How to Import K-Beauty Products from Korea

Importing K-beauty products starts with one question: do the formula and label meet both Korea’s rules and the rules of the market where you will sell? Korean manufacturers follow the Cosmetics Act and guidance from the Ministry of Food and Drug Safety (MFDS). Once the goods leave Korea, the importer or the legally responsible party in the destination market is responsible for local compliance, and those rules differ a lot between the United States and the European Union.

Key takeaways

• Confirm the Korean supplier is properly registered with the MFDS and can provide full ingredient lists and test reports.
• In the US, MoCRA requires facility registration, product listing, safety records and serious adverse-event reporting.
• In the EU, you need an EU-based Responsible Person, a Product Information File and a CPNP notification before you sell.

What are the Korean-side MFDS basics?

Under Korea’s Cosmetics Act, cosmetics manufacturers and the businesses that place cosmetics on the market register with the MFDS. The law and its notices set safety standards such as:

• lists of prohibited and restricted ingredients
• limits for heavy metals
• microbiological criteria

“Functional cosmetics” with claims such as brightening, anti-wrinkle or UV protection go through an extra review in Korea.

Before ordering, ask the supplier for:

• proof of its MFDS registration status
• a full ingredient list in INCI names
• relevant test reports, such as stability, microbiological or preservative efficacy tests

Meeting Korean rules does not mean a product meets yours. An ingredient, concentration or claim allowed in Korea may need changing for another market.

What does MoCRA require in the United States?

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) added new duties to US cosmetics law:

• Facility registration. Facilities that manufacture or process cosmetics for the US market must register with the FDA and renew the registration every two years.
• Product listing. The “responsible person” must list each product with its ingredients and update the listing every year. This is the manufacturer, packer or distributor named on the label.
• Safety records. The responsible person must keep records showing adequate safety substantiation.
• Adverse events. Serious adverse events must be reported to the FDA within 15 business days.

Some small businesses are exempt from parts of these rules, but the exemptions do not cover every product type. Ordinary cosmetics do not need FDA pre-approval. However, products such as sunscreens, and those making certain therapeutic claims, are regulated as over-the-counter drugs in the US and follow a separate, stricter pathway. Check the FDA’s MoCRA and registration and listing pages for current procedures.

What does CPNP require in the European Union?

EU Regulation (EC) No 1223/2009 sets these rules:

• Every cosmetic product sold in the EU must have a Responsible Person established in the EU. A non-EU manufacturer cannot fill this role itself and must appoint one in writing.
• The Responsible Person must notify the product on the free Cosmetic Products Notification Portal (CPNP) before the product goes on sale.
• A Product Information File must be kept for ten years after the last batch is placed on the market. It includes a Cosmetic Product Safety Report.
• The formula must comply with the Regulation’s annexes on prohibited, restricted and permitted substances.

A CPNP notification is not an approval. It informs the authorities and poison centres.

What are the practical import steps, and what does landed cost look like?

Find suppliers, check samples and documents against your market’s rules, appoint a responsible person and complete MoCRA listing or CPNP notification. Then make sure labels comply before shipment and keep records after arrival.

1. Find suppliers through public channels; see how to find Korean manufacturers and suppliers.
2. Get samples and documents, and have them checked against your market’s rules.
3. Arrange a US responsible person or an EU Responsible Person, and complete MoCRA listing or CPNP notification.
4. Make sure labels meet local language and content rules before shipment.
5. Keep batch records and an adverse-event procedure after the goods arrive.

Worked example: landed cost. These are illustrative figures; confirm duty rates and the customs value basis with your own customs authority.

• Product cost for 1,000 units, FOB Busan: 8,000 USD.
• Sea freight and insurance: about 400 USD.
• Customs value on a CIF basis: 8,000 + 400 = 8,400 USD.
• Duty at an assumed 5%: 8,400 × 0.05 = 420 USD.
• Running total: 8,400 + 420 = 8,820 USD, or about 8.82 USD per unit, before VAT, broker and local fees.

Some countries, including the US, value goods on an FOB basis instead. In that case the duty here would be 8,000 × 0.05 = 400 USD.

What are the common mistakes when importing K-beauty?

The usual mistake is assuming a product made for Korea can be sold unchanged in the US or EU. Registration, responsible-person and labelling steps have to come before sales.

• Assuming a product made and labelled for Korea can be sold unchanged in the US or EU.
• Starting sales before appointing a responsible person and completing MoCRA listing or CPNP notification.
• Missing that sunscreens and some functional claims are treated as drugs or need extra review.
• Paying for production before confirming the supplier can provide the documents your regulator requires.

FAQ

Do Korean cosmetics need FDA approval before they are sold in the US?

Ordinary cosmetics do not need pre-approval. Under MoCRA, however, the facility must be registered, products must be listed, and the responsible person must keep safety records and report serious adverse events.

What do I need to sell K-beauty in the EU?

You need a Responsible Person established in the EU, a Product Information File with a safety report, and a CPNP notification before the product goes on sale.

Can the Korean manufacturer act as the responsible person?

Not in the EU, where the Responsible Person must be established in the EU. In the US, the responsible person is the business named on the label. Many brands use a US-based company for this role.

Where can I find the official MoCRA and CPNP rules?

The FDA website has MoCRA and registration and listing guidance. The European Commission publishes the CPNP information and the text of Regulation 1223/2009.

Sources

• U.S. FDA, Modernization of Cosmetics Regulation Act of 2022 (MoCRA): https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra
• U.S. FDA, Registration and Listing of Cosmetic Product Facilities and Products: https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products
• European Commission, Cosmetic Products Notification Portal (CPNP): https://single-market-economy.ec.europa.eu/sectors/cosmetics/cosmetic-product-notification-portal_en
• EUR-Lex, Regulation (EC) No 1223/2009 on cosmetic products: https://eur-lex.europa.eu/eli/reg/2009/1223/oj
• Ministry of Food and Drug Safety (Korea), official English website: https://www.mfds.go.kr/eng/

Last checked: 2026-10-10