WORLD TRADE
ORGANIZATIONG/SPS/GEN/318
7 May 2002
(02-2580)
Committee on Sanitary and Phytosanitary Measures Original:  English
STANDARDS & PROCEDURES FOR AUTHORIZATION OF DOMESTIC/FOREIGN
OFFICIAL LABORATORIES AND FOR RECOGNITION O
INSPECTION CERTIFICATES OR CERTIFICATES OF
LABORATORY TEST RESULTS
1999.5
KOREA FOOD AND DRUG ADMINISTRATION
Note:  This publication has been prepared to help understanding of inspection procedures for food
imported into KOREA .  Since this is not an official translation, in case of divergence, the standards
and procedures in Korean language shall prevail.  Interested parties should refer to the original
Korean texts when definitive information on le gal requirements for application is needed.
For further information, contact  Food Division, Korea Food and Drug Administration,
5-Nokbun-Dong, Eunpyong-Ku, Seoul, Korea.
TEL : 380-1733-4, FAX : 388-6392
Notification of the KFDA  No. 1999-26 May 7. 1999
Commissioner of Korea Food  and Drug AdministrationG/SPS/GEN/318
Page 2
STANDARDS & PROCEDURES FOR AUTHORIZATION OF DOMESTIC/FOREIGN
OFFICIAL LABORATORIES AND FOR RECOGNITION OF
INSPECTION CERTIFICATES OR CERTIFICATES
OF LABORATORY TEST RESULTS
Article 1.  Purpose .  The purpose of this notification is to enhance the efficiency of conducting
inspection of imported foods by stipulating necessary conditions, standards, and procedures required
for authorization of domestic/foreign official laboratories and for recognition of inspection certificatesor certificates of laboratory test results issued by  authorized official laboratories in accordance with
Article 16 of the Food Sanitation Act and Article 11-1-5 of the Ministerial Ordinance of the food
Sanitation Act.
Article 2.  Definitions.   Definitions of terms used in this notification shall be interpreted in
accordance with terms defined in the Food Sanitation Act (hereinafter referred to as "the Act"), the
Presidential Decree of the Food Sanitation Act (hereinafter referred to as "the Presidential Decree"),
and the Ministerial Ordinance of the Food Sanitation Act (hereinafter referred to as "the Ministerial
Ordinance").
Article 3.  Requirements for Application for Authorization, etc.   ① Laboratories can apply for
authorization as an official laboratory according to procedures described in items 1 and 2 below.
1. A domestic official laboratory shall be designated as a food sanitation inspection
laboratory by the Commissioner of the KFDA  in accordance with Article 18 of the Act and
Article 16 of the Ministerial Ordinance.
2. A foreign official laboratory shall be a laboratory operated by the government of the
exporting country or a private laboratory approved or designated by the central or local
government of the exporting country (hereinafter referred to as the "government of the
exporting country").
② Domestic food sanitation inspection laboratory stipulated in provision 1.1 shall be recognized as a
domestic official laboratory in accordance with this notification.  The standards and procedures for
authorization of domestic food sanitation inspection laboratories shall be in compliance with those
defined in Article 18 of the Act and Article 16 of the Ministerial Ordinance.
Article 4.  Application and Authorization, etc.   ① In accordance with the provision of Article 3-1-2
of this notification, a party who wishes to be authorized as a foreign official laboratory shall submit anapplication form (Appendix 1) attached to accompanying documents.  The application form can be
submitted via the government of an exporting country or can be submitted directly to the
Commissioner of the KFDA.
② To check the credibility of an application and documents submitted under provisions of Article 4-
1, the Commissioner of the KFDA  may conduct an on-site survey or ask an Embassy of Korea to do
so.  A foreign official laboratory which is operated by the government of the exporting country can be
exempted from on-site survey.
③ When a foreign official laboratory is authorized, the Commissioner of the  KFDA  should refer
details of the authorization to the relevant foreign official laboratory.G/SPS/GEN/318
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Article 5.  Standards and Criteria for Recognition of Inspection Certificates and Certificates of
Laboratory Test Results, etc .  ① Principle test methods shall be the methods defined in the Korea
Food Code and Korea Food Additives Code or in the methods and procedures listed in  CODEX,
AOAC, and PAM .  If testing is conducted according to methods other than those listed above, such
testing methods shall be documented in detail.
② Authorized official laboratories can issue certif icates of laboratory test results using their own
form;  an original copy should be submitted.  Test requirements, test methods, test results, etc., shall
be included in a certificate of laboratory test results.
③ An inspection certificates by an authorized domestic/foreign official laboratory shall be issued in
accordance with the form provided in Appendix  ; the original copy should be submitted.
④ If an importer submits an inspection certificate or a certificate of laboratory test results issued by
an authorized domestic/foreign official laboratory provided in Articles 5-2 or 5-3, the Commissionerof each regional KFDA  or the director general of each National Quarantine Station (hereinafter
referred to as "regional KFDA  or quarantine station") can substitute it for a laboratory test or can
adjust the testing requirements on the basis of the following principles.
1. If an inspection certificate or certificate of laboratory test results issued by an
authorized inspection laboratory is submitted by the importer and meets the requirements of
Article 5-1, it can be substituted for the laboratory test by the regional KFDA  or quarantine
station.
2. If the test is not conducted according to the testing method described in Article 5-1 or if
the testing method submitted is not verified, the test requirements can be adjusted by the
regional KFDA  or quarantine station.
⑤ In the case where an inspection certificate and a certificate of laboratory test results falls under one
of the following categories, the regional KFDA or quarantine station is permitted to refuse
recognition of such inspection certificates and certificates of laboratory test results.
1. As the result of an on-the-spot inspection, in accordance with Appendix Table 6 of
Article 11 of the Ministerial Ordinance of  the shipment is considered to be a potential cause
of food safety problems.
2. When an original copy of inspection certificate or certificates of  laboratory test results
is not submitted.
Article 6.  Approval of Changes in Details Authorized.  ① When any of the following changes are
made by a foreign authorized official laboratory, the Commissioner of the KFDA  shall immediately
be requested to approve such changes.
1. In the case of a foreign private laboratory, when items recognized by the government of
the exporting country have been changed.
2. When the kinds of foods subject to testing, as authorized by the Commissioner of the
KFDA,  have been changed.
② The Commissioner for the KFDA  can check for changes as provided for in Article 6-1 by
documentation or by an on-site survey.G/SPS/GEN/318
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Article 7.  Revocation of Authorization, etc.  The Commissioner of the KFDA can 1) revoke
authorization of an official foreign laboratory, 2) suspend performance up to 6 months, or 3) require
correction of existing documents if any of the following occur.
1. A false inspection certificate or certificate of laboratory test results has been issued.
2. The changes described in Article 6-1 have not been approved.
3. Other duties imposed by the Commissioner of the KFDA have not been implemented.
Supplementary Provision
(Notification of the Ministry of Health and Welfare No. 1996-44, April 18, 1996)
Article 1.  Date of Enforcement.   This notification shall be in force from April 25, 1996.
Article 2.  Exclusion of Application.   This notification shall not apply to an authorized inspection
organization of an exporting country carrying out quarantine and sanitation inspection of livestock
products and shall not apply to a quarantine certificate issued by such organization.
Supplementary Provision
(Notification of the Korea Food and Drug Administration No. 1998-118, December 7, 1998)
Article 1.  Date of Enforcement.   This notification shall be in force from the date of notification.
Article 2.  Measurement from Time of Previous Application .  An application for authorization that
has been in progress since the time when former notification became effective will be handled by the
former notification.
Supplementary Provision
(Notification of the Korea Food and Drug Administration No. 1999-26, May 7, 1999)
Article 1.  Date of Enforcement.   This notification shall be in force from the date of notification.
Article 2.  Measurement from Time of Previous Application.   An application for authorization that
has been in progress since the time when former notification became effective will be handled by the
former notification.G/SPS/GEN/318
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[Appendix 1]
PeriodThe Application for Authorization of Foreign Official Laboratory60 days
Name
Applicant
Address
Name of Organization
Tel
Location
Fax
Food to be Tested and
Test Items
I HEREBY FORMALLY APPLY FOR AUTHOR IZATION AS AN OFFICIAL FOREIGN
LABORATORY IN ACCORDANCE WITH ARTICLE 4-1 OF STANDARDS ANDPROCEDURES FOR AUTHORIZATION OF FO REIGN OFFICIAL LABORATORIES  AND
FOR THE RECOGNITION OF INSPECTION CERTIFICATES OR TESTING RESULT
CERTIFICATES.
                                                   YEAR    MONTH     DATE
                                          APPLICANT       SIGNATURE(SEAL)
 TO : THE COMMISSIONER, KOREA FOOD AND DRUG ADMINISTRATION
Fee
Free
 ○ DOCUMENTS TO ACCOMPANY THE APPLICATION
  1. GENERAL STATUS(FUNCTIONS AND HISTORY)
  2. ORGANIZATION AND DIVISIONS (INCLUDING AN ORGANIZATION CHART)  3. THE CONTENT OF MAIN BUSINESS
  4. LABORATORY TEST PERFORMANCES(SEPARATE, RECENT
    THREE-YEAR RECORD FOR FOOD, FOOD ADDITIVE, APPARATUS,
    CONTAINERS ·PACKAGING, AGRICULTURAL ·DAIRY·SEA FOOD)
  5. DESCRIPTION MAJOR ANALYTIC AND TEST EQUIPMENT STATUS  6. DESCRIPTION OF LABORATORY FACILITY STATUS
  7. LABORATORY PERSONNEL STATUS(INCLUDING WORK EXPERIENCE OF
INDIVIDUAL STAFF MEMBERS)
  8. DOCUMENTS APPROVED BY THE GOVERNMENT OF EXPORTING COUNTY
REGARDING INSPECTION OF LABORATORIES(ONLY REQUIRED IF THE
    INSPECTION LABORATORY IF NOT OPERATED BY THE CENTRAL
GOVERNMENT
 OF LOCAL GOVERNMENT)G/SPS/GEN/318
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[Appendix 2]
INSPECTION CERTIFICATE
 NO. OF ISSUANCE   DATE OF SUBMISSION
 ISSUING COUNTRY   DATE OF INSPECTION
NAME NAME OF
COMPANY
ADDRESS(OR
LOCATION)APPLICANT
 TEL NO AND
 FAX NO.
ADDRESS
(OR LOCATION)
 TEL NO.
AND FAX NO. IMPORTER
 NAME OF
FOOD IMPORT QUANTITY
 (TOTAL QUANTITY)                KgPACKING
UNIT
SHIPPING AREA BY AIR
 OR SEATRANSPORTATION METHOD
 MANUFACTURING CODE DATE OF MANUFACTURING
NAME OF PRODUCTS  SHELF LIFE
COLLECTING FOOD
         AREADATE OF COLLECTING FOOD
TEST LIST  TEST METHOD TEST STANDARD TEST RESULT REMARKS
  THIS IS TO CERTIFY THAT THE ABOVE STATEMENTS ARE TRUE.
                                                    YEAR     MONTH    DATE
  ADDRESS OF OFFICIAL LABORATORY :
  NAME OF OFFICIAL LABORATORY  :
                             SEAL
  NAME OF REPRESENTATIVE OF
  OFFICIAL  LABORATORIES  :                                    SIGNATUREG/SPS/GEN/318
Page 7
List of Foreign Official Laboratories
Feb. 2002
Country No. Name  Food items Date
USA 1 Export Service Center,
 Department of Agriculture, Oregon Foods,
 Agricultural Product, Etc.'96.12.3
THAILAND 2  Bangkok Fish Inspection Center
THAILAND 3  Songkhla Fish Inspection Center Fish & Fishery
Product'98.6.5
4 Bureau of Standard lnspection (BSMI),
 6th Department
5  BSMI, Keelung Branch
6  BSMI, Tainan BranchTAIWAN
7  BSMI, Kaohsiung Branch Fish & Fishery
Product'99.1.21
8 Australian Government Analytical
 Laboratories(AGAL), Victoria
9 Australian Government Analytical
 Laboratories (AGAL), New South Wales
10  AWT Tasmaina
11  Microserve Laboratory Pty Ltd
12 Institute of Medical and Veterinary Science,
 Food and Environmental Laborator y
13  Centre for Food Technology
14  Queensland Health Scientific Services(QHSS)
15  Dunn Son and Stone
16  EML Consulting Services PtyAUSTRALIA
17 East Laboratory Pty Ltd, Port Kembla,
 New South Wales Fish & Fishery
Product'99.1.21
FINLAND 18 National Veterinary and Food Research
 Institute Foods, Fish &
Fishery Product
USA 19  OMIC USA Inc. Foods,
Agricultural Product
GERMANY 20  German Control lnternationale Warenprufung Foods,
Agricultural Product'99.3.3G/SPS/GEN/318
Page 8
__________Country No. Name  Food items Date
21 Fish Inspection Center of Surat Thani
22  Fish Inspection Center of Samut sakorn Fish & Fishery
Product2000.
8.25
23 Division of Food - for - Export
 Department of Medical Sciences Ministry of Public Health
24  Regional Medical Sciences Center, Trang
25  Regional Medical Scie nces Center, Songkhla
26  Regional Medical Sciences Center, Surat Thani
27 Regional Medical Sciences Center,
 Samut SongkhramTHAILAND
28  Regional Medical Sciences Center, Chiang Mai Foods 2000.
8.25
AUSTRALIA 29  Bernard Heath & Associates Agricultural
 Product, Foods2000.
8.25
30 NAFIQACEN(National Fisheries Inspection
 and Quality Assurance Center) Branch Ⅰ
31 NAFIQACEN - Branch Ⅱ
32 NAFIQACEN - Branch Ⅲ
33 NAFIQACEN - Branch Ⅳ
34 NAFIQACEN - Branch Ⅴ VIETNAM
35 NAFIQACEN - Branch Ⅵ Fish & Fishery
Product2001.
3.27