분야별 정보자료/식품·건강기능식품

REGULATIONS CONCERNING RECOGNITION OF FUNCTIONAL INGREDIENTS AND STANDARDS AND SPECIFICATIONS FOR HEALTH FUNCTIONAL FOODS

식약처 컨설팅 2019. 5. 27. 13:25


Scope of Data to Be Submitted-----------------

Data to be submitted to be recognized as a functional ingredient shall be as follows:
1.An executive summary of all data submitted;
2.Data regarding the origin, the details of development, the current status of recognition and use of the functional ingredient in the Republic of Korea or abroad, etc.;
3.Data regarding manufacturing methods;
4.Data regarding the properties of the functional ingredient;
5.Data regarding specifications and testing methods for functional components (or index component), and a test report;
6.Data regarding specifications and testing methods for hazardous substances;
7.Data regarding safety;
8.Data regarding the details of functionality;
9.Data regarding the intake of the functional ingredient, cautions for ingestion; and the creation thereof;
10.Data verifying that the relevant ingredient is not identical or similar to a pharmaceutical drug.