MFDS Approval Saffron Extract: Affron® Achieves Regulatory Milestone in South Korea

Affron®, Pharmactive’s standardized saffron extract, has officially obtained MFDS approval as an individual functional ingredient in South Korea for stress relief.

This achievement marks a significant milestone in the global regulatory positioning of Affron®, positioning it as the first saffron extract to receive individual approval from the Ministry of Food and Drug Safety (MFDS) in Korea for a stress-related health claim.

The MFDS approval saffron extract recognition qualifies finished products containing Affron® to carry the official Health Functional Food (HFF) seal, subject to local compliance requirements.

What Does MFDS Approval Mean for a Saffron Extract?

The Ministry of Food and Drug Safety (MFDS) operates one of the most stringent regulatory systems for nutraceutical ingredients worldwide.

To obtain individual functional ingredient approval, companies must submit a comprehensive scientific dossier including:

• Human clinical efficacy data

• Defined biomarkers and mechanisms of action

• Toxicological safety validation

• Analytical consistency and reproducibility data

• Stability and batch-to-batch verification

The MFDS approval process for Affron® extended over more than two years and required detailed documentation covering chemical fingerprinting, manufacturing processes, and the full history of preclinical and clinical studies.

Clinical Evidence Behind Affron®

Affron® is supported by:

• 12 human clinical trials

• More than 1,000 study participants

• Multiple trials specifically evaluating stress and mood support

Pharmacokinetic research has shown evidence of bioavailability of crocetin, a key saffron metabolite. In addition, preclinical research, including an in vivo study conducted in Korea, suggested a potential influence on pathways related to the hypothalamic–pituitary–adrenal (HPA) axis, alongside changes in stress-related biomarkers such as corticosterone and ACTH.

Affron® is standardized to Lepticrosalides® and produced using a proprietary solvent-free extraction technology designed to preserve saffron’s fragile bioactive compounds.

South Korea: A High-Trust Nutraceutical Market

South Korea represents one of the most advanced and tightly regulated nutraceutical markets globally.

The Korean Health Functional Food sector is valued at approximately USD 14.8 billion and is recognized as a growing and highly regulated sector. Within this market, stress relief and sleep support products represent a high-growth category.

By securing MFDS approval for its saffron extract, Pharmactive strengthens its position in Asia and enables Korean brands to formulate stress-management products with an individually recognized ingredient.

This regulatory milestone was achieved in collaboration with Hyundai Bioland Co., Ltd., whose local expertise supported the successful navigation of the MFDS approval pathway.

Strengthening Global Regulatory Leadership

The MFDS approval saffron extract milestone reinforces Affron®’s positioning as a clinically validated, analytically defined botanical ingredient developed in alignment with rigorous regulatory standards.

Through science-driven development and regulatory excellence, Pharmactive continues expanding the global footprint of its premium botanical portfolio.