Regulations for Systematic Inspection of Imported Food 
(Draft of amendment on appendix of article 3)  
Promulgated on February 11, 2014. 
Amended on ○○, 2014 
Article 1 These Regulations are established in acco rdance with the provisions of Paragraph 2 of 
Article 35 of the Act Governing Food Safety and Sanitation (hereina fter 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 th e governments 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 expor ting country (territo ry) provided by the 
governmental authority of the exporting country (territory). 
4. “On-site inspection” means the inspec tion authority designates inspectors to 
conduct the systematic inspection of the food safety management system in the 
exporting country (territory). 
Article 3 The scope of products s ubject to systematic inspection is outlined in the attachment. 
Article 4 To perform systematic  inspection, the exporting country (territory) sha ll apply to the 
Inspection authority for approval of impor t of the product described in the above 
paragraph. Inspection authority shall c onduct the document revi ew.  If required, 
on-site inspection can be conducted followi ng the document review.  Only if the 
food safety management system of the exporti ng country (territory) is determined as 
equivalent based on the systematic insp ection, the applicatio n 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. 
Article 5 For any exporting country (territory) th at has been systematica lly inspected and been 
approved to import or that is exempted fr om systematic inspection in accordance with 
the provisions of Article 7, in case of a ny of the following, the inspection authority 
may proceed document review or on-site insp ection to confirm the equivalence of the 
management system of the exporting country (territory). 1. Significant changes of food safety ma nagement system or the supervisory 
measures of the exportin g country (territory). 
2. Occurrence of significant f ood sanitation and safety incidents in the exporting 
country (territory). 3. Significant violation of the food or re lated product from the exporting country 
(territory) found by the inspect ion authority or other impor ting country (territory). 
4. Food or related products which from the exporting country (territory) were 
determined as jeopardizing food safety.  
Article 6 If the results of on-s ite inspection are non-compliant, th e exporting coun try (territory) 
may be required to submit co rrective actions, to the inspection authority for review 
before deadline. If required, on-site inspect ion might be performed again to verify the 
effectiveness of the corrective actions and on-site inspection cost shall be borne by 
the exporting country (territory). 
Article 7 Products, subjected to th e scope of this regulation, ha d existed import records before 
promulgation of these Regulation were exempted from the systematic inspection.  
Article 8 These Regulations are impleme nted from the date of publication. 
 Attachment Scope of Products 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, primates, aquatic mammals are not subject to systematic inspection. 
Products of 
bovine 
origin  1. Bovine derivatives food products, not 
classified as meat produc ts, from BSE infected 
countries. The following foods are exempted:  
i. Milk and dairy products.  
ii. Tallow and its derivatives without 
protein.  
iii. Calcium hydrogen phosphate without 
protein.  
iv. bovine hide;  
v. gelatin and collagen from bovine hide.