Recently, the Ministry of Food and Drug Safety (MFDS) of South Korea officially approved Affron®, a saffron extract developed by Pharmactive, for health function claims related to stress relief. Following this approval, dietary supplement products formulated with this ingredient marketed in South Korea can obtain relevant certification and bear the “Health Functional Food (HFF)” label. This marks a key milestone in the global regulatory progress of saffron extract. Against the backdrop of rising global consumption demand for mood soothing, stress regulation and sleep health, this botanical ingredient rooted in the dual tradition of food and medicine in the East and backed by modern clinical research enjoys expanded industrial potential. It is poised to become the next blockbuster ingredient in the health food sector.

Nowadays, emotional stress and anxiety have evolved into prevalent public health concerns worldwide, driving continuous expansion of the global market for mood management health supplements. As a classic food-medicine dual-use raw material in China, saffron boasts high recognition across Asia and globally. The recent approval of stress-related health function claims in South Korea represents a major regulatory breakthrough for saffron extract, paving the way for its commercialization worldwide. Supported by both traditional application heritage and modern scientific data, saffron extract is rapidly transforming from a conventional herbal material into a modern functional food ingredient.

Rigorous Review Completed with Multiple Scientific Datasets Supporting Regulatory Compliance

This South Korean approval was jointly pursued by Pharmactive and Hyundai Bioland, a regional functional food manufacturer, following a multi-year full review procedure. MFDS imposed stringent requirements on application dossiers, mandating complete submission of biomarkers, mechanisms of action, full clinical trial data and safety assessment documentation.

In terms of compositional consistency, high-performance liquid chromatography analysis confirmed stable and uniform levels of crocin and picrocrocin across more than 80 industrial batches. A 36-month long-term stability test was also completed to sufficiently verify that active components can be retained steadily during storage.

The safety assessment program included high-dose animal studies, hepatic mechanistic research and extensive human clinical data accumulation. Pharmactive submitted evidence comprising 12 clinical trials with over 1,000 participants covering diverse populations including healthy adults, adolescents and perimenopausal women.

Mechanistic studies demonstrate that saffron extract alleviates stress by modulating corticosterone levels and reducing stress hormone signaling. In a randomized, double-blind, placebo-controlled clinical trial, 202 participants were monitored over a 12-week period for changes in mood and sleep status. Data showed that 72.3% of subjects in the treatment group achieved clinically meaningful improvements on the Depression Anxiety Stress Scales (DASS), compared with 54.3% in the placebo group.

Built on robust scientific evidence, beyond the latest South Korean approval, Affron® saffron extract has also secured regulatory recognition including US FDA NDI, Japanese functional food status and approvals in Canada and other regions. It supports a wide range of dosage forms such as capsules, tablets, stick-pack powders and gummies. Currently, this ingredient is used in more than 400 finished products across Europe, North America, Asia-Pacific, Australia and other regions, covering applications including emotional balance, stress management, sleep care and women’s health.

Deep Food-Medicine Dual-Use Heritage Targeting the Trillion-Yuan High-Growth Mood & Sleep Segment

Saffron is a precious herbal resource classified as a food-medicine dual-use substance, rich in natural active constituents such as safranal, crocin, crocetin and picrocrocin. It is documented in ancient classics including Pin Hui Jing Yao and Compendium of Materia Medica. The 2020 edition of Chinese Pharmacopoeia records saffron as neutral in nature and sweet in flavor, traditionally used for relieving depression and clearing the heart. Iran and Spain serve as the world’s core saffron producing regions.

From a market perspective, mood, stress and sleep have developed into a trillion-yuan premium track. iiMedia Research data shows that China’s emotional economy market reached 2.7185 trillion yuan in 2025 and is projected to exceed 4.5 trillion yuan by 2029. Reports from Future Market Insights indicate that the Asia-Pacific region has become the fastest-growing market for melatonin-based sleep supplements, with China registering a compound annual growth rate of 20.1% from 2025 to 2035. High-pressure working environments and poor sleep quality continuously fuel demand for relevant functional foods. South Korea’s nutritional health food market stands at approximately USD 14.8 billion and is expected to approach USD 27.3 billion by 2033, with categories related to mental health and sleep health leading industry growth.

Compared with popular mood and sleep ingredients such as GABA and melatonin, saffron extract carries distinct differentiated strengths. Backed by both centuries of traditional Eastern use and multiple human clinical trials, its natural herbal identity earns greater consumer trust. As consumption demands upgrade, consumers no longer seek only short-term sleep aid, but prioritize long-term daily care for stress relief and emotional stability — a need well matched by saffron.

Diversified Finished Products and Formulation Innovation Unlock Broader Commercial Opportunities

Across global markets, finished saffron product formats continue to diversify, with brands exploring innovative ingredient combinations. Gummy manufacturers formulate saffron with chamomile, magnesium and lemon balm for sleep-targeted gummies. Many overseas dietary supplement brands launch saffron capsules for stress and mood support. Fish oil brands have innovatively introduced saffron-fish oil blends focusing on dual benefits for mood and sleep.

Technological upgrades are also underway. Technologically enhanced ingredients such as liposomal saffron have emerged to improve absorption and bioavailability, and technological iteration will become a key competitive factor in this ingredient track. Proven formulation combinations validated by the market include saffron plus magnesium, saffron plus herbal extracts, and saffron plus fish oil. These fit mainstream domestic food dosage forms such as gummies, pressed candies, oral liquids and solid beverages.

Alongside opportunities, the industry must address practical challenges. The inherently high price of saffron raw materials creates cost pressure for finished products. Active components are sensitive to storage and processing conditions, requiring formulation and process optimization by downstream manufacturers. Domestic consumer awareness of standardized saffron extracts remains in the cultivation phase, calling for sustained market education. In addition, enterprises must strictly comply with regulations in different jurisdictions and enforce compliant management of efficacy claims during product development.

The approval of health function claims in South Korea represents a major milestone for the global development of saffron extract. Rooted in Eastern food-medicine dual-use culture and supported by abundant human clinical evidence and multi-country regulatory endorsements, saffron extract enters the high-growth track for mood, stress and sleep wellness. Evolving from a single raw material toward diversified formulation innovation and transitioning from a traditional medicinal herb to a modern functional food ingredient, saffron extract holds the potential to replicate the growth trajectory of GABA and deliver greater industrial value in the global health food market. With continuous launches of downstream finished products and ongoing optimization of raw material processing, saffron is expected to become a star botanical ingredient within the mood and sleep sector.

Disclaimer: This article is industry news compiled from public industrial materials and academic literature and does not constitute any efficacy claims. Enterprises using relevant ingredients must strictly comply with regulatory requirements of corresponding countries and regions.

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