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Regulatory Partner for Nutrition Industry in South Korea
End-to-End strategic regulatory service provider for Nutrition industry in South Korea.
Artixio is a trusted and leading global regulatory service provider company. With our global experts team and integrated solutions, we help our clients to successfully launch their product by reducing the time to market entry. We provide end-to-end services for nutrition products in the South Korea including product branding and launching strategies, product registration in compliance with regulatory requirements of South Korea, and market strategy as well.
Nutrition Industry in South Korea
The regulatory agency of South Korea, Ministry of Food and Drug Safety (MFDS) established a Food Safety Management System to provide safer food.
In South Korea, the Standards and specifications for Health functional food, was established to set criteria for manufacturing processing, production, import, distribution and preservation of health functional food products.
As per the MFDS South Korea, Health functional foods are products manufactured and processed with functional ingredients or elements useful for human health. Here the term “Functional” means adjustment of nutrients in the human body structure or function, or those that bring useful health effects for e.g., in physiological reaction, etc.
The term “functional ingredient” means 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;
Approval of functional ingredient for Health Functional Food
The approval criteria of functional ingredient is as follows:
- It shall be complied with the Health Functional Food Act; and
- Safety and functionality shall be ensured and scientifically proved.
The approval procedure for functional ingredient with the MFDS, South Korea is as follows
The applicant must submit application to Korea Food and Drug Administration (Korea FDA) to get the functional ingredient approved and notified in South Korea market.
In the step of notification of approval, the Commissioner of the FDA will issue the “Certificate of Functional Ingredient for Health Functional Food”, to the applicant when recognizing the ingredient.
Registration of foreign food facilities
For foreign food facilities exporting their products to Korea, registration to MFDS is mandatory and MFDS on-site inspection is carried out to verify sanitation status of foreign food facilities and to certify eligible establishments as a ‘Good Foreign Food Facility’.
The registration as a foreign food facility to MFDS must be completed before import declaration.
Importers or business operators of foreign food facilities are subject to registration
Applicant must online application through the Imported Food Information Maru (https://impfood.mfds.go.kr)
Letter of consent for registration or an official document proving business registration (in English) is required for submission.
The processing period for application is 3 days.
Registration procedure takes place through following steps
- Application
- Receipt of documents
- Review
- Approval
- Notification of registration
Artixio team provides
- Stepwise guidance approval of a nutrition product in South Korea
- Strategies for compliance with MFDS requirements
- Support throughout product lifecycle
- Product registration and notification requirements
- Global regulatory support
Why Artixio?
nutrition products successfully approved
Product launch strategies by reducing time to market entry
Well-networked with Health Authorities
Global presence
Client focused services
Experts with decades of experience in successful product launch
FAQs
What is the approval timeline for functional ingredient in South Korea?
For the approval of functional ingredient in South Korea, 120 days are required from the date of receiving the documents.
Is there a provision by FDA to modify the contents of the certificate of functional ingredient? If yes, what is the procedure for it?
A person who intends to modify the contents of the certificate must submit the “Application of modification on Certificate of Functional Ingredient for Health Functional Food” to the commissioner of the FDA. Then the commissioner of the FDA will determine whether he accepts the modification under the condition without changing ingredient after reviewing the validity of modification reasons.
What is the applicable fees for approval application of Functional Ingredient for Health Functional Food?
For approval application of Functional Ingredient for Health Functional Food, the applicable fees is 100,000 won.
What is the processing time for application of modification on Certificate of Functional Food Ingredient for Health Functional Food?
5 days processing period is required for application of modification on Certificate of Functional Food Ingredient for Health Functional Food.
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