Republic of Korea - : Proposed Amendments for "Regulations for Re-assessment of Functional Ingredients" Ministry of Food and Drug Safety has issued regulation which is pursuant to Article 15(2) of the "Functional Health Foods Act" and Article 20(3) of the Enforcement Rules of the Act, to establish the requirements for the standards, methods, procedures, etc. of reviewing and assessing the safety and functionality of functional ingredients (including final products) that have been previously identified, as well as of health functional foods, to the latest scientific level. · To set forth conditions and methods of re-assessment of functional ingredients · To determine matters related to the publishing of re-assessment results · Related data of functionality contents, including the human study, cases collected through distribution, literature information, etc. · Related data of safety, including adverse event, toxicological data, cases collected through distribution, literature information, etc. · To determine the scope of data of functional ingredients needed to be submitted for their re- assessment To determine matters needed to be taken into account in examining draft proposals for re-assessment Proposed date of adoption: To be determined Proposed date of entry into force: To be determined Final date for comments: 60 days from notification |