Type: Ingredient entity — regulatory & claim record
Topic: EPA and DHA-Containing Oil (EPA 및 DHA 함유 유지) — health functional food ingredient
Evidence basis: MFDS Health Functional Food Code (「건강기능식품의 기준 및 규격」, 고시 제2026-43호) Section 3, article 2-16; MFDS drug approval records (NEDRUG); 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.
“EPA and DHA-Containing Oil” (Korean: EPA 및 DHA 함유 유지) is the name of a notified ingredient article listed in Korea’s Health Functional Food Code.
It is worth stating at the outset that this entity is not a single chemical compound. It is a regulatory article: a defined category of oil described by its permitted raw materials, manufacturing methods, specifications, and minimum content of two indicator compounds. Those two indicator compounds are eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which are recorded separately as chemical entities.
This distinction matters when interpreting Korean health functional food labels. The notified article is the oil category, while the functional wording attached to the article is based on the sum of EPA and DHA. The notified wording does not attach independently to EPA or DHA as isolated compounds. The Code provides four functional statements for this article, and each is tied to a specified daily intake range expressed as that sum.
The colloquial term “omega-3” is broader than this regulatory article. Omega-3 describes a family of fatty acids, while article 2-16 covers oils meeting the article’s specific raw-material, manufacturing, indicator-component, and specification requirements. One boundary follows directly from that difference. Alpha-linolenic acid (ALA), a plant-origin omega-3 fatty acid found in sources such as flaxseed, is not part of article 2-16’s definition. The Code specifies edible fish, algae, and harp seal as permitted raw materials and uses the sum of EPA and DHA as the indicator content. ALA is chemically an omega-3 fatty acid, but it does not enter this notified article merely because it belongs to the same broader chemical family, and the functional wording recorded below does not extend to ALA-based products.
Ingredient Snapshot
| Field | Value |
|---|---|
| Ingredient Name | EPA and DHA-Containing Oil |
| Korean Name | EPA 및 DHA 함유 유지 |
| INCI Name | Not applicable — this is a health functional food article, not a cosmetic ingredient |
| Synonyms | Omega-3, a colloquial term broader than this article; fish oil and algal oil, which describe possible raw-material origins rather than the notified article name |
| CAS No. | Not applicable — this is a composite regulatory article, not a single compound. See the separate EPA and DHA entities. |
| Indicator Components | EPA (PubChem CID 5282847, C20H30O2) and DHA (PubChem CID 445580, C22H32O2), measured as their sum |
| Ingredient Type | Composite functional ingredient — notified type (고시형), Health Functional Food Code Section 3, article 2-16 |
| Cosmetic Role | Not applicable |
| Supplement Function | Four functional statements provided in the Code — see Claim Safety Matrix |
| Daily Intake | Varies by functional statement: 0.5–2 g/day for blood triglyceride and blood circulation wording; 0.9–2 g/day for memory wording; 0.6–2.24 g/day for dry-eye wording — expressed as the sum of EPA and DHA |
| Status | To Review |
Chemical identity information for the two indicator compounds is taken from PubChem. The article definition, indicator content, specifications, functional statements, daily intake ranges, and intake precautions are taken from the MFDS Health Functional Food Code.
Regulatory Records
| Record Type | Jurisdiction | Issuing Body | Record Number | Scope | Status | Source |
|---|---|---|---|---|---|---|
| Notified-type HFF ingredient (고시형) | Korea (KR) | MFDS (식품의약품안전처, 식품기준과) | 식품의약품안전처고시 제2026-43호, 2026-06-11 | Section 3, article 2-16, part 1: manufacturing standard. Permitted raw materials are edible fish and algae, and harp seal (Pagophilus groenlandicus). Permitted processing includes heating, pressing, and extraction using hexane or supercritical carbon dioxide, followed by filtration, or esterification of the extracted oil. Minimum indicator content is expressed as the sum of EPA and DHA: fish-derived oil ≥180 mg/g, algae-derived oil ≥300 mg/g, harp-seal-derived oil ≥120 mg/g. | To Review | MFDS Health Functional Food Code; 식품안전나라 ingredient record 2-16, board no. 1062819 |
| Notified-type HFF ingredient (고시형) | Korea (KR) | MFDS (식품의약품안전처, 식품기준과) | 식품의약품안전처고시 제2026-43호, 2026-06-11 | Section 3, article 2-16, part 2: specifications. The sum of EPA and DHA must be at or above the labeled amount for a raw-material product, and 80–120% of the labeled amount for a finished product. Residual hexane ≤5.0 mg/kg where hexane is used. Heavy metals: lead ≤3.0, cadmium ≤1.0, mercury ≤0.5 mg/kg. Coliform negative. Oxidation specifications and their stated scope. The article sets acid value ≤3.0, peroxide value ≤5.0, anisidine value ≤20.0, and TOTOX ((2 × peroxide value) + anisidine value) ≤26.0. The article text places these under an explicit applicability clause, part 2 (4)(가), which limits them to four product categories: (ㄱ) a raw-material product that is 100% EPA and DHA-Containing Oil; (ㄴ) a finished product manufactured from (ㄱ) alone, excluding cases where the capsule contains colorants or flavorings; (ㄷ) a raw-material product containing only EPA and DHA-Containing Oil and antioxidants listed in the Food Additives Code; and (ㄹ) a finished product manufactured from (ㄱ) or (ㄷ) with only such antioxidants added, again excluding cases where the capsule contains colorants or flavorings. The heavy metal, residual solvent, and coliform specifications carry no equivalent limiting clause. |
To Review | MFDS Health Functional Food Code; 식품안전나라 ingredient record 2-16 |
| Notified-type HFF ingredient (고시형) | Korea (KR) | MFDS (식품의약품안전처, 식품기준과) | 식품의약품안전처고시 제2026-43호, 2026-06-11 | Section 3, article 2-16, part 3: finished-product requirements. Four functional statements, three daily intake ranges, and three intake precaution statements. | To Review | MFDS Health Functional Food Code; 식품안전나라 ingredient record 2-16 |
| Individually-approved ingredient search — dated negative finding | Korea (KR) | MFDS (식품의약품안전처) | No record number — this is a search result, not a regulatory determination | Searches of the individually-approved ingredient (개별인정원료) register for the terms “EPA”, “DHA”, and “오메가” returned no results on 2026-05-27. On the same date, the notified article 2-16 was the confirmed registration of this kind. This finding does not exclude ingredients that may be registered under another raw-material, extract, complex, source-organism, process, or proprietary name, and it must not be read as proof that no individually-approved ingredient has any relationship to EPA, DHA, algae, fish oil, or omega-3 chemistry. | To Review | 식품안전나라 individually-approved ingredient register, searched 2026-05-27 |
| Prescription drug approval — boundary record | Korea (KR) | MFDS (식품의약품안전처) | Item code 200500497, approved 2005-09-15; ATC C10AX06 | Omacor Soft Capsule (오마코연질캡슐), containing omega-3-acid ethyl esters 90, is an approved prescription drug rather than a health functional food. Its current approved indication concerns dietary-adjunct reduction of elevated triglyceride levels in specified forms of endogenous hypertriglyceridemia. | To Review | NEDRUG drug product record, item code 200500497 |
| Prescription drug approval — safety-label boundary | Korea (KR) | MFDS (식품의약품안전처) | Item code 200500497 | The prescription-drug precautions state that the product must not be administered to patients hypersensitive to its components or to children under 18. They also state that a dose-related increase in atrial fibrillation risk was identified in patients with cardiovascular disease or cardiovascular risk factors, with the highest observed risk at 4 g/day. These statements belong to this prescription drug’s labeling and do not transfer to health functional food products. | To Review | NEDRUG drug product record, item code 200500497 |
| Prescription drug approval — historical record | Korea (KR) | MFDS (식품의약품안전처) | Item code 201904669, approved 2019-07-11; cancelled 2024-07-11 following expiry of the validity period | Olmark Soft Capsule (올마크연질캡슐), carrying the same named active ingredient category and ATC C10AX06. Retained as a historical boundary record so that older references to this item code can be identified as referring to a cancelled product record. | To Review | NEDRUG drug product record, item code 201904669 |
Notification-Number Note
The article text used for this record was captured from the 식품안전나라 record for article 2-16 while notification 제2025-11호 was current.
Subsequent amendment notices — 제2026-32호 dated 2026-04-13 and 제2026-43호 dated 2026-06-11 — were reviewed at the amendment-summary level. Article 2-16 was not identified among the provisions described as amended in those summaries, and the current consolidated Code is therefore cited here as notification 제2026-43호.
This method establishes the current consolidated notification number and checks the amendment summaries for an identified change to article 2-16. It is not a substitute for a clause-by-clause comparison of the complete notification text across versions.
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 that their use depends on the product being a qualifying health functional food, meeting the relevant ingredient and formulation requirements, and supplying the specified daily intake of EPA and DHA. It does not indicate that the notified wording lacks a basis in the Code.
| Claim Text | Claim Type | Why It Matters | Safer or Source-Bound Wording | Source |
|---|---|---|---|---|
| Improvement of blood triglyceride (혈중 중성지질 개선) | Caution | One of the four functional statements provided in the Code for this article. Its basis is limited to qualifying health functional food labeling at a daily intake of 0.5–2 g as the sum of EPA and DHA, and it does not transfer automatically to general food, cosmetic, or drug labeling. The wording also sits close to the approved indication of a prescription drug, which makes treatment-oriented expansion the most significant boundary risk for this statement. | “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 at a daily intake of 0.5–2 g as the sum of EPA and DHA, limited to the health functional food framework. Recasting it as prevention of thrombosis, atherosclerosis, stroke, myocardial infarction, or cardiovascular disease goes beyond the notified wording. | “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 at a daily intake of 0.9–2 g as the sum of EPA and DHA. Its lower threshold differs from the threshold for the triglyceride and circulation statements, so a product formulated only to meet another statement’s intake range does not automatically qualify for memory wording. Expansion into dementia prevention, treatment of cognitive impairment, guaranteed cognitive enhancement, or infant brain-development claims is not supported by article 2-16. | “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, supporting eye health (건조한 눈을 개선하여 눈 건강에 도움) | Caution | A notified functional statement at a daily intake of 0.6–2.24 g as the sum of EPA and DHA. It should not be expanded into treatment of dry-eye disease, restoration of vision, or prevention of macular disease, and it should not be conflated with the separate eye-health statements notified for other ingredients, such as lutein. | “May help improve dry eyes and support eye health” — 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 hypertriglyceridemia, including Type IV monotherapy or Type IIb treatment with statins | Prohibited | This wording corresponds to the approved indication of a specific prescription drug, Omacor, item code 200500497. It is not a functional statement notified for EPA and DHA-Containing Oil as a health functional food ingredient. The distinction has to be maintained precisely because the health functional food statement about improving blood triglyceride levels reads as linguistically similar. | “May help improve blood triglyceride levels” — only where the health functional food conditions for that wording are satisfied | NEDRUG item code 200500497; MFDS Health Functional Food Code, article 2-16 |
| Post-myocardial-infarction adjunct therapy or prevention of cardiovascular events | Prohibited | This wording is not among the four functional statements in article 2-16, and it is not included in the current Korean approved indication displayed for Omacor item code 200500497 either. A historical or foreign product indication must not be presented as a current Korean health functional food claim, nor as the current Korean indication of that drug record. | No substitute cardiovascular-event-prevention wording is supported by article 2-16 | MFDS Health Functional Food Code, article 2-16; current NEDRUG record for item code 200500497 |
| Atrial fibrillation risk, or citing the 4 g/day pharmaceutical dose | Prohibited | The atrial fibrillation warning and the 4 g/day figure belong to the precautions and dosage context of a prescription drug. The health functional food intake ranges for article 2-16 are 0.5–2 g, 0.9–2 g, and 0.6–2.24 g depending on the functional statement. The figures arise from different regulatory products and purposes and are not interchangeable. A regulatory database may document the drug warning to explain the boundary, but it should not be presented as the intake precaution applicable to article 2-16. | For a qualifying health functional food, use the Code’s own precaution: consult a specialist when taking medication such as anticoagulants, antiplatelet agents, or antihypertensives | NEDRUG item code 200500497; MFDS Health Functional Food Code, article 2-16 |
| Reproducing the prescription-drug label’s safety warnings verbatim, including drug contraindications and monitoring instructions | Avoid | Recorded as Avoid rather than Prohibited for a specific reason: health functional foods do require intake precautions, and suppressing safety information entirely would work against consumer safety. The issue is the source and framing of the warning, not the act of warning. Copying a prescription-drug label verbatim can make a supplement appear to share that drug’s approved dosage, indication, contraindications, monitoring requirements, and risk profile. Article 2-16 supplies its own intake precautions, which should be used for health functional food labeling unless another valid product-specific requirement applies. | “Individual skin-related adverse reactions may occur” and “Discontinue intake and consult a specialist if an adverse event occurs” — reflecting the Code’s own precautionary statements | NEDRUG item code 200500497; MFDS Health Functional Food Code, article 2-16, part 3 |
Evidence Boundaries: What This Page Does Not Claim
Treatment or prevention of disease
This page does not claim that EPA and DHA-Containing Oil treats or prevents any disease. Article 2-16 places the ingredient within Korea’s health functional food framework; it does not establish it as a drug. Claims such as treatment of hypertriglyceridemia, prevention of myocardial infarction or stroke, prevention or treatment of dementia, and treatment of dry-eye disease fall outside the notified functional wording recorded for this article. A Korean prescription drug containing omega-3-acid ethyl esters 90 exists separately under item code 200500497; its approved indication belongs to that pharmaceutical product and does not transfer to EPA and DHA-Containing Oil as a health functional food article.
Pharmaceutical dosing and drug-specific safety information
The daily intake ranges recorded on this page — 0.5–2 g/day for blood triglyceride and blood circulation wording, 0.9–2 g/day for memory wording, and 0.6–2.24 g/day for dry-eye wording, each as the sum of EPA and DHA — are health functional food figures tied to specified functional statements. The 4 g/day figure appearing in the Omacor prescription-drug record belongs to that drug’s dosage and safety context. It is recorded here solely to identify a regulatory boundary, and is not presented as an intake recommendation, threshold, maximum, or precaution for article 2-16.
Claims covering omega-3 as a whole, or alpha-linolenic acid
The term “omega-3” covers a broader chemical family than article 2-16. The article defines permitted raw materials and uses the sum of EPA and DHA as its indicator content; ALA falls outside that indicator-component definition. Biological conversion of ALA into EPA or DHA is a separate scientific question, and it does not place ALA within article 2-16 or extend the article’s notified functional wording to an ALA-based product.
Claims for EPA or DHA individually
Every functional statement in article 2-16 is tied to an intake measured as the sum of EPA and DHA. This page does not assign the notified wording separately to isolated EPA or isolated DHA. Chemical identity information for each compound does not create an independent regulatory claim authorization.
Universal application of the oxidation specifications
This page does not claim that the acid value, peroxide value, anisidine value, and TOTOX specifications apply to every raw material or finished product containing some amount of EPA and DHA-Containing Oil. Article 2-16 states its own applicability clause at part 2 (4)(가), limiting those four specifications to the product categories reproduced in the Regulatory Records table above. Whether a specific product falls inside or outside those categories is a determination for the product’s manufacturer and the competent authority, not something this page decides. The heavy metal, residual solvent, and coliform specifications in the same part carry no equivalent limiting clause.
Nonexistence of individually-approved ingredients
This page records that searches for “EPA”, “DHA”, and “오메가” produced no results in the individually-approved ingredient register on 2026-05-27. It does not claim that no individually-approved ingredient has any chemical, biological, or raw-material relationship to EPA, DHA, algae, fish oil, lipid extracts, or omega-3 fatty acids. Individually-approved ingredients may be registered under distinct raw-material, extract, complex, source-organism, process, or proprietary names, so a negative keyword search is a dated search result rather than proof of universal absence.
Guaranteed results for an individual or a product
A notified functional statement identifies wording that a qualifying product may use when the applicable conditions are satisfied. It is not a guarantee that every product will share the same composition, stability, bioavailability, or quality, and it does not predict an outcome for a particular person. This page records regulatory and chemical-identity information; it does not compare brands, evaluate individual products, recommend dosages, or independently assess clinical efficacy.
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. Later amendments, interpretations, drug-label changes, register additions, cancellations, and database corrections may change the applicable record.
Related Entities
Related Ingredients
- Eicosapentaenoic Acid (EPA) — indicator component of this article
- Docosahexaenoic Acid (DHA) — indicator component of this article
- Alpha-Linolenic Acid (ALA) — plant-origin omega-3 fatty acid outside this article’s indicator-component definition
- Lutein — separate notified ingredient with its own eye-health functional statement
- Magnesium — separate notified nutrient in the same Health Functional Food Code
Related Product Types
- Health functional food — omega-3 softgel capsules using fish-derived EPA and DHA-Containing Oil
- Health functional food — algal-derived omega-3 providing non-fish-source EPA and DHA
- Prescription drug — omega-3-acid ethyl esters 90, a distinct pharmaceutical category rather than a health functional food
Related Claims
- Improvement of blood triglyceride — notified functional statement, 0.5–2 g/day
- Improvement of blood circulation — notified functional statement, 0.5–2 g/day
- Improvement of memory — notified functional statement, 0.9–2 g/day
- Improvement of dry eye and support of eye health — notified functional statement, 0.6–2.24 g/day
- Treatment of hypertriglyceridemia — prescription-drug indication, not transferable to health functional food claims
All intake amounts above are expressed as the sum of EPA and DHA.
Related Regulatory Concepts
- Notified-type ingredient (고시형) and individually-approved ingredient (개별인정형)
- Health Functional Food Code (「건강기능식품의 기준 및 규격」), Section 3 ingredient articles
- Indicator component (기능·지표성분)
- Labeled-amount specifications and finished-product tolerances
- Health functional food and prescription-drug claim boundaries
- Applicability clauses that limit a specification to defined product categories
- Acid value, peroxide value, anisidine value, and total oxidation value (TOTOX)
- Dated negative keyword searches and their evidentiary limits
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 | Article definition, permitted raw materials, manufacturing standards, specifications and their stated applicability clauses, notified functional statements, daily intake ranges, and intake 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 | Records returned for the search terms used, on the search date | A negative keyword search does not exclude records listed under another ingredient, complex, source-organism, extract, or proprietary name |
| NEDRUG (MFDS drug product database) | Pharmaceutical boundary | Prescription-drug status, active ingredient, approved indications, dosage, precautions, and cancellation status | Pharmaceutical indications, doses, contraindications, warnings, and monitoring requirements do not transfer to health functional food products |
| PubChem | Chemical identity | Chemical names, molecular formulas, CAS-linked identity information, and identifiers for EPA and DHA | 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 the indicator compounds are; it does not establish what may be stated about their health effects or how they 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 article. All functional wording recorded here traces to the Health Functional Food Code text rather than to a chemical database or a naming source.
Frequently Asked Questions
Is EPA and DHA-Containing Oil a regulated ingredient in Korea?
Yes. EPA and DHA-Containing Oil (EPA 및 DHA 함유 유지) is listed as a notified-type functional ingredient article in Korea’s Health Functional Food Code, Section 3, article 2-16. The article defines permitted raw materials, manufacturing standards, minimum indicator content, specifications, functional wording, daily intake ranges, and intake precautions. The consolidated Code verified for this page reflects MFDS notification 제2026-43호 dated 2026-06-11.
What functional statements does the Code provide for EPA and DHA-Containing Oil?
The Code provides four: improvement of blood triglyceride levels, improvement of blood circulation, improvement of memory, and improvement of dry eyes supporting eye health. Each is tied to a specified daily intake measured as the sum of EPA and DHA. On this page these statements are recorded as Caution rather than Allowed, reflecting that their use depends on the product qualifying as a health functional food and meeting the stated intake conditions. That classification does not mean the statements lack a basis in the Code.
Is omega-3 the same thing as EPA and DHA-Containing Oil?
No. “Omega-3” is a broad chemical-family term, while EPA and DHA-Containing Oil is a specific notified regulatory article with defined raw materials, manufacturing standards, indicator components, and specifications. ALA is also an omega-3 fatty acid, but it is not included in article 2-16’s indicator-component definition, so a product relying on ALA does not acquire the article’s functional wording merely by being described as an omega-3 product.
Can EPA and DHA-Containing Oil claims mention disease treatment?
Article 2-16 does not provide disease-treatment or disease-prevention claims. Treatment of hypertriglyceridemia, prevention of cardiovascular events, prevention or treatment of dementia, and treatment of dry-eye disease all go beyond the notified wording recorded for this health functional food article. A Korean prescription drug containing omega-3-acid ethyl esters 90 exists separately and has its own approved indication; that indication belongs to the specific drug product and does not transfer to EPA and DHA-Containing Oil as a health functional food ingredient.
Why do the daily intake ranges for EPA and DHA-Containing Oil differ by functional statement?
Because the Code specifies separate intake conditions. Measured as the sum of EPA and DHA, the ranges are 0.5–2 g/day for improvement of blood triglyceride levels and for improvement of blood circulation, 0.9–2 g/day for improvement of memory, and 0.6–2.24 g/day for improvement of dry eyes and support of eye health. A product meeting one statement’s intake condition does not automatically qualify for the others. An intake of 0.6 g/day, for example, falls within the circulation range but does not reach the 0.9 g/day lower threshold for memory wording.
Do the oxidation specifications apply to every product containing EPA and DHA-Containing Oil?
Not according to the article’s own text. Article 2-16 places the acid value, peroxide value, anisidine value, and TOTOX specifications under an applicability clause at part 2 (4)(가), which limits them to four product categories: a raw-material product that is 100% EPA and DHA-Containing Oil; a finished product made from that alone, excluding capsules containing colorants or flavorings; a raw-material product containing only the oil plus antioxidants listed in the Food Additives Code; and a finished product made from either of those with only such antioxidants added, again excluding capsules containing colorants or flavorings. The heavy metal, residual solvent, and coliform specifications in the same part carry no equivalent limiting clause. Whether a particular product falls within the listed categories is a determination for its manufacturer and the competent authority.