Test
The Ministry of Food and Drug Safety designates testing laboratories outside of the Republic of Korea as Foreign Testing Laboratories to ensure the
safety of imported foods and expand foreign capacity of food testing. When a test report issued by a MFDS-designated Foreign Testing Laboratory is presented at the point of
its country’s export to Korea, laboratory tests can be omitted and data provided from the laboratory is adopted.
What you need to know about Foreign Testing Laboratories
1) What is a “Foreign Testing Laboratory”?
- A “Foreign Testing Laboratory” is a MFDS-designated testing laboratory, outside of the Republic of Korea, that has demonstrated its competence to carry out specific laboratory testing.
2) How would a testing laboratory become a Foreign Testing Laboratory?
- A testing laboratory seeking to be designated by the MFDS as a Foreign Testing Laboratory must satisfy one or more of the following conditions:
- A public laboratory established by the government of an exporting country
- A laboratory designated by the government of an exporting country
- A laboratory, outside of Korea, established and operated by a MFDS-designated domestic food testing laboratory
- A laboratory is required to submit an application along with supporting documents demonstrating its sufficient testing capability to the MFDS. An on-site audit is required for all applicant laboratories. Laboratory Performance Assessment and laboratory’s compliance to Laboratory Quality Assurance Standards will be conducted as necessary
- An application for designation must contain the following information:
- General information (history of the laboratory, etc.)
- Laboratory organization and laboratory personnel (including work experiences)
- Floor plan of testing facility
- A list of equipment necessary for testing (name of the equipment, manufacturer, model name, quantity, etc. (including laboratory floor plan)
- Testing records (Recent three-year records of testing fields that the laboratory is seeking to get designated). However, for laboratories located outside of Korea that are established and operated by a MFDS-designated food testing laboratory, testing
- A copy of documents including certificate of testing laboratory issued by the government of exporting country
- A copy of laboratory testing report form(not necessary when the laboratory testing report is issued in accordance with the form 10 prescribed in this Act)
- Application Form
- Laboratory Quality Assurance Standards
- Laboratory Quality Assurance Standards check list
- Certificate of Laboratory Testing
(as prescribed in The Act on Testing and Inspection in the Food and Drug Industry) - A fixed fee of 380,000 Korean Won (approximately 360 U.S dollars) will be charged for each application for designation In addition, actual costs on travel and per diem (including accommodations) of MFDS officials for an on-site audit will also be charged. You may pay the fee at a designated bank after you receive a bill from the MFDS. The duration of an on-site audit is normally three days and does not include travel time. On-site audits generally involve two to three auditors and estimated on-site audit costs are shown below. (The calculation of costs may depend on foreign exchange rates and countries that auditors plan to visit)
Estimated On-Site Audit Cost
| Location | Flight Fares |
Per Diem
(for a three-day inspection) |
|---|---|---|
| Europe | $2,500 | $250 x 3 |
| North America | $2,000 | $250 x 3 |
| Asia | $1,500 | $200 x 3 |
- The completed application form and evidential documents should be submitted to:
Laboratory Audit and Policy Division, Ministry of Food and Drug Safety Osong Health Technology Administration Complex, 187
Osongsaengmyeong2-ro, Osong-eup, Heungduk-gu, Chungju-si, Chungcheongbuk-do, Korea 363-700
3) What product groups do the Foreign Testing Laboratories test?
- A testing laboratory may apply to obtain designation by the MFDS for the testing of food and livestock products. Foreign Testing Laboratories can perform laboratory testing of the product group(s) for which designation has been obtained Testing groups can be classified into 8 product classifications; Agricultural/forestry products, Livestock products, Health functional foods, Food additives, Fishery products, Processed foods and Apparatus, container, package for food products
4) Once designated, how can I change details of designation?
- When a laboratory wishes to change its designated product classification(s), the laboratory should apply to get an approval prior to any changes being made. Please refer to the process described in question 2 above
- The laboratory should notify the Ministry of Food and Drug Safety within 30 days of any changes involving legal name, address, representative, or authorized signatories
- The completed application form and evidential documents should be submitted to:
Laboratory Audit and Policy Division, Ministry of Food and Drugs Safety Osong Health Technology Administration Complex, 187 Osongsaengmyeong2-ro, Osong-eup, Heungduk-gu, Chungju-si, Chungcheongbuk-do, Korea 363-700
5) What are the obligations of a Foreign Testing Laboratory?
- Foreign Testing Laboratories should comply with the following conditions and issue a test report as prescribed in the attachment 10 of the Enforcement Regulation
of the Act
- Foreign Testing Laboratories shall conduct laboratory testing in compliance with Article 11(1)1 and Article 11 (1)2. Testing may also be conducted in accordance with internationally accepted test methods and in case of any dispute arising in relation to test results and a final decision shall be made based on laboratory testing carried out in accordance with Article 11(1) and Article 11(1)2.
- Foreign Testing Laboratories shall not engage in any of the following activities:
a) Skipping of a confirmatory test when the initial laboratory testing indicates a further confirmatory test is required
b) Use of reference materials, reagents, or medium beyond the expiration data
c) Omission of test items or application of wrong standards or specifications - Foreign Testing Laboratories shall retain test reports, testing records, etc. for not less than three years in accordance with the standards set forth by the pertinent laboratory. These documents may also be stored in electronic form
- Foreign Testing Laboratories shall submit the following documentation to the Minister of Food and Drug Safety at the end of every year
a) List of test reports which has seen sent to the Korean government
b) A copy of documents demonstrating evaluation of laboratory performance by the pertinent government or evaluation of laboratory performance obtained through participation proficiency testing programs.
6) My laboratory has been designated by the MFDS as a Foreign Testing Laboratory Do we need to get designated again in accordance with the new Act?
- Since your laboratory has obtained designation from the MFDS before the enforcement of the new Act, it is not necessary to apply for designation again. However, make sure that you renew your certificate by the end of 2014 and it’s free of charge.
7) I have test reports issued before the Act on Testing and Inspection in the Food and Drug Industry has become effective. Are they still valid?
- Yes, they are still valid under the Food Sanitation Act, Livestock Products Sanitation Control Act, Pharmaceutical Affairs Act, Medical Devices Act, Cosmetics Act, and Health Functional Act
8) Does a Foreign Testing Laboratory have to participate in proficiency testing programs every year?
- All testing laboratories including Foreign Testing Laboratories which have obtained designation from the Minister of Food and Drug Safety must participate in proficiency testing programs. There is no cost associated with proficiency testing programs and quality assurance assessment.