WORLD TRADE
ORGANIZATIONG/SPS/N/KOR/131
4 July 2003
(03-3580)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION
1. Member to Agreement notifying:   REPUBLIC OF KOREA
If applicable, name of local government involved:
2. Agency responsible:  Ministry of Health and Welfare
3. Products covered (provide tariff item number(s) as specified in national schedules
deposited with the WTO; ICS numbers should be provided in addition, where
applicable):  Health  Functional Food
4. Regions or countries likely to be affected, to the extent relevant or practicable:  Any
trading partners
5. Title, language and number of pages of the notified document:  Proposed Draft
Presidential Decree and Ministerial Ordi nance of the Health Functional Food Act
6. Description of content:  The purpose of the "Health Functional Food Act" is to contribute
to the improvement of public health and consumer protection by assuring safety and
quality improvement of the health functional food (hereafter the food) and by establishing
the soundness in distributions and sales of the food.
"Health Functional Food" is defined as the manufactured or processed food in the form of
tablets, capsules, powders, granules, liquid phase, and pills using raw materials oringredients with the function that benefit the human body.
The main contents of the Proposed Draft Presidential Decree and Ministerial Ordinance of
the Act are as follows:
- A manufacturer of the health functional food should obtain the permit from the
Commissioner of the Korean Food and Drug Administration(hereafter the
Commissioner).  A food importer and a distributor should report to the
Commissioner and  the Mayor or the provincial Governor.
- A person who holds the permit, should self-inspect to ensure conformity assessment
of criteria and standards of the food manufactured, according to the MinisterialOrdinance of the Act.  A manufacturer must appoint the quality control manager for
quality control, facility management, and job training for the employed, and be
qualified as described by the Act.
- A person who wants to import the food for commercial purposes, should report to the
Commissioner, as stipulated by the Act.  The Commissioner may, if necessary, order
appropriate inspection of the food by the relevant authority or inspection agency
before custom clearance.G/SPS/N/KOR/131
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- The Commissioner may establish the "Prior Confirmed Registration" of the imported
food. This new program is to provide pre-approval for an imported food after the
documentation review (including test certification showing the product complies
with the relevant Korean regulations) and on-site inspection.  The registration will be
given on a product by product basis and excludes fresh products.  The productobtaining the pre-registration from the KFDA may be imported into Korea with
document review only.
- In order to review and investigate the criteria, standards, labeling, advertising and
policies on the food in response of the consultation of the Minister of Health and
Welfare and the Commissioner of the KFDA, the Health Functional Food Review
Committee shall be established in the Ministry of Health and Welfare.
- The Commissioner should publish "Good Health Functional Food Manufacturing
Practice" containing the criteria on manufacturing and quality control and will
provide incentives to the firms observing the regulation.
- If it is deemed necessary to protect the public health, the Commissioner may
determine and publicly notify the criteria for manufacturing, processing, and
preservation methods and standards for the ingredients of the food.
When a businessman advertises and labels the product function, he/she should consult the
"Advertisement Review Committee" to comply with the national health functional food
policies for promoting the public health and  protecting the consumer and to  reflect a
scientific evidence base.
7. Objective and rationale:  [  X ] food safety, [   ] animal health, [   ] plant protection,
[   ] protect humans from animal/plant pest or disease,  [   ]  protect territory from other
damage from pests
8. International standard, gu ideline or recommendation:
[   ] Codex Alimentarius Commission, [   ] Office International des Epizooties,
[   ] International Plant Prot ection Convention, [ X ] None
If an international standard , guideline or recommendation exists, give the appropriate
reference and briefly identify deviations:
9. Relevant documents and language(s ) in which these are available: MOHW Public
Notification 2003-81, published in the Korean official Gazette 6.24, available in Korea.
10. Proposed date of adoption:   To be determined.
11. Proposed date of entry into force:   To be determined.
12. Final date for comments:  60 days after publication.
Agency or authority designated to handle comments:  [   ] National notification
authority, [ X ] National enquiry point, or address, fax number and E-mail address (if
available) of other body:
Pharmaceutical and Food Policy Division
Ministry of Health and Welfare
1 Jungang-Dong, Kwacheon-City, Kyoungi-Do, 427-760, Republic of Korea
Telephone:  +82-2-504-6233;  Fax:  +82-2-504-1456;  E-mail:  jonsu@mohw.go.krG/SPS/N/KOR/131
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13. Texts available from:  [   ] National notification authority,  [ X ] National enquiry point,
or address, fax number and E-mail address (if available) of other body:
Pharmaceutical and Food Policy Division
Ministry of Health and Welfare
1 Jungang-Dong, Kwacheon-City, Kyoungi-Do, 427-760, Republic of Korea
Telephone:  +82-2-504-6233;  Fax:   +82-2-504-1456;  E-mail:  jonsu@mohw.go.kr