Title : Regulation and current status of temporary approval of novel food ingredient in the Republic of Korea
S ince 2010, Ministry of Food and Drug Safety (MFDS) has conducted the safety evaluation of novel food ingredients according to the regulation ‘Temporary Standards and Specifications for Food Ingredient’. Novel food ingredients mean the ingredient which is no history of taking it as a food in Korea, and include the agricultural, livestock, marine products and microorganisms newly used in Korea not only that the ingredients produced by extraction, separation and cultivation of those raw materials. Applicants could be anyone wants to approve as novel food ingredient including food processors, food importers, researcher and so forth. Data required for submission to approval of novel food ingredient are the scientific name, development details of original substances, domestic/overseas approval/use situation, method of manufacture, characteristics of applied ingredient and safety information (toxicity test data, safety and allergy information data and dietary exposure data, etc.). By 2017, a total of 24 ingredients, including 10 cases of plant origin, 4 cases of insect, 6 cases of allulose, and 3 other cases, are approved as novel food ingredients. And, the approved ingredients are only available to those who are approved until those ingredients are registered in Food Code. Of 24 ingredients, 4 cases of insect are available to anyone wanting to produce, process and manufacture, because of registration in Food Code. In order to provide convenience and efficacy to applicants, MFDS issued the ‘Safety Evaluation Guidelines for Novel Food Ingredients and has operated the prior consultation system.