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South Korea Consults on Health Functional Food Code

On June 10, 2021, the Ministry of Food and Drug Safety (MFDS) issued two announcements (No. 2021-2521 and No. 2021-2532), soliciting public opinions of the drafts of Health Functional Food Code. Stakeholders can send suggestions to MFDS before August 10, 2021.

1. Proposed Amendments in Announcement No. 2021-252

(1) New Precautions for Intake of Eight Functional Ingredients

a.Ginseng

Newly added:

People with an allergy to ginseng should be cautious;

If any adverse reactions occur, please stop the intake of this product and consult experts immediately.

b. Red Ginseng

Newly added:

People with an allergy to red ginseng should be cautious;

If any adverse reactions occur, please stop the intake of this product and consult experts immediately.

c. Chlorella

Newly added:

If any adverse reactions occur, please stop the intake of this product and consult experts immediately.

d. Milk Thistle (Cardus marianus) Extract

Newly added:

Children, pregnant and lactating women should avoid this product;

If any adverse reactions occur, please stop the intake of this product and consult experts immediately.

e. Marigold Extract

Newly added:

Children, pregnant and lactating women should avoid this product;

Smokers shall consult experts before taking this product;

If any adverse reactions occur, please stop the intake of this product and consult experts immediately.

f. Nondigestible Maltodextrin

Newly added:

If any adverse reactions occur, please stop the intake of this product and consult experts immediately.

g. Aloe Gel

Newly added:

Children, pregnant and lactating women should avoid this product;

Please consult experts before taking this product if you have kidney or liver disease, or if you are taking diabetes drug;

If any adverse reactions occur, please stop the intake of this product and consult experts immediately.

h. MSM (Methyl sulfonylmethane/ dimethyl sulfone)

Newly added:

Please consult experts before taking this product if you have kidney disease;

If any adverse reactions occur, please stop the intake of this product and consult experts immediately.


(2) Other Amendments

The draft enhances the safety control of clorella by reducing the content of lead from "less than 3.0 mg/kg" to "less than 1.0 mg/kg". The daily intake of "Nondigestible Maltodextrin" and "Aloe Gel" are modified as well.

2. Proposed Amendments in Announcement No. 2021-253

(1) New Raw Material for Manufacturing Vitamin K

Announcement No. 2021-253 specifies Vitamin K2 (Menaquinone-7, MK-7) as a new raw material for manufacturing Vitamin K.

(2) Modifications of Testing Methods

The draft deletes Vitamin K1's No. 1 testing method, to simplify the complicated testing methods of Vitamin K1. In addition, the testing method of Vitamin K2 and the simultaneous determination method of catechin and caffeine are introduced. The testing method of pantothenic acid is proposed to be modified.

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