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Government Legislation

  • Partial Amendment to the Food Additives Criteria and Standards
    • Competent Ministry : Ministry of Food and Drug Safety
    • Advance Publication of Legislation : 2019-03-13
    • Opinion Submission Deadline : 2019-05-12

(1) Reasons for Proposal

In light of cases where nitrous oxide permitted as food additives has been directly inhaled, this proposal aims to amend the Food Additives Criteria and Standards to: prevent misuse of nitrous oxide by newly inserting manufacturing criteria so that containers in the form of cartridges are not used; clarify regulations on types, etc., of food additives used in cultivation of microorganisms, etc., for edible purposes by newly inserting general usage criteria; amend relevant usage criteria by taking into account the comprehensive amendments to the food types in Food Criteria and Standards; and amend the list of food additives usable in infant food as well as the list of origin material used in natural flavors, while aiming to improve the composition standards regarding six (6) items including sodium L-glutamate, etc., and the sanitizer efficacy test of sanitizers of instruments, etc.

(2) Major Provisions

A. New Insertion of Manufacturing Criteria on “Nitrous Oxide” Containers

1) Recognize that there is a need to limit containers to prevent misuse where nitrous oxide is directly inhaled.
2) Newly insert manufacturing criteria that limit nitrous oxide containers in the form of cartridges (II. 1. 5).
3) Expect that public health will be ensured by preventing misuse of nitrous oxide.

B. New Insertion of General Usage Criteria on Food Additives Used in Cultivation of Microorganisms, etc.

1) Recognize that there is a need to clarify regulations on matters such as types and usage criteria of food additives used in cultivation of microorganisms, etc.
2) Newly insert general usage criteria on the scope and usage criteria of food additives which may be used in cultivation of microorganisms, etc. (II. 2. 4)
3) Clarify regulations on food additives which may be used in cultivation of microorganisms, etc., thereby energizing the food industry and enhancing the understanding of civil petitions.

C. Amendment of Composition Criteria of Six Items Including “Glutamic Acid,” etc.

1) Recognize that there is a need to substitute hazardous reagent with low-toxic reagent and align composition standards with international standards.
2) Improve testing method of pyrrolidone carboxylic acid in purity test of three (3) items including “L-glutamic acid,” etc. (II. 4. A. L-Glutamic Acid, Ammonium L-Glutamate, Potassium L-Glutamate).
3) Improve testing method of identification test, purity test, quantitative method, etc., of three (3) items including “annatto, water-soluble,” etc. (II. 4. A. Annatto, Water-Soluble, Vitamin B12, preservative products).
4) Protect the health of investigators and comply with international standards through improvement of testing methods.

D. Change of Names, etc., of Origin Material Used in Natural Flavors

1) Recognize that there is a need to make changes to the names of original material used in natural flavors including statement of their Korean names, etc.
2) Change the names and/or scientific names of 59 types of original material used in natural flavors (II. 4. A. Natural Flavors).
3) Clarify information on original material of natural flavors.

E. Amendment of Usage Criteria Regarding 13 Items Including Potassium Hydroxide, etc.

1) Recognize that there is a need to ensure alignment with amendments to food types and amend usage criteria regarding food additives which may be used in infant food.
2) Amend usage criteria of 11 items including copper gluconate, etc., to take into account the unification of cereal-based infant food and other infant food into infant food (II. 5. A. Copper Gluconate, Manganese Gluconate, Zinc Gluconate, Ferrous Gluconate, Vitation K1, 5’-Cytidylic Acid, Disodium 5’-Cytidylate, 5’-Adenylic Acid, Disodium 5’-Uridylate, Copper Sulfate, Zinc Sulfate)
3) Align usage criteria of potassium hydroxide, among usage criteria of food additives which may be used in infant food, with usage criteria according to item, and transfer heme iron to the list of food additives used for nutrition enhancement (II. 5. C. (1), (2)).
4) Enhance understanding of civil petitions by aligning food types with those in the Food Standards Codex and clarifying usage criteria of food additives.

F. Improvement of Sanitizer Efficacy Testing Method

1) Recognize that there is a need to make amendments to enhance the understanding of sanitizer efficacy testing methods and the ease of performing such tests.
2) Improve sanitizer efficacy testing method among general testing methods (IV. 37.).
3) Improve convenience of test analysis.

G. Improve Regulations on Materials to Be Submitted on Safety In Case of New Designation of Food Additives

1) Recognize that there is a need to clarify regulations on the scope of materials to be submitted on the safety of new designations of food additives.
2) Newly insert regulations stating that, when food additives accepted as processing aids are used for other purposes, materials on safety shall be additionally submitted in the same manner as in the existing case of food additives ([attached Table 1]).
3) Improve public health by ensuring the safety of food additives.



Regulatory effect assessment
  • 규제영향분석서(e-규제영향분석서 등록본).hwp [download]
Legislative proposal (draft)
  • ☆식품첨가물의 기준 및 규격 일부개정고시(안)_행정예고(최종).hwp [download]