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South Korea Revises Health Functional Food Code (MFDS Notice No. 2021-95)

On November 23, 2021, the Ministry of Food and Drug Safety (MFDS) issued the updated Health Functional Food Code1. It mainly modified the precautions of seven functional ingredients, enhanced the specifications of two raw materials, and updated test methods.

The new regulation will come into effect on November, 24, 2022. Nevertheless, the provisions related to test method are implemented on the issuance date. The amendments are specified as below:

1. Modifying Precautions for Intake

Seven functional raw material's precautions for intake are modified in accordance with the result of material efficacy re-examination:

Previous

Present

Ginseng:

People who are taking medicines related to diabetes and anticoagulant should be cautious to take this product.

Ginseng:

(a) People who are taking medicines related to diabetes and anticoagulant should be cautious to take this product;

(b) Allergy may be triggered for people with an allergic constitution;

(c) If any adverse reactions occur, stop eating and consult an expert immediately.

Red ginseng:

People who are taking medicines related to diabetes and anticoagulant should be cautious to take this product.

Red ginseng:

(a) People who are taking medicines related to diabetes and anticoagulant should be cautious to take this product;

(b) Allergy may be triggered for people with an allergic constitution;

(c) If any adverse reactions occur, stop eating and consult an expert immediately.

Chlorella

Chlorella (Newly added):

If any adverse reactions occur, stop eating and consult an expert immediately.

Milk Thistle (Cardus marianus) extract:

Stop eating if an allergic reaction occurs.

Be cautious to take the product when gastrointestinal disease occurs, such as diarrhea, stomachache, abdominal distension, etc.

 

 

Milk Thistle (Cardus marianus) extract:

(a) Children, pregnant and lactating women should avoid this product;

(b) Stop eating if an allergic reaction occurs;

(c) Be cautious to take the product when gastrointestinal disease occurs, such as diarrhea, stomachache, and abdominal distension, etc.;

(d) If any adverse reactions occur, stop eating and consult an expert immediately.

Marigold Extract:

Excessive intake may turn the skin yellow temporarily.

Marigold Extract:

(a) Children, pregnant and lactating women should avoid this product;

(b) Smokers shall consult experts before taking this product;

(c) Excessive intake may turn the skin yellow temporarily;

(d) If any adverse reactions occur, stop eating and consult an expert immediately.

Indigestible Maltodextrin:

Drink sufficient water when taking the product (except for liquid type product)

Indigestible Maltodextrin:

(a) Drink sufficient water when taking the product (except for liquid type product)

(b) If any adverse reactions occur, stop eating and consult an expert immediately.

MSM (Methyl sulfonylmethane/dimethyl sulfone)

MSM (Methyl sulfonylmethane/dimethyl sulfone) (Newly added):

(a) People with kidney disease should consult an expert before taking this product;

(b) If any adverse reactions occur, stop eating and consult an expert immediately.

2. Amendments of Raw Material Specifications

(1) The recommended daily intake of Indigestible Maltodextrin is changed:

Previous

Present

(a) Helpful to maintain healthy postprandial glucose level:

11.9~30 g as indigestible maltodextrin: (in case of liquid ingredients, 11.6~44 g);

 

(b) Helpful to maintain healthy triglyceride level:

12.7~30 g as indigestible maltodextrin (in case of liquid ingredients, 12.7~44 g);

 

(c) Helpful to maintain healthy bowel function:

2.5~30 g as indigestible maltodextrin (in case of liquid ingredients, 2.3~44 g).

(a) Helpful to maintain healthy postprandial glucose level:

Indigestible maltodextrin: 4.0~30 g (in case of liquid ingredients, 4.0~44 g);

 

(b) Helpful to maintain healthy triglyceride level:

5.0~30 g as indigestible maltodextrin (in case of liquid ingredients, 5.0~44 g);

 

(c) Helpful to maintain healthy bowel function:

4.2~30 g as indigestible maltodextrin (in case of liquid ingredients, 4.2~44 g).

 (2) The heavy metal limit of Chlorella is intensified:

Previous

Present

Lead(mg/kg): less than 3.0

Lead(mg/kg): less than 1.0

3. Updating Test Methods

(1) Two test methods of Vitamin K are unified into one.

(2) The test method for simultaneous determination of catechin and caffeine is newly added.

(3) Pantothenic acid's test method is modified.


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