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South Korea Revises the Health Functional Food Code

MFDS unveiled the amendments to Health Functional Food Code on July 10, 2020. The method for manufacturing probiotics in liquid form is approved. New functions of probiotics, ginseng, Vitamin E, and Vitamin C are specified. The test method of water-soluble vitamins submitted by the enterprises will be permitted where the test methods designated by MFDS are not applicable.

MFDS promulgated the amendments to the Health Functional Food Code on July 10, 2020. [1] The main changes include:

1. Revised Provisions about Probiotics

Previously, the probiotics are required to be produced in dry form for further use in health functional products. If the probiotics used is cultured in liquid form, the relevant product is subject to the management of individual authorized health functional food and should undergo a safety inspection by MFDS (See the details in the“Background" below).

Therefore, to decrease the burden of industry, MFDS approves the probiotics to be manufactured in liquid form in this notice.

Additionally, a new function of probiotics is added as helping promote gut health.

2. Addition of Ginseng’s Function

The individually recognized function of “helpful to bone health” is approved as the notified function of ginseng and listed in Health Functional Food Code. [2]

At present, the notified functions of ginseng are “helpful to improve immunity, recover from fatigue and benefit for bone health”.

Background

 

In South Korea, two types of active ingredients can be   used in functional foods:

 

1) Ingredients notified in the Health Functional Food Code;

2) Ingredients individually authorized (case by case basis) by MFDS (Safety and efficacy documents shall be submitted to MFDS).

 

As stipulated in Article 6 of Health Functional Food Code, individually authorized functional ingredients can be considered as notified ingredients six years after the first approval date. Meanwhile, a newly approved function of the pre-notified ingredient can be added into Health Function Food Code officially three years after being approved. Thus, other companies can use the functional ingredient or purport the products with the relevant functions. 

3. Other amendments

Vitamin E and Vitamin C are stated with antioxidant properties as per the KDRIs (Dietary Reference Intakes for Koreans). [3]

Enterprises are allowed to analyze the content of water-soluble vitamins in soft capsules following the test methods submitted by themselves when the material is hard to be detected by the test methods recognized by MFDS.  


Implementation Date

The revised version came into effect on July 10, 2020, while the updates for the new functions of ginseng and proposal will take effect one year later.


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