1. Definition
The term "milk formula (조제유류)" or “infant formula” refers product that is processed to resemble the composition of breast milk by adding nutrients such as minerals and vitamins necessary for infants and young children's growth. The main material of infant formula is crude milk or dairy products. Infant formula is under the special nutritional foods category in South Korea, which is also a livestock product at the same time.
2. Competent authority
Competent authority | Responsibility |
Ministry of Food and Drug Safety (MFDS, formerly known as the Korea Food & Drug Administration or KFDA) | Law Making New ingredient and standard registration Business registration |
3. Market access approval
3.1 Essential prerequisite for import
Only the milk formula that meets the corresponding standards in Food Code can be exported to South Korea.
3.2 Business Registration
Overseas companies intending to sell products to South Korea shall register the import business with MFDS or appoint an agent to conduct the business registration.
The import business registrations include four types:
1. Business of importing and selling imported food, etc. (referring to the business of importing and selling imported food, etc.);
2. Business of filing import declarations of imported food, etc. by proxy;
3. Business of online purchasing of imported food, etc. by proxy;
4. Business of storing imported food, etc.
3.3 Foreign Food Facility Registration
As stipulated in the Imported Food Act, foreign food facility registration (해외제조업소 등록) is mandatory for all imported food products. Business entities shall apply for foreign food facility registration to MFDS before exporting.
3.4 Import Declaration
The business entity shall file an import declaration of the relevant foods with the MFDS. The ingredient information needs to be filed in the import declaration application letter.
The submission dossier for import declaration includes an application letter along with the following:
1. A wrapper printed in Korean (including wrappers to which a label printed in Korean is attached) or a document mentioning content in Korean; 2. A test or inspection report (applicable to imported foods subject to a thorough test); 3. GMO food relevant certificates (applicable for food using GM materials); 4. A statement of reasons for setting the expiration date (applicable to OEM); 5. An exporting plan (applicable to the importation of raw materials for earning foreign currency); 6. A copy of the business approval or manufacture item report (applicable to the importation of raw materials for earning foreign currency); 7. Other supplementary certificates required by MFDS |
3.5 Import Inspection
The imported foods whose import declaration has been filed, are subject to necessary inspections before customs clearance formalities for the products. MFDS adopts four types of imported inspections: document inspection, on-site inspection (sensory test), thorough inspection (strictest inspection), and random sampling inspection. Foods imported to South Korea for the first time, must undergo a thorough inspection.
Recommended resources |
4. Product Compliance
4.1 Product requirements
(1) Raw materials in infant formula can be:
No. | Category | Note |
1 | Main materials: crude milk or dairy products | Shall comply with Livestock Products Sanitary Control Act |
2 | General food materials | Shall comply with Food Code |
3 | Food additives | Shall comply with Food Additive Code |
Note that irradiated food materials cannot be used for manufacturing infant formula.
(2) Product type
There are two types of infant formula in South Korea, namely, milk formula for infants(영아용 조제유) and milk formula for growing-up infants(성장기용 조제유).
a. Milk formula for infants(영아용 조제유) | Powdered product(60.0% or more of milk component) or ready-to-eat liquid product (9.0% or more of milk component) that is manufactured and processed similarly to breast milk. It serves as a substitute for breastfeeding when it is difficult to breastfeed |
b. Milk formula for growing-up infants(성장기용 조제유) | Powdered (60.0% or more of milk component) or liquid (9.0% or more of milk component) processed for infants and children aged six months or older. |
The standards of calories, water, cruel protein, crude fat, linoleic acid, carbohydrates, and other nutrients, as well as the specifications, are detailed in Article 10-1 of Chapter 5 under Food Code.
4.2 Label
With reference to the Act on Labeling and Advertising of Foods, the product name, contents, ingredients, registered business entity’s name and address, precautions, expiration date, package material, and other items should be marked on the product package in Korean. Enterprises can put a sticker/label/tag on the imported foods. The sticker should not be peeled off easily.
To be noticed, infant formula must be labeled with the statement "Breast milk is the best food for babies (모유가 아기에게 가장 좋은 식품입니다)".
If the product is sterilized or disinfected, it shall be labeled as "sterilized (살균제품)" or " disinfected(멸균제품)" accordingly. The sterilization temperature or disinfection temperature and time shall also be indicated. Products to showcase low-temperature long-time sterilization or high-temperature short-time sterilization can be labeled as "pasteurization(파스퇴라 이제이션)". For products treated by fermentation and heating, they should be labeled as " fermented and heated product (발효후 가열처리 제품)". For detailed requirements for infant formula labeling, please refer to Food Labeling Standards.
Regardless of food categories, the label and advertisement shall not involve any information implying the food is a drug, or a non-health functional food is a health functional food. Fraudulent labelling, morally wrong labels, labels that compare the product with other company’s products, and labelling a food as the product is not a food (e.g., cosmetic) are prohibited as specified in the Act on Labeling and Advertising of Foods.
* Global Food Compliance Service
We provide various market entry services to help stakeholders better understand exporting requirements, establish business and secure a competitive place to facilitate trade development.
Covered Countries
China, Thailand, Vietnam, Singapore, Malaysia, Philippines, Indonesia, Japan, South Korea, United States, European Union, Australia, New Zealand etc.
Our Services
Food Ingredient Review
Label Review
Product Registration
Regulatory Consultation
Monitoring, Training and customized report
Please feel free to contact us via food@chemlinked.com if you need any help.
