Overview:
The revision strengthens safety management standards for 8 functional ingredients.
INTRODUCTION
The Ministry of Food and Drug Safety of Republic of Korea announced an advance administrative notice on revision of Standards and Specifications for Health Functional Food, which include addition of warning notice for intake of 8 functional ingredients:
Ginseng, red ginseng, chlorella, milk thistle extracts, marigold flower extracts, indigestible maltodextrin, aloe gel and MSM (Methyl sulfonylmethane)
This revision reflects the results of re-evaluation of safety, functionality and analysis conditions of the test method of these products.
MAJOR REVISIONS
Add warning notice for intake of 8 types of functional ingredients:
- The expression “Consult a health care practitioner and stop intake if you are having adverse event” was added to warning notice;
- For people with sensitive condition, vulnerable groups, patients with certain diseases and those taking medicines, warning notice was added to be careful when consuming each functional ingredient.
Change daily intake amount of indigestible maltodextrin and aloe gel:
The alteration was based on the results of the re-evaluation of safety and functionality.
Strengthen lead specifications of chlorella from 3.0 mg/kg to 1.0 mg/kg.
Vitamin K2 (Menaquinone, MK-7) was added as ingredient for Vitamin K.
Establish simultaneous analysis method for catechin and caffeine:
The test method for pantothenic acid (vitamin B5) was clarified.
REFERENCES
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.