South Korea Approves Saffron Extract for First Stress Relief Health Claim

South Korea's Ministry of Food and Drug Safety (MFDS) has granted an individual license approval to Affron® saffron extract for its efficacy in stress relief claims. This regulatory action makes Affron® the first saffron-derived ingredient authorized by the South Korean food regulation authority to carry a scientifically substantiated claim for managing stress. The approval follows a strategic collaboration with Hyundai Bioland Co., Ltd., a company specializing in functional foods and K-beauty ingredients based in Cheongju-si, Seoul.

The rigorous vetting process conducted by the MFDS, recognized globally for its stringent standards for bioactive product endorsements, spanned more than two years. To secure the designation, Pharmactive Biotech Products, S.L.U., the developer of Affron®, submitted a comprehensive dossier. This submission detailed the ingredient's chemical fingerprint, toxicological data, and a complete history of preclinical and clinical trials supporting its use.

Affron® utilizes a proprietary green extraction technology, meticulously standardized for its active components known as Lepticrosides®. This standardization enables an effective daily dosage as low as 28 mg. Clinical evidence from multiple trials involving over 1,000 participants has demonstrated the extract's capacity to regulate stress hormones and contribute to improved mood. The ingredient, derived from Crocus sativus L., is scientifically characterized by standardization to a minimum of 3.5% Lepticrosalides®, which includes safranal and crocin isomers, ensuring product quality reproducibility.

This regulatory success is set to unlock significant market penetration within South Korea's demanding health supplement sector, currently valued near USD14.8 billion and projected to reach USD27.3 billion by 2033. Supplements containing Affron® marketed in the nation will now feature the Health Functional Food (HFF) seal, a mark highly valued by South Korean consumers. The approval is timely, as the "Stress Relief & Sleep" segment of the HFF market is expanding at a Compound Annual Growth Rate (CAGR) exceeding 10 percent.

Hyundai Bioland, established in 1995, leveraged its expertise in extraction, separation, and refinement technologies to navigate the regulatory landscape for securing the MFDS seal. This regulatory achievement for Pharmactive Biotech Products, based in Madrid, Spain, solidifies its standing as a developer of evidence-based botanical ingredients, following previous milestones such as securing a U.S. patent for mood support applications.