Korea Food and Drug Administration  
Public Announcement No. 2009 -170 
 
 
 
 
 
Proposed Enactment of Regulation to Sanitary Inspection Standard 
of Manufacturer or Processor of the  
OEM Imported Food Products etc .  
 
 
 
 
 
 
 
 
 
 
June 19, 2009  
 
 
 
 
 
 
 
 
 
 
 
 
Korea Food and Drug Administration   
Korea Food and Drug Administration  
Public Announcement No. 2009 -170 
 
 
We hereby announce, in accordance with provisions in the Article 46 of the ‘Administrative 
Procedures Act’, the intent, reason and the key elements of the prop osal of the ‘ Sanitary 
Inspection Standard of Manufacturer or Processor of the OEM Imported Food Products etc. ’; to 
notify the citizens in advance and to collect the public’s opinions.  
 
June 19, 2009  
                                                         
Commissioner,                                                                                                                         
Korea Food and Drug Administration  
 
 
 
 
Proposed Enactment of Regulation to Sanitary Inspection Standard of 
Manufacturer or Processor of the OEM Imported Food Products etc . 
 
 
 
1. Reason for the enactment  
 
The ‘ Food Sanitation Act’ was revised, on February 6th 2009, to strengthen safety control of 
imported food products. A new policy to require importers and sellers of OEM food products to 
carry out sanitary inspection on manufacturer s or processor s in the exporting country is instituted  
to make it compulsory for importers to carry out the sanitary and quality control. This enactment 
has been proposed to provide detailed standard and method for the sanitary inspection.  
 
2. Key elements  
 
A. Provided detailed checklist to be used by the sanitary inspection authority when it is carrying 
out required sanitary inspection on the OEM food products m anufacturer or processor in the 
exporting country; therefore to e nsure objectivity of the inspection  (Article 2 Paragraph 1).  
 
(1) Made it compulsory for OEM food products importers and sellers to carry out the sanitary 
and quality control in order to provide safe imported food products to citizens. For this, a 
detached checklist is provided to be used when conducting sanitary inspection on the 
manufacturer  or processor in the exporting country, therefore fairness of the inspection will 
be ensured.      (2) Established  a detailed checklist which covers control of raw materials, facilities, food 
processing and end products, information for consumers, employee trai ning, etc.  
(3) By conducting the sanitary inspection  on manufacturing facilities in the exporting country, 
ensured objectivity of the inspection  and the safety of imported food products.  
 
3. Presenting written opinions  
 
Any individual or group who have opinion (s) about the proposed enactment of regulation to  
‘Sanitary Inspection Standard of Manufacturer or Processor of the OEM Imported Food 
Products etc .’ are welcome to present opinions in writing to the Commissioner of the Korea 
Food and Drug Administration ( Postal Code: 122 -704, Address: 194 Tongilro, Eunpyeong -gu, 
Seoul, CC: Foreign Inspection Division, Phone: 02 -380-1565,1567 Fax: 02 -385-2416)  with the 
following information by July 11th, 2009 : 
 
  A. Opinions about this announcement (Whether you are for or a gainst it and the reasoning)  
B. Your name (For groups, name of the group and name of the representative), address and 
phone number   
  C. Other references  
 Korea Food and Drug Administration  
Public Notice No. 2009 - 
 
 
Pursuant to the Article 44 Paragraph 5 of the ‘ Food Sanitation Act’, w e hereby notify to the 
public the enactment of regulation to ‘Sanitary Inspection Standard of Manufacturer or Processor 
of the OEM Imported Food Products etc .’ as follows.  
 
2009  
Commissioner,                               
Korea Food and Drug Administration   
 
Proposed Enactment of Regulation to Sanitary Inspection Standard of 
Manufacturer or Processor of the OEM Im ported Food Products  
 
 
Article 1 (Purpose)  The purpose of this enactment is, in accordance with the provision of 
Article 44 Paragraph 5 of the ‘Food Sanitation Act’ , to establish sanitary inspection standard and 
the method to be used by the sanitary inspec tion authority when it is carrying out required sanitary 
inspection on the OEM food products m anufacturer or processor.  
 
Article 2 (Sanitary Inspection Standard etc .) (1) The standard of sanitary inspection that shall 
be conducted against the OEM food prod ucts manufacturer or processor pursuant to the Article 
44 Paragraph 5 Subparagraph 1 of the ‘Food Sanitation Act’ by the sanitary inspection authority 
in accordance with the Article 33 Paragraph 1 of the Enforcement Ordinance of the same Act, is 
as specifi ed in the Appendix.   
 
(2) Any business proprietor who import or sell OEM food products shall conduct sanitary 
inspection more than once per year against the OEM food products manufacturer or processor 
complying with the preceding Paragraph (1). 
 
Article 3 (Review Period)  Pursuant to ‘Regulations for the issuance and management of 
directives, established rules etc .’ (Presidential Directive No.248), the review period for taking 
necessary measures such as to abolish or revise this notice after the Act and subo rdinate statute 
or changes in actual circumstances etc . had been considered shall be until August 07th, 2012.  
 
ADDENDUM  
 
 
This notice shall take effect from August 07th, 2009.   
[Appendix]  
 
Sanitary Control Standard Checklist of Manufacturer in Importing C ountry 
(Related to the Article 2)  
 
 Importer:   Representative:                              (seal)  
 Address:  
 Contact Number:  
 
 Manufacturer:  
 Representative:                              (seal)   Superintendent:                             (sea l) 
 Address:  
 Contact Number:  
 
1.Inspect/Store Raw materials  
Serial #  Items to Check  Pass/Fail  Remarks  
Raw materials, Containers/Packages Inspection  
1 Is the inspection for raw materials and containers/packages 
conducted? Is the inspection report kept?    
2 Are there raw materials, containers/packages that would be harmful 
to health?  
 - rotten or spoiled raw materials  
 - raw materials, containers/packages (at the risk of) containing or 
stained with poisonous or hazardous substances  
 - raw materials  contaminated (or in danger of contamination)  with 
pathogenic microorganism  
 - unsanitary raw materials, or raw materials that other substances are 
mixed with/added to    
Storing Raw materials, Containers/Packages  
3 Is there any periodical sanitary man agement on storages for raw 
materials, containers/packages (such as anti -pest and anti -rat 
devices)?    
4 When unsuit able  raw materials, containers/packages are stored with 
other raw materials, are there any marks to distinguish them?    
5 Is the warehousi ng status of raw materials, containers/packages 
managed and recorded?    
  
2.Facilities  
Serial #  Items to Check  Pass  
/Fail  Remarks  
Location of the Building  
6 Is the building located in a polluted environment or in an industrial area 
that will cause ser ious contamination to food products?    
Ventilation  
7 Is the ventilator installed and running?    
Workplace Layout  
8 Are the work areas and the non -work areas separated?    
9 Does the food processing area have restricted access and have an access 
contro l system?    
Drainage  
10 Is there a proper drainage system to prevent pollution around the 
building?    
Workplace  
11 Are walls, partitions and floor covered with hygienic  water -proof 
material?    
12 Do the walls and partitions have smooth surfaces up to the working 
height?    
13 Does the floor have a drainage system and is it washable?    
14 Is the workplace designed to minimize the forming of dust/ condensed 
water, the falling of particles  from the ceiling, and the fixtures on it?    
15 Are the gates, wi ndows, ventilati on openings, and drains installed to be 
able to block pollutants?    
Anti -pest, anti -rat Systems  
16 Are the holes and drains equipped with pest control devices?    
17 Is the inside and outside of the factory area kept clean enough to prev ent 
pests/rats?    
18 Are pest attack s around the factory and the surrounding area checked 
periodically?    
19 Are there prompt measures ready to carry out for pest attacks without 
causing bad effects on safety/conformity of the food products?    
Food hand ling Facilities/equipments  
20 Is the surface of the workbench, which has direct contact with food, 
durable as well as easy to clean, maintain and sterilize?    
21 Is the surface of the  workbench made of smooth and non absorbent 
material, and does not affe ct the food?    
22 Is the surface of the workbench not affected by detergent and sterilizer 
under general working conditions?    Temperature Control  
23 Is the temperature control system equipped based on the nature of each 
progress of food processing?    
24 Is there any temperature control and measures prepared for 
temperature changes when cooking, cooling, processing and storing the 
food product?    
25 Is the temperature recording device checked in regular intervals and its 
accuracy has been measured?    
Facilities for Personal Hygiene  
26 Is the restroom designed hygienically (with flush toilets)?    
27 Does the restroom have a separate ventilation system?    
28 Are the wall s, floor, ceiling and door water -proofed and resistant to 
corrosion?    
Foreign Substances (Physical/Chemical Contamination) Removal  
29 Is there any device or precaution for preventing food contamination 
from foreign substances (glass pieces, metal pieces, dust, harmful smoke 
and chemical substances)?    
Raw material storage, Process ing room, Charging/Packaging room Management  
30 Is there a regulation of sanitation established, including regulation  of 
access, clothing, cleansing/sterilization?    
 
3.Production Control  
Serial #  Items to Check  Pass  
/Fail  Remarks  
Personal Hygiene  
31 Do employees working to manufacture/process/cook food products wear 
disinfected cap, overgarment and shoes?    
32 Are employees required  to remove accessories such as rings, which may 
be harmful to food products, inside the food dealing area?    
33 Is th ere a device to wash/dry/sterilize for personal hygiene at the 
entrance of workplace?    
34 Do employees with an infectious disease report to the manager about 
their illness and symptoms?    
35 Are employees with infectious disease prevented from working o n 
processes that have direct contact with food?    
36 Are visitors advised to follow the same sanitary rules as the employees?    
Machines/tools and Food containers Management  
37 Are there sufficient facilities or equipments to clean or sterilize 
machiner ies, tools and containers?    
38 Has the cleansing device been cleaned properly?    
39 Is a guideline or standards for hand washing displayed in the eyeshot of 
every employee?    
40 Is a detergent/disinfectant, device or container to be used for cleansing    and sterilization kept and managed at the designated place?  
Preventing Contamination by Microorganism  
41 Is there method to prevent cross contamination between uncooked food, 
non-processed food, and instant food?    
Waste Management  
42 Are containers  for garbage, by -products, inedible materials, or dangerous 
substances distinguishable from each other?    
43 Are containers for garbage, by -products, inedible materials, or dangerous 
substances made of water -proof material, airtight, and safe from leakage  
of leachate and smell?    
44 Are containers for dangerous substances distinguishable, and can they be 
locked when necessary?    
Water Management  
45 Is water that is fit for drinking used for handling and processing food?    
46 Are ices and steam produced , dealt with, and stored using drinking 
water?    
 
4. Quality Control/Store End Product  
Serial #  Items to Check  Pass  
/Fail  Remarks  
Quality Control of End Products  
47 Is the inspection on end products conducted?    
48 Are the inspection results recorded and kept appropriately?    
Storing/Transporting End Products  
49 Are the end products stored and transported at the right temperature?    
50 Is there a temperature, humidity and other sanitary management going 
on for end products storage?    
51 Is there a condition (tool or type of containers) on transportation based 
on the nature of the food product?    
52 Do the carriage tool and bulk container meet following criteria?  
 - the food and packing containers are prevented from contamination  
 - easy to clean a nd can be sterilized when necessary  
 - can be effectively separated from other food or inedible products 
during transportation  
 - protected from pollutants such as dust and smoke  
 - deterioration protected and the storing condition is maintained  
 - tempera ture, humidity and other conditions can be checked    
53 If the same tool and container were used to transport other food or 
inedible products prior to loading the food product, have they been  
washed (and sterilized when necessary)?    
Hazard Information  
54 Has the inspection for the harmful substances been conducted when 
information about harmful substances was detected in the exports?     
5. Information for Consumers  
Serial #  Items to Check  Pass  
/Fail  Remarks  
Provide Information for Consumers  
55 Was t he name of the producer, the manufacture r’s serial number,  
production date marked on each container?    
 
6.Training  
Serial #  Items to Check  Pass  
/Fail  Remarks  
Training  
56 Has the food handler acquired necessary knowledge and skills for 
hygienically deal ing with food?    
57 Does the manager/supervisor of food process have appropriate 
knowledge for the task?    
58 When dealing with strong chemicals for cleansing or other chemical 
substances that have potential hazard s, was the handler trained for safe 
hand ling?    
59 Are the following included in the training program?  
 - the nature of the food (possibility of persistent proliferation of 
pathogens or  decomposed microorganisms)  
 - food dealing and packaging methods including potential contamination  
 - degree and character of food processing, or whether it requires  
additional cooking prior to consumption  
 - storing condition  
 - time required from processing to consumption    
60 Is the training supervised and checked for its efficiency 
(recommendation)?    
 
 Date of Inspection  
 Inspector  
 
    Division                            Function(Title)                              Name                             (seal)  
    Division                            Function(Title)                              Name                             (seal)  
    Division                            Function(Title)                              Name                             (seal)