South Korea Revises Health Functional Food Code

The competent authority permitted that individually-recognized functional ingredients can be used in Based Materials. It also issued new substances for the functional ingredients, and adjusted the maximum intake of EPA and DHA Oil, etc.

On March 25, 2021, MFDS revealed the latest version of Health Functional Food ¹. The Main Modifications are:

1. Permit Individually-Recognized Functional Ingredients to be used in Based Materials

South Korean competent authority permits enterprises to manufacture based materials with individually-recognized ingredients. Based material (원료성 제품) refers to ingredients produced by blending functional materials with fructose, starch, glucose, or other materials.

According to the authority's previous explanation ², if the enterprise intends to change the essence (or form) of individually-recognized ingredient, for instance, from extract to powder, the enterprise needs to apply for a new certificate. To reduce entity's burden, MFDS revised the regulation, and now it is allowed to change the form of individually-recognized ingredients by adding substances that won’t affect its efficacy, such as starch.

2. Add New Chemical Compound Sources for the Functional Ingredients

The new regulation permits three chemical compounds for the sources of Calcium and Magnesium:

New compound for producing Calcium	Calcium Stearate, Calcium L-Ascorbate
New compound for producing Magnesium	Magnesium Stearate

3. Adjust the Maximum Daily Intake of EPA and DHA Oil

The maximum daily intake of oil containing EPA and DHA is increased to 2.24g.

Present

Efficacy: to improve the dry eye symptoms

Daily intake: 0.6~1g

Efficacy: to improve the dry eye symptoms

Daily intake: 0.6~2.24g

4. Other Amendments

The test methods of (-)-Hydroxycitric acid, Ginkgolic acid, and (αS1-casein) (f91-100) are modified. The amino acid score for converting protein is changed.