food and Drug Administration as of December 2024; regular verification for updates is recommended.)