Nutraceutical Registration In South Korea: MFDS Regulatory Guide For Health Functional Foods

Modern lifestyles, long working hours, and changing dietary habits have significantly increased reliance on nutraceuticals and dietary supplements worldwide. In South Korea, these products are not merely consumer goods they are strictly regulated health products known as Health Functional Foods (HFFs).

With rising consumer awareness and demand for preventive healthcare, South Korea has developed one of the most robust nutraceutical regulatory frameworks in Asia, overseen by the Ministry of Food and Drug Safety (MFDS).

At Maven Regulatory Solutions, we support global nutraceutical companies in navigating MFDS registration, ingredient approval, manufacturing authorization, import compliance, labeling, and post-market obligations to ensure successful market entry into South Korea.

This guide provides a comprehensive, MFDS-aligned overview of nutraceutical (Health Functional Food) regulation in South Korea, including timelines, fees, ingredient classification, manufacturing, imports, labeling, and post-marketing surveillance.

South Korea MFDS Regulatory Framework for Nutraceuticals

In South Korea, nutraceuticals are legally classified as Health Functional Foods (HFFs) and regulated under the Health Functional Food Act by the MFDS.

Regulatory Authorities Involved

• Ministry of Food and Drug Safety (MFDS) – Primary regulatory authority
• National Institute of Food and Drug Safety Evaluation (NIFDS) – Scientific evaluation of functional ingredients
• Korea Health Supplement Association (KHSA) – Industry and regulatory support (non-approval body)

Key MFDS Regulations Governing Health Functional Foods

Health Functional Foods are regulated under the following legislation:

• Health Functional Food Act
• Enforcement Decree of the Health Functional Food Act
• Enforcement Rule of the Health Functional Food Act
• Regulation on Recognition of Functional Ingredients
• Standards and Specifications for Health Functional Foods
• Labeling Standards for Health Functional Foods
• Health Functional Food Code

These regulations collectively govern ingredient approval, health claims, manufacturing, importation, labeling, advertising, and post-market monitoring.

What Are Nutraceuticals Under MFDS?

In South Korea, nutraceuticals are legally defined as Health Functional Foods, which are:

Products manufactured using functional ingredients that provide beneficial physiological effects to the human body beyond basic nutrition.

Classification of Functional Ingredients in South Korea

MFDS classifies nutraceutical ingredients into two regulatory categories:

1. Publicly Notified Functional Ingredients

• Listed in the Health Functional Food Code
• Can be used by any manufacturer
• Must comply with predefined standards and specifications

2. Individually Recognized Functional Ingredients

• Not listed in the Code
• Require MFDS safety and efficacy approval
• Exclusive to the approved applicant

Requirements for an Ingredient to Qualify as a Functional Ingredient

An ingredient must meet Article 15 of the Health Functional Food Act and satisfy the following:

• Derived from microorganisms, plants, animals, or water
• Extracted, purified, or synthetically replicated versions
• Combination of approved functional ingredients
• Scientifically validated for safety and functionality
• Compliant with MFDS standards and specifications

Dietary intake references are defined in Annex Table 3 of the Health Functional Food Code.

Clinical Evidence Requirements for Nutraceuticals

MFDS requires scientific evidence, including clinical trial data, when:

• Introducing a new functional ingredient
• Modifying safety, efficacy, or intake levels
• Adding or changing health claims

Clinical studies must demonstrate functional benefits, safety margins, and bioavailability.

Health Functional Food Registration Pathway (MFDS)

Standard Registration Process

1. Verify ingredient classification
2. Conduct safety and efficacy assessment
3. Submit HFF registration application
4. Register manufacturing facility
5. Receive MFDS approval
6. Comply with post-market surveillance

Documents Required for Nutraceutical Registration

• Application form
• Product information dossier
• Ingredient specifications
• Formulation details
• Manufacturing and quality control data
• Safety and efficacy evidence
• Labeling and packaging artwork
• Product samples
• Authorization letter / Power of Attorney

MFDS Registration Timeline and Fees

Fees are subject to change per MFDS updates.

Manufacturing Authorization for Health Functional Foods

Any entity manufacturing or selling HFFs must obtain MFDS business permission per site.

Key Manufacturing Documents

• Manufacturing process description
• Facility layout and equipment list
• Land use certification
• Quality management appointment report
• Water analysis results
• Training certificates (where applicable)

Both specialized manufacturers and venture businesses have defined documentation requirements.

Import of Health Functional Foods into South Korea

All imported nutraceuticals require an MFDS Health Functional Food Import Report (Form 19).

Import Key Points

• Submit at least 5 days before arrival
• Reviewed by Regional MFDS authority
• Certificate issued in Form 20 upon compliance

Import Documentation

• Certificate of examination
• Korean labeling or labeling content
• Identity preserved handling certificate (where applicable)

Important MFDS Applications, Timelines & Fees

MFDS Labeling Requirements for Health Functional Foods

Labels must include:

• “Health Functional Food” designation
• Product name
• Business name and address
• Expiry date and storage method
• Net quantity
• Nutritional and functional information
• Ingredient composition
• Usage instructions
• Warning statements
• Mandatory disclaimer (not medicine)

Post-Market Surveillance & Compliance

MFDS enforces strict post-marketing obligations, including:

• Adverse event reporting system
• Routine market inspections
• Food Traceability System
• GMP compliance
• Labeling audits

Non-compliance may result in fines, recalls, or market withdrawal.

MFDS Administrative Penalties

Administrative fines of up to 3 million KRW may be imposed for violations related to:

• Reporting failures
• Quality control breaches
• Training non-compliance
• Labeling violations

Why MFDS Compliance Matters

Health Functional Foods directly impact public health. MFDS regulations ensure:

• Consumer safety
• Scientific credibility
• Product quality
• Market trust

Proactive regulatory compliance protects both brands and consumers.

How Maven Regulatory Solutions Supports MFDS Compliance

Maven Regulatory Solutions provides end-to-end nutraceutical regulatory consulting, including:

• MFDS ingredient approval strategy
• Health Functional Food registration
• Clinical evidence planning
• Manufacturing & import compliance
• Labeling review and localization
• Post-market regulatory support

Frequently Asked Questions (FAQs)

Q1. What is the MFDS approval timeline for HFFs?
Typically 20–120 days depending on ingredient classification.

Q2. Are clinical trials mandatory?
Yes, for new or modified functional ingredients.

Q3. Can foreign manufacturers register products?
Yes, through an authorized local representative.

Q4. Is GMP mandatory?
Yes, GMP compliance is required throughout the product lifecycle.

Conclusion

South Korea’s MFDS framework for nutraceuticals is science-driven, consumer-focused, and compliance-intensive. Successful market entry requires a deep understanding of Health Functional Food regulations, ingredient approval pathways, labeling laws, and post-market obligations.

With the right regulatory strategy, nutraceutical brands can confidently enter and sustain success in the Korean market.

Maven Regulatory Solutions stands as your trusted partner in achieving MFDS compliance with speed, clarity, and confidence.