Food Compliance
Intelligence & Solutions
South Korea Health Functional Food Regulation
Oct 27, 2022
Lorraine T.S. Li
Pedia Details Our Service Read More
CONTENTS

1. Definition

The term "health functional foods (건강기능식품)" means foods manufactured with functional raw materials or ingredients beneficial to human health. 

2. Competent Authority

Competent authority

Responsibility

Ministry of Food and Drug Safety (MFDS, formerly known as the Korea Food & Drug Administration or KFDA)

Law making

New ingredient and standard registration

Business and facility registration

3. Market Access Approval

3.1 Essential Prerequisite for Import

Only health functional foods that meet corresponding standards in Health Functional Food Code or have been recognized by MFDS are allowed to be exported to South Korea.

3.2 Business Registration

Overseas company intending to sell food products to South Korea shall register the import business with MFDS or appoint an agent to conduct business registration.

3.3 Foreign Food Facility Registration

As stipulated in Imported Food Act, foreign food facility registration (해외제조업소 등록) is mandatory for all imported food products. Business entities shall apply for foreign food facility registration to MFDS before exporting.

3.4 Import Declaration

Business entities shall file an import declaration of relevant foods with MFDS. The product type, business entity, import amount, ingredient list, and other food information need to be indicated in the application letter.

3.5 Import Inspection

The imported foods whose import declaration has been filed, are subject to import inspections before customs clearance formalities. MFDS adopts four types of imported inspections: document inspection, on-site inspection (sensory test), thorough inspection (the strictest inspection), and random sampling inspection. Foods imported to South Korea for the first time, must undergo a thorough inspection.

3.6 Traceability of Imported Food

The "traceability of imported food" is to control and track the imported food's information at every step from importation to sale, so necessary measures can be taken immediately when food safety issues occur.

Imported foods subject to traceability are:

  1. Infant and children food

  2. Health functional foods

  3. Manufactured milk products

  4. Food for pregnant or lactating women, foods for special medical purpose and manufactured food for weight control

  5. Other imported food for which a business entity voluntarily registers traceability

Recommended resources:

4 Product Compliance

4.1 Product Requirements

Raw materials used in a health functional food can be:

No.

Category

Notes

1

Functional materials (including noticed and individually recognized materials):

 a. Functional ingredients (e.g. vitamins, dietary fibre)

 b. Functional raw materials (e.g. lecithin, ginseng)

Shall comply with Health Functional Food Code

2

General food materials

Shall comply with Food Code

3

Food additives

Shall comply with Food Additive Code

New functional ingredients shall be recognized by MFDS following the provisions under Regulation on Certification of Functional Ingredients and Specification before being used in health functional food manufacturing.

4.2 Label

With reference to Act on Labeling and Advertising of Foods, registered business entity’s name and address, functional material’s information and contents, nutrition facts label, a health functional food mark, and other basic items should be placed on the package in Korean. Enterprises can put a sticker( or label or tag) on the food package. The sticker should not be easy to be peeled off.

Regardless of food categories, the label and advertisement shall not involve any information implying the food is a drug, or a non-health functional food is a health functional food. Fraudulent labelling, morally wrong labels, labels that compare the product with other company’s products, and labelling food as a product that is not food (e.g., cosmetic) are all prohibited as specified in the Act on Labeling and Advertising of Foods.

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ChemLinked has helped hundreds of global food enterprises in terms of market access. Please feel free to contact us if you need assistance on health functional food import declaration, new ingredient application, foreign food facility registration, or any consultation service.