Regulations for Systematic Inspection  of Imported Food  
Promulgated  on February 11, 2014  
Amended on October  17, 2014  
Amended on August 4 , 201 7 
Amended on September 17 , 201 8 
Amended on September 26 , 201 9 
 
Article 1  These Regulations are established in accordance with  the provisions of  
Paragraph 2 of  Article 35 of the Act Governing Food Safety and 
Sanitation  (hereinafter  referred to as  “Act”).  
Article 2  The terms used in these Regulations are defined as follows:  
1. “Systematic inspection ” means  inspecting the  food safety 
management  system  and the supervisory measures taken by the 
government s of the exporting country (territory).  
2. “Inspection  authority” means  the Food and Drug Administration, 
Ministry of Health and Welfare.  
3. “Document  review”  means  reviewing  the documentation relating  to 
the food safety management  system in the exporting country (territory) 
provided by the governmental  authority of the exporting country 
(territory).  
4. “On-site inspection ” means  the inspection authority  designates 
inspect ors to conduct the systematic inspection of the food safety 
management system in the exporting country (territory) . 
Article 3  The scope of products subject to systematic  inspection  is outlined  in the 
attachment.  
Article 4  To perform systematic inspection  and evaluate  the equival ance of the 
food safety management system of the exporting country (territory) , the 
exporting country (territory) shall apply to the inspection authority with 
documents for approval of import of the product des cribed in the above 
paragraph. Inspection authority shall conduct the document s review. If 
required, on -site inspection can be conducted  following the document 
review.  Only i is determined as equivalent  Formatted :  Font:  (Default)  Times  New  Roman,  14 ptThe inspection authority  may make the follow ing decision  based on the 
result of  systematic inspection : 
1. Market access approv al for products of the establishments  design ated 
by competent authority of the exporting country (territory) . 
2. Market access  approv al for products of the establishments which 
have been inspected and qualified by the inspection authority.  
Article 4 3. Disapprov al of the application  for market access . based on the 
systematic inspection , the application of the exporting country 
(territory) will be approved.  
If necessary, inspection authority shall request the exporting country 
(territory)  (territory)  to provide the documents within the designated 
period  when performing the pre -said document review.  
Product s which are subject ed to the scope of this regulation, are not 
conforming to the  paragraph 12 of this Article  shall not apply  for import 
inspection at border, except for the exempt ion according to Article 7  or 
according to the bilateral agreement with the exporting country 
(territory) . 
Article 5  For any exporting country (territory) that has been systema tically 
inspected  and been approved to import or that is exempted  from 
systematic inspection  in accordance with the provisions of Article 7, in 
case of any of the following, the inspection authority  may request  
document  review or  on-site inspection  to confirm the equivalence of the 
management system  of the exporting country (territory).  
1. Significa nt change s of food safety management  system  or the 
supervisory measures of the exporting country (territory).  
2. Occurrence of significant food sanitation and safety incident s in the 
exporting country  (territory) . 
3. Significant violation of the f ood or related product from the exporting 
country (territory)  found by the inspection authority  or other 
importing country (territory) . Formatted :  Justifie d,  Indent:  Left:   2 cm,  No bullets  or numbering
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Formatted :  Font:  (Default)  Times  New  Roman,  14 pt4. Any exporting country (territory) that is exempted from systematic 
inspection in accordance with the provisions of Article 7 or  that has 
been finished systematically inspected more than three years, deemed 
necessary to conduct documents review  or on-site inspection by the 
inspection authority.  
5. Food or related product s which from the exporting country (territory) 
were determined as jeopardizing food safety.  
Article 6  If the results of  on-site inspection  are non-compliant, the exporting 
country  (territory)  may be required to submit  corrective action s, to the  
inspection  authori ty for review before deadline. If required, on-site 
re-inspection  might be performed again to  verify the effectiveness of the 
corrective action s. 
The expenses  of on-site inspection shall be borne by the exporting 
country  (territory)  in the follow ing circumstances : 
1. Re-inspection  of the paragraph 1 of this Article . 
2. Appl ication for expanding designated establishment s in the case  of the 
subparagraph 2  of paragraph  2 of Article  4. 
3. Re-application for  systematic inspection  in the case of the 
subparagraph 3 of paragraph  2 of Article  4. 
Article 6  If necessary, t he inspection authority  will request the 
exporting country (territory)  to bear the expenses  of on -site inspection 
other than the circumstances of the paragraph 2 of this Article . and 
on-site inspection cost shall be borne by  the exporting country  (territory) . 
Article 7  Product s, subjected to the scope of this regulation, had existed import 
records before promu lgation of these Regulation might be  exempted from 
the systematic inspection .  
Article 8  These Regulations shall be  implemented from the date of promulgation  
unless other specified . 
  Formatted :  Justifie d,  Indent:  Left:   2 cm,  No bullets  or numbering
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Formatted :  Font:  14 ptAttachment Scope of Prod ucts Subject to Systematic Inspection  
Type  Item Remarks  
Meat 
Products  Livestock  and poultry  products listed in 
02, 050 4, 1601 and 1602 of the 
Harmoni zed System Codes (HS Codes) 
established by the World Customs 
Organization.  1. Products on the left 
column  subject to 
importation rules F01 
or F02.  
2. Products from 
amphibians, reptiles, 
primat es, aquatic mammals 
are not subject to systematic 
inspection.  
Fishery  
Products  Products listed in 0 3, 1604 and 1605  of the 
Harmoni zed System Codes (HS Codes) 
established by the World Customs 
Organization.  1. Products on the left 
column subject to 
importation rules 
F01 or F02.  
2. These products 
come into 
enforcement from  
January 1, 2018 . 
Dairy 
Products  Products listed in 0 401, 0402, 0403, 0404 , 
0405,  0406 , 19011000907, 19019021004 
and 19019022003  and 9806  of the 
Harmoni zed System Codes (HS Codes) 
established by the World Customs 
Organization.  1. Products on the left 
column subject to 
importation rules 
F01 or F02.  
2. These products 
listed in 
19011000907, 
19019021004 and 
19019022003 of the 
Harmonized System 
Codes (HS Codes) 
come into 
enforcement from  
January 1 , 20198 Formatted :  Font:  14 pt
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from  January 1 , 
2018.. 
Egg 
products  Products listed in 0 407, 0408 and 3502  of 
the Harmoni zed System Codes (HS 
Codes) established by the World Customs 
Organization.  1. Products on the left 
colum n subject to 
importation rules 
B01 and F01. 
2. These products 
come into 
enforcement from  
January 1 , 2019. 
Animal oil  
products  Products listed in 15 of the Harmoni zed 
System Codes (HS Codes) established by 
the World Customs Organization.  1. Products on the left 
colum n subject to 
importation rules 
B01 and F 01. 
2. These products 
come into 
enforcement from  
January 1 , 2019. 
Products of 
cervidae 
bovine origin  Products listed in 0507  of the Harmoni zed 
System Codes (HS Codes) established by 
the World Customs Organization Bovine 
derivatives food products , not classified as 
meat products, from BSE CWD  infected 
countries.  1. Products on the left 
column subject to 
importation rules 
F01 or F02. 
2. These products 
come into 
enforcement from  
January 1 , 2020. 
Products on the left 
column belong to 
following foods are 
exempted:  
(1) Tallow and its Formatted :  Font:  (Default)  Times  New  Roman,  14 pt
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Formatted :  Normal,  Line  spacing:   single,   No bullets  or numberingderivatives without protein ； 
(2) Calcium hydrogen 
phosphate without protein ； 
(3) Bovine hide ； 
(4) Gelatin and collagen 
from bovine hide ； 
(5) Bovine deriv ed 
products from non - 
BSE-infected countries  or 
the BSE infected -countr y 
has been completed the 
systematic inspection  with 
certificate of origin of the 
material and sanitation 
(health) certificate of the 
product.