Functional ingredient · Business access
BCS-001F Black Cumin Seed Extract Powder
BCS-001F is a powdered extract of Nigella sativa L. (black cumin) seed with individually recognised ingredient status in Korea. Specification, analytical, regulatory and study documents are released after business verification. Once you have reviewed them, we agree how far AriBnC takes the work, described by development stage (nonclinical, clinical, regulatory) and engagement model: running the human application study, the MFDS submission on top of it, or a full-service engagement across the whole ingredient development path. The MFDS recognition number is 2025-3, granted on 7 February 2025.
- Source: Nigella sativa L. seed
- Format: extract powder
- Individually recognised ingredient, Korea
- Registered trademark No. 40-2209581
- Origin and manufacturing process information: provided after business verification
- Design, biostatistics and EDC: Yongin head office laboratory
What the MFDS recognised
As written on the Certificate of Recognition of a Functional Ingredient for Health Functional Foods, issued by the Ministry of Food and Drug Safety.
| Item | Detail |
|---|---|
| Recognition number | No. 2025-3 |
| Date of recognition | 7 February 2025 |
| Issued by | Ministry of Food and Drug Safety (MFDS) |
| Recognition held by | AriBnC Co., Ltd. |
| Ingredient name on the certificate | Black cumin extract (FJ) |
| Legal basis | Article 10(1) of the Regulation on the Recognition of Functional Ingredients and Standards and Specifications for Health Functional Foods |
Study design and data management
Carried out at the Yongin head office laboratory
Study design, biostatistics, EDC build and operation and CRF design for this ingredient are carried out at the Yongin head office laboratory. AriBnC has been a KoNECT-registered CRO since April 2023 and has supported individually recognised ingredient submissions.
What is released after verification
Request them through the form above; we send them together once the business registration is checked.
Ingredient specification and analytical documents
Appearance, marker compound items, test items and limits, and storage and distribution conditions, set out as a specification sheet. Released together with the marker compound method summary as part of the verified documents.
Country-by-country regulatory status table
A table setting out which procedural route this ingredient falls under, and what dossier components each route needs, for Korea MFDS, US FDA (NDI, GRAS), Health Canada NNHPD (NHP) and the EU novel food route (Reg. 2015/2283).
Study and research summaries
Summaries covering the split between in vitro, in vivo and human application studies, the design outline of each, and the report inventory.
Supply format and scope of support
Supply unit and minimum order quantity, the scope of technical documentation provided, and the basis on which we agree how far AriBnC takes the work — which development stages, under which engagement model — when you develop a finished product.
What the dossier contains
What each document covers
| Document | Contents covered |
|---|---|
| Ingredient specification | Appearance, marker compound items, test items and limits, storage and distribution conditions |
| Marker compound method summary | Outline of analytical conditions and the list of validation parameters |
| Regulatory status table by country | Procedural routes and required dossier components for Korea MFDS, US FDA (NDI, GRAS), Health Canada NNHPD (NHP) and EU novel food (Reg. 2015/2283) |
| Study and research summary | Study categories (in vitro, in vivo, human application), design outlines, report inventory |
| Full study reports | Complete reports |
Where a project can be picked up is set out by development stage on the CRO and regulatory services overview.
Frequently asked questions
Can we receive a sample?
Sample terms and quantities are agreed case by case. Tell us the intended use and the quantity you need through the contact page and we will come back to you.
Do you support overseas registration as well?
We design and prepare dossiers for the US FDA routes (NDI, GRAS), Health Canada NNHPD (NHP), and the EU novel food (Reg. 2015/2283) and health claim (Reg. 1924/2006, EFSA) routes.
What does it take to put a functional claim on a finished product made with this ingredient?
Evidence for the function you intend to claim, and the studies and submission route that fit the product and the target market. AriBnC designs and prepares these within the nonclinical, clinical and regulatory stages we take on.
Request the BCS-001F documents through the form above; supply terms, overseas registration and joint development go through the contact page.