Health functional foodproducts

Proposed Amendments for "Regulations for Re-assessment of Functional Ingredients"(13 pages, available in Korean)

Main proposed amendment of the "Regulations for Reassessmentof Functional Ingredients" as follows:This regulation is pursuant to Article 15(2) of the "Functional Health Foods Act" andArticle 20(3) of the Enforcement Rules of the Act, to establish the requirements for thestandards, methods, procedures, etc. of reviewing and assessing the safety andfunctionality of functional ingredients (including final products) that have been previouslyidentified, 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, casescollected through distribution, literature information, etc.- Related data of safety, including adverse event, toxicological data, casescollected through distribution, literature information, etc.- To determine the scope of data of functional ingredients needed to be submitted fortheir re-assessment- To determine matters needed to be taken into account in examining draft proposalsfor re-assessment