Individually-Approved vs Notified Functional Ingredients for Korean Health Supplements

Two Tracks for Functional Ingredients in Korea

Korea's health functional food regulatory system recognizes two distinct categories of functional ingredients:

• Notified (고시형) ingredients: Functional ingredients that MFDS has officially published in its regulations, complete with approved functional claims, minimum and maximum daily intake ranges, and quality standards. Any manufacturer can use these ingredients if the formulation meets the published standards.
• Individually approved (개별인정형) ingredients: Ingredients for which a company has submitted functional substantiation data to MFDS and received individual recognition. The approving company holds exclusive rights to use the approved functional claims for that ingredient for a defined period.

The analogy I found most useful: notified ingredients are items on a shared menu that anyone can order. Individually approved ingredients are proprietary recipes that only you can serve — but developing them takes time and investment.

Notified Ingredients: The Practical Entry Point

Familiar ingredients dominate this category: red ginseng, vitamins (B-complex, C, D), omega-3 (EPA/DHA), calcium, magnesium, probiotics, lutein, coenzyme Q10, and many more. Each has a published daily intake range and a set of approved functional claim statements.

Using notified ingredients means:

• No separate approval process — formulate within the standards and you're clear
• Stable supply chains with multiple sourcing options
• High consumer recognition for established ingredients
• Competition: any brand can use the same ingredient with the same claims

For first-time OEM projects, notified ingredients are almost always the right starting point. The competitive challenge is addressed through thoughtful curation — choosing the right combination of ingredients for a specific target consumer — rather than through ingredient exclusivity.

Individually Approved Ingredients: When Differentiation Matters

A company that has successfully obtained individual recognition holds a meaningful competitive advantage: competitors cannot use the same ingredient to make the same functional claim.

However, the investment required is substantial:

• Functional substantiation data (typically human clinical trials, supported by in-vitro or animal data and literature review)
• Regulatory submission and MFDS review process
• Significant time commitment before any product can reach market

For most small to mid-size OEM brands at launch stage, applying for individual recognition directly is impractical. The alternative — sourcing an already-recognized ingredient from the holding company — is a middle path that provides some differentiation while avoiding the full development burden. This approach requires purchasing the specific raw material from the recognition holder, which can limit pricing flexibility.

Formulating with Multiple Ingredients

Combining multiple functional ingredients in a single product is common, but requires careful attention:

• Each ingredient's daily dosage must independently meet its minimum standard for the corresponding functional claim to be permitted on the label
• Research has reported potential interactions between certain ingredient combinations that may affect absorption — a factor worth reviewing with the factory R&D team
• Dosage form compatibility varies: certain oil-based ingredients, for example, are not suited to hard capsule formats

Choosing the Right Ingredient: A Practical Framework

The selection process that proved most useful:

1. Start with the target consumer's health concern and work backward to relevant functional categories
2. Check whether suitable ingredients exist in the notified list — this is almost always the right starting point
3. Evaluate supply chain stability, especially for imported ingredients
4. Confirm the factory's experience handling the specific ingredient
5. Assess consumer awareness: high-recognition ingredients need less consumer education; novel ingredients require brand investment in explanation

Marketing Implications

The ingredient story is often the most compelling marketing content for supplement brands. Explaining why you chose a specific ingredient — the source, the evidence base, the dosage rationale — creates substantive content that performs better than generic health claims.

For individually approved ingredients, the exclusivity itself is a marketing signal worth communicating. For notified ingredients, the curation logic and combination rationale can serve the same differentiating function.

All functional benefit communications must stay within the approved claim language. Disease treatment or prevention statements are prohibited regardless of ingredient type.