1 Regulations of Inspection of Imported Foods and Related 
Products  
 
Chapter 1  General Principles  
Article 1  The regulations are duly enacted in  accord ance  with Paragraph 3 of 
Article 33 of the Act Governing Food Sanitation  (hereinafter “the Act ”). 
Article 2  The inspection  and declaration  of imported food,  food additives, food 
utensils, food containers, food packaging or food cleansers, and other 
related products (here inafter "products "), or consignment of such 
inspection and declaration, preferential  measures of inspection  and 
declaration for registered excellent industry , prior release  qualification , 
inspection , margin collecting, and other compulsory rules,  shall be 
performed accord ance  with the regulations.  
Article 3   The terms herein are defined as follows:  
1. Obligatory Inspection Applicant : Business  who imports  food products.  
2. Inspection A uthority : The central competent authority  or its 
commissioned  organization or institution.  
3. On-site Inspection : On-site check product name, specificatio n and 
package of p roducts applied for inspection . 
4. Sampling and Analysis : The inspection authority take samples and 
send to laboratories to  conduct sensory, chemical, biological, or 
physical ex amination.  
 
Chapter 2  Application for Inspection  
Article 4 The Obligatory Inspection Applicant or Representative shall file an 
application for inspection to the inspection authority at the port  of entry 
within fifteen  days prior to  the entry  date.  
If the representative files the application, an identification document for 
the representative shall be provided.  
Article 5  Any entity , who under takes application and declaration agent  as 2 business, shall submit its broker license, business license and 
identificat ion documents to the inspection authority  for future reference . 
If the inspection authority  discovers any failure to declare full and 
accurate product information , the inspection authority may temporarily 
suspend the agent's application and declaration age nt business  for six 
months period . 
Article 6 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 photo copy of application for import declaration.  
4. Necessary certificates required by the inspection authority.  
The inspection authority  may require  Obligatory Inspection Applicants  to 
provide other n ecessary certificates for its inspection needs . The 
Obligatory Inspection Applicants  shall not evade, obstruct or refuse.  
Article 7  Products for inspection application  in the same  shipment shall have the 
same  import declaration 、CCC code 、product name 、ingredients 、brand 、
producer and country  of origin . However,  the inspection authority may 
permit the applicant  to apply different products in one inspection 
application.  
Article 8 For any Obligatory Inspection Applicant belong to one of the following 
situations, the competent authority shall dismiss his/her  applica tion for 
inspection:  
1. Applicants  fail to apply  an inspection application pursuant to Article 6  
of this regulation . 
2. Incorrect inspection  application  form、product information  declaration 
form、 or other  related form ， or fail to fill in information req uired by 
relevant provisions.  
 
Chapter 3  Inspection Procedures  3 Article 9 In addition to review documents as prescribed in Article 6, the inspection 
authority may proceed  product inspection with the following measures:  
1. Batch -by-batch inspection: Inspect e ach submitted batch of product 
by on -site inspection 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 inspection 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 on a 20 -50% inspection rate.  
3. Batch -by-batch verification: On -site inspect each submitted batch of 
product.  
4. Certification inspection: Document inspection for products that 
produced by the competent -authority -registered excellent industry 
and foreign manufacturer.  
5. Oversee inspecti on: For specific  products, each submitted batch of 
product  shall be inspected  by in-site inspection and 
randomly -selected batch inspection  basis. For those products not be 
selected in r andomly -selected batch inspection , the inspection 
authorize  may exam ex tra by in -site inspection and in -site inspection 
basis; For products  be designate d for b atch-by-batch inspection , the 
inspection authorize  may exam extra by r andomly -selected batch 
inspection  basis.  
For the abovementioned inspections, verification, and cer tification, if 
necessary, the inspection authority shall take samples of an appropriate 
amount to conduct sensory, chemical, biological, or physical laboratory 
examination.  
Article 10 Products applied  for inspection that belong to one of the following 
situations shall be inspected on a batch -by-batch basis:  4 1. Products proved to cause harm to humans according to domestic and 
foreign product safety information or scientific evidence.  
2. Products designa ted for batch -by-batch inspection are listed in the 
annual inspection plan 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 prod ucts belonging to reinforced 
randomly -selected batch inspections of the same obligatory 
inspection applicant, and whose inspection results do not conform to 
regulations.  
4. The inspection  authority in consideration of health and safety, 
determine that it i s 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 o n a batch -by-batch basis.  
Article 11 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 annual inspection plan for imported 
products.  
2. Products applied for inspection originally belongs to batch -by-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. However, if the preceding batch before these 
five consecutive batches of the same obligatory inspection applicant 
failed to conform to regulations, then the quantit y of these five 
consecutive batches of such products shall be three times greater 5 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 same obligatory inspection applicant, and whose inspection 
results do not conform to regulations.  
4. The inspection authority, out of considerations of health and safety, 
determine that it is necessary to carry out the inspection on a 
reinforced randomly -selected batch basis.  
For products applied for 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 12 Products applied for inspection that belong to one of the following 
situations shall be inspected on a regular randomly -selected batch 
basis:  
1. Cases not as described in Article 10 and preceding article . 
2. Products appli ed for 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 r esults conform to regulations.  
However, 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 t hree times greater than the preceding batch of unqualified 
products.  
For p roducts applied for inspection originally belongs to reinforced 
randomly -selected batch inspection , the inspection authority  may not be 
restricted by the restrictions stipulated in t he subparagraph  2 of 
preceding paragraph based on its considerations of health and safety . 6 Article 13 If an obligatory inspection applicant imports products after failing on -site 
inspection 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 previous unqualified products, then the 
same products for future import can be exempt from batch -by-batch 
verification.  
Article 14 The inspection authority may adopt oversee inspection on specific 
products based on considerations of health and safety . 
 
Chapter 4  Excellent Industry an d Preferential Measure  
Article 15  The Obligatory Inspection Applicants shall 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 b eing submitted on application of inspection.  
Term of validity for the preceding approval document is two 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 year.  
Article 16 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 q uality 
assurance project  to inspection authority, and been approved and 
registered by inspection authority, and have ten consecutive batches 
of produc ts pass the randomly -selected batch  inspection within one 7 year.  
2. Obligatory Inspection Applicants import products belong to the same 
origin country and CCC Code , and have twenty  consecutive batches 
of products  pass the randomly -selected batch  inspection within one 
year.  
3. Obligatory Inspection Applicants import products belong to the same 
origin country and CCC Code , and have thirty  consecutive batches 
of products  pass the randomly -selected batch  inspection within two 
year.  
Article 17  Obligatory Inspection Applicants import products in proceeding article, 
and all the inspected  products conform to the regulations , then their 
future import products may be inspected on  certification inspection  
basis.  
The inspection authority may inspect pr oducts in preceding paragraph 
by on -site inspection or randomly -selected batch  inspection basis. If the 
result is not qualified , future import products of the o bligatory inspection 
applicant  cease to apply to the preferential  measures in preceding 
paragrap h. 
 
Chapter 5  Inspection Operation  
Article 18  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 i ssue a receipt for sampling to the Obligatory Inspection 
Applicants.  
Article 19  Checking and sampling of inspection shall conduct in the centralized 
inspection area of port and the storehouse , Obligatory Inspection 
Applicants shall cooperate  with the inspe ction authority ’s checking and 
sampling operation.  8 During t he sampling in preceding  paragraph, Obligatory Inspection 
Applicants shall not appoint any specific  sample . 
Article 20  Examination  shall be conducted in the order of sampling. However, the 
inspecti on authority shall first inspect products that applied for 
re-examination according to these regulations.  
 
Chapter 6  Prior Release  
Article 21  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 
Release for import for customs clearance. However , for products 
designated for batch -by-batch inspection shall be retained at border 
temporarily.  
Article 22  In the case of products belongs to Reinforced randomly -selected batch 
inspection, if the obligatory inspection applicant apply  to inspection 
authori ty for prior release  in accordance with preceding article, the 
obligatory inspection applicant shall pay a guarantee bond at the same 
time with application. And the amount of the guarantee bond shall be 
twice as the products CIF price . 
Article 23  Paying the guarantee bond in accordance with preceding article  by an 
obligatory inspection applicant  shall be by promissory notes , checks  
issued by  financial  institutions  deposits or  postal orders . 
After the products applied for inspection conform to the regulations, and 
no violat ion of  Paragraph  2 of Article 33  of the Act, the obligatory 
inspection applicant  may request the inspection authority  to refund the 
guarantee  bond.  
Chapter 7  Issuance of Certifications  
Article 24 After the products applied for inspection conform to the regulations, the 
inspection authority shall issue  a permission notice to the obligatory 9 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 notice 
of inspection results. However, for samples with short shelf life, the 
inspection authority shall dispose of the samples directly.  
Article 25 Products that fail to conform to the regulations, a notification of 
noncompliance for import food and relevant products shall be issued.  
The obligatory inspection applicant can apply fo r 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 sampl es for the re -examination.  If the remaining 
samples of food  utensils, food containers, food or packaging are 
insufficient for re - examination, the inspection authority may re -sampling 
in accordance with Article 18.  
Remaining samples of products that do not  conform to regulations shall 
be destroyed at the end of the period of application for re -examination.  
Article 26  Imported products that do not conform to regulations upon inspection 
shall be disposed of in one of the following ways by the obligatory 
inspe ction applicant:  
1. Returned or destroyed.  
2. Reconditioning, disinfection or taking the enforcement of appropriate 
safety measures approved by the inspection authority.  
3. Relabeling approved by the inspection authority.  
When the obligatory inspection applicant takes appropriate action in 
accordance with the Subparagraph 2 or 3 of the preceding Paragraph, 
the inspection authority may issue a prior release notice to the obligatory 
inspection applicant.  
If imported products that have been released via a p rior release notice 10 do not conform to regulations mentioned in the paragraph 1, 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 Articl e. 
 
Chapter 8  Other Regulations of Imported Food Product  
Article 27  Products applied for inspection that belong to one of the following 
situations, the competent authority may require the obligatory inspection 
applicant or government of the exporting count ry to provide written 
document before a given date, to explain the reasons for 
non-conformance, and a proposed improvement plan with preventative 
measures:  
1. Obligatory inspection applicant import products belong to the same 
origin country and CCC Code, a nd its inspection results do not 
conform to regulations for two times within six months.  
2. Products, and whose inspection results do not conform to regulations 
for three times within six months.  
Article 28  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. Disinfection, reconditioning  or taking the enforcement of appropriate 
safety measures  approved by the inspection authority  within a limited 
time period.  
3. Relabeling  approved by the inspection authority  within a limited time 
period . 
When t he obligatory inspection  applicant  takes appropriate action in 
accordance with the Subparagraph 2 or 3 of the preceding Paragraph,  
the inspection authority  may issue a prior release notice  to the obligatory 
inspection applicant  for prior release.  11 If imported products that have  been released via a prior release notice 
do not conform to regulations mentioned in the paragraph  1, the 
inspection authority shall order the obligatory inspection applicant to 
retrieve and take appropriate action in accordance with the provisions of 
Para graph 1 of this Article.  
 
Chapter 9  Supplementary Provisions  
Article 2 9 When  conducting on -site inspections according to the regulations, 
inspectors shall carry their identification documents with them.  
Article 30  Except  for Article 22 and 2 3 come into enforcement  from June 21 2014 , 
the other provisions  shall come into enforcement from the  date of  
promulgation.