The “complex and lengthy process” for the saffron extract, named Affron, was conducted in collaboration with Hyundai Bioland Co Ltd.
According to Pharmactive, the main challenge was ensuring that its international clinical data and standardization parameters were aligned precisely with MFDS’s expectations.
“Hyundai Bioland is a prominent healthcare-focused organization in South Korea, with prior experience and in-depth knowledge of the individual license application process, having already obtained such approvals for other ingredients in the past.
“More importantly, they also have the capability to efficiently distribute clinically studied nutraceutical ingredients in the country, reaching major brands across multiple sales channels,” Carlos Rodriguez, Communication Manager at Pharmactive, told NutraIngredients.
He added that Hyundai Bioland’s proficiency in navigating the individual license process, including a unique ability to identify and address potential gaps prior to the application stage, was critical in saving time and costs.
The approval positions Affronas the first saffron ingredient to be approved for a stress relief claim by the MFDS and is to date the sole holder of this recognition.
It also allows supplements containing Affron marketed in South Korea to bear a Health Functional Food (HFF) seal, which is said to be highly regarded among consumers in the country and the wider Asia-Pacific (APAC) region.
The company intends to explore additional health claim opportunities in South Korea.
“Affron is an ingredient supported by multiple clinical studies, with research spanning areas such as occasional stress and sleep quality. Through our partnership with Hyundai Bioland, we intend to explore additional health claim opportunities in alignment with regulatory requirements.”
Rodriguez said that the objective was to enable consumers in South Korea and other markets that accept South Korean formulations to access products that reflect the full scientific profile of Affron.
Solid science, global adoption
There are 12 human clinical trials conducted using Affron, with application potential in occasional stress, emotional well-being, and sleep support. According to the company, these categories have shown steady global growth.
“Thanks to its low effective dose and solid clinical backing, it is particularly well-suited for premium formulations targeting emotional well-being. From a formulation perspective, Affron can be incorporated into capsules, tablets, stick packs and gummies, giving brands flexibility across multiple consumer formats,” Rodriguez explained.
Currently, Affron has been incorporated in over 400 finished products across Europe, North America, Asia and Australia.
It is used in emotional balance supplements, stress-support formulations, sleep aids, and increasingly in women’s well-being and lifestyle products. An example is Utah-based firm Solaray’s Stages range, which focuses on women’s health, particularly during menopause.
Aside from South Korea, the ingredient has received regulatory recognition in key international markets, including New Dietary Ingredient (NDI) notification with the US FDA, compliance under Japan’s Foods with Function Claims (FFC) system, and authorization in Canada.
Growing demand for stress support
Stress’s impact on long-term well-being and overall quality of life is increasingly recognized across APAC, where it has become one of the top five concerns requiring attention, said Rodriguez.
“Stress is no longer an issue that is brushed aside or spoken about lightly. Major brands in the region have traditionally approached this challenge through herbal and conventional solutions as complementary options to prescribed medication. However, some of these approaches have presented certain limitations.”
As stress management becomes a priority across different population segments, the emphasis has shifted towards ensuring that formulations contain stress-support ingredients backed by high-quality science.
Affron can be combined with well-established traditional medicine ingredients in South Korea, such as ginseng, Zizyphi Spinosae, and Acorus gramineus.
The ingredient has also gained interest among Korean exporters due to its global presence and rising consumer awareness related to emotional well-being and occasional stress support.
“Consumers in markets beyond South Korea, particularly in China and South East Asia, value formulations containing ingredients with claims approved by the MFDS, and such products are widely trusted and highly sought after.”
