Korea | Newly Revised Health Functional Food Code (No. 2018-12)
In accordance with the requirement to apply the use of “Good Manufacturing Practice (GMP)” standards from the Health Functional Food Act, previous regulations pertaining to its recommended use shall be deleted and the ingredients which can be used for the coating for enteric capsules, granules and tables shall be clarified.
The provisions of the appraisal rule in which the standard value is set in the range (a to b) are revised to be same as the provisions of the Food Code; the raw material name of Lutein shall be revised in order to avoid confusion among people engaged in food preparation.
This amendment will make it possible to apply lead and cadmium standards to functional raw materials for which heavy metal standards have not been established, and to set the standards for peracidity and peroxide value for EPA and DHA containing fats and oil to contribute to the safety of health functional food.
Individually recognized functional raw materials meeting the requirements for additional listing of functional raw materials in the "Standards and Specifications for Health Functional Foods" will be notified and contribute to the expansion of consumer’s selection by promoting the industry through the production and distribution of various products.
The Ginsenoside test method has been revised and new analytical method for Threonic acid to improve the efficiency and reliability of analysis has been established.
Main Revisions
Deletion of recommendations to manufacture in accordance with the "GMP"
standards
Regulations recommending the use of GMP has been deleted as it is now mandatory as required by the 「Health Functional Food Act」 to comply with the “GMP” standards (Article 22 of the Health Functional Food Act, effective from Dec 18, 2018).
Clarification of the basis of substances that can be used in capsule capsules, granules and tablets
To use ingredients that conform with this notice in accordance with the Pharmaceutical Affairs Law for enteric and enteric film coating, Table 7 of the “Approval, Submission, Examination Regulations for Pharmaceutical Items”.
Establishment of lead and cadmium standards for functional raw materials without heavy metal standard
Revised to apply lead and cadmium standards for functional raw materials that do not have individual heavy metal specifications
The provisions of the appraisal rule in which the standard value is set in the range (a to b) are revised to be same as the provisions of the Food Code. The revised 'a to b' will be defined as “above a ~ below b).
Establishment of specifications and standards of peracidity and peroxide value for EPA and DHA containing fats and oils
Establishment of standard of peracidity and peroxide value in order to manage oxidation and rancidity of fats and oil.
Revision of raw material name of Lutein
Revision of the ingredient name of Lutein to "marigold flower extract"
Conversion of individual functional raw materials and test method of functional (index) ingredient of copper extract
Establishment of new specifications and standards for extracts of pagoda tree fruit and analytical method for Sophoricoside.
Amendment and establishment of new analytical method
Specify detailed pre-treatment procedures for cases where the sample contains a large amount of excipients in the Ginsenoside analytical method.
Establishment of new analytical method of Threonic acid for Calcium Ascorbate containing Threonic acid (< 2% Threonic acid)