Regulations for Systematic Inspection  of Imported Food  
Promulgated on  February 11,  2014. 
Amended o n ○○,  2014  
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, the exporting country (territory) shall apply to the 
Inspection authority for approval of import of the product des cribed in the above 
paragraph. Inspection authority shall conduct the document review.  If required, 
on-site inspection can be conducted following the document review.  Only if the 
food safety management  system of the exporting country (territory) is determined as 
equivalent based on the systematic inspection, the application of the exporting 
country (territory) will be approved.  
If necessary, Inspection authority shall request the exporting coun try (territory)  
(territory) to provide the documents within the designated period  when performing 
the pre -said document review.  
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 proceed document  review or  on-site inspection  to confirm the equivalence of the 
management system  of the exporting cou ntry (territory).  
1. Significant 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) . 4. 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 inspection  might be performed again to  verify the 
effectiveness of the corrective action s 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 
promulgation of these Regulation were exempted from the systematic inspection .  
Article 8  These Regulations are implemented from the date of publication.  
 
Attachment Scope of Prod ucts Subject to Systematic Inspection  
Type  Item Remarks  
Meat 
Products  Products listed in 02, 0504, 1601 and 1602 of the 
Harmonised 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.  
Products of 
bovine 
origin 1. Bovine deriv atives food products, not 
classified as meat products , from BSE infected 
countries . The following foods are exempted:  
i. Milk and dairy products.  
ii. Tallow and its derivative  s not 
containing protein.  
iii. Calcium hydrogen phosphate not 
containing  protein.  
iv. bovine hide ; 
v. gelatin and collagen from bovine  skin.