Type: Ingredient entity — regulatory & claim record
Topic: Lutein (루테인) — health functional food supplement ingredient
Evidence basis: MFDS 건강기능식품공전 고시 제2025-11호 (마리골드꽃추출물 2-26); 식품안전나라 개별인정형 3건 (제2008-66호, 제2023-37호, 제2024-25호); 건강기능식품의 표시기준 고시 제2023-9호; PubChem CID 5281243; NEDRUG pharmaceutical search (0 results)
Last Verified: 2026-05-26
This page does not make treatment, disease prevention, or efficacy claims. See the Evidence Boundaries section below.
Lutein is a carotenoid xanthophyll found naturally in marigold flowers (Tagetes erecta) and various foods. In Korea, it is regulated as a health functional food ingredient — registered both as a notified ingredient under the official food safety codex and as an individually recognized ingredient by multiple companies. This page records lutein’s regulatory status, official functionality wording, and claim boundaries as verified from Korean official sources.
The Korean official name for the notified raw material is 마리골드꽃추출물 (marigold flower extract), not “루테인” (lutein) directly. The codex entry requires the extract to contain lutein at 700 mg/g or more. Consumer products and marketing commonly use “루테인” as the ingredient label, but the regulatory designation at the ingredient level is marigold flower extract.
Ingredient Snapshot
| Field | Value |
|---|---|
| Ingredient Name | Lutein |
| Korean Name | 루테인 |
| Notified Raw Material Name (KR) | 마리골드꽃추출물 (Marigold Flower Extract) |
| CAS No. | 127-40-2 |
| Molecular Formula | C40H56O2 / MW 568.9 g/mol |
| Ingredient Type | Functional Ingredient (고시형 + 개별인정형) |
| Category | Health Functional Food (건강기능식품) |
| Cosmetic Role | Unknown — cosmetic relevance not verified in this pass |
| Pharmaceutical Status (KR) | No pharmaceutical registration found (NEDRUG 0 results, 2026-05-26) |
| Status | To Review |
Regulatory Records
| Record Type | Issuing Body | Record Number | Scope | Source |
|---|---|---|---|---|
| 고시형 (Notified) | MFDS | 식약처 고시 제2025-11호 / 공전 entry 2-26 | 마리골드꽃추출물 (루테인 700 mg/g 이상); 눈 건강; 10~20 mg/일 | 건강기능식품공전 제3.2.2-26 |
| 개별인정형 | MFDS | 제2008-66호 | 루테인/지아잔틴복합추출물; ㈜노바렉스; 10~20 mg/일 | 식품안전나라 |
| 개별인정형 | MFDS | 제2023-37호 | 루테인지아잔틴추출복합물; 한국암웨이㈜; 12 mg/일 | 식품안전나라 |
| 개별인정형 | MFDS | 제2024-25호 | 마리골드꽃추출물(지아잔틴함유); ㈜엘지생활건강; 12 mg/일 | 식품안전나라 |
| 표시기준 | MFDS | 식약처 고시 제2023-9호 | 건강기능식품 라벨 의무 표시 — 기능성 표시 범위, 의약품 오인 방지 | 국가법령정보센터 |
| Pharmaceutical Boundary (Negative) | MFDS / NEDRUG | N/A | 루테인 의약품 검색 결과 0건 (2026-05-26) | NEDRUG |
Claim Safety Matrix
| Claim Text | Claim Type | Why It Matters | Safer Alternative Wording | Source |
|---|---|---|---|---|
| 노화로 인해 감소될 수 있는 황반색소밀도를 유지하여 눈 건강에 도움을 줄 수 있음 | Caution (To Review) | Official MFDS-registered functionality wording. Scope-limited to registered raw materials and daily intake ranges. Allowed classification pending human review. | Use the official wording as-is. Do not modify or extend. | 건강기능식품공전 제2025-11호; 개별인정 3건 |
| 황반변성 예방 / 황반변성 치료 / AMD 예방 | Avoid | Disease name + prevention/treatment wording. Outside registered functionality scope. Risks medicine misrecognition under 건강기능식품의 표시기준 고시 제2023-9호. | 노화로 인해 감소될 수 있는 황반색소밀도를 유지하여 눈 건강에 도움을 줄 수 있음 | 건강기능식품의 표시기준 고시 제2023-9호 |
| 질병의 예방 및 치료를 위한 의약품이 아님 | Caution (Mandatory) | Mandatory disclaimer required on all health functional food labels and related content under MFDS labeling standards. | 본 제품은 질병의 예방 및 치료를 위한 의약품이 아님 (use verbatim) | 건강기능식품의 표시기준 고시 제2023-9호 |
Evidence Boundaries: What This Page Does Not Claim
Disease treatment or prevention. Lutein is registered as a health functional food ingredient in Korea. Expressions such as “황반변성 예방,” “황반변성 치료,” “AMD 예방,” or “prevents macular degeneration” are outside the registered scope and risk medicine misrecognition under MFDS labeling standards.
Pharmaceutical equivalence. A NEDRUG search for lutein as a pharmaceutical ingredient returned 0 results as of 2026-05-26. Lutein is not registered as an OTC or prescription medicine in Korea.
Individual efficacy guarantee. The registered wording uses “도움을 줄 수 있음” (may support). Individual results vary. This page does not guarantee outcomes.
Cosmetic functionality. Cosmetic ingredient relevance was not verified in this research pass. This page covers supplement use only.
Product-specific claims. This page records ingredient-level regulatory evidence only. No specific product’s efficacy or superiority is asserted.
Related Entities
Related Ingredients
- Zeaxanthin (지아잔틴) — co-ingredient in multiple lutein individual recognition records
- Marigold Flower Extract (마리골드꽃추출물) — official Korean codex raw material name
Related Regulatory Concepts
- 건강기능식품 고시형 원료 (Notified Health Functional Food Ingredient)
- 건강기능식품 개별인정형 원료 (Individually Recognized Health Functional Food Ingredient)
- 건강기능식품의 표시기준 (Health Functional Food Labeling Standards)
Related Claims
- 황반색소밀도 유지 — 눈 건강 (Caution / To Review)
- 황반변성 예방 / AMD 예방 (Avoid)
- 의약품 아님 면책 표시 (Caution / Mandatory)
Source Transparency Note
| Source | Role | Authority Scope | Limit |
|---|---|---|---|
| MFDS 건강기능식품공전 고시 제2025-11호 | Regulatory | Notified ingredient status, functionality wording, daily intake | 고시형 범위 내 한정 |
| 식품안전나라 개별인정형 기록 | Regulatory | Individual recognition numbers, functionality wording, daily intake | 인정 업체 및 원료 범위 한정 |
| 건강기능식품의 표시기준 고시 제2023-9호 | Labeling Standard | Permitted claim scope, mandatory disclaimers, prohibited wording | 표시기준 적용 범위 한정 |
| PubChem CID 5281243 | Chemistry Identity | CAS No., molecular formula, synonyms | 규제·claim 정보 없음 |
| NEDRUG | Pharmaceutical Boundary | Korean pharmaceutical registration search | Negative result only |
FAQ
Is lutein a regulated ingredient in Korea?
Yes. Lutein is regulated in Korea as a health functional food ingredient. The official raw material name in the Korean codex is 마리골드꽃추출물 (marigold flower extract), which must contain lutein at 700 mg/g or more. It is registered under MFDS notice 제2025-11호 and three individual recognition numbers.
What is the officially registered functionality wording for lutein in Korea?
The MFDS-registered functionality wording is: “노화로 인해 감소될 수 있는 황반색소밀도를 유지하여 눈 건강에 도움을 줄 수 있음” — May support eye health by maintaining the density of macular pigments which can be affected by aging.
Can lutein products in Korea claim to prevent or treat macular degeneration?
No. Disease name expressions such as “황반변성 예방” or “AMD 예방” are outside the registered functionality scope and risk medicine misrecognition under Korean health functional food labeling standards.
Is lutein classified as a pharmaceutical in Korea?
A NEDRUG search for lutein as a pharmaceutical ingredient returned 0 results as of 2026-05-26. Lutein is not registered as an OTC or prescription medicine in Korea based on this search.
What is the daily intake range for lutein health functional food products in Korea?
For the notified raw material (마리골드꽃추출물), the daily intake is 10 to 20 mg of lutein. For individually recognized ingredients: 10 to 20 mg per day (제2008-66호), or 12 mg per day as the combined total of lutein and total zeaxanthin (제2023-37호, 제2024-25호).