Composition of the Health Functional Food Code - Part I

The standards and specifications for health functional foods are referred to as the 'Health Functional Food Codex.' Additionally, health functional foods are also known as 'Geongisiks' for short.

 

The most recent revision (Notification No. 2024-16, revised on March 20, 2024) of the Health Functional Food Codex was issued by the Ministry of Food and Drug Safety (MFDS). The updated regulations can be found on the MFDS website. Now, let’s take a closer look at how the Health Functional Food Codex is structured.

 

Firstly, there is an overview of the main amendments since the legal basis for health functional foods was established by law on August 26, 2002, up to the most recent amendment on March 20, 2024 (including the addition of Vitamin K2 as a Vitamin K ingredient). The contents are broadly structured as follows:

1. General Provisions
2. Common Standards and Specifications
3. Individual Standards and Specifications
   1. Nutritional Ingredients
   2. Functional Ingredients [Appendix 1] Random Number Table and Usage Method [Appendix 2] Daily Nutrient Intake Standards [Appendix 3] Nutrient Intake Standards for Koreans [Appendix 4] Application Table for Testing [Appendix 5] Ingredients Not Permitted for Use in the Manufacture of Health Functional Foods

In the General Provisions (Chapter 1), an important section to note is the definition of 'Product Types,' which appears in item 5. You should ensure the product type of health functional foods manufactured domestically or imported from abroad matches the definitions provided, and if in doubt, it’s best to check with the MFDS. Particularly, products available overseas may not be permissible for import into Korea, so it’s crucial to verify in advance.

1. Definitions of Product Forms (1) Tablet: A product compressed into a certain shape. (2) Capsule: A product filled or coated with a capsule base; there are hard and soft capsules. (3) Pill: A product formed into a spherical shape. (4) Granule: A product made into granular form. (5) Liquid: A product in a fluid state or a concentrated form of liquid. (6) Powder: A product with particle sizes smaller than that of granules. (7) Flake: A product in thin, flat fragments. (8) Paste: A semi-solid with strong fluidity, intermediate between solid and liquid. (9) Syrup: A semi-liquid with weak fluidity, intermediate between solid and liquid. (10) Gel: A product made by adding a gelling agent such as pectin, gelatin, or agar to a liquid, resulting in a solid or semi-solid state with fluidity. (11) Jelly: A solid or semi-solid product made by adding a gelling agent such as pectin, gelatin, or agar to a liquid with no fluidity. (12) Bar: A product in the form of a stick. (13) Film: A product made in the form of a thin sheet.
2. Definitions Based on Disintegration Properties (1) Delayed-release Products: Products that do not disintegrate in the acidic conditions of the stomach and only disintegrate in the intestines. (2) Long-acting Products: Products that disintegrate more slowly than regular products, limited to water-soluble vitamins (Vitamin B1, Vitamin B2, Niacin, Pantothenic acid, Vitamin B6, Folate, Vitamin B12, Biotin, Vitamin C).

In the Common Standards and Specifications (Chapter 2), it’s important to note that certain food additives should not be used in health functional foods intended for children.

(1) Colorants (except for coating tablets or capsules): Sodium copper chlorophyllin, Synthetic iron oxide, FD&C Green No.3 and its aluminum lake, FD&C Red No.2 and its aluminum lake, FD&C Red No.3, FD&C Red No.40 and its aluminum lake, FD&C Red No.102, FD&C Blue No.1 and its aluminum lake, FD&C Blue No.2 and its aluminum lake, FD&C Yellow No.4 and its aluminum lake, FD&C Yellow No.5 and its aluminum lake, Titanium dioxide, Caramel color (only for products using ginseng or red ginseng as ingredients) (2) Preservatives: Natamycin, Nisin, Sodium dehydroacetate, Sorbic acid and its salts (Potassium, Calcium) (except for liquid and aloe gel products), Benzoic acid and its salts (Sodium, Potassium, Calcium) (except for aloe gel products), Parabens (Methyl, Ethyl), Propionic acid (except for use as a flavor agent) and its salts (Sodium, Calcium) (3) Bleaching agents: Sodium metabisulfite, Potassium metabisulfite, Anhydrous sulfur dioxide, Sodium bisulfite, Sodium sulfite, Sodium dithionite. (4) Antioxidants: Butylated hydroxytoluene, Propyl gallate, Butylated hydroxyanisole, Tertiary butylhydroquinone, EDTA, EDTA calcium disodium. (5) Aluminum-containing food additives: Sodium-aluminosilicate, Sodium aluminum phosphate, Ammonium aluminum sulfate, Potassium aluminum sulfate.

 

Additionally, the standards and specifications for the form of health functional foods are as follows: (1) Disintegration test standards apply only to tablets, capsules, pills, granules, and film products, following the disintegration test method in Chapter 4, Section 2-1 of the Codex. However, exceptions apply in the following cases: (a) Products intended to be chewed or dissolved. (b) Granule products with less than 5% residue on a 35-mesh sieve (500 μm). (c) Long-acting products [standards submitted by the business operator as per Section 2, Subsection 4(4)]. (2) For liquid products, standard bacterial count regulations (not exceeding 100 per mL) apply, following the general bacterial count test method in Section 8.4.5.1 of the Food Standards and Specifications Guide. Exceptions are as follows: (a) Products using probiotics as functional ingredients. (b) Oil-based products. (c) Sterilized products (in which case the bacterial count must be negative). The MFDS applies these procedures to make suitability judgments on the final product. If there are no predetermined standards, the following guidelines apply, particularly for capsule products where only the contents are assessed.

1. For harmful contaminants like heavy metals, food-borne pathogens, mycotoxins, and radioactive substances, and residues like pesticides and veterinary drugs, suitability judgments follow the Food Standards and Specifications Guide and the Food Additives Standards and Specifications Guide. If relevant guidelines are not available, the standards of the Codex Alimentarius Commission (CAC) may be used. If not available in either, the MFDS can apply standards based on foreign regulations, acceptable daily intake (ADI), and relevant data.
2. Where no official test method recognized by the MFDS exists, relevant guidelines, CAC regulations, AOAC, PAM, and other internationally acknowledged methods can be used with the presentation of the source and method. For soft capsule products' water-soluble vitamin content tests and long-acting product dissolution tests, methods submitted by the business operator may be used, following the guidelines in [Appendix 1] of the Health Functional Food Functional Ingredients and Standards Guide, including validation data.
3. Standards and specifications for capsules apply to the contents, not the capsule base, except for microbial, impurity, disintegration, and visual test items which include the capsule base. For water-soluble vitamin soft capsules, the manufacturer's submitted method may be used.
4. Detection of food additives (including preservatives) derived from raw materials (including capsule bases and coatings) in health functional foods is not regulated if within permissible limits.

Next time, we will continue with Chapter 3, Individual Standards and Specifications.