Taiwan Health Food and Special Dietary Food Regulatory Compliance

Taiwan's Food Regulatory System

In Taiwan, the Taiwan Food and Drug Administration (TFDA) under the Ministry of Health and Welfare (MOHW) oversees the safety, efficacy, and quality of all food products. The primary legal framework is the Health Food Control Act, which stipulates that only products scientifically proven to offer health benefits and granted a "Health Food" permit may be marketed as such.

Products not carrying the official "Health Food" logo are regulated as general foods and are strictly prohibited from making health-related or medicinal efficacy claims.

Classification of Health-Related Foods

Taiwan categorizes health-oriented products into three main regulatory groups:

1. General Food

Includes products and raw materials intended for human consumption via eating or chewing.

2. Special Dietary Food

Refers to infant formula, follow-up formula, food for specific diseases, or other single/compound nutrient products intended for individuals with special nutritional requirements as permitted by the central authority.

3. Food Additives

Substances used for coloring, flavoring, preserving, bleaching, emulsifying, enhancing aroma, stabilizing quality, promoting fermentation, thickening, nutritional fortification, anti-oxidation, or other necessary purposes. Compound food additives must be composed only of single additives permitted by the central authority and must possess official permit numbers.

Market Access Prerequisites

To enter the Taiwan market, several critical documents and conditions must be met:

• Letter of Authorization: Formal empowerment from the manufacturer to the applicant.
• GMP Certificate: Evidence of compliance with Good Manufacturing Practices or equivalent quality standards.
• Technical Dossier: Comprehensive records including formulation, packaging, labeling, and product instructions.
• Safety and Efficacy Reports: Includes safety assessment reports, health effect evaluation reports, and stability reports.
• Analytical Data: Functional ingredient test reports and specific detection methods.
• Manufacturing and Hygiene Data: Production flowcharts, product hygiene inspection specifications, and laboratory reports.
• Nutritional Analysis: A complete analysis report of general nutritional components.

Mandatory Registration and Import Procedure

The process of bringing a health-related food to the Taiwan market follows a precise technical workflow:

• Food Classification: Determine if the product is General Food, Special Dietary Food, or Health Food.
• Ingredient Review: Verify all ingredients and additives against the Taiwan permitted lists.
• Labeling Review: Ensure all Traditional Chinese labels meet mandatory standards.
• Dossier Preparation: Compile all required safety, efficacy, and manufacturing documentation.
• Submission and Audit: Submit the application for TFDA technical and administrative review.
• Obtain Registration: Receive the official permit or record filing to initiate legal importation.

Proregulations' Taiwan Compliance Services

• Product Classification and Feasibility Analysis
  Determining the most efficient registration pathway or identifying if the product meets the criteria for Special Dietary Food.
• Dossier Preparation and Technical Support
  Compiling technical data, including safety assessments, efficacy reports, and stability studies required for TFDA submission.
• Labeling Review and Design
  Drafting and reviewing Traditional Chinese labels to ensure they meet mandatory standards and avoid prohibited medical claims.
• Test Monitoring and Laboratory Coordination
  Coordinating mandatory product analysis and verification tests with TFDA-accredited laboratories.
• Permit Maintenance and Renewal
  Health Food permits are valid for five years. We manage the renewal process, which must be initiated three to six months before expiration.

If you need to ensure your health food products meet TFDA standards or require assistance with the dual-track registration process, please contact us.