To have a brief overview of health functional food import requirements, please refer to our new foodpedia here.
Chapter 1. General Introduction
In South Korea, “dietary supplement” is referred to as “Health Functional Food (HFF, 건강기능식품).” Despite the different naming, the concept is similar. Health Functional Food means foods manufactured or processed with functional materials beneficial to human health. Health Functional Food is the food between general food and medicine. The target consumers are the sub-health crowd who intend to improve their physical fitness or to prevent getting ill.
As South Korea manages the food import within a single framework, enterprises can export Health Function Food to South Korea following the imported food procedure 1. This foodpedia focuses on the Health Functional Food product compliance.
Chapter 2. Law Hierarchy
On August 27, 2003, South Korea officially promulgated the first version of Health Functional Food Act 2, enhancing the safety management of Health Functional Food. The competent authority, the Ministry of Food and Drug Safety (hereafter referred to as MFDS), enriched the law hierarchy by successively revealing subordinate laws and regulations.
The primary laws and requirements of Health Functional Food in South Korea include:
Enforcement Decree of Health Functional Food Act 3
Enforcement Rule of Health Functional Food Act 4
Regulation on Certification of Functional Ingredients and Specification 6
Among all the above laws, the Health Functional Food Code 5 is the one that the entities refer to the most frequently. It details the standards and specifications for manufacturing, processing, testing, importing, storing, and selling Health Functional Food in Korea.
Chapter 3. Product Requirement
3.1 Types of Health Functional Food
The Health Functional Food can be made in any of the following forms:
Nevertheless, other food forms can be accepted after an extra application. For example, packaged rice can be labeled as Health Functional Food after the business entity applying for an extra certificate, as rice is not in a typical Health Functional Food form.
3.2 Ingredients and Raw Materials
(A) Approved Materials
As stated in Article 2 of Health Functional Food Code 5, ingredients and raw materials that can be used in Health Functional Food include functional materials, general food materials, and specific food additives:
a. Functional Ingredients (e.g., vitamins, dietary fiber)
b. Functional Raw Materials (e.g., lecithin, ginseng)
Shall comply with Health Functional Food Code 5
General Food Materials
Shall comply with Food Code 8
Shall comply with Food Additive Code 9
Note that prohibited materials 10 listed in Attached Table 5 of Health Functional Food Code 5 cannot be used in Heath Functional Food.
In addition, functional materials can be sorted as the notified ones and the individually recognized ingredients.
MFDS has notified twenty-eight functional ingredients and sixty-eight functional raw materials. (Find the whole list at ChemLinked Translation 11)
While to manufacture or sell Health Functional Food with non-notified ingredients, the entity shall apply for an individual recognition for the effectiveness and safety of the relevant material. Up to now, MFDS has published more than 300 kinds of individually recognized ingredients. However, only the applicant can use the relevant individually recognized ingredients.
(B) Application for New Ingredients
Following the Regulation on Certification of Functional Ingredients and Specification 6, the manufacturer or importer shall submit the following four application materials to MFDS to evaluate the effectiveness and safety of relevant ingredients:
(1) Application letter, including the company name, principal business, product information, and other necessary information of the enterprise.
a. A summary of the dossier
b. Information about the ingredient's origin, development process, certification, and the using status
c. Manufacture method
d. Property of the ingredient
e. Specification, test method, and test result of the active ingredient
f. Specification and test method of hazard ingredient
g. Safety information
h. Effectiveness information
i. Acceptable daily intake, precautions, etc.
(4) Inspection report issued by inspection and testing institution designated by MFDS.
Having received the application materials, MFDS will conduct the review through the consultation with the Health Functional Food Deliberation Committee (HFF Committee). When the safety and effectiveness are confirmed, MFDS will release the approval for the individually recognized ingredient (See Table 1). The result will also be unveiled on MFDS website.
(Table 1. Example of Approved Functions of Individually Recognized Raw Materials)
MFDS can request the applicant to complement the data when further information is needed. The applicant needs to submit complementary documents; otherwise, the "individually recognized ingredient" application would be rejected. (See Figure 1).
(Figure 1. Evaluation Procedure)
The official charge for certificating "individually recognized ingredient" is 1,900,000 KRW (about 1,710 USD). The evaluation period lasts for 60 to 120 days, depending on different situations. It might take longer if the documents are incomplete.
3.3 Application for Health Functional Food Certificate
Products using permitted functional materials need to apply for the certificate of Health Functional Food before distribution. However, if the product's active ingredients are listed in the twenty-eight approved functional ingredients, it can be exempted from the product certificate application.
The evaluation procedure of HFF certificate application is the same as that of the new ingredient, as shown in Figure 1, though the dossiers for the product certificate are easier to prepare.
Enterprises need to submit the application documents to MFDS for the product certificate:
(1) Application letter
a) A summary of the dossiers
b) Information about product type
c) Ingredient name and amount
d) Manufacturing method
e) Standard and specification
f) Safety information
g) Effectiveness information
h) Nutrient information
(4) Inspection report
The relevant product could label the mark of "Health Functional Food" (Figure 2) or advertise its efficacy after going through the official evaluation.
(Figure 3. Health Functional Food Mark)
Chapter 4 Label
Labeling Standard of Health Functional Food 7 specifies the labeling items of Health Functional Food:
1. Health Functional Food mark
2. Product name
3. Business entity and address
4. Sell-by date and storage condition
5. Net quantity
6. Nutrition facts
8. Dosage, suggested use and warnings of use
9. Raw material names and contents
10. A statement that this health functional food is not a drug for preventing, treating or curing any disease
11. Precautions for safety use
12. Other detailed items
Apart from the above, other items such as the food additives, packaging materials, dietary reference intakes for Koreans, etc., shall comply with the Food Labeling Standard 12.
ChemLinked provides consultation services about Korean health functional food compliance to help enterprises trade with S. Korea smoothly. Please contact us via firstname.lastname@example.org.