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Selling infant formula and baby food in South Korea

In South Korea, baby food is regulated by the Ministry of Food and Drug Safety (MFDS). The Livestock Products Sanitary Control Act lists milk formula among processed milk products, and the Food Sanitation Act covers food generally. Baby food makers, larger formula sellers and infant formula importers register traceability.

Updated · Each section links to the official source it comes from

Regulator
Ministry of Food and Drug Safety (MFDS)
Milk formula
Processed milk product (축산물 위생관리법)
Other baby food
Food under the Food Sanitation Act
Traceability
Registration required for baby food makers and formula importers
Records kept
At least two years past the use-by date
Labelling
Act on Labeling and Advertising of Foods

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Is the product a milk formula under the livestock products law, or a food under the Food Sanitation Act? Read more
  2. 2Does it meet the MFDS standards and specifications for its type? Read more
  3. 3Does the label carry the required particulars and the nutrition label? Read more
  4. 4Is traceability registered, and is the traceability label on the pack? Read more
  5. 5Is the foreign facility registered, and is each consignment declared? Read more
  6. 6Who recalls the product if it turns out to be harmful? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

Which law covers the product

Milk formula and other baby food sit under different MFDS Acts.

  • "Processed milk products" include milk, powdered milk, milk formula, fermented milk, butter and cheese, as prescribed by Presidential Decree (Article 2, Livestock Products Sanitary Control Act).
  • The Food Sanitation Act defines "foods" as all types of foods and beverages, other than those taken as medicine, and names manufacturers and processors of baby food in its traceability rules (Article 49).
  • The Act on Labeling and Advertising of Foods covers food, food additives, health functional foods and livestock products alike (Article 2).

How we help: Compliant Always records which Act each product is sold under, with the specification that places it there. Ask about this

Standards and specifications

What the product is made, packed and stored to.

  • MFDS may set standards for processing, packaging, storing and distributing livestock products, and specifications for their ingredients; products that fail them may not be sold, stored or displayed for sale, and the same applies to imports (Article 4, Livestock Products Sanitary Control Act).
  • Livestock product processing businesses obtain permission from the Mayor/Do Governor for each place of work (Article 22), and those prescribed by Prime Ministerial Decree comply with HACCP (Article 9).
  • For other foods, MFDS publicly notifies standards and specifications, and food that fails them may not be sold or imported for sale (Article 7, Food Sanitation Act).
  • MFDS sets separate standards for food additives in health functional foods made to be taken by children (Article 14, Health Functional Foods Act).

How we help: Compliant Always reads your specifications and lab reports against the standards that apply, and keeps them with each lot. Ask about this

Labelling and advertising

What the pack shows, and what it may not claim.

  • Food and livestock products are labelled with the product name, net quantity and ingredient names; the business name and location; warnings for consumer safety; and the date of manufacture, use-by or best before date, with further particulars set by Prime Ministerial Decree (Article 4).
  • Foods prescribed by Prime Ministerial Decree carry a nutrition facts label (Article 5).
  • No label or advert may present the product as preventing or curing disease, as a drug, or be false, exaggerated or deceptive (Article 8).

How we help: Compliant Always sets the particulars beside what your label shows, with the article for each. Ask about this

Traceability

Baby food and formula are among the products whose traceability must be registered.

  • Manufacturers and processors of baby food register food traceability with MFDS (Article 49, Food Sanitation Act). They keep the records in an electronic device for at least two years after the use-by date (Article 49-2).
  • Manufacturers of milk formula meeting a sales threshold, and sellers meeting a store size threshold, register processed livestock products traceability with MFDS (Article 31-3, Livestock Products Sanitary Control Act).
  • Registered milk formula carries the traceability label, records are kept for at least two years after the use-by date, and MFDS evaluates those registrants every two years (Article 31-4).
  • Businesses importing infant formula register traceability with MFDS (Article 23, Special Act on Imported Food Safety Control).

How we help: Compliant Always ties each document to the lot it came from, and shows which records are missing or due for keeping. Ask about this

Import and recall

The border steps, and what happens when a product is harmful.

  • The foreign facility is registered with MFDS before the import declaration, and each consignment is declared and inspected before customs clearance (Articles 5, 20 and 21, Special Act on Imported Food Safety Control).
  • A business that becomes aware that a livestock product it handles breaches the standards takes the measures needed to recall and scrap it (Article 31-2, Livestock Products Sanitary Control Act).
  • A food business that becomes aware that food it sold is harmful recalls it without delay (Article 45, Food Sanitation Act).

How we help: Compliant Always keeps the facility registration, declarations and inspection reports with each lot, so a recall question is answered from the record. Ask about this

Who answers for what

WhoWhat they answer forHow we help
BrandWhat the label and advertising say.The label read against the particulars, with the evidence in one place.
ManufacturerIts permission, the MFDS standards, HACCP where required, and traceability registration.Specifications, test reports and traceability records kept with each lot.
ImporterFacility registration, import declarations and infant formula traceability.Registrations and inspection reports read and dated before the goods arrive.
SellerTraceability registration for milk formula above the store size threshold.Product documents ready for the retailer that asks.

National ministries and local government

Product law in South Korea is national. Each Act names the minister in charge, such as the Minister of Food and Drug Safety for food and cosmetics, and the Minister of Trade, Industry and Resources for electrical, consumer and children's products.

Many licences, reports and inspections under those Acts are handled by a Mayor or Do Governor or the head of a Si/Gun/Gu, so the local office named in the Act is often the one a business deals with.

Questions businesses ask

Who regulates infant formula in South Korea?
The Ministry of Food and Drug Safety (MFDS). Milk formula is listed among processed milk products in the Livestock Products Sanitary Control Act, and labelling follows the Act on Labeling and Advertising of Foods.
Is traceability registration required for baby food in Korea?
Yes. Manufacturers and processors of baby food register food traceability with MFDS under Article 49 of the Food Sanitation Act.
Do infant formula importers register traceability?
Yes. Businesses importing infant formula are among those that register traceability with MFDS (Article 23, Special Act on Imported Food Safety Control).
How long are traceability records kept?
At least two years after the use-by date, in an electronic recording device (Article 49-2, Food Sanitation Act; Article 31-4, Livestock Products Sanitary Control Act).
Does milk formula need a traceability label?
Yes, for registrants required to register under Article 31-3: manufacturers above a sales threshold and sellers above a store size threshold (Article 31-4, Livestock Products Sanitary Control Act).
How often does MFDS evaluate formula traceability?
Every two years for those required to register; other registrants are evaluated every three years (Article 31-4, Livestock Products Sanitary Control Act; Article 49, Food Sanitation Act).
What does a baby food label have to show in Korea?
Product name, net quantity and ingredient names; the business name and location; warnings for consumer safety; and the date of manufacture, use-by or best before date, plus particulars set by Prime Ministerial Decree (Article 4, Act on Labeling and Advertising of Foods).
Can a baby food label make health claims?
No label or advert may present a food as preventing or curing disease, as a drug, or as a health functional food, or be false, exaggerated or deceptive (Article 8, Act on Labeling and Advertising of Foods).
Do formula makers need a licence?
Livestock product processing businesses obtain permission from the Mayor/Do Governor for each place of work (Article 22, Livestock Products Sanitary Control Act).
How is imported baby food cleared?
The foreign facility is registered with MFDS, and each consignment is declared and inspected before customs clearance (Special Act on Imported Food Safety Control).
How does Compliant Always help with selling in South Korea?
Our team reads the rules for the markets you sell in, from Korean law and the regulators' own pages. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

Name the product and the markets you sell in. We will come back to you with what applies in South Korea and what your paperwork needs to show.

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