분야별 정보자료/식품·건강기능식품

MFDS to Overhaul Food Additive Classification System and Ease Regulations on Nutrient Fortifiers(Administrative Notice Issued on July 22)

식품 및 건강기능식품 인허가 컨설팅 2025. 7. 23. 11:13

The Ministry of Food and Drug Safety (MFDS) announced a comprehensive revision to the “Standards and Specifications for Food Additives,” aiming to restructure the classification system of food additives based on their intended use and relax regulations on nutrient fortification ingredients.


🔑 Key Amendments:

Reorganization of the Food Additive Classification System

  • In alignment with EU and Codex standards, food additives will now be classified into three distinct categories based on their function:
    • General Food Additives
    • Processing Aids
    • Nutrient Fortifiers
  • Each category will have dedicated general standards and item-specific standards, allowing for a more systematic and transparent regulatory framework.

Relaxation of Usage Restrictions for Seven Nutrient Fortifiers

  • Seven ingredients, including Zinc Gluconate and Vitamin K1, which were previously limited to use in health functional foods or special medical purpose foods, will now be allowed in general foods:
    • Vitamin K1, Vitamin K2, Chromium Chloride, Manganese Gluconate, Zinc Gluconate, Zinc Sulfate, Sodium Ferrous Citrate
  • This change responds to growing consumer demand for personalized nutrition and nutrient-enhanced general foods.
  • Ten existing ingredients, such as Vitamin B2 and Magnesium Oxide, currently classified only as nutrient fortifiers, will now have additional technical uses recognized internationally (e.g., as coloring agents or anti-caking agents):
    • Example ingredients: Vitamin B2, Magnesium Oxide, etc.
  • These expanded uses will be newly added to reflect global practices and ensure regulatory harmonization.

③  Approval of Modified Hop Extract for Use in Non-Alcoholic Beer

  • The use of modified hop extract, known for providing beer’s distinctive bitterness, will now be permitted in the manufacture of non-alcoholic beer, expanding its applicable product scope.

④  International Harmonization of Specifications for 39 Enzymes

  • The definitions of 39 enzyme products will be improved by:
    • Clarifying reaction mechanisms and resulting products
    • Adding international classification numbers and synonyms
  • This aims to simplify the verification process for importers and manufacturers when determining whether a specific enzyme is approved for use in Korea.

「식품첨가물의+기준+및+규격」+전부개정고시(안)_공고+제2025-316호(2025.7.22).pdf
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