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MFDS Rolls Out New Mechanism to Expedite Approval of Health Foods

In order to expedite the approval of health foods (also known as health functional foods), South Korea will help enterprises confirm whether they need to apply for approval of functional claims and will also inform enterprises of the application materials required. To protect consumers MFDS will also conduct more rigorous investigations of all applications and ensure therapeutic or clinical efficacy claims are not used.

On Nov. 6th, MFDS released a guideline [1] introducing a new consultation service to help enterprises expedite approval of functional foods. On Nov. 13th, NIFDS (The National Institute of Food and Drug Safety Evaluation) released a brief report [2] detailing the implementation procedures. Here’re the content.

Necessity of introducing a consultation service

In South Korea, it has generally taken the government around 120 days to assess functional food ingredients and issue results (this step excludes time required to conduct safety review, etc.). However, if the scientific evidence supporting the application is deemed insufficient during the review the application is rejected, requiring applicants to start the whole process again. This results in significant time and resources wasted for both the applicant and the government. 

Procedures for implementing the new consultation mechanism 

  • Preparation stage:

The expert team will help judge if your case fits consultation criteria 
  • Consultation stage: 

The government will consult with applicants and provide guidance.
  • Processing stage: 

Business operators can apply for approval of functional claims on products. 


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