Lion's Mane: EU-wide Approval as a Novel Food

Summary

The medicinal mushroom Lion's Mane (Hericium erinaceus) has been officially approved as a Novel Food in the EU.

Background

This article covers recent developments in the regulation of dietary supplements. The information provided is based on official publications from EFSA, BfR, UK FSA, and other European authorities.

Key Points

• Point 1: Regulatory changes have a direct impact on your products
• Point 2: Compliance checks should be conducted regularly
• Point 3: Multi-country launches require country-specific adjustments
• Point 4: Health claims must strictly comply with EFSA guidelines
• Point 5: Labeling requirements vary between EU member states

Practical Recommendations

For Manufacturers

1. Immediate Review: Assess your existing formulations
2. Documentation: Ensure complete compliance documentation
3. Multi-Market: Account for country-specific requirements
4. Timeline: Plan reformulations in a timely manner

For Distributors

1. Supplier Check: Request up-to-date compliance documents
2. Product Review: Use automated tools like Supplement-Check.eu
3. Inventory: Check existing stock for compliance
4. Marketing: Adjust claims and descriptions

Compliance Check with Supplement-Check.eu

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✅ Automatic maximum levels check (BfR, EFSA, UK FSA, Swiss FSVO)
✅ Health claims validation
✅ Country-specific warnings and recommendations
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Conclusion

The regulatory landscape for dietary supplements in Europe is continuously evolving. Regular compliance checks are essential to avoid sales bans, warnings, and hefty fines.

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Published on: 2025-07-20
Category: regulatory-updates
Reading time: 7 minutes

Disclaimer: This article is for informational purposes only and does not constitute legal advice. For legally binding information, please consult a specialist lawyer in food law.