New Food Ingredient Application in South Korea

Scope of Recognition of New Food Ingredients

- Agricultural products, livestock products, aquatic products and microorganisms newly used in South Korea;

- Raw materials for food use obtained by extraction, concentration, isolation, culture, etc. from agricultural products, livestock products, aquatic products, and microorganisms;

- Raw materials for use in food obtained through new technologies such as cell culture and microorganism culture:

- Raw materials for foodstuffs using cell culture technology;

- Food ingredients manufactured and processed using genetically modified microorganisms, but not containing genetically modified microorganisms, imported or developed for production for the first time. For example, new food ingredients commonly recognized in recent years include plant extracts, alternative proteins, and HMOs (e.g., 2’-Fucosyllactose).

Procedure of Determination

Application process for new GM food raw materials in South Korea

Time-limited determination of food raw materials & Safety assessment of food raw materials from GM microorganism source (only applicable to GM microbial source).

Supervision department

MFDS，Ministry of Food and Drug Safety

Applicable regulation

• Food Hygiene Law;
• Detailed Rules for the Implementation of the Food Hygiene Law;
• Food and other Time-limited Standards and Specification Identification Standards;

Applicant qualification

South Korean manufacturers or South Korean importers. The identified food raw materials are only valid for the applicant, even if it is the same raw material, without certification, shall not be produced, imported.

Determination effectiveness (protection period)

1. The time-limited standards and specifications have been protected for 3 years from the date of determination;

2. When the time-limited standards and specifications are identified as more than 3 applicants, the protection will be invalid;

3. Applicants who have been recognized as the time-limited standards and specifications shall apply for addition to the food raw material list.

Application materials

• Origin and development process, current certification status at home and abroad, and related information on current usage;
• Manufacturing method related materials;
  • Cultivation and breeding methods of raw materials, etc.,
  • Manufacturing method;
• Raw material characteristics data
  • General components, etc.
  • Usage and purposes,
  • harmful substances;
• Safety data
  • Human impact data;
  • Allergenicity data;
  • Toxicity test data;
  • Intake assessment data.

Application procedure

The following steps will be conducted in order to obtain the registration of your products:

Step 1: Applicant shall prepare the test and the application materials;

Step 2: Fill out and submit the Application Form;

Step 3: Safety evaluation of food ingredients of genetically modified microbial origin by the Ministry of Food and Drug Safety (when applicable);

Step 4: Ministry of Food and Drug Safety shall conduct a review of the time-limited identification of food raw materials;

Step 5: Ministry of Food and Drug Safety shall make a determination decision.

Application timeline

This is typically 1-1.5 years, including the Food and Drug Safety Service's safety evaluation and information supplementation.

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