EU Nutrient & Health Claims Registration: Full 2025 Guide

EU Nutrient & Health Claims Registration: Full 2025 Guide

Understanding how to register nutrition and health claims in the European Union is essential for brands launching food, beverages, or dietary supplements. With evolving regulations in 2025, accurate compliance ensures market access, builds consumer trust, and avoids costly legal issues.

What Are Nutrition and Health Claims?

Nutrition claims describe the nutritional content of a product—such as ‘rich in vitamin C’ or ‘low in saturated fat’—while health claims link a substance to a specific physiological function, like ‘calcium contributes to normal bone maintenance’. Both require official approval to prevent misleading consumers.

The EU Regulatory Framework

The European Food Safety Authority (EFSA) oversees all health and nutrition claims under Regulation (EC) No ¹⁹²⁴⁄₂₀₀₆, updated with 2024 enforcement guidelines. Companies must submit scientific evidence proving a claim’s validity, including study design, population data, and dose-response relationships. Nutrition claims follow similar but distinct rules under Regulation (EU) No ¹¹⁶⁹⁄₂₀₁₁, focusing on factual, non-comparative language.

Step-by-Step Registration Process

1. Determine Claim Type & Eligibility: Identify whether the claim is nutrition-based or health-related, then check EFSA’s approved list to ensure alignment.
   
2. Prepare Scientific Evidence: Gather robust, peer-reviewed research demonstrating the claim’s accuracy under real-world conditions. EFSA emphasizes dose, population relevance, and reproducibility.
   
3. Submit Application via EU Transparency Register: File detailed dossier with EFSA, including study summaries, analytical data, and proposed claim wording. Include contact info and product details.
   
4. Wait for EFSA Evaluation: Review typically takes 6–9 months. EFSA may request additional data or clarifications—respond promptly to avoid delays.
   
5. Official Approval & Publication: Once approved, claim can be used in labeling and marketing. The EU database publishes registered claims for public access.
   

Key Supporting Terms & Concepts

• Nutrition claims: Statements about nutrient content or contribution (e.g., ‘high in fiber’).
• Health claims: Assertions about disease prevention or physiological effects (e.g., ‘supports immune function’).
• EFSA validation: Scientific assessment ensuring claim accuracy and consumer safety.
• EU Transparency Register: Central registry for authorized registration data and approved claims.
• Scientific substantiation: Required evidence proving a claim holds under defined conditions.

Common Pitfalls to Avoid

• Using unapproved claims before EFSA approval.
• Overstating benefits without strong evidence.
• Failing to update submissions if product formulation changes.
• Ignoring EFSA’s demand for clear, precise language.

Compliance in 2025: What’s New?

In 2025, EFSA tightened guidelines on ‘natural’ and ‘clean label’ claims, requiring explicit scientific backing. Claims must reference specific nutrients or biological mechanisms. Brands now must disclose any sponsorship or conflicting interests in submissions, enhancing transparency. Digital tools and AI-assisted evidence review are streamlining processing, but human expertise remains critical.

How to Stay Ahead

• Build internal compliance teams trained on EFSA protocols.
• Partner with EFSA-recognized consultants for audit readiness.
• Monitor updates via the EU Commission’s official portals and industry newsletters.
• Train marketing and R&D teams on claim validation processes.

Stay compliant, build credibility, and succeed in the EU market. Begin your registration planning today—consult an expert and verify all documentation before submission.