Indian Ayush (Ayurveda, Yoga, Unani, Siddha, Homeopathy) and wellness brands face a unique challenge when exporting to the EU: many traditional Indian ingredients are classified as "Novel Foods" requiring EFSA approval before market entry.
What is a Novel Food?
Under EU Regulation 2015/2283, a Novel Food is any food not consumed "to a significant degree" in the EU before May 15, 1997. Common Indian ingredients requiring approval:
Requires Approval
- • Ashwagandha (Withania somnifera)
- • Moringa leaf powder
- • Certain mushroom extracts
- • Novel processing methods
Already Approved
- • Turmeric (curcumin)
- • Ginger
- • Green tea extract
- • Standard herbal teas
Two Approval Pathways
Pathway 1: Article 4 Consultation (Faster)
If you can prove safe consumption history outside EU:
- • Timeline: 3-6 months
- • Cost: €15,000-€30,000
- • Success rate: 60-70%
Pathway 2: Full Dossier (Comprehensive)
Complete safety assessment with scientific studies:
- • Timeline: 9-24 months
- • Cost: €50,000-€150,000
- • Success rate: 80-90%
eufta.in EFSA Services
Initial Assessment
Determine if ingredient requires Novel Foods approval
Documentation Preparation
Compile safety data, consumption history, scientific studies
EFSA Submission
Manage complete dossier submission and follow-up
Health Claims Audit
Ensure packaging complies with Regulation EC 1924/2006
Need EFSA Approval Support?
Contact eufta.in for complete EFSA Novel Foods compliance management.
Get EFSA Guidance