Pharmactive teams up with Hyundai Bioland to unlock South Korean nutraceutical market Pharmactive Biotech Products, S.L.U announces its flagship Affron saffron extract has officially received individual license approval for its…

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

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 breakthrough for Pharmactive.

“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 to obtain approval. These typically include specific biomarkers, mechanisms of action, clinical evidence, and clear safety validation. The MFDS also specifies the types of studies (e.g., in vitro, in vivo) that are accepted to fulfil these parameters.