Chandigarh Nutraceutical Company Navigates EU Novel Food Regulation for Ashwagandha Export

Curated by Vinod Kumar Jain & Amit Jain · All Frontier Global · free, no login

India-UK

Challenge

A Chandigarh-based nutraceutical manufacturer wanted to export ashwagandha (Withania somnifera) root extract capsules to UK and EU. They had FSSAI approval for domestic sale and WHO-GMP certification. Their UK distribution partner informed them that ashwagandha was classified as a novel food in the UK (post-Brexit Great Britain) and required pre-market authorisation. The manufacturer was unaware of novel food status and had already produced 50,000 units for export.

Solution

AJG connected the manufacturer with a UK novel food regulatory consultant. UK FSA novel food application was submitted: GRAS (Generally Recognised as Safe) history documented, traditional use evidence compiled from Ayurvedic literature and Indian food safety standards, safety data submitted. Simultaneously, AJG identified that ashwagandha had received a positive EU EFSA opinion under a separate application — meaning EU 27 member states could proceed under existing botanical framework while UK application was pending. UK distribution was paused; EU distribution (Netherlands, Germany) commenced.

Outcome

EU distribution commenced within 6 months. UK novel food authorisation received 18 months after application. UK rollout commenced month 19. Annual EU and UK combined revenue: GBP 1.2M. The 50,000 units produced for UK were redirected to EU markets during the UK authorisation wait period — zero inventory write-off.

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