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Information current as of 7 October 2026. This is general information, not regulatory or legal advice for a specific product.

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Why regulation decides your timeline

Whoever files the import declaration is responsible for the product's safety and quality in Korea. Ingredients and products must meet Korean standards before shipment, not just home-country rules (Imported Food Act, Art. 20).

If your product contains an ingredient new to Korea, approval comes first. Statutory review periods run from 120 days for a conventional new ingredient to 270 days for a cell-cultured one. Each data request from the Ministry of Food and Drug Safety (MFDS) gives you 30 days, extendable twice (Notice 2025-75). In December 2025, an MFDS director said one incomplete cell-cultured dossier had spent over 1.5 years in supplementation (The Medical).

1. Novel and cell-cultured ingredients

What it is. MFDS can temporarily recognise standards for an ingredient not yet in the Food Code. Since 2023 this route covers ingredients made by cell or microbial culture (MFDS guide).

Typical steps. For a cell-cultured ingredient, apply via foodsafetykorea.go.kr with the form, a dossier and its summary, and a product or prototype. Foreign-language material needs a Korean summary plus the original (MFDS guide). The fee is KRW 45,000,000 (Gov24).

What founders get wrong. Until the ingredient enters the Food Code, a recognition covers only the applicant and that exact ingredient (MFDS portal). One mycoprotein culture was recognised three times, for three Korean companies (MFDS portal). A draft Food Code amendment for cell-cultured foods closed for comment on 31 August 2026 (Notice 2026-311), but official registers did not show it as final on 7 October 2026 (MFDS). The Gyeongbuk special zone's trial exemptions cover animal and livestock law, not food-safety approval (Policy Briefing).

2. Health functional food claims

What it is. A health functional food (HFF) uses ingredients with a useful effect on the body. An ingredient is either on MFDS's notified list, open to any business, or individually recognised after review (HFF Act).

Typical steps. The applicant must be a licensed HFF manufacturer, a registered importer or another listed body (HFF Act, Art. 15). The dossier has nine parts. Toxicity studies must follow OECD guidelines under GLP. Human studies need IRB approval, and randomised controlled designs are preferred (Notice 2026-33). The electronic filing fee for a new ingredient is KRW 4,500,000 (Fee annex).

What founders get wrong. Approved claims use fixed Korean wording, such as "may help ○○" (Annex 4). An ordinary food can carry a function claim for eligible ingredients instead. It needs at least 30% of the daily reference intake per serving and cannot be a tablet, capsule, stick or sachet powder, or ampoule. Some product groups and claim types are excluded. Imports are exempt from the HACCP and GMP plant rules (Notice 2024-62).

3. Importing and labelling

What it is. Any food you import for sale in Korea goes through this route.

Typical steps.