Takehome:
- Korean functional ingredient reassessment requirements have been clarified to help ensure the safety and efficacy of functional ingredients (including final products) with reference to the latest scientific advancements.
On Nov. 1, 2016, the Ministry of Food and Drug Safety of Korea (MFDS) preannounced the revision of “Regulations for Reassessment of Functional Ingredients”, which will be open to public consultation for 60 days from the circulation of this notification.
The regulation is formulated according to “Functional Health Foods Act”, and aims at establishing the requirements for the standards, methods and procedures of reviewing and assessing the safety and functionality of functional ingredients (including final products) that have been previously approved.
The following data is required during reassessment:
- Relevant efficacy and safety data including human clinical trials etc., market circulation data and supporting literature review
- Safety data including adverse event monitoring, toxicological data, cases collected through distribution, literature information, etc.
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