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Taiwan Proposes Amendments to Inspection Regulations for Imported Foods

On May 7, 2025, the Taiwan Food and Drug Administration announced draft amendments to the Regulations of Inspection of Imported Foods and Related Products. Stakeholders may submit opinions within 60 days of the announcement. Key proposed amendments are summarized below.

Changes to Application Requirements

  • Under current regulations, importers must apply for inspection within 15 days prior to the product's arrival at the port. The amendment allows applicants to submit inspection applications after the product arrives at the port of entry.

  • A new provision states that incomplete application documents must be corrected within 30 days of receiving notification. A one-time extension of up to 30 additional days may be granted if needed.

  • The inspection authority will not accept repeated inspection applications for the same batch of products (i.e., with the same declaration number), regardless of the inspection methods applied.

Amendments to the Scope of Batch-by-Batch Verification

Implementation of batch-by-batch verification

Proposed provision

Existing provision

  •  If the previously imported products, upon verification, are found non-compliant with Article 15, Paragraph 1, Subparagraphs 8 to 10, or Article 18 of the Act Governing Food Safety and Sanitation ( i.e. products past their expiry date, products not previously used for human consumption in Taiwan and lacking proof of safety, use of unapproved food additives, or food additives that do not meet specified standards, scope of use, or limits), then subsequent import of products with the same origin and CCC code shall be subject to batch-by-batch verification.

  • The authority deems it necessary to conduct batch-by-batch verification to mitigate potential safety risks, based on international safety information or scientific evidence.

  • If an applicant imports products following a failed on-site verification for products of the same origin and CCC code, the import of such products shall be subject to batch-by-batch verification.

 

 

 

 

Lifting of batch-by-batch verification

Proposed provision

Existing provision

  • If a batch of products from the same origin and CCC Code is found non-compliant, and the same applicant subsequently imports three consecutive batches that pass inspection, with a total volume at least twice that of the non-compliant batch, the batch-by-batch verification requirement may be lifted.

  •  If the applicant has not previously imported the product, or if the most recent import of such products was compliant, then after three consecutive compliant batches, the batch-by-batch requirement may be lifted.

  • If three consecutive batches of products designated for batch-by-batch verification conform to regulations, and the total amount of products is twice that of the previous non-compliant products, then future imports of the same products may be exempted from batch-by-batch verification.

Revised Criteria for Excellent Importers

In Taiwan, excellent importers benefit from the regular randomly-selected batch inspections at the lowest inspection rate. Under the current regulations, the status is granted based on a specific number of consecutive compliant batches passing regular randomly-selected inspections. The amendment removes the “consecutive batch” and “regular randomly-selected inspections” requirements, and instead bases eligibility on all imported products passing various inspection methods and meeting a specified number of compliant batches.

Proposed criteria  

Existing criteria

  • At least 10 batches inspected and compliant within one year, and the importer has submitted a product quality control plan approved by the inspection authority.

  • At least 20 batches have passed the inspections within one year.

  • At least 30 batches have passed the inspections within two years.

  • 10 consecutive batches compliant through regular randomly-selected inspections within one year, plus an approved quality control plan

  • 20 consecutive batches compliant through regular randomly-selected inspections within one year.

  • 30 consecutive batches compliant through regular randomly-selected inspections within two years.

Revisions to Prior Release Provisions

  • The amendment removes the prior release mechanism for imported organic products. Imported organic products are subject to certification by agencies designated by the Taiwan Agriculture and Food Agency. Only certified products may be sold, labeled, or advertised as organic. For compliant products, a permission notice will be issued directly without the need for a prior release.

  • It introduces a new security deposit requirement for applicants seeking prior release, along with rules for recycling the deposit.

Clarification on Inspection Fees

The amendment clarifies that inspection fees shall be borne by the applicant.

Full Digitization of the Inspection Process

The entire import inspection process has been fully digitized, covering all steps from application submission to the issuance of the permission notice.

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