Pharmactive’s Affron saffron extract wins first stress relief approval from South Korean regulator
Madrid-based Pharmactive Biotech Products has secured a significant regulatory milestone after its Affron® saffron extract received individual licence approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for a stress relief health claim. The approval makes Affron the first saffron ingredient to receive this designation from the South Korean authority, and currently the sole holder of the recognition.
The process was conducted in collaboration with Hyundai Bioland Co., Ltd., a South Korean company active in health supple-ments, cosmetics, and biomedical ingredients. Supplements containing Affron sold in South Korea may now carry the Health Functional Food (HFF) seal, a mark regarded as a strong indicator of regulatory credibility among consumers across the APAC region.
MFDS: A demanding approval pathway
The MFDS is widely regarded as one of the more stringent food and drug regulatory bodies globally. Its approval framework requires companies to define specific biomarkers, demonstrate mechanisms of action, provide clinical evidence, and meet clear safety validation standards. The authority also prescribes the categories of acceptable study types, including both in vitro and in vivo data.
Pharmactive’s approval process took more than two years. The company submitted a comprehensive dossier covering its botanical’s chemical fingerprint, toxicological data, and a full history of pre-clinical and clinical trials. “This designation marks a major regulatory victory for Pharmactive, as the MFDS is noted to be among the world’s most rigorous authorities when it comes to bioactive product approvals,” said María Muñoz, Head of Quality Assurance and Regulatory Affairs at Pharmactive. “To earn this endorsement, companies must demonstrate that their products meet the highest standards of quality, efficacy, and safety through a uniquely demanding and lengthy screening process.”
Analytical rigour and consistency data
To meet MFDS requirements, Pharmactive applied High-Performance Liquid Chromatography (HPLC) to characterise crocin isomers and other key compounds, ensuring that the molecular profile of Affron was reproducible and consistent with material used in clinical studies. An analytical study across 88 industrial batches confirmed highly consistent crocin/picrocrocin profiles, with quality and profile maintained over a 36-month storage period.
Affron is produced using a solvent-free, proprietary green extraction technology and is standardised to contain Lepticrosalides®, the compound class associated with saffron’s bioactive properties. The extract is reported to require the lowest dose of pure saffron currently available on the market.
Clinical evidence base
The submission drew on 12 human clinical trials involving more than 1,000 participants in total. “Results of pharmacokinetic studies demonstrate the bioavailability of key metabolites, such as crocetin. Several preclinical studies focused specifically on stress-response biology, helped identify important mechanisms of action. From this overall body of evidence, at least four human trials specifically confirmed Affron’s benefits on occasional stress and mood. Moreover, Affron was tested on diverse populations, including healthy adults, adolescents, and perimenopausal women,” said Marina Diez, Head of R&D and QC at Pharmactive.
A preclinical in vivo study conducted in Korea, using a chronic stress model in rodents, indicated that Affron helped regulate the hypothalamic–pituitary–adrenal (HPA) axis, with findings showing reduced corticosterone and ACTH levels.
South Korea as a strategic market
Korea’s nutraceutical market is currently valued at approximately US$14.8 billion and is projected to reach US$27.3 billion by 2033, with year-on-year growth above 9% between 2026 and 2033. Within the HFF category, the Stress Relief & Sleep segment is growing at a CAGR of more than 10%.
“South Korea is a strategically important market for us,” said Lim Tian Cai, Business Development Manager in APAC. “MFDS-granted health claims are highly respected by the locals. Moreover, ‘Korea-made’ is highly valued across Asia and beyond.”
For more information, visit: www.pharmactive.eu
