Nutraceutical Regulations & Registration In The European Union (EU): A Complete Compliance Guide For 2025

The European nutraceutical market is expanding rapidly, driven by growing consumer awareness of preventive healthcare, functional nutrition, and scientifically backed wellness products. At a CAGR of 4.91% (2023–2028), the European nutraceutical market is projected to grow from USD 79.95 billion in 2023 to USD 101.60 billion by 2028. 

However, market opportunity comes with strict regulatory oversight. In the European Union, nutraceuticals are regulated not as medicines, but under the food and dietary supplement regulatory framework, requiring compliance with EU food law, EFSA scientific evaluation, and national authority notification systems. 

For brands planning EU market entry, misunderstanding the regulatory pathway can delay launches, trigger enforcement actions, or restrict health claims. This comprehensive guide from Maven Regulatory Solutions explains nutraceutical regulations and registration in the European Union, covering legal frameworks, documentation requirements, labelling rules, and the end-to-end regulatory process. 

How Are Nutraceuticals Classified in the European Union? 

In the EU, nutraceuticals fall within the broader category of: 

Food Supplements / Dietary Supplements 

They are regulated under EU food legislation, not as pharmaceutical products. Importantly: 

• The European Medicines Agency (EMA) does not directly approve nutraceuticals 
• Oversight lies with national competent authorities, supported by scientific evaluations from the European Food Safety Authority (EFSA) 

This distinction is critical for compliance strategy, claims development, and product positioning. 

EU Regulatory Framework Governing Nutraceuticals 

1. Regulation (EU) No 1169/2011 – Food Information to Consumers (FIC) 

This regulation governs labelling and consumer information requirements for nutraceuticals and food supplements. 

Key Requirements: 

• Product name and category 
• Complete ingredient list 
• Recommended daily dose 
• Directions for use 
• Allergen declaration 
• Mandatory warnings (e.g., not exceeding recommended dose) 

2. Directive 2002/46/EC – Food Supplements Directive

This directive forms the core regulatory framework for food supplements in the EU. 

Key Provisions: 

• Defines food supplements as concentrated sources of nutrients 
• Establishes permitted vitamins and minerals 
• Sets maximum and minimum levels for vitamins and minerals 
• Applies harmonized labelling rules across EU Member States 

Ingredients other than vitamins and minerals (e.g., botanicals, bioactive) may fall under national laws or other EU regulations. 

3. Regulation (EC) No 1924/2006 – Health Claims Regulation 

This regulation strictly controls nutrition and health claims made on nutraceutical products. 

Important Points: 

• Health claims must be EFSA-authorized 
• Claims must be scientifically substantiated 
• Disease prevention, treatment, or cure claims are prohibited 

Key Definition: Food Supplements Under EU Law 

Food supplements are defined as: 

“Concentrated sources of nutrients or other substances with a nutritional or physiological effect, intended to supplement the normal diet.” 

They are marketed in dose form, such as: 

• Capsules 
• Tablets 
• Powders 
• Liquids 

Documents Required for Nutraceutical Registration in the EU 

Although there is no centralized EU-wide registration, most Member States require notification before placing a nutraceutical on the market. 

1. Product Information 

• Product and brand name 
• Category (vitamin, mineral, herbal, functional ingredient) 
• Dosage form (capsule, tablet, liquid) 
• Intended use and target population 
• Recommended daily intake 

2. Ingredients & Composition 

• Complete ingredient list 
• Quantity per daily dose 
• Ingredient specifications and purity 
• Source of ingredients (plant, animal, synthetic) 

3. Safety Assessment Documentation 

• Toxicological and exposure data 
• Ingredient safety history 
• Interaction and risk evaluation 
• EFSA opinions (if applicable) 

4. Quality & Manufacturing Information 

• GMP compliance documentation 
• Manufacturing site details 
• Quality control procedures 
• Batch consistency information 

5. Labelling & Packaging Drafts 

• Label artwork complying with EU FIC regulation 
• Mandatory warnings and disclaimers 
• Nutrition and health claims (if any) 

 6. Scientific Substantiation for Claims 

• EFSA-approved claim references 
• Clinical or scientific evidence supporting functional claims 

 7. Notification / Authorization Evidence 

• National authority notification forms 
• Fees and country-specific documents 
• Mutual recognition evidence (if applicable) 

Nutraceutical Labelling & Packaging Requirements in the EU 

Labels must be clear, accurate, and consumer-friendly, with no misleading medical implications. 

EU Nutraceutical Regulatory Process: Step-by-Step 

1. Ingredient Eligibility Check 

• Verify ingredients listed in Annex II of Directive 2002/46/EC 
• For non-listed ingredients, assess Novel Food status 

2. Formulation Compliance 

• Ensure ingredient levels meet EU limits 
• Confirm bioavailability and stability 

3. Safety Assessment 

• Evaluate exposure, vulnerable populations, and risk 
• Compile safety dossier if needed 

4. Label & Claim Review 

• Align with EFSA-approved health claims 
• Remove disease-related or medicinal wording 

5. National Authority Notification 

• Submit product notification before market entry 
• Requirements vary by Member State 

6. Cross-Border Market Access 

Once legally marketed in one Member State, the product can typically be sold across the EU under the principle of mutual recognition, subject to local language and notification rules. 

Recent EU Nutraceutical Regulatory Trends (2024–2025) 

• Increased scrutiny of botanical extracts 
• Expansion of Novel Food approvals 
• Enhanced enforcement of misleading health claims 
• Focus on bioavailability and safety margins 
• Stronger digital traceability expectations 

How Maven Regulatory Solutions Supports EU Nutraceutical Compliance 

Maven Regulatory Solutions provides strategic regulatory support for: 

• EU nutraceutical classification 
• Ingredient and Novel Food assessments 
• EFSA health claim strategy 
• Labelling and packaging compliance 
• Member State notification management 
• Cross-border EU market access planning 

Our experts ensure your nutraceutical products meet EU food law, EFSA standards, and national authority expectations efficiently and compliantly. 

Frequently Asked Questions (FAQs) 

1.Are nutraceuticals regulated by EMA in the EU? 

No. Nutraceuticals are regulated under EU food law, with scientific oversight from EFSA and enforcement by national authorities. 

2.Do nutraceuticals require EFSA approval? 

Only health claims and novel ingredients require EFSA scientific evaluation. 

3.Is EU registration centralized? 

No. Notification is typically handled at the Member State level. 

4.Can EU-approved nutraceuticals be sold across all countries? 

Generally, yes, under mutual recognition, subject to local notification and language requirements. 

Conclusion 

The EU nutraceutical regulatory landscape is robust, science-driven, and strictly enforced. Success in this market depends on early regulatory planning, accurate classification, compliant labelling, and scientifically justified claims. 

With the right regulatory strategy, nutraceutical brands can access one of the world’s most valuable wellness markets. Maven Regulatory Solutions stands ready to guide you through every stage of EU nutraceutical compliance—from formulation to market launch.