South Korea Revises Health Functional Food Code: MFDS Notification No. 2022-69

On September 15, 2022, the Ministry of Food and Drug Safety (MFDS) issued the latest version of Health Functional Food Code¹. The new regulation is implemented along with its issuance, except for the modifications about Aloe Whole Leaf and Saw palmetto fruit extracts which are effective after January 1, 2024.

The modifications are specified as below：

1. Expanding Raw Material Scope for Manufacturing Protein

The competent authority expanded the scope of raw materials for manufacturing protein products to all permitted food ingredients, intending to help enterprises develop new protein products. Previously only nine kinds of raw materials could be used.

Present

Manufacturing Standard

Raw Material:

Legumes, oils, eggs, fishes, shellfishes, meats, nuts, cereals, edible insects.

(Edible insects used for manufacturing protein should be on the list of the Food Code2)

Manufacturing Standard

Raw Material:

Protein products shall be manufactured or processed from food ingredients and can supplement protein.

ChemLinked Comments

The permitted food ingredients can be found in the Attached Table 1 of Food Code².

2. Adding New Function of Ginseng

Ginseng is a traditional and one of the most popular health supplement ingredients in South Korea. The latest regulation adds a new function claim of “benefit for liver health” to ginseng, which was an individually recognized function claim previously.

ChemLinked Comments

As stipulated in Article 6 under Chapter 1 of Health Functional Food Code, an individually recognized function of a pre-notified ingredient can be officially added into Health Function Food Code three years after the first approval date. Thus, all companies can use the relevant function to purport the products.

Before adding the “individually recognized function” to the Code only the applicant of the function can make the relevant health claim on the product.

Therefore, the notified function claims of ginseng listed in Health Functional Food Code are:

(a) Helpful to improve immunity, recover from fatigue, and benefit for bone health;

(b)Benefit for liver health

The recommended daily intake of the product purporting “benefit to liver” is detailed as well: Total amount of ginsenoside Rg1 and Rb1: 28.8 mg.

3. Removing Aloe Whole Leaf from The Functional Ingredient List

The side effect of hepatotoxicity was found after continuous consumption of the aloe whole leaf for a long time. Therefore, the authority deleted the “Aloe Whole Leaf” from the functional ingredient list.

Note the aloe gel still remains a functional ingredient.

4. Clarifying Ginkgo Leaf Extract’s Manufacture Method

In terms of ginkgo leaf extract’s content of functional compounds, the obscure specification of the ratio of quercetin and kaempferol is clarified as:

quercetin: kaempferol =1: 0.8~1.2

5. Adding New Specifications of Saw Palmetto Fruit Extracts

To prevent the illegal mixing of cheap edible oil and fat to the Saw palmetto fruit extracts, MFDS newly added the specifications of total fatty acid and phytosterol for the functional ingredient:

Fatty acid: total fatty acid shall exceed 80% (limited to raw material products)

Phytosterol (limited to raw material products):

(a) sterol: over 0.2 %

(b) β-sitosterol: over 0.1 %

6. Amending Test methods

The "Folin- Ciocalteu’s Phenol Reagent" is newly added to the test method of total polyphenol.