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Link to TFDA Application Forms for Special Dietary Food

  • Last updated:2024-11-19
  • Count Views:1280

The regulation of special dietary foods is based on Article 21 of the Food Safety and Hygiene Management Act and the "Regulations Governing the Management of the Review, Registration and Issuance of Permit Documents for Food and Related Products". Applicable special dietary foods include the following: (1) Infant formula and follow-up formula; (2) Formula for certain disease including Nutritionally complete food with balanced formula, Nutritionally complete food with customized formula, Nutritionally adjusted supplementary formula food, and Special modular formula food; and (3) other formula foods permitted by the TFDA for special nutritional needs. 

Special dietary foods are provided for individuals with special nutritional needs. The required documents for review include the Original table of ingredient content of the product (formula table); Original product specification; Original hygiene and nutrients analysis report (test report), Manufacturing process summary, Clinical study report for the product under applicant (or foreign sales certificate); Physical or color drafts of the Chinese label; Container or outer packaging; List of registration information for special dietary foods, Product samples; Company registration or business registration certificate; Factory registration certificate; and related health certificates.

Special Dietary Food-Related Regulations Announcement

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