Botanical extract specialist Activ'Inside's Vaccinium angustifolium ingredient has now been approved for inclusion into Belgium’s Arrêté Royal list 3 for dietary supplements.
The list, which requires ingredients to undergo rigorous safety and efficacy evaluations, includes analgesics, ADHD medications and methadone.
Through this regulatory approval, Memophenol's market entry will be simplified significantly.
To achieve this approval, Activ'Inside worked closely with Belgian authorities to provide a robust safety dossier.
Although the Advisory Commission for Plant Preparations of the Federal Public Service for Public Health has approved Memophenol, the company will still have to wait for the official modification of Belgium's Arrêté Royal — which may take several months to complete.
Currently, the regulatory board advises a maximum daily blueberry consumption of 150g of fresh fruits or 20g of dried fruits.
“This was no small feat,” said Benoît Lemaire, CEO and Founder of Activ’Inside. “Adding a new species to the Belgium’s Arrêté Royal list at the request of an industrial player is an uncommon achievement, highlighting the rigorous scientific and regulatory work we put into this project.”
By achieving this regulatory milestone, Activ'Inside can expedite the regulatory process within the region, while also facilitating mutual recognition within the European Union (EU), simplifying the product distribution process.
“This milestone is a win not only for Activ’Inside but for the entire industry,” added Lemaire . “It demonstrates the importance of proactive regulatory engagement in ensuring safe and effective products reach consumers.”
