Type: Ingredient entity — regulatory & claim record
Topic: Eicosapentaenoic Acid / EPA (에이코사펜타엔산) — indicator component of a notified health functional food article
Evidence basis: MFDS Health Functional Food Code (「건강기능식품의 기준 및 규격」, 고시 제2026-43호) Section 3, article 2-16; MFDS drug approval records (NEDRUG); 식품안전나라 individually-approved ingredient register; PubChem chemical identity
Last Verified: 2026-08-02
This page records regulatory, identity, and claim-boundary information. It does not independently endorse treatment, disease-prevention, or efficacy claims. See the Evidence Boundaries section.
Eicosapentaenoic acid (Korean: 에이코사펜타엔산), almost always written as EPA, is a long-chain marine omega-3 fatty acid. In Korea’s health functional food system it occupies an unusual position: it is regulated, but not as an ingredient in its own right. The registered entity is an article of the Code called EPA and DHA-Containing Oil (EPA 및 DHA 함유 유지), and EPA is one of the two indicator components by which that article is defined and measured.
The practical consequence runs through everything on this page. Every functional statement in the article is expressed as the sum of EPA and DHA — never as EPA alone. The daily intake figures are stated as “the sum of EPA and DHA”. A product cannot carry the article’s functional wording on the strength of its EPA content by itself, and a label or an article that attributes one of those functions specifically to EPA is describing something the Code does not say.
This record therefore documents EPA as an identity and as a component, and points to the article record for the functional and compositional requirements. Where EPA appears in the Korean drug register — as part of omega-3-acid ethyl esters in prescription products — that is recorded here as a boundary, not as a source of supplement claims.
Ingredient Snapshot
| Field | Value |
|---|---|
| Ingredient Name | Eicosapentaenoic Acid (EPA) |
| Korean Name | 에이코사펜타엔산 / EPA |
| INCI Name | Unknown — cosmetic naming not researched within this record’s scope |
| Synonyms | EPA; icosapentaenoic acid; timnodonic acid. Marketing terms such as “omega-3” refer to a fatty-acid class, not to this compound, and are not an ingredient identity. |
| CAS No. | 25378-27-2 (primary). A second registry number, 1553-41-9, designates the specific 5Z,8Z,11Z,14Z,17Z stereoisomer. |
| Other Identifiers | PubChem CID 5282847; molecular formula C20H30O2 |
| Ingredient Type | Long-chain marine n-3 polyunsaturated fatty acid — indicator component of Health Functional Food Code Section 3, article 2-16 |
| Cosmetic Role | Unknown — not researched within this record’s scope |
| Supplement Function | No functional statement attaches to EPA alone. Functions belong to the article “EPA and DHA-Containing Oil” and are expressed as the sum of EPA and DHA — see Claim Safety Matrix |
| Daily Intake | Not set for EPA alone. The article states intake as the sum of EPA and DHA, in three ranges by function: 0.5–2 g (blood triglyceride and blood circulation), 0.9–2 g (memory), 0.6–2.24 g (dry eye) |
| Content Specification | Finished product: the sum of EPA and DHA at 80–120% of the labeled amount (specification of the article, not of EPA separately) |
| Individually-Approved Status | Not registered. A search of the individually-approved ingredient register returned no entries for EPA, DHA, or omega-3 — see Regulatory Records |
| Status | To Review |
Chemical identity is taken from PubChem. Functional statements, intake ranges, and specifications are taken from the MFDS Health Functional Food Code. Drug status and indications are taken from the MFDS drug product database.
A note on chemical identity
One registry number circulating for EPA, 10417-94-4, was examined during preparation of this record and does not appear among the references for PubChem CID 5282847. It is not recorded here. Its identity is unresolved — it may designate an ester form rather than the free acid — and this database does not enter an identifier it cannot trace to a source. The two numbers recorded above, 25378-27-2 and 1553-41-9, are the ones the chemical source supports.
Regulatory Records
| Record Type | Jurisdiction | Issuing Body | Record Number | Scope | Status | Source |
|---|---|---|---|---|---|---|
| Notified-type HFF functional ingredient (고시형) | Korea (KR) | MFDS (식품의약품안전처, 식품기준과) | 식품의약품안전처고시 제2026-43호, 2026-06-11 | Section 3, article 2-16 “EPA and DHA-Containing Oil”, part 3, finished-product requirements. Functional content: improvement of blood triglyceride; improvement of blood circulation; improvement of memory; improvement of dry eye, helping eye health. Daily intake, in every case stated as the sum of EPA and DHA: 0.5–2 g for blood triglyceride and blood circulation; 0.9–2 g for memory; 0.6–2.24 g for dry eye. Precautions: consult a specialist when taking medicines such as anticoagulants, antiplatelet agents, or antihypertensives; skin-related adverse reactions may occur in some individuals; discontinue and consult a specialist if an adverse event occurs. | To Review | MFDS Health Functional Food Code; 식품안전나라 ingredient record 2-16, board no. 1062819 |
| Individually-approved ingredient register — dated negative finding | Korea (KR) | MFDS (식품의약품안전처) | No record number — this is a register search result, not a regulatory determination | A search of the individually-approved functional ingredient register using the terms EPA, DHA, and omega-3 returned no entries on the date searched. On that evidence, the notified article 2-16 is the only registered basis for these functions in the Korean health functional food system; there is no separate individually-approved EPA ingredient behind them. | To Review | 식품안전나라 individually-approved ingredient register, searched 2026-05-27 |
| Prescription drug approval — boundary record | Korea (KR) | MFDS (식품의약품안전처) | Item code 200500497; ATC C10AX06 | Omacor Soft Capsule (오마코연질캡슐), active ingredient omega-3-acid ethyl esters 90, is an approved prescription medicine. Its indication is stated as an adjunct to diet to reduce elevated triglyceride levels in patients with endogenous hypertriglyceridaemia, and its labeling carries a dose-dependent atrial fibrillation warning. A related product, Olmark Soft Capsule (item 201904669), was cancelled on 2024-07-11 and is retained here only as history. | To Review | NEDRUG drug product records, item codes 200500497 and 201904669 |
Why EPA Has No Daily Intake of Its Own
Article 2-16 is written around a material — an oil meeting a manufacturing standard — rather than around a single purified compound. The article defines the permitted starting materials as fish, algae, or seal oil, and sets minimum combined EPA and DHA content for the raw material. Every downstream figure follows the same logic: the finished product specification is the sum of EPA and DHA at 80–120% of the labeled amount, and each functional statement carries an intake range expressed as that same sum.
There is no clause in the article assigning a function or an intake to EPA on its own, and this record does not construct one. Where a source distinguishes EPA from DHA in a research context, that distinction belongs to the research literature and not to the Korean regulatory text — and a research distinction does not become a labeling basis.
The intake ranges are also not interchangeable between functions. Memory has a higher floor (0.9 g) than blood triglyceride and circulation (0.5 g), and dry eye has both a distinct floor and the highest ceiling (0.6–2.24 g). A product supplying 0.6 g of EPA and DHA combined meets the stated range for blood circulation but not the range for memory. This is the kind of detail that disappears when the three ranges are collapsed into a single “0.5–2.24 g” figure, which is why they are recorded separately here.
Notification-Number Note
The quoted article text was captured from the 식품안전나라 ingredient record and its attached PDF while notification 제2025-11호 was current. Two amendments have been issued since — 제2026-32호 dated 2026-04-13 and 제2026-43호 dated 2026-06-11 — and both were examined at the MFDS amendment board. Neither lists article 2-16 among the amended provisions, so the article text is recorded as unchanged and only the notification number was brought to the current one.
One qualification is recorded deliberately. The 2026-04-13 amendment revised test methods including one for fatty acids. That revision sits in Section 4 (test methods), while what is cited on this page comes from Section 3 (the article itself). If a test-method coordinate is added to this record later, it will need its own verification. The comparison performed here was against amendment summaries, not against a clause-by-clause redline of the full text.
Claim Safety Matrix
The classifications below are the claim-handling categories recorded in this database — Allowed, Caution, Avoid, and Prohibited. They describe how wording is treated in this record and require human review; they are not legal determinations issued by MFDS, and they do not by themselves settle the lawfulness of a particular label, advertisement, news report, or academic discussion.
The four notified functional statements are recorded as Caution rather than Allowed. This reflects two conditions: the product must be a qualifying health functional food meeting article 2-16, and the wording attaches to the combined EPA and DHA content at the stated intake — not to EPA by itself. It does not indicate that the notified wording lacks a basis in the Code.
The Prohibited entries below rest on positive regulatory instruments — approved prescription drug indications and drug-label safety statements — that occupy the wording. The single Avoid entry concerns wording that is accurate in its own register but misleading when transplanted.
| Claim Text | Claim Type | Why It Matters | Safer or Source-Bound Wording | Source |
|---|---|---|---|---|
| Improvement of blood triglyceride (혈중 중성지질 개선) | Caution | A notified functional statement of article 2-16, conditioned on a daily intake of 0.5–2 g as the sum of EPA and DHA, with the finished product at 80–120% of its labeled amount. It is not a statement about EPA alone, and it does not transfer to general food or cosmetic labeling. It also sits adjacent to a prescription drug indication with similar subject matter, which makes precise wording matter more here than elsewhere. | “May help improve blood triglyceride levels” — reflecting the Code wording, 혈중 중성지질 개선에 도움을 줄 수 있음 | MFDS Health Functional Food Code, Section 3, article 2-16, part 3 |
| Improvement of blood circulation (혈행 개선) | Caution | A notified functional statement under the same intake range of 0.5–2 g as the sum of EPA and DHA. Expansions into vascular, cholesterol, or blood-pressure language go beyond the notified wording and move toward drug territory. | “May help improve blood circulation” — reflecting the Code wording, 혈행 개선에 도움을 줄 수 있음 | MFDS Health Functional Food Code, Section 3, article 2-16, part 3 |
| Improvement of memory (기억력 개선) | Caution | A notified functional statement, but at a higher intake floor than the circulatory functions: 0.9–2 g as the sum of EPA and DHA. A product that meets the 0.5 g floor does not thereby support this statement. The wording is also distinct from cognitive-decline or dementia language, which is not part of the notified statement. | “May help improve memory” — reflecting the Code wording, 기억력 개선에 도움을 줄 수 있음 | MFDS Health Functional Food Code, Section 3, article 2-16, part 3 |
| Improvement of dry eye, helping eye health (건조한 눈을 개선하여 눈 건강에 도움) | Caution | A notified functional statement at its own intake range, 0.6–2.24 g as the sum of EPA and DHA — the highest ceiling among the four. The notified wording is specific to dry eye rather than to eye health generally, and shortening it to “good for eyes” drops the condition the statement is built on. | “May help eye health by improving dry eye” — reflecting the Code wording, 건조한 눈을 개선하여 눈 건강에 도움을 줄 수 있음 | MFDS Health Functional Food Code, Section 3, article 2-16, part 3 |
| Treatment of hypertriglyceridaemia (고트리글리세라이드혈증 치료) | Prohibited | This is the approved indication of a prescription medicine — omega-3-acid ethyl esters 90, approved as an adjunct to diet in patients with endogenous hypertriglyceridaemia. It is occupied wording, tied to a diagnosis, a prescription product, and a prescriber. The health functional food statement about blood triglyceride is not an abbreviated version of it, and a supplement label that names the condition is stating a drug indication. | “May help improve blood triglyceride levels” — the notified health functional food wording | NEDRUG drug product record — 오마코연질캡슐, item code 200500497 |
| Post-myocardial-infarction adjunct therapy / prevention of cardiovascular events (심근경색 후 보조요법 / 심혈관 사건 예방) | Prohibited | This wording appears frequently in marketing but is not found in the current approved indication for the prescription product either. It states disease treatment and prevention, which is outside the health functional food framework entirely, and it is not supported by the drug register that is otherwise the source of the adjacent boundary. Recorded as Prohibited on the disease-claim ground rather than as a mere overstatement. | (No health functional food equivalent. The four notified statements are the available wording.) | NEDRUG drug product record — 오마코연질캡슐, item code 200500497 (indication text) |
| Atrial fibrillation risk / citing the 4 g per day pharmaceutical dose (심방세동 위험 / 4 g/일 의약품 용량) | Prohibited | The atrial fibrillation warning is a drug-label safety statement, and it is dose-dependent: the observed risk was highest at 4 g per day in patients with cardiovascular disease or risk factors. That dose belongs to a prescription regimen and lies outside the health functional food intake range of 0.5–2.24 g. Reproducing the warning or the dose figure in a supplement context imports a pharmaceutical dosing frame that the product does not operate in — in either direction, as reassurance or as alarm. | “Consult a specialist when taking medicines such as anticoagulants, antiplatelet agents, or antihypertensives” — the Code’s own precaution wording | NEDRUG drug product record — 오마코 precautions; MFDS Health Functional Food Code, article 2-16, part 3(3) |
| Reproducing pharmaceutical safety warnings verbatim (출혈·간기능·생선 알러지·18세 미만 금기 등 의약품 라벨 문구 인용) | Avoid | Safety cautions on a supplement page are appropriate and necessary; the issue is the source of the wording. Drug-label contraindications — such as the statement that the product must not be given to patients under 18 or to those hypersensitive to its components — are written for an approved medicine with a defined patient population. Transplanted verbatim, they signal to a reader that the supplement is a medicine. The Code supplies its own precaution text for this article, and that is what this record uses. | “Skin-related adverse reactions may occur in some individuals” and “discontinue and consult a specialist if an adverse event occurs” — the Code’s precaution wording | MFDS Health Functional Food Code, article 2-16, part 3(3); NEDRUG 오마코 precautions (as the contrasting source) |
Evidence Boundaries: What This Page Does Not Claim
The following claims are outside the scope of this ingredient record:
Treatment or prevention of any disease. Omega-3 compounds appear in Korea as prescription medicines with approved indications, and those indications belong to those products and to the framework that granted them. Nothing on this page states or implies that a health functional food treats hypertriglyceridaemia, prevents cardiovascular events, or substitutes for a prescribed medicine.
Any function attributed to EPA alone. This is the boundary specific to this record. The Code’s functional statements are expressed as the sum of EPA and DHA, and no clause assigns a function or an intake to EPA by itself. Statements separating EPA’s contribution from DHA’s are not supported by the regulatory text used here.
Pharmaceutical dosing or pharmaceutical safety framing. The 4 g per day figure and the atrial fibrillation warning are reproduced only to mark where the frameworks diverge. They are not intake guidance and are not comparable to the health functional food intake ranges.
Individual outcomes. Intake ranges in the Code are product-composition and labeling standards, not personal recommendations. Nothing here predicts what any particular person will experience, and the Code’s own precaution about medicines such as anticoagulants, antiplatelet agents, and antihypertensives is recorded precisely because individual circumstances differ.
Product-level guarantees or source comparisons. This page does not evaluate specific products and does not rank fish, algal, or seal oil sources, or triglyceride against ethyl-ester forms, for efficacy or absorption. The article sets its standards on combined EPA and DHA content and does not differentiate on those grounds.
Cosmetic status. Cosmetic naming and role for EPA were not researched within the scope of this record and are marked Unknown rather than inferred.
Currency beyond the verification date
The Health Functional Food Code is amended periodically — twice between March 2025 and June 2026 for this Code alone. The notification number and article information on this page reflect verification as of 2026-08-02. The register finding recorded above is dated 2026-05-27 and describes the register on that date only. Later amendments, drug-label changes, and register additions or cancellations may change the applicable record.
Related Entities
Related Ingredients
- EPA and DHA-Containing Oil — the notified article this compound is an indicator component of; manufacturing standard, specifications, and functional requirements are recorded there
- Docosahexaenoic Acid (DHA) — the second indicator component; the article’s functions are expressed as the sum of the two
- Alpha-linolenic acid (ALA) — a plant-derived omega-3 fatty acid that is not part of the article’s definition, despite being marketed under the same “omega-3” umbrella
- Magnesium — notified nutrient in the same Code, for comparison of nutrient articles against functional ingredient articles
Related Product Types
- Health functional food — omega-3 soft capsules from fish, algal, or seal oil
- Health functional food — combination products supplying EPA and DHA alongside other ingredients
- Prescription medicine — omega-3-acid ethyl ester products
Related Claims
- Improvement of blood triglyceride — notified statement, 0.5–2 g/day as the sum of EPA and DHA
- Improvement of blood circulation — notified statement, same intake range
- Improvement of memory — notified statement, 0.9–2 g/day
- Improvement of dry eye — notified statement, 0.6–2.24 g/day
- Treatment of hypertriglyceridaemia — prescription drug indication, not transferable
Related Regulatory Concepts
- Indicator components and article-level definitions in the Health Functional Food Code
- Functional statements expressed as a sum of two components
- Function-specific daily intake ranges within a single article
- Notified-type articles versus individually-approved ingredients
- Health functional food and prescription drug boundaries
- Dated negative findings from public registers
Source Transparency Note
This page uses the following source classification:
| Source | Role | Authority Scope | Limit |
|---|---|---|---|
| MFDS Health Functional Food Code, via the current consolidated notification and 식품안전나라 ingredient record 2-16 | Regulatory | Manufacturing standard, specifications, notified functional statements, daily intake ranges, and precautions | Applies within the health functional food framework and does not transfer automatically to general food, cosmetic, or drug claims |
| 식품안전나라 individually-approved ingredient register | Regulatory search source | Whether a separately approved EPA, DHA, or omega-3 ingredient was found registered, on the search date | A dated register finding; the register changes, and absence on one date is not permanent absence |
| NEDRUG (MFDS drug product database) | Pharmaceutical boundary | Prescription drug status, active ingredient, approved indication, dosing, and label warnings for omega-3-acid ethyl ester products | Pharmaceutical indications, doses, and warnings do not transfer to health functional food products |
| PubChem | Chemical identity | Chemical identity and identifiers for eicosapentaenoic acid | Does not determine Korean regulatory status or permitted health functional food claims |
Naming-layer and identity-layer sources are not used as functional-claim evidence. Chemical identity from PubChem establishes what eicosapentaenoic acid is; it does not establish what may be stated about its health effects or how it may be labeled in Korea. KCIA (Korea Cosmetic Industry Institute) is not cited on this page, because cosmetic ingredient naming does not determine the status or functional wording of a health functional food component. All functional wording recorded here traces to the Health Functional Food Code text, and all indication wording to the drug approval records.
Frequently Asked Questions
Is EPA a regulated ingredient in Korea?
EPA (에이코사펜타엔산) is regulated, but not as a standalone ingredient. Korea’s Health Functional Food Code registers an article called EPA and DHA-Containing Oil at Section 3, article 2-16, and EPA is one of the two indicator components by which that article is defined and measured. The consolidated Code verified for this page reflects MFDS notification 제2026-43호 dated 2026-06-11. There is no separate registration for EPA on its own — a search of the individually-approved ingredient register returned no entries for EPA, DHA, or omega-3 on the date searched.
What claims are allowed for EPA in Korean health functional foods?
Four functional statements exist, and all of them belong to the article rather than to EPA individually: improvement of blood triglyceride, improvement of blood circulation, improvement of memory, and improvement of dry eye helping eye health. Each is expressed as the sum of EPA and DHA, and each carries its own daily intake range. All four are recorded here as Caution rather than Allowed, reflecting that they attach to a qualifying health functional food meeting the article’s requirements. A claim attributed to EPA alone is not supported by the Code text.
How much EPA is needed for the notified functions?
The Code does not set an amount for EPA by itself. It sets three intake ranges, each stated as the sum of EPA and DHA and each tied to a specific function: 0.5–2 g per day for improvement of blood triglyceride and blood circulation, 0.9–2 g per day for improvement of memory, and 0.6–2.24 g per day for improvement of dry eye. These are not interchangeable. A product supplying 0.6 g combined meets the range stated for blood circulation but not the one stated for memory.
Why are EPA and DHA always counted together in Korea?
Because article 2-16 is written around a material rather than a purified compound. It defines permitted starting materials — fish, algal, or seal oil — sets a minimum combined EPA and DHA content for the raw material, requires the finished product to hold the sum of EPA and DHA at 80–120% of its labeled amount, and expresses every functional statement as that same sum. No clause in the article assigns a function or an intake to either component separately. Distinctions drawn between EPA and DHA in research literature are not part of the Korean regulatory text and do not become a labeling basis.
Is an EPA supplement the same as an omega-3 prescription medicine?
No. Omega-3-acid ethyl esters 90 is approved in Korea as a prescription medicine, with an indication as an adjunct to diet to reduce elevated triglyceride levels in patients with endogenous hypertriglyceridaemia, and its label carries a dose-dependent atrial fibrillation warning that was highest at 4 g per day. That indication, that dose, and that warning belong to the medicine. The health functional food statement about blood triglyceride is not a shortened version of the drug indication, and a supplement that names the condition is stating a drug indication.
Does “omega-3” mean the same thing as EPA and DHA on a Korean label?
Not within this article. “Omega-3” is a class of fatty acids that includes plant-derived alpha-linolenic acid (ALA), whereas article 2-16 is defined by marine-origin materials and measured by the combined content of EPA and DHA. ALA is not part of the article’s definition. A product marketed as omega-3 is not necessarily supplying the components the notified functional statements are built on, which is why this record documents EPA and DHA as the indicator components rather than treating “omega-3” as the entity.