Affron Saffron Attains First Stress Relief Claim by South Korean Ministry of Food and Drug Safety

Pharmactive teams up with Hyundai Bioland to unlock South Korean nutraceutical market

MADRID, Feb. 10, 2026 /PRNewswire/ — Pharmactive Biotech Products, S.L.U announces its flagship Affron® saffron extract has officially received individual license approval for its potential to relieve stress by the Ministry of Food and Drug Safety (MFDS) of South Korea. The complex and lengthy process was conducted in collaboration with Hyundai Bioland Co., Ltd., Cheongju-si, Seoul, a leading force in K-beauty and functional foods.

The endorsement positions Affron® as the first saffron ingredient to be approved for a stress relief claim by the South Korean food regulation authority and is to date the sole holder of this recognition. Supplements containing Affron® marketed in South Korea are certified to bear a Health Functional Food (HFF) seal, highly regarded among consumers in South Korea and the wider APAC region. It further confirms that Affron® is regulated and approved by the Korean government as a health-benefit food that has been scientifically vetted for its positive impact on occasional stress.

Stress is currently ranked as a key health category in Korea for which many consumers are seeking a natural solution. The individual license permits Korean brands using Affron to label their products with stress management claims, representing a major breakthrough for Pharmactive.

MFDS, the most stringent gatekeeper

“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,” proclaims 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.”

The MFDS imposes hefty demands before granting any license for a health claim. It defines specific claims for each health category and provides parameter tables that must be met in order to obtain approval. These typically include specific biomarkers, mechanisms of action, clinical evidence, along with clear safety validation. The MFDS also specifies the types of studies (e.g., in vitro, in vivo) that are accepted to fulfill these parameters.

The approval process stretched to more than two years. Pharmactive was required to submit a comprehensive dossier detailing their branded botanical’s chemical fingerprint and toxicological data, as well as a full history of pre-clinical and clinical trials.

Pharmactive’s saffron extract boasts the lowest needed dose of pure saffron on the market. The company applies a proprietary green extraction technology, without solvents, to safeguard the potent compounds of one of nature’s most venerated and fragile botanicals. These actives encompass standardized concentrations of Lepticrosalides®, the compounds responsible for saffron’s bioactive benefits. 

In line with the exacting requirements listed by the MFDS, advanced analytical tools were applied to ensure Affron® met a consistent molecular pattern. That pattern aligned with the material used in clinical studies and so could demonstrate a reproducible chemical fingerprint. High-Performance Liquid Chromatography (HPLC) was used to obtain comprehensive characterization of crocin isomers and other key compounds.

An extensive analytical study on 88 industrial batches revealed highly consistent crocin/picrocrocin profiles. Original quality and profile were maintained over a storage period of up to 36 months. Affron’s safety was demonstrated through a weight-of-evidence approach combining high-dose animal studies, mechanistic liver safety data, and extensive human clinical experience.

Affron is backed by 12 human trials

“Affron’s safety and efficacy are supported by a solid evidence base, comprising 12 clinical trials on 1,000+ total participants” explains Marina Diez, Head of R&D and QC at Pharmactive. “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 occassional stress and mood. Moreover, Affron was tested on diverse populations, including healthy adults, adolescents, and perimenopausal women.”

One of the preclinical in vivo studies, conducted in Korea, provided invaluable mechanistic insights: Using a chronic stress model in rodent subjects, Affron® was shown to enhance resilience to stress by helping regulate the hypothalamic–pituitary–adrenal (HPA) axis, the body’s central stress-response system. Findings indicated reduced stress hormone signaling, as reflected by lower corticosterone and ACTH levels.

South Korea Emerging as Core Market

“South Korea is a strategically important market for us,” adds Lim Tian Cai, Business Development Manager in APAC. “This is not only because it is a premier cross-border nutraceutical manufacturing hub in Asia but also home to a regulatory authority that is considered gold standard. MFDS-granted health claims are highly respected by the locals. Moreover, ‘Korea-made’ is highly valued across Asia and beyond. Finished products emanating from there are making significant inroads into Asians markets given Korea’s reputation as an advanced and high-trust market for Health Functional Foods.”

Korea’s nutraceutical market is currently valued at approximately USD14.8 billion, and is projected to reach USD27.3 billion by 2033, with 2026-2033 year-on-year growth above 9%, significantly outpacing the global average. The South Korean market for mental health- and stress-related products is already dynamic. The broader mental health services and products market in South Korea is valued at approximately USD8.5 billion. Within that, the “Stress Relief & Sleep” segment of the Health Functional Food (HFF) market is growing at a CAGR of more than 10%.

Deepening its market development in South Korea and across Southeast Asia, Pharmactive entered collaborations with Hyundai Bioland Co., Ltd., a comprehensive healthcare company specializing in the production and sales of health supplements, cosmetics, and biomedical ingredients. The biotech firm has been instrumental in driving Pharmactive’s regional expansion while steering them through the bureaucratic landscape to secure the coveted MFDS seal.

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SOURCE Pharmactive Biotech Products, S.L.U.