Korea Food and Drug Administration  
Public Announcement No. 2009 -169 
 
 
 
 
 
Proposed Enactment of Regulation to Sanitary Inspection Standard 
of Manufacturer in the Exporting Country for the  
Registration of Good Importer  
 
 
 
 
 
 
 
 
 
June 19, 2009  
 
 
 
 
 
 
 
 
 
 
 
 
Korea Food and Drug Administration   
Korea Food and Drug Administration  
Public Announcement No. 2009 -169 
 
 
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 proposal of the ‘ Sanitary 
Inspection Standard of Manufacturer in the Exporting Country for Registration of Good 
Importer ’; 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 in the Exporting Country for the  
Registration of Good Importer  
 
 
 
1. Reason for the enactment  
 
The ‘Food Sanitation Act’ was revised, on February 6th 2009, to strengthen the safety control of 
imported food products by establishing a sanitary inspection system against the m anufacturer in 
the exporting country. T he responsibility for safety control is placed on the importer and a Good 
Importer registration system is established. This enactment has proposed to provide a necessary 
standard to sanitary inspection as a part of the follow -up measures for the revised Act.  
 
2. Key elements  
 
A. Provided a detai led checklist to be used by the importer or the sanitary inspection authority 
when they are carrying out the sanitary inspection on the m anufacturer in the exporting country 
(Article 2).  
 
(1) As the applicant for Good Importer registration or an authority is t o conduct the sanitary 
inspection on the m anufacturer in the exporting country to strengthen preliminary safety control of imported food products, a detailed checklist which covers control of raw materials, 
facilities, food processing and end products, emp loyee training, etc . has been established . 
(2) By conducting the sanitary inspection  on manufacturing facilities in the exporting country, 
objectivity of the inspection  and the safety of imported food products will be ensured.  
 
 
3. Presenting written opinions  
 
Any individual or group who have opinion(s) about the proposed enactment of regulation to  
‘Sanitary Inspection Standard of Manufacturer in the Exporting Country for Registration 
of Good Importer ’ are welcome to present opinions in writing to the Commissi oner 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 abo ut this announcement (Whether you are for or against 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 - 
 
 
We hereby notify to the public the enactment of regulation to ‘Sanitary  Inspection Standard of 
Manufacturer in the Exporting Country for Registration of Good Importer ’ as follows.  
 
 
 
2009  
Commissioner,                                              
Korea Food and Drug Administration   
 
Proposed Enactment of Regulation to Sanitary Inspection Standard of 
Manufacturer in the Exporting Country for the  
Registra tion of Good Importer  
 
 
Article 1 (Purpose)  The purpose of this enactment is, in accordance with the provision of 
Article 20 Paragraph 1 of the ‘Food Sanitation Act’ , to establish a sanitary control checklist 
against the Good Importer’s manufacturer in the  exporting country.  
 
Article 2 (Sanitary Inspection Standard)  The sanitary control standard for the manufacturer in 
the exporting country, which any person who submitted the entry report of food products in 
accordance with the Article 19 of the ‘Food Sanit ation Act’ shall conduct in order to apply for the 
registration of Good Importer according to the Article 20 Paragraph 2, is as specified in the 
Appendix . 
 
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 subordinate 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 for Manufacturer in Importing Country 
(Related to the Article 2)  
 
 Importer:   Representative:                              (seal)  
 Address:  
 Contact Number:  
 
 Manufacturer:  
 Representative:                              (seal)   Superintendent:                             (seal)  
 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 cont amination)  with 
pathogenic microorganism  
 - unsanitary raw materials, or raw materials that other substances are 
mixed with/added to    
Storing Raw materials, Containers/Packages  
3 Are raw materials and containers/packages stored separately?    
4 Is th ere any periodical sanitary management on storage for raw 
materials, containers/packages (such as anti -pest and anti -rat 
devices)?    
5 Are unsuit able  raw materials, containers/packages picked out and 
stored separately?    
6 When unsuit able  raw materials, containers/packages are stored with 
other raw materials, are there any marks to distinguish them?    
7 Is the warehousing status of raw materials, containers/packages   managed and recorded?  
 
2.Facilities  
Serial #  Items to Check  Pass  
/Fail  Remarks  
Locat ion of the Building  
8 Is the building located in a polluted environment or in an industrial area 
that will cause serious contamination to food products?    
9 If the building is located in a flood -prone area, is there any precaution 
against the flood?    
10 If the building is located in an area that has frequent appearance of 
noxious insects, is there any precaution against it?    
11 Is the building located in an area with an effective garbage collection 
system?    
Ventilation  
12 Is the ventilator install ed and running?    
13 Is the ventilator designed and installed to properly regulate the air flow?    
Workplace Layout  
14 Are the work areas and the non -work areas separated?    
15 Does the food processing area have restricted access and have an access 
control system?    
16 Are rooms divided and separated by the manufacturing process (when 
necessary)?    
Drainage  
17 Is there a proper drainage system to prevent pollution around the 
building?    
Workplace  
18 Are walls, partitions and floor covered with hygi enic water -proof 
material?    
19 Do the walls and partitions have smooth surfaces up to the working 
height?    
20 Does the floor have a drainage system and is it washable?    
21 Is the workplace designed to minimize the forming of dust/ condensed 
water, th e falling of particles  from the ceiling, and the fixtures on it?    
22 Are the windows installed such that is it easy to clean and to minimize 
the accumulation of dust?    
23 Do the doors have smooth and non -hygroscopic surfaces and are easy to 
clean and s terilize (when necessary)?    
24 Are the gates, windows, ventilati on openings, and drains installed to be 
able to block pollutants?    
Anti -pest, anti -rat Systems  
25 Are the holes and drains equipped with pest control devices?    
26 If food product is vu lnerable to attacks from pests, is it stored in a pest -   proof container or stacked at the proper distance from the wall and the 
floor?  
27 Is the inside and outside of the factory area kept clean enough to prevent 
pests/rats?    
28 Is the waste stored in an anti -pest container with a lid?    
29 Are pest attack s around the factory and the surrounding area checked 
periodically?    
30 Are there prompt measure s ready to carry out for pest attack s without 
causing bad effects on safety/conformity of the food pro ducts?    
Food handling Facilities/equipments  
31 Is the surface of the workbench, which has direct contact with food, 
durable as well as easy to clean, maintain and sterilize?    
32 Is the surface of the  workbench made of smooth and non absorbent 
material , and does not affect the food?    
33 Is the surface of the workbench unaffected by detergent and sterilizer 
under general working conditions?    
Temperature Control  
34 Is the temperature control system equipped based on the nature of each 
stage  of food processing?    
35 Is there any temperature control , and are there measures prepared for 
temperature changes when cooking, cooling, processing and storing the 
food product?    
36 Is the temperature recording device checked at regular intervals and has 
its accuracy been measured?    
Facilities for Personal Hygiene  
37 Is the restroom designed hygienically (with flush toilets)?    
38 Does the restroom have a separate ventilation system?    
39 Are the wall s, floor, ceiling and door water -proofed and resistant to 
corrosion?    
40 Are there proper means to wash and dry hands, including  a washing 
stand and hot/cold water (or temperature controllable water) supply?    
41 Are personal goods replaced properly?    
Foreign Substances (Physical/Chemical Contamination) Removal  
42 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, Processing room, Charging/Packaging room Management  
43 Is there a r egulation  of sanitation established, including the r egulation  of 
access, clothing, cleansing/sterilization?    
 
 
 
  
 
3.Production Control  
Serial #  Items to Check  Pass  
/Fail  Remarks  
Personal Hygiene  
44 Do employees working to manufactur e/process/cook food products wear 
disinfected cap, overgarment and shoes?    
45 Are employees required to remove accessories such as rings, which may 
be harmful to food products, inside the food handling area?    
46 Are employees informed about  prohibited behaviours that may cause 
food contamination?  
 - Smoking, spitting, chewing (gums), eating and sneezing /coughing over 
food    
47 Is there a device to wash/dry/sterilize for personal hygiene at the 
entrance of workplace?    
48 Do employees with an infecti ous disease report to the manager about 
their illness and symptoms?    
49 Are employees with infectious disease prevented from work ing on 
processes that have direct contact with food?    
50 Are visitors advised to follow the same sanitary rules as the empl oyees?    
Machines/tools and Food containers Management  
51 Are there sufficient facilities or equipments to clean or sterilize machines, 
tools and containers?    
52 Has the cleansing device been cleaned properly?    
53 Is a guideline or standards for hand  washing displayed in the eyeshot of 
every employee?    
54 Is a detergent/disinfectant, device or container to be used for cleansing 
and sterilization kept and managed at the designated place?    
55 Is the effect of cleansing and sterilization checked? Ate the cleansing and 
sterilization carried out according to the defined management plan?    
Preventing Contamination by Microorganism  
56 Is there a method to prevent cross -contamination between uncooked 
food, non -processed food, and instant food?    
Waste Management  
57 Are containers for garbage, by -products, inedible materials, or dangerous 
substances distinguishable from each other?    
58 Are containers for garbage, by -products, inedible materials, or dangerous 
substances made of water -proof material, ai rtight, and safe from leakage 
of leachate and smell?    
59 Are containers for dangerous substances distinguishable, and can they be 
locked when necessary?    
60 Is garbage managed accordingly?    Water Management  
61 Is water that is fit for drinking used for handling and processing food?    
62 Is ice and steam produced, dealt with, and stored using drinking water?    
63 Are pipelines for drinkable water and undrinkable water clearly marked? 
Are they interoperably used or joined together?    
 
4. Quality Co ntrol/Store End Product  
Serial #  Items to Check  Pass  
/Fail  Remarks  
Quality Control of End Products  
64 Is the inspection on end products conducted?    
65 Are the inspection results recorded and kept appropriately?    
Storing/Transporting End Products  
66 Are the end products stored and transported at the right temperature?    
67 Is there temperature, humidity and other sanitary management going on 
for end products storage?    
68 Is there a condition (tool or type of containers) on transportation based 
on the nature of the food product?    
69 Do the carriage tool s and bulk container s meet following criteria?  
 - the food and packing containers are prevented from contamination  
 - easy to clean and can be sterilized when necessary  
 - can be effectively separa ted from other food or inedible products 
during transportation  
 - protected from pollutants such as dust and smoke  
 - deterioration protected and the stor age condition is maintained  
 - temperature, humidity and other conditions can be checked    
70 If the same tool s and container s were used to transport other food or 
inedible products prior to loading the food product, have they been 
washed (and sterilized when necessary)?    
71 In case of bulk transporting, are the containers and carriage tools marked 
as to be used only for food?    
Hazard Information  
72 Is there a hazard information collecti on system in operation?    
73 Is there an established standard for handling food that contains or is in 
danger of containing harmful substances?    
74 Has the inspecti on 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  
75 Was the name o f the producer, the manufacture r’s serial number,  
production date marked on each container?    
76 Has i nformation such as clear instructions on safe and accurate method s 
to handle, display, store, prepare and use the product been provided?    
 
6.Training  
Serial # Items to Check  Pass  
/Fail  Remarks  
Training  
77 Has the food handler acquired necessary knowledge and skills for 
hygienically dealing with food?    
78 Does the manager/supervisor of food process ing have appropriate 
knowledge for the task?    
79 When d ealing with strong chemicals for cleansing or other chemical 
substances that have potential hazard s, was the handler trained for safe 
handling?    
80 Are the following included in the training program?  
 - the nature of the food (possibility of persistent p roliferation 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    
81 Is the training supervised and checked for its efficiency 
(recommendation)?    
82 Are training and instruction programs evaluated on a regular basis 
(recommendation)?    
83 Is the training program exa mined and complemented on a regular basis?    
 
 Date of Inspection  
 Inspector  
 
    Division                            Function(Title)                              Name                             (seal)  
    Division                            Function (Title)                              Name                             (seal)  
    Division                            Function(Title)                              Name                             (seal)