CJEU: Melatonin Dosage Remains a National Matter

Summary

The Court of Justice of the European Union has ruled that EU member states may continue to set their own maximum levels for melatonin.

Background

This article addresses 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 adhere to EFSA guidelines
• Point 5: Labeling requirements vary between EU member states

Practical Recommendations

For Manufacturers

1. Immediate Review: Evaluate 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 Retailers

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 accordingly

Compliance Check with Supplement-Check.eu

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✅ Automatic verification of maximum levels (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 continues to evolve. Regular compliance checks are essential to avoid sales bans, warnings, and hefty fines.

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Published on: 2025-11-22
Category: case law
Reading time: 9 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.