Are Nutritional Supplements Regulated in Europe? A Guide to EU Law and National Rules

November 17, 2025 •

4 min read

According to European law, food supplements are considered a type of food, and companies are required to comply with strict national and EU legislation to ensure their safety and quality. This comprehensive legal framework governs how nutritional supplements are regulated in Europe, but with variations across member states.

Quick Summary

Nutritional supplements are regulated as food in the EU under a combination of harmonized directives and national laws. The European Food Safety Authority (EFSA) assesses ingredient safety and health claims, while member states manage notification processes and certain ingredient restrictions.

Key Points

EU and National Laws: Supplements are regulated by both harmonized EU legislation (e.g., Directive 2002/46/EC) and distinct national rules within each member state.
Supplements are Food: Legally, food supplements are classified as a type of food, not medicine, and are therefore subject to food law.
EFSA's Scientific Role: The European Food Safety Authority (EFSA) is responsible for evaluating the scientific evidence for health claims and assessing the safety of new ingredients.
Ingredient Harmonization: The EU has positive lists for vitamins and minerals, but regulation for 'other substances' like botanicals often falls under national law, leading to variations.
Strict Labeling Rules: Mandatory labeling regulations require manufacturers to provide specific information on dosages, ingredients, and warnings, and prohibit unapproved health claims.
Pre-Market Notification: While not universal, many EU countries require pre-market notification to national authorities to ensure product compliance before sale.

The Foundation of EU Regulation: Directive 2002/46/EC

At the heart of the European Union's regulatory framework for food supplements is Directive 2002/46/EC. This directive defines food supplements as 'foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect.' It established a harmonized list of vitamins and minerals and their permitted forms that can be used in supplements across the EU. This was a crucial step toward creating a single market, ensuring a minimum level of safety and standardization for these products.

However, it's important to understand that this directive provides a harmonized baseline. It does not regulate all aspects of food supplements, leaving significant areas for national control. This is where the complexity arises, as different member states have interpreted and transposed the directive in varying ways, leading to national lists, different maximum permitted levels for certain ingredients, and distinct notification procedures.

The Role of the European Food Safety Authority (EFSA)

Any discussion of EU supplement regulation is incomplete without mentioning the European Food Safety Authority (EFSA). This body provides scientific advice to the European Commission, which is essential for consumer protection. EFSA's responsibilities include:

Assessing health claims: Manufacturers must submit applications to EFSA to scientifically substantiate any health or nutrition claims made about their products. Claims are regulated under Regulation (EC) 1924/2006, and only approved claims can be used on packaging or in advertising.
Evaluating novel ingredients: Ingredients not commonly consumed in the EU before 1997 are considered 'novel foods' and require a pre-market authorization process involving a safety assessment by EFSA. This ensures that new ingredients are proven safe before they enter the market.
Providing risk assessments: EFSA carries out safety evaluations of substances that might pose a potential health risk to consumers. Based on these assessments, the European Commission can decide to restrict or prohibit the use of certain ingredients.

Navigating the Harmonized and National Layers

While the EU aims for harmonization, national rules and variations are significant and necessary for companies to navigate. This is particularly true for 'other substances' not covered by the positive list of vitamins and minerals.

Some EU countries, like France, Belgium, Germany, and Italy, require manufacturers to notify the national authorities before placing a supplement on the market. This often involves submitting the product's composition, intended population, and a copy of the label for review. In contrast, other countries may not have this pre-market notification requirement, though compliance checks still occur through inspections.

For ingredients like botanicals and herbal extracts, the situation is even more varied. The EU does not have a harmonized positive list for these substances, so their regulation often falls under national legislation. A botanical approved for use in one country may be restricted or classified as a medicinal product in another, highlighting the importance of understanding the specific rules of each target market.

Labeling and Health Claims: Clear Communication

Beyond ingredient composition, strict regulations govern the presentation and labeling of food supplements to prevent misleading information. Key requirements are outlined in both the Food Supplements Directive and Regulation (EU) No 1169/2011 on food information to consumers. A compliant label must include specific details, such as:

The name of the nutrient(s) or substance(s) in the product.
The recommended daily serving size.
A warning not to exceed the recommended dose.
A statement that supplements should not replace a varied and balanced diet.
A warning to keep the product out of the reach of young children.

Manufacturers are strictly prohibited from marketing supplements with therapeutic claims, suggesting the product can prevent, treat, or cure diseases. All health claims must be scientifically proven and authorized by the European Commission, following EFSA's evaluation.

Comparing EU Harmonization with National Rules


Feature	Harmonized EU Law	National Variations (Examples)
Definition of Supplements	Unified under Directive 2002/46/EC as foodstuffs.	Consistency in definition across EU countries.
Vitamins & Minerals	Positive lists of approved vitamins, minerals, and their sources.	Maximum levels for certain vitamins and minerals can vary significantly by country.
Other Substances (e.g., Botanicals)	No harmonized list; subject to mutual recognition and national scrutiny.	Approval varies. Some ingredients are restricted or classed as medicines in certain countries.
Health Claims	Approved by the European Commission following EFSA assessment.	Some countries may have their own lists of permitted botanical claims that are awaiting EU approval.
Product Registration	Not uniformly mandatory across all states.	In countries like France, a notification process is required before market entry.
Labeling Requirements	Mandatory information (dose, ingredients, warnings) largely harmonized.	Language requirements and specific local regulations may apply.

The Final Word on Regulation

Are nutritional supplements regulated in Europe? Yes, comprehensively. While the EU framework establishes a strong baseline for consumer safety, it operates within a layered system. Harmonized rules ensure consistency on core issues like ingredient safety and health claim approval for vitamins and minerals, but significant national variations persist, particularly concerning botanicals and maximum dose levels. For any manufacturer or consumer, understanding both the pan-European directives and the specific national rules of a given member state is crucial for safe and compliant trade within the European market. The ongoing work of EFSA and national authorities ensures that the regulatory landscape remains dynamic and responsive to emerging safety concerns.

For more detailed information, consult the European Food Safety Authority's official website: efsa.europa.eu.

Conclusion

The regulation of nutritional supplements in Europe is a robust and multifaceted system designed to protect consumers from misleading information and potential health risks. It is a shared responsibility between EU-wide directives, scientific assessments from bodies like EFSA, and individual member state legislation. This intricate balance means that while the core principles are consistent across the European market, companies and consumers must remain aware of national differences regarding ingredients, dosing, and notification procedures to ensure full compliance and safety.

Frequently Asked Questions

No, in Europe, nutritional supplements are regulated as a specific category of foodstuffs, not as medicinal products. This is a fundamental distinction, though some ingredients can be restricted nationally if they are deemed to have a pharmacological effect.

The primary EU law is Directive 2002/46/EC, which defines food supplements and establishes harmonized rules for the vitamins and minerals that can be used in their manufacture.

EFSA does not approve individual supplements. Instead, it provides scientific risk assessments and evaluates the substantiation of health claims and the safety of novel ingredients. The responsibility for ensuring product safety lies with the manufacturer.

Under the principle of mutual recognition, a product lawfully marketed in one EU member state can generally be sold in others. However, national variations in rules can lead to conflicts, requiring companies to navigate country-specific restrictions, especially for botanicals or maximum dose limits.

Yes. The EU has a harmonized list for approved vitamins and minerals. However, for 'other substances' such as herbal extracts, there is no single EU-wide list, and regulation is often managed by national authorities, leading to differing rules across countries.

Manufacturers are forbidden from making health claims that are not scientifically substantiated and approved by the European Commission. Crucially, they cannot claim that a supplement can prevent, treat, or cure a human disease.

If an ingredient was not widely consumed in the EU before 1997, it is classified as a 'novel food.' Manufacturers must undergo a specific authorization process, including a safety assessment by EFSA, before the ingredient can be legally used.