Nutraceutical Regulatory Consulting: EU Market Entry for Functional Foods

“Nutraceutical” is a marketing term, not a regulatory category. The EU doesn’t have a nutraceutical regulation. What it has is a framework of food law, food supplement law, novel food law, and medicinal product law that collectively determines how any product making health-related claims can be marketed in Europe. Navigating that framework — and avoiding the food-medicine borderline trap — is where nutraceutical regulatory consulting adds its most significant value.

What Is a Nutraceutical in EU Regulatory Terms?

In the EU, products marketed as nutraceuticals typically fall into one of three regulatory categories depending on their composition, claims, and presentation:

Food supplement: A foodstuff intended to supplement the normal diet, in concentrated form, presented in dose form (capsules, tablets, sachets). Governed by EU Directive 2002/46/EC and national implementing legislation.

Functional food: A conventional food that has been modified to provide additional health benefits beyond basic nutrition. No specific EU regulation for functional foods — they are governed by general food law (Regulation (EC) No 178/2002) and the health claims regulation (Regulation (EC) No 1924/2006).

Medicinal product: If a product is presented as having properties for treating or preventing disease, or if it functions as a medicinal product by pharmacological, immunological, or metabolic means, it is classified as a medicinal product under Directive 2001/83/EC — regardless of how the manufacturer labels it.

The third category — the food-medicine borderline — is where nutraceutical brands most frequently encounter regulatory problems.

The Food-Medicine Borderline: Why It Matters

The food-medicine borderline is one of the most practically significant regulatory concepts for nutraceutical brands. A product that crosses the line from food to medicinal product faces:

• Marketing authorisation requirements (€150,000+ in regulatory costs, 2+ years timeline)
• GMP requirements under EudraLex Volume 4 (pharmaceutical GMP, not food GMP)
• Prescription-only status in some cases
• Prohibition from sale as a food supplement

The borderline is determined by two criteria under Directive 2001/83/EC:

Presentation: A product is a medicinal product if it is presented as having properties for treating or preventing disease. This includes explicit disease claims (“treats diabetes”), but also implicit claims that a reasonable consumer would interpret as disease treatment claims.

Function: A product is a medicinal product if it can restore, correct, or modify physiological functions by exerting a pharmacological, immunological, or metabolic action. This is assessed based on the product’s composition, pharmacological properties, and the dose at which it is used.

Practical Examples

Melatonin: In the EU, melatonin is classified as a medicinal product in most member states when sold in doses above 0.5 mg per serving. Low-dose melatonin (0.5 mg) may be sold as a food supplement in some member states. This creates a fragmented regulatory landscape — the same product may be a food supplement in one EU country and a medicinal product in another.

High-dose vitamins: Vitamin D at 1,000 IU per day is a food supplement. Vitamin D at 50,000 IU per dose is a medicinal product. The dose determines the classification.

Omega-3 fatty acids: Fish oil supplements at typical doses (1-3g EPA/DHA per day) are food supplements. Prescription omega-3 products (Lovaza, Vascepa) at 4g/day are medicinal products with cardiovascular indications.

Key EU Regulatory Requirements for Food Supplements

Ingredient Compliance

Before any EU market entry, every ingredient must be assessed against:

1. EU Directive 2002/46/EC Annex I and II: Positive lists of permitted vitamins and minerals and their chemical forms. Only listed substances are permitted.

2. Novel Food Regulation (EU) 2015/2283: Ingredients not consumed in the EU before 15 May 1997 require Novel Food authorisation.

3. REACH Annex XVII: Substances restricted in consumer products.

4. National botanical lists: France, Germany, and other member states have national lists of permitted botanical ingredients for food supplements.

Health Claims Compliance

All health claims must be authorised under Regulation (EC) No 1924/2006. The EU Register of authorised health claims is the definitive source. Claims not on the register are prohibited.

Labelling Requirements

EU food supplement labels must comply with Regulation (EU) No 1169/2011 and the specific labelling requirements of Directive 2002/46/EC:

• Product name including “food supplement”
• Names of the categories of nutrients or substances characterising the product
• Recommended daily dose
• Warning not to exceed the recommended daily dose
• Statement that food supplements should not replace a varied diet
• Statement to keep out of reach of young children
• Nutrient reference values (NRVs) as percentage of recommended daily intake

GMP Requirements

Food supplements must be manufactured in compliance with food safety GMP. In practice, ISO 22716 (cosmetic GMP) is sometimes applied to supplement manufacturing, but the more appropriate standard is ISO 22000 (food safety management) or FSSC 22000.

The French Market: Specific Requirements

France is the largest food supplement market in the EU, with estimated retail sales of €2.2 billion in 2024. French-specific requirements for food supplements include:

DGCCRF notification: Before marketing a food supplement in France, a notification must be submitted to DGCCRF (Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes). This is a national requirement not present in all EU member states.

Positive list of plants: DGCCRF maintains a list of plants and plant parts authorised for use in French food supplements. Plants not on this list require specific authorisation.

Maximum levels: France has set national maximum levels for certain vitamins and minerals that are stricter than the EU baseline.

Labelling in French: Products sold in France must have labels in French. This is a general EU requirement (labels must be in the official language(s) of the member state where the product is sold) but is strictly enforced in France.

How Nutraceutical Regulatory Consulting Adds Value

For brands entering the EU nutraceutical market, regulatory consulting typically provides:

Regulatory classification: Determining whether the product is a food supplement, functional food, or medicinal product — and if it’s on the borderline, developing a strategy to maintain food supplement classification.

Ingredient compliance review: Systematic assessment of every ingredient against EU positive lists, Novel Food requirements, and national botanical lists.

Claims audit: Review of all health claims against the EU Register of authorised claims and national rules for botanical claims.

Market entry strategy: Determining which EU markets to enter first, in what sequence, and through which regulatory pathways.

Labelling development: Developing EU-compliant labels for each target market, including country-specific language requirements.

DGCCRF notification management: For French market entry, managing the DGCCRF notification process.

At Care Europe, we provide nutraceutical regulatory consulting for brands entering the EU market, with specific expertise in the French market and the food-medicine borderline. Contact us at [email protected].