Regulations of Inspection of Imported Foods and 
Related Products  
DOH Food No. 0900074645 Promulgated, December 14, 2001.  
DOH Food No. 0960403095 Amended and promulgated on 
June 22, 2007; these regulations are effective as on July 1, 
2007.  
DOH Food No. 0991304411 Amended and promulgated on 
December 30, 2010 and the title was amended to 
“Regulations of Inspection of Imported Foods and Related 
Products ”. 
DOH Food No. 1021300813 Partial amended and promulgated 
on April 1, 2013  
MOHW Food No. 1022051463 Amended and promulgated on 
January 27, 2014.  
 
Chapter 1 General Principles  
 
Article 1  The regulations are duly enacted in accordance with 
Paragraph 3 of Article 33 of the Act Governing Food 
Sanitation (hereinafter “the Act”).  
 
Article 2  The terms herein are defined as follows:  
1. Obligatory Inspection Applicant: Business who imports food, 
food additives, food utensils, food packaging, or food 
cleansers, and other related products (hereinafter 
"products").  
2. Inspection Authority: The  central competent authority or its 
commissioned organization, institution, corporation or 
group.  
3. Verification : The inspection authority check product name, 
specification and package of products appl ied for inspection. 
And exam its appearance, shape, properties, indication and 
other examination in accordance with laws and regulations.  
4. Analysis: The inspection authority take samples and send 
to laboratories to conduct sensory, chemical, biological, or 
physical examination  and experiment.  
 
Chapter 2 Application for Inspection  
 
Article 3  The Obligatory Inspection Applicant or Representative shall 
file an application for inspection to the inspection authority at 
the port of entry within fifteen (15) days prior to the entry date.  
If the application be filed by r epresentative, an identification 
document for the representative shall be provided. If the 
representative is an individual, he/she shall submit his/her 
certificate of identification. If any enti ty, who undertakes application and declaration agent as business, shall submit its 
broker license, business license and identification documents 
to the inspection authority for future reference.  
 
Article 4  Obligatory Inspection Applicants shall submit the following 
documents to the inspection authority for inspection:  
1. An application form for inspection.  
2. A declaration form of product information.  
3. A photocopy of application for import declaration.  
4. Necessary certificates required by the Food and Drug 
Administration, Ministry of Health and Welfare (hereinafter 
as“TFDA”).  
In accordance with Article  32 of the Act, the inspection 
authority may require Obligatory Inspection Applicants to 
provide other necessary certificates and data. The Obligatory 
Inspection Applicants shall not evade, obstruct or refuse.  
 
Article 5  The Obligatory Inspection Applicant s can apply for 
pre-declaration of product information to the inspection 
authorities.  Documents referred to in subparagraph 2 of 
paragraph 1 of the preceding article for those who acquired 
approval of documents from inspection authorities, shall be 
exempt from submitting the declaration form of product 
information  on application of inspection.  
Term of validity for the preceding approval document is two (2) 
years.  
If products applied for inspection are not conformant with the 
pre-declaration of product information, the inspection 
agencies shall abolish all approval documents issued to 
Obligatory Inspection Applicants, and suspend their 
applications for pre -declaration of product information within 
one (1) year.  
 
Article 6  Products for inspection applicat ion in the same shipment shall 
have the same import declaration 、CCC code 、product name 、
ingredients 、brand、producer and country  of origin.  
If the import products were live, fresh or chilled fish, prawn, 
crab, shellfish, or belong to the same class from four c lasses 
of mollusk, the inspection authority may permit the applicant 
to apply different products in one inspection application.  
 
Article 7  For any Obligatory Inspection Applicant belong to one of the 
following situations, the competent authority shall dismiss 
his/her application for inspection:  1. Applicants fail to apply an inspection application pursuant to 
Article 4 or the preceding article of this regulation.  
2. Incomplete inspection application form 、product information 
declaration form 、 or other re lated form, and fail to make 
correction within a limited period.  
 
Chapter 3 Inspection Procedures  
 
Article 8  The inspection  authority may proceed product inspection with 
the following measures:  
1. Batch -by-batch inspection: Inspect each submitted batch of 
product by on -site verification  and sampling analysis basis.  
2. Randomly -selected batch inspection: Randomly select 
each submitted batch of product by following inspection rate, 
and inspect the chosen product by on -site verification  and 
sampling analysis.  
(1)Regular randomly -selected batch inspection: The 
inspection is performed based on a 2 -10% inspection 
rate. 
(2)Reinforced randomly -selected batch inspection: The 
inspection is performed based o n a 20 -50% inspection 
rate. 
3. Batch -by-batch verification: On -site inspect each submitted 
batch of product.  
4. Certification inspection: Certificate Document inspection for 
an excellent industry which is registered by an entente or 
agreement between the health and safety competent 
authority of Taiwan and the exporting country.  
5. Oversee inspection: For specific products, each submitted 
batch of product shall be inspected by on-site verification  
and sampling analysis . And the inspection rate  is not 
change d by the inspection result.  
For those products  not be selected in randomly -selected 
batch inspection, the inspection authorize may exam extra by 
on-site verification  and sampling analysis ; For products be  
designated for batch -by-batch verification , the ins pection 
authorize may exam extra by sampling analysis . 
 
Article 9  Products applied for inspection that belong to one of the 
following situations shall be inspected on a batch -by-batch 
basis:  
1. Products proved to cause harm to humans according to 
domestic and foreign product safety information or scientific evidence.  
2. Products designated for batch -by-batch inspection are 
listed in the TFDA annual inspection plan (hereinafter as 
“inspection p lan”) for imported products.  
3. Products with the same origin and commodity classification 
code of the Republic of China (hereafter referred to as 
‘CCC Code’) as preceding batches of products belonging to 
reinforced randomly -selected batch inspections of t he same 
obligatory inspection applicant, and whose inspection 
results do not conform to regulations.  
4. For products applied to oversee inspection and fail the 
inspection two batches in a row.    
5. The inspection authority determines that it is necessary to 
carry out the inspection on a batch -by-batch basis.  
Prior to the completion  of the batch -by-batch inspection 
procedures for the preceding batch, the batches re -applied for 
inspection to such batch of products shall be subject to 
inspection on a batch -by-batch basis.  
 
Article 10  Products applied for inspection that belong to one of the 
following situations shall be inspected on a reinforced 
randomly -selected batch basis:  
1. Products designated for reinforced randomly -selected 
batch inspection are listed in the inspection plan for 
imported products.  
2. Products applied for inspection originally belong to 
batch -by-batch inspection, and the same obligatory 
inspection applicant has imported five consecutive batches 
of such products from the same origin and CC C Code, and 
whose laboratory examination results conform to 
regulations. However, if the preceding batch before these 
five consecutive batches of the same obligatory inspection 
applicant failed to conform to regulations, then the quantity 
of these five con secutive batches of such products shall be 
three times greater than the preceding batch of unqualified 
products.  
3. Products with the same origin and CCC Code as preceding 
batches of products belonging to regular randomly -selected 
batch inspection of the s ame obligatory inspection applicant, 
and whose inspection results do not conform to regulations.  
4. The inspection authority determines that it is necessary to 
carry out the inspection on a reinforced randomly -selected 
batch basis.  For products applied to inspection originally belongs to 
batch -by-batch inspection , the inspection authority  may not be 
restricted by the restrictions stipulated in the preceding 
paragraph based on its considerations of health and safety . 
 
Article 11  Products applied for inspect ion that belong to one of the 
following situations shall be inspected on a regular 
randomly -selected batch basis:  
1. Products do not apply to batch -by-batch inspection, 
reinforced randomly -selected batch inspection, certification 
inspection or oversee insp ection.  
2. Products applied to inspection originally belongs  to 
reinforced randomly -selected batch inspection, and the 
same obligatory inspection applicant has imported five 
consecutive batches of such products from the same origin 
and CCC Code, and whose laboratory examination results 
conform to regulations. Howev er, if the preceding batch 
before those five consecutive batches of the same 
obligatory inspection applicant fail to conform to regulations, 
then the quantity of these five consecutive batches of such 
products shall be three times greater than the precedin g 
batch of unqualified products.  
For products applied to inspection originally belongs to 
reinforced randomly -selected  batch inspection, the inspection 
authority  may not be restricted by the restrictions stipulated in 
the subparagraph 2 of preceding paragr aph based on its 
considerations of health and safety . 
 
Article 12  If an obligatory inspection applicant imports products after 
failing on -site verification  for products belong to the same 
origin country and CCC Code,  those products shall be 
inspected on a batch -by-batch verification basis.  
If three consecutive batches of products designated for 
batch -by-batch verification in preceding paragraph conform to 
regulations, and the total amount reach two times as the 
previo us unqualified products, then the same products for 
future import can be exempt from batch -by-batch verification.  
 
Article 13  The inspection authority may adopt oversee inspection on 
specific products based on considerations of health and 
safety.  
 
Chapter 4 Preferential Measure for Excellent Industry   
Article 14  Import products belong to following situations may apply to 
the minimum inspection rate of normal randomly -selected 
batch inspection.  
1. Obligatory Inspection Applicants apply an imports product 
quality assurance project to inspection authority, and been 
approved and registered by inspection authority, and have 
ten consecutive batches of products pass the 
randomly -selected batch inspection within one year.  
2. Twenty consecutive batches of import prod ucts pass the 
randomly -selected batch inspection within one year.  
3. Thirty consecutive batches of import products pass the 
randomly -selected batch inspection within two year.  
Any product  applied to minimum inspection rate in 
accordance with preceding paragraph failed a border 
inspection or market randomly -selected inspection, shall 
cease to apply to preferential measure in preceding 
paragraph.  
 
Article 15  Obligatory Inspection Applicants import products in pr eceding 
article and all the inspected products conform to the 
regulations within two (2) years, then their future import 
products may be inspected on certification inspection basis in 
accordance with Article 4.  
If necessary, the inspec tion authority may inspect products in 
preceding paragraph by on -site verification  or sampling 
analysis . If the result is not qualified, future import products of 
the obligatory inspection applicant cease to apply to the 
preferential measures in preceding paragraph.  
 
Chapter 5 Inspection Operation  
 
Article 16  The samples required for inspection may be taken 
free-of-charge from the Obligatory Inspection Applicants by 
the inspection authority, but the amount of sampling shall be 
limited to the requirement of examination and sample 
retention purposes.  
After collecting the samples, the authority shall issue a receipt 
for sampling to the Obligatory Inspection Applicants.  
 
Article 17  Verifying  and sampling of inspection shall conduct in the place 
where the products were stored. If the products were shipped 
in full container  load, the inspection authority may conduct verifying  and sampling in the centralized inspection area of 
port. The Obligato ry Inspection Applicants shall cooperate 
with the inspection authority’s verifying  and sampling 
operation.  
During the sampling in preceding paragraph, Obligatory 
Inspection Applicants shall not appoint any specific sample.  
 
Article 18  Examination shall be conducted in the order of sampling. 
However, the inspection  authority shall first inspect products 
that applied for re -examination according to these regulations.  
 
Chapter 6 Prior Release  
 
Article 19  Due to requiring five or more days for examination, or 
sampling of such products is difficult in a container yard, or the 
product is perishable, after the obligatory inspection applicant 
sign an affidavit of custodial responsibility, the inspection 
authority may issue a Notice of Prior Rele ase for import for 
customs clearance. However, for products designated for 
batch -by-batch inspection shall be retained at border 
temporarily.  
 
Article 20  Products that belong to one of the following situations, the 
inspection authority  may issue a prior re lease notice  after the 
obligatory inspection applicant  paying a guarantee bond ： 
1. Products were belongs to Reinforced randomly -selected 
batch inspection.  
2. Products were belongs to Oversee inspection and the result 
is not qualified.  
The amount of the guarantee bond in the preceding 
paragraph shall be twice as the products DDP (Delivered Duty 
Paid) price.  
 
Article 21  Paying the guarantee bond in accordance with preceding 
article by an obligatory inspection applicant shall be by 
financial -institutions -issued cashier's check or check, or postal 
order.  
After the products  applied for inspection conform to the 
regulations, and no violation of Subparagraph 3 of Article 51 
of the Act, the obligatory inspection applicant may request the 
inspection authority to refund the guarantee bond.  
 
Chapter 7 Issuance of Certifications   
Article 22  After the products applied for inspection conform to the 
regulations, the inspection authority shall issue a permission 
notice to the obligatory inspection  applicant. Obligatory 
inspection applicant may also apply to the inspection authority 
for a written permission notice.  
The obligatory inspection applicant can claim remaining 
samples by presenting the sampling receipt within 15 days 
after receipt of the n otice of inspection results. However, for 
samples with short shelf life, the inspection authority shall 
dispose of the samples directly.  
 
Article 23  Products that fail to conform to the regulations, a notification 
of noncompliance for import food and relev ant products shall 
be issued.  
The obligatory inspection applicant can apply for 
re-examination to the original inspection authority within 15 
days after receipt of the notification of results. Application for 
re-examination is limited to one time only, and  shall be 
performed by the original inspection authority using remaining 
samples for the re -examination.  
Remaining samples of products that do not conform to 
regulations shall be destroyed at the end of the period of 
application for re -examination.  
 
Articl e 24 Imported  products that do not conform to regulations upon 
inspection shall be disposed of in one of the following ways by 
the obligatory inspection applicant:  
1. Return or destroy . 
2. For products do not conform to Article 22 or Article 18 of 
this Act, or violate Paragraph 1 of Article 21 of this Act, the 
obligatory inspection applicant may apply to TFDA for 
disinfection, reconditioning or taking the enforcement of 
appropriate safety measures.  
3. For products  violate Article 22, Article 24, Article 26, Article 
27 or Paragraph 1 of Article 28 of this Act, the obligatory 
inspection applicant may apply to TFDA for relabeling.  
When the obligatory inspection applicant takes appropriate 
action in accordance with the Subparagraph 2 or 3 of the 
preceding Paragraph,  the TFDA may issue a prior release 
notice to the obligatory inspection applicant for prior release.  
If imported products that have been released via a prior 
release notice fail an inspection, the inspection authority shall order the obligatory inspection applicant to retrieve and take 
appropriate action in accordance with the provisions of 
Paragraph 1 of  this Article.  
 
Chapter 8 Other Regulations of Inspection  
 
Article 25  If an obligatory inspection applicant import products belong to 
the same origin country and CCC Code, and its inspection 
results do not conform to regulations for two times within six 
months, the TFDA may require the obligatory inspection 
applicant to provide written document before a given date, to 
explain the reasons for non -conformance, and a proposed 
improvement plan with preventative measures.  
If products belong to the same origin country and CCC Code, 
and its inspection results do not conform to regulations for 
three times within six months, the TFDA may require the 
government of the exporting country to provide written 
document before a given date, to explain the reasons for 
non-conformance, and a proposed improvement plan with 
preventative measures.  
 
Article 26  If the obligatory inspection applicant or government of the 
exporting country/area fails to provide written document 
before the given date or after receiving the notification 
mentioned in the preceding article and following imported 
products applied for re -examination still do not conform to 
regulations, the TFDA may temporarily suspend the 
inspection application of related industry, country of origin and 
products.  
 
Chapter 9 Supplementary Provisions  
 
Article 27  When conducting  on-site inspections according to the 
regulations, inspectors shall carry their identification 
documents with them.  
 
Article 28  Except for Article 20 and 21  that were amended in January 27 
2014  come into enforcement  from June 19 2014, the other 
provisions shall come into enforcement from the date of 
promulgation.