South Korea Regulatory Overview

With a population of over 48 million people, South Korea represents one of the best and highest value markets for nutritionals and dietary supplements. According to Euromonitor, South Korea ranks fifth in market value for nutritionals at nearly $2.8 billion USD.

The market is Korea is quick to adopt new products and one can find a significant and growing organic market as well as products utilizing DNA tests to support customized nutrition.

The regulatory body responsible for approval of health food products and supplement ingredients is the Korean Food & Drug Administration. Nutritional supplements are regulated under the "Health Functional Food Act" that became law in January of 2004. Under this act, importers of health products/functional foods are required to provide "Import Notification" to import products that are included on a positive list in the Health Functional Food Code. This positive list covers products that may be sold in Korean and contains 37 product groups including nutritional supplements such as vitamins. If the product complies, the Import Notification must be submitted to the Korea Food & Drug Administration with specifications and Certificate of Authenticity to confirm a product's identity and safety. The product must also have the appropriate labeling in the Korean language.

Unlike other markets, the KFDA only issues import notification certificates to locally-based firms in Korea. Therefore, foreign-based importers must work with an approved Korean importer or establish a Korean-registered subsidiary.

If your materials or products are not currently on the approved list of materials allowed in Korea, there is a registration process to get approval. This process is similar to other regulatory processes and typically takes around 1 to 2 years to complete. Information needed when submitting a new registration includes:

1. Origin, developing history, current status of approval and use in domestic or foreign countries
2. Manufacturing methods and related data
3. Characteristics of the ingredients
4. Specification on functional component and date on test method
5. Safety data
6. Functionality contents and related data

South Korea represents a solid market for supplements and a majority of consumers use them daily. As with any market, it will take some time to develop the right relationships that lead to building your business. Being patient and persistent will yield great returns.

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