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All You Need to Know about the S. Korean Dietary Supplement Ingredients: Understanding the Requirements of Health Functional Foods Ingredient

Functional ingredients of Korean health functional food (dietary supplement) include noticed ingredients and individually recognized ingredients. The noticed ingredient list is provided by ChemLinked Translation. The procedures and methods on how to apply for individually recognized ingredients are listed below. The market trends and potential opportunities are also presented.

The dietary supplement is referred to as Health Functional Food (HFF) in South Korea, which is a category with massive potential as reported by Korea Functional Food Material Information System [1] who reported that the import value had been increasing from 2014 to 2018 with a YOY of 10.5%. During Covid-19, the demand amongst Korean consumers for health functional foods blew up in popularity. According to Statista's report, the sales of health functional products skyrocketed to 579% from January 27 to February 11, 2020 [2] (See Figure 1). The sales of vitamin products grew over 2,000% compared to the previous year.

f1-health-functional-food.jpg

(Figure 1. Sales of functional products from January 27 to February 11, source: Statista Research Department)

HFF is food manufactured with functional raw materials or ingredients. From the definition of HFF, we can tell the ingredient compliance is on the front burner for the manufacturing the HFF products. However, the requirements of HFF ingredients are complicated. So to help enterprises transcend the regulatory obstacles, this article will focus on a comprehensive introduction to the South Korean HFF ingredients.

1. Mandatory Requirements

Superordinate laws:

Health Functional Food Act [3]

Enforcement Decree of Health Functional Food Act [4]

Enforcement Rule of Health Functional Food Act [5]

 

Supporting regulations:

Health Functional Food Code [6]

Regulation on Certification of Functional Ingredients and Specification   [7]

Labelling Standard of Health Functional Food [8]

Above are the laws and requirements of HFF in South Korea, amongst which the Health Functional Food Code [6] belongs to, though it's a supporting regulation, it is the primary standard for entities for reference. It details the standards and specifications for manufacturing, testing, importing, storing, and selling HFF in Korea. Manufacturing that follows the requirements stated in Health Functional Food Code [6], enterprises can sell or import HFF without a pre-evaluation. (S. Korea Health Functional Food Code contains standards and specifications of different ingredients. No official English version has been published so far but ChemLinked provides translation services, and you can choose to translate only the parts needed. Please contact us via food@chemlinked.com.)

Health Functional Food Act [3], along with its enforcement decree [4] and enforcement rule [5], regulates the overarching policy of HFF, such as the supervision department, the subordinate regulations, etc. The Regulation on Certification of Functional Ingredients and Specification [7] specifies the certificate requirements. The Labeling Standard of Health Functional Food [8] states the provisions about labelling an HFF product.

2. Functional Materials

As stipulated in Article 2 of Health Functional Food Code [6], an HFF product contains functional materials, general food materials, and food additives:

No.

Category

Note

1

Functional Materials (including noticed and individually recognized materials):

  1.  Functional Ingredients (e.g. vitamins, dietary fiber)

  2.  Functional Raw Materials (e.g. lecithin,   ginseng)

Shall comply with Health Functional Food Code [6]

2

General Food Materials

Shall comply with Food Code [9]

3

Food Additives

Shall comply with Food Additive Code [10]


2.1 Noticed Ingredients

As previously mentioned, when manufacturing products with the notified functional materials following the manufacture process and methods under the Health Functional Food Code [6], the enterprise could sell or import the products in or to South Korea directly. MFDS has notified twenty-eight nutrient ingredients and sixty-eight functional raw materials so far.

It's highly recommended that overseas enterprises confirm the ingredient list prior to exporting dietary supplement business to S. Korea.(Find the whole list at ChemLinked Translation: South Korean Health Functional Food Ingredients [11]).


2.2. Individually Recognized Ingredients      

To produce or import HFF with “non-notified ingredients”, the entities shall apply for a certificate for the effectiveness and safety of the relevant functional material. Until now, MFDS has reviewed and published more than 500 kinds of individually recognized ingredients.

Note that only the applicant can use the relevant recognized ingredients.


2.2.1 Application for Individually Recognized Ingredients Certificate

Following Regulation on Certification of Functional Ingredients and Specification [7], the manufacturer or importer shall submit the following four application materials to MFDS to evaluate the effectiveness and safety of the relevant ingredient: 

(1) Application letter, including the company name, major business, product information, and other necessary information of the enterprise.

(2) Dossiers:

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