South Korea

I. HEALTH FUNCTIONAL FOODS

Pursuant to the Health Functional Food Act, “health functional foods” are defined as “foods manufactured with functional raw materials or ingredients useful for the human body”.

 It follows that the term “functionality” means controlling nutrients for the structure or functions of the human body or providing useful effects for hygienic purposes, such as physiological effects.

The term ´Functional ingredient´ is further defined in Regulation on Approval of Functional Ingredient for Health Functional Food as “any ingredient with functionality used in manufacturing of health functional food such as raw materials from animal, plant or raw material originated from microorganisms; its extracts and purified substances; vitamins and minerals; or their synthetics or composites, etc”

 The are no restrictions as to the form of presentation other than that the health functional food should be easy for intake per serving. The following examples are given; a form of capsule, tablet, powder, granule, liquid, pill, paste, syrup, gel, bar, etc.

II. REGISTRATION OF HEALTH FUNCTIONAL FOODS

(i) Business License

A locally registered partner with a corresponding business license is necessary in order to register a health functional food; this demands the local entity is eligible for a business license, it complies to national standards and it notifies the intended activities to the local district (“Gu”, Article 4-13 Health Functional Food Act).

(ii) Type of registration

Any person wishing to import health functional foods, needs to file a declaration with the Korea Food and Drug Administration (FDA) (Article 8 Health Functional Food Act). A distinction is made for products containing substances included in the positive list [the Health Functional Food Code] - subject to simple notification - and substances which have not been approved which are subject to registration.

(iii)Approval of functional ingredients

The approval of new functional ingredients is further elaborated upon in the Regulation on Approval of Functional Ingredient for Health Functional Food.

Article 4 of the Regulation requires (i) that the food complies with the Health Functional Food Act, and (ii) that the safety and functionality shall be ensured and scientifically proven.

The applicant should complete the provided form together with the following files:

• Two copies of the required documentation [See following subsection ´Documentation´] (including original copy)
• A CD containing the documentation
• A sample of the product or test product and the standard of function component (or marker compound)
• Written result of examination issued by a domestic [Korean] health functional food examination laboratory

(iv) Documentation

Only in the case of new functional foods/substances, data needs to be submitted. Article 12 of the Regulation on Approval of Functional Ingredient for Health Functional Food lists to following documents to be submitted:

• Executive summary of all submitted documents
• Origin information: developing history, current history of approval and use in domestic or foreign countries, etc..
• Manufacturing methods and related data
• Characteristics of the ingredients
• Specification functional component (or marker compound) and data on test method
• Specification on hazardous substances and related data for test method
• Safety
• Functionality contents and related data
• Consumption amount, consumption method, warning notice for consumption and related data for such establishment
• Confirmation data that the ingredients are not identical with or similar to medicine

A detailed description per aspect of required documentation can be found under article 13 of the Regulation.

The Regulation also establishes the formal requirements that the documents are marked with a table of contents, index number, and document number according to their sequence per section. In case one of the required documents cannot be provided, the reasons should be stated and included in the relevant section.

An original copy and executive summary shall be submitted together with a Korean translation of the documents. However, the latter requirement does not apply if the documents are in English. The provided documents will be treated confidentially.

(v) Outcome and time-line

The procedure for approval of a functional ingredients will take 120 days from receival of the application. The FDA may however request additional information in which case a supplementary period will be determined. In case the product cannot be approved or no additional documentation is submitted, the reasons for denial will be stated and the dossier will be returned to the applicant (articles 6-10 of the Regulation on Approval of Functional Ingredient for Health Functional Food).

If approved, the Commissioner of the FDA will issue a ´Certificate of Functional Ingredient for Health Functional Food´. The certificate can provide for an exclusive use of the substance (´data protection´) for a period of 5 year.

(vi) Modifications

The contents of the Certificate may be amended through an ´Application of Modification on Certificate of Functional Ingredient for Health Functional Food´.

III. CONTENT AND COMPOSITION OF HEALTH FUNCTIONAL FOOD

(i) Nutrients

Nutrients in the sense of the Code comprise vitamins, minerals, dietary fiber, protein and essential fatty acids.

Under II of the Health Functional Food Code (Standards and specifications for each functional ingredient) the allowed sources, specifications, prerequisites for the use of health claims and testing methods are specified. The following general rules apply:

• Vitamins and minerals included in the Code may be combined.
• Minimum level of each vitamin/mineral per daily portion of the product, shall be 30% of the DRI values established in Annex to the Code (applicable to general population or specific target group).
• If a product contains 30% or more of the DRI values of a vitamin/mineral, the substance shall be presented among the nutrition facts.
• It is not required to provide a claim for each of the substances included in a product.
• The sources should comply with purity criteria established in the Code or in the Additives Regulation.

(ii) Functional ingredients

The second branch (II.2) of the Health Functional Food Code lists the approved functional ingredients.

Functional ingredients are either (i) Materials originated from animal, plant, microorganism or water, etc., (ii) an extract or purified substance of any ingredient described in subparagraph of ´i´, (iii) a synthetic duplicate of purified substance of any ingredient described in ´ii´ or (iv) a combination of any of the former.

Under the Health Functional Food Code, they are categorized as Terpenes (II.2.1), Phenols (II.2.2), Fatty acids and lipids (II.2.3), Sugar and carbohydrates (II.2.4) and Fermentation organisms (II.2.5).

(iii) Additives and excipients

Article 38 of the Health Functional Food Act determines that the provisions on standards and specifications for food additives under article 7 of the Food Sanitation Act applies mutatis mutandis to food additives used for health functional foods.

IV. MANDATORY LABELLING REQUIREMENTS OF HEALTH FUNCTIONAL FOODS

Article 17 of the Health Functional Food Act entails the basic labelling requirements for health functional foods. The following elements are mandatory:

(i) The word ‘Health Functional food’ or a diagram showing health functional food

(ii) Indication of the functional ingredients or nutrients and their proportion to dietary reference intake (where it exists)

(iii) Directions for use (including daily recommended portion) and precautions regarding the consumption of health functional foods

(iv) Expiration date and storage instructions

(v) Indication that health functional foods are not medicines intended for prevention of treatment of disease

(vi) Other indications which may be prescribed by the Commissioner of the FDA

V.   USE OF CLAIMS IN HEALTH FUNCTIONAL FOODS

By virtue of article 16-1 of the Health Functional Food Act, the use of claims (labelling the functionality of a health functional food) requires prior deliberation by the FDA - and industry organizations.

If the outcome of the deliberation is negative, an appeal can be brought with the FDA within one month from the date the decision was notified.

Authorized health claims for nutrients and other functional ingredients are listed in the Health Functional Food Code. The allowed claims are indicated per substance together with the conditions of use.