South Korea’s Customized Health Functional Food System

MFDS permitted seven enterprises to engage in a pilot program to run a “Customized Health Functional Food” system. "Customized Health Functional Foods” are functional foods formulated using a mix of different active ingredients by accredited healthcare workers made to meet the individual nutritional or physiological requirements of consumers. Products are formulated based on clinical assessment, genetic testing or dietary assessment.

On December 3, 2019, MFDS put forward a strategic plan focusing on five major food sectors, one part of which was to stimulate the health functional food industry ^[1]. Following this plan, a trial run on “Customized Health Functional Food System” was announced on April 27 ^[2]. In this notice, MFDS granted the seven firms below with special 2 year exemptions allowing them to engage in a pilot program involving formulation of “Customized Health Functional Foods”.

Company Name	Material Supplier
Pulmuone-lohas	Pulmuone
AmorePacific	AESTURA
Amway(Korea)	Amway(US)(imported material) Amway(Korea)
Herbalife	Cosmaxbio Herbalife(imported material)
Bigsum	Naturalway
COSMAX NBT	COSMAX NBT
Monolabs	Kolmarbnh

Innovation and Special Requirements of Customized Health Functional Food

“Customized Health Functional Foods” will be formulated based on the recommendations of an expert consultant according to the specific physical condition, dietary habits, or based on genetic testing. The product is designed to meet the particular nutritional and physiological requirements of individual consumers.

For instance, Customer Ms. A's medical examination report shows her blood pressure reading and cholesterol are higher than average but do not require pharmaceutical intervention. Under this situation, she can go to a Customized Health Functional Food store to have a product formulated to meet her demands. The consultant can suggest formulating a product containing Coenzyme Q10 tablets (assists in lowering blood pressure) and Oat dietary fiber tablets (assist in improving cholesterol).

Enterprises offering “Customized Health Functional Foods” must engage the services of an expert consultant in the healthcare domain, such as a pharmacist or a dietitian. Furthermore, the ingredients allowed for the production of “Customized Health Functional Foods” shall be in the form of a tablet, capsule, bolus, flake, bar, or jelly. No deterioration shall be found when the ingredient packages are opened. Additionally, facilities for dividing and packing must comply with hygiene standards.

At present, overseas enterprises are ineligible to participate in the "Customized Health Functional Food" business in South Korea, health functional food suppliers may export ingredients/raw materials in the future. The COVID-19 pandemic has also precipitated a surge in demand for functional food active ingredients.

In line with Health Functional Food Code, the materials applicable for health functional food are:

Functional materials;
Nutritional ingredients;
Other materials used during the manufacture;
Raw materials.

The detailed contents and relevant standards can be found in the Food Database^[3].

More Information about Health Functional Food