The FAQs for health functional foods are concluded as below following the MFDS Notice and South Korean Law Center, including the specification application, labeling, packaging, and precautions.
According to the Health Functional Food Code, individually recognized ingredients approved following the Regulation on Certification of Functional Ingredients and Specification can only be used by those who have been issued with a recognition certificate. The behavior of “use” covers importing, manufacturing, and selling the recognized functional ingredient.
Background information Functional materials can be sorted as the notified ones and the individually recognized ingredients. MFDS has notified twenty-eight functional ingredients and sixty-nine functional raw materials in the Health Functional Food Code. 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. Only these who have been issued with a certificate can use the individually recognized ingredients |
Is it possible to manufacture a product whose vitamin D content exceeds the labeled amount? The specifications for vitamin D state that "Vitamin D: 80-180% of the labeled amount" is acceptable. However, is it possible to manufacture a product whose vitamin D content exceeds 200% of the labeled amount?
As specified in Chapter 3.1-3 of Health Functional Food Code, the vitamin D content shall be 80-180% of the labeled amount for health functional food.
However, following the requirements of the nutrient’s daily intake amount in Article 1 of Chapter 3 under the Health Functional Food Code, the minimum daily intake of a nutrient shall be more than 30% of that specified in Attached Table 2 of Health Functional Food Code. The maximum content shall be established to ensure safety from excessive intake.
Therefore, it is allowed to manufacture vitamin product that exceeds the maximum content standard for daily nutrient intake. However, in this situation, adverse effects may occur due to excessive intake. So, it is suggested to comply with the daily nutrient intake range of nutritional ingredients, which is 80-180% of the labeled amount for vitamin D.
According to the specifications in Chapter 3. 2-16 of the Health Functional Food Code, application objects of the specifications for peroxide value, acid value, anisidine value, and total oxidation value are:
(a) Raw material products with 100% EPA and DHA oil
(b) Final products made only from raw material with 100% EPA and DHA oil (except for capsules containing colorants and flavorings)
(c) Raw material products with only EPA and DHA oil and the antioxidants specified in the Food Additive Code
(d) Final products made by adding only antioxidants specified in Food Additive Code to (a) or (c) (except for capsules containing colorants and flavorings)
Therefore, if other ingredients other than the antioxidants, such as lecithin, are added to the EPA and DHA oil, then the peroxide value, acid value, anisidine value, and total oxidation value specifications are not applied.
As per Imported Food Act, the business enterprises importing and selling imported foods shall import safe and high-quality imported foods, and always check and inspect the safety of the imported foods.
Therefore, the imported and cleared products are not allowed to be repackaged due to concerns about safety, storage stability, and false labels.
According to subparagraph b of Article 6 (8) of the Labeling Standards for Health Functional Foods, if there are any precautions for consumption due to the concerns about adverse symptoms, potential side effects, or the possibility of side effects from excessive consumption, such precautions must be labeled accordingly.
If there are any precautions for consumption specified for the nutritional ingredients and functional ingredients used in health functional foods in the in the Health Functional Food Code, they must be labeled on the container or packaging of the minimum sales unit. However, if no precautions for consumption are specified in the regulation, it is deemed acceptable to omit the labeling of such precautions at the discretion of the business operator.
According to Enforcement Rule of the Act on Labeling and Advertising of Foods, for liquid foods containing caffeine at a concentration of more than 0.15 mg/ml, it is necessary to label with a statement such as "Children, pregnant women, and caffeine-sensitive individuals should be cautious when consuming". On the product’s main display surface, the phrases of "High Caffeine " and "Total Caffeine Content OOO mg" shall also be labeled.
The above labeling requirements under the Enforcement Rule of the Act on Labeling and Advertising of Foods apply to all foods, food additives, and health functional foods. Therefore, if the final product contains more than 0.15 mg/ml caffeine, it shall be labeled as "High Caffeine".
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