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On August 10, 2022, the Ministry of Food and Drug Safety (MFDS) issued the latest version of Food Additive Code1, in which the food additives for manufacturing health supplements, amino acids applicable for "milk formulas, etc.", and components of Steviol Glycoside are modified. The regulation came into effect along with its issuance. Imported food shipped after August 10, 2022, shall comply with the new regulation.
1. Adding a New Additive for Manufacturing Enteric-coated Health Supplements
A new food additive Hydroxypropylmethyl Cellulose Phthalate (프탈산히드록시프로필메틸셀룰로스) is newly added in the regulation. It serves as a coating agent for manufacturing enteric-coated capsules, granules, and tablets of Health Functional Foods (HFF).
2. Permitting Calcium Silicate for Health Functional Food Manufacture
Due to Calcium Silicate's high water absorption property, it is permitted to be used in manufacturing tablet- or capsule-formed Health Functional Foods, especially for those using liquid raw materials such as EPA/DHA oil.
3. Amending Amino Acids Used in Milk Formulas
Eleven kinds of Amino Acids are newly specified for manufacturing "milk formulas, etc.":
("Milk formulas, etc." refer to "Milk formulas, Infant formulas, Follow-up formulas, Baby foods for infants/young children, and Special formulas for infants/young children. )
Amino Acids (Previous) | Amino Acids (Present, new additived are marked in red) |
L-Leucine L-Methionine L-Valine L-Cystine L-Arginine L-Isoleucine L-Threonine L-Tryptophan L-Tyrosine L-Phenylalanine L-Histidine | L-Glutamine L-Glutamic Acid L-Glycine L-Lysine L-Lysine Monohydrochloride L-Leucine L-Methionine L-Valine L-Serine L-Cysteine Monohydrochloride L-Cystine L-Arginine L-Aspartic Acid L-Alanine L-Isoleucine L-Threonine L-Tryptophan L-Tyrosine L-Phenylalanine L-Proline L-Histidine L-Histidine Monohydrochloride |
4. Amending the Main Use Purposes of 24 Additives
(1) The major usage purposes of 18 additives are amended as per the latest international standards:
Additives | Amendments for usage purposes |
Guar Gum（구아검） | Newly adding: Emulsifier |
Diacetyltartaric and Fatty Acid Esters of Glycerol（글리세린디아세틸주석산지방산에스테르） | Newly adding: Stabilizer |
Glycerin Esters of Fatty Acids (글리세린지방산에스테르) | Newly adding: Stabilizer |
Lecithin (레시틴) | Newly adding: Antioxidant |
Locust Bean Gum (로커스트콩검) | Newly adding: Emulsifier |
Methyl ethyl cellulose (메틸에틸셀룰로스) | Newly adding: Emulsifier |
Food Starch Modified (변성전분) | Newly adding: Emulsifier |
Vitamin C (비타민C) | Newly adding: Acidity regulator |
Glacial Acetic Acid (빙초산) | Newly adding: Preservative Flavoring agent |
Arabic Gum (아라비아검) | Newly adding: Emulsifier Coating agent |
DL-Alanine (DL-알리닌) | Newly adding: Flavoring agent |
Potassium Lactate (젖산칼륨) | Newly adding: Humectant |
Acetic Acid (초산) | Newly adding: Flavoring agent |
Calcium Acetate (초산칼슘) | Newly adding: Preservative Stabilizer |
Carnauba Wax (카나우바왁스) | Newly adding: Coating agent |
Karaya Gum (카라야검) | Newly adding: Emulsifier |
Calcium Carbonate (탄산칼슘) | Newly adding: Colorant |
Polyglycerol Esters of Fatty Acids (폴리글리세린지방산에스테르) | Newly adding: Stabilizer |
(2) The major usage purposes of six additives are modified to be consistent with the definition.
Additives | Amendments for usage purposes |
Glucono-δ-Lactone (글루코노-δ-락톤) | Tofu Firming agent -> Coagulant |
Magnesium Chloride (염화마그네슘) | Tofu Firming agent -> Coagulant |
Calcium Chloride (염화칼슘) | Tofu Firming agent -> Coagulant |
Crude Magnesium Chloride(Sea Water) (조제해수염화마그네슘) | Tofu Firming agent -> Coagulant |
Magnesium sulfate (황산마그네슘), | Tofu Firming agent -> Coagulant |
Calcium Sulfate (황산칼슘) | Tofu Firming agent -> Coagulant |
5. Modifying the Specifications of Five Food Additives
To increase the sweet taste of Steviol Glycoside, four substances are newly specified as the components of Steviol Glycoside, including Rebaudioside E, Rebaudioside O, Rebaudioside N, and Rebaudioside M.
Besides, the CAS numbers of four additives are corrected:
Additives | Modifications |
Riboflavin 5’-Phosphate Sodium (비타민B2인산에스테르나트륨) | CAS No.: 103-40-5-> 130-40-5 |
Sodium Aluminium Phosphate, Acidic (산성알루미늄인산나트륨) | CAS No.: 7785-88-8-> 0305-76-7 |
Sodium Phosphate, Dibasic(제이인산나트륨) | CAS No.: 7785-79-4-> 7558-79-4 |
Sodium Phosphate, Monobasic (제일인산나트륨) | CAS No.: 7758-80-7-> 7558-80-7 |
6. Other Amendments
Modifications related to food categories are adopted in Food Additive Code2 following the changes of “Food for Special Medical Use”, “Products with Milk”, and “Special Formulas for Infants and Young Children” in Food Code3. Therefore, the food additives’ usage scopes are modified accordingly.
Test methods of nine food additives are optimized.
Twenty-two substances used for disinfecting utensils are deleted.
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