Korea | Import as a General Food Product or Health Functional Food?
3D render by Zsolt Popa
Food products can be generally be imported in two ways into Korea. As 1) General Food (with no special health claims) and 2) Health Functional Food (which allows health claims approved under the Health Functional Food Code (No. 2018-12).
According to National Statistical Office of South Korea, people over 65 years old will account for 38.2% of Korea's population by 2050, making it the most aged society among the 30 member economies of the Organization for Economic Cooperation and Development (OECD).
Consequently, this will mean that Korea will see a significant increase in the silver-food market in view of this. And health functional food will become one of the leading players in this market. Hence, we see an influx of investors trying to tap on this market.
Many have asked, "But which would be the better route to take for now?"
The answer is that it really depends on your objectives and marketing strategies such as where do you want to place your product in the market, your target market, your pricing policies and so on.
Pros of importing as a general food product :
- Less stringent criteria to fulfil.
- Pre-market approval is not necessary. Importers only need to register their products during customs clearance in the form of an import declaration.
If your product is regulatory compliant, a regular food product will normally take a 2~3 weeks to be imported and you can expect customs clearance to be expedited on subsequent imports.
Cons of importing as a general food product :
- No health claims can be made.
Pros of importing as a health functional food (HFF) :
- Health claims can be made for 37 generic functional ingredients/food without pre-market approvals.
- With longer life expectancy and education, people are
more willing to pay a higher price for premium food as such health functional food. Hence, health functional food usually fetch a higher price than regular food supplements.
Cons:
- Currently, health claims can only be made for the 37 generic functional ingredients approved under the Health Functional Food Code.
- Health claims beyond those prescribed by the code cannot be claimed.
-For new ingredients or product specific functional ingredients, the required treatment period to certify the safety and efficacy of the product will at least take 120 days to be approved.
- Costly investments and approval process to be overcome before launch.
Regardless, of the time and cost investments involved, HFF may still seem to be the way to go for many given the increasing aging popultion and projected increase in the senior-friendly food market.
Overview of the required documents for import clearance and registration.
1) Importing of General Food
General food products (without any special health claims) can be imported without any pre-market approval. by filing import declarations of imported food.
Businesses that wish to import and sell imported foods or those that wish to make online purchases of imported food by proxy must register with the regional office of the Ministry of Food and Drug Safety (hereafter referred to as "MFDS").
Moreover, businesses that wish to import overseas foods, etc. to Korea or those that establish and operate overseas manufacturing facilities must register the name, address and production item of the overseas manufacturing facility with the regional office of FDS at least seven days prior to import declaration.
※ If pre-registration is not done, import declaration will be rejected.
Documents required for registration of the foreign facility:
Name of manufacturing facility, address, representative, phone number and E-mail address
Type of business, and whether food safety management system is applied
Type of food (processed foods, food additives, health functional foods, etc.)
Consent for on-site inspection by visit if Minister of MFDS deems it necessary
Confirmation that the registered information is true
(If importer is applying) Confirmation that the person who established and operates the overseas manufacturing facility agreed to the registration
Documents required for import:
A completed application for an import permit (Please see attached)
A lading bill
Invoice containing a description of goods, brand name, quantity, specifications, type or model number, unit price, freight, insurance and other expenses, as well as any amount of duty reduction or exemption of duties obtained at the port of shipment.
Packing list
Price declaration
Certificate of Origin
Formulation Sheet
Manufacturing Process Flow Sheets of product and ingredients used.
2) Import as Health Functional Food (HFF)
According to the Health Funcitonal Food Act (No. 14476),
1) The “health functional food” means food manufactured or processed in a form of tablet, capsule, powder, granule, liquid or pill, etc. with ingredients or components, that possess the functionality useful for human body.
2) The term “functionality” means gaining useful effect on health purposes by the adjustment of nutrients or the physiological effect, etc. for human body structure and function.
There are 2 kinds of HFF:
1) Generic
2) product-specific
There are currently 37 generic health/functional foods which do not require pre-market approvals. The list are as follows:
Alkoxy-glycerol-containing product
Red yeast rice product
Octacosanol-containing product
Fructooligosaccharide-containing product
Lecithin product
Phytosterol-containing product
Embroyo bud product
Soy-protein-containing product
Embroy bud oil product
Green-tea-extract product
Gamma-linolecnic acid-containing product
Propolis-extract product
Spirulina product
Glucosamine-containing product
Chlorella product
Chitooligosacharide-containing product
Probiotics-containing product
Chitosan-containing product
Yeast-containing product
Beta-carotene product
Squalene-containing product
Soft-shelled-turtle product
Pollen product
Japanese apricot-extract product
Yeast product
Aloe product
Royal jelly product
Mushrooms product
EPA/DHA containing product
Chlorophyll-containing product
Eel oil product
Mucopolysaccharide product
Red ginseng product
Fermented vegetable-extract product
Ginseng product
Grape seed oil product
Nutritional supplements
All other new ingredients that are not included in the above list or considered as generic health/functional food must undergo pre-market evaluation by MFDS. Anyone selling health/functional food are required to obtain pre-market approval by the government.
They are two possible approaches:
1) Approval as a new ingredient
2) Approval as a functional ingredient, which is product-specific (only considered a functional ingredient when used in a certain product)
1. Standardization
Provide information on the “special characteristics of the functional ingredient (inclding it's yield and change in content of functional component)”
2. Safety evaluation
a. Provide information on the “history of use, manufacturing processes, amount to be consumed, results of toxicity tests, results of human study, and results of nutritional evaluation and bio-availability”
b. Provide data showing scientific validation of safety of active ingredient
3. Efficacy evaluation
a. Provide data substantiating the functional food‟s claim – “component and reliable scientific evidence”
b. When applying to certify functional food ingredient as a generic functional food, the KFDA will perform its own efficacy trials.
4. Specification
a. Provide sample final product
b. Provide “documentation on the method used to analyze the functional component and, if the decision is made to grant approval for the product as a health/functional food, confirms the period of conformity and hygiene specifications”
Once certified, a functional food is allocated to one of four grades on the basis of scientific evidence, which in turn determines the level of the health claim a product may issue.
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