Are Supplements Regulated in Germany? A Comprehensive Guide to Compliance

Unlike medicinal products, supplements do not require pre-market authorization in Germany, a fact that often surprises consumers. This critical difference raises an important question: are supplements regulated in Germany, and if so, how does the system ensure safety and transparency for consumers?

Quick Summary

Supplements in Germany are regulated as food under a layered framework of EU and national laws. Manufacturers must notify authorities like the BVL before marketing, though no pre-approval is required. Strict labeling, safety standards, and market surveillance are enforced.

Key Points

• Dual Regulation: German supplement laws combine EU directives and national legislation like LFGB and NemV.

• No Pre-market Approval: Supplements don't need official pre-market authorization in Germany.

• Mandatory Notification: Companies must notify the BVL before selling a new supplement.

• Strict Labeling and Claims: Labels must be in German, include specific warnings, and disease claims are prohibited. Health claims need EU approval.

• Post-Market Surveillance: Regional authorities perform random checks to ensure compliance and safety.

• Manufacturer Responsibility: Legal responsibility for product safety lies with the manufacturer or distributor.

The Dual Regulatory Framework: EU and German Law

Food supplements in Germany are governed by a combination of European Union (EU) and national German laws. The EU provides overarching principles for food law, while Germany implements more detailed rules, particularly for product notification.

Key EU Regulations

• Directive 2002/46/EC: Defines food supplements and lists permitted vitamins and minerals, also mandating labeling requirements.
• Regulation (EC) No 178/2002: The General Food Law establishing food safety principles and requiring manufacturers to ensure products are safe and traceable.
• Regulation (EC) No 1924/2006: Governs health claims on food, requiring scientific substantiation and EU authorization after EFSA assessment.

National German Legislation

Germany adds national layers of regulation:

• German Food and Feedstuffs Act (LFGB): A broad law covering all food, including supplements, for safety and consumer protection.
• German Ordinance on Dietary Supplements (NemV): The main law for supplements, detailing composition, labeling, and mandatory notification.

The Notification Process: How Supplements Enter the German Market

Germany uses a mandatory notification system instead of pre-market authorization. Before selling a supplement, the responsible company must notify the Federal Office of Consumer Protection and Food Safety (BVL).

Steps in the Notification Process:

• Submit an online notification to the BVL with product details, dosage, and German labeling.
• Include a copy of the German product label.
• Receive confirmation of receipt from the BVL; this is not an approval, and the company remains responsible for compliance.
• The BVL forwards information to regional food monitoring authorities for market checks.

This system facilitates market access while placing legal responsibility on the company.

Distinguishing Supplements from Medicines

Germany's regulations clearly differentiate food supplements from medicinal products, impacting their legal requirements and permissible claims.

Feature	Food Supplements (Nahrungsergänzungsmittel)	Medicinal Products (Arzneimittel)
Regulatory Pathway	Mandatory notification to BVL; no pre-market approval.	Requires official authorization by a competent authority (e.g., BfArM), assessing quality, efficacy, and safety.
Purpose	To supplement the diet with concentrated nutrients or substances having nutritional or physiological effects.	To diagnose, cure, treat, or prevent disease.
Claims	Nutrition and health claims allowed only if EU-approved via EFSA. Disease-related claims prohibited.	Therapeutic claims for disease treatment/prevention permitted after authorization.
Safety Assessment	Manufacturer responsible for safety. Market monitored by regional authorities via random checks.	Safety proven through extensive testing during official authorization.
Availability	Available in supermarkets, health food stores, online.	Primarily in pharmacies, often requiring a prescription.

Labeling and Advertising Requirements

German law mandates strict labeling for supplements in German to prevent misleading consumers.

Essential label information includes:

• The term "Nahrungsergänzungsmittel".
• Ingredient list.
• Recommended daily dose and warning against exceeding it.
• Statement that it's not a diet substitute.
• Warning to keep out of reach of children.
• Any legally permitted health or nutrition claims.

Advertising must not claim supplements prevent, treat, or cure diseases, and approved health claims must not be exaggerated.

Consumer Protection and Market Surveillance

The regulatory system ensures consumer protection through multiple layers. Manufacturers are primarily responsible for product safety and compliance. The notification process provides traceability. Regional food monitoring authorities conduct regular random checks on products sold in Germany to verify compliance. Non-compliance can lead to significant penalties, including fines up to EUR 50,000 and product recalls. Consumers can contact manufacturers with concerns. Germany's involvement in the EU's RASFF system ensures quick action on safety alerts.

The Role of Reputable Suppliers and Online Marketplaces

Buying supplements online, especially from outside the EU, requires caution. Products from non-EU sources may not meet German or EU safety and regulatory standards. Ingredients could be illegal or classified as medicines in Germany. Consumers should check supplier reputation and origin.

For more details on EU supplement regulations, including testing requirements and approved substances, see the Measurlabs summary: https://measurlabs.com/blog/food-supplement-regulations-and-testing-in-the-eu/.

Conclusion

Yes, supplements are regulated in Germany through a combined framework of EU and national laws. They are classified as food and require mandatory notification to the BVL, though not pre-market approval like medicines. Key aspects include stringent rules on labeling, restricted health claims, and robust market surveillance by regional authorities. This system, with its post-market controls and penalties, is designed to ensure safety and consumer protection in the German market.

Frequently Asked Questions

Who is responsible for regulating supplements in Germany?

Regulation involves both the EU and Germany. The BVL handles the notification process, and regional food monitoring authorities oversee market surveillance and enforcement.

Do I need approval to sell a food supplement in Germany?

No, supplements don't need pre-market approval. However, you must submit a mandatory notification to the BVL when the product is first offered for sale.

What is the difference between a supplement and a medicine in Germany?

Supplements are regulated as food to complement the diet, while medicines are authorized to treat or prevent disease. Medicines require authorization and proven efficacy, supplements require notification.

Are there limits on the ingredients in food supplements in Germany?

Yes, EU and German law specify permitted substances. The BfR also provides recommendations for maximum daily intake.

Can I make health claims on my supplement in Germany?

Only claims scientifically assessed by EFSA and authorized by the EU Commission are permitted.

What happens if a supplement does not comply with German regulations?

Non-compliant products can face fines up to EUR 50,000 under the LFGB and mandatory recalls.

What should consumers be aware of when buying supplements online from abroad?

Be cautious, as non-EU products may not meet German/EU safety standards or be legally classified as supplements.

Who monitors the safety of food supplements in the German market?

Food monitoring authorities of the German federal states conduct random checks on market products.