1. Reason for Revision
As the Functional Health Foods Act has been revised (Act No. 19914; promulgated on January 2, 2024; enforced on January 3, 2025) to provide for the establishment of customized functional health food sales businesses and the appointment of customized health functional food managers in order to perform such duties as the safety management of customized functional health foods and the hygiene management of subdivision facilities at customized health functional food sales businesses, so as to meet the diverse needs of consumers for health functional foods and to contribute to the development of the health functional food industry, this revision stipulates the standards for customized functional health food sales business facilities, compliance-related matters for business operators and customized functional health food managers, safety management and sales standards for subdivided and combined foods, and the number of hours of safety and hygiene training for the operators of customized functional health food sales businesses and the managers of customized functional health food managers, all of which are matters delegated by the law.
2. Main Contents
A. The revision provides the facility standards for customized functional health food sales businesses (Newly established Attached Table 1 Subparagraph 5 of the draft).
Facility standards are classified into sales offices, subdivision/combination sites, and subdivision/combination facilities; however, special provision allows for exemption from having subdivision/combination sites and facilities if the subdivision and combination processes are entrusted.
B. The revision stipulates compliance-related matters for the operators of customized functional health food sales businesses (Newly established Attached Table 4 Subparagraph 4 of the draft).
Matters related to safety and hygiene, matters related to records and management, matters related to consumer consultation, types of business that can be entrusted with subdivision/combination, etc.
C. The revision stipulates safety management and sales standards for subdivided and combined foods (Newly established Attached Table 4-2 of the draft).
Formulation of functional health foods that can be subdivided and combined, restrictions on overlapping subdivisions and combinations of the same functional foods, upper limit on the number of types of functional health foods that can be subdivided and combined, content standards including daily intake, and matters related to indications, etc.
D. The revision stipulates compliance matters for the managers of customized functional health foods (Article 16-5 of the draft).
Duty to record and keep work performance records, prohibition of unfair labeling and advertising, duty to request business operators to improve quality, safety, and hygiene issues, etc.
E. The revision stipulates training for business operators and managers (Article 19 of the draft).
3 hours of advance safety and hygiene training for the sellers of customized health functional foods; 6 hours of new safety and hygiene training for the managers of customized health functional foods; and 3 hours of refresher training once per year.
