Food supplement registration in the European Union (EU) remains very complex and usually case by case process. Unlike medicinal products, food supplements (FS) cannot be registered with one pan-European application or be submitted simultaneously in each of the EU countries.

Why is Food Supplement Registration in the EU so Complex

Several factors contribute to the complexity of FS registration across EU countries:

• National-Specific Process: Food supplement registration is handled at the national level, and legal documentation is often only available in the local language
• Ingredient Restrictions: If your product contains herbal ingredients, it is crucial to verify compliance with the national prohibited plant list
• Local Labelling and Packaging Requirements: Labels and packaging must be prepared in the official language of the respective country

Registration vs. Notification

In some EU countries, food supplements require full registration, while in others, only a notification process is needed. In notification-only countries the product can be placed on the market without prior approval of the Authority. However, compliance with national and EU rules of food supplements (prepared application, label and other relevant documents) is only assessed during regular inspections, making early compliance essential to avoid potential risks.

Benefits of Inpharmatis Support for Food Supplement Registration  

Navigating the European Union food supplement registration landscape can be challenging. Our expert Team has extensive experience in handling food supplement registration and notification procedures across all European Union countries. Inpharmatis can assist with:

• Compliant Labelling – ensuring your product labelling meets national language and regulatory requirements
• Regulatory Compliance – verifying your product against national prohibited plant lists and ingredient regulations
• Collecting of safety and efficacy literature to support health claims for Health Authorities’ approval
• End-to-End Support – managing the entire registration or notification process, reducing delays and regulatory risks

Contact us to streamline your food supplement registration process and ensure compliance across the EU – info@inpharmatis.com.

Key EU Regulations Governing Food Supplements

• Directive 2002/46/EC of The European Parliament and of The Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements.
• Consolidated text: Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods
• Consolidated text: Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (text with European Economic Area relevance)

For expert guidance on EU food supplement registration, reach out to Inpharmatis – info@inpharmatis.com.