After conducting a trial run on “Custom Health Functional Food”1 in 2020, South Korea has finally implemented regulatory provisions related to this new food category by amending the Health Functional Food Act2 on January 1, 2024, which will be effective on January 3, 2025. The new food category aims to stimulate South Korea's health functional food industry, provide more options for consumers, and effectively control product safety.
Custom Health Functional Food (맞춤형건강기능식품) refers to the process of dividing and combining one or more types of health functional foods according to an individual's needs.
Anyone who intends to engage in the business must report the business to the Ministry of Food and Drug Safety (MFDS). Additionally, the business entity must appoint a Custom Health Functional Food Manager at the custom health functional food sales place to oversee the safety management and the hygiene management of the facility.
2 Reporting on Business
As mentioned above, stakeholders intending to engage in custom health functional food business must be equipped with necessary facility and report to MFDS. However, for a registered pharmacy, the custom health functional food business report can be exempted.
3 Custom Health Functional Food Manager
Appointing a Custom Health Functional Food Manager is necessary for custom health functional food business, unless the business operator has the qualification of the Custom Health Functional Food Manager and take the relevant responsibility.
The qualification requirements for the Custom Health Functional Food Manager are determined by the Health and Medical Service Support Act3, such as having the qualification of healthcare professionals.
Although the detailed requirements for Health Functional Food Manager are not released yet, as per the Health and Medical Service Support Act3, the term "health professionals" means those who have obtained any of the following license, qualification, etc.:
(a) Medical personnel and assistant nurses under the Medical Service Act;
(b) Pharmacists and oriental medicine pharmacists under the Pharmaceutical Affairs Act;
(c) Medical service technologists, health record administrators and opticians under the Medical Service Technologists Act;
(d) Emergency medical technicians under the Emergency Medical Service Act;
(e) The persons prescribed by Presidential Decree, who have obtained a license or qualification as prescribed by health-related statutes and regulations, such as dieticians under the National Nutrition Management Act.
Seen from the above provisions, It is predicted that the Custom Health Functional Food Manager might be required with medical or pharmacal education background.
The duties of the Custom Health Functional Food Manager include the following:
(1) Safety management of custom health functional food, including the division and combination of one or more types of health functional foods
(2) Hygiene management of facilities and equipment for the division and combination
(3) Consultation regarding the purchase and consumption of custom health functional food
(4) Other matters related to the safety and hygiene management of custom health functional food, as prescribed by the Prime Minister's decree
Besides, the manager should maintain the records and documents related to the duty fulfilment.
In addition, Custom Health Functional Food Managers is required to regularly receive safety and hygiene education about custom health functional food.
Please note that the business operators selling custom health functional food must not obstruct the duties of Custom Health Functional Food Managers. The operators must report the appointment or dismissal of Custom Health Functional Food Managers to the MFDS. The MFDS must notify the person who made the report of the decision on the report within three days. Failure to comply the report of the appointment or dismissal will result in administrative penalties.
The introduction of Custom Health Functional Food products and businesses is expected to provide convenience for consumers and benefit the whole health industry, from distributors to material suppliers.